DE102011054176B4 - Treatment catheter system - Google Patents

Abstract

A treatment catheter system (2) for treating a circulatory valve (4) having a circumferential valve tissue structure (6), comprising: a.) An elongate catheter device (8) to be disposed within the circumferential valve tissue structure (FIG. 6) and to be removed therefrom after treatment, wherein the catheter device (8) extends along a longitudinal axis (12) and has an inner lumen (14) and a proximal (18) and a distal (16) end region, and wherein the catheter device (8) comprises a capture component (20) positioned at the distal end region (16) of the catheter device (8) such that it is inseparable from the catheter device (8), at least when positioned at the distal end region (16) of the catheter device (8), and which, at least when positioned at the distal end region (16) of the catheter device (8), has a lateral groove (22) extending transversely to the lo extends longitudinal axis (12) and opens to a lateral outer side (24) so as to form a lateral catching opening (26), b.) an elongated flexible outer device (28) to the outer (30) of the flap structure (6) being disposed on a plane of the lateral groove (22), the outer device (28) extending at least partially circumferentially about the catheter device (8), wherein valve tissue of the circumferential valve tissue structure (6) is correspondingly circumferentially interposed between the catheter device (8 and c.) a capture mechanism (32) operable to reduce a radial distance (D1) between the catheter device (8) and the outer device (32); so as to catch at least a portion of the flap structure (6) between the outer device (28) and the catheter device (8) within the lateral groove (22) via the capture opening (26) to thereby capture the captured flap tissue immobilizing the distal end region (16) of the catheter device (6), wherein the capture component (20) is formed by a cage (36), and wherein the lateral groove (22) is provided as a circumferential groove located in the outer Peripheral surface of the cage (36) is formed.

Description

Technical area

Embodiments generally relate to a treatment catheter system comprising a catheter device and an external device.

background

Heart valve diseases affect about 300,000 people annually worldwide. These diseases manifest themselves in abnormal suture tissue (excessive tissue growth, tissue degradation / tear, tissue hardening / calcification) or in abnormal tissue position during the cardiac cycle (ie, annular dilatation, ventricular remodeling), leading to a decrease in valve function such as, for example Leakage / blood reflux (valvular insufficiency) or resistance to forward blood flow (valve stenosis).

These diseases can usually be treated by a surgical approach to a resting heart, which requires the use of a heart-lung machine, and in many cases by invasive surgery. Some patients, because of their overall health, may be at a higher risk of open heart surgery, or even contraindicated, and may benefit from beating heart therapy through catheterization techniques.

Accordingly, a treatment catheter system that allows interaction with tissue on a beating heart is desirable.

The publication US 2011/0218620 A1 discloses a retention mechanism for an artificial heart valve implant. The publication US 2002/0013571 A1 discloses devices and methods for catching and securing leaflets in the repair of leaflets.

Summary

Various embodiments provide a treatment catheter system for treating a circulatory valve, such as a heart valve, having a circumferential valve tissue structure comprising an elongate catheter device, for example, a flexible elongate catheter device, for placement on the interior of the circumferential valve tissue structure and remotely after treatment, wherein the catheter device extends along a longitudinal axis and has an inner lumen and proximal and distal end regions, and wherein the catheter device has a capture component positioned at the distal end region of the catheter device can be so that it is inseparable from the catheter device, at least when it is positioned at the distal end portion of the catheter device, and which, at least when it is positioned at the distal end portion of the catheter device, a lateral Groove, which is transverse to the longitudinal. Axis extends and opens to a lateral outside, so that it forms a lateral catching component, an elongated flexible outer device for locating on the outside of the flap structure in a plane of the lateral groove, wherein the elongate device at least partially circumferentially around the catheter device with flap tissue of the circumferential valve tissue structure disposed circumferentially between the catheter device and the outer device, and a capture mechanism operable by an interventional cardiologist or surgeon to allow radial distance between the catheter device and the outer device to reduce or enlarge at least a portion of the valve tissue between the outer device and the catheter device in the lateral groove via the capture opening so as to capture the captured valve tissue at the distal end region of the cat immobilize device. The catching component is formed by a cage, and the lateral groove is provided as a circumferential groove formed in the outer circumferential surface of the cage.

Brief description of the drawings

In the drawings, like reference characters generally refer to the same parts throughout the several views. The drawings are not necessarily to scale, it is in its general value to illustrate the general principles of the invention. In the following description, various embodiments will be described with reference to the following drawings in which: FIG

1 shows a treatment catheter system according to an embodiment in partially sectioned form,

2 shows a partially cutaway perspective view of a catheter device of a treatment catheter system according to an embodiment,

3 schematically shows the interaction of an external device and a catheter device of a treatment catheter system according to an embodiment,

4a to 4d schematically show a treatment catheter system according to embodiments

5 schematically shows a catheter device of a treatment catheter system according to an embodiment,

6 schematically shows a catheter device of a treatment catheter system according to an embodiment,

7 - 9 illustrate a method of using a treatment catheter system according to one embodiment.

description

The following detailed description refers to the accompanying drawings which illustrate, by way of illustration, specific details and embodiments in which the invention may be practiced. These embodiments are described in sufficient detail to enable those skilled in the art to practice the invention. Other embodiments may be utilized and structural, logical and electrical changes may be made without departing from the scope of the invention. The various embodiments are not necessarily mutually exclusive, as some embodiments may be combined with one or more other embodiments to form new embodiments.

With reference to the figures, a treatment catheter system 2 for treating a heart valve 4 which has a circumferential valve tissue structure 6 has, according to one embodiment, an elongated catheter device 8th , to arrange at the heart 10 the circumferential valve tissue structure 6 and removing it after the treatment of the heart valve 4 wherein the catheter device 8th along a longitudinal axis 12 extends and an inner lumen 14 (compare for example 2 ) and a proximal one 18 and a distal one 16 End portion has, with the distal end portion 16 for placement in a human or animal body and the proximal end region 18 , for example, can be kept outside the human or animal body and with a grip device 19 may be connected to be manually operable, for example by an interventional cardiologist or surgeon, and wherein the catheter device 8th a catch component 20 at the distal end portion 16 the catheter device 8th is positioned or can be, so that they are inseparable from the catheter device 8th is, at least when in the distal end region 16 the catheter device 8th is arranged, and which, at least when in the distal end region 16 the catheter device 8th is arranged, a lateral groove 22 which is transverse to the longitudinal axis 12 extends and extends to a lateral outside 24 opens so as to have a side catch opening 26 to build. The lateral groove 22 may be an axial distance from one end of the proximal and / or distal end region 17 . 18 to have.

The treatment catheter system 2 further includes an elongate outer device 28 for placing on the exterior 30 the circumferential valve tissue structure 6 on a plane of the lateral groove 6 , wherein the outer device 28 at least partially circumferentially around the catheter device 8th flap tissue of the circumferential valve tissue structure 6 corresponding (at least in part) circumferentially between the catheter device 8th and the outer device 28 is arranged.

The treatment catheter system 2 also has a catch mechanism 32 on (which, for example, the lateral groove 22 and the outer device 28 which is operable, for example manually operable, by an interventional cardiologist or surgeon by a radial distance D1 (see, for example, US Pat 7 ) between the catheter device 8th and the outer device 28 reduce to at least part of the valve tissue between the outer device 28 and the catheter device 8th in the lateral groove 28 over the catch opening 26 so as to catch the trapped tissue at the distal end region 16 the catheter device 8th to immobilize. The catch mechanism 32 may also be operable to increase the radial distance D1 so as to remove the outer device 28 and the catheter device 8th to facilitate. The outer device 28 may also remain around the valve tissue, with the outer device 28 from a self-dissolving material. The outer device 28 can also be cut after the treatment so as to interfere with the external device 28 and the valve tissue which is (at least partially) circumferentially through the outer device 28 is engaged to remove.

As mentioned above, the treatment catheter system 2 in 1 according to an embodiment illustrated in a state in which it relies on a mitral valve as the heart valve 4 which is to be captured, immobilized and treated. However, the treatment catheter system may 2 also be applied to other heart valves, such as the tricuspid valve and / or the aortic valve and / or the pulmonary valve. Additionally, the treatment catheter system 2 also be applied to other hollow body tissue structures that allow between the inner flexible catheter device and the outer device 28 to be caught.

The elongated flexible outer device 28 may be a wire or a thread or a chain or any other convenient, flexible device that allows it to be guided around the circumferential flap fabric structure. It can also be a hollow component that allows the flap 4 or to deliver a substance to the surrounding tissue. The flexible outer device 28 can completely surround the circumferential flap tissue structure 4 be arranged to form a closed ring around this. However, the flexible outer device 28 also have the shape of an open ring, as long as they have the flap tissue in the lateral groove 22 to be caught in the said lateral groove 22 can force. To get the catching force that is needed to get the flap tissue into the lateral groove 22 to force it into, d. H is required for the reduction of the radial distance D1 between the inner catheter device 8th and the outer device 28 To provide, the catch mechanism can 32 be provided by the contraction capacity of the external device 28 or may have this. That means the outer device 28 may be contractible provided the outer device 28 itself may be of a substantially inelastic and non-contractible material, the contraction of the outer device 28 can be achieved by lasso-like or loop-like contraction. The outer device 28 may also be of a shape memory material, wherein the outer device 28 can then contract itself when surrounding the circumferential flap tissue structure 6 is placed and when certain environmental conditions (for example, temperature conditions are met). In this regard, the external device 28 be from nitinol. The outer device 28 may also be made of an elastic material, the outer device 28 around the circumferential valve tissue structure 6 can be arranged in an elastically expanded state, and then self-contract by the corresponding elastic restoring forces.

As an alternative to using the external device 28 for providing or contributing to the catching mechanism 32 or in addition to that the outer device 28 contributes to the formation of the catch mechanism, the catch component can 20 have an expandable area, within which the lateral groove 22 is provided, and the radially against the inside of the outer device 28 is expandable, with the flap tissue rather in the lateral groove 22 is pressed, or in the lateral groove 22 both pressed and pulled when both the inner catheter device 8th expands as well as the outer device 28 is contracted. In this regard, the expandable area of the catching component 20 be made of a shape memory material or may be made of an elastic material.

To facilitate handling, for example, during insertion and approach to the tissue around which the flexible outer device 28 is placed to tissue in the lateral groove 22 the catheter device 8th The flexible outer device can catch 28 in an external device catheter 29 be sheathed. The Outer Device Catheter 29 may comprise a tubular body and an inner lumen (not shown) through which the elongated outer device 28 to the heart, for example to the heart valve structure 6 , and can be routed around the valve tissue structure and then into the Outer Device Catheter 29 can be pulled in so as to maintain a distance D1 between the inner catheter device 8th and the elongated flexible outer device 28 to change / decrease. The Outer Device Catheter 29 can also be flexible. The Outer Device Catheter 29 can be made of a plastic material, such. As polymers, or be made of metal or any other material. The Outer Device Catheter 29 For example, it may be an "active catheter," that is, a catheter that actively moves and / or bends according to a control signal, and is actuated, e.g. By components of shape memory alloy (eg nitinol) heated and / or cooled by electrothermal converters (eg Peltier elements) or actuated by hydraulic actuators. The Outer Device Catheter 29 may also include a separate sheath (not shown) in the lumen of the outer catheter device 29 for each end of the loop-shaped outer device 28 wherein all of the sheaths are relative to each other and / or relative to the external device catheter 29 be movable so as to position the flexible elongated outer device 28 to facilitate.

The catch component 20 can be separate from the catheter device 8th and may be provided to from the distal end region 16 the catheter device 8th into the inner lumen 14 to be insertable, and then can be passed through the inner lumen 14 to the distal end region 16 to be to the outside of the catheter device 8th in said distal end region 16 be exposed. Accordingly, the catching component 20 then through the inner lumen 14 the catheter device 8th be withdrawn and removed from the catheter device 8th at its distal end region 16 be removed. The catch component 20 but can not from the catheter device 8th be removed when attached to the distal end area 16 of the catheter device 8th is placed to make sure the catching component 20 not accidentally inside the valve tissue structure 6 lingers when the catheter device 8th is withdrawn from there.

The catch component 20 can also be integral with the catheter device 8th in the distal end region 16 the catheter device 8th be formed or fixed to the catheter device 8th in the distal end region 16 This will be attached to a stationary catching component 20 that is, stationary and immovable relative to the catheter device 8th , In terms of this, the catching component 20 by a tip body forming a tip end portion of the catheter device 8th at the distal end region 16 this provides.

The catch component 20 may generally be made of a solid body in which a lateral, transverse recess is formed around the lateral groove 22 provide. The catch component 20 however, may also be by a grid-like or net-like cage body 36 (See, for example 4b ), the grid elements 37 or mesh elements, wherein the grid elements 37 by respective elongated wires 38 may be formed, which are forwarded through the inner lumen 14 the catheter device 8th (See, for example, the embodiment of the 4a - 4d . 5 and 6 ). The wires 38 in turn, can be within elongated, flexible sheaths 39 can be arranged and relative to their respective sheaths 39 be movable so that they can be passed through and withdrawn. The catch component 20 , for example the wires 38 these may be made of steel (eg comprising iron, chromium and carbon), of nickel, of alloys having a substantially nickel (eg nichrome, eg Nitinol), of polymers (e.g. PVC, PP, PS, polyamides or aromatic polyamides), of titanium, of alloys consisting essentially of titanium (eg Ti 6Al 4V), of platinum, of gold, of aluminum or of alloys which essentially comprise aluminum , be prepared. The catch component 2Q can also be made of other materials. The catch component 20 can be made by casting process. The capture component can also be made by metal cutting processes.

The grid-like or net-like cage body 36 can into the inner lumen 14 the catheter device 8th be retractable. The forward bringing and / or the retraction of the wire body 36 (For example, basket) can be manually operated, or by an electric motor.

The cage body 36 can be a reinforcing sheath 40 (See, for example 6 ) having tubular shape which are circumferentially on the inner circumferential side of the cage body 36 or on the outer circumferential side of the cage body 36 can be arranged. The jacket 40 can be made of the same material as the cage body 36 be prepared. The jacket 40 can also be made of a different material than the cage body 36 be prepared. The jacket 40 can be made of steel (eg, comprising iron, chromium and carbon), of nickel, of alloys having a substantially nickel (eg Nichrome, eg nitinol), of polymers (eg PVC , PP, PS, polyamides or aromatic polyamides), of titanium, of alloys which essentially comprise titanium (for example Ti 6Al 4V), of platinum, of gold, of aluminum or of alloys which essentially comprise aluminum be. The jacket 40 can also be made of other materials.

The jacket 40 can with the cage 36 be connected by gluing, soldering, welding or otherwise. The jacket 40 can also be elastic and can be in the cage body 36 be inserted so that they are elastic against the circumferential inside of the cage body 36 is clamped, or it can around the cage body 36 be arranged so that they are elastic against the circumferential outside of the cage body 36 is clamped.

The jacket 40 can be a net-like body 40 having a mesh width D2 or a sheet of sheet material having holes. The mesh size D2 of the sheath 40 can be smaller than a mesh size of a net-like cage body 36 or as a circumferential distance of grid elements of a grid-like cage body 36 be. For example, the mesh size D2 may be equal to or less than 50%, 30%, or 20% of the mesh size of a net-like cage body 36 or the circumferential spacing of grid elements of a grid-shaped cage body 36 be. The jacket 40 may be a sheet material having substantially no holes.

The catch component 20 can be a temporary, artificial heart valve 42 exhibit. The temporary artificial heart valve 42 Can be fixed to the catching component 20 fastened, for example, firmly attached to the cage body 36 , The temporary artificial heart valve 42 can be on the sheath 40 be attached. The artificial temporary valve 42 can be radially compressible. The artificial temporary valve 42 may be radially expandable. The artificial temporary valve 42 can be compressed when in the inner lumen 14 the catheter device 8th is. The artificial temporary valve 42 can be expanded when it's out of the inner lumen 14 the catheter device 8th is forwarded to the outside. The artificial temporary valve 42 can be provided to an extended Surgical procedure without the risk of creating valve insufficiency.

The cage-type or mesh-type cage body 36 , as part of the catch component 20 and part of the catching mechanism 32 , allows the peripheral flap tissue 6 safely between the cage body 36 and the outer device 20 yet allowing blood flow, for example, between the ventricular chamber 4a and the atrial chamber 4b through the gaps between the grid elements and / or mesh elements, the net-like casing 40 does not significantly restrict blood flow. Accordingly, a treatment of the heart may be performed on the beating heart, wherein a slight reflux may be acceptable during the contraction period of the heart, wherein the slight reflux may be further reduced or even prevented when the above-described temporary artificial valve 42 is used. The device used in 2 can only allow a small blood flow, so that the treatment time can be reduced accordingly.

The cage body 36 can be due to a substantially non-compressible front body 44 , for example, a distal end connector 44 , to be finished. The front body 44 can have a rounded outside. The front body 44 can have a dull front. The front body 44 may have an outer diameter that is slightly larger than an inner cross-sectional diameter of the inner lumen 14 of the distal end region 16 the catheter device 8th so that he is able to make a stopper for closing a frontal end opening of the inner lumen 14 the catheter device 8th provide.

The front body 44 can work with some or all of the wires 38 that the cage body 36 form, be connected to the cage body 36 to distort or bias. The front body 44 Can on some or all wires 38 that the cage body 36 form, be attached to it at the longitudinal axis 12 the catheter device 8th Accordingly, the front body is coaxial with the longitudinal axis 12 the catheter device 8th can be arranged. The cage body 36 That means, for example, the wires 38 and / or the mesh or net-like body thereof, may / may converge to their leading end (s), and accordingly may correspond to the front body 44 converge.

The non-compressible front body 44 can fulfill several functions: the inner lumen 14 the catheter device 8th seal when the catch component 20 into the inner lumen 14 the catheter device 8th is withdrawn and / or the atraumatic insertion and positioning of the catheter device 8th to facilitate by providing a conical tip.

The lateral groove 22 can be continuous or in an interrupted manner around the entire circumference of the catching component 20 transverse to the longitudinal axis 12 extend. The lateral groove 22 may be formed only around a peripheral portion, for example forming a circular arc equal to or smaller than 30, 45, 90, 180 or 270 degrees. The lateral groove 22 can also be through the transverse (transverse to the longitudinal axis 10 ) extending recesses (see. 2 ) be formed.

The lateral groove 22 can on the cage body 36 the catch component 20 be provided in a way so that they are on each wire 38 or on a wire or on a variety of wires or on all wires except a wire holding the cage 36 form, is provided so that each groove 22 transverse to the longitudinal axis 12 the catheter device 8th extends (see, for example 4b and 6 ).

The lateral groove 22 on the cage body 36 may be through radially and inwardly bent portions of each or some of the wires 38 that the cage 36 be provided, ie the groove 22 can be provided without the removal of material but by bending (see, for example 4b and 6 ), wherein the bent portions are in the substantially same axial plane along the longitudinal axis 12 are provided.

The wires 38 or arms 38 that the cage body 36 may be arranged so that they have the same angular or circumferential distance from each other. The wires or arms 38 that the cage body 36 may be arranged to have different angular or circumferential distances between each wire 38 to have.

The wires 38 that the cage body 36 may be arranged to be substantially round (transverse to the longitudinal axis) 12 seen) cage body 36 form coaxial with the longitudinal axis 12 the catheter device 8th is positioned and aligned, at least when the cage body 36 at the distal end region 16 the catheter device 8th stretched out. The wires 38 that the cage body 36 may be arranged to have a substantially triangular or rectangle-shaped or pentagon-shaped or hexagon-shaped or dodecagon-shaped or otherwise polygonal-shaped cage body 36 provide coaxial with the longitudinal axis 12 the catheter device 8th is positioned and aligned, at least when the cage body 36 at a distal end region 16 the catheter device 8th is extended. The cage body 36 may also be arranged so that it is not coaxial with the longitudinal axis 12 the catheter device 8th is aligned, for example, so that it is eccentric to the longitudinal axis 12 the catheter device 8th is aligned.

The catheter device 8th may be a hollow tubular body, with the inner lumen 14 or additional lumens may have such a cross-sectional diameter, allowing one or more treatment tools to treat the captive flap tissue 6 or the valve tissue adjacent to the captured valve tissue may be disposed therein simultaneously and relatively movable therethrough. Such treatment tools can be a perforation component 48 for perforating the valve tissue 6 or drug delivery tools that involve delivering a drug to the valve tissue 6 which is to be treated, such as anti-calcification drug, anti-platelet drug, antithrombotic drug or platelet activator.

The catch component 20 can relative to the catheter device 8th be movable. The catch component 20 may be arranged so that it can be brought forward and withdrawn according to a control command. The catch component 20 when completely withdrawn, can be completely enveloped in a lumen 14 the catheter device 8th , The catch component 20 can be integral with the catheter device 8th at the distal end region 16 be formed.

The catch component 20 may have a conical and / or blunt front part and may be attached to the catheter device 8th be arranged so that they are at the distal end 16 the catheter device 8th exposed, whereby it is designed so that it causes the least tissue damage when the catheter device 8th introduced and brought to the tissue to be treated.

The perforation component 48 can be a needle, a hollow needle or another tubular body 48 that is an inner lumen 54 and has or have a sharpened or pointed end. The perforation component 48 can be provided so that they pass through some or all of the wire sheaths 39 the wires 38 that the cage body 36 form (see for example 4d ) can be brought forward or withdrawn to perforate tissue. The perforation component 48 can in the inner lumen 14 or any additional lumen of the catheter device 8th be provided, for example, parallel to and separate from the vagina 39 and wires 38 so as to tissue 6 that in a lateral groove 22 the catch component 20 is trapped, perforated. The perforation component 48 can be set up to an anchor component 50 to carry around the trapped tissue with the said anchor component 50 to perforate, which then remains on the tissue when the catheter device 8th withdrawn. The anchor 50 can be on a tip of the perforation component 48 be placed. A tendon, for example, an artificial tendon 52 , for example, ePTFE, nylon or kevlar, can be fixed to the anchor 50 be attached. The tendon 52 can be used to replace a ruptured natural tendon, such as a mitral or tricuspid valve. The anchor 50 may be configured to allow two adjacent tissue layers to be joined together, for example to join two, three, or four tissue layers or a plurality of tissue layers. In this regard, a so-called edge-to-edge mitral valve repair (Alfieri stitch) can be performed by, for example, half of the circumferential mitral valve tissue in the lateral groove 22 is trapped and opposing pieces of tissue through the anchor 50 on the perforation component 48 (See, for example 7 - 8th ) are perforated. The tendon 52 can be in an inner lumen 54 of the perforation tool 48 be arranged. The perforation component 48 can be designed so that the anchor 50 after it is attached to the tissue or adjacent tissue layers to which tissue remains attached when the catheter device 8th withdrawn. This allows tissue to remain connected to each other after the catheter device 8th withdrawn. Similarly, a tendon 52 at the anchor 50 remain attached, which in turn is attached to the tissue and / or tissue together, after the catheter device 8th was withdrawn.

The perforation component 48 can with a needle, z. B. be provided a hollow needle. The needle may be used to deliver drugs and / or substances to the tissue.

The perforation component 48 can be flexible and / or the needle can be flexible. The perforation component 48 may be rigid and / or the needle may be rigid or may have a rigid end portion.

The perforation component 48 may also be a separate part outside the catheter device 8th and may be sheathed in a separate sheath (not shown) in which they are. is movably received. The perforation component 48 can be brought forward through the catheter device 8th through the inner lumen 14 the catheter device 8th and / or through the vagina 39 one wire 38 holding the cage body 36 the catch component 20 forms.

According to the 1 are the catheter device 8th and the flexible outer device 28 relative to each other so positioned that the outer device 28 and the lateral groove 28 arranged in a manner so that flap tissue 6 over the catch opening 26 in the lateral groove 22 forced, for. B. is pulled, by the external device 28 when a radial distance D1 (see, for example, FIG 2 ) between the external device 28 and the catheter device 8th is reduced. This causes the valve tissue structure 6 in the lateral groove 22 is immobilized by being in the lateral groove 22 is caught and in it by the external device 28 held (see also eg 2 and 3 ). The immobilization of the valve tissue or other cardiac tissue allows the safe treatment of said immobilized tissue to, for example, heart valve repair or cardiac valve replacement 4 through a valve prosthesis.

The radial distance D1 between the outer device 28 and the catheter device 8th is through a catch mechanism 32 , which can be operated by an interventional cardiologist or a surgeon or any other person, decreases. In all embodiments, the catching mechanism 32 A lasso or a sling included by the flexible outer device 28 are formed to allow the operator to pull the loop together and thereby the radial distance D1 between the outer device 28 and the catheter device 8th to reduce (cf. 1 . 4a . 4b and 4d ). In some embodiments, the catching mechanism may be powered, for example, by a servomotor or directly by the hands of the operator.

2 shows a more detailed, partially sectioned, perspective view of the catheter device 8th according to an embodiment serving as a catheter device in the embodiment of the 1 can be used. In general, the catheter device has 8th an elongated, tubular structure. In some embodiments, the catheter device 8th different radii, diameters and / or chamfers to the insertion into the heart and access to the heart valve 4 to facilitate.

The catch component 20 at the distal end region 16 the catheter device 8th has a lateral groove 22 on, extending across the longitudinal axis 12 the catheter device 8th extends. The lateral groove 22 makes a catch opening 26 on a circumferential outside 24 the catch component 20 ready. About the catch opening 26 can heart valve tissue 6 in the lateral groove 22 through the interaction of the catching component 20 with the flexible outer device 28 (not in 2 shown), so that the valve tissue 6 between the flexible. external device 28 and the lateral groove 22 is caught. According to the 2 is the catch component 20 as a tubular device extending longitudinally through the catheter device 8th extends and relative to the catheter device 8th rotating and / or movable in the longitudinal direction thereof. This defines the catch component 20 itself an inner lumen coincident with the inner lumen 14 the catheter device 8th and through which the surgical tools reach the distal end region 16 be guided. The catch component 20 of the 2 can also be integral at the distal end 16 the catheter device 8th be formed. In addition, the catching component 20 longitudinal inner channels 46 each containing surgical or treatment tools, such as the perforation component 48 assigned to it can be assigned. The catheter device 8th can also be a flexible solid body that has longitudinal guide channels that cover the inner lumen 14 define as a plurality of separate lumens and the surgical or treatment tools to the distal end region 16 Lead them where they are with the above-described inner channels 46 in the catch component 20 can be aligned.

In this embodiment, the catching component is 20 also with an elongated perforation tool 48 , for example a needle or a hollow needle 48 , equipped to perforate or puncture the trapped valve tissue or adjacent valve tissue, such as, for example, an anchor 50 with a tendon 52 (see eg 4c for an illustrative embodiment of anchors 50 and tendon 52 ) on the valve tissue 6 or the tissue leading to the flap 4 adjacent to fasten. This can be an anchor 50 with or without a tendon attached 52 through the inner lumen 64 the hollow needle 48 in the lateral groove 22 be led into it.

The needle 48 loaded with an anchor 50 and / or a tendon 52 , is in the inner lumen 42 the catheter device 8th can be controlled by an interventional cardiologist, a surgeon or any other person, so that they are forward to the distal end 16 moved and on the way flap tissue, which is in the lateral groove 22 is trapped, perforated. After that, the needle can 48 controlled in a similar manner, completely rearward to the distal end portion 16 pull back so that they pass completely through the catheter device 8th wrapped is. The anchor 50 can through the hollow needle 48 to be brought forward and exposed at the distal end thereof so as to penetrate the perforation created by the needle. The anchor 50 can then remain lodged in the valve tissue, with the tendon 52 extends through the valve tissue.

In 2 is the needle 48 shown in an intermediate position, with its tip in the lateral groove 22 extends into it.

In other embodiments, drugs or other substances (eg, to enhance medical imaging) and / or devices for treatment or interaction through the needle (rather than an anchor) may be used 48 in the catch component 20 be applied to the captured valve tissue. In some embodiments, the needle 48 be replaceable, so that an optimal needle can be selected, for example, an anchor 50 on the valve tissue 6 attach, release drugs, or allowing the needle 48 can be replaced if worn after use. In some embodiments, the elongate perforation component 48 (for example, the needle 48 ), so that it can be guided laterally out of the lateral groove to penetrate tissue located laterally to it, for example, to deliver a drug thereto.

In the embodiment shown in FIG 2 shown is the catching component 20 relative to the catheter device 8th movable and can through the inner lumen 14 the catheter device 8th brought forward or withdrawn so as to minimize collateral damage to tissue during insertion of the catheter device 8th to create. In other embodiments, the capture component is 20 integral with the catheter device 8th at the distal end region 16 the catheter device 8th educated. 2 illustrates the catching component 20 in a position in which they are from the inner lumen 14 the catheter device 8th brought forward and (apart from, for illustration, not completely retracted needle 48 ) is ready to work with the flexible outer device 28 to interact with valve tissue 6 in the lateral groove 22 to draw.

The catheter device 8th can be made flexible so that it is flexible along its longitudinal direction.

In 2 is the distal end area 16 the catheter device 8th with a conical and round distal end 16 shown, wherein the distal end portion 16 can also be dull.

3 schematically shows the interaction of the flexible outer device 28 and the catheter device 8th a treatment catheter system 2 to tissue 6 the flap 4 to immobilize according to one embodiment. In 3 is the radial distance D1 between the outer device 28 and the catheter device 8th decreased so as to tissue 6 the flap 4 in the lateral groove 22 located at the distal end 16 the catheter device 8th located above the catch opening 26 catch. In the 3 is the path along which the flexible perforation tool 48 can be brought forward and withdrawn to the valve tissue 6 according to one embodiment, perforated by a dashed line 70 indicated.

The lateral groove 22 can be designed so that it can have different geometric dimensions. The larger the lateral groove 22 , The more tissue is the circumferential tissue structure 6 can in the lateral groove 22 be caught, reducing the length of the sail fabric along the surface of the lateral groove 22 may be increased, causing the perforation component 48 can perforate the sail fabric in two areas. In this case, an anchor 50 be designed to be positioned so that it fastens two perforated sites together. The anchor 50 can be fixed in each of the two perforated places. This produces a local shrinkage or shortening of the sail length (eg, the circumferential fabric structure 6 ) in an axial direction of the circumferential tissue structure 6 , This can be done in several places of the tissue structure 6 be carried out (eg by the use of one or more arms 38 of the wire body 36 each with a lateral groove 22 has), so that a uniform shortening of the sail can be achieved. The inner basket (for example, the wire body 36 ) may also include a tissue that can be adhered to the natural sail (eg, to the circumferential tissue structure 6 ).

4a and 4b show a treatment catheter system 2 according to another embodiment. Regarding 4a and 4b are the flexible outer device 28 and the catheter device 8th around tissue 6 a heart valve 4 arranged, in this case again the Mitralklappe 4 However, the flexible outer device can 28 and the catheter device 8th also be arranged to interact with other heart valves, such as the tricuspid valve, the pulmonary valve or the aortic valve.

The distal end area 16 the catheter device 8th is shown arranged so that it is ready with the outer device 28 to interact. In this embodiment, the capture component includes 20 the catheter device 8th an extendable and retractable cage body 36 that through the elongated wires 38 is formed, which from the catheter device 8th at the distal end of these emerge and which have a circumferential distance to the grid body as cage elements 36 define. The wires 38 are connected together at their distal ends.

The catch component 20 can be from the inner lumen 14 be extended and / or in the inner lumen 14 of the distal end region 16 the catheter device 8th to be withdrawn.

In 4a are the wires 38 that the cage body 36 form in a position where they enter the lumen 14 of the distal end region 16 are withdrawn. In some embodiments, the wires are 38 strained and / or compressed to contain elastic energy when in the lumen 14 of the distal end region 16 the catheter device 8th are retracted so that they self-expand in the radial direction when removed from the inner lumen 14 the catheter device 8th to be moved out.

According to the 4a and 4b is the distal end area 16 by a substantially non-compressible front body 44 , z. For example, a distal end connector 44 , finished with a rounded outside (here has the front body 44 an ellipsoidal shape) and having an outer diameter slightly larger than a cross-sectional inner diameter of the lumen 14 of the distal end region 16 the catheter device 8th in order to be able to have a plug for closing a front end opening of the inner lumen 14 the catheter device 8th provide. A front wire or thread 58 may be provided to help with the catheter device 58 to lead to their final position in the heart. The end-area plug 44 of the distal end region 16 can be conical, as in the 4a and 4b is shown to position the catheter device 8th in the heart and / or other human or animal organs to facilitate, taking the plug 44 may have a blunt front end or nose.

In some embodiments, the front body is 44 with some or all wires 38 that the cage 36 form, connected to the cage 36 to limit at its distal end in the radial direction.

In some embodiments, the non-compressible front body 44 fulfill several functions: the inner lumen 14 the catheter device 8th seal when the catch component 20 into the inner lumen 14 the catheter device 8th is withdrawn and / or the atraumatic insertion and positioning of the catheter device 8th to facilitate by providing a conical tip.

In 4b is the treatment catheter system 2 shown with the catch component 20 stretched out from the distal end region 16 the catheter device 8th , The wire cage body 36 is radial due to the elastic energy in the tensioned / compressed wires 38 is stored, outstretched. The radial extension of the wire cage body 36 can also be achieved by an auxiliary expander, such as by a radially expandable (e.g., by inflation) balloon, within the cage body 36 is arranged and is expandable in a controlled manner.

In the 4a or 4b is the catch mechanism 32 by the radially contractible loop structure of the outer device 28 in combination in the radially expandable cage body 36 and the lateral groove 22 passing through the wires 38 of the cage body 36 is defined, formed. The catch mechanism 32 may be actuated by an interventional cardiologist or surgeon to provide a radial clearance or gap D1 between the external device 28 and the catheter device 8th reduce, so that tissue of the mitral valve 4 in the lateral groove 22 between the outer device 28 and the inner catheter device 8th is caught.

If the tissue of the flap 4 as above with respect to the 4a and 4b has been described, trapped and immobilized, interaction with and / or treatment of the tissue (s), for example valve repair or restoration, can be safely and reliably performed.

The 4c and 4d show an embodiment of the treatment catheter system 2 , which is designed similar to the embodiment, with reference to the 4a and 4b and also allows interaction, for example, attaching an anchor 50 with or without a tendon 52 or delivering substances or drugs to the tissue of the valve 4 or adjacent tissue via a perforation component 48 ,

4c shows an enlarged view of the area, which by a frame in the 4b is displayed. In this embodiment of the treatment catheter system 2 are the wires 38 that the cage body 36 form, in hollow, tubular sheaths 39 arranged, which is a respective inner lumen 60 exhibit. If tissue of the flap 4 in the lateral groove 22 through the outer device 22 is trapped and thereby immobilized, the elongated flexible perforation tool 48 , to the Example the flexible needle 48 , from the lumen 60 one or more of the vagina 39 to be stretched out. The flexible perforation tool 48 may be designed as described above, and therefore may be a hollow needle or a solid needle and may be configured to be an anchor 50 and / or a tendon 52 on the tissue 6 the flap 4 to fix. The 4c shows the flexible perforation tool 48 with the anchor 50 and the tendon 52 Mounted at its top while there are tissues 6 perforated so as to anchor 50 in the tissue 6 of the valve 4 to fix. The end of the tendon 52 that the anchor 50 For example, at the discretion of the surgeon, it may be attached to surrounding tissue such as the papillary muscle or the ventricular apex.

In other embodiments, the perforation tool 48 be set up to flap the tissue 4 Medicines or other substances to be supplied.

In other embodiments, the perforating tool or a needle 48 not in an inner lumen 60 a wire 38 holding the cage body 36 forms, but can be separated from the cage 36 and can be independent through the inner lumen of the catheter device 8th be forwarded and be independently operable.

4d shows the treatment catheter system 2 after the anchor 50 on the tissue of the flap 4 was attached. A radial distance D1 between the outer device 28 and the catheter device 8th was increased by loosening the previously radially-contracted outer device 28 , and the catch component 20 (which the wire cage body 36 is partially in the distal end region 16 the catheter device 8th withdrawn and was from the heart valve 4 and the outer device 28 away. The tissue of the heart valve 4 that between the lateral groove 22 and the outer device 28 can be immobilized by increasing the distance between the catheter device 8th and the outer device 28 by pressing the catch mechanism 32 be released (ie the length of the outer device 28 is increased, resulting in a larger circumferential length of the outer device 28 results). In other embodiments, the tissue 6 the flap 4 by retracting the catch component 20 that the wire basket 36 contains, in the distal end region 16 the catheter device 8th released (ie, reducing the circumferential diameter of the lateral groove 22 ). In some embodiments, the capture mechanism becomes 32 operated to the circumferential length of the outer device 28 increase, and the catch component 20 is withdrawn at the same time to the tissue 6 that between the lateral groove 22 and the outer device 28 is caught, release.

5 shows an embodiment of a catheter device 8th a treatment catheter system 2 according to an embodiment. The embodiment is similar to the embodiments described with reference to FIGS 4a to 4c have been described. However, in this embodiment, the lateral groove 22 through the vagina 39 that the cage body 36 the catch component 20 form, formed, with the vagina 39 a corresponding lateral recess on a plane of the lateral groove 22 have, and thereby the lateral groove 22 form circumferentially in an interrupted manner. The wire cage body 36 is retractable in the distal end region 16 the catheter device 8th and can be extended from a retracted position. The tips of the vagina 39 that the cage 36 are in the 5 as straight / blunt, whereas they can be conical. The interaction of the catheter device 8th and the outer device 28 (not shown in 5 ) to the tissue 6 a heart valve 4 in the lateral groove 22 over the side catch opening 26 to capture and immobilize is similar to the previously described embodiments. The sheaths 39 that the cage 36 have an inner lumen 60 that involves bringing forward and retracting a flexible perforation component 48 , z. B. a needle 48 , allows, through the lumen 60 in the lateral groove 22 into and back into the lumen 60 the vagina 39 that the cage body 36 form. One or more of the vagina 39 can also be replaced by a solid body, for example a wire that has no inner lumen.

Although the 5 an embodiment shows in which the lateral groove 22 through a recess on each of the sheaths 39 that the cage body 36 form, formed or defined, there may be other embodiments in which only one or some of the sheaths 39 that the cage body 36 form a recess, which is the lateral groove 22 forms / defines. In this regard, if a radial distance D1 between the outer device 28 and the catheter device 8th is reduced, the tissue is only in the vagina 39 that the cage body 36 form, firmly trapped and immobilized, which have a recess that the lateral groove 22 Are defined.

The elongated, flexible perforation tool 48 , z. B. a needle or hollow needle 48 , is set up to catch the trapped valve tissue 6 or puncture or puncture adjacent tissue to an anchor with or without a tendon on the valve tissue 6 or adjacent to tissue the flap 4 for example, as described above (not shown in FIG 5 ). An anchor can be used with or without a attached tendon on top of the hollow needle 48 Sit and the tendon can pass through the lumen of the needle 48 be guided (only if the embodiment has a chord).

The needle loaded with the anchor and the tendon 48 is in the inner lumen 14 the catheter device 8th may be controlled by an interventional cardiologist or surgeon, forward to the distal end 16 to move and on the way the tissue, which is in the lateral groove 22 is trapped, perforate. After that, the needle can 48 be controlled in a similar way, completely backwards to the distal end region 16 move towards (cf. 1 ) so that they are completely in the inner lumen 60 the vagina 39 that the cage body 36 form, is enveloped. The anchor remains in the valve tissue 6 sitting back, with the tendon extending from the anchor. In some embodiments, the other end of the tendon may be attached to the side opposite the anchor, for example to the tissue that houses the flap 4 surrounds.

In the 5 is the needle 38 without an anchor or tendon shown in an intermediate position with its tip in the lateral groove 22 extends into it.

Regarding 6 becomes another embodiment of a catheter device 8th a treatment catheter system 2 shown. The catheter device 8th , in the 6 is shown and works similar to that used in the 4a to 4d is shown, and indicates a catheter device 8th which has a distal end area 16 with a safety gear 20 has a wire cage 36 , a temporary artificial heart valve 42 , a substantially non-compressible front body 44 and a guidewire or thread 58 , The temporary artificial heart valve 42 is inside the cage 36 arranged and on the inside side of the cage 36 attached. In the expanded state of the cage 36 is the artificial heart valve 42 unfolds from a compressed state and can temporarily change the function of the natural flap 4 take over as long as the catch component 20 within the interior of the circumferential valve tissue structure 6 is arranged. A lateral sealing function is achieved by engaging the valve tissue structure 6 inside the lateral groove 22 reached. The embodiment that is in 6 shown additionally has a reinforcing network 62 on. The network 62 can be made of a flexible wire, thread, polymer or any other material and is with the sheaths 39 the wires 38 connected; the vagina 39 also contribute to making the cage 36 at a distal end portion of the cage 36 in that there is a tubular net sheathing 62 inside the cage body 36 forms when the catch component 20 from the catheter device 8th outstretched. The network 62 can improve the mechanical stability of the cage body 36 and / or the mechanical stability of the temporary artificial valve 42 improve. Embodiments that do not have a temporary artificial heart valve 42 (for example, the in 5 shown embodiment) can also be a network 62 as described above to improve the mechanical properties.

In other embodiments, instead of an anchor, drugs or other substances (for example, to enhance medical imaging) and / or devices for treatment or interaction with the trapped valve tissue 6 be applied by one or more needles 48 in the catch component 20 , In some embodiments, the needle (s) may / may 48 be replaceable, so that an optimal needle can be selected to, for example, an anchor 50 on the valve tissue 6 to attach or drug or so that the needle 48 can be replaced when the tip of the needle 48 worn out after use. In all embodiments, the elongated) perforation component (s) may 48 (eg the needle (s)) 48 ) to be flexible.

In all embodiments, the perforation component 48 a lumen 60 through which a drug delivery component 64 , for example a hollow needle 64 , can be brought forward or withdrawn to deliver drugs or substances. This allows the catheter system 2 according to some embodiments, the perforation component 48 to use an anchor 50 on the valve tissue 4 to attach or interact with it, and then a hollow needle 64 via the perforation component 64 to bring forward, ie the perforation component serves two functions: to connect with the fabric of the valve 4 to interact and to act as a vagina for a hollow needle 64 to serve to deliver drugs or substances. The drug can also go directly through the inner lumen 60 the hollow perforation component 48 be brought forward.

Some of the vagina 39 , the wires 38 to make the basket 36 may be configured to bring forward an anchor 50 , with or without a tendon 52 to allow through it, while at the same time other vagina 39 may be configured to deliver drugs and / or other substances.

Although the cage 36 in the 4a to 4c and 5 to 6 four wires 38 including As shown, in other embodiments, it may include one wire, two wires, three wires, five wires, or a plurality of wires 38 depending on the operational requirements.

Similarly, the wires can 38 that the cage 36 be arranged on a (same) circle, each having the same or a different angular distance from each other. If the cage 36 four wires 38 have, they can be arranged on a circle and each have an angular distance of 90 degrees from each other.

In other embodiments, they may be arranged on a circle and have a freely selectable angular distance between each other, for example 170 degrees between a first and a second wire, 30 degrees between the second and a third wire, 69 degrees between the third and a fourth wire (which results in an angle of 360 degrees - 170 degrees - 30 degrees - 69 degrees = 91 degrees between the fourth wire and the first wire). Therefore, two or more vagina can 39 be arranged at a small angular distance, for example less than or equal to 1 degree, 5 degrees, 10 degrees or 15 degrees. Therefore, it is possible a medicine or a substance 39 through a first vagina 39 feed so that the area in which the anchor 50 is fastened, (by a second sheath 39 ) can be treated with a drug or a substance before the anchor 50 is fastened while the anchor 50 is attached or after the anchor 50 was attached.

In other embodiments, the wires form 38 not a substantially round cage 36 as it is in the 4a to 4c and 5 to 6 is shown, but for example, a triangular-shaped body, a rectangular-shaped body or a polygonal-shaped cage 36 ,

In still other embodiments, the cage 36 a plurality of vagina 39 but not all vagina 39 may be configured to bring forward and / or retract a perforation component 48 through her inner lumen 60 respectively. If, for example, the cage 36 four sheaths 39 can have only one or two or three sheaths 39 be configured to bring forward and / or retracting a perforation component 48 while the rest of the vagina (s) 39 no inner lumen 60 can be (ie massive bodies).

One or more additional perforation components 48 that are separate and independent of the wires 38 of the wire cage 36 from the distal end area 16 the catheter device 8th can be extended can be provided.

None of the vagina 39 can be a perforation component 48 and it may only have one or more perforation components 48 enter from the distal end area 16 The catheter device can be extended and the independent and separate from the vagina 39 are.

Some embodiments of the treatment catheter system 2 For example, an inflatable balloon coated with drugs or substances may be in the distal end region 16 the catheter device 8th exhibit. The balloon can pass through the inner lumen 14 the catheter device 8th brought forward and inflated by the surgeon so that he comes into contact with the heart tissue, whereby he supplies the drugs on its surface to the tissue with which it is in contact. The balloon may also be deflatable by an operator to retract the catheter device 8th to relieve from the heart.

All embodiments of the catheter device 8th may be configured to deliver drugs or substances to the heart tissue or other tissue. Such substances may, for example, comprise a plasmid encoding a particular protein. For example, the protein can be expressed by the natural sail cells and used to treat the sail 4 or adjacent tissue. For this purpose, a suitable electric field or other energy source may be provided between the external device 28 and the catch component 20 can be used to achieve the opening of holes in the cell membrane (e.g., electroporation) to promote the entry of the plasmid into the cells. The outer device 28 and the catch component 20 For example, they may include electrodes (or, alternatively, if made from electrically conductive materials such as metals, may themselves act as electrodes without having additional electrodes) connected to an electrical energy source via electrically conductive means, such as electrical leads that of an inner lumen 14 the catheter device 8th are encased and / or from an inner lumen of the external device catheter 29 are sheathed. The catheter device 8th and / or external device catheters 29 may serve as an electrically conductive device without additional means such as wires, if they are made of an electrically conductive material. The energy source may be placed outside the human body and may include a controller for selectively controlling the voltage, current, and / or direction of the current of the electrical energy source. The energy source may be a battery (the for example, generating a direct current (DC)) or may be a generator (generating, for example, alternating current (AC)) or may be any other source of electrical AC and / or DC current. The control means may be, for example, a square-wave voltage or a saw-tooth voltage or a sine voltage or any other periodic or non-periodic voltage applied to the electrodes of the external device 28 and / or the catch component 20 can be routed (or to the outer device 28 and / or the catch component 28 even if they have no additional electrodes, but act as electrodes themselves) via the electrical conductive devices or via the catheter device 8th and / or the outer catheter device 29 even if they are made of electrically conductive material. The electric field so between the outer device 28 and the catch component 20 (or between their respective electrodes) may interact with the tissue and openings in the cell membranes of cells, for example, cells that surround the heart valve 4 and / or the papillary muscle of one heart and / or any other cardiac cell, so that substances can diffuse through the opened openings into the cells or be moved by the electric field. The apertures may close again when the voltage and / or current of the electrical energy source is interrupted by the controller at the discretion of an interventional cardiologist or surgeon, resulting in the substance being "trapped" in the cells. Substances may also include substances that enhance medical imaging, for example, substances that have radioactive isotopes, or substances that alter the electro-magnetic properties of the tissue to improve visibility and / or contrast when using electro-magnetic imaging techniques such as x-ray imaging (e.g., angiography or echocardiography), magnetic resonance imaging, or other medical visualization techniques.

In other embodiments, the catheter device 8th is the catch component 20 at the distal end 16 the catheter device 8th is positioned or can be designed so that it is inseparable from the catheter device 8th is, at least when at the distal end 16 the catheter device 8th is positioned.

All embodiments of the treatment catheter system 2 may include positioning and / or orientation means for relative and / or absolute positioning of the catheter device 8th and the flexible elongated outer device 8th to facilitate. These devices may include passive markers (eg, marker devices) fixed to the catheter device 8th and / or the outer device 28 are attached. The passive markers may be made of materials other than the materials of the catheter device 8th and / or the outer device 28 to improve contrast during medical imaging, for example when using magnetic resonance or x-ray based imaging techniques. The passive markers may, for example, be made of high-radiopaque material, thereby allowing the relative and / or absolute position of the components of the treatment-catheter system 2 precise with respect to the body. The passive markers may also have an asymmetric shape to allow one to identify the absolute and / or relative position and orientation, and thereby also the position and orientation of the catheter device 8th and / or the outer device 28 , The lateral groove 22 the catheter device 8th and / or the external device 28 may have attached passive markers to themselves to facilitate positioning them relative to one another using imaging techniques, for example, passive markers made from high-radiopaque materials when using electro-magnetic radiation based imaging techniques (e.g. B. X-ray imaging) can be used. Additionally or alternatively, the lateral groove 22 and / or other parts / components of the catheter device 8th and / or the outer device 28 be made of radiopaque material. Other positioning and / or orientation devices may include "active devices", ie devices which provide a signal, e.g. An ultrasound signal or an x-ray signal, or generally an electro-magnetic signal, are emitted and received and arranged to sense the relative and / or absolute position of the components (eg, catheter device 8th and outer device 28 ) of the operative treatment system 2 and / or organs of the human / animal body (eg, the heart) and / or parts of the living body (eg, the mitral valve 4 ) measure up. These active devices may be part of the catheter device 8th and / or the external device catheter 29 or the outer device 28 its or some components (eg, signal generators, transmitters, and / or receivers) of the active devices may be part of the catheter device 8th and / or the external device catheter 29 while other components (eg, a signal processing device and / or a display device) of the active devices may be placed outside the human body. The catheter device 8th may also include a metal detector that can detect metals (eg, by using an alternating electrical current that flows through a wire coil and measuring the resulting magnetic field which is a function of the size, spacing and / or material of the surrounding matter). The outer device 28 may also include or consist of passive markers of a material having a high magnetic permeability (eg, iron, nickel, cobalt) to facilitate detection by a metal detector, e.g. In the catheter device 8th is positioned to facilitate, and thus allow, a distance and / or the relative position of the outer device 28 and the catheter device. The catheter device 8th and / or the external device catheter 29 may also include a glass fiber connected to a lens system provided at a distal end portion thereof so as to optically detect an absolute or relative position of the catheter device 8th and external device 28 to enable. The glass fiber and the lens system may also be configured to transmit light from an external light source into the heart. The distal end portions of the catheter device 8th and / or the outer device 29 can also active light sources, eg. B. LEDs have. In all embodiments, the exterior device catheter 29 and / or the catheter device 8th an ultrasound generator, transmitter and receiver so as to transmit and receive ultrasound sound signals to sonograms of the flap 4 , the catheter device 8th and / or the outer device 28 to obtain. In some embodiments, "active" and "passive" devices that work together are used, ie, the imaging capability of an active device is enhanced by the use of a convenient passive marker. In some embodiments, only passive "tags" are used along with external imaging (eg, a signal generator, signal transmitters, and signal receivers placed outside the living body).

• – Anordnen einer länglichen, zum Beispiel flexiblen, äußeren Vorrichtung 28, so dass sie sich ganz oder nur teilweise um einen Umfang einer umfänglichen Herzklappengewebestruktur erstreckt,
• – Anordnen einer Kathetervorrichtung 8, an der sich eine seitliche Nut 22 zu der seitlichen Außenseite der Kathetervorrichtung öffnet, im Inneren der umfänglichen Herzklappengewebestruktur, so dass die äußere Vorrichtung 28 und die seitliche Nut 22 miteinander fluchten,
• – Verringern eines radialen Abstands D1 zwischen der äußeren Vorrichtung 28 und der Kathetervorrichtung 8, um Klappengewebe der Herzklappengewebestruktur 6 in die seitliche Nut 22 hineinzuzwingen, um so das Klappengewebe 6 in der seitlichen Nut 22 der Kathetervorrichtung 8 zu fangen und zu immobilisieren.

A method of immobilizing a circumferential heart valve tissue structure using, for example, the treatment catheter system as described above may include:

• - Arrange an elongated, for example, flexible, external device 28 such that it extends wholly or partially around a circumference of a circumferential heart valve tissue structure,
• - Arrange a catheter device 8th , which has a lateral groove 22 to the lateral outside of the catheter device, inside the circumferential heart valve tissue structure, so that the outer device 28 and the lateral groove 22 cursing each other,
• - Reducing a radial distance D1 between the outer device 28 and the catheter device 8th to flap tissue of the heart valve tissue structure 6 in the lateral groove 22 to force it in, so the flap tissue 6 in the lateral groove 22 the catheter device 8th to catch and immobilize.

• – Entfernen der Kathetervorrichtung 8 und/oder der äußeren Vorrichtung 28 von der Herzklappe 4,
• – Anordnen der flexiblen äußeren Vorrichtung 28, um sich so ganz oder nur teilweise, z. B. nur um ein Viertel oder ein Drittel oder die Hälfte oder Dreiviertel, eines äußeren Umfangs der umfänglichen Herzklappengewebestruktur 6 zu erstrecken.

The method may additionally comprise one or more of:

• - Remove the catheter device 8th and / or the outer device 28 from the heart valve 4 .
• - Arrange the flexible outer device 28 to be completely or partially, e.g. By only a quarter or a third, or half or three quarters, of an outer perimeter of the circumferential heart valve tissue structure 6 to extend.

To the catheter device 8th and / or the external device 28 at the heart valve, the following approaches may be used: 1) arterial retrograde access (eg, through the femoral artery through a puncture in the groin) entering the heart via the aorta, 2) through venous access, possibly in connection with a puncture of the atrial septum (transseptal access), 3) via a puncture through the apex of the heart (transapical access), 4) via a puncture through the atrial wall from outside the heart, or 5) through any other access to the Is known in the art.

Further, the method may include bringing a catch component forward including the side groove 22 , where the catch component 20 through a grid-type or mesh-type cage 36 can be formed by an inner lumen 14 the catheter device 8th Leaving it to the outside at a distal end 16 the catheter device 8th exposed.

The outer device 28 (from an external device catheter 29 can be wrapped) and the catheter device 8th can use the same access or using a different access for the external device 28 or the catheter device 8th be introduced.

Reducing the radial distance D1 between the outer device 28 and the catheter device 8th may include decreasing a distance D1 by reducing a length of the external device 28 and / or by increasing a diameter of the cage 36 , for example by using a catch mechanism 32 ,

Further interaction and / or treatment may include attaching one or more anchors 50 or anchor 50 with tendons 52 on the tissue, the delivery of substances or Pharmaceuticals and / or medical imaging. In addition, a temporary artificial heart valve 42 to the heart valve 4 during the interaction and / or treatment as described above, to avoid valve insufficiency, using the artificial heart valve 42 stuck to the catch component 20 can be attached. Fixing anchors 50 and the delivery of substances or drugs may involve the use of a perforating tool as described above 48 exhibit. Medical imaging may include the use of active and / or passive devices as described above. Attaching one or more anchors 50 may include joining together two, three, four, five or a plurality of fabric layers.

Removing the catheter device 8th and / or the outer device 28 may include retracting the cage 36 and / or the temporary artificial heart valve 42 in the distal end region 16 the catheter device 8th into it, whereby a radial distance D1 between the outer device 28 and the catheter device 8th is enlarged.

The removal may also include increasing a radial distance D1 between the outer device 28 and the catheter device 8th by increasing the length of the outer device 28 , for example by using the catching mechanism 32 or by stretching the outer one. contraption 28 (ie using the elastic properties of the external device).

The catheter device 8th and / or the external device 28 can be withdrawn from the heart using the same access through which they were introduced.

With reference to the 7 to 9 Exemplary methods of using the treatment catheter system 2 described. One exemplary method described is called the "Alfieri technique" and is used to create two separate passages for the blood through the natural sails 4 the mitral valve to flow.

7 shows a view of a human heart with a view from the left atrial chamber 4b on the mitral valve 4 , The elongated outer device 28 , located on the ventricular side of the mitral valve 4 (ie in 6 under the mitral valve 4 ) is indicated by a dashed line. The outer device 28 is arranged so that it has the circumferential mitral valve tissue structure 6 in the ventricular chamber 4a (please refer 1 ) surrounds only partially and diametrically across the longitudinal direction of the circumferential heart valve tissue structure 6 extends. However, the outer device may 28 in other embodiments, be arranged so that they are completely around a circumference of a heart valve 4 extends. In the 7 is the catheter device 8th shown how they differ from the ventricular chamber 4a via the mitral valve 4 to the atrial chamber 4b extends. The arrow 66 indicates the position and orientation of the capture component 26 the lateral groove 22 the catheter device 8th at. The elongated outer device 28 is introduced via a percutaneous access and the catch mechanism 32 which is set so that it has a radial distance D1 between the flexible elongate device 28 reduced or increased, is shown schematically outside the heart.

The 8th shows a further step of the method of using the treatment catheter system 2 , 8th shows a view of the human heart with a view from the left atrial chamber 4b on the mitral valve 4 , The elongated outer device 28 , located on the ventricular side of the mitral valve 4 (ie in 6 below the mitral valve 4 ) is indicated by a dashed line. It can be seen that the catheter device 8th from the ventricular chamber 4a via the mitral valve 4 to the atrial chamber 4b extends. The arrow 66 indicates the position and orientation of the catch opening 26 the lateral groove 22 the catheter device 8th at. A radial distance D1 between the elongate outer device 28 and the catheter device 8th were by the catching mechanism 32 resulting in heart valve peripheral tissue from two diametrically opposite sides of the circumferential heart valve tissue structure 6 the mitral valve 4 in the lateral groove 22 over the catch opening 26 is trapped and immobilized. The perforation component 48 is with an anchor 50 (shown schematically) fitted to tissue from two diametrical sides of the flap 4 to cling to each other. The perforation component 48 the one with the anchor 50 , as outlined above, is stretched out to the tissue that is in the lateral capture groove 22 is trapped and immobilized, to perforate. If after that, the perforation component 48 retired, the anchor remains 50 in its place and fasten the tissue 6 from two diametrical sides of the flap 4 together.

The 9 shows a further step of the method of using the treatment catheter system 2 , The 9 shows a view of a human heart with a view from the left atrial chamber 4b on the mitral valve 4 , The elongated outer device 28 , located on the ventricular side of the mitral valve 4 (for example in 6 below the mitral valve 4 ) is indicated by a dotted line. In 9 became a radial distance D1 between the elongate outer device 28 and the catheter device 8th increases what the flap tissue 6 that in the lateral groove 22 trapped and immobilized releases. Then the catheter device became 8th from the environment of the flap 4 moved away and is no longer in the 9 visible, noticeable. Eventually, the catheter device becomes 8th completely removed from the body. However, the anchor remains 50 on the valve tissue 6 attached and connecting tissue from two diametrical sides of the flaps 4 with each other, the outer device 28 is shown in the process of withdrawal from the heart. When the outer device 28 is completely withdrawn from the heart, is a method of using a treatment catheter system 2 completed according to one embodiment, and it remains only an anchor 50 , the tissue of two diametrical sides of the mitral valve 4 connects, in the heart back.

Claims (17)

A treatment catheter system ( 2 ) for the treatment of a circulatory valve ( 4 ) having a circumferential valve tissue structure ( 6 ), comprising: a.) an elongate catheter device ( 8th ) to be arranged inside the circumferential flap fabric structure ( 6 ) and to be removed from it after the treatment, whereby the catheter device ( 8th ) along a longitudinal axis ( 12 ) and an inner lumen ( 14 ) and a proximal ( 18 ) and a distal ( 16 ) End region, and wherein the catheter device ( 8th ) a catch component ( 20 ) located at the distal end region (FIG. 16 ) of the catheter device ( 8th ) or can be positioned so that they are separated from the catheter device ( 8th ) is inseparable, at least if at the distal end region ( 16 ) of the catheter device ( 8th ), and which, at least when at the distal end region (FIG. 16 ) of the catheter device ( 8th ), a lateral groove ( 22 ), which extend transversely to the longitudinal axis ( 12 ) and to a lateral outside ( 24 ) opens so as to have a lateral catch opening ( 26 b.) an elongated flexible outer device ( 28 ), to the exterior ( 30 ) of the flap structure ( 6 ) on a plane of the lateral groove ( 22 ), whereby the outer device ( 28 ) at least partially circumferentially around the catheter device ( 8th ), wherein valve tissue of the circumferential valve tissue structure ( 6 ) corresponding circumferentially between the catheter device ( 8th ) and the outer device ( 28 ), and c.) a catching mechanism ( 32 ) operable to maintain a radial distance (D1) between the catheter device (FIG. 8th ) and the outer device ( 32 ), so as to at least part of the flap structure ( 6 ) between the external device ( 28 ) and the catheter device ( 8th ) within the lateral groove ( 22 ) over the catch opening ( 26 ) to capture the trapped valve tissue at the distal end region (FIG. 16 ) of the catheter device ( 6 ), the capture component ( 20 ) through a cage ( 36 ) is formed, and wherein the lateral groove ( 22 ) is provided as a circumferential groove formed in the outer peripheral surface of the cage (FIG. 36 ) is formed. The treatment catheter system ( 2 ) according to claim 1, wherein the capture component ( 20 ) relative to the catheter device ( 8th ) is movable and can be brought forward or withdrawn or otherwise exposed via the inner lumen ( 14 ) of the catheter device ( 8th ). The treatment catheter system ( 2 ) according to claim 1, wherein the capture component ( 20 ) integral with the catheter device ( 8th ) at the distal end region ( 16 ) of the catheter device ( 8th ) is formed. The treatment catheter system ( 2 ) according to claim 1, wherein the cage ( 36 ) is provided so that it is radially compressible and expandable so that it is within the inner lumen ( 14 ) of the catheter device ( 8th ) can be housed in a radially-compressed state and at the distal end region (FIG. 16 ) of the catheter device ( 8th ) may be expanded or self-expanding. The treatment catheter system ( 2 ) according to claim 1 or 4, wherein the cage ( 36 ) is formed by a plurality of elongate wires extending substantially along the longitudinal axis (FIG. 12 ) of the catheter device ( 8th ) and at an angular distance about the longitudinal axis ( 12 ) of the catheter device ( 8th ) are arranged, wherein the elongated wires ( 38 ) each have a radially and inwardly bent bending region, wherein the bending regions form the lateral groove. The treatment catheter system ( 2 ) according to claim 5, wherein each wire ( 38 ) is provided in a vagina, which in the lumen ( 14 ) of the catheter device ( 8th ) and is movable relative thereto, and is movable relative thereto. The treatment catheter system ( 2 ) according to one of claims 4 to 6, wherein the wires ( 38 ) with each other by a substantially non-compressible front body ( 44 ) having a round outer side and an outer diameter slightly larger than an inner cross-sectional diameter of the lumen ( 14 . 46 ) of the catheter device ( 8th ), so he has a plug to a front end opening of the inner lumen ( 14 . 46 ) of the catheter device ( 8th ) can provide. The treatment catheter system ( 2 ) according to one of claims 1 to 7, wherein the catching component ( 20 ) has a blunt front part. The treatment catheter system ( 2 ) according to one of claims 1 to 8, further comprising an elongated flexible perforation component ( 48 ) passing through the inner lumen ( 14 . 46 ) of the catheter device ( 8th ) forward to the distal end region ( 16 ) of the catheter device ( 8th ) and which is operable to perforate through the valve tissue in the lateral groove 22 trapped or by flap tissue adjacent to the trapped valve tissue. The treatment catheter system ( 2 ) according to claim 9, wherein the perforation component ( 48 ) is formed by a needle which is provided and arranged to project forward into the lateral groove (FIG. 22 ) to be brought into it. The treatment catheter system ( 2 ) according to one of claims 1 to 10, additionally comprising an anchor component ( 50 ) passing through the inner lumen ( 14 . 46 ) of the catheter device ( 8th ) can be brought forward and can be positioned in the captured valve tissue or in adjacent valve tissue. The treatment catheter system ( 2 ) according to claim 11, further comprising a tendon ( 52 ) attached to the anchor component ( 50 ) is attached. The treatment catheter system ( 2 ) according to claim 9 or 10 in conjunction with claim 11 or 12, wherein the perforation component ( 48 ) is hollow, and wherein the anchor component ( 50 ) is provided by the perforation component ( 50 ) to the distal end region ( 16 ) of the catheter device ( 8th ) can be brought forward. The treatment catheter system ( 2 ) according to any one of claims 1 to 13, further comprising a medicinal drug delivery component ( 64 ) provided so as to pass through the inner lumen ( 14 . 46 ) of the catheter device ( 6 ) to the distal end region ( 16 ) of the catheter device ( 8th ) can be brought forward so that it can deliver a medicinal drug to the trapped valve tissue or adjacent valve tissue. The treatment catheter system ( 2 ) according to claim 14 in conjunction with any one of claims 9 to 13, wherein the perforation component ( 48 ) is hollow, and wherein the medical drug delivery component ( 64 ) is provided by the perforation component ( 48 ) to the distal end region ( 16 ) of the catheter device ( 8th ) can be brought forward. The treatment catheter system ( 2 ) according to one of claims 1 to 15, further comprising marking devices fixedly mounted on the catheter device ( 8th ) and the outer device ( 28 ), wherein the marking devices are made of a different material than the material of the catheter device ( 8th ) or the external device ( 28 ) so as to identify relative positions and orientations of the catheter device ( 8th ) and the outer device ( 28 ) through the use of material-sensitive imaging techniques. The treatment catheter system ( 2 ) according to any of claims 1 to 16, wherein the capture component ( 20 ) and the external device ( 28 ) each having an electrode electrically connected to an electrical energy source, the electrodes of the capture component ( 20 ) and the outer device ( 28 ) selectively generate an electric field between each other by using the electric energy supplied from the power source so as to open openings in cell membranes of the valve tissue.

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