Patent Description:
Although there has been significant progress in the treatment of cardiovascular diseases, globally they constitute the leading cause of deaths, according to the World Health Organization (WHO). <NUM>% of the population in first world countries die of cardiovascular diseases, but alongside economic growth, the prevalence in developing countries is rising, too. Consequently, an increasing number of people are in need of an invasive cardiovascular intervention every year.

Neonates with a ventricular septal defect (VSD) are born with a hole in the wall of the heart (septum) that separates the two lower chambers (ventricles). VSD is the most common heart defect and occurs when an infant's septum does not fully develop during pregnancy. The exact cause is unknown. A recent study by the Centers for Disease Control and Prevention in Atlanta estimated that <NUM> of every <NUM>,<NUM> infants are born with a VSD.

In a healthy human heart, the right side of the heart pumps blood to the lungs where the blood picks up oxygen and the left side of the heart then pumps the oxygen-rich blood to the rest of the body. In babies with VSD, blood that should be on the left side of the heart leaks into the right side. Hence, all of that extra blood gets pumped back into the lungs. This forces the heart and lungs to work harder, which can increase the infant's risk for other medical problems. Typically, VSD is treated by closing the hole with an implant. In some techniques, VSD is treated using open-heart surgery.

In general, open-heart surgery usually requires an incision along the sternum (median sternotomy), followed by cardiopulmonary bypass and the temporary arrest of the heart of the patient (cardioplegia), so that the operation can be done in a still environment without blood flowing. Such highly invasive techniques are not suitable for patients considered high risk due to their age, fragility or medical condition, as they involve a long recovery period and risks of trauma and infection. Therefore, in the past decade, many less invasive procedures for a variety of cardiovascular indications were developed, where the heart is accessed via a catheter through blood vessels (catheter-based cardiac surgery) or through very small incisions in the chest (minimally invasive cardiac surgery, MICS). These techniques are recently being expanded to also treat intermediate and low risk patients.

Many interventions depend on some kind of implant, e.g. heart valve replacements, annuloplasty rings, vascular grafts or septum defect repairs. Often, they are sutured to the human tissue to fix them into place, which must be done in a very careful manner by a well-trained surgeon in order to get the desired outcome. Placing the sutures adequately makes up a significant proportion of the operation time and the execution can sometimes be challenging or even impossible. Additionally, sutures can cut through, open up or loosen, or knot slippage may occur. Further, sutures have the disadvantage of a high application of stress concentrated where they are placed.

One example of an attachment mechanism is disclosed in <CIT>. <CIT> discloses a staple cartridge for stapling tissue. However, stapling has the disadvantage that relatively high forces are applied and tissues are damaged. Further, a distribution of the attachment force is concentrated around the staple leading to undesirable force transmission.

<CIT> discloses a catheter for retrograde perfusion of the heart through the coronary sinus. The catheter includes an inflatable balloon with retention means. The inflatable balloon includes spikes, a felt or a coating on the surface of the balloon as retention means that keep the balloon firmly in space. Though this document discloses a balloon as retention means, the retention is lost as soon as the balloon is deflated.

<CIT> describes apparatus and methods for fabricating tubular structures from a combination of fibrous materials for use in tissue engineering scaffold applications. The fiber scaffolds may include a nonwoven felt that is attached to a further nonwoven felt with an attachment device including a plurality of needles. Thereby, the fibers of the felts are entangled with each other.

<CIT> discloses an apparatus for treating a patent foramen ovale. The apparatus comprises an elongate catheter body having a proximal end and a distal end, an energy transmission element located on a distal portion of the catheter body for transmitting energy to contact tissue of the patent foramen ovale to close the patent foramen ovale, and a backstop element adapted to be positioned distal of the energy transmission element for facilitating energy delivery to the patent foramen ovale.

The problem of the present invention is providing devices and methods for attaching implants to a target site within the body in a minimally invasive fashion. In particular, it is an object of the invention to attach implants (e.g. cardiovascular implants) to the human tissue in a strong and durable fashion, while also simplifying the surgical procedure and therefore saving critical time, which would allow for a safer and more efficient intervention. A further optional object of the present invention is attaching the implant in a uniform manner allowing a uniform stress distribution of forces that are transmitted from and to the implant at the target site.

According to the invention the problem is solved with a minimally invasive fixation device for fixating a feltable textile according to claim <NUM> and a set comprising a fixation device according to claim <NUM>. Optional embodiments are described in the dependent claims.

In one aspect, it is suggested to provide a minimally invasive fixation device for fixating a feltable textile at a target site. The feltable material is fixated at a target site in a human or in an animal. Preferable the target site comprises soft tissue. The fixation device comprises an elongate tubular member, a needle and a drive assembly. The elongate tubular member has a proximal end and a distal end and an interior lumen extending between the proximal end and the distal end. The elongate tubular member may be at least partially flexible. Preferably, the elongate tubular member is flexible over its entire length.

A textile as mentioned herein may be understood as a material made of fibers, filaments, or yarn. Flexible as mentioned herein may be understood in that the elongate tubular member may be bent, in particular while navigating a twisting path of a hollow organ (e.g. a blood vessel) and/or is capable of being brought into a bent shape. Elongate as mentioned herein might be understood to mean that the tubular member has a longer length than width (e.g. diameter). Preferably the elongate tubular member is flexible over its entire length. Alternatively, the elongate tubular member may have one or more flexible section(s). In some embodiments "elongate" may be understood as the tubular member having a length which is at least <NUM> times the width. The interior lumen may include a distal opening and a proximal opening.

The needle assembly comprises at least one felting needle, which is arranged or arrangeable at the distal end of the elongate tubular member. The at least one felting needle is movable relatively to the elongate tubular member, wherein the at least one felting needle is movable with a reciprocal motion. Reciprocal as mentioned herein may be understood as a back and forth motion, in particular a linear or circular back and forth motion. The needle assembly may comprise <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> or more needles. The more felting needles the needle assembly comprises, the less reciprocal motions need to be made for a sufficiently strong attachment between the feltable textile and the target site.

The needle assembly can felt the feltable textile with fibers of the body by interweaving animal or human soft tissue fibers with fibers of the textile by pushing fibers from one into the other. If this is done repeatedly, a strong mechanical connection is achieved. The needle, its shape and the mechanism are explained in detail in the application <CIT> by the applicant ZuriMED Technologies AG.

The drive assembly is arranged in the interior lumen of the tubular member and operably connected to the needle assembly for moving the at least one felting needle with the reciprocal motion when the at least one needle is located at the distal end such that the feltable textile can be fixated at the target site. The drive assembly may be fixedly attached to the elongate tubular member or movable relatively to the elongate tubular member. For example, the drive assembly may comprise a wire that extends through the lumen of the elongate tubular member. In some embodiments the drive assembly is arranged fully within the interior lumen while in other embodiments only parts of the drive assembly are arranged in the inner lumen.

Additionally, the fixation device may comprise an actuator or motor for actuating the drive assembly. The actuator may be an electrical, mechanical, hydraulic and/or pneumatic motor. The at least one felting needle may be driven by a pneumatic or hydraulic or electromagnetic actuator or motor. The actuators may be arranged within or outside of the elongate tubular member. The actuators may be arranged or are arrangeable at a distal end or operable connected to a distal end of the drive assembly. The actuator may by be arranged in a proximal or distal part of the fixation device. In some embodiments the actuator may be arranged in a distal portion of the fixation device, such that the reciprocal motion does not need to be transferred from the proximal end of the elongate tubular member to the at least one felting needle.

The fixation device provides a minimal invasive device and allows a deployment, positioning and fixing a feltable textile onto human or animal tissue. This device provides a reliable fixation while at the same time minimizing navigation and multi degrees of freedom problems which can occur when suturing in locations which are difficult to reach.

The elongate tubular member may have a diameter in the range of <NUM> Fr to <NUM> Fr, more specifically <NUM> Fr to <NUM> Fr, more specifically <NUM> to <NUM> Fr. These ranges correspond to suitable sizes for an atrial or venous access towards the heart.

As used herein the terms proximal and distal are defined from the perspective of a user of the percutaneous fixation device, in particular from the perspective of a medical professional such as a surgeon using the device.

The feltable textile may comprise or consist of absorbable fibers, particularly polyglycolic acid, polylactic acid, polydioxanone, or caprolactone. As mentioned herein, the term absorbable may relate to materials which are degraded after implantation in a human or animal body.

In some embodiments, the feltable textile comprises or consists of non-absorbable fibers, particularly silk, polypropylene, polyester or polyamide. As mentioned herein, the term non-absorbable relates to materials which are not degraded after implantation in a human or animal body.

In some embodiments, the feltable textile comprises or consists of a combination of absorbable fibers, particularly polyglycolic acid, polylactic acid, polydioxanone, or caprolactone and non-absorbable fibers, particularly silk, polypropylene, polyester or polyamide.

In certain embodiments, the fibers of the feltable textile comprise or consist of a biocompatible polymer, particularly polyethylene (PE, <NPL>) polytetrafluorethylene (PTFE, <NPL>), polyethylene terephthalate (PET, <NPL>), poly(glycolide) (PGA, <NPL>), poly(lactic-co-glycolic acid) (PLGA, <NPL>), poly (L-lactic acid) (PLLA, <NPL>), polycaprolactone (PCL, <NPL>), <NUM>,<NUM>-propanediol (PDO, <NPL>) or <NUM>,<NUM>-propanediol (PDO,<NPL>).

In certain embodiments, the feltable textile could also be made of decellularized collagen tissue from human or animal origin.

In a preferred embodiment, the drive assembly is adapted to drive the reciprocal motion at a predetermined frequency. The frequency is preferably in a range from <NUM> to <NUM>. The range is further preferred from <NUM> to <NUM>, from <NUM> to <NUM> and <NUM> or <NUM> and most preferably from <NUM> to <NUM>. At these frequencies the felting needle can be moved without tearing single filaments of the material while at the same time providing a sufficient amplitude. At the same time, the feltable material can be attached quickly to the target site.

In a preferred embodiment the drive assembly is adapted to drive the reciprocal motion with an amplitude of <NUM> to <NUM>, particularly preferred <NUM> to <NUM>, further preferred from <NUM> to <NUM> most preferred from <NUM> to <NUM>. These amplitudes cover a sufficient thickness of feltable textile while penetrating the target soft tissue at the same time and result in a sufficiently strong attachment between the feltable material and the target site.

In a preferred embodiment, the fixation device additionally comprises the feltable textile. The feltable textile is arranged or arrangeable such that the at least one needle penetrates the feltable textile with the reciprocal motion. Further preferred, the at least one needle is arranged to penetrate through the feltable textile and into the target site. Thereby, the fixation device and the feltable textile are provided as a unit and are ready to be used together at the target site. As a result, only a single minimally invasive device or at least fewer minimally invasive device need to be inserted into the body of a human or animal.

In a preferred embodiment the at least one felting needle points in a distal direction of the elongate tubular member. This arrangement allows access to target sites that are arranged proximally to a distal tip of the elongate tubular member. In addition, this may allow pressing the feltable textile to the target site, which improves the felting. Further, the needle may be compact in the radial direction and a simple actuation mechanism can be provided.

In a preferred embodiment, the reciprocal motion of the at least one felting needle is linear, particularly preferred along a direction of the elongate tubular member. In an alternative embodiment, the reciprocal motion is rotational, preferably around an axis of the elongate tubular member. The type of reciprocal motion may be chosen depending on the feltable textile and the location of the target site. In case the feltable textile is expelled at the distal end of the elongate tubular member and fixated at the target site distally or proximally thereof, a linear motion is preferable. If the feltable textile is fixated to e.g. a vessel arranged at a radial direction of the elongate tubular member, a rotational motion may be preferable. For example, a feltable textile for an endograft for treating an aneurysm may be preferably fixated with the rotational motion. An annuloplasty ring or a heart valve may be preferably attached with a linear motion.

In a preferred embodiment, the drive assembly comprises an elongate driving wire or tube that extends from a proximal side of the elongate tubular member to the needle assembly. The elongate driving wire or tube is operably connected to the needle assembly such that the driving elongate wire or tube causes the reciprocal motion of the at least one felting needle. Thereby push and/or pull forces may be transmitted from a proximal end of the elongate tubular member to the distal end of the elongate tubular member.

The elongate tubular member as mentioned herein may be described herein as a catheter or sheath (i.e. an outer or inner catheter or sheath).

In a preferred embodiment the drive assembly comprises a resilient element that is arranged such that the resilient element forces the at least one felting needle to a preset position when the at least one felting needle is actuated by the driving elongate wire or tube. Thereby, the reciprocal motion is transmitted onto the at least one felting needle. Alternatively, the driving elongate wire or tube transmits both push and pull forces. In this case, the driving elongate wire or tube may be sufficiently stiff such that compressive forces are transmitted.

In a preferred embodiment the elongate driving wire or tube is configured to transfer tensile and optionally compressive force along the elongate direction of the elongate driving wire or tube to the needle assembly such that the wire or to actuates the reciprocal motion of the at least one felting needle. In a preferred embodiment the wire or tube is made of steel and may form a steel cable.

The driving elongate wire or tube may include a low friction coating on an outer surface. For example, the coating may be of polytetrafluoroethylene (PTFE). Thereby, forces along the longitudinal direction (i.e. compressive or tensile forces) are transmitted efficiently.

In a preferred embodiment, the elongate tubular member comprises at least one guiding element for the drive assembly in the interior lumen. The at least one guiding element preferably centers the elongate driving wire or tube in the elongate tubular member along the radial direction of the elongate tubular member. Thereby, a buckling of the elongate driving wire or tube is reduced, thus improving the efficiency of transmission of forces along the longitudinal direction. Further, vibration in the elongate tubular member may be reduced during operation of the felting needle(s). The guiding elements may also comprise a low friction coating for reducing friction between the driving elongate wire or tube and the guiding elements. This improves the guidance and force transmission of the driving wires or tubes.

In a preferred embodiment the feltable textile has the shape of a strip or patch. Further preferred, the textile may have an annular shape and/or forms an annuloplasty ring or forms part of an annuloplasty ring. Felting an annuloplasty ring is particularly advantageous, since reshaping the annulus of a heart requires a particularly strong and durable attachment due to the compression and expansion of the annuluses of the heart valves.

In a preferred embodiment, the fixation device additionally comprises a holding assembly for the feltable textile, wherein the holding assembly comprises at least one holder for securing the textile to the fixation device. The textile may be held in a folded position. Thereby, the textile and/or an implant comprising the textile has a compact shape and can be advanced to the target site. Further, only one minimally invasive device needs to be inserted that includes the felting needle(s) and a holding assembly with the feltable textile.

In a preferred embodiment, the fixation device additionally comprises a tube with an outer sheath with a distal end. The holding assembly is movable relatively to the outer sheath and upon being expelled from the distal end of the outer sheath, the holding assembly may assume an expanded position such that the textile is unfolded. The holding assembly may be made of a shape memory alloy such as nitinol.

A further aspect relates to a set comprising a fixation device as described above and an implant comprising the feltable textile.

A further aspect relates to a set comprising a fixation device as described above and a guidewire. The feltable textile may be attached or attachable to the guidewire.

A further aspect relates to a set comprising a fixation device as described above and a pusher, preferably a pusher rod. The pusher may be adapted to push the feltable textile to a target site. The pusher may include a distal end face and may be arranged arrangeable within the elongate tubular member. The feltable textile may be arranged a distal end face of the pusher.

A further aspect relates to a method for fixating a feltable textile at the target site in a patient with a minimally invasive fixation device. The fixation device is preferably a fixation device as described above. The method includes the step of guiding a flexible elongate tubular member in the body of the human or animal to a target site. The flexible elongate tubular member has a proximal end, a distal end and an interior lumen. The interior lumen extends between the proximal end and the distal end. A needle assembly is actuated. The needle assembly comprises at least one felting needle arranged at the distal end of the elongate tubular member. The needle assembly is actuated by moving the at least one felting needle relatively to the elongate tubular member with a drive assembly arranged in the interior lumen of the tubular member. The drive assembly is operably connected to the needle assembly and moves the at least one felting needle with a reciprocal motion such that the feltable textile can be fixated at the target site.

The fixation devices, sets and methods as provided herein may be used in the repair and fixation of anatomical structures of the circulatory system (heart and blood vessels), fixation of an implant to these structures, the creation of artificial moderator bands (trabecula septomarginalis) to avoid or treat heart failure with dilated ventricles or cleft closures. In particular, heart defects (e.g. patent foramen ovale, atrial septal defect, ventricular septal defect, patent ductus arteriosus, paravalvular leak closure), heart valve repair and replacements (e.g. aortic valve replacement, mitral valve repair or replacement, tricuspid valve repair or replacement, annuloplasty, chordoplasty), edge-to-edge repair in heart valves and portions such as commissures, repair of blood vessels (e.g. aortic dissections, aneurysms, atherosclerosis), ischemic heart disease (cardio vascular diseases closure, reinforcement of ischemic ventricles and other degenerative cardio vascular diseases may be treated.

In a further aspect, it is suggested to provide a minimally invasive fixation device for fixating a feltable textile at a target site as described above. An end of the at least one felting needle may be directable or directed in a generally distal direction. A generally distal direction may be understood as having a component in the distal direction. Preferably an angle between the distal direction and the end of the felting needle is less than <NUM>°, less than <NUM> ° or less than <NUM>° or the end of the felting needle points directly in the distal direction. Hereby the user can control the pressure on the tissue and the textile by pulling the fixation device instead of pushing the fixation device. This is particularly of interest where the target site (e.g. area in which surgical felting is performed) is behind anatomical structures such as e.g. valves. In particular, the needle may be curved or angled such that the at least one felting needle points in the generally distal direction.

The fixation device may additionally comprise a feltable textile and the at least one felting needle may be adapted to penetrate the feltable textile from a distal direction. The fixation device may comprise a holding assembly for an implant for the target site and the holding assembly may be adapted to apply a force on the implant in a distal direction. In a distal direction, higher forces can be applied, in particular when the elongate tubular member is bent.

The fixation device may additionally comprise an implant, in particular an annuloplasty ring or a heart valve, wherein the feltable textile is arranged on the implant.

The at least one felting needle may include a deformable joint, in particular a shape memory alloy, such that the at least one felting needle is directed in a generally distal direction when expelled from the interior lumen of the elongate tubular member.

In a further aspect, it is suggested to provide a minimally invasive fixation device for fixating a feltable textile at a target site as described above. The drive assembly may be adapted to move the at least one felting needle in a direction substantially orthogonal to the elongate tubular member with the reciprocal motion.

The at least one felting needle is preferably arranged to rotate around an axis during the reciprocal motion. The axis may be an axis, preferably a central or eccentrical axis, of the elongate tubular member. Thereby, an efficient transmission of the reciprocal motion to the at least one felting needle is provided.

In a preferred embodiment, the driving assembly comprises a driving rod operably connected to the at least one felting needle. The driving rod may be configured to transfer torque onto the needle assembly for rotating the at least one felting needle with the reciprocal motion.

In a preferred embodiment, the driving rod and/or the at least one felting needle is positioned as an eccentric position in the inner lumen of the elongate tubular member. Thereby, the at least one felting needle can be advanced to the inner lumen of the elongate tubular member.

In a preferred embodiment the at least one felting needle is directed or correctable in a direction substantially orthogonal to the elongate tubular member. In this way tissue laying in a radio position relatively to the catheter can be reached. For example, the feltable textile can be attached to walls of blood vessels through which the elongate tubular member may be advanced.

In a preferred embodiment, the at least one felting needle is curved or angled such that a distal tip of the needle is directed in the direction substantially orthogonal to the elongate tubular member. The at least one felting needle may have a curvature of a circle.

In a further aspect, it is suggested to provide a minimally invasive fixation device for fixating a feltable textile at a target site as described above. The fixation device may comprise a tubular outer sheath with a distal end, wherein the elongate tubular member is arranged in the outer sheath and wherein the elongate tubular member can be bent, in particular when the elongate tubular member is expelled from the distal end of the outer sheath such that the distal end of the elongate tubular member is steerable by rotating the elongate tubular member. Thereby, the needle assembly can be navigated to the feltable textile. In particular, the needle assembly can be rotated such that the feltable textile can be fixated along a circular track.

The elongate tubular member may comprise low friction outer coating such as PTFE or be made of a low friction material. Alternatively or additionally, the outer sheath may comprise a low friction outer coating (e.g. PTFE) or be made of a low friction material. As used herein any coating that reduces friction as compared to the base material may be considered to be a low friction coating. Material combinations which result in a dynamic coefficient of friction below <NUM> may be considered as "low friction". (e.g. Teflon (PTFE) on teflon, or teflon on steel is around <NUM>).

In a preferred embodiment, the elongate tubular member comprises a joint between its distal and proximal ends, wherein the elongate tubular member can be bent at the joint. Particularly preferred, the joint comprises a shape memory alloy. The joint may assume a bent position upon being expelled from the outer sheath.

Additionally, the elongate tubular member may comprise wires or cables or a pneumatic or hydraulic mechanism for rotating the elongate tubular member around its axis.

In a further aspect, it is suggested to provide a minimally invasive fixation device for fixating a feltable textile at a target site as described above. The elongate tubular member may comprise a distal tip portion that is arranged at least partially distal of the at least one felting needle, wherein the distal tip portion comprises a proximal counter surface opposed to the at least one felting needle for holding the feltable textile in place during fixation. Thereby, the tissue of the human or animal body may be held, e.g. clamped, in place during the felting. In alternative embodiments, the distal tip portion may also be arranged proximally of the at least one felting needle.

In a preferred embodiment, the distal tip portion includes a slot for receiving the feltable textile. The slot may be partially formed by the distal counter surface.

In a preferred embodiment, the distal tip portion may be formed by one, two, three or more tongues that are formed to provide a distal counter surface for the felting.

In a further aspect, it is suggested to provide a minimally invasive fixation device for fixating a feltable textile at a target site as described above. The fixation device may further comprise a textile holder and a feltable textile. At least a part of the feltable textile is held at the distal end of the elongate tubular member with the textile holder such that the feltable textile covers the needle assembly at least partially. The at least one felting textile is configured to penetrate the feltable textile.

In a preferred embodiment, the feltable textile has an elongate shape, a first end, an intermediate portion and a second end along the elongate extension. The elongate tubular member includes at least one, preferably two, guidance openings, preferably slots, for holding the feltable textile such that the feltable textile covers the new assembly at least partially. Thereby, the feltable textile may be hold in place during delivery and during fixation.

In a preferred embodiment the textile holder comprises a clamp for a frictional engagement between the feltable textile and the textile holder. Further preferred, the catheter assembly comprises a textile holder release mechanism for releasing the textile from the fixation device, wherein the textile holder release mechanism preferably comprises a textile with cables. Thereby, the feltable textile may be released from the fixation device. In a further preferred embodiment, the catheter assembly comprises a cutting-edge, preferably a knife for cutting the feltable textile. The cutting edge maybe rotatable, which allows an easy actuation of the textile cutting mechanism.

Nonlimiting embodiments of the invention are described, by way of example only, with respect to accompanying drawings. The drawings and its description provide examples of the invention, individual features of which may be used alone or in combination with each other.

<FIG> show an end portion of the first embodiment <NUM> of a fixation device. The fixation device <NUM> includes an elongate tubular member that is realized as a catheter <NUM>. The catheter <NUM> may be inserted into the body of a human or animal, for example through a short sheath with a valve (i.e. a portal). One example of the insertion of such a short sheath to gain access to a blood vessel and other hollow organs is the Seldinger technique. Before the catheter <NUM> is inserted, a guidewire <NUM> is inserted. The guidewire <NUM> navigates the vessels to reach a target site, such as particular vessel segments, e.g. heart valves or lesions. Then, the catheter <NUM> is pushed over the guidewire <NUM> to the target site.

The situation, where the catheter <NUM> has reached the target site is shown in <FIG>. Thereafter, hooks <NUM> and <NUM> are deployed (see <FIG>). The hooks <NUM>, and <NUM> may include a sharp tip to anchor the device in soft tissue to retain a location of the fixation device at the target site. The hooks <NUM>, <NUM> may penetrate the tissue or may reach behind the tissue and pull the tissue towards the catheter <NUM>. Alternatively, the guidewire <NUM> is retracted after the catheter <NUM> has reached the target site, and a second catheter <NUM> is introduced which includes the hooks <NUM>, and <NUM>.

In the next step, a pusher <NUM> is advanced through the catheter <NUM> over the guidewire <NUM> or over the second catheter <NUM>. On its distal end, the pusher <NUM> includes a flat surface. On the flat surface, a folded patch <NUM> made of a feltable textile is arranged and pushed through an inner lumen of the catheter <NUM>. When the folded patch is expelled from a distal end of the catheter <NUM> as shown in <FIG>, it unfolds as shown in <FIG>. The flat side of the distal end of the pusher <NUM> is used to push the patch <NUM> against the tissue of the human or animal. In order to prevent the patch <NUM> from moving, the pusher includes two barbed needles <NUM>, <NUM> that are deployed, i.e. moved in a distal direction through the patch and into the tissue of the human or animal to keep the patch in place. Then, a felting needle <NUM> is moved through the patch <NUM> and into the soft tissue of the human or animal, Then, the felting needle <NUM> is retracted again by moving the needle in the proximal direction. The advancement and retraction are repeated with a frequency of <NUM>. By repeatedly advancing a needle <NUM> through the patch <NUM> the fibers of the patch <NUM> are pushed or pulled through patch <NUM> into the soft tissue <NUM> by means of the needle <NUM> to produce a firm connection between the feltable textile of the patch and the soft tissue. This process may be supported by the needle additionally comprising felting barbs as described in <CIT>. Thereafter, the patch <NUM> is fixated at the target site.

The needle can be moved over the surface of patch <NUM> by rotating the catheter <NUM> around the second catheter <NUM>. To cover a greater area this can be repeated by navigating to a new target site on the patch with catheter <NUM>.

<FIG> shows a schematic view of a cross-section of a second fixation device. <FIG> illustrates how a felting needle, for example felting needle <NUM>, may be actuated. Patches of feltable materials such as patch <NUM> may be attached to target sites in the cardiovascular, urological, gastrointestinal, or neurovascular regions. Oftentimes this requires following the path of the respective hollow organ, e.g. blood vessels, along their bent paths. Therefore, catheters that are flexible, and sometimes soft, are used to allow the catheter to follow the shape of the hollow organ. However, this poses a challenge for actuating the felting needle with the reciprocal motion. In particular in case the fixation device comprises a motor to actuate the felting needle, the motion needs to be transmitted to the felting needle via a driving assembly. One example of such a driving assembly is shown with reference to <FIG> shows a fixation device <NUM> with a felting needle <NUM>. An actuator (not shown) generates the reciprocal motion and is directly connected to a driving wire <NUM>. The driving wire <NUM> is pulled by the motor in the proximal direction. Similarly to the fixation device <NUM>, the fixation device <NUM> comprises an elongate tubular member that is realized as a catheter <NUM>. As can be seen from <FIG>, the catheter <NUM> is flexible along its entire length and bends around curves. The driving wire <NUM> is held and guided within the catheter <NUM> by a guiding element. The guiding element may be a concentric lead element <NUM> as shown in <FIG>. The concentric lead elements <NUM> are circular, ring-shaped and extend from an inner side of the catheter. Those elements <NUM> have preferably also a low friction index to allow optimal guidance and force transmission. This feature reduces bending forces and ultimately reduces vibration during application. The concentric lead elements <NUM> center the driving wire in the catheter <NUM>, thereby preventing a bending or buckling of the driving wire in the tube beyond the bending of the catheter <NUM>. The concentric lead elements are covered by a PTFE coating to lower a friction between the driving wire <NUM> and the lead elements. Additionally or alternatively, the driving wire may also include a similar or different friction reducing (low friction) coating.

The catheter <NUM> comprises a linear bearing <NUM> at its distal end. Further, the catheter <NUM> includes a spring coil <NUM> and a felting needle <NUM> at its distal end. The driving wire <NUM> is rigidly connected to the felting needle <NUM> or forms the felting needle <NUM> and is connected to a distal end of the spring coil <NUM> with a washer <NUM>. On the other hand, the spring coil contacts the linear bearing <NUM>. When the wire <NUM> is pulled, the needle <NUM> is retracted and the spring <NUM> is compressed between the linear bearing <NUM> and the washer <NUM>. Upon releasing the wire <NUM>, the spring coil presses the felting needle forward. The amplitude (penetration depth) and frequency of the motion of the felting needle can be modulated and the suitable springs with resonance frequencies in the desired range may be chosen as is known in the art.

If a sufficiently stiff driving wire is used (e.g. steel cable) which is able to transport compressive and tensile forces from one end to the other end of the catheter, the spring <NUM> can be avoided. Alternatively to the above described driving assembly comprising an elastic element (spring <NUM>) and a driving wire, the needling mechanism can be driven by a pneumatic or hydraulic force or by an electro-magnetic actuator.

<FIG> show a schematic view of the third fixation device <NUM> with a textile patch <NUM> and an outer sheath <NUM>. In particular, <FIG> show one embodiment of how a patch of a feltable textile <NUM> may attached to a target site of soft tissue. In the embodiment of <FIG> the feltable textile <NUM> is advanced with a guidewire <NUM>. In first step of the operation the guidewire <NUM> is guided towards the target site as is known in the art. The tip of the guidewire is for example angled e.g. by having a J shape, allowing a navigation through hollow organs, such as blood vessels. Once, the guidewire <NUM> is at the target site, an outer sheath <NUM> is advanced over the guidewire into the body of the human or animal. The outer sheath <NUM> comprises an inner lumen, through which a further outer catheter <NUM> is advanced. The outer catheter <NUM> includes an inner catheter <NUM>. The inner catheter <NUM> may be a catheter such as catheter <NUM> as described with reference to <FIG>. The patch <NUM> can be provided with a small hole or simply be penetrated by the guidewire. Then the patch can be advanced over the guidewire <NUM> with a separate pusher (not shown). Otherwise the patch <NUM> can be advanced with the guidewire <NUM> when the guidewire is inserted or by being pushed with the outer sheath <NUM> or with the outer or inner catheter <NUM>, <NUM> over the guidewire <NUM>.

In addition, the inner catheter <NUM> comprises a joint <NUM>. The joint may comprise an elastic element such as a coil or an elastic material and a bearing, e.g. a pivot bearing. The elastic element is prestressed and forces the inner catheter to bend at the joint <NUM> around the bearing. For example, the elastic material may be compressed which would bend the inner catheter to an opposing side or the elastic material may be stretched, which would bend the inner catheter to the side of the elastic material. The angle of the joint may in one example be controlled by a user with a wire pulling the elastic element.

Additionally or alternatively, the joint <NUM> is made of a shape memory alloy. Further, upon being expelled from the outer catheter <NUM>, the joint bends the inner catheter <NUM> at a predetermined angle. The angle may be controlled by the axial position of the inner catheter <NUM> relative to the outer catheter. This allows the needle to cover a bigger felting area on the patch.

The predetermined angle may be less than <NUM>°, preferably less than <NUM>°, preferably less than <NUM>° and particularly preferred about <NUM>°. Due to the bending at the joint, a rotation of the inner catheter <NUM> around its own axis steers the distal tip of the inner catheter <NUM> similarly to a guidewire with a J-shaped end. Thereby, the end portion of the inner catheter with the felting needle can be guided to a desired position. As shown in particular in <FIG> (see arrows <NUM>, <NUM>), the steerable inner catheter is rotated around its own axis and thereby the circumference of the patch <NUM> is attached to the target site with the felting needle. The relative position of the inner catheter <NUM> and the outer catheter <NUM> may be adjustable. For example, at a first relative position, the joint may be end at an angle of <NUM>° at a first relative position while the angle may be <NUM>° at a second position. Thereby, an inner radius can be fixated. For example, the further the outer catheter <NUM> is withdrawn, the further the inner catheter <NUM> bent. Thereby, the entire surface of the eligible material can be attached to the target site by rotating the inner catheter and changing the angle of the joint <NUM>.

A particular application of the above technique is shown with respect to <FIG>. In this application, the feltable textile forms an annuloplasty ring <NUM>. An annuloplasty is a procedure to tighten or reinforce the ring (annulus) around a valve in the heart. The annuloplasty ring reshapes, reinforces and/or tightens the ring around a heart valve thereby preventing for example regurgitation through the valve. An outer catheter <NUM> includes a holder <NUM> for the feltable textile <NUM> that is ring-shaped. The holder has a mesh structure and is made of a shape memory alloy that expands upon being expelled from an outer sheath <NUM>. The holder <NUM> includes releasable anchors that may clamp the feltable textile. When the holder is expelled from the distal end, it spans the feltable textile <NUM>. Then, similarly to the inner catheter <NUM> of <FIG>, an inner catheter <NUM> is advanced through the outer catheter <NUM>. Similarly to the inner catheter <NUM> of <FIG>, the inner catheter <NUM> includes a bendable joint. Through a rotation around the axis of the inner catheter, the annuloplasty ring <NUM> is attached to an annulus of a heart valve. The annuloplasty ring is pressed against the tissue by pushing the catheter <NUM> in the proximal direction. The result of the procedure is shown in <FIG>. Here the annuloplasty ring <NUM> is attached to the mitral valve of a human heart on the side of the left atrium.

A further embodiment <NUM> of a fixation device is shown in <FIG>. The fixation device <NUM> includes an elongate tubular member formed as catheter <NUM>. In this fixation device, the eligible textile is provided as an elongate feltable textile strip <NUM> (e.g. an elongate patch or a braided suture). The feltable textile strip <NUM> extends along the surface of the tip of the catheter <NUM> and to goes into two slots <NUM> provided at the tip of the catheter <NUM>. <FIG> show a view, in which the catheter <NUM> is removed. As can be seen from <FIG>, the fixation device includes similar as elements as the catheter of <FIG>. In particular, the device comprises a spring coil, a linear bearing, a driving wire, a washer and a felting needle that can be advanced and retracted with the driving wire.

In addition, the device comprises two holders <NUM>, <NUM> for the strip <NUM>. A first holder <NUM> clamps an end of the strip <NUM>. The second holder <NUM> also clamps the strip <NUM>. On the side of the second holder, the strip <NUM> extends further along the length of the catheter <NUM> in the proximal direction. In some embodiments the strip may go along half or the entire catheter from the catheter tip. The catheter <NUM> also provides an inner lumen for a guidewire and a steering wire for positioning.

Strip <NUM> enters the catheter on one side and is stretched by the felt holders <NUM>, <NUM> to the opposite side, where it is attached. In another embodiment a felt holder only holds the textile over the tissue wall and a fixation device as previously described with reference to <FIG> starts fixating it. The holder <NUM> can release the strip after it is felted to a soft tissue by being rotated (for example with a release cable), and the catheter tip can be moved along a surface to which the strip <NUM> is to be attached. The catheter tip can be moved along a desired route, which pulls out the strip <NUM> continuously. Once the strip is felted to the soft tissue over a desired length, the felt strip is cut by rotating the holder <NUM> further. The holder <NUM> includes a cutting edge. By rotating the holder <NUM> further, the strip is cut. Then, or beforehand the first holder is released as well. Thereby, a strip of feltable textile is applied similarly to a correction roller. The feltable textile strip can be advanced for example by manual or electrical means.

In the previous embodiments, the felting needle was moved linearly along the elongate direction of the respective catheters. However, the needle may also rotate or move in a direction orthogonal to the catheter. An example of such a needle is shown with respect to <FIG> shows a cross-section of a catheter <NUM> of a fixation device <NUM>. In the cross-section, a felting needle <NUM> that is connected with a rod <NUM> is shown. In the position shown in <FIG> and on the left side of <FIG>, the needle may be advanced through the catheter <NUM>. As can be seen from <FIG>, the needle may either be angled or curved, in particular curved along an arc, e.g. a circular circumference. Further as can also be seen from <FIG>, the rod <NUM> is arranged eccentrically in the catheter <NUM>. Once the needle exits a distal end of the catheter <NUM>, the rod <NUM> may be rotated around its axis as indicated by arrow <NUM>. Then, the needle <NUM> can be used to felt a strip of felt of the material <NUM> to a tissue <NUM> as shown in <FIG>. Since the rod <NUM> and thus the needle <NUM> are arranged eccentrically, tissue <NUM> and feltable textile <NUM> can be attached to each other. Similarly to the previous embodiments, the needle is moved back and forth with a reciprocal motion to felt tissue <NUM> and textile <NUM>. In this way, tissue laying in radial position relative to the catheter can be reached, e.g. in blood vessels.

Additionally, the eccentric position of the rod <NUM> may be changed by moving the rod <NUM> relatively to the catheter to another eccentric position. For example, as shown to the right in figure 10C, the rod <NUM> is movable along a circular path within the cross-section of the catheter <NUM> as indicated by arrow <NUM>. The rod <NUM> can be moved to different circumferential positions of the catheter <NUM>. The positions may be defined by an inner wall, e.g. inner catheter <NUM>, and a core <NUM>. The core <NUM> may be a tube for the guidewire and is arranged within the lumen of the inner catheter. Thereby, a space <NUM> is formed between the inner catheter <NUM> and the core <NUM> that extends along the length of the inner catheter <NUM> and the core <NUM>. In the example of figure 10C the space has the shape of a hollow cylinder.

<FIG> show a schematic view and a cross-section of a fifth fixation device. The fifth fixation device <NUM> includes an outer sheath <NUM> and a catheter <NUM>. The catheter <NUM> additionally comprises a distal tip portion <NUM> with a slot <NUM> for receiving a feltable textile <NUM> and tissue <NUM>. On an opposing side of a felting needle <NUM>, a distal counter surface of the slot <NUM> is arranged. The distal tip portion and the counter surface hold the feltable textile and the tissue in place during fixation by generating resistance and keeping feltable textile <NUM> and tissue <NUM> in place.

A further embodiment of a fixation device <NUM> is shown with reference to <FIG>. <FIG> show the fixation device <NUM> in isolation while <FIG> illustrates an example implantation of the fixation device <NUM> in the annulus of the aortic valve of a human. The fixation device <NUM> includes an outer sheath <NUM> and an inner sheath <NUM>. A holder <NUM> for an implant comprising a feltable textile is arranged at the distal end portion of the inner sheath <NUM>. The holder includes a plurality of arms <NUM> as can be seen in <FIG>. These arms <NUM> hold the feltable textile that forms an annuloplasty ring <NUM> for the aortic valve in the shown embodiment as can be seen from <FIG>. The arms <NUM> may clamp, grasp, be laced through the feltable textile or otherwise fixate the annuloplasty ring to hold the annuloplasty ring. Similarly to the holder <NUM>, the arms <NUM> may be made of a shape memory alloy or comprise one or more joints made of a shape memory alloy. Thus, when the arms are expelled from the outer sheath <NUM>, they fold out radially and bring the annuloplasty ring in a position in which the annuloplasty ring <NUM> can be attached to a soft tissue.

The embodiment shown in figures 11A to 12D additionally includes two felting needles <NUM> with a driving assembly comprising two arms <NUM>. The driving assembly is moved past the annuloplasty ring (i.e. through the hole of the ring) in the distal direction. Upon being expelled from the inner sheath <NUM>, the arms unfold or are unfolded, such that the felting needles at their end point in a distal direction. Then, the two felting needles are actuated such that the felting needles stitch the annuloplasty ring proximally from a distal direction and felt the annuloplasty ring to a soft tissue proximally behind the annuloplasty ring. The shown arrangement allows a user to control the pressure on the tissue by pulling at the inner sheath <NUM>. This is particularly of interest where the target zone (area in which surgical felting is performed) is behind anatomical structures such as e.g. valves. Alternatively, the needles themselves might be curved or angled such that their tips point in a distal direction.

One application of the above described fixation devices and feltable textile is a mitral valve repair, optionally with replacement/enhancement of the chordae tendineae. During diastole, the opening of the mitral valve lets blood flow from the left atrium to the left ventricle. During systole, the mitral valve closes, so that blood gets pumped through the aorta to the body. Patients suffering from mitral regurgitation have a mitral valve that does not close tightly, which allows blood to flow from the left ventricle back to the left atrium. Depending on cause and severity of the case, one approach is to replace or enhance the chordae tendineae; the cords that transmit the contraction and relaxation of the papillary muscles to the mitral valve. Access to the mitral valve may be gained percutaneously through the femoral vein and puncture of the septum. The catheter enters the mitral valve and fixates the first end of a textile patch to the papillary muscle. A second end is fixated at the leaflet and gets released by the catheter. Thereby, the chordae tendineae are supported by the feltable textile that are fixated strongly and durably. In particular, the device shown with respect to <FIG> might be used for this purpose.

Another application of the above described fixation devices and feltable textiles is an Atrial Septal Defect (ASD). ASD is a congenital heart defect that occurs, when the septum between the two atria is not developed properly and a hole remains. Depending on the size and location of the defect, the hole needs to be closed. The majority of cases can be treated by a transcatheter approach shown above. Access to the defect of the septum is gained percutaneously through the femoral vein into the right atrium. The elongate tubular member in the form of a catheter contains a central rod with a folded disk at the tip, which is guided through the hole into the left atrium. There, the feltable textile can be unfolded and expanded. A holder as described above may fixate the feltable textile. The pusher may also push the folded textile that will occlude the hole. It gets pushed through the catheter, unfolds once it exits the catheter and is pressed onto the septum. Two hollow tubes, each equipped with a barbed needle next to the central rod are guided to the patch. They fixate the edge of the patch by rotating (in this case <NUM>°) in both directions (clockwise and counterclockwise) and thereby occluding the hole as shown in <FIG>. Alternatively, this surgery could also be performed with a continuous deployed feltable textile as shown with respect to <FIG>.

Claim 1:
A minimally invasive fixation device (<NUM>; <NUM>; <NUM>; <NUM>; <NUM>; <NUM>; <NUM>; <NUM>) for fixating a feltable textile (<NUM>; <NUM>; <NUM>; <NUM>) at a target site in a human or animal comprising:
- an elongate tubular member (<NUM>) having a proximal end and a distal end, an interior lumen extending between the proximal end and the distal end, wherein the elongate tubular member is at least partially flexible,
- a needle assembly comprising at least one felting needle (<NUM>) arranged or arrangeable at the distal end of the elongate tubular member, wherein the at least one felting needle is movable relatively to the elongate tubular member, and wherein the at least one felting needle is movable with a reciprocal motion, and
- a drive assembly (<NUM>, <NUM>, <NUM>) arranged in the interior lumen of the tubular member, wherein the drive assembly is operably connected to the needle assembly for moving the at least one felting needle with the reciprocal motion when the at least one felting needle is located at the distal end such that the feltable textile can be fixated at the target site.