Minimally invasive fixation device for securing a moldable textile, kit comprising the fixation device and method for securing a moldable textile at a target site of a patient

Abstract

It is suggested to provide a minimally invasive fixation device (200) for securing a feltable textile (108) at a target site. The feltable material is secured at a target site of a human or animal and includes an elongated tubular member (202), a needle (209) and a drive assembly (204, 205, 210). The elongated tubular member has a proximal end and a distal end, and a lumen extending between the proximal end and the distal end. The needle assembly includes at least one felting needle (209) disposed at or disposable at the distal end of the elongated tubular member. The at least one felting needle is movable relative to the elongated tubular member, wherein the at least one felting needle is moved in a reciprocating motion. The drive assembly is disposed in the lumen of the tubular member and is operably connected to the needle assembly for moving the at least one felting needle in a reciprocating motion when the at least one felting needle is at the distal end, such that the feltable textile is capable of being secured at the target site.

Description

[0001] This disclosure relates to a minimally invasive fixation device for securing feltable textiles, a kit including the fixation device, and a method for securing feltable textiles to a target site on a patient.

[0002] Despite significant progress in treating cardiovascular disease, it remains the leading cause of death globally, according to the World Health Organization (WHO). Cardiovascular disease accounts for 50% of deaths in developing countries, but its prevalence is rising in developing nations as economies grow. Consequently, an increasing number of people require invasive cardiovascular interventional procedures each year.

[0003] Newborns with a ventricular septal defect (VSD) have a hole in the wall of their heart (the diaphragm) that separates the two lower ventricles. VSD is the most common heart defect and occurs when the baby's diaphragm is not fully developed during pregnancy. The exact cause is unknown. A recent study by the Centers for Disease Control and Prevention in Atlanta estimated that 42 out of every 10,000 babies are born with VSD.

[0004] In a healthy human heart, the right side pumps blood to the lungs, where it absorbs oxygen, and the left side pumps the oxygenated blood to the rest of the body. In infants with visually impaired cardiac stenosis (VSD), blood that should be on the left side of the heart leaks to the right. Therefore, all the excess blood is pumped back to the lungs. This forces the heart and lungs to work harder, increasing the infant's risk of developing other conditions. Typically, VSD is treated by closing the hole with an implant. In some techniques, VSD is treated with open-heart surgery.

[0005] Generally, open-heart surgery typically requires an incision along the sternum (median sternotomy) to perform cardiopulmonary bypass and temporary cardiac arrest (cardioplegia), allowing the procedure to be performed in a quiescent environment without blood flow. This highly invasive technique is unsuitable for patients considered high-risk due to their age, fragility, or medical condition, as it involves long recovery periods and risks of trauma and infection. Therefore, over the past decade, numerous minimally invasive procedures have been developed for a variety of cardiovascular indications, involving access to the heart via catheters through blood vessels (catheter-based cardiac surgery) or through very small incisions in the chest (minimally invasive cardiac surgery, MICS). These techniques have recently been extended to treat low- to intermediate-risk patients.

[0006] Many interventions depend on a particular type of implant, such as heart valve replacements, annuloplasty rings, vascular grafts, or septal defect repair. Typically, these are sutured into the body tissue to secure them in place, a process that must be performed with great care by a highly trained surgeon to achieve the desired outcome. Proper placement of sutures constitutes a significant portion of the surgical time and is sometimes challenging, even impossible, to execute. Furthermore, sutures may cut, open, or loosen, or they may slip through knots. Another disadvantage of sutures is that they concentrate stress at the site of placement.

[0007] An example of a connecting mechanism is disclosed in EP 3132811A1. EP 3132811A1 discloses a staple cartridge for suturing tissue. However, a disadvantage of suturing is that it applies relatively large forces and can damage the tissue. Furthermore, the distribution of the connecting force is concentrated around the staple, resulting in undesirable force transmission.

[0008] WO95 / 32756 discloses a catheter for retrograde perfusion of the heart via the coronary sinus. The catheter includes an inflatable balloon with a holding device. The inflatable balloon comprises spikes, felt, or a coating on the surface of the balloon as a holding device to securely hold the balloon in space. Although this document discloses a balloon as a holding device, the holding force is lost once the balloon deflates.

[0009] WO 2016 / 044762A1 describes apparatus and methods for manufacturing tubular structures from combinations of fibrous materials, and their use in tissue engineering scaffolds. The fibrous scaffold may comprise a nonwoven felt attached to another nonwoven felt via a connecting device comprising a plurality of needles. Thus, the fibers of the felt are entangled together.

[0010] The problem of this disclosure is to provide apparatus and methods for attaching implants to target sites within the body in a minimally invasive manner. Specifically, one object of this disclosure is to attach implants (e.g., cardiovascular implants) to human tissue in a robust and durable manner, while also simplifying the surgical procedure and thus saving critical time, which will allow for safer and more effective interventions. Another optional object of this disclosure is to attach implants in a uniform manner, thereby allowing for a uniform stress distribution of forces transmitted from and to the implant at the target site.

[0011] According to this disclosure, the problem is solved by a minimally invasive fixation device for securing feltable textiles, a kit including the fixation device, and a method for securing feltable textiles to a target site on a person or animal, as described herein. Alternative embodiments are described in detail herein.

[0012] In one aspect, a minimally invasive fixation device is proposed for securing a feltable textile to a target site. The feltable material is fixed to the target site in a human or animal. Preferably, the target site comprises soft tissue. The fixation device includes an elongated tubular member, a needle, and an actuation assembly. The elongated tubular member has a proximal end and a distal end, and an internal lumen extending between the proximal and distal ends. The elongated tubular member may be at least partially flexible. Preferably, the elongated tubular member is flexible along its entire length.

[0013] The textiles described herein can be understood as materials made of fibers, filaments, or yarns. The flexibility described herein can be understood as the ability of an elongated tubular member to bend, particularly when manipulating the tortuous path of a hollow organ (e.g., a blood vessel), and / or to become curved. The elongation described herein can be understood as the length of the tubular member being greater than its width (e.g., diameter). Preferably, the elongated tubular member is flexible along its entire length. Alternatively, the elongated tubular member may have one or more flexible portions. In some embodiments, "elongate" can be understood as the length of the tubular member being at least five times its width. The lumen may include a distal opening and a proximal opening.

[0014] The needle assembly includes at least one felting needle, which is disposed or may be disposed at the distal end of an elongated tubular member. The at least one felting needle is movable relative to the elongated tubular member, and is reciprocating. Reciprocating motion as described herein can be understood as forward and backward movement, particularly linear or circular forward and backward movement. The needle assembly may include 2, 3, 4, 5, 6, 7, 8, 10, or more needles. The more felting needles included in the needle assembly, the less reciprocating motion is required to form a sufficiently strong connection between the feltable textile and the target area.

[0015] The needle assembly felts the body's fibers and feltable textiles by interlacing animal or human soft tissue fibers with textile fibers, pushing the fibers from one to the other. Repeating this process creates a strong mechanical connection. The needle, its shape, and mechanism are detailed in the applicant ZuriMED Technologies AG's application PCT / CH2019 / 000015.

[0016] A drive assembly is disposed within the cavity of the tubular member and operatively connected to the needle assembly for reciprocating movement of at least one felting needle when at least one needle is located distally, thereby securing the feltable textile to a target location. The drive assembly may be fixedly connected to the elongated tubular member or may be movable relative to the elongated tubular member. For example, the drive assembly may include a thread extending through the cavity of the elongated tubular member. In some embodiments, the drive assembly is entirely disposed within the cavity, while in other embodiments, only a portion of the drive assembly is disposed within the cavity.

[0017] Additionally, the fixing device may include an actuator or motor for actuating the drive assembly. The actuator may be an electric, mechanical, hydraulic, and / or pneumatic motor. The at least one felting needle may be driven by a pneumatic, hydraulic, or electromagnetic actuator or motor. The actuator may be disposed inside or outside the elongated tubular member. The actuator may be disposed at or operatively connected to the distal end of the drive assembly. The actuator may be disposed in the proximal or distal portion of the fixing device. In some embodiments, the actuator may be disposed in the distal end of the fixing device such that reciprocating motion does not need to be transmitted from the proximal end of the elongated tubular member to at least one felting needle.

[0018] This fixation device provides a minimally invasive approach that allows feltable textiles to be unfolded, positioned, and secured to human or animal tissue. It offers reliable fixation while minimizing navigation and multi-degree-of-freedom issues that can arise when suturing in hard-to-reach locations.

[0019] The diameter of the slender tubular member can range from 2 Fr to 30 Fr, more specifically from 4 Fr to 26 Fr, and even more specifically from 12 Fr to 22 Fr. These ranges correspond to suitable sizes for atria or venous access to the heart.

[0020] The terms “proximal” and “distal” used in this article are defined from the perspective of the user of the percutaneous fixation device, specifically from the perspective of medical professionals using the device, such as surgeons.

[0021] Feltable textiles may contain or be composed of absorbable fibers, particularly polyglycolic acid, polylactic acid, polydioxane, or caprolactone. As described herein, the term "absorbable" may refer to materials that degrade after implantation in the human or animal body.

[0022] In some embodiments, feltable textiles comprise or consist of non-absorbable fibers, particularly silk, polypropylene, polyester, or polyamide. As described herein, the term "non-absorbable" refers to materials that do not degrade after implantation in the human or animal body.

[0023] In some embodiments, feltable textiles comprise or consist of a combination of absorbable fibers (particularly polyglycolic acid, polylactic acid, polydioxanone or caprolactone) and non-absorbable fibers (particularly filament, polypropylene, polyester or polyamide).

[0024] In some embodiments, the fibers of the feltable textiles comprise or consist of biocompatible polymers, particularly polyethylene (PE, CAS No.: 9002-88-4), polytetrafluoroethylene (PTFE, CAS No.: 9002-84-0), polyethylene terephthalate (PET, CAS No.: 25038-59-9), poly(glycolic acid) (PGA, CAS No.: 26124-68-5), poly(lactic-co-glycolic acid copolymer) (PLGA, CAS No.: 26780-50-7), poly(L-lactic acid) (PLLA, CAS No.: 33135-50-1), polycaprolactone (PCL, CAS No.: 24980-41-4), 1,2-propanediol (PDO, CAS No.: 57-55-6), or 1,3-propanediol (PDO, CAS No.: 504-63-2).

[0025] In some embodiments, feltable textiles may also be made from decellularized collagen tissue derived from human or animal sources.

[0026] In a preferred embodiment, the drive assembly is adapted to drive reciprocating motion at a predetermined frequency. The frequency is preferably in the range of 1 Hz to 1 kHz. This range is further preferably 5 Hz to 500 Hz, 10 Hz to 200 Hz, and 50 Hz or 200 Hz, most preferably 20 Hz to 120 Hz. At these frequencies, the felting needle can move without tearing the material monofilaments while providing sufficient amplitude. Simultaneously, the feltable material can be quickly attached to the target area.

[0027] In a preferred embodiment, the drive assembly is adapted to drive the reciprocating motion with an amplitude of 2 mm to 25 mm, particularly preferably 5 mm to 20 mm, further preferably 8 mm to 12 mm, and most preferably 8 to 12 mm. These amplitudes cover a sufficiently thick feltable textile while piercing the target soft tissue and creating a sufficiently strong connection between the feltable material and the target site.

[0028] In a preferred embodiment, the fixation device further includes a feltable textile. The feltable textile is configured, or can be configured, such that at least one needle pierces the feltable textile through reciprocating motion. More preferably, the at least one needle is configured to pierce the feltable textile and enter the target site. Thus, the fixation device and the feltable textile are provided as a unit and are ready for use at the target site. As a result, only a single minimally invasive device, or at least fewer, needs to be inserted into the human or animal body.

[0029] In a preferred embodiment, at least one felting needle points towards the distal end of the elongated tubular member. This arrangement allows access to a target area located near the distal tip of the elongated tubular member. Furthermore, this allows for pressing feltable textiles onto the target area, improving felting performance. Additionally, the needle can be radially compact, providing a simple actuation mechanism.

[0030] In a preferred embodiment, the reciprocating motion of at least one felting needle is linear, particularly preferably along the direction of the elongated tubular member. In an alternative embodiment, the reciprocating motion is rotational, preferably about the axis of the elongated tubular member. The type of reciprocating motion can be selected based on the location of the feltable textile and the target site. Linear motion is preferred if the feltable textile is discharged at the distal end of the elongated tubular member and fixed at the target site at its distal or proximal end. Rotational motion may be preferred if the feltable textile is fixed to, for example, a container positioned radially on the elongated tubular member. For example, feltable textiles for internal grafts used to treat aneurysms can preferably be fixed by rotational motion. Annuloplasty rings or heart valves can preferably be connected with linear motion.

[0031] In a preferred embodiment, the drive assembly includes an elongated drive line or tube extending from the proximal end of the elongated tubular member to the needle assembly. The elongated drive line or tube is operatively connected to the needle assembly such that driving the elongated line or tube causes reciprocating motion of at least one felted needle. Thus, thrust and / or tension can be transmitted from the proximal end of the elongated tubular member to the distal end of the elongated tubular member.

[0032] The slender tubular components described herein may be described as conduits or sheaths (i.e., external or internal conduits or sheaths).

[0033] In a preferred embodiment, the drive assembly includes an elastic element configured such that when at least one felting needle is actuated by the elongated drive line or tube, the elastic element forces the at least one felting needle back to a predetermined position. Thus, reciprocating motion is transmitted to at least one felting needle. Alternatively, the elongated drive line or tube transmits both thrust and tension forces simultaneously. In this case, the elongated drive line or tube can be sufficiently rigid to transmit compressive forces.

[0034] In a preferred embodiment, an elongated drive wire or tube is configured to transmit tension and, optionally, compressive force to the needle assembly along its elongated direction, such that the wire actuates the reciprocating motion of the at least one felted needle. In a preferred embodiment, the wire or tube is made of steel and can be formed into a steel cable.

[0035] The elongated drive wire or tube includes a low-friction coating on its outer surface. For example, the coating may be a polytetrafluoroethylene (PTFE) coating. Therefore, forces (i.e., compressive or tensile forces) along the longitudinal direction are effectively transmitted.

[0036] In a preferred embodiment, the elongated tubular member includes at least one guide element for the drive assembly within the cavity. The at least one guide element preferably positions the elongated drive line or tube at the center of the elongated tubular member along its radial direction. This reduces bending of the elongated drive line or tube, thereby improving the efficiency of force transmission along the longitudinal direction. Furthermore, vibration within the elongated tubular member can be reduced during the operation of the felting needle. The guide element may also include a low-friction coating to reduce friction between the elongated drive line or tube and the guide element. This improves the guidance and force transmission of the drive line or tube.

[0037] In a preferred embodiment, the feltable textile has the shape of a strip or patch. More preferably, the textile has an annular shape and / or forms an annulusoplasty ring or a portion thereof. Felt annulusoplasty rings are particularly advantageous because the remodeling of the cardiac annulus requires a particularly strong and durable connection due to the contraction and expansion of the cardiac valve annulus.

[0038] In a preferred embodiment, the fixation device further includes a retaining component for the feltable textile, wherein the retaining component includes at least one retainer for securing the textile to the retaining component. The textile is in a folded position. Therefore, the textile and / or the implant comprising the textile has a compact shape and can be advanced to the target site. Furthermore, only a minimally invasive device comprising a felting needle and a retaining component with feltable textile needs to be inserted.

[0039] In a preferred embodiment, the retaining device further includes a tube having a tubular outer sheath at a distal end. The retaining component is movable relative to the outer sheath and, upon discharge from the distal end of the outer sheath, is positioned in an unfolded position, allowing the textile to unfold. The retaining component may be made of a shape memory alloy, such as nitinol.

[0040] Another aspect relates to a kit that includes the fixation device described above and an implant comprising feltable textiles.

[0041] Another aspect relates to a kit that includes the fastening device and guide wire as described above. Feltable textiles can be attached to or can be attached to the guide wire.

[0042] Another aspect relates to a kit comprising a fixing device and a pusher, preferably a push rod, as described above. The pusher is adapted to push a feltable textile to a target location. The pusher may include a distal face and may be configured to be disposed within an elongated tubular member. The feltable textile may be disposed on the distal face of the pusher.

[0043] Another aspect relates to a method for securing feltable textiles to a target site in a patient using a minimally invasive fixation device. The fixation device is preferably one as described above. The method includes the step of guiding a flexible, elongated tubular member from within a human or animal body to the target site. The flexible, elongated tubular member has a proximal end, a distal end, and a lumen. The lumen extends between the proximal and distal ends. An actuated needle assembly is included. The needle assembly includes at least one felted needle disposed at or potentially disposed at the distal end of the elongated tubular member. The needle assembly is actuated by moving the at least one felted needle relative to the elongated tubular member using a drive assembly disposed within the lumen of the tubular member. The drive assembly is operatively connected to the needle assembly and moves the at least one felted needle in a reciprocating motion, thereby securing the feltable textile to the target site.

[0044] The fixation devices, kits, and methods described herein can be used to repair and fix the anatomical structures of the circulatory system (heart and blood vessels), securing implants to these structures to create artificial speed bumps (septal trabeculae) to prevent or treat heart failure with dilated ventricles or closure of septal defects. Specifically, they can treat cardiac defects (e.g., patent foramen ovale, atrial septal defect, ventricular septal defect, patent ductus arteriosus, paravalvular leak closure), heart valve repair and replacement (e.g., aortic valve replacement, mitral valve repair or replacement, tricuspid valve repair or replacement, annuloplasty, chordae tendineae repair), edge-to-edge repair of heart valves and parts such as commissures, vascular repair (e.g., aortic dissection, aneurysm, atherosclerosis), ischemic heart disease (cardiovascular closure, reinforcement of ischemic ventricles), and other degenerative cardiovascular diseases.

[0045] In another aspect, it is proposed to provide a minimally invasive fixation device for securing feltable textiles to a target site as described above. One end of the at least one felting needle may be oriented or oriented in a generally distal direction. A generally distal direction can be understood as having a distal component. Preferably, the angle between the distal direction and the end of the felting needle is less than 60°, less than 45°, or less than 30°, or the end of the felting needle is directly oriented in a distal direction. Therefore, the user can control the pressure acting on the tissue and fabric by pulling rather than pushing the fixation device. This is particularly interesting when the target site (e.g., the area where surgical felting is performed) is located behind anatomical structures (e.g., valves). In particular, the needles may be bent or angled such that at least one felting needle is oriented in a generally distal direction.

[0046] The fixation device may additionally include feltable textile, and at least one felted needle may be adapted to pierce the feltable textile distally. The fixation device may include a retention component for the implant at the target site, and the retention component may be adapted to apply force to the implant distally. Greater force may be applied distally, particularly when the elongated tubular member is bent.

[0047] The fixation device may additionally include an implant, particularly an annulusop ring or heart valve, wherein felted textiles are applied to the implant.

[0048] The at least one felted pin includes a deformable joint, particularly a shape memory alloy, such that the at least one felted pin points in a generally distal direction when discharged from the inner cavity of the elongated tubular member.

[0049] In another aspect, it is proposed to provide a minimally invasive fixation device for securing feltable textiles to a target site as described above. The drive assembly is adapted to move at least one felting needle in a direction substantially perpendicular to the elongated tubular member in a reciprocating motion.

[0050] The at least one felting needle is preferably configured to rotate about an axis during reciprocating motion. This axis can be the axis of an elongated tubular member, preferably a central axis or an eccentric axis. Therefore, efficient transmission of reciprocating motion to at least one felting needle is provided.

[0051] In a preferred embodiment, the drive assembly includes a drive rod operably connected to at least one felting needle. The drive rod is configured to transmit torque to the needle assembly for rotating the at least one felting needle in the reciprocating motion.

[0052] In a preferred embodiment, the drive rod and / or at least one felting needle are located at an eccentric position within the cavity of the elongated tubular member. Therefore, at least one felting needle can advance into the cavity of the elongated tubular member.

[0053] In a preferred embodiment, the at least one felted needle is directed, or may be directed, in a direction substantially perpendicular to the elongated tubular member. In this way, tissue at a radio-position relative to the catheter can be reached. For example, felted textiles can be attached to the blood vessel wall, through which the elongated tubular member can advance.

[0054] In a preferred embodiment, the at least one felted needle is bent or angled such that the distal tip of the needle points substantially perpendicular to the direction of the elongated tubular member. The at least one felted needle may have a circular curvature.

[0055] In another aspect, it is proposed to provide a minimally invasive fixation device for securing feltable fabric to a target site as described above. The fixation device may include a tubular outer sheath having a distal end, wherein an elongated tubular member is disposed within the outer sheath, and wherein the elongated tubular member is bendable, particularly when the elongated tubular member is displaced from the distal end of the outer sheath, such that the distal end of the elongated tubular member can be manipulated by rotating the elongated tubular member. Thus, a needle assembly can be guided to the feltable textile. Specifically, the needle assembly is rotatable, allowing the feltable textile to be secured along a circular track.

[0056] Elongated tubular members may include a low-friction outer coating, such as PTFE, or be made of a low-friction material. Optionally or additionally, the outer sheath may include a low-friction outer coating (e.g., PTFE) or be made of a low-friction material. As used herein, any coating that reduces friction compared to the substrate can be considered a low-friction coating. A combination of materials that results in a dynamic coefficient of friction of less than 0.1 can be considered “low friction” (e.g., PTFE to Teflon, or Teflon to steel approximately 0.04).

[0057] In a preferred embodiment, the elongated tubular member includes a joint between its distal and proximal ends, wherein the elongated tubular member is bendable at the joint. Particularly preferably, the joint comprises a shape memory alloy. The joint may assume a bent position when discharged from the outer sheath.

[0058] In addition, the elongated tubular member may include a wire or cable or a pneumatic or hydraulic mechanism for rotating the elongated tubular member about its axis.

[0059] In another aspect, a minimally invasive fixation device is proposed for securing feltable textiles to a target site as described above. The elongated tubular member may include a distal tip at least partially disposed at the distal end of the at least one felting needle, wherein the distal tip includes a proximal opposing surface opposite the at least one felting needle for holding the textile in place during fixation. Thus, tissues of a human or animal body can be held, e.g., clamped in place, during felting. In an alternative embodiment, the distal tip may also be disposed proximal to the at least one felting needle.

[0060] In a preferred embodiment, the distal tip includes a slot for receiving the feltable textile. The slot is partially formed by the opposing distal surface.

[0061] In a preferred embodiment, the distal tip may be formed by one, two, three or more tongues, which are configured to provide a distal opposing surface for felting.

[0062] In another aspect, it is proposed to provide a minimally invasive fixation device for securing a feltable textile to a target site as described above. The fixation device may further include a textile retainer and a feltable textile. At least a portion of the feltable textile is held at the distal end of the elongated tubular member by the textile retainer, such that the feltable textile at least partially covers the needle assembly. The at least one felted needle is configured to pierce the feltable textile.

[0063] In a preferred embodiment, the feltable textile has an elongated shape, a first end, a middle portion, and a second end along the elongated extension. The elongated tubular member includes at least one, preferably two, guide openings, preferably slots, for retaining the feltable textile such that the feltable textile at least partially covers the needle assembly. Therefore, the feltable textile can be held in place during transport and during fixing.

[0064] In a preferred embodiment, the textile retainer includes a clamp for frictional engagement between the feltable textile and the textile retainer. More preferably, the conduit assembly includes a textile retainer release mechanism for releasing the textile from the textile retainer, the textile retainer release mechanism preferably including a textile release cable. Thus, the feltable textile can be released from the retaining device. In a further preferred embodiment, the conduit assembly includes a cutting edge, preferably including a rotating cutting edge for cutting the feltable textile. The cutting edge can be rotatable, which allows easy actuation of the textile cutting mechanism.

[0065] Non-limiting embodiments of this disclosure are described by way of example only with reference to the accompanying drawings. The drawings and their description provide examples of this disclosure, and various features may be used individually or in combination with each other.

[0066] Figure 1A : This is a schematic diagram of the end of the first fixing device in the first stage of fixing.

[0067] Figure 1B :yes Figure 1A A schematic diagram of the fixing device at the end of the fixed second stage.

[0068] Figure 2A :yes Figure 1A A schematic diagram of the fixing device at the end of the third fixing stage.

[0069] Figure 2B :yes Figure 1A A schematic diagram of the fixing device at the end of the fixed fourth stage.

[0070] Figure 3 A schematic cross-sectional view of the second fixing device is shown.

[0071] Figures 4A to 4C A schematic diagram of a third fastening device with a textile patch and an outer sheath is shown.

[0072] Figures 5A to 5C A schematic diagram of a third fastening device is shown, consisting of a textile patch in the form of a petiole ring and an outer sheath.

[0073] Figure 6 : A schematic diagram of a third fixation device with textile patches after implantation is shown.

[0074] Figure 7 : This is a schematic diagram of the end of the fourth fixing device.

[0075] Figures 8A to 8B : This is a schematic diagram of the fourth fixing device during the fixing process.

[0076] Figures 9A to 9C : is a cross-sectional view showing a portion of a fastening device in an exemplary embodiment of the needle assembly.

[0077] Figures 10A to 10B A schematic diagram and cross-section of the fifth fixing device are shown.

[0078] Figures 11A to 11D This is a schematic diagram of the end of the sixth fixing device at the four fixing stages.

[0079] Figure 12 : is Figure 2B A schematic diagram of a cross-section of the human heart after fixation, showing the end of the fourth stage of fixation of the fixation device.

[0080] Figures 1A to 2B An end of a first embodiment of the fixation device 100 is shown. The fixation device 100 includes an elongated tubular member implemented as a catheter 102. The catheter 102 can be inserted into a human or animal body, for example, through a short sheath with a valve (i.e., an inlet). An example of inserting such a short sheath to access blood vessels and other hollow organs is the Seldinger technique. Before inserting the catheter 102, a guidewire 101 is inserted. The guidewire 101 guides the blood vessel to a target site, such as a specific segment of the vessel, such as a heart valve or lesion. The catheter 102 is then pushed past the guidewire 101 to reach the target site.

[0081] exist Figure 1A The image shows the catheter 102 having reached the target site. Subsequently, hooks 104 and 105 are deployed (see [link]). Figure 1B Hooks 104 and 105 may include sharp tips to anchor the device in soft tissue, thereby holding the device in place at the target site. Hooks 104 and 105 may pierce the tissue or reach behind the tissue and pull the tissue toward the catheter 102. Alternatively, guidewire 101 may retract after catheter 102 reaches the target site, and a second catheter 103 including hooks 104 and 105 may be introduced.

[0082] In the next step, the pusher 106 advances over the guidewire 101 or over the second conduit 103 through the conduit 102. At its distal end, the pusher 106 includes a flat surface. On this flat surface, a folded patch 108 made of feltable textile is disposed and pushed through the lumen of the conduit 102. Figure 2A As shown, when the folded patch is discharged from the distal end of the catheter 102, it is as follows: Figure 2BThe pusher 106 has a flat side at its distal end for pushing the patch 108 against the tissue of a person or animal. To prevent the patch 108 from moving, the pusher includes two barbed needles 110, 111 that are deployed, i.e., moved distally through the patch and into the tissue of the person or animal to hold the patch in place. A felting needle 109 is then moved through the patch 108 and into the soft tissue of the person or animal to hold the patch in place. The felting needle 109 is then retracted again by moving the needle proximally. This forward and retraction is repeated at a frequency of 60 Hz. By repeatedly pushing the needle 109 through the patch 108, the fibers of the patch 108 are pushed or pulled through the patch 108 into the soft tissue 3 by means of the needle 109 to create a strong bond between the feltable textile of the patch and the soft tissue. As described in PCT / CH2019 / 000015, this process can be supported by needles that additionally include felt barbs. The patch 108 is then secured to the target site.

[0083] By rotating the catheter 102 around the second catheter 103, the needle can move on the surface of the patch 108. To cover a larger area, this can be repeated by navigating the catheter 102 to a new target site on the patch.

[0084] Figure 3 A cross-sectional schematic diagram of the second fixing device is shown. Figure 3 The diagram illustrates how felted needles, such as felted needle 109, can be actuated. Patches of feltable material, such as patch 108, can be attached to target sites in cardiovascular, urinary, gastrointestinal, or neurovascular regions. Typically, this requires following the winding path of the corresponding hollow organ (e.g., a blood vessel). Therefore, flexible catheters, sometimes soft catheters, are used to conform the catheter to the shape of the hollow organ. However, this presents a challenge for actuating the needle through reciprocating motion. Especially when the fixation device includes a motor driving the felted needle, this motion needs to be transmitted to the felted needle via a drive assembly. (See reference...) Figure 3 An example of such a driver component is shown. Figure 3 A fastening device 200 with felted needles 209 is shown. An actuator (not shown) generates reciprocating motion and is directly connected to a drive line 210. The drive line 210 is pulled by a motor in the proximal direction. Similar to fastening device 100, fastening device 200 includes an elongated tubular member implemented as a conduit 202. Figure 3 As can be seen, catheter 202 is flexible along its entire length and bends around a curve. The drive line 210 is held and guided within catheter 202 by a guiding element. The guiding element can be, for example... Figure 3The concentric lead element 201 is shown. The concentric lead element 201 is circular, annular, and extends from the inside of the conduit. These elements 201 preferably also have a low friction index to allow for optimal guidance and force transmission. This feature reduces bending forces and ultimately reduces vibration during application. The concentric guide element 201 centers the drive wire within the conduit 210, thereby preventing the drive wire from bending or twisting within the conduit outside the bend of the conduit 202. The concentric lead element is covered with a PTFE coating to reduce friction between the drive wire 210 and the lead element. Additionally or alternatively, the drive wire may also include a similar or different friction-reducing (low-friction) coating.

[0085] The conduit 202 includes a linear bearing 203 at its distal end. Furthermore, the conduit 202 includes a spring coil 204 and a felted needle 209 at its distal end. A drive wire 210 is rigidly connected to or forms the felted needle 209 and is connected to the distal end of the spring coil 204 via a washer 205. The spring coil, on the other hand, contacts the linear bearing 203. When the wire 210 is pulled, the needle 209 retracts, and the spring 204 is compressed between the linear bearing 203 and the washer 205. When the wire 210 is released, the spring coil presses the felted needle forward. As is known in the art, the amplitude (penetration depth) and frequency of the felted needle's movement can be adjusted, and a suitable spring with a resonant frequency within a desired range can be selected.

[0086] If a sufficiently rigid drive line (e.g., a steel cable) capable of transmitting compressive and tensile forces from one end of the conduit to the other is used, the spring 204 can be avoided. As an alternative to the aforementioned drive assembly, which includes an elastic element (spring 204) and a drive line, the needle-piercing mechanism can be driven by a pneumatic, hydraulic, or electromagnetic actuator.

[0087] Figures 4A to 4C A schematic diagram of a third fastening device 300 having a textile patch 308 and an outer sheath 302 is shown. Specifically, Figures 4A to 4C This illustrates one embodiment of how a patch of feltable textile 308 can be attached to a target area of ​​soft tissue. Figures 4A to 4C In this embodiment, a feltable textile 308 advances along with a guidewire 301. As is known in the art, in the first step of a procedure, the guidewire 301 is guided to the target site. The tip of the guidewire is angled, for example by having a J-shape, thereby allowing navigation through hollow organs (e.g., blood vessels). Once the guidewire 301 is at the target site, an outer sheath 302 advances over the guidewire into the human or animal body. The outer sheath 302 includes an inner lumen through which another outer conduit 303 advances. The outer conduit 303 includes an inner conduit 305. The inner conduit 305 may be a catheter, for example, as described in [reference needed]. Figure 3The described catheter 200. The patch 308 may be provided with a small hole or simply pierced by the guidewire. The patch can then be advanced on the guidewire 301 using a separate pusher (not shown). Alternatively, when the guidewire is inserted, the patch 308 may advance along with the guidewire 301, or by being pushed onto the guidewire 301 together with the outer sheath 302 or with the external or internal catheters 303, 305.

[0088] Furthermore, the inner conduit 305 includes a connector 304. The connector may include an elastic element, such as a coil or elastic material, and a bearing, such as a pivot bearing. The elastic element is prestressed, forcing the inner conduit to bend around the connector 304 around the bearing. For example, the elastic material may be compressed, which would cause the inner conduit to bend to the opposite side, or the elastic material may be stretched, which would cause the inner conduit to bend to one side of the elastic material. In one example, the angle of the connector can be controlled by the user using a line that pulls on the elastic element.

[0089] Alternatively or additionally, the connector 304 is made of shape memory alloy. Furthermore, upon exiting from the outer conduit 303, the connector bends the inner conduit 305 at a predetermined angle. This angle can be controlled by the axial position of the inner conduit 305 relative to the outer conduit. This allows the needle to cover a larger felt area on the patch.

[0090] The predetermined angle can be less than 90°, preferably less than 60°, more preferably less than 45°, and particularly preferably about 30°. Due to the bend at the connector, the rotation of the inner catheter 305 about its own axis is similar to manipulating the distal tip of the inner catheter 305 with a guidewire having a J-shaped end. Therefore, the end of the inner catheter with the felted needle can be guided to the desired position. Specifically, as follows... Figure 4B and 4C As shown (see arrows 309, 310), the steerable inner conduit rotates about its own axis, thereby using felting needles to attach the circumference of patch 308 to the target site. The relative positions of the inner conduit 305 and the outer conduit 303 are adjustable. For example, in a first relative position, the connector can terminate at an angle of 15°, while in a second position, this angle can be 30°. This allows for a fixed inner diameter. For example, the further the outer conduit 303 retracts, the deeper the inner conduit 305 is bent. Therefore, by rotating the inner conduit and changing the angle of connector 304, the entire surface of a suitable material can be attached to the target site.

[0091] Reference Figures 5A to 6A specific application of the above-described technology is illustrated. In this application, the feltable textile 408 forms an annuloplasty ring. Annuloplasty is a surgical procedure that tightens or reinforces the ring surrounding a heart valve (valvular annulus). The annuloplasty ring reshapes, strengthens, and / or tightens the ring surrounding the heart valve, thereby preventing backflow, for example, through the valve. The external catheter 403 includes a retainer 409 for the annular feltable textile 408. The retainer has a mesh structure and is made of a shape memory alloy that expands upon discharge from the outer sheath 402. The retainer 409 includes a releasable anchor that clamps the feltable textile. As the retainer is discharged distally, it spans the feltable textile 408. Then, similar to... Figures 4A to 4C The inner catheter 305, and the inner catheter 405 advance through the outer catheter 403. Similar to... Figures 4A to 4C The inner catheter 305 and inner catheter 405 include a flexible connector. An annulusopreservation ring 408 is attached to the annulus of the heart valve by rotation about the axis of the inner catheter. The annulusopreservation ring is pressed against the tissue by pushing the catheter 400 in the proximal direction. The result of this procedure is as follows: Figure 6 As shown. Here, the annulusoplasty ring 408 connects to the mitral valve of the human heart on the left atrial side.

[0092] Figures 7 to 8B Another embodiment of the fastening device 500 is shown. The fastening device 500 includes an elongated tubular member formed as a conduit 502. In this fastening device, a suitable textile is provided as an elongated feltable textile strip 508 (e.g., an elongated patch or braided stitch). The feltable textile strip 508 extends along the tip surface of the conduit 500 and enters two slots 509 disposed at the tip of the conduit 500. Figure 8A and 8B A view showing the removal of catheter 502 is provided. Figure 8A and 8B It can be seen that the fixing device includes and Figure 3 The device consists of components similar to those in a conduit. Specifically, it includes a spring coil, a linear bearing, a drive line, a washer, and a felted needle that can advance and retract with the drive line.

[0093] In addition, the device includes two retainers 510, 511 for the strip 508. The first retainer 510 clamps one end of the strip 508. The second retainer 511 also clamps the strip 508. On one side of the second retainer, the strip 508 extends further along the length of the catheter 502 in the proximal direction. In some embodiments, the strip may extend from the catheter tip along half or the entire length of the catheter. The catheter 502 also provides a lumen for the guidewire and the manipulator line for positioning.

[0094] The strip 508 enters the catheter on one side and is stretched to the opposite side by felt retainers 510, 511, where it is joined. In another embodiment, the felt retainer simply holds the textile to the tissue wall, and as previously referenced. Figure 3 The aforementioned securing device begins to secure it. The retainer 511 can release the strip after it has been felted onto the soft tissue by rotation (e.g., with a release cable), and the guide tip can move along the surface to which the strip 508 is attached. The guide tip can move along a desired path, which continuously pulls out the strip 508. Once the strip has been felted onto the soft tissue at the desired length, the felt strip is cut by further rotating the retainer 511. The retainer 511 includes a cutting edge. By further rotating the retainer 511, the strip is cut. The first retainer is then released, or pre-released. Thus, feltable textiles are similarly applied to the correction roller. The feltable textile strip can be advanced, for example, manually or electrically.

[0095] In the preceding embodiments, the felting needle moves linearly along the elongation direction of the corresponding catheter. However, the needle can also rotate or move in a direction perpendicular to the catheter. See reference... Figures 9A to 9C An example of this needle is shown. Figure 9A A cross-sectional view of the conduit 605 of the fixing device 600 is shown. In the cross-sectional view, the felted needle 602 connected to the rod 601 is shown. Figure 9A The positions shown and Figure 9C On the left side, the needle can advance through catheter 605. From Figures 9A to 9C It can be seen that the needle can be angled or curved, especially curved along an arc, such as a circle. Furthermore, from... Figures 9A to 9C It can also be seen that the rod 601 is eccentrically positioned within the guide tube 605. As indicated by arrow 606, once the needle leaves the distal end of the guide tube 605, the rod 601 can rotate about its axis. Then, as... Figure 9B As shown, needle 602 can be used to felt a felt strip of material 603 onto tissue 604. Due to the eccentric arrangement of bar 601 and needle 602, tissue 604 and feltable textile 603 can be connected to each other. Similar to the previous embodiment, the needle moves back and forth in a reciprocating motion between the feltable tissue 604 and textile 603. This allows access to tissue, such as a blood vessel, located radially relative to the conduit.

[0096] Furthermore, the eccentric position of rod 601 can be changed by moving rod 601 relative to the conduit to another eccentric position. For example, as Figure 9CAs shown on the right, rod 601 is movable along a circular path within the cross-section of conduit 605, as indicated by arrow 607. Rod 601 can be moved to different circumferential positions of conduit 605. These positions can be defined by an inner wall (e.g., inner conduit 608) and a core 609. Core 609 can be a tube for a guidewire and is disposed within the lumen of the inner conduit. Thus, a space 610 is formed between the inner conduit 608 and the core 609, extending along the length of the inner conduit 608 and the core 609. Figure 9C In the example, the space has the shape of a hollow cylinder.

[0097] Figures 10A to 10B A schematic diagram and cross-sectional view of the fifth fixation device are shown. The fifth fixation device 700 includes an outer sheath 701 and a conduit. The conduit 702 also includes a distal tip 706 having a slot 707 for receiving feltable textiles and tissues 703. On the opposite side of the felting needle 704, a distal opposing surface 708 of the slot 707 is provided. During fixation, the distal tip and the opposing surface 708 hold the feltable textiles and tissues in place by generating resistance and holding them in place.

[0098] Reference Figures 11A to 12 Another embodiment of the fixing device 800 is shown. Figures 11A to 11B A separate fixing device 800 is shown, while Figure 12 An example of implanting a fixation device 800 into a human aortic valve annulus is shown. The fixation device 800 includes an outer sheath 801 and an inner sheath 802. A retainer 803 for an implant comprising a feltable textile is disposed at the distal end of the inner sheath 802. Figure 11A As shown, the retainer includes multiple arms 804. Figures 11B to 12 As shown, in the illustrated embodiment, these arms 804 hold the felted fabric forming the aortic valve annulusoplasty ring 805. The arms 804 can clamp, grip, pass through the felted textile, or otherwise secure the annulusoplasty ring to retain it. Similar to the retainer 409, the arms 804 can be made of shape memory alloy or include one or more connectors made of shape memory alloy. Thus, as the arms are discharged from the outer sheath 802, they fold radially outward and bring the annulusoplasty ring to a location where the annulusoplasty ring 805 can be attached to soft tissue.

[0099] Figures 11A to 11DThe illustrated embodiment also includes two felting needles 806 having a drive assembly comprising two arms 807. The drive assembly moves distally through the annulusoplasty ring (i.e., through a hole in the ring). When discharged from the inner sheath 802, the arms unfold such that the felting needles point distally at their ends. The two felting needles are then actuated such that they suture the annulusoplasty ring proximally from distal to distal, felting the annulusoplasty ring to the posterior proximal soft tissue. The illustrated setup allows the user to control pressure on the tissue by pulling the inner sheath 802. This is particularly interesting when the target area (the area in which surgical felting is performed) is located behind anatomical structures such as valves. Alternatively, the needles themselves may be curved or angled such that their tips point distally.

[0100] One application of the aforementioned fixation device and feltable textile is mitral valve repair, optionally replacing / reinforcing the chordae tendineae. During diastole, the opening of the mitral valve allows blood to flow from the left atrium to the left ventricle. During systole, the opening of the mitral valve allows blood to flow from the left atrium to the left ventricle. During systole, the mitral valve closes, so blood is pumped throughout the body via the aorta. In patients with mitral regurgitation, the mitral valve does not close properly, causing blood to flow back from the left ventricle to the left atrium. Depending on the cause and severity of the condition, one approach is to replace or reinforce the chordae tendineae; the chordae tendineae transmit the contraction and relaxation of the papillary muscles to the mitral valve. Percutaneous access to the mitral valve can be made via femoral vein and diaphragmatic puncture. A catheter enters the mitral valve and secures the first end of the textile patch to the papillary muscles. The second end is secured to the leaflet and released through the catheter. Thus, the chordae tendineae are supported by a strong and durable feltable textile. Specifically, see [reference needed]. Figures 7 to 8B The apparatus shown can be used for this purpose.

[0101] Another application of the aforementioned fixation device and feltable textile is for atrial septal defects (ASD). ASD is a congenital heart defect that occurs when the septum between the two atria develops abnormally, leaving a hole. Depending on the size and location of the defect, the hole needs to be closed. Most cases can be treated using the aforementioned transcatheter method. The ASD can be accessed percutaneously through the femoral vein into the right atrium. The catheter-like, elongated tubular structure includes a central rod with a folded disc at its tip, which is guided through the hole into the left atrium. There, the feltable textile can be unfolded and expanded. A retainer, as described above, secures the feltable textile. A pusher also pushes the folded textile to close the hole. It is pushed through the catheter, unfolds once out of the catheter, and is pressed against the septum. Two hollow tubes, each equipped with a barbed needle next to the central rod, are guided onto the patch. They secure the edges of the patch by rotating in both directions (clockwise and counterclockwise, 90° in this case), thereby closing the hole, as described above. Figures 4A to 4C As shown. Alternatively, the procedure can also be performed using, for example... Figures 7 to 8B The continuously unfolded feltable textile shown is being processed.

[0102] In another example of the surgical procedure, a feltable textile is advanced through the septal defect such that the main portion is located within the defect, with a first connecting portion positioned in the left atrium and a second connecting portion in the right atrium, and vice versa. The upper portion of the first connecting portion can then be attached to the upper portion of the atrial septum adjacent to the atrial septal defect, while the upper portion of the second connecting portion can be attached to the upper portion of the atrial septum by repeatedly advancing a surgical felting needle through the corresponding portion of the respective connecting portion and into the atrial septum. In this way, the fibers of the respective connecting portions are inserted into the atrial septum to securely attach the medical implant to the cardiac tissue. Subsequently, mechanical force (e.g., an upward force in the lower part of the heart and thus in the lower part of the atrial septum, or a downward force in the upper part of the heart and thus in the upper part of the atrial septum) can be applied to momentarily close the septal defect, and then the lower portions of the first and second connecting portions can be attached to the cardiac tissue in the lower part of the atrial septum by repeatedly advancing a surgical felting needle through the corresponding portion of the respective connecting portion and into the tissue in the lower part of the atrial septum. Preferably, the procedure is performed using minimally invasive surgery, i.e., by advancing one or more catheters into the left and / or right atrium of the heart via the patient's vascular system.

Claims

1. A minimally invasive fixation device (100; 200; 300; 400; 500; 600; 700; 800) for fixing feltable textiles to a target site in a human or animal, comprising: - An elongated tubular member (202) having a proximal end and a distal end, and an inner cavity extending between said proximal end and said distal end, wherein said elongated tubular member is at least partially flexible. - A needle assembly comprising at least one felted needle (209) disposed or potentially disposed at the distal end of the elongated tubular member, wherein the at least one felted needle is movable relative to the elongated tubular member, and wherein the at least one felted needle moves in a reciprocating motion, and - A drive assembly (204, 205, 210) is disposed in the inner cavity of the tubular member, wherein the drive assembly is operatively connected to the needle assembly for moving the at least one felting needle in the reciprocating motion when the at least one felting needle is located at the distal end, so that the feltable textile can be fixed at the target location.

2. The fixing device according to claim 1, wherein, The drive assembly is adapted to drive the reciprocating motion, the amplitude of which is in the range of 2 mm to 25 mm.

3. The fixing device according to claim 2, wherein, The amplitude is in the range of 6 mm to 16 mm.

4. The fixing device according to claim 2, wherein, The amplitude is in the range of 8 mm to 12 mm.

5. The fixing device according to claim 1, wherein, The fastening device also includes the feltable textile (108), wherein the feltable textile (108) is configured or may be configured such that at least one felting needle (209) pierces the feltable textile in the reciprocating motion.

6. The fixing device according to claim 1, wherein, The at least one felt needle (209) points toward the distal end of the elongated tubular member.

7. The fixing device according to claim 1, wherein, The reciprocating motion of the at least one felting needle is either linear or rotational.

8. The fixing device according to claim 1, wherein, The drive assembly includes an elongated drive line (210) or tube extending from the proximal end of the elongated tubular member to the needle assembly, wherein the elongated drive line or tube is operatively connected to the needle assembly such that the elongated drive line or tube causes the reciprocating motion of the at least one felted needle.

9. The fixing device according to claim 8, wherein, The elongated tubular member includes at least one guide element for the drive assembly within the cavity.

10. The fixing device according to claim 9, wherein, The at least one guide element positions the elongated drive line or tube at the center of the elongated tubular member along its radial direction.

11. The fastening device of claim 1, comprising the textile, wherein the textile has an annular shape and / or forms a petiolus angioplasty ring.

12. The fixing device according to claim 1, wherein, The fastening device further includes a retaining component for the feltable textile, wherein the retaining component includes at least one retainer for securing the textile to the retaining component, wherein the textile is in a folded position.

13. A kit comprising the fixation device according to claim 1, and an implant comprising the feltable textile.

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