WO2025104662A1

WO2025104662A1 - Left atrial appendage clamp

Info

Publication number: WO2025104662A1
Application number: PCT/IB2024/061358
Authority: WO
Inventors: Piotr Suwalski
Original assignee: Clip For Life Sp Z O O
Current assignee: Clip For Life Sp Z O O
Priority date: 2023-11-15
Filing date: 2024-11-14
Publication date: 2025-05-22
Anticipated expiration: 2026-05-15
Also published as: PL446728A1; WO2025104662A4

Abstract

The subject of the invention is a left atrium appendage clamp consisting of two clamping jaws attached to a common elastic element in the form of at least one bow, which maintains them at a constant distance from each other and where said at least one bow constitutes a cut-out collar, each end of which is connected to a clamping jaw, characterized in that each of the clamping jaws (3) consists of a straight bow part (3a), which passes successively into a radius part (3b) with a bend (4) behind which the end of the jaw (3c) is located, wherein said bend (4) in the radius part (3b) constitutes a bend (4) at least along the first longitudinal axis (X) relative to the straight bow part (3a). Another subject of the invention is a dedicated applicator for attaching the clamp according to the invention and a set for closing and electrically insulating the left atrium appendage consisting of a left atrium appendage clamp according to the invention and an applicator according to the invention.

Description

Left atrial appendage clamp, a dedicated applicator and a kit for closing the left atrial appendage and its electrical isolation, comprising the said clamp and the applicator

The subject of the invention is a left atrial appendage clamp, a dedicated applicator and a kit for closing the left atrial appendage and its electrical isolation, comprising the said clamp and the applicator.

During atrial fibrillation, there is insufficient blood exchange in the left atrial appendage of the heart resulting in stasis. This stasis can cause activation of the coagulation system and the formation of a thrombus which, released from within the left atrial appendage, can travel into the circulatory system and then flow to the brain, causing a stroke.

A number of solutions are known from the state of the art aimed at stopping blood flow through the inside of the left atrial appendage, which includes clamps and applicators dedicated to their application.

For applicators, from the description of US2015366605 Al, there is known a treatment system for ablating patient tissue that includes an actuator handle assembly and a clamp assembly connected to the actuator handle assembly, the clamp assembly having a first jaw mechanism and a second jaw mechanism. Whereby the first jaw mechanism includes a first flexible jaw, the first guide positioned at least partially inside the first flexible jaw, and a first flexible ablative element connected to the first flexible jaw. In contrast, the second jaw mechanism includes a second flexible jaw, the second rotatable jaw positioned at least partially inside the second flexible jaw, and the second flexible ablative element connected to the second flexible jaw.

From US Application US2011295060 Al is known a left atrial appendage (LAA) clamp applicator, which comprises an extension having a proximal end and a distal end. The extension may be, for example, a flexible wire contained in a bendable sheath or advantageously a stiffened hollow sheath with little or no bend. This sheath is movable when the LAA or similar tissue is gripped to facilitate movement of the distal assembly with the tissue. In addition, the device includes a rigid clamping bar to stabilise the flexible extension during insertion into the patient's body and to subsequently grip and stabilise the target tissue. Once the device is inserted into the patient, the clamping bar can be removed so that the flexible extension and pin holder can move independently to provide maximum flexibility and surgical control.

From US Application US2010185232 Al, a known surgical clamp comprising a handle and an end effector comprising a first jaw, a second jaw, and a head comprising an articulating mechanism. Whereby, said articulating mechanism includes a first rotary offset mounted to the head and pivotally connected to the first jaw and a second rotary offset mounted to the head remote from the first rotary offset and pivotally and slidingly connected to the first jaw. In addition, the said articulating mechanism articulates the first jaw when the first rotary offset and the second rotary offset are rotated. On the other hand, there is an actuating mechanism in the handle, which may be a piston used to actuate the jaws. The said plunger contains a slot with a hole. When the jaws are in the closed position, the hole is aligned with the lock. The spring pushes the lock into the hole, preventing the proximal movement of the plunger, thus keeping the jaws in the closed position. Pressing the lock will release the plunger, thus allowing proximal movement. However, with regard to clamps, a clamp for the left atrial appendage of the heart is known from European patent description EP3125780 Bl comprising at least two clamping jaws attached to a common elastic element in the form of a bow which holds these jaws in close proximity next to each other. Whereby said bow is a flange with a slot cut out, wherein each edge of said slot is connected to a pressure jaw, wherein each of the pressure jaws (advantageously in the form of a tube) comprises an internal channel. Advantageously, the channels of the pressure jaws on the side of the bow are open, while on the opposite side, these channels of the pressure jaws are closed. Advantageously, the closures of the channels of the two pressure jaws on the side opposite the bow are conical in shape, the apexes of the two cones being tilted outwards from each other. Advantageously, the bow has in the central part of its circumference a cross-section larger than the cross-section at the points where the arms of the bow are joined to the pressing jaws. However, in the present solution, the longitudinal arms of the jaws overlap during the operation of the implant, which causes the clamp to relax in time, and consequently, the stopping blood flow through the inside of the left atrial appendage of the heart is incomplete/unstable in time.

Therefore, the present invention aims to develop a new design of a left atrial appendage clamp with improved jaw clamp stability.

The subject matter of the invention is a clamp for the left atrial appendage of the heart comprising two clamping jaws attached to a common elastic element in the form of at least one bow which keeps them at a constant distance from each other and where said at least one bow is a notched flange, each end of which is connected to the clamping jaw, characterised in that each of the clamping jaws comprises a straight near the bow portion which transitions in turn into a radius portion with a bend behind which the end of the jaw is located, said bend in the radius portion being a bend in at least the first longitudinal axis relative to the straight near the bow portion.

In one embodiment, said bend in the radius portion is in the opposite direction of the front of the cut-out flange of the at least one bow.

In one embodiment, the bend along the first axis in the radius portion is at an angle of 10° to 60°, advantageously at an angle of 20° to 40°, advantageously at an angle of 25° to 35°, advantageously at an angle of 30°.

In one embodiment, the bend in the radius portion is a bend along a first longitudinal axis with respect to the straight cusp portion and a bend in a second axis orienting the radius portions of each jaw coincidentally to each other.

In one embodiment, the ends of the pressing jaws on the side opposite to at least one bow are outwardly biased from each other.

In one embodiment, the shape of the ends of the clamping jaws is selected from the group consisting of: conical shaped ends, radius rounded ends, cylindrical ends with a rounded or chamfered edge. Advantageously, the at least one bow in its central part has a cross-section larger than the cross-section at the connection points between the arms of the at least one bow and the pressure jaws.

Preferably the clamping jaws have a circular, rectangular or asymmetrical cross-section.

Advantageously the pressure jaws are rods or tubes.

Advantageously, each of the pressing jaws is provided with an inner channel open at least on the side of at least one bow and extending at least to the end of the casing part.

Advantageously, at least one of the pressure jaws is provided with an opening.

Advantageously, the inner outline of the bow in the central part has a contour.

Advantageously, at least one bow is offset from the upper surface of the clamping jaws and arranged above the clamping jaws.

Advantageously, the pressing jaws of the clamp according to the invention are textured.

Advantageously, the clamp according to the invention is entirely or partly made of a material opaque to X-rays.

Advantageously at least one bow is multilevel.

Advantageously the clamp according to the invention comprises one bow.

Advantageously, the clamp according to the invention comprises two or more bow.

A further embodiment of the invention is a clamp applicator for clamping the left atrial appendage of the heart according to the invention comprising a handle, a clamping assembly in the form of a fixed jaw and a movable jaw, and a tubular part connecting the handle to the clamping assembly, characterised in that it is provided with a locking mechanism comprising a locking pin, a knob and a movable jaw of the clamping assembly; the tubular part being a curved element, the fixed chuck being provided with a movable element with a knob for opening the jaws of the clamping assembly, a locking pin, and a release mechanism in the form of a slider; whereby from the slider located in the chuck an implant lock extends through the interior of the tubular part, the end of which is protrudingly located in the fixed jaw of the clamping assembly.

Advantageously, the tubular part is bent at an angle of between 4 and 20°, advantageously at an angle of 10.

A further essence of the invention is a kit for closing and electrically isolating the left atrial appendage of the heart, comprising a left atrial appendage clamp according to the invention and an applicator according to the invention.

The invention provides the following advantages:

- The design of the clamp according to the invention provides adequate clamping pressure on the appendage and opening forces during application and tension in the clamp (both during maximum opening of the clamping jaws - during insertion of the clamp on the ear, and after implantation - acting through the clamping jaws with a constant force on the closed ear); - The bent ends of the jaws were directed towards 'their' side (towards each other) - this is the neutral position, without the action of tension. When the clamp according to the invention is placed on the appendage piece, the jaws 'move' and align themselves evenly on the appendage piece, providing constant pressure along the entire length;

- The introduced bend of the end of the pressing jaws of the clamp according to the invention makes the implant better adapted to the root of the appendage (more favourably positioned in the anatomical curves of the heart). The risk that the ends and edges of the clamp according to the invention will act as an irritant to the surrounding tissues is reduced;

- The introduction of the contouring of the inner outline of the bow in the middle part of the bow makes the implant better embrace and lay on the appendage without causing additional tissue compression;

- The introduction of cone-shaped, outwardly inclined pressing jaw ends makes the implant fit better on the appendage and find the correct position more easily;

- The fabrication of the clamp in optically translucent or partially optically translucent material, as well as the positioning of the bow and the marker in relation to the length of the jaws facilitates the correct localisation of the clamp on the ear;

- The fabrication of the implant with materials with no or reduced tendency to create inflammatory reactions, which, among other things, reduces the risk of complications;

- Fabrication of the implant with materials or placement of components made of materials that are visible on X-ray imaging;

- The design of the clamp (the size of the bow can be reduced by changing the material or using several materials, or by changing the shape including making spatial forms such as multicoil springs) and the applicator allows implantation also by minimally invasive methods, which reduces the patient's recovery time after surgery;

- The implant blocker inserted in the applicator acts on the implant at all times, from the moment the implant is placed on the applicator. The locking device prevents the implant from detaching. The applicator disconnects the implant unequivocally, according to the operator's decision;

- The implant retention lock inserted in the applicator allows the position of the implant on the appendage to be changed or corrected until the implant is detached from the applicator;

- The design of the applicator and the implant ensures that, once the implant is placed on the appendage and released, it is possible to grasp and remove the implant (removal/extraction from the appendage) using the applicator. Subsequently, the removed implant can be placed back onto the appendage and detached from the applicator (released);

- The design of the applicator allows one-handed operation. The spacing between the locking mechanism and the release mechanism on both sides of the handle, taking into account the need to depress the locking mechanism knob (to open the jaws of the implant), has been designed to allow the applicator to be manipulated with one hand - with simultaneous access to the elements 'controlling' the operation of the applicator;

- Texturing of the implant surface to prevent slipping of the implant from the ear;

- Use of optically translucent materials and markers to increase implant precision (correct implant placement);

- Matching the curvature of the implant to the anatomical shape of the vestibule;

- Adjustment of the curvature of the working part of the applicator to the anatomical contours of the patient;

- Matching the geometry of the applicator to the surgical access route to the appendage; - The design of the clamp according to the invention allows simultaneous closure and electrical isolation of the appendage, which is particularly advantageous when the arrhythmogenic substrate is located inside the appendage;

- The bow can be worm-shaped (as in a paperclip);

- The clamp according to the invention is suitable for 12-14m ports.

Detailed description of the invention:

Unless otherwise specified, all technical and scientific terms used herein have the same meaning as commonly understood by a person of ordinary skill in the art.

Whereby, within the meaning of the invention, the phrase 'in an execution' is to be understood as in one or more executions. Furthermore, the features present in the various executions may be combined with each other. The descriptions of the executions of the invention in the present application are given by way of example and are not intended to limit the scope of the invention. The described implementations include various features, not all of which are required in all implementations of the invention. Some implementations use only some of the features or possible combinations of features. The described variants of the executions of the invention and the executions of the invention comprising different combinations of the features mentioned in the described executions will come to the mind of experts in the field. The scope of the invention is limited only by the claims.

In a first aspect, the invention relates to a clamp for the left atrial appendage of the heart comprising two clamping jaws attached to a common elastic element in the form of at least one bow which keeps them at a constant distance from each other and wherein said at least one bow is a notched flange, each end of which is connected to the clamping jaw. The clamp according to the invention may be provided with one or more bows, and is characterised in that each of the clamping jaws comprises a straight bow portion which transitions successively into a radius portion with a bend behind which the end of the jaw is located. Whereby said bend in the radius portion is a bend in at least along the first longitudinal axis relative to the straight cecum portion.

In one embodiment, the clamp according to the invention is provided with one bow. In another embodiment, the clamp according to the invention is provided with two bows. In another embodiment, the clamp according to the invention is provided with three bows.

The bow is a kind of cut-out collar, the ends of which are attached to the clamping jaws. In some designs, the bow is located at a predetermined distance, above or below the clamping jaws. The plane of the axis of the jaws may be offset from the plane of the bow. In some versions, the thickness of the shackle may not be the same along its entire length: in its central part, the shackle may have a greater cross-section than where the arms of the shackle are joined to the pressing jaws. It is possible to attach the bow to the clamping jaws in a different way and it is also possible to use other cross-sections and shapes of the bow, so as to ensure that the clamp according to the invention exerts the appropriate pressure on the appendage and the opening forces during application and stresses in the implant (both at the time of maximum opening of the clamping jaws of the clamp - during insertion of the clamp on the appendage - and after implantation - acting through the clamping jaws with a constant force on the closed appendage). The bend introduced at the radius of the clamping jaw ends improves the fit of the clamp to the eye socket.

In some designs, the bow(s) in its central part has a cross-section larger than the cross-section where the arms of the bow connect with the pressing jaws.

In a good version, the inner part of the bow is profiled.

In some embodiments, the bow is offset from the upper surface of the pressing jaws and arranged above the pressing jaws.

In one embodiment, the clamp according to the invention is provided with a single multi-level bow.

In some embodiment, both the bow and the jaws may be made of a single material, a mixture of materials, composites, or may be made of more than one material bonded together. Components may be added to the material to improve the X-ray visibility of the clamp. Metallic materials such as 316LVM steel, Co-Cr L605 alloy, NiTi alloy, gold, platinum (PtlO%lr) can be used in the clamp.

In some embodiment, the clamp jaws are straight and parallel to each other along the length where the channel is located inside. They may also take a different shape so that the fit to the curvature of the atrium is as good as possible and so that application of the clamp with the applicator is possible. When applied to the distal portion of the clamp, the bends in the tips of the pressing jaws may be in one plane or in more than one plane. They may be bent in the opposite direction to the bow, but in addition the bent ends are directed towards each other, towards the inside of the clamp.

In one embodiment, the bend in the radius portion of the clamp is a bend along the first longitudinal axis relative to the straight casing portion.

In one embodiment, said bend in the radius portion is in an opposite direction to the front of the cut flange of the at least one bow.

In one embodiment, the bend along the first axis in the radius portion is at an angle of 10°. In another embodiment, this angle may be 20°. In another embodiment, this angle may be 25°. In another embodiment, this angle may be 30°. In another embodiment, this angle may be 35°. In another embodiment, this angle may be 40°. In another embodiment, this angle may be 45°. In another embodiment, this angle may be 50°. In another embodiment this angle may be 60°.

In one embodiment, said bend in the radius portion is a bend along the first longitudinal axis with respect to the straight portion of the bow and a bend in the second axis orienting the radius portions of each jaw coincidentally to each other.

In one embodiment, the ends of the pressing jaws on the side opposite the bow are bent outwards from each other.

In some embodiments, both the bow(s) and the jaws may be made of a single material, a mixture of materials, composites, or may be made of more than one material bonded together. The incorporation of metallic elements into the design of the bow can increase its mechanical properties, compared to a bow made of only one material. Adding a material that is opaque to X-rays will improve the visibility of the clamp mounted on the appendage.

In one embodiment, the ends of the clamping jaws are conical. In another version, the ends of the pressing jaws are rounded with a radius. In other designs, the ends of the pressing jaws are cylindrical with a rounded or chamfered edge. In other embodiment, the ends of the pressing jaws are other derivatives of the above-mentioned variants.

In one embodiment, the pressing jaws have a circular cross-section. In another embodiment, the pressing jaws have a rectangular cross-section. In another embodiment, the pressing jaws have an asymmetrical cross-section.

In one embodiment, the clamping jaws are rods. In another embodiment, the pressing jaws are tubes.

In some embodiments, each of the pressing jaws is provided with an internal channel open at least on the side of at least one bow and extending at least to the end of the bow portion.

In some embodiments, the ends of the pressure jaws may be curved or straight. The blank ends of the pressure jaws may be solid or hollow. In some advantageous embodiments, the channels of the pressing jaws may be open on the bow side, while on the opposite side these jaw channels may be closed. The channels can also be open on both sides.

In some embodiments, the clamping jaw from the side of the bow to the point where the bend appears may have an internal channel of uniform wall thickness. In other embodiments, the wall thickness of the channel may also vary along the length of the jaw.

In one embodiment, at the point where the bend appears, the internal channel in the clamping jaw closes and, further to the end of the conical end of the jaw, is completely filled with clamp material. In some embodiments, the internal channels of the implant pressure jaws are parallel to each other. In other embodiments, the channels may also close at other points of the jaw, or they may remain open along their entire length.

In one embodiment, in order to correctly position the clamp on the applicator, one of the clamp jaws has a hole, which is the location of the pin attachment (part of the applicator), securing the clamp against accidental, undesired sliding off. However, the clamp may also have other safeguards against unwanted slipping.

In one embodiment, the pressing jaws of the clamp are textured.

In one embodiment, the clamp according to the invention is entirely made of X-ray opaque material. In another embodiment, the clamp according to the invention is in part made of an X-ray opaque material. The part of the clamp may be made of a material containing additional X-ray opaque components such as barium sulfate, bismuth trioxide, bismuth oxychloride, bismuth subcarbonate. May also contain metals: gold, platinum (PtlO%lr), which are opaque to X-rays.

In a further aspect, the invention relates to an applicator for clamping the left atrial appendage of the heart according to the invention, the applicator according to the invention comprising a handle, a clamping assembly in the form of a fixed jaw and a movable jaw, and a tubular part connecting the handle to the clamping assembly. Furthermore, the applicator according to the invention is provided with a locking mechanism comprising a locking pin and an implant lock. Whereby, the tubular part of the applicator is a curved element. On the other hand, the stationary holder is provided with a movable element with a knob for opening the jaws of the clamping assembly, a locking pin and a release mechanism in the form of a slider. Whereby an implant locking device extends from the slider positioned in the chuck through the interior of the tubular part, the end of which is positioned protruding into the stationary jaw of the clamping assembly. The locking mechanism has the task of locking the open jaws of the clamp-on applicator (prior to application to the appendage) and then releasing the locking mechanism, which causes the jaws to retract/close (neutral/exit position of the jaws of the applicator).

By depressing the knob, the movable jaw of the applicator moves away from the fixed jaw and the jaws are locked in an open position. The locking pin extends to lock the jaws open, preventing them from sliding apart. When the locking pin is depressed, the locking of the jaws is released: the depressed knob retracts and both jaws slide back: the movable jaw returns to its original position.

The implant lock is placed in the fixed jaw of the applicator, in the tensioned state: the implant lock abutment is extended from the fixed jaw. When applying the clamp to the jaws of the applicator - the jaws enter the internal channels of the clamp, move the slide towards the jaws and apply the clamp. Once the clamp has been applied to the jaws, the implant locking clip enters the hole in the clamp, located on one of the clamping jaws. The slider is moved towards the knob and the clamp remains locked. To release the clamp, the slider must be moved towards the jaws. The implant lock retracts into the fixed jaw, the implant lock abutment slides out of the hole in the pressing jaw and the clamp can be detached from the applicator.

In one embodiment, the tubular part of the applicator is bent at an angle of 10°. In another embodiment, the tubular part of the applicator is bent at 20°. In another embodiment, the tubular part of the applicator is bent at an angle of 4°. In another embodiment, the tubular part of the applicator is bent at an angle of 7°. In another embodiment, the tubular portion of the applicator is bent at an angle of 15°.

In a further aspect, the invention relates to a set for closing and electrically isolating the left atrial appendage of the heart, which comprises a left atrial appendage clamp according to the invention and an applicator according to the invention.

In one embodiment, the mentioned procedure for inserting clamp 1 includes the following steps:

1. Placing the clamp on the applicator:

(a) Move the slide towards the jaws - the implant locking abutment retracts into the fixed jaw. b) Place the clamp on the jaws of the applicator - the jaws enter the inner channels of the clamp pressure jaws. c) The implant locking abutment enters the hole in the clamp, positioned on one, adjacent to the fixed jaw. d) The slide is moved towards the knob and the clamp remains locked.

2. Clamp application: e) Move the clamp mounted on the applicator to the vicinity of the left atrial appendage. f) Push in the knob - the clamp jaws are extended and locked in position; the locking pin extends to keep the jaws open, preventing them from slipping. g) The extended clamp jaws are applied to the appendage - the end of the jaw facilitates the clamp to be placed on the appendage in the correct position. h) Once the clamp is confirmed to be in the correct position on the ear, it is closed. i) Press the locking pin - the applicator jaws are unlocked and close, the clamp pressure jaws are slid down and close on the appendage.

3. Disconnect the clamp: j) Move the slide towards the jaws. The implant locking device retracts into the fixed jaw, the locking device clip slides out of the hole, located on one, adjacent to the clamping jaw. k) Slide the applicator jaws out of the inner channels of the clamping jaws. The clamp is detached from the applicator and remains in the human body. l) Move the applicator away from the patient.

The invention is shown in examples of embodiments in the figure, where fig. 1 shows the clamp according to the invention in an overview view with particular reference to the bow; fig. 2 shows the clamp according to the invention with particular reference to the opening on the pressing jaws; fig. 3 shows a section of the clamp according to the invention in side view with particular reference to the bending part of the radius; fig. 4 shows the clamp according to the invention in bottom view; fig. 5 shows the conical ends of the jaws tilted outwards; fig. 6 shows the clamp according to the invention in side view with particular reference to the channel of the pressing jaws; fig. 7 shows the clamp according to the invention with particular reference to the thickness of the pressure jaw channels; fig. 8 shows the applicator according to the invention in an overview view; fig. 9 shows the applicator according to the invention (A) in top view, (B) in side view, (C) with particular reference to the clamping unit with implant locking; fig. 10 shows the handle of the applicator according to the invention; fig. 11 shows details of the handle and jaw assembly of the handle according to the invention, where (A) shows the applicator handle according to the invention with particular reference to the slider, (B) shows the jaw assembly with particular reference to the implant lock; fig. 12 shows the tubular part of the applicator according to the invention and its interior, where A) shows a side view, B) shows a top view; fig. 13 shows the kit according to the invention; fig. 14 shows a heart model with the clamp according to the invention in place, where A) shows a front view of the heart, B) shows a side view of the heart; fig. 15 shows a simulation of the operation of the clamp according to the invention (FEM analysis); fig. 16 shows the straight clamping jaws of the known clamp disclosed in EP3125780 Bl; fig. 17 shows a simulation of the clamping action of the known clamp disclosed in EP3125780 Bl (FEA analysis), where A) shows the result of the analysis of the implant extended by 1.5 mm, B) shows the result of the analysis of the implant extended by 3 mm, C) shows the result of the analysis of the implant extended by 6 mm, D) shows the pressure of 1.5 mm; fig. 18 shows a graph depicting the relationship between the pressure force and the thickness of the appendage of the clamp disclosed in EP3125780 Bl; fig. 19 shows the profile (w) of the bow in the central part; fig. 20 shows the bow offset from the upper surface of the clamping jaws and positioned above the clamping jaws.

The invention is presented in examples of embodiments. Wherein, the following examples of embodiments are illustrative and explanatory in nature and are intended to illustrate the invention and its advantageous exemplary implementations, which in no way constitutes a limitation of the claimed protection embodied in the patent claims.

Through routine experimentation, an expert in the field will recognize obvious modifications and variations that can be made without departing from the essence of the invention. All such modifications fall within the scope of the patent claims as equivalents. Example 1.

Clamp 1 according to the invention is shown in fig. 1-7, where 1 denotes the clamp, 2 denotes the bow, 3 denotes the clamping jaw, 4 denotes the bend, 5 denotes the inner channel, 6 denotes the hole, X denotes the first axis, Y denotes the second axis, w denotes the contouring. In this example of embodiment, clamp 1 of the left atrial appendage of the heart comprises two pressure jaws 3 attached to a common elastic element in the form of a single bow 2 which keeps them at a constant distance between each other and where the said bow is a 2 cut flange, each end of which is connected to the pressure jaw 3. The clamping jaws 3, on the other hand, are in the form of tubes, and each of the clamping jaws 3 consists of a straight cap portion 3a which transitions successively into a radius portion 3b with a bend 4 behind which the end of the jaw 3c is located.

Whereby, in this non-limiting example of implementation, said bend 4 in the radius portion 3b is a bend along the first X axis longitudinally relative to the straight cecal portion 3a and a bend in the second Y axis orienting the radius portions 3b of each jaw converging towards each other. Whereby, the bend along the first X axis is at an angle of 30°. In contrast, the clamp 1 itself is entirely made of X-ray opaque material - it contains additives of barium sulphate or bismuth trioxide or bismuth oxychloride or bismuth subcarbonate.

In this example of embodiment, the ends 3c of the pressing jaws on the side opposite to the bow 2 are biased outwards from each other. Furthermore, in this example embodiment, the ends 3c of the pressing jaws have a conical shape.

In this example of embodiment, the bow 2 in its central part has a cross-section larger than the cross-section in the areas where the arms of the bow 2 connect with the pressing jaws 3, which have a circular cross-section and are textured. In this example of implementation, each of the pressing jaws 3 is provided with an inner channel 5 open at the side of the bow 2 and extending to the end of the casing part 3a. Furthermore, one of the pressing jaws 3 is provided with a hole 6.

Example 2.

Clamp as in example 1, except that the bend 4 along the first X-axis in the radius portion 3b is at an angle of 10° or more and the ends 3c of the pressing jaws are rounded with a radius. On the other hand, the clamp 1 in the part of the pressing jaws 3 is made of an X-ray opaque material - the part of the clamp may be made of a material containing additional X-ray opaque components such as barium sulfate, bismuth trioxide, bismuth oxychloride, bismuth subcarbonate. It may also contain the metals gold, platinum (PtlO%lr), which are opaque to X- rays.

Example 3.

Clamp as in example 1, except that the bend 4 along the first X axis in the radius section 3b is at an angle of 60° or more and the ends 3c of the clamping jaws are cylindrical with a rounded edge.

Example 4. Clamp as in example 1, except that the bend 4 along the first X axis in the part of radius 3b is at an angle of 20° and the ends 3c of the pressing jaws are cylindrical with a chamfered edge.

Example 5.

Clamp as in example 1, except that the bend 4 along the first X axis in the radius section 3b is at an angle of 40° or more and the clamping jaws 3 have a rectangular cross-section.

Example 6.

Clamp as in example 1, except that the bend 4 along the first X-axis in the part of radius 3b is at an angle from 25° and the pressing jaws 3 have an asymmetrical cross-section.

Example 7.

Clamp as in example 1, except that the bend 4 along the first X-axis in the part of the radius 3b is at an angle from 35° and the pressing jaws 3 are bars.

Example 8.

Clamp as in example 1, except that it is fitted with two bows 2.

Example 9.

Clamp as in example 1, except that bow 2 is multilevel.

Example 10.

Clamp as in example 1, except that the inner outline of the bow 2 in the central part has a contour w.

Example 11.

The applicator 7 according to the invention is shown in figs. 8-12, where 7 stands for the applicator according to the invention, 8 stands for the clamping assembly, 8a stands for the movable jaw, 8b stands for the fixed jaw, 9 stands for the tubular part, 10 stands for the handle, 10' stands for the handle element giving finger support 11 stands for the knob, 12 stands for the locking pin, 13 stands for the slide, 14 stands for the implant lock.

In this non-limiting manufacturing example, the applicator 7 according to the invention comprises a handle 10, a clamping assembly 8 in the form of a fixed jaw 8b and a movable jaw 8a, as well as a tubular part 9 connecting the handle 10 to the clamping assembly 8.

The applicator 7 according to the invention is provided with a locking mechanism comprising a locking pin 12, a knob 11 and a movable jaw 8a of the clamping assembly 8. Its tubular part 9 is a member bent at an angle of 10°. On the other hand, the fixed chuck 10 is provided with a movable element with a knob 11 for expanding the jaws of the clamping assembly 8, a locking pin 12, and a release mechanism in the form of a slider 13. Whereby, from the slider 13 located in the chuck, an implant lock 14 extends through the interior of the tubular part 9, the end of which is positioned protrudingly in the fixed jaw 8b of the clamping assembly 8.

Whereby, the locking mechanism of the applicator 7 according to the invention has the task of locking the open jaws of the applicator 7 with the applied clamp 1 (before being applied to the ear) and then releasing the locking pin 12, which causes the jaws 8a and 8b to slide/close (neutral/exit position of the applicator jaws).

Depressing knob 11 causes the movable jaw 8a of the applicator to move away from fixed jaw 8b and the jaws are locked in the open position. The locking pin 12 extends to lock the jaws open, preventing them from sliding apart.

When the locking pin 12 is depressed, the locking jaws are released: the depressed knob 11 retracts and both jaws retract: the movable jaw 8a returns to its initial position.

The operation of the implant lock 14 includes - in the tensioned state: the implant lock 14 abutment is extended from the fixed jaw 8b. When applying the clamp 1 to the applicator jaws 8a and 8b - the jaws enter the inner channels 5 of the clamp, the slider 13 is moved towards the jaws and the clamp 1 is applied. When the clamp 1 is applied to the jaws 8a and 8b, the implant locking abutment 14 enters the opening 6 of the clamp, located on one of its pressing jaws 3. The slider 13 is moved towards the knob 11 and the clamp 1 remains locked. To release the clamp 1, the slider 13 is moved towards the jaws 8a and 8b. The implant lock 14 retracts into the fixed jaw 8b, the implant lock abutment slides out of the hole in the pressing jaw and the implant can be detached from the applicator.

As indicated in fig. 12, through the curved tubular part 9 of the applicator pass the elements of the locking mechanism for disengagement of the pressing jaws 3 of the clamp 1 and of the release mechanism of said clamp 1. Through the tubular part 9 pass the curved implant lock 14 and the curved movable jaw 8a. The curvature of the passing elements is adapted to the curvature of the tubular part 9, providing the target displacements required for the passing elements.

Example 12.

Applicator as in example 11, except that its tubular part 9 is bent at an angle of 4°.

Example 13.

Applicator as in example 11, except that its tubular part 9 is bent at an angle of 20°.

Example 14.

A set for closing and electrically isolating the left atrial appendage according to the invention comprises a left atrial appendage clamp according to the invention (e.g. as in example 1) and an applicator according to the invention (e.g. as in example 11). The assembly is shown in fig. 13.

The kit according to the invention makes it possible to effectively install the clamp 1 on the left atrial appendage of the heart by means of the applicator 7. Whereby, the said procedure for installing the clamp 1 comprises the following steps:

1. Place clamp one on applicator 7: a) Move the slide 13 towards the jaws 8a and 8b - the implant locking clip 14 retracts into the fixed jaw 8b. b) Place clamp 1 on the jaws of applicator 8a and 8b - the jaws enter the inner channels 5 of the pressing jaws 3 of clamp 1. c) The implant locking catch 14 enters the hole 6 in clamp 1, located on one cecal part 3a of the pressing jaws. d) The slide 13 is moved towards the knob 11 and clamp 1 remains locked.

2. Application of clamp 1: e) Move clamp 1 mounted on applicator 7 around the left vestibular appendage. f) Press knob 11 - the jaws 3 of clamp 1 are stretched and locked in position; locking pin 12 extends to keep the jaws 8a and 8b open, preventing them from slipping. g) The extended clamping jaws 3 of clamp 1 are applied to the appendage - the end of jaw 3c facilitates the positioning of clamp 1 on the appendage in the correct position. h) Once the correct positioning of clamp 1 on the appendage is confirmed, it is closed. i) Press the locking pin 12 - the jaws 8a and 8b of the applicator 7 are unlocked and close, the pressing jaws 3 of the clamp 1 are slid down and close on the appendage.

3. Disconnecting the clamp 1: j) Move the slider 13 towards the jaws 8a and 8b. The implant lock 14 hides in the fixed jaw 8b, and the locking catch slides out of hole 6, located on one, near the bow part 3a of the pressure jaw. k) Slide the jaws 8a and 8b of the applicator 7 out of the internal channels 5 of the pressure jaws 3 of the clamp 1. The clamp 1 is disconnected from the applicator 7 and remains in the human body. l) Move the applicator 7 away from the patient.

The heart model with the clamp 1 attached is shown in Fig. 14.

Example 15.

Comparison of the effectiveness of the damp according to the invention with the closest prior art, i.e. the clamp known from European patent specification EP3125780 Bl. In this example of embodiment, the clamp 1 according to the invention was compared with the closest prior art - i.e. the clamp known from European patent specification EP3125780 Bl.

STAGE I - comparative analysis of the structure of both clamps

In the first stage of the analysis, the structure of both clamps was compared, which showed a number of properties constituting a higher effectiveness of the clamp according to the invention:

1) The bend 4 on the radius of the clamping jaw 3 is in the opposite direction than the front of the cut-out collar of the bow 2. The design of the clamp 1 ensures that it will be better adapted to the base of the appendage and the curves of the heart (bends on the radius of the jaw), and the arrangement of the bow 2 will allow for a safe embrace of the appendage without irritating the surrounding tissues.

2) The bend 4 of the clamping jaw 3 of the clamp 1 along the longitudinal axis X in the radius part is at an angle of 10-60°, preferably 30°. Thanks to this, it is better adapted to the base of the appendage (it is more advantageously arranged in the anatomical curves of the heart, fewer protruding elements). The risk that the protruding ends and edges of the clamp 1 will be irritating to the surrounding tissues is reduced.

3) The ends of the clamping jaws 3c on the side opposite the bow 2 are tilted outwards from each other. Thanks to this, the clamp 1 is better placed on the ear, it is easier to find the right position.

4) The ends of the clamping jaws 3c are conical. This shape means that when clamp 1 is put on, the clamping jaws 3 are atraumatic - they spread/open the tissues without causing them to tear.

5) The bow 2 in its central part has a larger cross-section than the cross-section at the points where the bow arms 2 and the clamping jaws 3 connect. The central part of the bow 2 is responsible for generating the appropriate forces and stresses to ensure the proper functioning of the clamp 1.

6) The internal outline of the bow 2 in its central part is profiled in. With this shape, the clamp 1 does not generate stresses that could result in the displacement of the clamp 1.

7) The bow 2 is moved away and positioned above the clamping jaws 3. With this design solution, the clamp 1 is well clamped on the appendage and takes up little space - limited irritation to the surrounding tissues.

8) The clamping jaws 3 preferably have a round cross-section (tubes). The round cross-section of the clamping jaws 3 means that the clamp 1 securely closes the ear, and in the absence of edges, it does not irritate the surrounding tissues. 9) The pressure jaws 3 have an internal channel 5, open on the side of the bow 2. The jaws 8a and 8b of the applicator 7 are inserted into the internal channels 5 of the pressure jaws 3, on which the clamp 1 is stretched.

10) There is an opening 6 in the pressure jaw 3 of the clamp 1. After the clamp 1 is placed on the jaws 8a and 8b of the applicator 7, the implant locking hook 14 slides out of the fixed jaw 8b of the applicator 7 and is placed in the opening 6 of the jaw 3 of the clamp 1, which makes the clamp 1 secured against disconnection.

11) The clamp 1 is not made of transparent material, thanks to which it is clearly visible after being clamped on the appendage.

12) The design of the clip 1 ensures that after it has been applied to the appendage and released, it can be re-captured and removed (removed/pulled off the ear) using the applicator. The removed clip 1 can be re-applied to the appendage and disconnected from the applicator (released).

Compared to clamp 1 according to the invention, the following weaknesses of the clamp were selected from European patent description EP3125780 Bl:

1) Wide implant bow. The large width of the implant influences the irritation action of the surrounding tissues.

2) Implant bow fully extends beyond the ends of the clamping jaws. Excessively long implant length - protruding ends and edges of the implant irritate the surrounding tissues.

3) Implant bow adheres to the upper surface of the pressing jaws in the middle, the ends of the bow are below. The implant will be clamped on the appendage, but the bow takes up a lot of space and, by causing additional pressure (with the extremities of the bow), acts as an irritant to the surrounding tissues.

4) Straight clamping jaws (fig. 16). The implant is not aligned with the root of the appendage (it is not able to align with the anatomical curvature of the heart), there are protrusions. The ends and edges of the implant protruding excessively, may have an irritating effect on the surrounding tissues.

5) Minimum gap between the clamping jaws. An implant clamped on the appendage will act with considerably more force than required. Spacing between the pressing jaws not adapted to the thickness of the appendage wall.

6) Implant material with high rigidity. Implant does not have the ability to extend the implant jaws well enough to place the implant on the appendage efficiently. Risk of prolonging the procedure.

7) Impossibility of correct separation of the clamping jaws. The rigid material forces the application of large forces when opening the implant. Significant force required to operate the applicator with one hand.

STAGE II - Simulation of terminal performance (FEA analysis)

A) Clamp 1 according to the invention A simulation of the operation of clamp 1 according to the invention is shown in fig. 15. The analysis has shown that the introduced bending of the end of the clamping jaws makes the clamp according to the invention better adapted to the root of the appendage (more favourably positioned in the anatomical curvature of the heart). The risk of the ends and edges of the implant acting as an irritant to the surrounding tissues is reduced.

The stresses that occur in the implant, at the moment of maximum opening of the implant pressing jaws (simulation of implant stretching to overlap the appendage) are shown. The stress on the appendage is shown assuming a 2 mm thickness of the appendage wall.

The values obtained in the simulations: the pressure on the appendage with a wall thickness of 2 mm and the emerging stresses in the implant when the jaws are opened to 16 mm, as assumed.

Clamp 1 according to the invention takes into account additional assumptions, compared to the clamp known from EP3125780 Bl with straight jaws. The introduction of the bending of the clamping jaws has resulted in:

• The channels of the pressure jaws have been shortened, compared to the clamp known from EP3125780 Bl, which has channels almost along the entire length of the pressure jaw. The channel in the pressure jaw does not occur on the bent section of the clamp according to the invention.

• The bend in the clamp according to the invention forced the parallel and assumed force pressure of the jaws of clamp 1 on the ear, under the conditions of actual operation of clamp 1. The bent ends of the jaws were directed towards "their" side - this is a neutral position, without stress. When clamp 1 is placed on the appendage, the jaws "move" and arrange themselves evenly on the appendage, ensuring constant pressure along the entire length.

• The operation of clamp 1 was ensured within the assumed values of forces and stresses.

A) The clamp known from the European patent description EP3125780 Bl

As indicated in Fig. 16, the clamp known from EP3125780 Bl has straight pressing jaws, and therefore it will not be adapted to the principle of the appendage (it does not fit into the anatomical curves of the heart) to the same extent as the clamp 1 according to the invention. There is therefore a risk that the ends and edges of this known clamp will act irritatingly on the surrounding tissues.

In this embodiment, the simulation of the clamp known from EP3125780 Bl (FEM analysis), made of PA12, was carried out.

Material properties of PA12 (used for testing): • Rm=45 MPa,

• E=0.015x10 ^s MPa

• A5=20%

• p=0.9-?0.95 g/cm³

The results of the analysis are presented in Fig. 17. The analysis showed that the maximum stress in the material at 3 mm of opening was approximately 54 MPa, which exceeds the assumed tensile strength.

In addition, it is visible that when expanding by 3 and 6 mm, the tube loses its straightness, which may affect the non-uniformity of the clamping force of the appendage.

The graph in Fig. 18 shows that at 1.5 mm of the opening width, a force of approx. 36 N is obtained. This graph also shows that extending the implant to 6 mm requires the use of a force of approx. 120 N.

The high stresses in the material of the tested clamp suggest that the force required to spread the jaws of this clamp to the appropriate width by the applicator, in order to put it on the ear, will be high. Operating the applicator will require significant force and will be troublesome for the operator.

Conclusions:

The analysis carried out confirmed the advantage of the clamp construction according to the invention over the closest state of the art, which at the same time does not reduce the usefulness of known solutions.

List of designations:

1 - clamp according to the invention;

2 - bow;

3 - pressure jaw;

4 - bend;

5 - internal channel;

6 - hole;

7 - applicator according to the invention;

8 - clamping unit:

8a - movable jaw,

8b - fixed jaw,

9 - tubular part;

10 - handle;

10' - handle element providing support for fingers

11 - knob;

12 - locking pin;

13 - slider;

14 - implant lock;

X - first axis;

Y - second axis; w - bow profiling

Claims

Patent claims

1. A left atrium appendage clamp comprising two clamping jaws attached to a common elastic element in the form of at least one bow which maintains them at a constant distance from each other and wherein said at least one bow constitutes a cut-out collar each end of which is connected to a clamping jaw, characterized in that each of the clamping jaws (3) consists of a straight bow portion (3a) which successively passes into a radius portion (3b) with a bend (4) behind which the jaw end (3c) is located, said bend (4) in the radius portion (3b) constituting a bend (4) at least along a first longitudinal axis (X) relative to the straight bow portion (3a).

2. The clamp according to claim 1, characterized in that said bend (4) in the radius part (3b) is in the opposite direction to the front of the cut-out collar of at least one bow (2).

3. The clamp according to claim 1 or 2, characterized in that the bend (4) along the first axis (X) in the radius part (3b) is at an angle of 10° to 60°, preferably at an angle of 20° to 40°, more preferably at an angle of 25° to 35°, preferably at an angle of 30°.

4. The clamp according to any one of the preceding claims 1 to 3, characterized in that the bend (4) in the radius part (3b) is a bend along a first longitudinal axis (X) relative to the straight bow part (3a) and a bend in the second axis (Y) directing the radius parts (3b) of each of the jaws to converge towards each other.

5. The clamp according to any one of the preceding claims 1 to 4, characterized in that the ends (3c) of the clamping jaws on the side opposite to at least one bow (2) are deflected outwards from each other.

6. The clamp according to any one of the preceding claims from 1 to 5, characterized in that the shape of the ends (3c) of the pressing jaws is selected from the group consisting of: conical shape, ends rounded by a radius, cylindrical ends with a rounded or chamfered edge.

7. The clamp according to any one of the preceding claims from 1 to 6, characterized in that at least one bow (2) in its central part has a cross-section larger than the crosssection at the places where the arms of at least one bow (2) connect with the pressing jaws (3).

8. The clamp according to any one of the preceding claims from 1 to 7, characterized in that the clamping jaws (3) have a round, rectangular or asymmetrical cross-section.

9. The clamp according to any one of the preceding claims from 1 to 8, characterized in that the clamping jaws (3) are rods or tubes.

10. The clamp according to any one of the preceding claims from 1 to 9, characterized in that each of the clamping jaws (3) is provided with an internal channel (5) open at least on the side of at least one bow (2) and extending at least to the end of the bow part (3a).

11. The clamp according to any one of the preceding claims 1 to 10, characterized in that at least one pressing jaw (3) is provided with an opening (6).

12. The clamp according to any one of the preceding claims 1 to 11, characterized in that the inner contour of the bow in the central part has a profiling (w).

13. The clamp according to any one of the preceding claims 1 to 12, characterized in that at least one bow (2) is offset from the upper surface of the pressing jaws and arranged above the pressing jaws (3).

14. The clamp according to any one of the preceding claims 1 to 13, characterized in that its pressing jaws (3) are textured.

15. The clamp according to any one of the preceding claims 1 to 14, characterized in that it is made entirely or in part of a material that is opaque to X-rays.

16. The clamp according to any one of the preceding claims 1 to 15, characterized in that at least one bow is multi-level.

17. The clamp according to any one of the preceding claims 1 to 16, characterized in that it comprises one bow (2).

18. The clamp according to any one of the preceding claims 1 to 16, characterized in that it comprises two or more bows (2).

19. An applicator for left atrial appendage clamp according to any one of claims 1 to 18, comprising a handle, a clamping assembly in the form of a fixed jaw and a movable jaw, and a tubular part connecting the handle with the clamping assembly, characterized in that it is equipped with a locking mechanism consisting of a locking pin (12), a knob (11) and a movable jaw (8a) of the clamping assembly (8); the tubular part (9) is a bent element, the fixed handle (10) is equipped with a movable element with a knob (11) for opening the jaws of the clamping assembly (8), the locking pin (12), and a release mechanism in the form of a slider (13); wherein an implant lock (14) extends from the slider (13) placed in the handle through the interior of the tubular part (9), the end of which is retractably placed in the fixed jaw (8b) of the clamping assembly (8).

20. The applicator according to claim 19, characterized in that the tubular part (9) is bent at an angle of 4 to 20°, preferably at an angle of 10°.

21. A kit for closing and electrically isolating a left atrial appendage comprising a left atrial appendage clamp as claimed in any one of the preceding claims 1 to 18 and an applicator as claimed in any one of the preceding claims 19 to 20.