Single strand self-locking suspension device for medical use

Abstract

An implantable suspension device (1) for fixing an elongated flexible implant (G) or tissue (B) at a desired position comprises a suspension plate (100) and a single suture element (200), the single suture element being engaged with the suspension plate (100) so that the suture element (200) forms an adjustable suspension loop (300) for connecting the implant (G) or tissue (B) to the suspension plate (100), wherein the single suture element (200) comprises a free first end section (201) and a second end section (202), and wherein the single suture element (200) comprises a stopper (20) arranged on the second end section (202), and wherein the suture element (200) forms a locking loop (40) for pressing the first end section (201) against the suspension plate (100) and thereby locking the first end section (201) of the suture element (200) relative to the suspension plate (100).

Description

Technical Field

[0001] The present invention relates to an implantable suspension device, in particular to an implantable suspension device for reconstruction of anterior cruciate ligament (ACL). Background Art

[0002] Due to its anatomical location, the ACL is subject to potentially extreme forces during sports and other physical activities. ACL rupture is considered the most common and serious of all ligament injuries.

[0003] For ACL reconstruction, a suspension device, also known as a cortical fixation device (CFD), is often used. Such a device typically includes a plate, also known as a button, that helps secure the tendon or ligament graft to its desired position when performing an anterior cruciate ligament (ACL) reconstruction. Such a device may also be used in conjunction with other ligament or tendon grafts or other flexible (e.g., elongated) members.

[0004] In ACL reconstruction, fixation of a graft, such as a hamstring graft or patella-tendon-bone graft (BTB), to the cortex of the femur at the proximal end of the femoral tunnel is a critical part of a successful procedure.

[0005] Here, a titanium (or steel) plate holds a continuous hanging loop formed by sutures, which are usually made of polyester, polyethylene or similar materials. The loop is the attachment site for a graft (e.g., a hamstring graft, a BTB graft, or a synthetic graft). Once the graft is attached, the plate or button can be pulled through the tibial tunnel or femoral tunnel by the temporarily attached sutures until it reaches the cortex of the femur. The button is pulled flush against the cortex of the femur by pulling the graft backwards or using a second suture to flip the button. The graft can be viewed as being suspended from the cortex of the femur.

[0006] Variations between devices exist in the prior art, and in particular relate to the manner in which the suspension loop is locked and the length of the suspension loop is adjusted. In particular, according to US2010268273A1, the device comprises two interconnected adjustable eye loop knots. In addition, EP2777612A1 uses a self-locking knot to fix the suspension loop. In addition, the device according to WO2012154922A2 comprises a suture having a first end, which is received in the suture by the opened second end of the suture to form a loop with only one free end, wherein the length of the suture between the fixing member and the tissue graft can be adjusted by pulling the free end of the suture.

[0007] Based on the above, the problem underlying the present invention is to provide an improved implantable suspension device allowing a rapid adjustment and a safe fixation of the suture elements. Summary of the invention

[0008] This problem is solved by a suspension device according to an embodiment of the present application. Preferred embodiments of this aspect of the invention are set out in the detailed description and described below.

[0009] Further aspects of the invention relate to a method for constructing a suspension device according to the invention, a suspension plate, a tool, and a method for forming a stop on an end section of a suture element.

[0010] According to an embodiment of the present application, an implantable suspension device is disclosed, in particular, an implantable suspension device for anterior cruciate ligament (ACL) reconstruction, which is configured to fix an elongated flexible implant (e.g., a ligament or tendon implant) or tissue (such as bone tissue) in a desired position, wherein the suspension device includes a suspension plate and a single (particularly elongated and flexible) suture element, which is engaged with the suspension plate so that the suture element forms an adjustable suspension loop for connecting the implant or tissue to the suspension plate, wherein the single suture element includes a free first end segment and a second end segment, and wherein the single suture element includes a stop portion arranged on the second end segment, and wherein the suture element forms a locking loop for pressing the first end segment against the suspension plate and thereby locking the first end segment of the suture element relative to the suspension plate.

[0011] Advantageously, therefore, the suspension device comprises in particular only one, ie exactly one, suture element.

[0012] In particular, the suspension device can be used to fix soft tissue to bone. In addition, in particular, the suspension plate is formed of a biocompatible material, in particular a biocompatible metal, such as titanium or a titanium alloy or stainless steel. In addition, the suture element is formed of one of the following materials: polyethylene, polyester, polypropylene, and other similar biocompatible suture materials.

[0013] In addition, the suture element may include a plurality of fibers connected to each other to form the suture element. However, the suture element may also be formed by a single filament. In particular, the suture element is flexible.

[0014] The suspension device according to the invention can be used for many indications of fixing or suspending soft tissue to bone, fixing bone to bone. In particular, the suspension device according to the invention can be used for anterior cruciate ligament (ACL) reconstruction. In particular, in the case of ACL reconstruction, the front side of the suspension plate is configured to abut against the tibia or femur of the patient, wherein, in particular, the suspension loop extends through a bore hole drilled into the tibia or femur.

[0015] According to an embodiment of the suspension device, the suspension loop is configured to be shortened by pulling a first pulling section formed by a portion of a first end section of the suture element protruding out of the locking loop.

[0016] Furthermore, according to an embodiment of the suspension device, the load on the suspension loop and / or the length of the suspension loop is proportionally related to the pulling force on the first pulling section / the displacement of the first pulling section. In particular, this means that the displacement of the pulling strand is proportional to the shortened length of the suspension loop, and in particular the force exerted on the implant by the suspension loop is proportional to the pulling force on the first pulling section.

[0017] Therefore, the load on the suspension loop and the length of the suspension loop can be reliably controlled.

[0018] Furthermore, according to an embodiment of the implantable suspension device, the slack force on the first pulling section is reduced by a suspension loop comprising at least two deflection points that are movable relative to the suspension plate (e.g. when the suspension loop is shortened) and at least one deflection point that is fixed relative to the suspension plate. Thus, in combination with the locking loop, a self-locking function is achieved, i.e. the suspension loop is a self-locking suspension loop.

[0019] In other words, according to an embodiment of the suspension device, the suspension eye comprises at least two folding points movable relative to the suspension plate and at least one folding point fixed to the suspension plate. Thus, in particular, the suspension eye forms a pulley.

[0020] In the context of the present invention, a turning point is a point at which the direction of a suture element changes its orientation (sign) so that the suture element turns around at this point of the suture element. In particular, a movable turning point is located at the implant / tissue around which the suspension loop is placed, around which a fixed turning point is located at the suspension plate, at which the suture element also turns around. In particular, one of the movable turning points comprises a first loop of the suspension loop and the other movable turning point comprises a second loop of the suspension loop (see also below).

[0021] In particular, when the first pulling section is pulled, the suspension loop will be shortened. When the first pulling section is released, the implant (e.g., graft) or tissue connected to the suspension loop will then apply a load to the suspension loop. This load will be transferred to the first pulling section in a relaxation direction corresponding to the relaxation force.

[0022] Due to the proportional relationship (movable pivot point and fixed pivot point), the slack force on the pulling section is divided by four, for example, which is relatively low and allows the first pulling section to be locked by the (upper) locking ring.

[0023] Furthermore, according to an embodiment of the implantable suspension device, the suspension plate comprises a front side and a rear side, the rear side facing away from the front side.

[0024] Furthermore, according to an embodiment of the implantable suspension device, the suspension plate comprises a plurality of through holes, wherein each through hole extends from a front side portion to a rear side portion of the suspension plate, wherein the suture element is configured to extend through the through holes to engage with the suspension plate.

[0025] Furthermore, according to an embodiment of the suspension device of the present invention, the plurality of through holes is formed by at least or exactly six through holes. In particular, each through hole may comprise a circular cross section.

[0026] In particular, the diameter of the stopper is greater than the diameter of the rest of the suture element. In particular, the diameter of the stopper is greater than the diameter of a first through hole of the plurality of through holes into which the suture element is initially inserted with the first end section ahead.

[0027] In addition, according to an embodiment of the suspension device, the suture element is inserted into the first through hole among the multiple through holes in a manner with the first end section first, so that the stop portion abuts against the suspension plate (in particular, against the front side and / or the inner wall of the first through hole) to prevent the suture element from being completely pulled through the first through hole of the suspension plate.

[0028] In addition, according to an embodiment of the suspension device, the suture element is also successively inserted into the second through hole, the third through hole, the fourth through hole and the fifth through hole among the multiple through holes, so that the adjustable suspension ring is formed to extend from the front side of the suspension plate and / or so that the locking ring is formed on the rear side of the suspension plate, wherein the first end segment of the suture element is also inserted into the locking ring, so as to clamp the first end segment of the suture element to the rear side of the suspension plate with a locking force by means of the locking ring.

[0029] Furthermore, according to an embodiment of the suspension device, the suspension loop comprises a first loop and a second loop formed by the suture element, wherein, in particular according to an embodiment, the two loops extend along one another.

[0030] In addition, according to an embodiment of the suspension device, the suture element is inserted into the first to fifth through holes so that the pulling force applied to the first end segment of the suture element and transmitted to the suspension loop is amplified by at least four times, and / or in particular so that the locking force is a friction force in the presence of the following pressing force, and the pulling force is at least twice the pulling force on the first pulling segment of the suture element.

[0031] In addition, according to an embodiment of the suspension device, the multiple through holes include a second through hole, wherein the suture element is inserted into the second through hole in a first-end section manner, in particular, is inserted into the second through hole from the rear side of the suspension plate, so that a locking ring is formed on the rear side of the suspension plate.

[0032] In addition, according to an embodiment of the suspension device, the multiple through holes include a third through hole, wherein the suture element is inserted into the third through hole in a first-end section manner, in particular, is inserted into the third through hole from the front side of the suspension plate, so that a first loop of the suspension loop is formed on the front side of the suspension plate.

[0033] Furthermore, according to an embodiment of the suspension device, the plurality of through holes comprises a fourth through hole, wherein the suture element is inserted into the third through hole with the first end section first, in particular from the rear side of the suspension plate.

[0034] In addition, according to an embodiment of the suspension device, the multiple through holes include a fifth through hole, wherein the suture element is inserted into the fifth through hole in a first-end section manner, in particular, is inserted into the fifth through hole from the front side of the suspension plate, so that a second loop of the suspension loop is formed on the front side of the suspension plate.

[0035] In addition, according to an embodiment of the suspension device, the first end segment extending from the fifth through hole is inserted into the locking loop, wherein a portion of the first end segment of the suture element extending from the locking loop forms a first pulling segment of the suture element, and the first pulling segment is used to pull the suture element so as to shorten / tighten the suspension loop.

[0036] In addition, according to an embodiment of the suspension device, the suspension device includes a sixth through hole, wherein the first end segment extending from the locking ring can be inserted into the sixth through hole, in particular, inserted into the sixth through hole from the rear side of the suspension plate, so as to respectively form a second and third pulling segments (from the first end segment) extending from the sixth through hole and used to pull the suspension device through the bone tunnel.

[0037] Furthermore, according to an embodiment of the suspension device, the first, second, third and fourth through holes are arranged at the corners of a (virtual) quadrilateral, in particular a square. Furthermore, in particular, the first, second, third and fourth through holes are also arranged between the fifth and sixth through holes. Furthermore, in particular, the fifth through hole faces the sixth through hole in the direction of the longitudinal axis of the suspension plate. Furthermore, in particular, the first through hole and the second through hole are arranged adjacent to the fifth through hole. Furthermore, in particular, the first through hole faces the second through hole in a direction perpendicular to the longitudinal axis. Furthermore, in particular, the first through hole faces the third through hole in the direction of the longitudinal axis. Furthermore, in particular, the fourth through hole is arranged diagonally to the first through hole.

[0038] Furthermore, according to an embodiment of the suspension device, the sixth through hole has a larger opening area than the first to fifth through holes.

[0039] Furthermore, according to an embodiment of the suspension device, the stop comprises at least one knot formed in the second end section of the suture element.

[0040] Furthermore, according to an embodiment of the suspension device, the stop comprises a portion of the suture element arranged adjacent to at least one knot, the portion being formed by merging fibers of the suture element. In particular, the fibers are merged by heating and at least partially melting them.

[0041] In addition, according to one embodiment of the suspension device, the suspension device includes an adapter plate, wherein the adapter plate includes a recess for accommodating the suspension plate in a form-fitting manner. In particular, the adapter plate can be made of other materials, such as biocompatible polymers such as PEEK, PLA, etc., or biocompatible ceramics such as HA, TCP, etc. According to another embodiment of the suspension device, the suspension device includes a plate member, wherein the plate member includes a recess extending through the suspension ring. Such an embodiment can be used to connect a bone to a suspension plate resting on another bone, or to apply tension to a bone on which both a suspension plate and a plate member are resting. In particular, the function of this feature is to maintain the tension of two bones, for example to compensate for the force of an injured ligament, or to correct the position of a fractured bone or two bones, or to compensate for the force of an injured ligament.

[0042] Furthermore, according to an alternative embodiment of the suspension device, the suspension device comprises a first plate member, wherein the first plate member comprises a recess extending through a first loop of the suspension loops, and wherein the suspension device comprises a second plate member, wherein the second plate member comprises a recess extending through a second loop of the suspension loops. Such an embodiment can also be used to connect a bone to a suspension plate resting on another bone, in particular to maintain tension in both bones, for example to compensate for the forces of an injured ligament.

[0043] According to a further aspect of the present invention, a tool for use with an implantable medical suspension device, in particular for use with an implantable medical suspension device according to the present invention, is disclosed, wherein the tool comprises:

[0044] - a handle for holding the tool,

[0045] - a guide rod extending from the handle,

[0046] - at least one first groove formed into said guide rod (and in particular also into the handle) for receiving a suture element, and

[0047] - A distance probe slidably arranged in the guide rod.

[0048] In particular, the tool can also be included in a suspension device according to the present invention, for example, a suspension device comprising the tool as a separate component. Such a suspension device kit provides the following benefit: the user also has a special tool that helps to arrange the suspension plate, suture elements, and in particular the implant in the desired position (for example, in a bone tunnel) and adjust (for example, tighten) the suspension loop.

[0049] In particular, according to an embodiment, the tool comprises a second slot extending parallel to the first slot and formed into said guide rod (and in particular also into the handle) for accommodating a suture element.

[0050] Furthermore, according to an embodiment of the tool of the present invention, the tool is configured to clamp the suture element (particularly the first pulling section) in the first groove, and / or wherein the tool is configured to clamp the suture element (particularly the second and third pulling sections) in the second groove.

[0051] Furthermore, according to an embodiment of the tool, the tool comprises a first actuating element that can be actuated to clamp the first pulling section of the suture element in the first groove, and / or wherein the tool comprises a second actuating element that can be actuated to clamp the second and third pulling sections of the suture element in the second groove. In particular, the two actuating elements are arranged on the handle, in particular on opposite sides of the handle.

[0052] Furthermore, according to an embodiment of the tool, the tool comprises a force indicator for indicating (eg optically) a pulling force applied via the tool to the suture element, in particular to the first pulling section.

[0053] Furthermore, according to an embodiment of the tool, the tool comprises a distance indicator for indicating (eg optically) the distance measured with the distance probe.

[0054] In particular, the force indicator and / or the distance indicator is arranged on the guide rod.

[0055] Furthermore, according to an alternative embodiment of the tool according to the invention, the distance probe comprises a handle at one end of the distance probe for moving the distance probe relative to the guide rod (eg into the bone tunnel).

[0056] Furthermore, according to an embodiment, the distance probe is configured to contact a suspension plate of a suspension device located in the bone tunnel in order to provide user feedback to the user regarding the current position of the suspension plate in the bone tunnel.

[0057] This is a very advantageous feature because it allows the user / surgeon to flip the suspension plate in a more controlled manner to avoid the risk of soft tissue bridging. In particular, this feature allows the user to place the suspension plate directly outside the bone tunnel, on the bone surface, without excessively clamping the soft tissue between the suspension plate and the bone surface.

[0058] According to further embodiments of the tool, the tool includes a rotatable distance measurement wheel configured to measure a displacement of the suture element relative to the tool.

[0059] Furthermore, in accordance with an embodiment of the tool of the present invention, the tool includes a force indicator configured to receive and indicate a force applied by the suture element when the range probe handle is moved to tension the suture element.

[0060] Furthermore, according to an embodiment of the tool, the distance measuring wheel and the force indicator are mounted to the guide rod such that the suture element is tied between the distance measuring wheel and the force indicator when received in the first slot.

[0061] Furthermore, according to an embodiment of the tool, the tool includes a self-locking clamp for clamping the suture element when the suture element is received in the first groove.

[0062] According to another aspect of the present invention, an implantable suspension plate (particularly for use with a single suture element) is disclosed, comprising a front side and a rear side facing away from the front side, wherein the suspension plate comprises six through holes, wherein each through hole extends from the front side to the rear side, and wherein the first, second, third and fourth through holes are arranged at the corners of a square, the first, second, third and fourth through holes are also arranged between the fifth and sixth through holes, the fifth through hole faces the sixth through hole in the direction of the longitudinal axis of the suspension plate, the first through hole and the second through hole are arranged adjacent to the fifth through hole, and the first through hole faces the second through hole in a direction perpendicular to the longitudinal axis and faces the third through hole in the direction of the longitudinal axis, and the fourth through hole is arranged diagonally to the first through hole.

[0063] Furthermore, according to an embodiment of the suspension plate of the present invention, the sixth through hole has a larger opening area than the first to fifth through holes.

[0064] According to a further aspect of the invention, a method for constructing an implantable suspension device (in particular according to the invention) is disclosed, the method comprising the steps of:

[0065] - providing a suspension plate comprising an anterior side for abutting against a surface of a patient's bone and a posterior side facing away from the anterior side, and wherein the suspension plate comprises six through holes extending from the anterior side to the posterior side of the suspension plate,

[0066] - providing a single elongated and flexible suture element comprising a free first end section and a free second end section, and

[0067] A stop is provided on the second end section.

[0068] In particular, providing the stopper on the second end section of the suture element may further comprise the step of forming at least one knot in the second end section of the suture element.

[0069] Additionally, alternatively, forming the stop on the second end segment of the suture element may further include the step of forming a portion of the merged fibers of the suture element, wherein at least one knot is then formed adjacent to the portion.

[0070] Furthermore, in particular, the stopper portion may also be formed using the method for forming a stopper portion disclosed below.

[0071] In addition, according to an embodiment of the method of the present invention, the method also includes the following step: inserting the suture element into the first through hole of the six through holes with the first end section first, so that the stopper abuts against the suspension plate (especially against the front side of the suspension plate and / or the inner wall of the first through hole) to prevent the suture element from being completely pulled through the first through hole of the suspension plate.

[0072] In addition, according to an embodiment of the method, the method also includes the following step: inserting the suture element into the second through hole of the six through holes in a manner with the first end section first, in particular from the rear side of the suspension plate, so that a locking loop is formed on the rear side of the suspension plate.

[0073] In addition, according to an embodiment of the method, the method also includes the following step: inserting the suture element into the third through hole of the six through holes in a first end section manner, in particular from the front side of the suspension plate, so that a first loop is formed on the front side of the suspension plate.

[0074] Furthermore, according to an embodiment of the method, the method further comprises the step of inserting the suture element into a fourth through hole of the six through holes with the first end section first, wherein the suture element is inserted into the fourth through hole, in particular from the rear side of the suspension plate.

[0075] In addition, according to an embodiment of the method, the method also includes the following step: inserting the suture element into the fifth through hole of the six through holes in a manner with the first end section first, wherein the suture element is inserted into the fifth through hole, in particular from the front side of the suspension plate, so that a second loop is formed on the front side of the suspension plate, and the second loop together with the first loop forms a suspension loop on the front side of the suspension plate.

[0076] In addition, according to an embodiment of the method, the method also includes the following step: inserting the first end portion extending from the fifth through hole into the locking loop, so that a portion of the first end segment of the suture element extending from the locking loop forms a first pulling segment of the suture element, which is used to pull the suture element to shorten / tighten the suspension loop.

[0077] In addition, according to an embodiment of the method, the method also includes the following steps: inserting the first end portion of the suture element extending from the locking ring into the sixth through hole among the six through holes, particularly from the rear side of the suspension plate, so as to respectively form a second and third pulling section extending from the sixth through hole for pulling the suspension device through the bone tunnel.

[0078] According to yet another aspect of the present invention, a method for forming a stopper on an end section of a suture element is disclosed, wherein the method comprises the following steps:

[0079] - providing a suture element having first and second end sections,

[0080] - forming a portion of merged fibers of the suture element by merging the heated individual fibers of the suture element at the second end section,

[0081] - forming at least one knot adjacent to a portion of said combined fibers,

[0082] - inserting the suture element into the through hole of the plate with the first end section first, and

[0083] - Pressing said at least one knot towards said portion of consolidated fibers by pulling on the first end portion of the suture element so that the knot is pressed against the surface of the plate delimiting said through hole. BRIEF DESCRIPTION OF THE DRAWINGS

[0084] Other features and advantages of the present invention will be described by way of a detailed description of embodiments with reference to the accompanying drawings, in which:

[0085] Figure 1 The working principle of an embodiment of an implantable suspension device according to the present invention is shown.

[0086] Figure 2 Components of an embodiment of an implantable suspension device according to the present invention, namely a single suture element and a suspension plate, are shown,

[0087] Figure 3 Shown is a method of constructing a system by mounting a suture element to a suspension plate. Figure 4 The steps of the embodiment of the suspension device shown,

[0088] Figure 4 shows an embodiment of an implantable suspension device according to the present invention,

[0089] Figure 5 The invention shows an implant, in particular an implant in the form of a graft, connected to Figure 4 The suspension ring of the suspension device shown,

[0090] Figure 6 Shows the Figure 5 The suspension device is inserted into the bone tunnel.

[0091] Figure 7 The second and third pulling sections of the suture element are shown Figure 5 The sixth through hole of the suspension plate of the suspension device is removed,

[0092] Figure 8 The first pulling section of the suture element is shown. Figure 5 The suspension ring of the suspension device is shortened.

[0093] Fig. 9 Shows the use of Figure 8 The first pulling section shown brings the implant (eg, a transplant) into the desired position.

[0094] Fig.10 shows severing the first pulling section from the suture element after positioning the implant,

[0095] Fig.11 shows different views of an embodiment of a tool according to the present invention, the tool being configured for pulling a pulling section of a suture element with a controllable force and distance,

[0096] Figures 12 to 15 Shows the use of Fig.11 The tool shown positions the implant.

[0097] Fig.16A further embodiment of a suspension device according to the invention is shown, which is used to connect two bones to one another or to apply tension to a bone,

[0098] Fig.17 A further embodiment of a suspension device according to the invention for connecting two bones to one another is shown,

[0099] Fig.18 An adapter plate for a suspension plate is shown,

[0100] Fig.19 An embodiment of a method for forming a stop on a second end portion of a suture element is shown, and

[0101] Figure 20 to Figure 22 An alternative embodiment of the tool according to the invention is shown. DETAILED DESCRIPTION

[0102] In particular, according to Figure 1 The embodiment of the suspension device 1 according to the invention shown, Figure 1 (A) comprising a suspension mechanism having a locking mechanism based on a movable hinge point (at Figure 1 (B) schematically shown as a pulley) with a double force locking pressure on the free end section 201. Advantageously, according to an embodiment of the suspension device 1 of the invention, the suspension device comprises a strand design, i.e. the device 1 specifically requires only one suture element 200. Here, the entire mechanism and procedure is implemented by only one suture element 200.

[0103] This results in better usability of the device 1, since only one strand (e.g. the first pulling section 211) needs to be pulled. Thus, the suspension device 1 according to the invention is easier to use and the risk of misuse is greatly reduced. The resulting design is more cost-effective and easier and faster to produce.

[0104] like Figure 1 As shown in (A), an embodiment of the suspension device according to the present invention comprises a suture element 200 having a first end section and a second end section, wherein the first end section remains free and forms a pulling section, and a stopper 20 is arranged on the second end section.

[0105] like Figure 1 As shown in (A), the suture is passed through a through hole formed in the suspension plate 100 and placed around the implant / tissue G so that the suspension loop 300 includes two hinge points P (one on each loop 301, 302) that can move relative to the suspension plate 100 and a hinge point P' that is fixed relative to the suspension plate 100. This mechanically corresponds to Figure 1(B) is a schematic illustration showing two movable pulleys P and one fixed pulley P'.

[0106] Due to the two movable pulleys P, the force F applied to the free pulling section 211 of the suture element 200 is amplified four times and transmitted to the suspension force applied to the graft G through the suspension loop 300 including the first loop 301 and the second loop 302 .

[0107] When the free pulling section 211 is released, the first free end section 201 is locked by pressure with the locking ring 40. In particular, the force on the locking ring 40 is twice the force F on the free first end section 201.

[0108] In particular, the locking force F L is converted into friction. 松弛 (See also Figure 5 ) is equal to the force on the first free end section 201 minus the system friction, which mainly comes from the fixed pulley part P', that is, from the friction between the suture element 200 and the corresponding through hole of the suspension plate 100. Therefore, the self-locking mechanism can be described as follows:

[0109] Locking force F L (Friction force under 2F pressure) > relaxation force F 松弛 (Force on the free first end section 201 (F) - system friction)

[0110] Generally, this mechanism can be generalized by increasing the number of loops (i.e. movable and fixed hinges / pulleys) according to different indications. The more movable / fixed hinges (pulleys), the higher the relative ratio of the suspension force transmitted from the pulling section 211.

[0111] The present invention thus differs significantly from the known solutions of the prior art (see also above), in which high friction is created by passing one suture through the sleeve of another suture, or by using a self-locking knot. In contrast, the present invention in particular uses a movable / fixed hinge point to reduce the slack force on the free (first) pulling section 211 and in particular locks it by pressing it with twice the slack force using the upper loop 40.

[0112] like Figure 2 As shown, the suspension device 1 according to the present invention comprises two main components, one is Figure 2 (A) shows an elongated and flexible (particularly pliable) suture element 200, and another Figure 2 (B) The suspension plate 100 shown.

[0113] In particular, the suture element 200 has a free first end section 201 on one side and a stop 20 on the other side, ie, a second end section 202 .

[0114] Furthermore, in order to allow the suture element 200 to engage with the suspension plate 100, the latter comprises a plurality of through holes 11, 12, 13, 14, 15, 16 which are organized in such a way as to enable the use of the movable and fixed hinge points to reduce the slack forces.

[0115] In addition, if Figure 2 As shown in (B), the suspension plate 100 particularly has six through holes 11, 12, 13, 14, 15, 16, and these through holes particularly have smooth edges and surfaces.

[0116] Preferably, according to an embodiment, the six through holes 11 , 12 , 13 , 14 , 15 , 16 may be arranged in the following manner.

[0117] In particular, the suspension plate 100 comprises a front side 100 a and a rear side 100 b facing away from the front side 100 a , wherein each through hole 11 , 12 , 13 , 14 , 15 , 16 extends from the front side 100 a to the rear side 100 b of the suspension plate 100 . In particular, the first, second, third and fourth through holes 11, 12, 13, 14 are arranged at the corners of a virtual quadrilateral, wherein the first, second, third and fourth through holes 11, 12, 13, 14 are arranged between the fifth and sixth through holes 15, 16, the fifth through hole 15 faces the sixth through hole 16 in the direction of the longitudinal axis L of the suspension plate (100), the first through hole 11 and the second through hole 12 are arranged adjacent to the fifth through hole 15, the first through hole 11 faces the second through hole 12 in a direction perpendicular to the longitudinal axis L and faces the third through hole 13 in the direction of the longitudinal axis L, and the fourth through hole 14 is arranged diagonally to the first through hole 11.

[0118] To build Figure 4 The suspension device shown in FIG. 1 is particularly performed to mount the suture element 200 to the suspension plate 100, as follows: Figure 3 As shown:

[0119] The free first end section 201 of the suture element 200 is passed through the first through hole 11 of the suspension plate 200 until the stopper 20 contacts the first through hole 11 or the surrounding surface of the front side 100a of the suspension plate 100 (see Figure 3 (A)).

[0120] The first end section 201 of the suture element 200 is passed through the second through hole 12 of the suspension plate 100 from the rear side 100b, and a small locking loop 40 is left for subsequent steps (see Figure 3(B)).

[0121] The first end section 201 of the suture element 200 is passed through the third through hole 13 of the suspension plate 100 to form the first loop 301 of the final suspension loop 300 to be formed (see Figure 3 (C)).

[0122] The first end section 201 of the suture element 200 is passed back through the fourth through hole 14 of the suspension plate (see Figure 3 (D)).

[0123] The first end section 201 of the suture element 200 is passed through the fifth through hole 15 of the suspension plate 100 to form a second loop 302, and thereby form a combined suspension loop 300 (see Figure 3 (E)).

[0124] Pass the first end section 201 of the suture element through the locking loop 40 (see also Figure 3 (B)), and shorten the locking ring 40 to form a single-strand self-locking structure (see Figure 3 (F)).

[0125] The first end section 201 of the suture element 200 is passed through the sixth through hole 16 of the suspension plate 100 to form the second and third pulling sections 212, 213 of the suture element 200 (see Figure 3 (G)).

[0126] In particular, according to Figure 3 (A) to Figure 3 The above-mentioned assembly step of (G) is performed outside the patient's body, i.e., ex vivo.

[0127] exist Figures 5 to 10 As shown in Figure 4 An exemplary use of an embodiment of a suspension device 1 according to the invention is shown.

[0128] like Figure 4 As shown, the device 1 comprises a first and a second loop 301, 302 forming the actual suspension loop 300, said loops 301, 302 being arranged on the front side 100a of the suspension plate 100. In addition, there are three pulling sections 211, 212, 213 extending on the rear side 100b of the suspension plate 100, wherein the first pulling section 211 is configured for shortening the loops 301, 302 (i.e., the suspension loop 300), while the other two pulling sections 212, 213 are configured for pulling the suspension device 1 through the bone tunnel T.

[0129] like Figure 5As shown, a graft G (or some other implant or tissue) is strapped into a suspension loop 300, wherein loops 301, 300, which extend in particular along each other, are placed around the periphery of the graft G.

[0130] In particular, when the first pulling section 211 is released, the tension (F 移植物 ) will be transmitted to the pulling section 211 in the opposite direction to the pulling, and this force is defined as the relaxation force F 松弛 .

[0131] When the first pulling section 211 is released, the loop 300 has a tendency to relax / stretch due to the tension of the graft G. The stronger the tension of the graft G, the higher the locking force on the locking loop 40. This creates a self-locking mechanism.

[0132] To bring the graft into the bone tunnel T, Figure 6 As shown by the arrow in , by pulling on the second and third pulling sections 212, 213, tension is maintained on the graft G and the graft is pulled into the bone tunnel. In this way, the entire suspension device 1 is brought into the bone tunnel T together with the graft G.

[0133] like Figure 7 As shown, when the suspension plate 100 is located outside the bone tunnel T, the second and third pulling sections 212, 213 are removed from the suspension plate as shown by the arrows while maintaining tension on the graft G.

[0134] Then, in order to shorten the loops 301, 302, Figure 8 Pull the first pulling section 211 in the direction of the arrow shown. Do this until the graft G reaches the desired position, such as Fig. 9 Finally, the pulling section 211 can be cut from the suture element 200. The graft G is now securely suspended in the bone tunnel T, as shown in FIG. Fig.10 shown.

[0135] Advantageously, the above-described procedure can be performed using only a single suture element, thereby achieving the entire function without the need for additional pulling sutures.

[0136] Furthermore, to shorten the loops 301, 302 (ie, suspend the loop 300), only one pulling section 211 needs to be pulled without having to worry about pulling equal forces / distances on multiple strands, which significantly simplifies the use of such a device.

[0137] Finally, the suture element 200 may be secured by means of a locking loop in a knot-free manner securely secured by a self-locking mechanism.

[0138] The above-described steps for using / operating the suspension device 1 according to the invention are fully functional without the tool 3 provided by the invention.

[0139] However, pulling a thin suture element 200 with high force always carries the risk of, for example, cutting off the glove and injuring the user's fingers. This is a very common problem that every surgeon faces in every surgical operation. The current solution is to use several rolls of gauze to hold the suture for pulling. It works, but it takes some time and sometimes it slips and needs to be redone.

[0140] Therefore, the present invention also provides a tool 3 to standardize suture pulling in order to ease the handling. In particular, the tool 3 according to the present invention is suitable for use with the suspension device according to the present invention.

[0141] The implementation of tool 3 is Fig.11 According to this, the suture pulling tool 3 has a handle 33 which may include a cylindrical shape and a guide rod 30 extending from the handle, in particular perpendicular to the longitudinal axis or cylindrical axis of the handle 33. The tool 3 includes two suture grooves 31, 32 passing through the guide rod 30 and the handle 33, which are used to accommodate the pulling sections 211, 212, 213.

[0142] Furthermore, the tool comprises a first and a second actuation element 35 , 36 (eg in the form of buttons) arranged on the handle 33 .

[0143] These actuating elements 35 , 36 are used to control clamps in the suture slots 31 , 32 , which are configured to hold or release the respective pulling section 211 or 212 , 213 arranged in the respective slot 31 , 32 .

[0144] Furthermore, the tool 3 comprises a distance probe 34 embedded in the guide rod 30, which can slide into and out of the guide rod 30 in the extension direction of the guide rod 30 and is used to measure the distance between the tip of the guide rod 30 and the patient's soft tissue M, in particular during pulling. Furthermore, there are two indicators 37, 38 embedded on the side of the guide rod 30 facing away from the slots 31, 32, namely a force indicator 37 and a distance indicator 38 for indicating the distance measured by the distance probe 34.

[0145] exist Figures 12 to 15 It is shown in Fig.11 Exemplary use of tool 3.

[0146] like Fig.12As shown, the first pulling section 211 of the suture element 200 is arranged in the first groove of the tool, and the second and third pulling sections 212, 213 are arranged in the second groove 32. By operating the actuating elements 35, 36, the pulling sections 211, 212, 213 are clamped in the grooves 31, 32 so as to bring the suspension device 1 into the bone tunnel T. This step corresponds to the step of not pulling the tool 3. Figure 6 .

[0147] like Fig.13 As shown, when the suspension plate 100 is located outside the bone tunnel T, the second slot operates with the second actuating element 36 to release the second and third pulling sections 212, 213. In addition, these pulling sections 212, 213 are removed from the suspension plate 100 and the second slot 32 of the tool 3. This step corresponds to the step of not pulling the tool 3. Figure 7 .

[0148] Then, if Fig.14 As shown, the tool 3 is moved toward the patient's skin M until the distance probe 34 contacts the skin M. The first slot 31 is operated using the first actuating element 35 to hold a single first pulling section 211. This step corresponds to the step of not pulling the tool 3. Figure 8 .

[0149] In addition, if Fig.15 As shown, the distance probe 34 is then held in place at the skin M, and the tool 3 is then pulled away from the skin M to shorten the loops 301, 302, i.e., the suspension loop 300. When the graft G reaches the desired position, the pulling is stopped and the suture element 200 / pulling section 211 is released from the first groove 31. The force applied via the pulling section 211 and the distance generated when pulling can be indicated by using the indicators 37, 38. This step corresponds to the step of not pulling the tool 3. Fig. 9 .

[0150] In order to control the holding and release of the pulling sections 211, 212, 213, the corresponding actuating elements 35, 36 can be manually operated by the user. According to another embodiment, the distance can be preset into the tool 3 according to the bone tunnel length, wherein the distance probe 34 is now configured to automatically trigger the corresponding actuating element according to the preset distance. With this function, the surgeon does not need to worry about when the suspension plate is located outside the bone tunnel or when which pulling section needs to be pulled. As long as the bone tunnel distance is measured and input into the suture pulling tool 3, the actuating element (e.g., switch) for controlling the holding of the pulling section and the release from the groove can be automatically triggered. The surgeon just pulls the tool 3 to the bottom, and the rest is handled automatically by the tool 3.

[0151] also, Fig. 20 Combination Fig.21 and 22A further embodiment of a tool 3 according to the invention is shown.

[0152] Here, the distance probe 34b is slidably arranged in the guide rod 30b of the tool 3, wherein the tool 3 also includes a handle 33c connected to the guide rod 30b. The distance probe 34b also includes a distance probe handle 33b arranged at one end of the distance probe 34b, so that the distance probe 34b moves relative to the guide rod 30b or the handle 33c. With the help of the handle 33b, the distance probe 34b is inserted into the bone tunnel T. The tip 203 of the guide rod 30b should be in direct contact with the cortical bone. The resulting distance between one end of the bone tunnel B and the tip of the distance probe 34b is known and will help the user obtain information about the insertion depth of the distance probe 34.

[0153] Then, the first end segment 201 of the suture element 200 (i.e., the three pulling segments 211, 212, 213) is guided through the first groove 31b and tied between a distance measuring wheel 38b (e.g., a rotating wheel with a distance measuring function) arranged on the guide rod 30b and a force indicator 37b (e.g., a spring-loaded block with a force measuring function depending on the suture tension), and the pulling segments 211, 212, 213 can be clamped by means of a self-locking clamp 35b mounted to the distance probe 34b.

[0154] like Fig.21 As shown, once the user feels resistance during the manual pulling of the pulling segments 211, 212, 213 of the suture element 200 due to the interaction (e.g., contact) of the suspension plate 100 with the distance probe 34b, the user releases the second and third pulling segments 212, 213. In addition, these pulling segments 212, 213 are removed from the suspension plate 100 to receive a single free (first) pulling segment 211 from the suspension plate 100. After the first pulling segment 211 / first end segment 201 is guided through the first slot 31b and tied between the distance measuring wheel 38b and the force indicator 37b, it is clamped by means of the clamp 35b. In particular, the clamp 35b can be formed as a (e.g., unidirectional) self-locking cam bolt (see Fig.21 and 22 ).

[0155] If the distance probe handle 33b is now pulled in the transverse direction (i.e., away from the body / bone tunnel T), the suture element 200 will be tightened, resulting in compression of the force indicator 37b and indicating a certain force. If this force exceeds the total friction force (tool 3 friction and graft G friction in the tunnel T), it will rotate the distance measurement wheel 38b, and the displacement of the suture element 200 can be read from the wheel 38b. If the free first pulling section 211 / first end section 201 is pulled, once it reaches the outside of the bone B, it will automatically flip the suspension plate 100. The user can apply a certain pulling force on the handle 33b and read it when the force indicator 37b reaches a sufficient threshold. Finally, the user can use a small rotating knife 204 to cut the first pulling section 211 / first end section 201 close to the top of the bone B, which can be attached to the tool 3 and operated by a lever (lever, handle, joystick) 205 hinged to the guide rod 30b or the handle 33C.

[0156] Furthermore, in addition to ACL reconstruction, the present invention, in particular Fig.16 (A)(See also Figure 4 ) can be used for a variety of different indications.

[0157] For example, by adding Fig.16 The example shown in FIG. 1 may include two recesses 71, 72 (see Fig.16 (B)) or even four recesses 71, 72, 73, 74 (see Fig.16 (C) or Fig.16 (D)) of the plate member 70, the two bones B, B' can be connected to each other, such as Fig.16 Alternatively, tension may be maintained on a single bone B, as shown in (E). Fig.16 (F) shown.

[0158] By adding a second and a third plate member 80, 90, each of which may include two recesses 81, 82 or 91, 92, Fig.17 The device 1 shown in (A) can be used to maintain tension between two bones B, B'.

[0159] The additional plate members 70, 80 or 90 may be pre-installed with closed recesses (e.g. holes 71, 72, 73, 74, 81, 82, 91, 92) or may be subsequently installed using, for example, Fig.16 , 17 The open recess shown is installed. Potential indications are bow leg correction, tarsometatarsal ligament repair, AC joint fixation, syndesmosis repair, etc.

[0160] Furthermore, the shape of the suspension plate 100 can be adapted to the respective use / indication of the suspension device 1 .

[0161] In particular, according to Fig.18 According to another embodiment of the suspension device 1 of the present invention, the suspension device (see Fig.18 The right-hand side of the adapter plate 50 comprises an adapter plate 50, wherein the adapter plate 50 comprises a recess 51 for receiving the suspension plate 100 in a form-fitting manner, in particular so that the through holes 11, 12, 13, 14, 15, 16 are accessible from the front side 100a and the rear side 100b of the suspension plate 100 when the suspension plate is arranged in said recess 51 of the adapter plate 50. The adapter plate 50 can be designed to fit into a special bone tunnel T in a form-fitting manner.

[0162] at last, Fig.19 An embodiment is shown with respect to the manufacture of the stop 20 disposed on the second end section 202 of the suture element 200 .

[0163] according to Fig.19 The stopper 20 can be formed by performing the following steps, for example:

[0164] - severing the rigid end of the suture element 200 at the second end section 202 to expose the individual fibers 23,

[0165] - Particularly to separate the fibers 23, for example so that they form a "mushroom"-like shape

[0166] - heating the fibers 23 so that the fibers 23 merge into the closed portion 22 of the suture element 200, in particular the end portion 22,

[0167] - Tie a knot 21 (e.g. a self-tie knot) next to the portion / end 22

[0168] - Pass the suture element 200 through the hole 61 of the plate 60

[0169] - Pulling the first end section 201 of the suture element 200 to compress the knot 21

[0170] - Removing the suture element 200 from the plate 60 .

Claims

1. An implantable suspension device (1) for fixing an elongated flexible implant (G) or tissue (B) at a desired position, comprising: A suspension plate (100) and a single suture element (200), wherein the suspension plate (100) comprises a plurality of through holes (11, 12, 13, 14, 15, 16), wherein the plurality of through holes (11, 12, 13, 14, 15, 16) are formed by six through holes, each through hole (11, 12, 13, 14, 15, 16) extends from a front side (100a) to a rear side (100b) of the suspension plate (100), the suture element (200) extends through the through holes (11, 12, 13, 14, 15, 16), and the The single suture element is engaged with the suspension plate (100) so that the suture element (200) forms an adjustable suspension loop (300) for connecting the implant (G) or tissue (B) to the suspension plate (100), wherein the single suture element (200) includes a free first end section (201) and a second end section (202), and wherein the single suture element (200) includes a stopper (20) arranged on the second end section (202), and the suture element (200) is connected with the first end section (201). The end section (201) is inserted into the first through hole (11) of the plurality of through holes (11, 12, 13, 14, 15, 16) in a first manner, so that the stopper (20) abuts against the front side (100a) of the suspension plate (100) to prevent the suture element (200) from being completely pulled through the first through hole (11) of the suspension plate (100), and wherein the suture element (200) forms a locking ring (40) formed on the rear side of the suspension plate (100). (100b), the locking ring is used to press the first end section (201) against the suspension plate (100) and thereby lock the first end section (201) of the suture element (200) relative to the suspension plate (100), wherein the suspension ring (300) is configured to be shortened by pulling a first pulling section (211) formed by a portion of the first end section (201) of the suture element (200), the first pulling section (211) extending from the locking ring (40), wherein the suspension loop (300) comprises a first loop (301) and a second loop (302) formed by the suture element (200), and wherein the suture element (200) is inserted into the through hole (11, 12, 13, 14, 15) so that the pulling force (F) applied to the first pulling section (211) of the first end section (201) of the suture element (200) and transmitted to the suspension loop (300) is amplified by at least 4 times, and the locking force (F L ) is the friction force in the presence of a pressing force that is at least twice the pulling force (F) on the first pulling section (211) of the suture element (200), and The first end section (201) forms a second pulling section (212) and a third pulling section (213) for pulling the suspension device through a bone tunnel.

2. The implantable suspension device according to claim 1, characterized in that: The force loaded on the suspension ring (300) is proportionally related to the force applied to the first pulling section (211), and / or the change in the length of the suspension ring (300) is proportionally related to the displacement of the first pulling section (211).

3. The implantable suspension device according to claim 1 or 2, characterized in that: In order to reduce the relaxation force (F 松弛 ) and supports the self-locking of the suspension ring (300), wherein the suspension ring includes a turning point (P, P').

4. The implantable suspension device according to claim 1, characterized in that: The suture element (200) is also successively inserted into the second through hole (12), the third through hole (13), the fourth through hole (14) and the fifth through hole (15) among the plurality of through holes, so that the adjustable suspension ring (300) is formed on the front side (100a) of the suspension plate (100) and / or the locking ring (40) is formed on the rear side (100b) of the suspension plate (100), wherein the first end section (201) of the suture element (200) is also inserted into the locking ring (40) so as to lock the first end section (201) of the suture element (200) with a locking force (F) by means of the locking ring (40). L ) is clamped to the rear side (100b) of the suspension plate (100).

5. The implantable suspension device according to claim 4, characterized in that: The plurality of through holes (11, 12, 13, 14, 15, 16) include a second through hole (12), wherein the suture element (200) is inserted into the second through hole (12) so that the locking ring (40) is formed on the rear side (100b) of the suspension plate (100).

6. The implantable suspension device according to claim 4 or 5, characterized in that: The plurality of through holes include a third through hole (13), wherein the suture element (200) is inserted into the third through hole (13) so that the first loop (301) of the suspension loop (300) is formed on the front side (100a) of the suspension plate (100).

7. The implantable suspension device according to claim 4 or 5, characterized in that: The plurality of through holes include a fourth through hole (14), wherein the suture element (200) is inserted into the fourth through hole (14).

8. The implantable suspension device according to claim 4 or 5, characterized in that: The plurality of through holes include a fifth through hole (15), wherein the suture element (200) is inserted into the fifth through hole (15) so that the second loop (302) of the suspension loop (300) is formed on the front side (100a) of the suspension plate (100).

9. The implantable suspension device according to claim 8, characterized in that: The first end section (201) extending from the fifth through hole (15) is inserted into the locking ring (40), wherein a portion of the first end section (201) of the suture element (200) extending from the locking ring (40) forms the first pulling section (211) of the suture element (200) for pulling the suture element (200) to shorten the suspension ring (300).

10. The implantable suspension device according to claim 9, characterized in that: The plurality of through holes include a sixth through hole (16), wherein the first end section (201) of the suture element (200) extending from the locking ring (40) can be inserted into the sixth through hole (16) to respectively form a second pulling section (212) and a third pulling section (213) extending from the sixth through hole (16) for pulling the suspension device (1) through the bone tunnel (T).

11. The implantable suspension device according to claim 1 or 2, characterized in that: The stop (20) includes at least one knot (21) formed in a second end section (202) of the suture element (200).

12. The implantable suspension device according to claim 11, characterized in that The stopper (20) comprises a portion (22) of the suture element (200) arranged adjacent to the at least one knot (21), the portion (22) being formed by consolidated fibers (23) of the suture element (200).

13. The implantable suspension device according to claim 1 or 2, characterized in that: The suspension device (1) comprises an adapter plate (50), wherein the adapter plate (50) comprises a recess (51) for receiving the suspension plate (100) in a form-fitting manner.

14. The implantable suspension device according to claim 1 or 2, characterized in that: The suspension device (1) comprises a plate member (70), wherein the plate member (70) comprises recesses (71, 72, 73, 74) extending through the suspension ring (300).

15. The implantable suspension device according to claim 1 or 2, characterized in that: The suspension device (1) comprises a first plate member (80), wherein the first plate member (80) comprises recesses (81, 82) extending through the first loop (301) of the suspension loop (300), and wherein the suspension device (1) comprises a second plate member (90), wherein the second plate member (90) comprises recesses (91, 92) extending through the second loop (302) of the suspension loop (300).

Images