Patent Application
20210169469
The invention relates to an insert holding device and a suture holding device for connecting a suture to an insert for insertion into a bone, a kit of parts comprising the insert holding device and the suture holding device, and a method for connecting a suture to an insert for insertion into a bone. In particular, the suture and the insert may be comprised in an implant for ligament repair in a human or animal joint, more particularly anterior cruciate ligament repair in a human or animal knee.
Implants for ligament repair comprising a flexible graft (e.g. an autograft from a patient hamstring) connected to at least one osteoconductive element (OCE) are known from the prior art (i.e. WO 2016/113142 A1). In addition, so-called bone-tendon-bone (BTB) grafts have been described in the prior art.
In such implants, the flexible graft replaces the torn or damaged ligament (e.g. the anterior cruciate ligament, ACL), and the osteoconductive element or bone graft is inserted into boreholes of associated bones (such as the tibia and/or femur in case of ACL repair). Therein, the purpose of the insert is to fix the implant in the bone and to facilitate ingrowth of bone cells leading to increased long-term stability of the implant.
In addition, so-called cortical fixation devices (CFD) are typically used to attach the implant on the outside of the borehole of the associated bone to apply sufficient tension to the flexible graft for replacing the function of the native ligament. Typical CFDs comprise a plate member to be positioned outside of the borehole, wherein sutures extending through the bone tunnel connect the plate member to the osteoconductive element or bone graft.
In clinical practice, attaching sutures to an insert for insertion into a bone (such as an OCE or a bone graft), in particular to connect the insert to a CFD or a flexible graft, is challenging for the surgeon, particularly since small components are handled. However, positioning the insert in the implant correctly is of great importance for achieving good biological performance.
Therefore, the objective of the present invention is to provide a means to facilitate attachment of sutures to an insert for insertion into a bone.
This objective is attained by the subject matter of independent claim 1 relating to an insert holding device, independent claim 9 relating to a suture holding device, independent claim 12 relating to a kit of parts, and independent claim 13 relating to a method for connecting a suture to an insert for insertion into a bone.
Embodiments of the present invention are described in dependent claims 2 to 8, 10 to 11, and 14 to 15 and are described hereafter.
A first aspect of the invention relates to an insert holding device for connecting a suture to an insert for insertion into a bone, comprising a holding structure configured to releasably hold an insert for insertion into a bone, at least one first recess for receiving a first suture, and at least one second recess for receiving a looped second suture, wherein the at least one first recess and the at least one second recess are configured such that the first suture can be laid around the second suture and the insert, thereby connecting the second suture to the insert when the insert is held by the holding structure.
In particular, the at least one first recess is configured such that the first suture can be arranged around the insert when the insert is held by the holding structure.
By means of the holding structure and the first and second recess, the insert and the first and second sutures are pre-arranged, such that a surgeon may easily attach the second suture to the insert by laying the first suture around the insert and second suture and e.g. tying a knot of the first suture.
In the context of the present specification, the term ‘insert’ describes any component suitable to be inserted into a bone of a human or animal, in particular components comprising an osteoconductive and/or osteoinductive material. This includes bone grafts, such as xenografts and allografts, in other words natural bone material, as well as artificial osteoconductive and/or osteoinductive materials, such as e.g. tricalcium phosphate (TCP).
Therein the term ‘osteoinductive’ describes a material which is adapted to serve as a scaffold for new bone growth that is perpetuated by the native bone. The term ‘osteoconductive’ describes a material which is adapted to stimulate osteoprogenitor cells to differentiate into osteoblast, thereby facilitating new bone formation.
In the context of the present specification, the term ‘suture’ describes any elongated member which is suitable to be used for connecting components, particularly by sewing or knotting, to be implanted into the human or animal body.
The insert holding device can be manufactured from any suitable material, such as a metal or a polymer. For example, a foldable paper sheet, plastic sheet or polymer sheet may be used to produce the insert holding device.
In particular, the insert is adapted for use in an implant for anterior cruciate ligament repair, wherein the implant further comprises a flexible graft, particularly replacing the anterior cruciate ligament. More particularly, the implant further comprises a cortical fixation device comprising a plate member for applying tension to the flexible graft.
Due to its anatomical location, the anterior cruciate ligament (ACL) is subjected to potentially extreme forces during sports and other physical activities. Rupture of the ACL has been counted as the most frequent and severe of ligament injuries. Although several surgical options, including hamstring graft approach, bone patella tendon bone graft, etc. for ACL reconstruction have been practiced for the restoration of knee joint function, several unavoidable drawbacks exist, such as donor site morbidity, ligament laxity, mechanical mismatch, etc.
Clinically implemented graft fixation methods largely rely on tendon to bone ingrowth to provide long term ligament stability, with many requiring bone ingrowth to a non-osteoconductive graft. The non-osteoconductive nature of the graft material often critically limits the success of ACL repair. Failure of timely bone ingrowth can lead to “bone tunnel expansion”, and ultimately a failed reconstruction that may necessitate a revision surgery with large cost and burden to the patient.
To minimize bone tunnel expansion and to achieve an optimized attachment of a graft within the bone tunnel, an osteo-conductive element (OCE) can be used between bone tunnel and graft, resulting in a so-called “bony bridge”. Such an OCE has been described in patent application WO 2016/113142 A1.
In certain embodiments, the at least one first recess of the insert holding device is configured such that the first suture can be arranged in a straight line. In certain embodiments, the at least one second recess is configured such that the second suture can be arranged in a straight line.
In certain embodiments, the at least one first recess is configured such that the first suture can be arranged along a first axis when the first suture is received in the at least one first recess, wherein the at least one second recess is configured such that the second suture can be arranged along a second axis, when the second suture is received in the at least one second recess, wherein the first axis is non-parallel to the second axis and wherein the first axis is arranged at an angle of 30° to 150°, particularly 45° to 135°, more particularly 60° to 120°, most particularly 90°, in respect of the second axis.
In certain embodiments, the holding structure of the insert holding device comprises a slot for receiving the insert, a first wall and a second wall opposing the first wall, wherein the slot is delimited by the first wall and the second wall, and wherein the first wall and the second wall are adapted to releasably hold the insert within the slot by static friction. In other words, the insert is held in the slot by a press-fit. Alternatively, any other suitable means for holding the insert in place can be used as a holding structure.
In particular, the slot is open along the first axis, such that the insert can be slid in the slot along the first axis.
In certain embodiments, the first wall and/or the second wall comprises a flexible material having a Young's modulus of 10000 MPa or less, particularly 5000 MPa or less, more particularly 2000 MPa or less, most particularly 1800 MPa, according to DIN EN ISO 178:2013-09. Thus, due to the flexibility of the material, static friction with the insert is generated when the first and/or second wall is deformed by the insert in the slot.
In certain embodiments, the first wall and/or the second wall comprises or consists of polypropylene.
In certain embodiments the insert holding device comprises a force-generating element, for example a spring, such as a leaf spring, adapted to exert a force on the first and/or second wall. Thereby, static friction with the insert is generated when the insert is positioned in the slot.
In certain embodiments, the device further comprises a third wall and a fourth wall, wherein the third wall and the fourth wall are perpendicular to the first and second wall. In other words, the third wall and the fourth wall form a roof over the slot.
In certain embodiments, the insert holding device comprises a first surface and a second surface opposing the first surface.
In certain embodiments, the at least one first recess extends from the first surface of the insert holding device to the second surface of the insert holding device. In particular, this allows the first suture to be passed from the second surface through the at least one first recess to the first surface and around the insert when the insert is held by the holding structure of the insert holding device and back through the at least one first recess to the second surface in order to be laid around the second suture and the insert.
In certain embodiments, the at least one second recess extends from the first surface of the insert holding device to the second surface of the insert holding device. In particular, this allows the second suture to be passed from the second surface through the at least one second recess to the first surface and back through the at least one second recess to the second surface in order to be arranged around the insert.
In other words, the at least one first recess and the at least one second recess can be formed by through-holes or notches in the third surface (or edge) of the insert holding device.
In certain embodiments, the at least one first recess extends along the first axis, particularly between the first wall and the second wall.
In certain embodiments, the at least one first recess comprises a first end section, a second end section and a middle section connecting the first end section and the second end section.
In certain embodiments, the width of the first end section is greater than the width of the middle section, and the width of the second end section is greater than the width of the middle section. Therein, the term width refers to a maximum extension of the respective section measured perpendicular to the first axis. The greater width facilitates passing of the suture below the insert in the holding structure.
In certain embodiments, the insert holding device comprises a first recess, wherein the first recess extends along the first axis. In other words, the at least one first recess consists of the first recess (there is only one first recess).
In certain embodiments, the insert holding device comprises a first notch and a second notch (e.g. opposing the first notch), in particular extending along the first axis, wherein the first notch and the second notch are adapted to hold the first suture, such that the first suture can be arranged from the first notch over the at least one first recess to the second notch.
In certain embodiments, the insert holding device comprises a first notch and a second notch (e.g. opposing the first notch), in particular extending along the second axis, wherein the first notch and the second notch are adapted to hold the second suture, such that the second suture can be arranged from the first notch over the at least one second recess to the second notch.
In certain embodiments, the insert holding device comprises a first notch, a second notch, a third notch, and a fourth notch, wherein the first notch and the second notch are adapted to hold the first suture, such that the first suture can be arranged from the first notch over the at least one first recess to the second notch, and wherein the third notch and the fourth notch are adapted to hold the second suture, such that the second suture can be arranged from the third notch over the at least one second recess to the fourth notch.
In certain embodiments, the insert holding device comprises a first surface, a second surface facing away from the first surface, and a circumferential third surface connecting the first surface and the second surface.
In certain embodiments, the at least one second recess is open towards the third surface, such that the second suture can be received by, in particular inserted into, the at least one second recess from the third surface.
In certain embodiments, the insert holding device comprises two second recesses. In other words: the at least one second recess comprises or is constituted by two second recesses.
In certain embodiments, at least a part of the at least one first recess is positioned between the second recesses such that the second suture can be arranged between the second recesses above the at least one first recess on the first surface, such that the first suture can be laid around the second suture and the insert.
In certain embodiments, the two second recesses extend along the first axis.
In certain embodiments, the two second recesses are open towards the third surface. Thereby, the second suture can be arranged between the second recesses above the at least one first recess by inserting the second suture into the second recesses from the third surface (e.g. from the edge of the insert holding device).
In certain embodiments, the second recesses each comprise a width of 1 mm or less, particularly 0.5 mm or less. Therein, in particular, the width is measured along the second axis. Due to the small width, a certain amount of force has to be applied to move a surgical suture of typical width through the second recess, such that the suture is prevented from slipping out of the second recess.
In certain embodiments, the at least one second recess comprises a respective holding section for receiving the second suture and a respective entry section for moving the second suture towards the respective holding section, particularly from an opening in the third surface, wherein the respective holding section comprises a width, particularly along the second axis, which is larger than a width, particularly along the second axis, of the respective entry section. In particular, this prevents moving of the second suture back into the entry section.
In certain embodiments, the entry section comprises a width of 0.5 mm or less, particularly 0.2 mm or less.
In certain embodiments, the insert holding device comprises a protrusion, particularly a pointed end, along the first axis, wherein the protrusion is positioned between the second recesses, such that the protrusion can be moved through the looped second suture, thereby inserting the second suture into the second recesses. In particular, the pointed end facilitates insertion into the looped second suture held by a suture holding device according to the second aspect.
In certain embodiments, the at least one first recess and the at least one second recess are open towards the first surface and closed towards the second surface. Therein, in particular, the at least one first recess is adapted to receive the first suture from the first surface, and the at least one second recess is adapted to receive the second suture from the first surface, wherein more particularly the holding structure of the insert holding device is adapted to hold the insert above the first suture and the second suture, such that the first suture can be arranged around the insert and the second suture, thereby connecting the second suture to the insert. Therein, in particular, the insert holding device comprises a first recess and a second recess, in other words, the at least one first recess consists of a (single) first recess and the at least one second recess consists of a (single) second recess.
In certain embodiments, the slot of the holding structure of the insert holding device is formed by blind hole which is open towards the first surface. In certain embodiments, the slot is positioned at an intersection between the at least one first recess and the at least one second recess, particularly between the first recess and the second recess.
In certain embodiments, the insert holding device comprises a groove for inserting the second suture, wherein the groove extends along the third surface of the insert holding device in a circumferential direction, and wherein the at least one second recess is connected to, particularly extends into, the groove.
In certain embodiments, the insert holding device comprises an upper portion and a lower portion, wherein the upper portion comprises the at least one first recess and the at least one second recess, particularly the first recess and the second recess, wherein particularly the third axis extends along a third axis which is perpendicular to the first axis and the second axis.
In certain embodiments, the upper portion comprises a respective first surface and a respective circumferential third surface, and the lower portion comprise a respective first surface, a second surface opposing the respective first surface, and a respective third circumferential surface connecting the first surface and the second surface of the lower portion. Therein, in particular, the second surface of the lower portion is the same as the second surface of the insert holding device.
In certain embodiments, the groove extending along the third surface of the insert holding device in a circumferential direction is positioned on the third surface of the upper portion, in particular adjacent to the first surface of the lower portion.
In certain embodiments, the upper portion and the lower portion are arranged along a third axis, wherein the upper portion comprises a first maximum extension perpendicular to the third axis, in particular a first diameter, and the second section comprises a second maximum extension perpendicular to the third axis, in particular a second diameter, wherein the first maximum extension is smaller than the second maximum extension.
In certain embodiments, the insert holding device comprises a circular cross-section in respect of the third axis.
In certain embodiments, the upper portion and the lower portion comprise a circular cross-section in respect of the third axis. Therein, in particular, the first maximum extension of the upper portion perpendicular to the third axis is the first diameter of the upper portion, and the second maximum extension of the lower portion perpendicular to the third axis is the second diameter of the lower portion.
In certain embodiments, the insert holding device comprises a planar geometry. In other words, the insert holding device comprises a sheet of material extending in a plane defined by the first axis and the second axis.
In certain embodiments, the insert holding device is folded from a sheet of material. Suitable materials for folding include paper sheets, plastic sheets or polymer sheets.
In certain embodiments, the sheet of material is configured to form the walls delimiting the slot when the flat sheet of material is folded.
In certain embodiments, the insert holding device is adapted to be mechanically connected to a suture holding device for holding at least the second suture, particularly according to the second aspect of the invention.
A second aspect of the invention relates to a suture holding device for connecting a suture to an insert for insertion into a bone comprising a first recess for inserting a flexible graft, a holding structure for positioning a looped second suture across the first recess, wherein the first recess is configured such that an insert for insertion into a bone held by the holding structure of an insert holding device, in particular according to the first aspect of the invention, can be positioned in or adjacent to the first recess and a first suture can be laid around the second suture and the insert, thereby connecting the second suture to the insert.
In certain embodiments, the suture holding device is configured to be assembled with an insert holding device according to the first aspect of the invention, such that the first suture can be laid around the second suture and the insert, thereby connecting the second suture to the insert, when the insert is held by the holding structure of the insert holding device and the suture holding device and the insert holding device are assembled.
In certain embodiments, the first recess of the suture holding device is configured such that a flexible graft (in particular a tendon graft, e.g. from a hamstring) can be passed through the first recess in order to connect the flexible graft to the second suture.
In certain embodiments, the suture holding device comprises a further holding structure for positioning a first suture across the first recess.
In certain embodiments, the holding structure of the suture holding device comprises a first protrusion and a second protrusion, wherein the first recess of the suture holding device is arranged between the first protrusion and the second protrusion, such that the second suture can be arranged from the first protrusion above the first recess towards the second protrusion.
In certain embodiments, the suture holding device comprises a first groove adapted to hold a plate member connected to the second suture, wherein the plate member is configured to be positioned on the outside of a borehole in a bone in order to apply tension to the second suture when the second suture extends from the plate member through the borehole. In particular, the plate member is comprised in a cortical fixation device.
In certain embodiments, the holding structure of the suture holding device further comprises a second recess adjacent to the first protrusion opposite the first recess of the suture holding device, wherein the holding structure comprises a third recess adjacent to the second protrusion opposite the first recess, wherein the second recess and the third recess are configured to receive the second suture.
In certain embodiments, the suture holding device comprises at least one groove for arranging at least one further suture (for example a passing suture and/or a flipping suture of a cortical fixation device) on the suture holding device.
In certain embodiments, the suture holding device comprises at least one hole for arranging at least one further suture (for example a passing suture and/or a flipping suture of a cortical fixation device) on the suture holding device.
In certain embodiments, the suture holding device comprises at least one notch for receiving the first suture, wherein the at least one notch is configured such that the first suture can be arranged across the first recess of the suture holding device.
A third aspect of the invention relates to a kit of parts comprising an insert holding device according to the first aspect of the invention and a suture holding device according to the second aspect of the invention, wherein the first recess of the suture holding device is configured such that an insert for insertion into a bone held by the holding structure of the insert holding device can be positioned in or adjacent to the first recess of the suture holding device, and a first suture can be laid around a second suture and the insert, thereby connecting the second suture to the insert, wherein the second suture is positioned across the first recess of the suture holding device by the holding structure of the suture holding device.
A fourth aspect of the invention relates to a method for connecting a suture to an insert for insertion into a bone, wherein an insert holding device, particularly according to the first aspect of the invention, is provided, and wherein an insert for insertion into a bone is received by a holding structure of the insert holding device, such that the holding structure releasably holds the insert, and wherein a first suture is received by at least one first recess of the insert holding device, and wherein a looped second suture is received by at least one second recess of the insert holding device, and wherein the first suture is laid around the second suture and the insert held by the holding structure of the insert holding device, thereby connecting the second suture to the insert.
In certain embodiments, the insert is subsequently removed from the holding structure of the insert holding device.
In certain embodiments, a flexible graft is connected to the insert, particularly after removing the insert from the holding structure of the insert holding device. Therein, in particular, the flexible graft is connected to the second suture, thereby connecting the flexible graft to the insert. For example, the flexible graft can be folded around the second suture and optionally stitched together at at least one stitching position.
In certain embodiments, the insert is first received by the holding structure of the insert holding device, wherein the second suture is subsequently received by the at least one second recess of the insert holding device, and wherein the first suture is subsequently received by the at least one first recess of the insert holding device.
In certain embodiments, the insert is first received by the holding structure of the insert holding device, wherein the first suture is subsequently received by the at least one first recess of the insert holding device, and wherein the second suture is subsequently received by the at least one second recess of the insert holding device.
In certain embodiments, the first suture is first received by the at least one first recess of the insert holding device, wherein the second suture is subsequently received by the at least one second recess of the insert holding device, and wherein the insert is subsequently received by the holding structure of the insert holding device.
In certain embodiments, the first suture is tied into a knot around the second suture and the insert, thereby connecting the second suture to the insert.
In certain embodiments, the first suture is passed from the first surface of the insert holding device to the second surface of the insert holding device through the first recess, passed below the insert in the holding structure of the insert holding device, passed below the first suture and passed back to the first surface through the first recess of the insert holding device, wherein subsequently the second suture is received by the at least one second recess of the insert holding device above the first suture, wherein in particular the first suture is inserted into the first notch and the second notch of the insert holding device.
In certain embodiments, the second suture is held by a holding structure of a suture holding device, particularly according to the second aspect of the invention, wherein the second suture is positioned across a first recess of the suture holding device, and wherein the insert held by the holding structure of the insert holding device is positioned in or adjacent to the first recess of the suture holding device, and wherein the first suture is laid around the second suture held by the holding structure of the suture holding device and the insert held by the holding structure of the insert holding device, thereby connecting the second suture to the insert.
In certain embodiments, the insert holding device is connected to the suture holding device when the first suture is laid around the second suture held by the holding structure of the suture holding device and the insert held by the holding structure of the insert holding device.
In certain embodiments, the insert holding device is removed from the suture holding device, wherein a flexible graft is inserted into the first recess of the suture holding device after removing the insert holding device from the suture holding device, and wherein the flexible graft is connected to the second suture, thereby connecting the flexible graft to the insert. For example, the flexible graft can be folded around the second suture and optionally stitched together at at least one stitching position.
In certain embodiments, the insert, the first suture, the second suture, and the flexible graft are removed from the suture holding device after connecting the flexible graft to the second suture, wherein the flexible graft is pulled, and wherein particularly the suture holding device is bent. In particular, the plate member is removed from the suture holding device after connecting the flexible graft to the second suture.
A fifth aspect of the invention relates to a method of manufacture of the insert holding device according to the first aspect of the invention, wherein a foldable sheet of material is provided, and wherein the material is folded to obtain the insert holding device.
In certain embodiments, at least one folding line is introduced into the sheet, particularly by indenting or heat treatment.
In certain embodiments, the first wall and the second wall delimiting the slot of the holding structure of the insert holding device are generated by folding segments of the sheet.
In certain embodiments, the third wall and the fourth wall delimiting the slot of the holding structure of the insert holding device are generated by folding segments of the sheet.
The invention is further described by the following examples and figures, from which additional embodiments may be derived. Therein
The implant I thus extends from the outside of the tibia T bone through the borehole B of the tibia T, the joint space and the borehole B of the femur F to the outside of the femur F bone, wherein the flexible graft 900 replaces the native anterior cruciate ligament. Tension can be applied to the flexible graft 900 by pulling on the second sutures 500 between the plate members 510 and the inserts 300, wherein the plate members 510 prevent the ends of the second sutures 500 from being pulled into the respective borehole B when tension is applied to the flexible graft 900.
Typically, the flexible graft 900 is an autograft comprising segments cut from a patient's hamstring tendon.
In particular, the insert 300 comprises an osteoconductive and/or osteoinductive material, such that ingrowth of bone cells into the implant I occurs, improving the stability of the implant I. Such an insert 300 is also termed “osteoconductive element”. Alternatively, the insert 300 may be constituted by a bone block, preferably an autograft. In this case, the resulting implant I is termed “bone-tendon-bone autograft”.
A schematic drawing of a typical plate member 510 of a cortical fixation device 520 for fixing an implant I (such as shown in
Furthermore, the plate member 510 comprises a third hole 513 for receiving a pulling suture 700 and a fourth hole 514 for receiving a flipping suture 800. The third hole 513 and the fourth hole 514 are positioned adjacent to opposing ends of the plate member 510 along a longitudinal axis L of the plate member 510. The pulling suture 700 can be used to pull the plate member 510 through a borehole B of the femur F and/or tibia T bone, wherein the longitudinal axis L of the plate member 510 is parallel to the borehole B. After the plate member 510 has reached the outside of the borehole B, the plate member 510 can be rotated by pulling the flipping suture 800, such that the longitudinal axis L is perpendicular to the borehole B. In this configuration, the plate member 510 prevents the end of the second suture 500 from being pulled into the borehole B when tension is applied to the flexible graft 900 (see also
Furthermore, the insert holding device 100 comprises a holding structure 110 for receiving an insert 300, wherein the holding structure 110 comprises a first wall 112, a second wall 113 opposing the first wall 112, and a third wall 114 and a fourth wall 115 extending parallel to the first surface 101 and perpendicular to the first wall 112 and the second wall 113. The first wall 112 is connected to the third surface 103 (edge) of the insert holding device 100 by means of a first strut 116, and the second wall 113 is connected to the third surface 103 by means of a second strut 117 opposite the first strut 116.
The first wall 112, the second wall 113, the third wall 114 and the fourth wall 115 form a slot 111 for receiving the insert 300, wherein the first and the second wall 112,113 form side walls of the slot 111 and the third and the fourth wall 114,115 form a roof of the slot 111. The slot 111 is open along a first axis A1 of the insert holding device 100, such that an insert 300 can be slid in the slot 111 along the first axis A1.
In particular, the first wall 112 and the second wall 113 are formed from a flexible material, and the distance between the first wall 112 and the second wall 113 is chosen such that an insert 300 of appropriate dimensions is held in the slot 111 by static friction (press-fit) between the first wall 112, the second wall 113 and the insert 300 when no external force is applied, but can be easily removed from the slot 111 by applying a force along the first axis A1 (for instance by hand). Optionally, the third and fourth wall 114,115 forming the roof of the slot 111 can also be adapted to generate static friction to hold the insert 300 in the slot 111.
Alternatively, the insert holding device 100 may comprise at least one force-generating element (e.g. a leaf spring) adapted to exert a force on an insert 300 in the slot 111, wherein the force acts perpendicular to the first axis A1. In this manner, a press-fit of the insert 300 in the slot 111 may be achieved with first and second walls 112,113 from a less flexible material.
As shown in
Furthermore, the insert holding device 100 comprises a first notch 141 and a second notch 142 opposing the first notch 142, wherein the first notch 141 and the second notch 142 are arranged along the first axis A1 in line with the first recess 120. The first and second notch 141,142 are configured to receive a first suture 400 and hold the first suture 400 in place when the first suture 400 is arranged along the first recess 120. The first suture 400 can be received in the first and second notch 141,142 by inserting the first suture 400 from the third surface 103 of the insert holding device 100, in other words from its edge. In particular, the first and second notch 141,142 are narrow enough, such that a certain force has to be applied to insert the first suture 400 into the first and second notch 141,142, wherein the first suture 400 is held by static friction once inserted into the first and second notch 141,142.
In addition, the insert holding device 100 according to the example shown in
The width (maximum extension measured perpendicular to the first axis A1) of the entry sections is smaller than the width of the respective holding sections 132. In particular, the width of the entry sections 131 is such that a certain amount of force has to be applied to insert the second suture 500 into the entry sections 131 (see
In particular, as illustrated in
Of course, in case the first suture 400 has been fixed by insertion into the first and second notch 141,142, the first suture 400 has to be removed from the first and second notch 141,142 prior to laying the first suture 400 around the insert 300 and the second suture 500 and tying the knot.
The insert holding device 100 according to the invention facilitates connecting the insert 300 to the second suture 500, since the insert 300, the second suture 500, and (optionally) also the first suture 400 can be secured on the insert holding device 100 in an arrangement allowing fast and easy connection by means of the first suture 400.
After joining of the insert 300 and the second suture 500, the insert holding device 100 can be removed and the insert 300 can be connected to a flexible graft 900 to generate an implant I, in particular for anterior cruciate ligament repair, in a manner known from the prior art (see
Further fold 118 lines are generated to delimit segments constituting the first and second struts 116,117, and the third and fourth wall 114,115. The segments constituting the struts 116,117 are then folded inside towards the first surface 101, the segment constituting the third wall 114 is inserted into the slit 119 of the first wall 112, and the segment constituting the fourth wall 115 is inserted into the slit 119 of the second wall 113.
The fold lines 118 on the side segments 162 of the pointed end 160 can be used to fold the side segments upwards in order to facilitate joining of the insert holding device 100 with the suture holding device 200 described below (see
Optionally, the above-described insert holding device 100 can be combined with a suture holding device 200 according to the present invention as depicted in
As shown in
Furthermore, the suture holding device 200 comprises a first recess 210 comprising a slot section 211 and a circular section 213 connected at a neck 212. The first recess 210 is positioned adjacent to a holding structure 220 for arranging a second suture 500 across the first recess 210 along the second axis A2.
The holding structure 220 comprises a first protrusion 221 and a second protrusion 222 opposite the first protrusion 221, wherein the slot section 211 of the first recess 210 is positioned between the first and the second protrusion 221,222. The protrusions 221,222 each comprise a triangular shape, wherein the protrusions 221 each comprise an inner edge adjacent to the slot section 211, wherein the inner edges are arranged at an acute angle in respect of the first axis A1, such that the width of the slot section 211 (measured along the second axis A2) decreases towards the circular section 213 of the first recess 210, thereby forming a neck 212 at the narrowest position.
A second recess 231 is positioned adjacent to the first protrusion 221 opposite the slot section 211, and a third recess 232 is positioned adjacent to the second protrusion 222 opposite the slot section 211.
Furthermore, the suture holding device 200 comprises a first groove 240 for receiving a plate member 510, particularly a plate member 510 of a cortical fixation device 520 as described above and depicted in
Moreover, according to the embodiment shown in
A cortical fixation device 520 (see
As shown in
One end of the open loop L2 is then arranged from the plate member 510 to the third recess 232 on the back surface 202, across the neck 212 of the first recess 210 to the second recess 231 on the front surface 201, and from the second recess 231 to the second groove 250 on the back surface 202 of the suture holding device 200. The other end of the open loop L2 is arranged from the plate member 510 to the second groove 250 on the back surface 202 of the suture holding device 200. Subsequently, the first and the second end of the open loop L2 are arranged from the second groove 250 to the third groove 260 on the front surface 201, from the third groove 260 to the fourth groove 270 on the back surface 202, from the fourth groove 270 to the opening 280 on the front surface 201, and through the opening 280 to the second surface 202 of the suture holding device 200.
The pulling suture 700 and the flipping suture 800 are arranged from the plate member 510 to the second groove 250 on the back surface 202, from the second groove 250 to the third groove 260 on the front surface 201, from the third groove 260 to the fourth groove 270 on the back surface 202, from the fourth groove 270 to the third groove 260 on the front surface 201, again from the third groove 260 to the fourth groove 270 on the back surface 202, from the fourth groove 270 to the opening 280 on the front surface 201 and through the opening 280 to the back surface 202 of the suture holding device 200.
The final configuration of the sutures on the front surface 201 of the suture holding device 200 is depicted in
The insert 300 is first received by the holding structure 110 of the insert holding device 100 (e.g. inserted into the slot 111), and the first suture 400 is received by the first recess 120 of the insert holding device 100 as described above. In detail, the first suture 400 is passed from the first surface 101 of the insert holding device 100 through the first end section 121a of the first recess 120 to the second surface 102, passed below the insert 300 towards the second end section 121b of the first recess 120, and passed through the second end section 121b back to the first surface 101. Optionally, as shown in
Next, the second suture 500 is arranged on the holding structure 220 of the suture holding device 200 as described above (
Subsequently, the insert holding device 100 is assembled with the suture holding device 200 as shown in
The pointed end 160 facilitates positioning of the middle segment 161 below the second suture 500 on the holding structure 210 of the suture holding device 200.
In addition, the arrow shape of the side segments 162 indicates the direction of joining the insert holding device 100 with the suture holding device 200.
When the insert holding device 100 and the suture holding device 200 have been joined as shown in
After this step, the insert holding device 100 can be firstly removed from the suture holding device 200. Therein, the insert 300 is moved out of the slot 111, and stays attached to the suture 500. Then, a flexible graft 900 (see
Finally, the whole implant comprising the insert 300, the first suture 400, the second suture 500, the plate member 510, and the flexible graft 900 can be removed from the suture holding device 200 by pulling the flexible graft 900 and slightly bending the suture holding device 200 on the back surface 202.
The insert holding device 100 comprises a holding structure 110 comprising a slot 111 extending along a second axis A2 perpendicular to the third axis A3 on the first surface 101a of the upper portion 104 delimited by a first wall 112 and a second wall 113. Therein, the material of the walls 112,113 and the distance between the first wall 112 and the second wall 113 are chosen such that an insert 300 can be held in position by static friction between the first wall 112, the second wall 113 and the insert 300 when inserted into the slot 111, and easily removed from the slot (press-fit). For instance, the first wall 112 and the second wall 113 may comprise a flexible material which is compressed when the insert 300 is inserted into the slot 111.
Furthermore, the holding device 100 comprises a first recess 120 and a second recess 130 on the first surface 101a of the upper portion 104, wherein the first recess 120 extends along a first axis A1 perpendicular to the second axis A2 and the third axis A3, and the second recess 130 extends along the second axis A2. In other words, the first and the second recess 120 are formed by a cross-shaped slot on the upper portion 104.
In the example depicted in
The suture holding device 200 further comprises a first hole 281, a second hole 282, a third hole 283, a fourth hole 284, and a fifth hole 285 arranged essentially along a semi-circle around the first recess 210. Moreover, the suture holding device 200 comprises a first notch 287 and a second notch 288 in opposing edges, wherein the first and the second notch 287,288 are arranged along the first axis A1 in line with the first recess 210. In addition, a third notch 291 and a fourth notch 292 are provided in a further edge of the suture holding device 200, wherein a flap 290 is positioned between the third notch 291 and the fourth notch 292.
A second suture 500 can be arranged on the front surface 201 of the suture holding device 200 from the third notch 291 to the first hole 281, through the first hole 281 to the back surface 202 of the suture holding device 200, on the back surface 202 from the first hole 281 to the second hole 282, through the second hole 282 to the front surface 201, on the front surface 201 from the second hole 282 to the third hole 283, through the third hole 283 to the back surface 202, on the back surface 202 to the fourth hole 284, through the fourth hole 284 to the front surface 201, on the front surface 201 to the fifth hole 285, through the fifth hole 285 to the back surface 202, on the back surface 202 to the first through-hole 224 of the holding structure 220, through the first through-hole 224 to the front surface 201, on the front surface 201 across the first recess 210 to the second through-hole 225 of the holding structure 220, through the second through-hole 225 to the back surface 202, on the back surface 202 to the sixth hole 286, through the sixth hole 286 to the front surface 201, and on the front surface 201 back to the first hole 281, resulting in a closed loop L1 of the second suture 500. The second suture 500 can then be passed along in parallel to the closed loop L1 back to the sixth hole 286 and on the front surface 201 from the sixth hole 286 to the second notch 292, resulting in an additional open loop L2 of the second suture 500 (see
This results in the second suture 500 being fixed on the suture holding device 200 and arranged across the first recess 210 along the second axis A2. Of course, instead of the first to sixth hole 281-286 and the third and fourth notch 291,292, other suitable means of fixing the second suture 500 on the suture holding device 200 may be used.
A first suture 400 may be arranged between the first notch 287 and the second notch 288 across the first recess 210, in particular above the second suture 500.
Four second recesses 293 on opposing edges of the suture holding device 200 may match the surface of the insert holding device 100 (
The suture holding device 20 according to
In this manner, the first suture 400 may be easily be inserted into the first recess 120 of the insert holding device 100, and the second suture 500 may be easily inserted into the second recess 130 of the insert holding device 100. Subsequently, the insert 300 can be placed into the slot 111 of the holding structure 110 of the insert holding device 100, and the first suture 400 can be laid around the insert 300 and the second suture 500 (and e.g. tied into a knot), thereby connecting the second suture 500 to the insert 300.
Optionally, the diameter of the first recess 210 may be chosen according to the diameter of the upper portion 104 of the insert holding device 100, such that only the upper portion 104 is inserted into the first recess 210, and the suture holding device 200 rests on the first surface 101b of the lower portion 105 of the insert holding device 100. This facilitates assembly of the insert holding device 100 and the suture holding device 200.
A position reference hole 294 on the suture holding device 200 may be aligned with a marking (not shown) of the insert holding device 100 during assembly of the parts in order to position the first axis A1 of the insert holding device 100 parallel to the first axis A1 of the suture holding device 200.
| Number | Date | Country | Kind |
|---|---|---|---|
| 17204709.4 | Nov 2017 | EP | regional |
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/EP2018/083231 | 11/30/2018 | WO | 00 |
