Kit for endoscopic fixation of implants in intervertebral discs with the aid of nails or pins

Abstract

The present invention relates to a kit for endoscopically fixing an implant with the aid of a nail or a pin. The kit comprises: an applicator sleeve (1) which can be introduced into an intervertebral disc through an endoscope and through which an implant can be inserted into an intervertebral disc defect; a drilling needle guide sleeve (2) which has a size such that it can be inserted into the applicator sleeve (1); and a push rod (3) which is used to transmit impulses when fixing the implant in the intervertebral disc with the aid of a nail or a pin, wherein the push rod has a size such that it can be inserted into the applicator sleeve (1). In addition, the kit may include an implant and / or at least one nail or pin.

Description

Technical Field

[0001] The invention relates to a kit for endoscopically fixing an implant in an intervertebral disc by means of nails or pins. Background Art

[0002] In the spine, intervertebral discs act as shock absorbers between the vertebrae and provide cushioning by absorbing shock. They consist of a soft nucleus pulposus surrounded by a hard outer annulus fibrosus, which provides the necessary stability. Herniated discs often occur when there is a long-term, incorrect or excessive load, as well as tissue degeneration due to age. Nucleus pulposus ) presses the outer annulus fibrosus against the posterior longitudinal ligament, which separates the nucleus pulposus from the spinal canal. Annulus fibrosus ) gradually develop small cracks in the annulus. As a result, parts of the soft disc nucleus can escape from the annulus and enter the spinal canal. When this extruded medulla then compresses the nerve roots, severe pain, sensory impairment, or paralysis results. Surgical removal of the extruded medulla (sequestrectomy) decompresses the nerve roots and alleviates the symptoms. In 92% of cases, the treatment shows good results. However, a worsening of symptoms can be seen two years after the operation. The loss of tissue leads to a progression of degeneration and a subsequent decrease in the height of the intervertebral disc. Sequestrectomy is therefore a symptomatic treatment (pain caused by the dead bone) and not a cure for the underlying condition (degeneration of the intervertebral disc).

[0003] The development of new regenerative therapies for the treatment of mesenchymal tissue defects is becoming increasingly important in a very large number of patients diagnosed with a herniated disc. In particular, in the field of treatment of herniated discs, there is an increasing demand for regenerative therapies that stimulate and support the self-healing capacity. Most of the treatment options are considered innovative and long-term and are aimed at maintaining the disc height after a herniated disc. Implants are introduced into the disc to maintain the disc height or to construct repair tissue. The main problem here is the push-out (freeing, sequestering) of the implant under load, since the annulus fibrosus is already damaged and cannot heal. In existing surgical techniques, the implant is prevented from being pushed out of the disc by gluing the annulus fibrosus or by using a closed system. For this purpose, products such as the CE-certified Barricaid are used. © There are also so-called endocrine systems (Anulex Technologies, Minnetonka, MN, not certified in Europe). The problem of implants being pushed out under load has not yet been satisfactorily solved. Summary of the Invention

[0004] It is therefore an object of the present invention to provide a surgical kit with the aid of which an implant can be inserted and fixed in an intervertebral disc, and wherein the corresponding surgical method produces a long-lasting, good result.

[0005] The present invention relates to a kit for endoscopically securing an implant in an intervertebral disc using nails or pins. This kit has been innovatively adapted to the specific requirements of corresponding intervertebral disc surgeries. Within the scope of the present invention, it is first recognized that an implant should be secured in an intervertebral disc using, in particular, resorbable nails or pins. In other words, the present invention is based on the concept of a novel surgical procedure. However, this novel surgical procedure requires a specialized surgical kit tailored to it.

[0006] The use of resorbable nails or pins to secure implants is known from other medical fields. Pin fixation is used in plastic surgery to reattach detached sections of the meniscus. It is also used to secure resorbable implants in cases of articular cartilage defects in the knee. However, the properties of the articular cartilage in the knee differ significantly from those of the cartilage tissue in the intervertebral disc, making this method impractical for direct transfer to disc surgery. Furthermore, existing instruments for pin fixation in the knee joint are unsuitable for disc surgery, where implants are secured in the intervertebral disc using nails or pins.

[0007] The present invention relates to a kit for endoscopically fixing an implant in an intervertebral disc by means of nails or pins. The instrument kit can be used in intervertebral disc surgery with an endoscope commonly used in this field. The kit according to the invention comprises:

[0008] - an applicator cannula which can be introduced into the intervertebral disc via an endoscope and through which the implant can be inserted into the intervertebral disc defect;

[0009] - a drill needle guide cannula sized to be inserted into the applicator cannula; and

[0010] - a push rod for transmitting the impacts when the implant is fixed in the intervertebral disc by means of nails or pins, wherein the push rod has dimensions such that it can be inserted into the applicator sleeve.

[0011] Here, a cannula is understood to be an elongated, hollow, cylindrical object with a relatively thin wall. This hollow cylindrical object can be rotationally symmetrical about a central longitudinal axis in its wider portion. However, this does not preclude the possibility that certain areas of the cannula may deviate from this rotational symmetry, for example to fulfill specific functions. This applies in particular to the areas at the proximal or distal end of the respective cannula. The applicator cannula is preferably formed in one piece, but can also be formed in multiple pieces. The drill needle guide cannula is also preferably formed in one piece, but can also be formed in multiple pieces.

[0012] The applicator cannula can be introduced into the intervertebral disc through an endoscope. The applicator cannula can preferably be plugged onto the endoscope and / or can be connected to the endoscope without requiring additional fasteners, in particular without requiring screw connections. The applicator cannula preferably has no separate retaining portion or handle and can therefore be very easily manufactured.

[0013] The dimensions of the applicator sleeve are preferably selected so that the applicator sleeve can be introduced into the endoscope at least in the wider part. Preferably, a portion of the applicator sleeve cannot be introduced into the endoscope, but forms a stop to prevent the entire applicator sleeve from accidentally sliding into the endoscope. This stop does not form a holder or a handle. In all embodiments, a marker can be placed at the distal end of the applicator sleeve (i.e., at the outer end of the stop) to indicate the position of the inclined polished portion of the sleeve. Alternatively, in all embodiments, a marker can also be placed at the stop.

[0014] Similar content applies to the drilling needle guide cannula, which is sized so that it can be fully or partially inserted into the applicator cannula. A corresponding stop is also preferably provided to prevent the drilling needle guide cannula from sliding entirely into the applicator cannula. In order to be able to insert the drilling needle guide cannula into the applicator cannula, the inner diameter of the applicator cannula is matched to the outer diameter of the drilling needle guide cannula. There is preferably a small gap within a few tenths of a millimeter, which makes insertion easier, but due to the total length of the applicator cannula and the drilling needle guide cannula, the positioning accuracy of the drilling needle guide cannula in the applicator cannula in the proximal region of the two cannulae is practically unaffected. The size of the inner diameter of the drilling needle guide cannula thus makes it possible for the drilling needle to be guided through the drilling needle guide cannula without any problems and still accurately.

[0015] The push rod of the kit of the present invention is suitable for and is designed to transmit shocks when fixing an implant in the intervertebral disc with the aid of nails or pins. Therefore, the push rod is preferably compact and not hollow. This improves stability and makes it easier to transmit shocks or hammer blows during fixation. In addition, the size of the push rod enables it to be inserted into the applicator sleeve. The outer diameter of the push rod is correspondingly matched to the inner diameter of the applicator sleeve. Preferably, a small gap of a few tenths of a millimeter is provided between the applicator sleeve and the push rod. This makes it easier to insert the push rod into the applicator sleeve, but does not affect the accuracy of the push rod's positioning. The length of the push rod is preferably selected so that it is slightly longer than the applicator sleeve. In the context of fixing the implant in the intervertebral disc with the aid of nails or pins, such shocks must be freely transmitted (that is, without causing the applicator sleeve to vibrate) when transmitting shocks. The push rod is also preferably formed in one piece from a single workpiece, but can also be formed from multiple pieces.

[0016] According to a preferred embodiment of the present invention, this applicator sleeve tube has inclined tip, hollow columnar main body and flange-shaped terminal piece.The inclined tip is arranged at the proximal end of the applicator sleeve tube at this and the flange-shaped terminal piece is arranged at the distal end of the applicator sleeve tube at this.That is, the applicator sleeve tube can be functionally subdivided into three parts at this.The applicator sleeve tube can be one-piece or multi-piece manufacturing.If the applicator sleeve tube is made up of a plurality of components, then these components are preferably welded or bonded together.The flange-shaped terminal piece is hollow at this equally and is especially seamlessly connected to the hollow columnar main body at inside.In all embodiments, at the distal end of the applicator sleeve tube, i.e. at the outer end of the stopper, a marker can be placed, which shows the position of the inclined polished portion of sleeve tube.Alternatively, in all embodiments, the marker can also be placed at the stopper.

[0017] However, the outer diameter of the flange-shaped end piece is larger than the outer diameter of the hollow cylindrical main part, thereby preventing the applicator sleeve from sliding into the endoscope. The inclined tip is preferably formed by one or more hollow portions at the proximal end of the applicator sleeve or the hollow cylindrical main part. That is, it is preferred not to reduce the outer diameter of the applicator sleeve in the area of ​​the inclined tip. Maintaining the outer diameter allows the other components of the instrument kit and other parts that must be guided through the applicator sleeve to be positioned therein without any problems. In this regard, the inclined tip offers the following advantages: the view through the endoscope to the nail or pin, the implant, and the actual drilling needle is unobstructed, and it can be ensured that the nail or pin actually secures the implant. According to one embodiment of the present invention, the inclined tip has at least one, preferably two or more, tip ends formed in the applicator sleeve by the hollow portions. Additionally or alternatively, the tip of the applicator sleeve is tilted in a rotationally asymmetrical manner with respect to the longitudinal axis of the applicator sleeve. These pointed tips are used to accurately position the applicator cannula within the intervertebral disc space during surgery by contacting the adjacent vertebral bodies.

[0018] Here, these pointed ends are preferably formed into obtuse angles so that although they are fixed, they do not cause damage. These pointed ends are used to stabilize the applicator at the support position. These pointed ends can be formed in the form of blunt teeth, for example. They can have a narrow, especially rounded abutment surface or abutment line. The rotationally asymmetric inclined portion of the tip of the applicator sleeve makes it easier for the instrument kit to interact with the inserted endoscope. The result of the rotationally asymmetric inclined portion is that these pointed ends are at least asymmetrically located in the plane passed by the longitudinal axis of the applicator sleeve. In the simplest case, when the inclined tip has two pointed ends, the two hollow portions are geometrically described by a cross section with a plane. If the hollow cylindrical main body of the applicator sleeve is rotationally symmetrical, a corresponding ellipse is generated in the wall of the hollow cylindrical main body in this cross section, and then an inclined tip can be formed thereby.

[0019] A preferred embodiment of the present invention is characterized in that

[0020] The angled tip is angled in a rotationally asymmetrical manner about the longitudinal axis of the applicator cannula and has two tip ends; and wherein,

[0021] The two tip ends and at least one parallel line extending therethrough parallel to the longitudinal axis of the applicator cannula define at least one tip plane;

[0022] wherein, with respect to a tip plane, the upper inclined portion of the tip is geometrically described by a section with an upper plane that is inclined at an acute angle α relative to the tip plane; and / or

[0023] Therein, with respect to the same or another tip plane, the lower slope of the tip is geometrically described by a section with a lower plane which is inclined at an acute angle β relative to this tip plane.

[0024] Thus the applicator sleeve formed in this way can be manufactured in a simple manner.In addition, a favourable rotational asymmetry is achieved thus, which in turn provides corresponding advantages when handling kit of parts according to the present invention.

[0025] Be to limit a tip plane or two tip planes, this depends on the geometry of these two tip ends basically.If these two tip ends are for example obtuse angle and have certain height h, thereby can limit tip plane with height h at the upper end and lower end of these two tip ends respectively.Relate to two tip planes in this case, can produce hollowing out portion by with the cross section of angle α and β and applicator sleeve tube at these tip planes, make that tip has upper inclined portion and lower inclined portion accordingly.Yet, if these two tip ends are actually acute angles, then only produce single tip plane and this tip plane also directly extend through the tip of these two tip ends then.In this case, these two angles α and β directly abut each other.

[0026] According to a preferred embodiment of the present invention, for the upper acute angle, 20° ≤ α ≤ 30°, preferably α = 25°. Additionally or alternatively, for the lower acute angle, 20° ≤ β ≤ 30°, preferably β = 25°.

[0027] According to another preferred embodiment of the present invention, the two tip ends have a height h, perpendicular to the longitudinal axis of the applicator cannula, for which the following applies: 0.5 mm ≤ h ≤ 1.5 mm, preferably h = 1.0 mm. In other words, the two tip ends are formed at an obtuse angle and can form a narrow, rounded contact surface or contact arc when contacting the intervertebral disc.

[0028] According to another preferred embodiment of the present invention, the inclined tip has a plurality of, preferably three to five, tip ends, which are formed in the applicator sleeve by hollowing out.

[0029] According to a preferred embodiment of the present invention, the drill needle guide cannula has a hollow cylindrical main body and a flange-shaped end piece. The flange-shaped end piece forms a stop when the drill needle guide cannula is inserted into the applicator cannula. The flange-shaped end piece itself is also hollow and preferably seamlessly connects internally to the cavity in the hollow cylindrical main body of the drill needle guide cannula. The drill needle guide cannula is preferably equal to or shorter than the applicator cannula, including the tip end.

[0030] According to one embodiment of the present invention, the push rod has a thorn at its proximal end and a columnar main part and a push rod head at its distal end. Here, the thorn, the columnar main part and the push rod head are preferably formed to be compact and thus are not essentially hollow. The outer diameter of the thorn is significantly smaller than the outer diameter of the columnar main part, and the outer diameter of the columnar main part is in turn smaller than the outer diameter of the push rod head. The thorn serves as a connection point for a nail or a pin with a recess. The precise fit of the thorn in the recess of the nail or pin allows for optimal impact transmission when the implant is fixed in the intervertebral disc by means of the nail or pin, because the force or pressure expended during the impact is transferred to the head of the nail or pin in an optimal manner.

[0031] The push rod, with its three functional components (the spike, the cylindrical body, and the push rod head), can be manufactured in one piece or in multiple pieces. The spike and body are preferably manufactured in one piece, and the push rod head is attached separately later. If the individual components of the push rod are manufactured separately, they are preferably welded or glued together.

[0032] According to another embodiment of the present invention, as described above, the push rod is formed at its distal end by a cylindrical main portion and a push rod head. However, in this embodiment, the push rod has no thorns at its proximal end. In conjunction with this embodiment, it is preferable to use a nail or pin that does not have a notch at the end of its head. As a result, the push rod without thorns provides better impact transmission when securing an implant.

[0033] For the dimensions of the push rod or its parts, the following dimensions preferably apply:

[0034] - the length LSK of the tappet head along the longitudinal axis of the tappet is: 13 mm ≤ LSK ≤ 17 mm, preferably LSK = 15 mm; and / or

[0035] - for the outer diameter DSK of the tappet head: 8 mm ≤ DSK ≤ 12 mm, preferably DSK = 10 mm; and / or

[0036] - for the length LD of the thorn along the longitudinal axis of the push rod: 1.9 mm ≤ LD ≤ 2.1 mm, preferably LD = 2.0 mm; and / or

[0037] - For the outer diameter DD of the thorn: 0.9 mm ≤ DD ≤ 1.1 mm, preferably DD = 1.0 mm.

[0038] The outer diameter DSK of the push rod head allows for the simplest and most accurate positioning of the impact or hammer blow. The cylindrical body portion is dimensionally adapted to the inner diameter of the applicator sleeve or the applicator sleeve. The thorn of the push rod is dimensionally adapted to the dimensions of a usable nail or pin with a notch in the head, or preferably, in embodiments of nails or pins without a notch, no thorn is present.

[0039] According to another preferred embodiment variant, the outer diameter and the inner diameter of the instruments of the set are adapted to one another as follows:

[0040] - for the outer diameter DA of the applicator cannula: 3.9 mm ≤ DA ≤ 4.1 mm, preferably DA = 4.0 mm; and

[0041] - for the inner diameter dA of the applicator cannula: 3.3 mm ≤ dA ≤ 3.5 mm, preferably dA = 3.4 mm; and

[0042] - the outer diameter DB of the drill needle guide cannula is: 2.9 mm ≤ DB ≤ 3.1 mm, preferably DB = 3.0 mm; and

[0043] - For the inner diameter of the drill needle guide cannula dB: 2.3 mm ≤ dB ≤ 2.5 mm, preferably dB = 2.4 mm; and

[0044] - For the outer diameter DS of the push rod: 2.9 mm ≤ DS ≤ 3.1 mm, preferably DS = 3.0 mm.

[0045] In order to successfully fix the implant endoscopically in the intervertebral disc by means of nails or pins, the lengths of the applicator cannula, the drill needle guide cannula and the push rod are preferably also adapted to one another.

[0046] The following relationship preferably exists here:

[0047] - for the length LA of the applicator cannula: 250 mm ≤ LA ≤ 290 mm, preferably LA = 270 mm; and

[0048] - the length LB of the drill needle guide cannula is: 245 mm ≤ LB ≤ 285 mm, preferably LB = 265 mm; and

[0049] - for the length LS of the push rod: 265 mm ≤ LS ≤ 305 mm, preferably LS = 285 mm; and

[0050] - Additionally, according to this embodiment: LB < LA < LS; where when there is a flange-shaped end piece or head, the given lengths LA, LB, and LS are determined at the corresponding component without the corresponding flange-shaped end piece or without the head.

[0051] According to another preferred embodiment, the following relationships exist:

[0052] - For the length LA of the applicator cannula: 215 mm ≤ LA ≤ 290 mm, preferably LA = 230 to 250 mm, particularly preferably 235 to 245 mm, most preferably 240 mm; and

[0053] - For the length LB of the drilling needle guide cannula: 210 mm ≤ LB ≤ 285 mm, preferably LB = 230 to 240 mm, particularly preferably 235 mm; and

[0054] - For the length LS of the push rod: 220 mm ≤ LS ≤ 305 mm, preferably LS = 250 to 260 mm, particularly preferably 255 mm; and

[0055] - Additionally, according to this embodiment: LB < LA < LS; where when there is a flange-shaped end piece or head, the given lengths LA, LB, and LS are determined at the corresponding component without the corresponding flange-shaped end piece or without the head.

[0056] In a particularly preferred embodiment, the following relationships exist:

[0057] - For the length LA of the applicator cannula: 215 mm ≤ LA ≤ 290 mm, preferably LA = 230 to 250 mm, particularly preferably 235 to 245 mm, most preferably 240 mm; and

[0058] - For the length LB of the drilling needle guide cannula: 210 mm ≤ LB ≤ 285 mm, preferably LB = 230 to 240 mm, particularly preferably 235 mm; and

[0059] - For the length LS of the push rod: 220 mm ≤ LS ≤ 305 mm, preferably LS = 250 to 260 mm, particularly preferably 255 mm; and

[0060] - Additionally, according to this embodiment: LB < LA < LS; where when there is a flanged end piece or head, the given lengths LA, LB, and LS are determined at the corresponding part without the corresponding flanged end piece or without the head. Further, in this embodiment, the pusher formed by the cylindrical body part and the pusher head at its distal end has no barb at its proximal end. Together with this embodiment, it is preferred to use a nail or pin that does not have a notch at the end of its head; and thus when fixing the implant, the pusher without a barb has better shock conduction.

[0061] In all embodiments, slightly shortening the drill needle guide sleeve relative to the applicator sleeve enables: when pre-drilling in the intervertebral disc or vertebral body, the drill needle introduced through the drill needle guide sleeve has sufficient free space. Additionally, the line of sight through the endoscope is minimally obstructed thereby. The pusher is further longer than the applicator sleeve so that when fixing the nail or pin inside the intervertebral disc, impact can be exerted without obstruction or basically without being transmitted to the applicator sleeve. The pusher is about 2 mm to 50 mm longer than the applicator sleeve, preferably 5 mm to 40 mm, most preferably 10 mm to 20 mm, and extremely preferably about 15 mm.

[0062] According to another preferred embodiment of the present invention, for the length LFA of the flanged end piece of the applicator sleeve along the main axis of the applicator sleeve, and for the outer diameter DFA of the flanged end piece of the applicator sleeve, there are the following relationships: 2.9 mm ≤ LFA ≤ 3.1 mm, preferably LFA = 3 mm; and 9 mm ≤ DFA ≤ 11 mm, especially DFA = 10 mm.

[0063] Additionally or alternatively, for the length LFB of the flanged end piece of the drill needle guide sleeve along the main axis of the drill needle guide sleeve, and for the outer diameter DFB of the flanged end piece of the drill needle guide sleeve, there are the following relationships: LFB = LFA ± 0.1 mm, preferably LFB = 3 mm; and DFB ≥ DFA, preferably DFB = 12 mm.

[0064] If the outer diameter DFB of the flanged end piece of the drill needle guide sleeve is slightly larger than the outer diameter DFA of the applicator sleeve, then after the drill needle guide sleeve and the applicator sleeve are in a stop or inserted until full stop, the drill needle guide sleeve can be more easily removed from the applicator sleeve by slightly raising it relative to the end piece of the applicator sleeve in the area of the flanged end piece.

[0065] According to another preferred embodiment, the components of the kit can be reused after appropriate sterilization. The applicator cannula, the burr needle guide cannula and the push rod preferably each comprise at least one of the following materials: in particular stainless steel, in particular surgical steel, for example the following steel composition:

[0066] WNr. 1.4016 (X6Cr17), AISI 430;

[0067] WNr.1.4021 (X20Cr13), AISI 420;

[0068] WNr.1.4301 (X5CrNi18-10), AISI 304, (V2A), SUS304;

[0069] WNr.1.4404 (X2CrNiMo17-12-2), AISI 316L, (V4A, A4L);

[0070] WNr.1.4452 (X13CrMnMoN18-14-3), P2000;

[0071] Especially 1.4021, 1.4104, 1.4301, 1.4303, 1.4305, 1.4306, 1.4307, 1.4310, 1.4401, 1.4404, 1.4435, 1.4456, 1.4541, 1.4571, 1.4028, 1.4031, 1.4034, 1.4035, 1.4037, 1.4197, 1.4057, 1.4104, 1.4112, 1.4122, 1.4123, 1.4125, 9.9440, 1.4108, 1.4542, 1.4568 and 1.4543.

[0072] Furthermore, titanium and titanium materials, as well as sterilizable plastics with corresponding hardness, can be used. By mixing various components, modern high-performance polymers, such as PEEK (polyetheretherketone) or ceramic casting components (PIM / CIM methods), with corresponding hardness and elasticity properties can be created. Given the appropriate product design, these polymers exhibit similar stability to steel and are therefore suitable for the application. High-performance polymers behave like metal when treated with chemicals, heat, and UV light. Therefore, plastics of this type and quality are also suitable. Furthermore, the components of the kit according to the present invention can be manufactured using 3D printing. All materials known and used in 3D printing with corresponding properties can also be used in this regard. Surgical steel is preferably used.

[0073] According to another embodiment of the present invention, the kit also includes a drilling needle, particularly a Kirschner wire, for pre-drilling a hole through the implant into the bony part of the vertebral body. Such drilling needles or Kirschner wires are preferably made of surgical steel. Drilling needles are available in varying strengths. The front end typically has a threaded or unthreaded tip. The rear end may have a fastening device for attaching a drilling machine.

[0074] The drill needle is preferably at least 35 mm long. Advantageously, when the drill needle is used, about 10 mm to 40 mm, preferably about 35 mm, is available at the rear end for fastening in the drill. Thus, at the front end, the tip can protrude from the applicator cannula by about 1 mm to 25 mm, preferably about 20 mm.

[0075] According to another embodiment of the invention, the kit further comprises an implant for introduction into the intervertebral disc.

[0076] Within the scope of the present invention, an implant is understood to be a natural or artificial material that can be implanted in the human or animal body and is intended to remain there permanently or at least for a long time. The implant is preferably made of a resorbable material. The term "implant" preferably includes a biological or artificial matrix, a biological or artificial tissue or tissue part or a combination thereof; for example, allogeneic, autologous, xenogeneic or artificial tissue; a natural extracellular matrix or an acellular matrix or a combination thereof. The implant may in some cases include cells or cell components. Textile implants are preferably used. Such implants can, for example, be porous, spongy, compact, felt, non-woven or mesh-like. Such implants are particularly well suited for maintaining intervertebral disc height within the intervertebral disc after a herniated disc. Another advantage is that cells can migrate and settle in order to regenerate the defect. The implant is typically inserted into the intervertebral disc defect through an endoscopic channel and / or an applicator cannula, for example using forceps. In this case, the implant is guided through the endoscope channel and / or the applicator cannula while it occupies the smallest possible volume or has a very small diameter.

[0077] According to another preferred embodiment of the present invention, the implant comprises at least one of the following materials: collagen; hyaluronic acid (hyaluronic acid); polyethylene glycol acid; polylactic acid and / or its corresponding copolymers; polycaprolactone; natural membranes, in particular periosteum, perichondrium and / or fascia, and modifications thereof; alginate; agarose; fibrin; aluminum-containing materials; polysaccharides and / or combinations thereof.

[0078] According to another embodiment of the present invention, the kit further comprises at least one nail or pin for securing the implant in the intervertebral disc. The nail or pin is preferably formed from one or more resorbable materials. Resorbable nails or pins are particularly formed from one or more biodegradable materials, such as a polymer formed from polylactic acid (PLA). Alternatively, the nail or pin can be radiopaque, or both resorbable and radiopaque. For example, a resorbable and radiopaque nail or pin can be formed partially or entirely from hydroxyapatite.

[0079] The preferably resorbable and / or radiopaque nails or pins included in this kit are geometrically dimensioned to be particularly suitable for securing an implant in an intervertebral disc. The nails or pins preferably have a diameter DN, which is: 1.4 mm ≤ DN ≤ 1.6 mm, preferably DN = 1.5 mm. Additionally or alternatively, the nails or pins have a length LN, which is: 10 mm ≤ LN ≤ 30 mm. Most preferably, resorbable nails or pins having the aforementioned dimensions are used.

[0080] The embodiments of the present invention described above can be combined with one another in whole or in part, as long as no technical contradiction arises therein. BRIEF DESCRIPTION OF THE DRAWINGS

[0081] The present invention is better understood with reference to the accompanying drawings:

[0082] Figure 1 The applicator sleeve of the kit of the present invention is shown;

[0083] Figure 2 The drill needle guide cannula of the kit of the present invention is shown;

[0084] Figure 3 The putter of the kit of the present invention is shown;

[0085] Figure 4 A table showing typical dimensions for applicator cannulas, drill needle guide cannulas, and push rods for use with the kit of the present invention is shown;

[0086] Figure 5 Exemplary dimensions, including tolerances, are shown for a kit of the present invention with an applicator cannula, a burr guide cannula, and a push rod. DETAILED DESCRIPTION

[0087] Figure 1 The applicator sleeve 1 of the kit according to the invention is shown by way of example for endoscopic fixation of an implant in an intervertebral disc by means of nails or pins. Figure 1 a) A lateral cross-section through the longitudinal axis X of the applicator cannula 1 is shown. Figure 1 b) A cross-sectional view through the longitudinal axis X, which is rotated 90°, is shown in top view. The applicator sleeve 1 has a hollow cylindrical main part 12, wherein an inclined tip 11 is arranged at the proximal end of the applicator sleeve 1. A flange-like end piece 13 is located at the distal end of the hollow cylindrical main part 12. The inclined tip 11 is produced by recesses 18 and 19 in the cylindrical cover of the hollow cylindrical main part 12. The geometrical relationship is shown in FIG. Figure 1 a) is more clearly shown. The inclined tip 11 has two tip ends 21 and 22. Figure 1 In a), the two pointed ends coincide with each other, so that Figure 1 In the illustration in a), only the tip end 22 can be seen. The two tip ends 21, 22 each have a tooth with a height h, which is formed by the closure of the cylindrical cover surface of the applicator sleeve 1. The inclined tip 11 is tilted rotationally asymmetrically with respect to the longitudinal axis X of the applicator sleeve 1. Therefore, the two teeth 21, 22 are Figure 1 In the example shown in a), it is located below the longitudinal axis X of the applicator sleeve 1. The two tip ends 21, 22 and the parallel lines extending through them and parallel to the longitudinal axis X of the applicator sleeve 1 define tip planes E1, E2. Planes E1 and E2 are imaginarily defined at the upper end of the tip ends 21, 22 and at the lower end of the tip ends 21, 22, respectively. With respect to the tip plane E1, the upper inclined part 14 of the tip 11 is geometrically described by a section with the upper plane 14, which is inclined at an acute angle α above this tip plane E1. With respect to the tip plane E2, the lower inclined part 15 of the tip 11 is geometrically described by a section with the lower plane 15, which is inclined at an acute angle β below the tip plane E2. As a result of the cross-section, it can be seen that Figure 1 The hollows 18 and 19 are best seen in b).

[0088] In addition, Figure 1 The inner and outer diameters of the applicator sleeve 1 are indicated in FIG. The effective length LA of the applicator sleeve 1 is measured in the direction of the longitudinal axis from the tip end toward the start of the flange-shaped end piece 13. The flange-shaped end piece has a correspondingly larger outer diameter DFA and a different length LFA. The inner diameter in the flange-shaped end piece 13 is the same as the inner diameter inside the hollow cylindrical main body 12.

[0089] Figure 2The drill needle guide cannula 2 of the kit according to the present invention is shown as an example. The kit is used for endoscopically fixing an implant in an intervertebral disc by means of a nail or a pin. The drill needle guide cannula 2 comprises a hollow cylindrical main body 201 and a flange-shaped end piece 202. The drill needle guide cannula 2 has an inner diameter dB and an outer diameter DB. The effective length LB of the drill needle guide cannula 2 is preferably greater than Figure 1 The effective length LA of the applicator sleeve 1 is slightly shorter. Figure 2 The drill needle guide cannula 2 has an opening 203 at its proximal end. At its distal end, the drill needle guide cannula 2 has an opening 204 in its flange-like end piece 202. In the illustrated embodiment, the outer diameter DFB of the drill needle guide cannula 2 is slightly larger than the outer diameter DFA of the flange-like end piece 13 of the applicator cannula 1. This makes it easier to separate the drill needle guide cannula 2 and the applicator cannula 1 after they have been locked together.

[0090] Figure 3 A push rod for a kit for endoscopic fixation of an implant in an intervertebral disc is shown. The push rod 3 shown is formed in one piece and has two or three different functional areas: an optional thorn 301 at the proximal end, which is present or absent depending on the embodiment; a cylindrical main part 302 at the distal end and a push rod head 303. In the example shown, the push rod is formed completely solid, which allows for better force or pressure transmission when conducting impacts or hammering for fixation. The outer diameter DS of the push rod 3 or its cylindrical main part 302 matches the inner diameter dA of the applicator sleeve 1. In comparison, the outer diameter DD of the thorn is significantly smaller and the length LD of the thorn along the longitudinal direction or axial direction Z of the push rod 3 is very short and only a few millimeters. In contrast, the push rod head 303 is provided with a large outer diameter DSK and has a length LSK in the range of several millimeters. That is, the push rod head 303 is formed to be large and stable enough to be stable enough under impact and to serve as a surface for the impact instrument at right angles to the longitudinal axis Z, which is large enough to serve as a target for the impact.

[0091] The use of the kit according to the present invention for endoscopically fixing an implant in an intervertebral disc during surgery with the aid of a nail or pin can be carried out, for example, as follows: First, the applicator cannula 1 is introduced into the intervertebral disc through the endoscopic channel. The implant is then inserted into the intervertebral disc defect through the applicator cannula 1, for example using tweezers. After removing the tweezers, the drilling needle guide cannula 2 is inserted into the applicator cannula 1. With the aid of a drilling needle (especially a Kirschner wire), a hole is drilled through the implant into the bony part of the adjacent vertebral body. The drilling needle is then removed, and the drilling needle guide cannula 2 is also removed from the applicator cannula 1. The angle relative to the drilled hole should no longer change. In the next step, a resorbable nail or pin is introduced into the applicator cannula 1, which slides through the cannula 1 until the pre-drilled hole. With the help of the introduced push rod 3, the nail can be driven into the pre-drilled hole in the vertebral body with relatively short hammer blows. The head of the nail thereby secures the implant in the disc.

[0092] The length ratios of the applicator sleeve 1, the drilling needle guide sleeve and the push rod 3 are adapted to each other, as are their inner and outer diameters. Figure 1 、 Figure 2 and Figure 3 The kit parts shown in FIG. 1 can be combined with one another in the manner shown.

[0093] Figure 4 The length relationship and the mutually adapted inner and outer diameters of the applicator cannula 1, the drill needle guide cannula 2 and the push rod 3 are summarized again in the corresponding overview. The drill needle guide cannula 2 is slightly shorter than the applicator cannula 1 (LB is slightly shorter than LA). In contrast, the push rod 3 is correspondingly longer (LS>LA). The drill needle guide cannula 2 and the push rod 3 can be inserted into the applicator cannula 1 one after another. Correspondingly, the outer diameter DB of the drill needle guide cannula or the size DS of the push rod 3 are 3.0 mm in the example shown. The wall thickness of the applicator cannula 1 and the drill needle guide cannula 2 is only a few tenths of a millimeter. In contrast, the push rod 3 is formed to be compact.

[0094] Figure 5 The dimensions and tolerances of the applicator cannula 1, the drilling needle guide cannula 2 and the push rod 3 are shown in another exemplary embodiment variant. The tolerances given are permissible manufacturing tolerances that do not affect the operation of the kit according to the invention. In this case, the greatest precision is required in the case of the inner diameter dA of the applicator cannula 1 and the inner diameter dB of the drilling needle guide cannula 2. This should be manufactured with an accuracy of one tenth of a millimeter. The tolerance range in the case of the outer diameter DB of the drilling needle guide cannula 2 is slightly larger, at + 0.04 mm. The corresponding content applies to the outer diameter DS of the push rod 3. Only in this case can it be ensured that the drilling needle guide cannula 2 or the push rod 3 can be pushed through the applicator cannula 1 or inserted therein without tilting or friction effects.

[0095] The present invention provides for the first time a kit for endoscopically fixing an implant in an intervertebral disc by means of nails or pins, thereby enabling a long-term, significantly improved disc height maintenance effect to be expected during intervertebral disc surgery.

Claims

1. A kit for endoscopically fixing an implant in an intervertebral disc by means of nails or pins, comprising: an applicator cannula (1) which can be introduced into the intervertebral disc via an endoscope and through which the implant can be inserted into the intervertebral disc defect; a drill needle guide cannula (2) having a size such that the drill needle guide cannula can be inserted into the applicator cannula (1); a push rod (3) for transmitting shocks when the implant is fixed in the intervertebral disc by means of nails or pins, wherein the push rod (3) has a size such that it can be inserted into the applicator sleeve (1); as well as A drilling needle, used to pre-drill a hole through the implant into the bony part of the vertebral body; wherein the applicator sleeve (1) has an inclined tip (11); wherein the inclined tip (11) is inclined in a rotationally asymmetrical manner with respect to the longitudinal axis (X) of the applicator cannula (1) and has two tip ends (21, 22); and wherein a tip plane is defined at a height h at the upper end of the two tip ends (21, 22) and at the lower end of the tip ends (21, 22), respectively, and at least one parallel line passes through at least one tip plane (E1, E2) and is parallel to the longitudinal axis (X) of the applicator sleeve (1); At these tip planes, hollowing portions (17, 18) are created at angles α and β to the cross section of the applicator sleeve, so that the tip (11) has an upper slope (14) and a lower slope (15) respectively; the height h is the height in a direction orthogonal to the longitudinal axis (X) of the applicator sleeve (1); wherein, with respect to a tip plane (E1), the upper slope of the tip (11) is geometrically described by a section with an upper plane that is inclined upward at an acute angle α relative to this tip plane (E1); and / or Therein, with respect to the same or another tip plane (E2), the lower slope of the tip (11) is geometrically described by a section with a lower plane which is inclined downwards at an acute angle β relative to this tip plane (E2).

2. The kit according to claim 1, wherein the applicator sleeve (1) further comprises a hollow cylindrical main body portion (12) and a flange-shaped end piece (13).

3. The kit according to claim 1, For the acute angle α, 20°≤α≤30°; For the acute angle β, 20°≤β≤30°; For this height h: 0.5mm≤h≤1.5mm.

4. The kit according to claim 3, wherein for the acute angle α, α=25°; and / or For the acute angle β, β=25°.

5. The kit of claim 3, wherein for the height h: h=1.0mm.

6. The kit according to claim 1, wherein the drill needle guide cannula (2) has a hollow cylindrical main body portion (201) and a flange-shaped end piece (202).

7. The kit according to claim 1, wherein the push rod (3) has a thorn (301) at its proximal end and a columnar main body (302) and a push rod head (303) at its distal end; and / or For the length LSK of the pusher head (303) along the longitudinal axis (Z) of the pusher (3), there is: 13 mm ≤ LSK ≤ 17 mm; and / or For the outer diameter DSK of the pusher head (303), there is: 8 mm ≤ DSK ≤ 12 mm; and / or For the length LD of the spike (301) along the longitudinal axis (Z) of the pusher (3), there is: 1.9 mm ≤ LD ≤ 2.1 mm; and / or For the outer diameter DD of the spike (301), there is: 0.9 mm ≤ DD ≤ 1.1 mm.

8. The kit according to claim 1, For the outer diameter DA of the applicator cannula (1), there is: 3.9 mm ≤ DA ≤ 4.1 mm; and For the inner diameter dA of the applicator cannula (1), there is: 3.3 mm ≤ dA ≤ 3.5 mm; and For the outer diameter DB of the drill needle guide cannula (2), there is: 2.9 mm ≤ DB ≤ 3.1 mm; and For the inner diameter dB of the drill needle guide cannula (2), there is: 2.3 mm ≤ dB ≤ 2.5 mm; and For the outer diameter DS of the pusher (3), there is: 2.9 mm ≤ DS ≤ 3.1 mm.

9. The kit according to claim 2, For the length LA of the applicator cannula (1), there is: 215 mm ≤ LA ≤ 290 mm; and For the length LB of the drill needle guide cannula (2), there is: 210 mm ≤ LB ≤ 285 mm; and For the length LS of the pusher (3), there is: 220 mm ≤ LS ≤ 305 mm; and where additionally: LB < LA < LS; and where when there are flange-like end pieces (13, 202) or heads (303), the given lengths LA, LB, and LS are determined at the corresponding parts without the respective flange-like end pieces (13, 202) or without the corresponding head (303).

10. The kit according to claim 1, For the length LFA of the flange-like end piece (13) of the applicator cannula (1) along the longitudinal axis (X) of the applicator cannula (1), and for the outer diameter DFA of the flange-like end piece (13) of the applicator cannula (1), there is: 2.9 mm ≤ LFA ≤ 3.1 mm, and 9 mm ≤ DFA ≤ 11 mm; and / or For the length LFB of the flange-like end piece (202) of the drill needle guide cannula (2) along the main axis (Y) of the drill needle guide cannula (2) and for the outer diameter DFB of the flange-like end piece (202) of the drill needle guide cannula (2), there is: LFB = LFA ± 0.1 mm, and DFB ≥ DFA.

11. The kit according to claim 1, wherein the components of the kit can be reused after disinfection.

12. The kit according to claim 1, the kit additionally has: An implant for introduction into the intervertebral disc.

13. The kit according to claim 12, wherein the implant is porous, spongy or reticular.

14. The kit of claim 1 , wherein the implant comprises at least one of the following materials: -Collagen; -polyglycolic acid, polylactic acid and / or their corresponding copolymers; -polycaprolactone; -Natural membranes, and their modifications; - Fibrin; - Aluminum-containing materials; -Polysaccharides and combinations thereof.

15. The kit of claim 1 , further comprising: At least one resorbable and / or radiopaque nail or pin is used to secure the implant in the intervertebral disc.

16. The kit according to claim 15, wherein the resorbable nail or pin has a diameter DN for which: 1.4 mm ≤ DN ≤ 1.6 mm; and / or The resorbable and / or radiopaque nail or pin has a length LN, for which the following applies: 10 mm ≤ LN ≤ 30 mm.

17. The kit according to claim 1, wherein the applicator sleeve (1) is capable of being plugged into an endoscope; and / or wherein no other fasteners are required to connect the endoscope to the applicator sleeve (1); and / or The applicator sleeve (1) does not have a separate retaining portion or handle.

18. The kit of claim 7, wherein for the length LSK: LSK = 15 mm; and / or For the outer diameter DSK: DSK = 10 mm; and / or For length LD, we have: LD = 2.0 mm; and / or For the outer diameter DD: DD=1.0mm.

19. The kit of claim 8, wherein for the outer diameter DA: DA = 4.0 mm; and For the inner diameter dA: dA = 3.4 mm; and For the outer diameter DB: DB = 3.0 mm; and For dB we have: dB = 2.4 mm; and For the outer diameter DS: DS=3.0mm.

20. The kit of claim 10, wherein for the length LFA and for the outer diameter DFA LFA = 3 mm, DFA = 10 mm; and / or The length LFB and the outer diameter DFB are LFB=3 mm and DFB=12 mm.

21. The kit of claim 16, wherein DN = 1.5 mm.

22. The kit of claim 14, wherein: The natural membrane is periosteum, perichondrium and / or fascia.

23. The kit of claim 17, wherein: The fastener is a screw connection.

24. The kit of claim 12, wherein the implant is felt or non-woven fabric.

25. The kit of claim 14, wherein the polysaccharide is selected from hyaluronic acid, alginate, or agarose.

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