EP3522805A1

EP3522805A1 - Surgical repositioning instrument

Info

Publication number: EP3522805A1
Application number: EP17790967.8A
Authority: EP
Inventors: Zbiginiew Combrowski; Alexander Henninger; Christel Paroth
Original assignee: Individual
Current assignee: Individual
Priority date: 2016-10-04
Filing date: 2017-10-04
Publication date: 2019-08-14
Also published as: WO2018065436A1; DE102016118718A1; US20190290330A1

Abstract

The invention relates to a surgical instrument consisting of a repositioning instrument (2) and an adapter (3) for a pedicle screw unit (4), said pedicle screw unit (4) comprising a pedicle screw (5), a tulip (6) and an insertion sleeve (7), wherein the repositioning instrument (2) should comprise a first coupling point (8) and the adapter (3) should comprise a second coupling point (9) and said first coupling point (8) and second coupling point (9) can be interconnected force and/or form-fittingly.

Description

SURGICAL REPOSITIONING INSTRUMENT

Technical area

The invention relates to a surgical instrument according to the preamble of claim 1. State of the art

To stabilize the spine, fixators such as pedicle screws, rods, cages (cage is an intervertebral implant) are used.

Depending on the indication, open / minimally invasive surgery or in connection eg with a cage, after the pedicle screw on both sides of the Spine are used, for example, first the cage, then more screws and the rods are used. However, depending on the indication, both are also used as a stand-alone solution. For this purpose, various instruments such as retractors as spreading systems to provide access for the insertion of a cage, compression, - distraction instruments, Aufrichtinstrumente (generic term repositioning devices) are usually on the pedicle screws, their tulips, Einbringhülsen, extension shafts or extension instruments used. The vertebral bodies to be fixed can thus be distracted, compressed or erected in order to achieve the optimal reduction (one speaks here of the production of the sagittal balance) of the vertebral bodies.

For this one must produce and hold very high forces with these instruments. This should be possible with the instrument (s) as far as possible without loss of repositioning, tensions of the pedicle screw and rod construct, for example.

Depending on the type of pedicle screw used, for example, polyaxial, uniplanar or monoaxial and, depending on which spine region (lumbar or thoracic, for example), different rod shapes are also used, for example, straight, lordotic or kyphotic. So the repositioning of the screws must be parallel or at an angle. For this purpose, a tension-free reduction and prefixing of the construct should be possible during the reduction. Even with the final fixation, the instrument (s) of, for example, pedicle screws should leave as much axial freedom of movement as possible so that the pedicle screws can be fixed with the rods as tension-free as possible. Otherwise tensions lead to premature failure of the construct, as well as a loss of reduction. Depending on the indication and surgical technique, one manufacturer uses different types of screws with different tulips, introducer sheaths, extension instruments and the associated reduction instrument sets.

Also retractor instruments to provide access for the insertion of a Cages are offered in various designs. These often have the disadvantage that created with the retractor tissue and muscle access for setting the cage and kept open during the operation. At the same time, the disc space was to be spread and held open with a reduction instrument until the disc space for the cage was cleared and the cage was inserted. Here, the instruments often stand in the way. Disadvantageously, these retractor and reduction instruments consist of a variety of individual instruments and are of a complex design, so that only experienced surgeons and surgical assistants can use this instrument without suppliers' product specialists. In US Pat. Nos. 8,535,320, 8,906,034 and 8,100,828 pedicle-based retractor and reduction instruments are shown. Disadvantage of this is that they consist of very many individual parts for adjustment, so that all these systems do not have a bearing / pivot point in the tulip area, in which the entire screw remains poly-axially movable and tensions on the pedicle screws and rods during the reduction, prefixing and final fixation occur ( are thus designed, depending on the indication, mainly for polyaxial screws). Only the screw part, which is screwed into the vertebra, remains mobile, if this is a polyaxial screw. Depending on the indication, this is not enough to avoid tensions when using monoaxial or, above all, uniplanar screws, which is becoming more and more the trend in new surgical techniques in many indications such as spondolisthesis, trauma, deformities and tumors. It's easier, more stable, and faster. Object of the invention

The object of the present invention is to overcome the disadvantages of the prior art. In particular, a simple pedicle-based surgical device consisting of a surgical instrument, ie the adapter for a pedicle screw unit, reduction instrument and retractor blade is to be made available, which can be used openly and minimally invasively as a retractor as well as a reduction device and for For example, cages and their access in screws and rod systems allows a tension-free prefixing and / or final fixation without Repositionsverlust.

Solution of the task

To achieve the object, the features according to claim 1.

Advantageous embodiments are described in the subclaims. The surgical instrument consists of a reduction instrument and an adapter for a pedicle screw unit. The pedicle screw unit typically includes a pedicle screw, a tulip, and an introducer sheath. The reduction instrument in this embodiment is basically a spindle instrument which adjusts or adjusts the adapter to another adapter. The spindle instrument is manually operated via a tool or a drive wheel. The reduction instrument has a first coupling point and the adapter via a second coupling point, wherein the first coupling point and the second coupling point non-positively and / or positively with each other are connected. The first coupling point of the reduction instrument has a first corrugation and the second coupling point of the adapter has a second corrugation. The first coupling point is cylindrically shaped and the first corrugation is arranged on an outer side of the coupling point. The second coupling point is sleeve-shaped and the second corrugation is arranged on an inner side of the second coupling point. An outer diameter of the first coupling point is smaller than an inner diameter of the second coupling point. The adapter has at one end the second coupling point and at the other end comprises a bearing shell. The bearing shell is preferably annular, wherein the ring shape can be fully closed or partially open. In this case, the bearing shell, viewed from above or from below, has a U-profile.

Between the second coupling point and the bearing shell extends a connecting web. The connecting web is channel-shaped and has a bending of 70 ° to 100 °, preferably 80 ° to 95 ° and more preferably 90 °.

The bearing shell forms an expansion towards the connecting web, which is suitable for receiving the tulip of the pedicle screw unit in a polyaxially movable manner. The bearing shell has at the other end of the connecting web two arranged in a straight line recesses. These recesses are shaped such that they complete an unspecified slot of the tulip towards the pedicle screw. Here bars can be added. A slightly curved first rod is kyphotisch used. A second slightly bent rod is used lordotically and a third non-bent rod is used as needed. Furthermore, a not-shown retractor blade can be provided, which can be arranged between the adapter and another adapter. The surgical instrument mentioned in the context of the invention may be for use with any type of fixators, a cage, a pedicle screw, in particular a bone screw or other implants or extracorporeal extensions of these implants. The surgical instrument consists of the adapter for the pedicle screw unit, if necessary a retractor blade and the reduction instrument. This is intended both as a retractor spreader system to provide access and distraction of the intervertebral disc space, for inserting a cage, as well as compression, distraction instrument, Aufrichtinstrument for the reduction bspw. Pedicle screws are used.

For this purpose, very high forces should be generated and maintained with the surgical instrument. This should be possible with the surgical instrument as possible without loss of repositioning and avoid unwanted tension on the example. Pedicle screw and rod construct.

The reduction instrument allows the length of the rod to be determined via an integrated measuring scale prior to insertion of the rod, via the L + R spindle for uniform travel and force transmission when turning the spindle, and control of the reduction path during surgical instrument or adapter engagement , The thread is self-locking so that it holds the power and there can be no Repositionsverlust. The surgical instrument should be simple if possible. The surgical instrument can be used for both open and minimally invasive surgery and allows simultaneous reduction on both sides of the spinal column, which, for example, enables bilateral parallel reduction in a fracture and is also very important here.

The surgical instrument can be repositioned parallel or at any angle over any number of vertebral segments.

Preferably, the surgical instrument or the adapter of the surgical instrument is provided at one end with the coupling point and the other end with the annular bearing shell for example. A tulip or a pedicle screw. On the annular bearing shell, the additional two arranged in a straight line recesses are present. These allow the user depending on the application, the placement of the respective rod at the desired position, but also at other locations, for example, along the pedicle screw. This affects the position of the bearing / fulcrum for the introduction of force.

The closer the pivot point is to the respective rod, the easier it is to reposition. To reposition the screws must be able to slide easily with a minimum clearance to the rod, eg. Along the rod, ie axially, radially. The farther the fulcrum is from the rod axis, the larger the lever arm, thus leading to jamming and tensions. In between, the adapter or the connecting web is slightly cupped and angled so that it does not hinder the surgical field in connection with the repositioning instrument. The bowl-shaped design is very wide open and allows for repositioning a fixing that, for example, the pedicle screw can be aligned polyaxially outside the axis of the connecting web. The bearing shell is preferably closed annularly and has an expansion on an inner side, which serves as a bearing and pivot point. In this, the pedicle screw can move freely polyaxially. Preferably, a pedicle screw is received from the outside.

Depending on the type of pedicle screw used, for example, polyaxial, uniplanar or monoaxial and, depending on in which spine area (lumbar or thoracic, for example), different rod shapes are also used (for example straight, lordotic or kyphotic). Thus, the repositioning of the screws must be parallel or at an angle.

For this purpose, a tension-free re-construction, reduction or prefixing of the construct should be possible during reduction. Even with the final fixation, the surgical instrument should allow the pedicle screws so much additional polyaxial range of motion that the pedicle screws can be fixed as tension-free as possible with the / rod / rods. Otherwise tensions lead to premature failure of the construct as well as loss of reduction and associated revisions. For this purpose, the annular bearing shell of the adapter of the surgical instrument is preferably introduced via the pedicle screws and to the tulip rod area. The tulip is used to hold a rod, which connects various pedicle screws intracorporeally and is fixed in the tulip with an ini.

It is also conceivable, however, a recording on the extension of the tulip, in this case according to a predetermined breaking point, so the Einbringhülsen, extension shafts or extension instruments. Especially in a minimally invasive application, the surgical instrument or the adapter can be inserted and placed through the same access of the pedicle screws. For this, the screw access does not need to be extended become. Since the annular bearing shell is very thin-walled, there are no tensions due to tissue and musculature.

After the adapter has been inserted and placed, the reduction instrument is only now docked. Advantage here is the fine toothing or corrugation at both coupling points and a corresponding game of both parts. As a result, voltages are avoided.

It is also conceivable a rigid connection between the two instead of the coupling points, but this would complicate the insertion and placement of the instrument with the disadvantages mentioned.

The coupling point in the adapter is shown as an example. Cylindrical bore with a fine toothing or fine ribbing and the coupling point of Repositions instrument as a mandrel with a fine toothing or corrugation, which interact with each other in the game.

However, the coupling point can also have, for example, either a frontal toothing or corrugation, it can be conical or formed as a ball head with a kind of toothing, which can transmit large forces.

Also, a simple plug connection is possible, which is fixed only, for example. With a screw in any position. The retractor blade should preferably be produced as a simple sheet metal part and is preferably pedicle screws based adaptable.

At one end of the retractor blade has a handle portion and at the other end a receptacle with which it can be fixed in the pedicle screw and an angled tongue, which serves to keep away muscle mass. Preferably, only one retractor blade is used, but it can also be two. This is not shown in detail. This would be a mirrored variant the other pedicle screw, thus forming the access channel between the pedicle screws. It is conceivable that the two retractor blades can then be adjusted fan-shaped and are each provided with a detent, which allows a better fixation.

Advantageous is the use of two retractor blades as retractor spreader system to provide access and distraction, the disc space, to the onset of a Cages. After the surgical instruments or the adapters have been placed on the pedicle screws and coupled to the reduction instrument, the two retractor blades are fixed in the pedicle screws. Thus, the adapters are additionally secured against removal, so that they can not slip during repositioning and there would be no repositioning loss. The retractor blade may be of any shape, such as a tube nearly round, cylindrical or tapered, nor does it need to be closed (eg, half open like a gutter) and depicted in the present embodiment as a retractor blade. The pedicle screws have certain axialities. This allows the retractor blade to be placed in the desired position.

Preferably, the receptacle is cylindrical as a rod and formed in the diameter of the rod. In the illustrated embodiment, it is shown as a stable sheet, the surfaces to which it is fixed, are preferably rounded. Cylindrical like a rod and shaped in the diameter of the rod. The fixation is preferably done with the Ini. However, it is also conceivable fixation in the surgical instrument. Also, a stop or coupling to the surgical instrument for the retractor is possible

The surgical instrument can be used in open and MIS surgery and preferably consists of several parts to tension as possible and preferably introduced through a same access of the pedicle screws tissue preserving, so that the Pedicle screw remains polyaxially mobile even during very high forces during reduction. Thus, a tension-free pre-fixation, as well as final fixation without reduction loss of the construct is possible. The adapter is available in various lengths, preferably from 50 to 200 mm long and more preferably from 60 to 130 mm.

The second coupling point of the adapter has a groove which cooperates with a detent at the coupling point of the reduction instrument such that a solution of the two coupling points is possible only by a targeted pulling. This serves to prevent unwanted falling out.

The coupling point of the adapter is, as already mentioned above, preferably arranged on the inside and the coupling point of the reduction instrument on the outside. But this can also be the other way around.

The corrugations or the teeth can vary in fineness and spacing and are usually arranged in a 360 ° orbit.

figure description

Further advantages, features and details of the invention will become apparent from the following description of preferred embodiments and from the drawings; these show in:

Figure 1 is a perspective view of a surgical instrument according to the invention; Figure 2 is a front view of the surgical instrument of Figure 1;

Figure 3 is a side view of the surgical instrument of Figure 1;

Figure 4 is a perspective view of an adapter for use in the surgical instrument of Figure 1;

Figure 5 is a side view of the adapter of Figure 4;

Figure 6 is a rear view of the adapter of Figure 4;

FIG. 7 shows a further perspective view of the adapter according to FIG. 4.

Exemplary embodiment FIG. 1 shows a perspective view of a surgical instrument 1. The surgical instrument 1 consists of a reduction instrument 2 and an adapter 3 for a pedicle screw unit 4. The pedicle screw unit 4 comprises a pedicle screw 5, a tulip 6 and an insertion sleeve 7.

The reduction instrument 2 in this embodiment is basically a spindle instrument, which the adapter 3 to another adapter adjusted or adjusted. The spindle instrument is manually operated via a tool or a drive wheel. The reduction instrument 2 has a first coupling point 8 and the adapter 3 via a second coupling point 9, wherein the first coupling point 8 and the second coupling point 9 are non-positively and / or positively connected to each other.

The adapter 3 has at one end the second coupling point 9 and at the other end comprises a bearing shell 10. The bearing shell 10 is preferably annular, wherein the ring shape can be fully closed or partially open. In this case, the bearing shell 10 viewed from above or from below, more or less have a U-profile.

The first coupling point 8 of the reduction instrument 2 has a first corrugation 11 and the second coupling point 9 of the adapter 3 has a second corrugation 12.

The first coupling point 8 is cylindrically shaped and the first corrugation 1 1 is arranged on an outer side 13 of the coupling point 8. The second coupling point 9 is sleeve-shaped and the second corrugation 12 is arranged on an inner side 14 of the second coupling point 9.

An outer diameter di of the first coupling point 8 is smaller than an inner diameter d _{2 of} the second coupling point 9.

Between the second coupling point 9 and the bearing shell 10 extends a connecting web 15. The connecting web 15 is channel-shaped and has a bending of 70 ° to 100 °, preferably 80 ° to 95 ° and more preferably 90 °. The bearing shell 10 forms towards the connecting web 15 out a widening 16, which is adapted to receive the tulip 6 of the pedicle screw unit 4 movable in a polyaxial manner. The bearing shell 10 has at the other end of the connecting web 15 two arranged in a straight line recesses 17. These recesses 17 are formed such that they complete a not shown in detail oblong hole of the tulip 6 to the pedicle screw 5 out. A slightly curved first rod 18 is kyphotisch used. A second slightly bent rod 19 is used lordotically and a third non-bent rod 20 is used as needed.

Furthermore, a retractor blade not shown in detail can be provided, which can be arranged between the adapter 3 and a further adapter.

LIST OF REFERENCE NUMBERS

Claims

claims

1 . A surgical instrument comprising a reduction instrument (2) and an adapter (3) for a pedicle screw unit (4), the pedicle screw unit (4) comprising a pedicle screw (5), a tulip (6) and an insertion sleeve (7) therethrough characterized in that the reduction instrument (2) has a first coupling point (8) and the adapter (3) has a second coupling point (9), wherein the first coupling point (8) and the second coupling point (9) force and / or positively connected to each other.

2. Surgical instrument according to claim 1, characterized in that the adapter (3) at one end has the second coupling point (9) and at the other end comprises a bearing shell (10).

3. A surgical instrument according to claim 1 or 2, characterized in that the first coupling point (8) has a first corrugation (1 1) and the second coupling point (9) has a second corrugation (12).

4. Surgical instrument according to one of the preceding claims, characterized in that the first coupling point (8) is cylindrically shaped and the first corrugation (1 1) on an outer side (13) of the coupling point (8) is arranged.

5. Surgical instrument according to one of the preceding claims, characterized in that the second coupling point (9) is sleeve-shaped and the second corrugation (12) on an inner side (14) of the second coupling point (9) is arranged.

6. Surgical instrument according to one of claims 4 or 5, characterized in that an outer diameter (di) of the first coupling point

(8) is smaller than an inner diameter (d ₂ ) of the second coupling point (9).

7. Surgical instrument according to one of the preceding claims, characterized in that extending between the second coupling point (9) and the bearing shell (10) has a connecting web (15).

8. A surgical instrument according to claim 7, characterized in that the connecting web (15) is channel-shaped.

9. A surgical instrument according to claim 7 or 8, characterized in that the connecting web (15) has a bend of 70 ° to 100 °, preferably 80 ° to 95 ° and more preferably 90 °.

10. Surgical instrument according to one of the preceding claims 2 to 9, characterized in that the bearing shell (10) to the connecting web

(15) towards a widening (16) formed suitable to receive the tulip (6) of the pedicle screw unit (4) movable in a polyaxial manner.

1 1. Surgical instrument according to one of the preceding claims 2 to 10, characterized in that the bearing shell (10) at the other end of the

Connecting web (15) has two arranged in a straight line recesses (17).

12. Surgical instrument according to one of the preceding claims 2 to 1 1, characterized in that the bearing shell (10) is annular, wherein the annular shape can be fully closed or partially open, whereby the bearing shell (10) has a U-profile formed.

13. Surgical instrument according to one of the preceding claims 1 to 12, characterized in that a Pedikelschrauben (5) based retractor blade is provided which can be arranged between the adapter (3) and a further adapter.