DE102019102683A1 - Packaging system for a pedicle screw system and a removal tool for removing a locking screw from the packaging system - Google Patents

Abstract

The invention relates to a packaging system (1) for a pedicle screw system, with a plastic sleeve (2) for receiving a pedicle screw and a cover (3) that can be placed on the plastic sleeve (2) for receiving a locking screw (4) which has a fixing section (5) Has fixing of the locking screw (4), the cover (3) having a deformability element (6) which, when a force is applied from the outside, enables the cover (3) to be deformed in such a way that the fixing section (5) without touching the locking screw (4) the fixing of the locking screw (4) loosens. The invention also relates to a removal tool (17) for removing a locking screw (4) from a packaging system (1) according to the disclosure.

Description

The present disclosure relates to a packaging system for a pedicle screw system. Such a pedicle screw system is composed of a pedicle screw and a locking screw, also called a set screw.

The invention also relates to a removal tool for removing a locking screw from a packaging system according to the disclosure.

Background of the Invention

Pedicle screw systems are used in spinal surgery for stabilization operations. In order to prevent a patient's body from developing defense reactions against the pedicle screw systems, sterile transport and sterile provision of the pedicle screw systems must be implemented without any ifs and buts. Pedicle screw systems are also to be transported robustly in order to avoid plastic deformations which impair the suitability of the pedicle screw system during transport. Against this background, the invention is devoted to the problem of ensuring safe transportation and contamination-free provision of the pedicle screw systems.

State of the art

The locking screw and the pedicle screw are usually transported in different packaging. For example, injection-molded collapsible sleeves have been established for the transport of the pedicle screw, while so-called poly bags, that is, elastic bags with a corresponding protective film, are used for the locking screws.

Recent developments aim to both the locking screw and the pedicle screw, i.e. the entire pedicle screw system can be transported in a plastic transport system. There are considerations to fix the locking screw in the cover of the transport system.

However, it is not clear how the locking screw is actually to be fixed and transported in order to guarantee the strict requirements, in particular for the integrity of the screw when it is removed from the transport system / packaging system.

For example, in the case of a plastic lid, there is a great risk that a locking screw clamped in the lid will come into contact with plastic particles of the lid when removed from a non-positive and / or form-fitting holder and these particles will settle on the locking screw, which will contaminate the locking screw equals.

Although are about from the documents DE 10 2011 112 615 , DE 10 2011 112 616 and DE 10 2005 038 929 Basically, covers with brackets are known, but they do not disclose a solution as to how a locking screw can be made robust and free of play on the one hand, and sterile and contamination-free on the other.

The prior art contains information on how (plastic) packaging systems can meet the high medical sterilization criteria for locking screws.

Brief description of the invention

In view of this prior art, the present invention is based on the object of eliminating or at least alleviating the disadvantages of the prior art, and in particular of disclosing such a packaging system or a corresponding tool which enables the safe transport of the entire pedicle screw system in one package enables and at the same time permits removal of the pedicle screw system in the sterile operating room, so that no additional cleaning has to take place between removing the locking screw from the lid and placing the locking screw on an operating table.

Furthermore, the invention aims to be able to release the locking screw from the cover in such a way that when it is removed - even at the micro level - no plastic particles / hairs / lint / fibers / molecules are entrained by the locking screw and these are carried away in the Contaminate consequence. In other words, the invention aims to completely prevent plastic particles from adhering to the locking screw.

This is achieved according to the invention by means of a packaging system / a removal tool with the features of the independent claim (s). Advantageous embodiments are the subject of the dependent claims.

• - Das gesamte Pedikelschraubensystem wird in einer Verpackung transportiert.
• - Zwischen der Entnahme des Pedikelschraubensystems aus der Verpackung und der Bereitstellung des Pedikelschraubensystems auf dem Operationstisch ist keine zusätzliche Reinigung / Sterilisierung notwendig.
• - Die robuste Verpackung des Pedikelschraubensystems durch die Kunststoffkomponenten (d.h. Kunststoffhülse und Deckel) verhindert Beschädigungen während des Transports.
• - Eine direkte Entnahme des Pedikelschraubensystems, insbesondere der Verriegelungsschraube, ist möglich.
• - Das Pedikelschraubensystem wird innerhalb der Sterilbarriere transportiert.
• - Der Abpackprozess des Pedikelschraubensystems ist optimiert, da bei der Konfektionierung kein Abrieb erzeugt wird.

The following further advantages can thus be derived from this configuration of the packaging system according to the invention:

• - The entire pedicle screw system is transported in one package.
• - Between the removal of the pedicle screw system from the packaging and the Providing the pedicle screw system on the operating table requires no additional cleaning / sterilization.
• - The robust packaging of the pedicle screw system through the plastic components (ie plastic sleeve and lid) prevents damage during transport.
• - A direct removal of the pedicle screw system, especially the locking screw, is possible.
• - The pedicle screw system is transported within the sterile barrier.
• - The packaging process of the pedicle screw system is optimized since no abrasion is generated during assembly.

The object of the invention is accordingly a packaging system for a pedicle screw system, with a plastic sleeve for receiving a pedicle screw and a cover which can be placed / plugged on / screwed onto the plastic sleeve for receiving a locking screw, which has a fixing section for fixing / fixing the locking screw and for protecting the locking screw during of the transport has / accommodated / contains / has.

According to the invention, the lid also has a deformable element which, under the action of an external force, i.e. in the event of an external force acting on the cover, a deformation of the cover which releases the fixing of the locking screw enables the fixing section to remain in place without contacting / contacting the locking screw, i.e. abrasion-free, is removed from the locking screw.

Abrasion-free in the sense of the disclosure is accordingly understood to mean that there is no tribological interaction between the fixing section and the locking screw, so that when the fixing section is removed from the locking screw, no (plastic) molecules from the cover adhere to the locking screw.

The locking screw itself is therefore not the subject of the invention. Nevertheless, the advantages according to the invention only become apparent due to the interaction between the locking screw and the lid.

In other words, the cover is (resiliently) deformable in such a way that the fixing section, which holds the locking screw in a defined position during transport, is free of abrasion from the locking screw, i.e. without rubbing contact with the locking screw. The fixing section thus holds the locking screw in a first state (the transport state). The deformation of the fixing section that releases the holding effect does not cause any further contact between the locking screw and the fixing section.

The fact that the fixing section is removed from the locking screw without abrasion during the deformation thus represents a structural feature essential to the invention. It delimits the fixing section according to the invention (and the deformability element) from those fixing sections which (for example due to a bend) also during the deformation the locking screw come into contact.

Another object of the present disclosure is a removal tool for removing one or the locking screw from or the packaging system according to this disclosure. The removal tool has a handle and an active section and is characterized in that the active section deforms the fixing section of the packaging system when the locking screw is removed from the packaging system in such a way that the locking screw is contact-free, i.e. without touching the fixing section (from the cover).

In other words, the removal tool enables the locking screw to be removed from the cover without abrasion in order to achieve the advantages according to the invention (see above).

Advantageous embodiments are the subject of the subclaims and are explained in more detail below.

The deformability element of the packaging system is preferably designed as a deformation axis, in particular as a hinge, in an end face of the cover, so that when the force is exerted from outside, the cover can be swung open along the deformation axis. In this way, the locking screw is released sufficiently after being swung open so that it can be removed comfortably. According to the invention, the pivoting open is such that the fixing section does not come into contact with the locking screw.

In this embodiment, at least two (outer) side surfaces of the cover each preferably have a tear line which, when the cover is pivoted open, allows the side surfaces to be broken open or spread apart in order to give the cover the elasticity which is advantageously present for the pivoting open. The tear line further reduces the effort required to swing it open.

In a preferred exemplary embodiment of this embodiment, the axis of deformation runs when pivoting open along an axis of symmetry of the end face of the cover, so that two cover halves of the same size are pivoted towards one another. The manufacturing costs of the lid can be kept low due to the symmetrical conditions.

In a further exemplary embodiment of the packaging system according to the disclosure, the deformability element and the fixing section are integral with one another, i.e. configured as a component, as an elastic section. This means that the deformability element and the fixing section are the same component, as a result of which one component realizes several functions, namely fixing on the one hand and swiveling on the other hand. This reduces the complexity in the design geometry.

This elastic section of the lid advantageously clamps the locking screw (in the top view) in the manner of a (tension) diamond / eye-shaped / oval. When a force is exerted on at least two side surfaces of the cover, a first diagonal of the diamond is reduced and a second diagonal of the diamond is enlarged in order to release the locking screw. On the one hand, this enables a reliable fixation, on the other hand, a comfortable release of the locking screw. The (tension) diamond can also be referred to as a holding cable or can be designed as such.

In a further, to the above alternative embodiment, the elastic section clamps the locking screw in the plan view in the manner of a circle, which (ie the circle) turns / spreads / expands radially outwards when the elastic section is acted upon in order to release the locking screw and thus reliably enable abrasion-free removal.

A particularly advantageous exemplary embodiment is distinguished by the fact that the fixing section and the remaining cover are assembled by means of a multi-component injection molding, preferably a two-component injection molding. Here it is an example to produce the fixing section generally from TPE (thermoplastic elastomer) or specifically from TPS (styrene block copolymers), while the remaining cover is formed from PP (polypropylene).

In an advantageous embodiment of the invention, the fixing section fixes the locking screw on the end face of the cover, in order to enable the locking screw to be secured in a space-saving manner and also securely protected during transport.

The invention is explained in more detail below on the basis of preferred exemplary embodiments with reference to the accompanying figures.

• 1: ein Verpackungssystem mit einer Kunststoffhülse und einem Deckel, in dem eine Verriegelungsschraube angeordnet ist;
• 2: den Deckel aus dem Verpackungssystem gemäß 1 in einer aufgespreizten Stellung zur Entnahme der Verriegelungsschraube;
• 3: eine zweite Ausführungsform des Deckels in einer die Verriegelungsschraube fixierenden Stellung;
• 4 die zweite Ausführungsform des Deckels in einer die Verriegelungsschraube freigebenden Stellung;
• 5 eine dritte Ausführungsform des Deckels in einer die Verriegelungsschraube fixierenden Stellung;
• 6 die dritte Ausführungsform des Deckels in einer die Verriegelungsschraube mithilfe eines Werkzeugs freigebenden Stellung; und
• 7 eine vierte Ausführungsform des Deckels in einer die Verriegelungsschraube fixierenden Stellung.

Show it:

• 1 : a packaging system with a plastic sleeve and a lid, in which a locking screw is arranged;
• 2nd : the lid from the packaging system according to 1 in a spread position for removing the locking screw;
• 3rd : a second embodiment of the cover in a position fixing the locking screw;
• 4th the second embodiment of the cover in a position releasing the locking screw;
• 5 a third embodiment of the cover in a position fixing the locking screw;
• 6 the third embodiment of the cover in a position releasing the locking screw using a tool; and
• 7 a fourth embodiment of the lid in a position fixing the locking screw.

The figures are merely schematic in nature and serve only to understand the invention. The same elements are provided with the same reference symbols. The individual elements of different embodiments are interchangeable.

1 shows a packaging system 1 for a pedicle screw system. The packaging system 1 consists of a plastic sleeve 2nd (to hold a pedicle screw) and a lid 3rd (to hold a locking screw 4th ) together. Inside the lid 3rd is a fixation section 5 (to fix the locking screw 4th ) arranged. In this way, safe transport of the pedicle screw system is guaranteed.

The lid 3rd also has a deformability element 6 , such a deformation of the cover when subjected to external forces 3rd allows the fixation section 5 without further touching the locking screw 4th fixing the locking screw 4th abrasion-free.

According to the first embodiment 1 is the fixation section 5 of two semicircular brackets 7 educated. So clamp the two semicircular brackets 7 the locking screw 4th to fix them. The two semicircular brackets are for this 7 diametrically arranged to each other. To release the clamp without (even temporarily) any friction between the locking screw 4th and the fixing section 5 The lid is used to cause it to come off without abrasion 3rd pivoted here. The required flexibility of the side walls of the cover, which enables the pivoting and deformation, is in the present case via a tear line 8th realized. The tear line can be formed as an elastic region or as a type of predetermined breaking point. The pivoting itself is done via a hinge 9 / an axis of rotation that is in the plane of an end face 12th of the lid 3rd runs.

The abrasion-free deformation of the lid 3rd or the fixing section 5 according to the first embodiment is in 2nd shown. The cover is removed by external / external force, such as the hand or a tool of the operator / doctor 3rd along a pivoting direction 10th around the hinge 9 moved / twisted. The fixing bracket between the locking screw 4th and the fixing section 5 is thus released without the twisting being a temporary contact between the fixing section 5 and the locking screw 4th would follow. After deformation along the direction of pivoting 10th is an abrasion-free removal of the locking screw 4th along a removal direction 11 , in the present case perpendicular to the direction of pivoting 10th runs, enables.

The semicircular bracket 7 has a smaller height / a smaller amount in the longitudinal direction of the packaging system than the side walls / outer walls of the cover 3rd . This helps protect the locking screw 4th during transportation because of the lid 3rd has a greater depth than the locking screw 4th .

The lid 3rd According to the first embodiment, the locking screw can be loosened without abrasion 4th so over the hinge 9 as a deformability element 6 that has a kinked face 12th entails.

In 3rd is a second embodiment of the packaging system 1 shown. The fixation section 5 and the deformability element 6 are as the same component, namely an elastic section 13 , molded. This elastic section 13 is the fixation element in the transport state 5 , which is deformable due to its elasticity (via external force, compare direction of force 16 ), so the locking screw 4th release without abrasion.

The elastic section 13 According to the present embodiment, it is designed as a diamond-shaped holding cable that has a first diagonal 14 and a second diagonal 15 having. Once along the direction of force 16 a force on the lid 3rd is exercised, the second diagonal increases 15 , so it spreads out while the first diagonal 14 reduced, so it is compressed (cf. 4th ). This leads to the diamond shape of the diamond-shaped holding cable being deformed from a slim to a bulbous shape, which means that the locking screw is loosened without abrasion 4th brings with it.

The diamond-shaped holding cable according to the second embodiment runs across the entire width of the cover 3rd . The direction of force 16 is like squeezing the lid 3rd what about the enlargement of the second diagonal 15 ensures the abrasion-free loosening of the locking screw according to the invention.

The 3rd and 4th put the same lid 3rd once in the transport state ( 3rd ), once in the deformed state for the removal of the locking screw ( 4th ).

A third embodiment is shown in FIGS 5 and 6 shown. The fixation section 5 and the deformability element 6 are also here as the same component, namely as an elastic section 13 , molded. The external force that the loosening of the locking screw 4th by deforming the lid 3rd enabled, does not grip the side walls of the lid in the present case 3rd (as in the embodiment according to the 3rd and 4th ), but directly on the elastic section 13 on.

The elastic section 13 encloses the locking screw 4th in transport condition ( 5 ) flat, preferably in full. With the help of a removal tool 17th , which at its illustrated distal end has a geometric shape on the elastic section 13 adjusted effective section 18th has an abrasion-free deformation of the elastic section 13 via a radial protrusion / deformation / expansion of the elastic section 13 possible ( 6 ).

The effective section 18th of the removal tool 17th has a circular ring shape. The circular ring has a preferably circumferential tip, which is between the holding fixation between the fixation section 13 and the locking screw 4th intervenes. In this way, the fixing section is deformed / expanded in such a way that it is free from abrasion from the locking screw 4th solves.

The removal tool 17th furthermore has a screw receptacle within the annulus, which has a positive and / or non-positive connection between the removal tool 17th and the locking screw 4th enables so that Locking screw 4th can be removed comfortably and reliably.

Consequently, the removal tool practices 17th two functions: The deformation of the elastic section 13 one hand and the inclusion of the locking screw 4th on the other hand.

7 represents another embodiment of the lid 3rd The principle of operation of the abrasion-free removal of the locking screw 4th agrees with that related to the 5 and 6 explained so that the locking screw 4th out 7 also via the removal tool 17th is removed.

A distinction from the previous embodiment is achieved in that the elastic section 13 In the present case, it is designed as an integral component with its own bottom, that is, it has a pot shape. The bottom of the pot / elastic section 13 is with the face 12th of the lid 3rd connected via a multi-component injection molding. This enables the rest of the cover to be produced 3rd made of a first plastic, while the elastic section 13 is made of a second plastic. Thus, on the one hand, the manufacturing costs are kept low, on the other hand, an individual material adaptation of the respective areas is possible. For example, the elastic range 13 Made from an easily deformable material (e.g. TPE or TPS), while the rest of the lid is made from a robust material (e.g. PP) which is advantageous for transport.

Reference list

1

Packaging system

2nd

Plastic sleeve

3rd

cover

4th

Locking screw

5

Fixation section

6

Deformability element

7

Semicircular bracket

8th

Crack line

9

hinge

10th

Swivel direction

11

Withdrawal direction

12th

Face

13

Elastic section

14

First diagonal

15

Second diagonal

16

Force application

17th

Removal tool

18th

Effective section

QUOTES INCLUDE IN THE DESCRIPTION

This list of documents listed by the applicant has been generated automatically and is only included for the better information of the reader. The list is not part of the German patent or utility model application. The DPMA assumes no liability for any errors or omissions.

Patent literature cited

• DE 102011112615 [0008]
• DE 102011112616 [0008]
• DE 102005038929 [0008]

Claims (10)

Packaging system (1) for a pedicle screw system, with a plastic sleeve (2) for receiving a pedicle screw and a cover (3) which can be placed on the plastic sleeve (2) for receiving a locking screw (4), which has a fixing section (5) for fixing the locking screw (4), whereby the cover (3) has a deformable element (6) which, under the action of an external force, enables the cover (3) to deform, which releases the fixing of the locking screw (4), during which the fixing section (5) is removed from the locking screw (4) without abrasion. Packaging system (1) according to Claim 1 , characterized in that the deformability element (6) is designed as a deformation axis, preferably a hinge (9), in an end face (12) of the cover (3), so that when the force is exerted from outside, the cover (3 ) along the deformation axis is made possible. Packaging system (1) according to Claim 2 , characterized in that at least two side faces of the cover (3) each have a tear line (8) which enables the side faces to be broken open or spread out when the cover (3) is swung open. Packaging system (1) according to one of the Claims 2 or 3rd , characterized in that the deformation axis runs along an axis of symmetry of the end face (12) of the cover (3). Packaging system (1) according to Claim 1 , characterized in that the deformability element (6) and the fixing section (5) are designed integrally with one another as an elastic section (13). Packaging system (1) according to Claim 5 , characterized in that the elastic section (13) clamps the locking screw (4) in plan view in the manner of a rhombus and, when a force is exerted on two side surfaces of the cover, reduces a first diagonal (14) of the rhombus and a second diagonal (15) of the Diamond is enlarged to release the locking screw (4). Packaging system (1) according to Claim 5 , characterized in that the elastic section (13) clamps the locking screw (4) in the plan view in the manner of a circle which, when a force is exerted on the elastic section, turns radially outward in order to release the locking screw (4). Packaging system (1) according to one of the Claims 5 to 7 , characterized in that the fixing section (5) and the remaining cover (3) are assembled by means of a multi-component injection molding, preferably a two-component injection molding. Packaging system (1) according to one of the preceding claims, characterized in that the fixing section (5) fixes the locking screw (4) on the end face (12) of the cover (3). Removal tool (17) for removing a locking screw (4) from a packaging system (1) according to one of the preceding claims, with a handle and an active section (18), characterized in that the active section (18) when removing the locking screw (4) the fixing section (5) is deformed from the packaging system (1) in such a way that the locking screw (4) is removed without contact.

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