阅读说明：本技术 用于润滑动态器械支架的装置和方法 (Device and method for lubricating a dynamic instrument holder ) 是由 C·米乔 于 2019-03-12 设计创作，主要内容包括：本发明涉及一种用于润滑动态器械支架(300)的装置,其特征在于,所述装置包括一次性润滑组,所述一次性润滑组包含：容器(100),所述容器(100)含有预定量的润滑剂,所述量对应于单个动态器械支架(300)的润滑所需的量；以及管状末端件(200),所述管状末端件(200)预成形有连通的中空芯(230)且包括两个末端,所述末端件(200)的第一末端(210)以允许润滑剂流动到所述动态器械支架(300)的方式附接到所述动态器械支架(300)的开放末端,并且所述容器连接到第二末端(220)。本发明还涉及一种用于润滑动态器械支架的方法。本发明适用于例如动态器械支架等外科手术工具的润滑。(The invention relates to a device for lubricating a dynamic instrument holder (300), characterized in that it comprises a disposable lubrication group comprising: a container (100), the container (100) containing a predetermined amount of lubricant, the amount corresponding to an amount required for lubrication of a single dynamic instrument holder (300); and a tubular tip (200), the tubular tip (200) being pre-formed with a communicating hollow core (230) and comprising two ends, a first end (210) of the tip (200) being attached to an open end of the dynamic instrument holder (300) in a manner that allows lubricant to flow to the dynamic instrument holder (300), and the container being connected to a second end (220). The invention also relates to a method for lubricating a dynamic instrument holder. The invention is applicable to the lubrication of surgical tools such as dynamic instrument holders.)

1. A lubrication device for a dynamic instrument holder (300), characterized in that the lubrication device comprises a disposable lubrication set comprising:

-a container (100), said container (100) containing a predetermined amount of lubricant, said amount corresponding to the amount required for lubrication of a single dynamic instrument holder (300),

-a tubular end-piece (200), said tubular end-piece (200) being pre-formed with a communicating hollow core (230) and comprising two ends,

a first end (210) of the tip (200) is attached to an open end of the dynamic instrument holder (300) in a manner that allows the lubricant to flow to the dynamic instrument holder (300),

the container (100) is connected to the second end (220).

2. The device according to claim 1, wherein the container (100) is pre-shaped such that a tip (110) forms a neck, and the second tip (220) of the tip-piece (200) is pre-shaped such that the tip (110) forming the neck of the container (100) fits into the tip-piece (200) by friction.

3. The device of claim 1, wherein the tip and the container form a single unit ready for attachment to the open end of the dynamic instrument holder to be lubricated.

4. The device of claim 1, wherein the container (100) is flexible and contains a predetermined amount of lubricant and air that enters the dynamic instrument holder (300) under pressure exerted by a user on a wall of the container (100).

5. Device according to claim 2, characterized in that the tip (110) forming the neck of the container (100) fitting into the tip (200) is sealed and must be broken open for opening before fitting it into the tip (200).

6. Device according to claim 2, characterized in that the container (100) is preformed into a ramp shape which tapers from the tip (110) forming the neck.

7. The device according to claim 1, characterized in that it comprises a first package housing a single container (100) and a single end piece (200), said first sealed package being housed individually in a second, slightly larger sealed package.

8. The device according to claim 2, characterized in that said tubular tip (200) has a hollow core (230) pre-shaped to contain three adjacent coaxial hollow portions:

-a first hollow cylindrical portion (231) having a first diameter starting from the first end (210), the diameter of the first hollow cylindrical portion (231) allowing the tip piece (200) to fit into the rear end of the dynamic instrument holder (300),

-a second hollow cylindrical portion (232) having a second diameter smaller than the first diameter, the second diameter allowing to receive and retain by friction, after opening, the tip (110) forming the neck of the container (100),

-a third hollow frustoconical portion (233) flared towards the second end (220) allowing the end piece to centre and receive the end of the container (100) preformed into a frustoconical shape below the end (110) forming the neck.

9. Device according to claim 1, characterized in that said end-piece is made of polyethylene associated with a material such as SEBS (thermoplastic elastomer).

10. The apparatus of claim 1, wherein the lubricant is white oil.

11. The device of claim 1, wherein the container forms a one-piece assembly, wherein the tip of the container forms the neck that engages the tip piece, the neck being sealed after filling.

12. The device according to claim 2, wherein the container (100') is pre-formed with a first widened neck having an external and an internal threaded cylindrical shape, the internal thread (111') receiving a screwable sleeve (130') forming a narrow neck pre-formed to engage with the end-piece (200'), the external thread (112') receiving a screw cap (B).

13. Device according to claim 2, characterized in that the base of the tip forming the neck of the container fitting into the tip is pre-formed with an external thread and the tip is closed by means of a cap screwed onto the thread.

14. The device according to claim 2, characterized in that said tubular tip (200') has a hollow core (230') pre-shaped to contain three adjacent coaxial hollow portions:

-a first hollow cylindrical portion (231') having a first diameter starting from the first end, said diameter allowing the end piece to fit into the rear end of the dynamic instrument holder and taper inwardly until a second diameter smaller than the first diameter,

-a second hollow cylindrical portion (232') adopting said second diameter, which allows to receive and retain by friction, after opening, the end forming the neck of the container,

-a third hollow frustoconical portion (233') flared towards said second end, allowing said end piece to centre and receive said end of the container pre-shaped in a frustoconical shape below said neck.

15. The device according to claim 14 or 8, wherein the third portion (233') and the second portion (232') are dimensioned such that the open end (131') of the container (100') opens into the first portion (231') once the container is mounted in the end piece.

16. The device of claim 1, wherein the outer surface of the tip (200') has a frustoconical shape for attachment to the first end of the open end of the dynamic instrument holder.

17. A method of lubricating a dynamic instrument holder (300) using a device according to any preceding claim,

characterized in that the method comprises the following operations:

-filling a flexible container (100) with lubricant and air,

-closed by means of a cap (111),

-placing the container (100) and the end piece (200) in a first package,

-sealing the first package by means of a sealing device,

-placing the sealed first package in a second, slightly larger package,

-sealing the second package by means of a sealing means,

-sterilizing the package by means of a sterilization device,

-sterilizing the dynamic instrument holder (300),

-opening the second package by means of a second opening device,

-opening the first package by means of a first opening device,

-opening the container (100),

-fitting an opened container (100) into a tip (220) of the tip piece (200),

-fitting the tip (200) into the rear end of the dynamic instrument holder (300),

-the user presses the container (100) until it is completely empty.

18. The method of claim 17, wherein the sterilizing of the package is performed by gamma irradiation.

19. Method according to claim 17, wherein the second packages containing the first packages are placed in batches into a carton for bulk sterilization.

Technical Field

The present invention relates to mechanical medical devices known as dynamic instrument holders used in the medical field and, in particular, to the adaptation thereof to washing, drying, lubricating and disinfecting under the best conditions possible.

Background

Dynamic instrument holders, also known as contra-angulation or handpieces, are complex mechanical medical devices. These are all devices that produce movement (rotation, oscillation, etc.) of an instrument (bur, polisher, blade, etc.). An example of a dynamic instrument holder is a rotary tool holder known as a dental bur for oral surgery, but the surgical handpiece is also a dynamic instrument holder. In fact, the term "dynamic instrument holder" encompasses any instrument with moving elements used in the medical and/or surgical field.

These dynamic instrument holders must be properly cleaned, dried, lubricated, and sterilized after each use.

Cleaning, drying and sterilization operations are necessary to meet the hygienic and contamination-free constraints of a medical environment.

For mechanical reasons, lubrication operations are necessary in terms of the operation and service life of the device.

However, these operational embodiments have drawbacks.

In fact, the following two cases can be found.

Lubrication solutions are used to lubricate and then disinfect dynamic instrument mounts. Subsequently, a lubricant container without sterilization is used as described in document US 5131845. In this case, the operation of a sterilizer (steam autoclave) comprising a plurality of vacuum stages results in complete disappearance of the lubricant. The dynamic instrument holder is no longer lubricated, which risks failure and premature aging.

Another solution is to sterilize the dynamic instrument holder and then lubricate it. In this case, the sterilization is no longer guaranteed, since the lubricating device cannot be sterilized as is currently designed. Indeed, as explained above, the oils used are not resistant to the temperatures of the known rapid sterilization processes. Furthermore, the use of a common lubricant reservoir makes it difficult to sterilize between lubrications. Furthermore, the amount of lubricant is not controllable.

Disclosure of Invention

Starting from this prior art, the applicant has conducted studies aimed at being able to lubricate the dynamic instrument holder and at the same time ensure that this step can be performed under sterile conditions.

This research led to the design and production of a device for lubricating a dynamic device stent, characterized in that it comprises a disposable lubricating package comprising:

a removable container containing a predetermined amount of lubricant, said amount corresponding to the amount required for lubrication of a single dynamic instrument holder,

-a pre-formed end piece having a communicating hollow core and comprising two ends,

the first end of the end piece is attached to the open end of the dynamic instrument holder to allow lubricant to flow to the dynamic instrument holder,

The container is connected to the second end.

The amount of lubricant is a single use dose. The various subassemblies of the device of the present invention are defined as being disposable.

For example, the dynamic instrument holder may be sterilized by an autoclave, while the lubricant, its container and tips may be sterilized for a longer period of time to more gently handle the lubricant.

Thus, the sterilized dynamic instrument holder obtains a sterile lubricant from the sterile packaging. The lubricant is no longer destructively sterilized as is the case with dynamic instrument holders. Lubrication is performed after the lubricant is sterilized. The tip acts as a mechanical interface and fluid channel between the container and the dynamic instrument holder, ensuring a removable point-to-point attachment and seal. The lubrication is thus optimized.

Another advantage of such a device is that a single dose of lubricant is produced. Therefore, untrained users know that they must make full use of the predetermined amount of lubricant present in the container for full lubrication. Furthermore, they cannot use more than this amount of lubricant. The device of the invention thus optimizes the lubrication by ensuring good lubrication without excessive consumption of lubricant.

According to another particularly advantageous feature of the invention, the tip and the container form a single-piece assembly ready for attachment to the open end of the dynamic instrument holder to be lubricated. The one-piece solution avoids the production and handling of two elements.

According to another particularly advantageous feature of the invention, the container is preformed so that one end forms a neck and the second end of the end piece is preformed so that the end forming the neck of the container fits into the end piece by friction. This economical solution provides a simple point attachment, thereby ensuring tightness of the connection. This solution is easy to manufacture and makes it possible to consider the same model of container for a plurality of tip models (and therefore for a dynamic instrument holder).

More precisely, according to another particularly advantageous feature of the invention, the tubular end-piece has a preformed hollow core comprising three adjacent coaxial hollow portions:

a first hollow cylindrical portion having a first diameter starting from the first end, the diameter of the first hollow cylindrical portion allowing the end piece to be fitted to the rear end of the dynamic instrument holder,

a second hollow cylindrical portion having a second diameter smaller than the first diameter, allowing the end forming the neck of the container to be received and retained by friction after opening,

-a third hollow frustoconical portion flaring outwards towards the second end, allowing the end piece to be centred and receiving the end of the container pre-shaped in a frustoconical shape below the neck.

According to another particularly advantageous feature of the invention, the tubular end-piece has a preformed hollow core comprising three adjacent coaxial hollow portions:

a first hollow frustoconical portion having a first diameter opening from the first end, the first diameter allowing the tip to fit to the rear end of the dynamic instrument holder and tapering inwardly to a second diameter less than the first diameter,

a second hollow cylindrical portion, which adopts said second diameter, which makes it possible to receive and retain, by friction, the end forming the neck of the container after opening,

-a third hollow frustoconical portion flaring outwards towards the second end, allowing the end piece to be centred and receiving the end of the container pre-shaped in a frustoconical shape below the neck.

The third and second portions are sized such that once the reservoir is installed in the tip, the open end of the reservoir is open to the first portion, thereby allowing the lubricant to be more directly distributed within the dynamic instrument holder. In addition, partially entering the third portion of the dynamic device holder facilitates the passage of lubricant both inwardly and outwardly from a central axis equipped with some dynamic device holders by flaring outwardly toward the first end.

According to another particularly advantageous feature, the outer surface of the end piece of the first end has a frustoconical shape fitted to the open end of the dynamic instrument holder. The outer end of the tip piece that cooperates with the dynamic instrument holder is tapered so that it generally fits several diameters of the opening of the dynamic instrument holder. This tapering also makes it possible to optimize the seal between the tip and the dynamic instrument holder.

The material of the tip is the subject of research aimed at optimizing the coupling of the tip to the dynamic instrument holder and to the container in terms of friction and sealing.

According to a particularly advantageous feature of the invention, the end pieces are made of polyethylene. According to a preferred but non-limiting example, the polyethylene used is in the 5502 series.

According to another particularly advantageous feature, such polyethylene end-pieces are associated with a material of SEBS type (thermoplastic elastomer). This correlation makes it possible to obtain a hardness of 50 Shore A.

According to another particularly advantageous feature of the invention, the container forms a one-piece unit, wherein the end of the container forms a neck and cooperates with an end piece, the neck being sealed after filling.

According to another particularly advantageous feature of the invention, the container is pre-shaped with a first widened neck having an external and an internal threaded cylindrical shape, the internal thread receiving the screwable sleeve, thereby forming a narrow neck pre-shaped to cooperate with the end piece, the external thread receiving the screw cap. This arrangement is advantageous in that although the liquid is a lubricant, it optimises the closure of a single dose after filling.

According to a preferred embodiment, the container is made of plastic, and more particularly of polyethylene.

According to another particularly advantageous feature of the invention, the container is flexible and contains a predetermined amount of lubricant and air that enters the dynamic instrument holder under the pressure exerted by the user on the container wall. Displacing the fluid by pressure on the flexible wall is economical, reliable and avoids the use of actuators. Furthermore, the presence of air creates a lubricant emulsion that facilitates penetration of the lubricant and ensures that the entire volume of the lubricant is transferred into the body of the dynamic instrument holder.

Finally, the presence of air makes it possible to use containers which are larger in volume, easier to handle and easier to squeeze. Thus, the presence of air makes it possible to have a container of a more ergonomic design.

According to a preferred embodiment, the liquid occupies about 30% of the internal volume of the container.

According to another particularly advantageous feature of the invention, the end forming the neck of the container fitted into said end piece is sealed and must be broken open for opening before it is fitted into the end piece. In order to ensure the best possible aseptic conditions, the rupture is performed before the adaptation.

According to another particularly advantageous feature of the invention, the base forming the end of the neck of the container fitted to said end piece is pre-shaped with a thread and is closed by means of a cap screwed onto the thread. The cap is removed by unscrewing to allow the neck to fit in the tip and to allow lubricant to pass.

According to another feature, the container is preformed in a ramp shape tapering from the end forming the neck. This shape facilitates the gripping and draining of the lubricant while ensuring that the entire volume of lubricant is drained.

According to another particularly advantageous feature of the invention, the device comprises a first package housing the container and the end pieces, said first package being sealed being housed individually in a second, slightly larger, sealed package. This is a two bag system.

The single dose and the end piece slide together in a sealed first package of both paper and polyethylene plastic. This subassembly is slid into a sealed second larger package of both paper and polyethylene plastic.

The assembly of lubricating groups forming the package is combined with other identical groups and packaged in cardboard.

Therefore, three packaging rules are considered.

The second package is opened prior to entering the operating room. The first package is opened when lubrication is to be performed. Placing the lubricant container and the mechanical interface between the container and the dynamic instrument holder together in the same package avoids having to separately manage and store the two components.

It is understood that the device of the invention defines a new lubrication method, which is also the subject of the invention.

According to the invention, the method for lubricating a dynamic instrument holder using the device described above is remarkable in that it comprises the following operations:

-filling the flexible container with lubricant and air,

-closed by means of a cap,

-placing the container and the end piece in a first package,

-sealing the first package by means of a sealing device,

-placing the sealed first package in a slightly larger second package,

-sealing the second package by means of a sealing means,

-sterilizing the package by means of a sterilization device,

opening the second packaging (in case of use in an operating room, before entering the operating room),

opening the first package (in the operating room),

-opening the container by means of a nozzle,

-fitting the opened container into one end of an end piece,

-fitting the second end of the tip piece into the rear end of the dynamic instrument holder,

the user presses the container until it is completely empty.

This approach makes it possible to lubricate the sterilized dynamic instrument holder with the sterilized subassembly (i.e., the sterile lubrication set). Sterility and lubrication are thus optimized. This packaging principle of double packaging using an aseptic lubricating package is new.

According to another particularly advantageous feature of the invention, although the dynamic instrument holder can be sterilized in an autoclave, the sterilization of the packaging still takes place by means of a gamma irradiation process. This sterilization process is a low temperature process with respect to the lubricant and thus can retain all of its characteristics.

According to another particularly advantageous feature, the second packages containing the first packages are placed in batches into a carton for total sterilisation. These three successive packages make it possible to comply with the latest standards for aseptic preparation.

According to a particularly advantageous feature, the lubricant is white oil. This oil is sterilized by gamma irradiation, but its properties are not changed.

Furthermore, the end pieces and the container, as well as the package (first and second) are made of polyethylene which is subjected to this type of irradiation for sterilization purposes.

The basic concept of the invention has been explained above in its most basic form, and further details and features will become apparent from a reading of the following description and a reference to the accompanying drawings, in which several embodiments of the lubricating device according to the invention are described by way of non-limiting example.

Drawings

FIG. 1 is a schematic diagram of an external perspective view of an embodiment of a container according to the present invention;

FIG. 2 is a schematic view of an exterior side view of the container of FIG. 1;

FIG. 3 is a schematic diagram of an external perspective view of an embodiment of an end piece according to the present invention;

FIG. 4 is a schematic illustration of a side cross-sectional view of the tip of FIG. 3;

FIG. 5 is a schematic view of an exterior view of an assembly of containers from which a frangible cap has been removed with an end piece;

FIG. 6 is a schematic diagram of a cross-sectional view of an assembly of containers having end pieces;

FIG. 7 is a schematic diagram of an external side view of a container assembly having end pieces mounted on a dynamic instrument holder;

FIG. 8 is a schematic illustration of a side perspective view of another embodiment of a container according to the present invention;

FIG. 9 is a schematic illustration of a cross-sectional view of another embodiment of an end piece according to the present invention;

fig. 10 is a schematic illustration of a cross-sectional view of the container of fig. 8 fitted onto the tip of fig. 9.

Detailed Description

The lubricating device of the present invention essentially comprises a container 100, shown separately in the drawings of fig. 1 and 2, and an end piece 200, shown separately in the drawings of fig. 3 and 4. The adaptation is illustrated by the diagrams of fig. 5 and 6. It is mounted on a dynamic instrument holder 300 for lubrication purposes, as shown in the drawing of fig. 7.

Fig. 1 and 2 show a container 100 comprising a hollow body provided at its front end with a truncated cone shape ending at a neck 110 and at its other end 120 with a ramp shape tapering backwards. The container 100 is made of plastic material, here polyethylene, and its neck 110 is closed after filling by means of a cap 111. The ramp shape facilitates the discharge of the entire volume.

Fig. 3 and 4 show an end piece 200 comprising a tubular body having an outer shoulder 201 made of polyethylene. This tip piece 200 is pre-shaped to be versatile so that it can be inserted into all dynamic instrument holders, all handpieces and dihedral used in dental surgery, at a first end 210, and so that it can receive the open neck 110 of the container 100 at a second end 220. The outer shoulder 201 makes it possible to distinguish between the tip 220 that engages the container 100 and the tip 210 that engages the dynamic instrument holder 300 (see fig. 7).

The hollow core 230 is preformed to contain three adjacent coaxial hollow portions:

a first hollow cylindrical portion 231 having a first diameter from the first end 210, the diameter of the first hollow cylindrical portion 231 allowing the tip piece 200 to fit into the rear end of the dynamic instrument holder 300 (see FIG. 7),

a second hollow cylindrical portion 232 having a second diameter smaller than the first diameter, said second diameter making it possible to receive and retain by friction the open neck 110 of the container 100,

a third hollow frustoconical portion 233, flared towards the second end 220, allowing the end piece to be centred and to house the end of the container 100 pre-shaped in the shape of a truncated cone below the neck 110.

This friction also promotes the tightness of the bond. The frusto-conical shape aids in the positioning of the neck.

As shown in the drawings of fig. 5 and 6, such friction and sealing is made possible by:

a tight fit between the inner surface of the hollow cylinder 232 and the outer surface of the neck 110,

a concave truncated-cone preform for the end piece 200 (corresponding to the portion 233) and a convex surface 130 for the container 100.

The material of the container 100 is flexible and contributes to the elasticity of the neck 110, said neck 110 being deformable to allow its introduction into the cylinder 231 and to retain the container 100 in the end piece 200 by friction. The material of the tip 200 is also flexible to facilitate insertion, frictional retention, and sealing.

According to a preferred but non-limiting embodiment, the end-piece 200 and the container 100 are made of polyethylene. The material of the end piece 200 is also combined with a thermoplastic elastomer of the SEBS type to achieve a hardness of 50 shore a.

The hollow cylinder 231 is sized in length and diameter so as to allow it to be inserted over the open end corresponding to the rear of the dynamic instrument holder 300, as shown in the drawing of fig. 7. The outer diameter of the first end 210 of the tip element 200 is also defined to establish a tight frictional engagement with the end of the dynamic instrument holder. Subsequently, the dynamic instrument holder 300 is ready for lubrication.

According to the invention, this dynamic instrument holder 300 has been sterilized prior to the lubricating operation, and the container 100 and its tip 200 have been removed from the sterile packaging (not shown).

The user ensures that the cap 111 is broken in a sterile environment and that the container 100 is fitted in the tip piece 200, as shown in the drawing of fig. 5.

The assembly is then fitted onto the open end of the dynamic instrument holder 300. The assembly is oriented in a vertical position with the dynamic instrument holder down and the container up. The user then presses the container 100 to move the lubricant through the tip 200 into the dynamic instrument holder 300. Conventionally, the lubricant is spilled through the lower end of the dynamic device holder 300. The dynamic instrument holder is then sterilized and lubricated for full operation.

The tip 200 and the container 100 are disposable and therefore are discarded after a single use.

The drawings of fig. 8, 9 and 10 show other embodiments for both the container and the tip.

As shown in the drawing of fig. 8, the container 100' is a container closed by means of a screw cap B.

As shown in greater detail in the drawing of fig. 10, the container 100' adopts the same rear shape as the container 100, but it differs from the latter due to the screwing method for closing the container 100' and for receiving the sleeve 130' screwed into the neck 110' and engaged with the end piece 200 '.

Thus, this container 100 'is pre-formed with a first widened neck portion 110' having an external and internal threaded cylindrical shape. The internal thread 111 'receives a screwable sleeve 130', which screwable sleeve 130 'forms a narrow neck 131' pre-shaped at a first end to engage with the end piece 200 'and an external threaded cylinder 132' at a second end. The external thread 112' receives a nut B. Thus, the narrow neck 131 'remains smooth and may engage the hollow core 230' of the tip to wedge and maintain a seal during fluid flow from the reservoir to the dynamic instrument holder.

As shown in the drawing of fig. 9, the tubular end-piece 200 'has a hollow core 230' pre-formed to contain three adjacent coaxial hollow portions:

a first hollow frustoconical portion 231 'having a first diameter starting from the first end, said first diameter allowing the end piece 200' to fit into the rear end of the dynamic instrument holder and tapering towards the inside until a second diameter smaller than the first diameter,

a second hollow cylindrical portion 232' which adopts said second diameter, which allows to receive and retain by friction, after opening, the end 131' forming the neck of the container 100',

A third hollow frustoconical portion 233 'flaring out towards the second end, allowing the end piece 200' to be centred and receiving the end of the container preformed into the frustoconical shape 133 'below the neck 131'.

The first portion 231' has been shown to flare outwardly (or taper inwardly), but is barely visible due to the small taper angle.

Likewise, the outer surface does not take the shape of a simple cylinder, but rather the shape of two stems of a cone, so that the two outer ends of the end piece taper with respect to the middle part of the end piece. These tapered shapes are hardly visible due to the small taper angle. The ends of the tip 200 'are tapered with one end engaging the container 100' to allow demolding of the plastic part and the other end engaging the dynamic instrument holder so that it can adapt and provide a seal when fitting to different opening diameters of the dynamic instrument holder.

As shown in the drawing of fig. 10, the open end 131' of the container 100' opens into the first portion 231 '.

The first end of the tip 200' is beveled to facilitate its insertion into the dynamic instrument holder.

It is to be understood that the devices and methods described and illustrated above are for purposes of disclosure and not limitation. It will be apparent that various arrangements, modifications and improvements may be made to the above examples without departing from the scope of the invention.