EP4225178A1

EP4225178A1 - Packaging for a medical device

Info

Publication number: EP4225178A1
Application number: EP21810652.4A
Authority: EP
Inventors: Rodolphe Lourdel; Pierric Deransart; Jean Emmanuel CARDON; Eric RUNDSTADLER
Original assignee: Clariance SAS
Current assignee: Clariance SAS
Priority date: 2020-10-09
Filing date: 2021-09-27
Publication date: 2023-08-16
Also published as: US20240008908A1; FR3114959A1; FR3114959B1; WO2022074311A1

Abstract

The invention relates to packaging (E, E') for a medical device (D, 100'), the packaging comprising: - a first container (300, 300') receiving the medical device (D, 100'), - a second container (400, 400') receiving the first container (300, 300') and closed by a closure means (410, 4101), the packaging being characterised in that it comprises a frame (300, 600') for supporting the medical device (D), the support frame (300, 600') being preformed so as to have two walls which are arranged opposite each other and between which the medical device (D) is supported by means of at least one transversely arranged movable bearing stop (500, 61 T, 621').

Description

Title of the invention: PACKAGING FOR MEDICAL DEVICE

[1] FIELD OF APPLICATION OF THE INVENTION

[2] The invention relates to the field of packaging for medical devices such as screws or implants and in particular to adaptations of the packaging to avoid any contact with the packaged medical device.

[3] BRIEF DESCRIPTION OF PRIOR ART

[4] In the prior art, packaging specially designed for medical devices such as screws or implants is known. They are intended to avoid contact between the medical device and the outside as much as possible.

[5] Thus, there is a packaging adopting a pull-out configuration and comprising:

[6] - a first container closed by a cap and housing the medical device in its interior,

[7] -“ a second container having an interior volume accommodating the first container, closed by a sealed seal serving as a sterile barrier and protection for the first container

[8] During use, the ward nurse opens the second container by removing the seal. The first container then falls onto a sterile field and/or can be handled by an instrumentalist. The latter removes the cap and accesses the medical device.

[9] The sterile barrier formed by the second container prevents any contact between the outside and the medical device, which remains sterile until the last moment.

[10] The plaintiff nevertheless noted several disadvantages, among them:

[11] - the release of the medical device may require complex manipulation on the part of the technician and/or require a dedicated tool.

[12] - the screw or implant must in certain situations be held by the technician. [13] - the first container is limited in its ability to accommodate screws of different sizes,

[14] -» Pedicle screws are often intended to be linked to connecting rods. A headless retaining screw is then associated with the head of the preformed pedicle screw to accommodate and retain the rod. This grub screw ensuring the retention requires specific packaging or is in some cases housed in the cap of the first container, which requires handling of said cap or of a second packaging.

[15] BRIEF DESCRIPTION OF THE INVENTION

[16] Based on this observation and pre-established specifications, the plaintiff conducted research with the objective of handling medical devices without the technician having to touch said medical device in order to avoid the spread of bacteria.

[17] This research led to the design and production of packaging for a medical device defining a longitudinal axis, said packaging adopting a pull-out configuration and comprising:

[18] ~~ a first container accommodating the medical device in its interior volume,

[19] - a second container having an interior volume accommodating the first container, closed by a closure means and serving as a sterile barrier and protection for the first container

[20] According to the invention, said packaging is remarkable in that it comprises an elongated support frame supporting the medical device, said support frame being preformed so as to have two walls arranged opposite between which is supported the medical device by means of at least one mobile support abutment arranged transversely to the longitudinal axis of the medical device.

[21] The movable stop can be a removable stop which separates from the support frame or a stop which moves to allow the screw to be released. This characteristic is particularly advantageous in that it allows said support to accommodate several sizes of medical devices. The bets ensure lateral retention of the device in the support frame. The stop ensures its axial retention.

[22] Thus, for example in the case of a pedicle screw packaging, the use of a mobile stop makes it possible to provide a support surface for the screw head having different threaded part lengths but having substantially the same head size. This packaging also makes it possible to accommodate screws with different head sizes for the same threaded part.

[23] According to another particularly advantageous characteristic of the invention, said support frame is preformed with a zone for housing the mobile stop.

(241) According to another particularly advantageous characteristic of the invention, said support frame is preformed with several housing zones for the movable stop. The different possibilities for positioning the stop increase the capacity of the support.

[26] Said support frame can be preformed surfaces serving as a non-moving abutment complementing the reception possibilities.

[26] Another possibility of reception by movable stop according to the invention is implemented by another remarkable characteristic in that the two walls are preformed with at least one elastic blade with a retaining projection projecting towards the inside to form the mobile abutment and cooperating for retaining purposes with the medical device, once the medical device is positioned between the two walls of the support frame for elastic holding purposes. The removability of the abutment then consists of a separation of the latter.

[27] When the medical device is a pedicle screw, the two walls are preformed with at least one elastic blade with a retaining projection projecting inwards to form the movable stops and cooperating for retaining purposes with the head of the pedicle screw.

[28] This feature cooperates with a feature already present which is the presence of two side holes initially used for gripping the head of the screw by an instrument.

[29] Retaining the screw by the head makes it possible to use the same frame for a plurality of heads. [30] According to another particularly advantageous characteristic of the invention, said support frame constitutes the first container. Indeed, as the second container constitutes a sterile and protective barrier, the support can be housed directly in the second container and its walls can serve as a support surface for the purposes of manipulation without contact with the supported medical device.

[31] The alternative is that according to another particularly advantageous feature of the invention, said support frame fits into the first container.

[32] Whether it is housed in a first container or whether it itself constitutes the first container, the support frame of the invention makes it possible to remedy the drawbacks of the devices of the prior art,

[33] It is understood that according to a preferred application of this packaging, said medical device is a pedicle screw. Thus, according to another particularly advantageous characteristic of the invention, the head of the pedicle screw comes to rest on the mobile support stop sliding in at least two parallel grooves preclosed in the support frame allowing the different positioning of the stop support for the purpose of hosting screws of different sizes for the same support frame.

[34] This type of screw is of the type comprising a rod and a head and which is used associated with a headless screw called a securing screw,

[35] These headless securing screws are used when the head of the pedicle screw is preformed to accommodate an implant stem connecting, for example, two pedicle screws. The headless securing screw holds the connecting rod in position in the head of the pedicle screw. There is therefore an interest in certain applications, to provide the practitioner with the securing screw with the pedicle screw.

[36] Thus, according to a particularly advantageous characteristic of the invention, said support frame comprises a cell in which said grub screw is housed. The packaging of the invention thus provides a first container or a support frame containing both the medical device and, in the context of a pedicle screw, also the securing screw with which it cooperates. [37] According to another particularly advantageous feature of the invention, said recess for receiving the headless screw is equipped with an elastic tab with a retaining projection allowing its elasticity to accommodate the headless screw and keeping it in position in the cell with the projection. =

[38] According to another particularly advantageous feature of the invention, said support frame is preformed and sized so that the two walls come together at one end to form a tapered shape easily accommodated in the second container

(391 Of course, said support frame can be made of a biocompatible material.

[40] The fundamental concepts of the invention having just been explained above in their most elementary form, other details and characteristics will emerge more clearly on reading the description which follows and with regard to the appended drawings, giving by way of non-limiting example, several embodiments of a packaging in accordance with the invention,

[41] BRIEF DESCRIPTION OF THE DRAWINGS

[42] [Fig. 1] is a schematic drawing of a perspective view of an embodiment of a closed package according to the invention;

[43] [Fig. 2] is a schematic drawing of a perspective view of the partially open packaging of Figure 1;

[44] [Fig. 3] is a schematic drawing of a front view of the packaging of Figure 1;

[45] [Fig. 4] is a schematic drawing of a sectional view along a section plane defined in Figure 3 of the packaging of Figure 1;

[46] [Fig. 5] is a schematic drawing of a perspective view of another embodiment of a closed package according to the invention;

[47] [Fig. 6] is a schematic drawing of a perspective view of the packaging of Figure 6 partially open;

[48] [Fig. 7] is a schematic drawing of a front view of the packaging of Figure 1; [49] [Fig. 8] is a schematic drawing of a sectional view along a section plane defined in Figure 7 of the packaging of Figure 5;

[50] [Fig. 9] is a schematic drawing of an exterior view of the first repackaging container of Figure 1 accommodating a different screw;

[51] [Fig. 10] is a schematic drawing of an exterior perspective view of the first container of the packaging of Figure 5.

[52] DESCRIPTION OF PREFERRED EMBODIMENTS

[53] As illustrated in Figures 1, 2, 3 and 4, the packaging referenced E as a whole accommodates a medical device referenced D. This medical device here consists of a pedicle screw 100 of the type comprising a threaded rod 110 and a head 120 preformed with a groove 121 to accommodate an implant rod (not shown) and a tapping 122 for the purpose of receiving a securing screw 200. This screw 100 defines a longitudinal axis.

[54] Package E adopts a nested configuration and includes;

[55] ™ a first container 300 accommodating in its interior volume the pedicle screw 100,

[56] - a second container 400 having an interior volume accommodating the first container 300, closed by a closure means here a cap 410 senrent sterile barrier and protection to the first container 300.

[57] In accordance with the invention, it is a packaging which avoids any direct contact of the practitioner with the implant, here with the pedicle screw 100. When in use, the second container 410 is opened by removing the stopper 400. The first container 300 then falls onto a sterile field and/or can be manipulated by an instrument technician without touching the screw 100. Already known tools (not shown) make it possible to cooperate with the screw so as to remove it from the first containing 300.

[58] In this embodiment. the first container 300 slides into the hollow core of the second container 400.

[59] This first container 300 constitutes an elongated support frame supporting the pedicle screw 100 adopting a substantially quadrangular profile. This support frame 300 is preformed so as to present two longitudinal walls 310 and 320 arranged facing each other between which the screw 100 is positioned and supported. According to the illustrated embodiment, a third wall 330 connects the two walls 310 and 230 at one of their longitudinal edges. One face of said support frame with a quadrangular profile is perforated and allows the screw 100 arranged inside to be seen. The section formed by the assembly of these walls 310, 320, 330 is open at both ends. The perforated face accommodates at the level of the free longitudinal edges of the walls 320 and 310, two transverse grooves 340 and 350. The groove 340 accommodates a mobile abutment here removable 500.

[601 The depth of the grooves 340 and 350 and the dimensions of the abutment 500 make it possible to provide a bearing surface transverse to the head 120 of the screw 100. This bearing surface makes it possible to position the screw 100 so that the the end of the threaded portion 122 of its head 120 opens at the open end of the support frame 300 so as to be accessible for a tool (not shown).

[61] In accordance with the object of the invention, it is understood that, while guaranteeing this access to the head, the same support frame 300 can accommodate:

[62) - with the stopper 500 remaining in the same groove 340, screws with different lengths of threaded parts and with identical heads,

[63] - with the stop 500 positioned in the groove 350, screws of different lengths and heads (see Figure 9 for the screw 101).

[64] As illustrated, the end of the support frame 300 accommodating the head 120 of the screw 100 is preformed so as to block the accomodated head in rotation.

[65] Another feature of this support frame 300 concerns the reception of the securing screw 200. According to the illustrated embodiment, the support frame is preformed with a wall portion 360 coming opposite the wall 330. The outer surface of this portion 360 is preformed with a cell 361 provided in its bottom with an elastic tongue 362 equipped at its free end with a retaining projection 363. The cell 361 is preformed to axially retain the screw 200. The elasticity of the tongue 362 allows the radial reception of the screw 200 and ensures that it is held in position in the cell by means of the projection 363 which then constitutes a radial stop.

[66] As illustrated in Figures 5, 6, 7, 8 and 10, packaging E' adopts, like packaging E, a pull-out configuration and comprises: [67] - a first container 300' housing the pedicle screw 100 in its interior volume.

[68] - a second container 400' having an interior volume accommodating the first container 300' closed by a closure means here a cap 410' serving as a sterile barrier and protection for the first container 300'.

[69] Packaging E' differs from packaging E in that the support frame 600' is housed in the first container 300', the opening of which is controlled by a closing means, here a cap 370',

[70] This support frame 600' differs from the support frame 300 for repacking E in that the two walls 61 (7 and 620' arranged opposite each other which constitute it are each prefbrmées with an elastic blade with a projection of retainer 611' and 621' projecting inwards to form the movable stop and cooperating with the head 120' of the pedicle screw 100< Once the screw is positioned between the two walls 610' and 620' of the support frame 600', the stops which have moved apart to accommodate it come back into position due to the elasticity of the blades 611' and 621' and retain it by creating a transverse support surface.

[71] Another characteristic of this support frame 600' relates to the reception of the securing screw 200'. According to the illustrated embodiment, the support frame 600' is equipped with one end 630' preformed with a housing 631' arranged in its bottom with an elastic tongue 632' equipped at its free end with a retaining projection 633 ', The housing is preformed to retain axlalement the screw 200'. The elasticity of the tongue 632' allows the radial reception of the screw 200' and ensures that it is held in position in the housing by means of the projection 633' which then constitutes a radial stop.

[72] It is understood that the packaging, which has just been described and represented above, was for the purpose of disclosure rather than limitation. Of course, various adjustments, modifications and improvements may be made to the above examples, without departing from the scope of the invention.

Claims

[Claim 1] Packaging (E, E') for a medical device (D, 100') defining a longitudinal axis, said packaging adopting a pull-out configuration and comprising:

- a first container (300, 300') housing the medical device (D, 100') in its interior volume,

- a second container (400, 400') having an interior volume receiving the first container (300, 300'), closed by a closure means (410, 410') and serving as a sterile barrier and protection for the first container (300 , 300'), . CHARACTERIZED BY THE FACT QU1I comprises an elongated support frame (300, 600') supporting the medical device (D), said support frame (300, 600') being preformed so as to present two walls arranged facing each other between which the medical device (D) is supported by means of at least one mobile support abutment (500, 611', 621') arranged transversely to the longitudinal axis of the medical device (D),

[Claim 2] Packaging (E) according to claim 1, CHARACTERIZED IN THAT said support frame (300) constitutes the first container,

[Claim 3] Packaging (E') according to claim 1, CHARACTERIZED

BY THE FACT THAT said support frame (600') is housed in the first container (300').

[Claim 4] Packaging (E) according to any one of the preceding claims, CHARACTERIZED BY THE FACT THAT said support frame (300) is preclosed by several housing zones (340, 350) of the movable stop (500).

[Claim 5] Packaging (E, E') according to any one of the preceding claims, CHARACTERIZED BY THE FACT THAT said medical device is a pedicle screw (100, 100').

[Claim 6] Package (E) according to claim 5, wherein the pedicle screw (100) is of the type comprising a rod and a head and which is used associated with a grub screw (200), CHARACTERIZED BY THE FACT THAT said support frame (300) comprises a cell (361) in which said headless screw (200) is housed,

(Claim 7] Packaging (E) according to claim 6, CHARACTERIZED BY THE FACT THAT said reception cell (361) of the grub screw (200) is equipped with an elastic tab (362) with a retaining projection allowing due to its elasticity the reception of the headless screw (200) and keeping it in position in the cell with the projection.

(Claim 8] Packaging (E) according to any one of Claims 5 to 7, CHARACTERIZED BY THE FACT THAT the head of the pedicle screw (100) comes to bear on the mobile bearing abutment (500) sliding in at least two parallel grooves (340, 350) preformed in the support frame.

[Claim 9] Packaging (E') according to any one of Claims 1 to 7, CHARACTERIZED IN THAT the two walls (610', 620') are preformed with at least one elastic blade with a retaining projection ( 61 T.. 62 T) projecting inwards to form the movable stop and cooperating with the medical device (100'), once the medical device is positioned between the two walls (610L 62(7) of the support frame at elastic retaining ends.

[Claim 10] Packaging (E ^! ) according to claims 5 and 9, CHARACTERIZED BY THE FACT THAT the two walls (610', 620') are preformed with at least one elastic blade with a retaining projection (61 T. 621 ') projecting inwards to form the movable stop and cooperating with the head of the pedicle screw (100').

[Claim 11] Packaging (E) according to any one of the preceding claims, CHARACTERIZED BY THE FACT THAT said support frame (300) is preformed and dimensioned such that the two walls (310, 320) approach each other at one end to form a tapered shape easily accommodated in the second container (400).