Disposable pack for a sterilized medical device, in particular a surgical implant

Abstract

A packaging for a medical device including at least: a support including at least a first end and a second end opposite the first end, wherein the support is deformable between at least: a storage position in which the support is arranged fully inside in the outer casing, a display position, in which the support is arranged outside the outer casing and the first portion and the second portion of the support each extend along a secant axis to the third portion.

Claims

1. A pack for a medical device comprising at least: a hollow outer case comprising at least one plug and a body, configured to cooperate with one another so as to delimit a closed inner volume in which a medical device is intended to be disposed, a support comprising at least one first end and one second end opposite to the first end, a first portion including the first end, a second portion including the second end and a third portion arranged between the first portion and the second portion, the support further comprising at least one retaining member configured to retain the medical device, the retaining member being formed on the third portion of the support, wherein the support is deformable between at least: a stowing position in which the support is completely arranged within the outer case, the first end of the support is housed in the body of the outer case and the second end is housed in the plug of the outer case, and the first portion and the second portion are aligned with the third portion of the support according to a longitudinal axis of the support, a presentation position, in which the support is arranged outside the outer case and each of the first portion and the second portion of the support extends according to an axis secant to the third portion.

2. The pack according to claim 1, wherein the first portion is hinged relative to the third portion of the support and/or the second portion is hinged relative to the third portion of the support.

3. The pack according to claim 1, wherein the first end and the second end of the support are configured to cooperate with one another in the presentation position of the support.

4. The pack according to claim 3, wherein the first end or the second end comprises a projecting lug and respectively, the second end or the first end comprises a groove shaped so as to cooperate with the projecting lug.

5. The pack according to claim 1, comprising a protective part configured to protect the medical device, the protective part being configured to cooperate with the support.

6. The pack according to claim 1, wherein the body of the outer case comprises a closed end and an opposite open end.

7. The pack according to claim 6, wherein the open end of the body further comprises a sealing member, configured to ensure sealing of the closed inner volume of the outer case.

8. The pack according to claim 6, wherein the closed end of the body has a housing adjusted to the first end of the support.

9. The pack according to claim 8, wherein the assembly of the first end of the support with the closed end of the body is achieved by wedging of the first end of the support in the closed end of the body.

10. The pack according to claim 1, wherein the plug and the body of the outer case cooperate by screwing.

11. The pack according to claim 10, wherein each of the plug and the body of the outer case comprises an index element, the index element of the plug being configured to coincide with the index element of the body at the beginning of screwing and on completion of screwing.

12. The pack according to claim 1, wherein the support is detached from the outer case by translation according to the longitudinal axis of the outer case.

13. A medical device set comprising at least one medical device arranged in a pack according to claim 1, the support of the pack being in the stowing position, and the medical device extending generally in the axis of the support.

Description

BRIEF DESCRIPTION OF THE FIGURES

(1) The invention will be better understood, thanks to the description hereinafter, which relates to embodiments according to the present invention, provided as non-limiting examples and explained with reference to the appended schematic figures. The appended schematic figures are listed hereinbelow:

(2) FIG. 1 illustrates, according to a perspective view, the pack according to the invention.

(3) FIG. 2 illustrates the body of the outer case of the pack according to the invention.

(4) FIG. 3 illustrates the plug of the outer case of the pack according to the invention.

(5) FIG. 4 illustrates, according to a detail view, the open end of the body represented in FIG. 2.

(6) FIG. 5 illustrates, according to a longitudinal sectional view, the inside of the body of the outer case according to the invention.

(7) FIG. 6 illustrates, according to a detail view, the cooperation between the support and the body of the outer case according to the invention.

(8) FIG. 7 illustrates, according to a longitudinal section, the medical device set according to the invention.

(9) FIG. 8 illustrates, according to a perspective view, the support equipped with the protective part according to the invention.

(10) FIG. 9 illustrates, according to a perspective view, the support without the protective part according to the invention.

(11) FIG. 10 illustrates, according to a side view, the support according to the invention in the stowing position.

(12) FIG. 11 illustrates, according to a side view, the support according to the invention in the presentation position.

(13) FIG. 12 illustrates, according to a perspective view, the detail of one end of the support according to the invention.

(14) FIG. 13 illustrates, according to a perspective view, the detail of the other end of the support according to the invention.

(15) FIG. 14 illustrates an embodiment of the retaining member of the support according to the invention.

(16) FIG. 15 illustrates another embodiment of the retaining member of the support according to the invention.

(17) FIG. 16 illustrates another embodiment of the retaining member of the support according to the invention.

(18) FIG. 17 illustrates, according to a perspective view, the protective part according to the invention.

(19) FIG. 18 illustrates, according to a perspective view, one of the ends of the support equipped with a coupling lug according to the invention.

(20) FIG. 19 illustrates, according to a perspective detail view, the assembly of the support and of the protective part.

(21) FIG. 20 illustrates, according to a cross-sectional view, the assembly represented in FIG. 19.

(22) FIG. 21 illustrates the support in the presentation position with an implant, the implant being removed by one of its ends using an instrument.

(23) FIG. 22 illustrates the support in the presentation position with an implant, the implant being positioned directly on a pre-inserted wire.

(24) FIG. 23 illustrates the support in the presentation position with an implant, the implant being removed by its center using a clamp.

(25) FIG. 24 illustrates the main steps of assembly of the pack according to the invention.

(26) FIG. 25 illustrates a first step of removing the protective part in order to access the medical device.

(27) FIG. 26 illustrates a second step of removing the protective part in order to access the medical device.

(28) FIG. 27 illustrates a third step of removing the protective part in order to access the medical device.

(29) FIG. 28 illustrates a fourth step of removing the protective part in order to access the medical device.

DETAILED DESCRIPTION

(30) As illustrated in FIG. 1, the pack 1 according to the invention is intended for the protection of a medical device 101 during transport thereof till use thereof. The medical device 101 may consist of a surgical implant, a medical part, a surgical instrument, etc. The pack according to the invention is intended for one single use, that is to say it is disposable once the medical device 101 is removed. Furthermore, the pack 1 according to the invention allows preserving the sterility of the medical device 101 therewithin as long as the latter is not used.

(31) In the example illustrated in FIGS. 1 to 3, the pack 1 comprises a hollow outer case 2, formed by at least one hollow body 21 and by a hollow plug 22. Advantageously, and as shown in particular in FIG. 1, the outer case 2 has a generally cylindrical shape, for example in the form of a tube.

(32) The body 21 may have a slender shape for example, yet of course, the shape of the body 21 may be anything else, yet without departing from the scope of the invention. As shown, the body 21 comprises a closed end 21a and an opposite open end 21b. Optionally, an element 28 for identifying the type of the medical device contained in said pack 1 may be arranged on the closed end of the body 21 of the outer case 2, that being represented in particular in FIGS. 1 and 2. Advantageously, the open end 21b of the body 21 further comprises a sealing member 23, in this instance represented in FIG. 2, it consists of an O-ring gasket, configured to ensure sealing of the closed inner volume of the outer case 2. As shown in FIG. 2, a thread 24 is formed on the open end 21b of the body 21 and is shaped so as to cooperate with a complementary thread 27 formed on the plug 22 of the outer case 2.

(33) The body 21 of the case 2 has a so-called unsterilized handling area corresponding to the entire body 21 except the threaded open end 21b, which is configured to fit into the open end 22b of the plug 22.

(34) The plug 22 of the outer case 2 is illustrated in FIG. 3. It comprises a close end 22a and an opposite open end 22b. The open end 22b of the plug 22 is configured to cooperate with the open end 21b of the body 21 of the outer case 2.

(35) The body 21 and the plug 22 are configured to cooperate with the one another so as to delimit a sealed closed inner volume within which a medical device 101 is disposed. More particularly, the body 21 and the plug 22 of the outer case 2 cooperate by screwing. Advantageously, upon screwing of the plug 22 on the body 21 of the outer case 2, the sealing member 23 is deformed and collapses against the plug 22, so as to ensure sealing between the plug 22 and the body 21 of the outer case 21.

(36) As illustrated in FIG. 1, each of the body 21 and the plug 22 of the outer case 2 comprises an index element 26a, 26b, the index element 26b of the plug 22 being configured to coincide with the index element 26a of the body 21 at the beginning of screwing and on completion of screwing. In the example illustrated in FIGS. 1, 2 and 3, the index element 26b of the plug 22 and the index element 26a of the body 21 is a relief, for example a groove. As illustrated in FIGS. 2 and 4, the thread 24 formed on the open end 21b of the body 21 has a stop element 29 configured to come into contact with the thread 27 formed on the open end 22b of the plug 22.

(37) The pack 1 further comprises a support 3 represented in particular in FIGS. 7 to 11. The support 3 comprises a first end 31a and a second end 32a opposite to the first end, a first portion 31 including the first end 31a, a second portion 32 including the second end 32a and a third portion 33 arranged between the first portion 31 and the second portion 32, preferably in a centered manner, as shown in particular in FIGS. 9 and 10. Advantageously, the support 3 comprises a handling area, which corresponds to the portions 32, 33 of the support 3 that project from the body of the outer case 2, when the plug 22 is pulled off.

(38) Advantageously, the first portion 31 is hinged relative to the third portion 33 of the support 3 and is preferably jointed to the third portion by a hinge film 34 as illustrated in FIG. 10. Similarly, the second portion 32 is hinged relative to the third portion 33 of the support 3 and is preferably jointed to the third portion 33 by hinge film 34. Of course, the hinge may be in any form and the hinge film example is not restrictive.

(39) The hinge of the first portion 31 and second portion 32 relative to the third portion enables the deformation of the support 3 between at least two positions, a stowing position and a presentation position. Of course, the deformation of the support 3 may be due to the material used to make the support, complementarily with the hinge or alternatively to the hinge, the switch from one position to another then being based on the flexibility of said material.

(40) In the stowing position, as illustrated in FIGS. 7, 8, 9 and 10, the support 3 is completely arranged within the outer case 2, as shown in FIG. 7. The first end 31a of the support 3 is housed in the body 21 of the outer case 2 and the second end 32a is housed in the plug 22 of the outer case 2. In the stowing position, the support extends according to a longitudinal axis X-X and all of its portions 31, 32, 33 are aligned on this axis X-X.

(41) In the presentation position, as illustrated in FIG. 11, the support is taken out the outer case 2, and the first portion 31 and each of the second portion 32 of the support 3 extends according to an axis Y-Y; T-T secant to the longitudinal axis X-X in which only the third portion 33 extends.

(42) Thus, the deformation of the support 3 is advantageously achieved by exercising a pressure on the first end 31a and on the second end 32a in a direction substantially perpendicular to or at least secant with respect to the longitudinal axis X-X of the support 3, causing a rotation of the first 31 and second 32 portions of the support 3 relative to the third portion 33.

(43) In the presentation position and as shown in FIG. 11, the first end 31a and the second end 32a of the support 3 are configured to cooperate with one another. More particularly, in the illustrated example, the first end 31a comprises a groove 36 and the second end 32a comprises a projecting lug 35 which cooperates with the groove 36, as shown in FIGS. 12 and 13.

(44) Quite possibly, this configuration may be reversed, that is to say the first end 31a comprises a projecting lug 35 and the second end 32a comprises a groove 36.

(45) Moreover, the support 3 further comprises a retaining member 37 configured to retain the medical device 101, said retaining member 37 being formed on the third portion 33 of the support 3, as illustrated in particular in FIGS. 9, 10, 11, 14, 15 and 16. Advantageously, the shape of the retaining member 37 is adapted according to the fastening stress of the medical device 101 and the geometry of said medical device 101. In FIGS. 14 to 16, different embodiments of the retaining member are shown: in FIG. 14, the retaining member is a tubular hook; in FIG. 15, the retaining member is formed by two hooks spaced apart with a square-shaped cross-section; and in FIG. 16, the retaining member is formed by a tubular hook whose orifice has a diameter smaller than that of FIG. 14.

(46) In accordance with the invention and in order to add a safety barrier guaranteeing the sterility of the medical device 101, the pack 1 comprises a protective part 4 configured to protect the medical device 101 from contact with the hands of the operator. This protective part 4 is illustrated assembled with the support 3 in FIG. 8 and isolated in FIG. 17. As shown in FIG. 17, the protective part 4 is elongate shaped. The protective part 4 comprises gripping areas 41 with or without a grip enabling sliding or removal of the protective part 4 of the support 3.

(47) Furthermore, the protective part 4 has two opposite longitudinal edges 43 intended to cooperate with the support 3. The protective part 4 comprises at least one pair of studs 42 shaped so as to cooperate with a coupling lug 38 of the support 3, each of the studs 42 of the pair being arranged on one longitudinal edge and preferably opposite to one another. In a non-represented variant, the studs may be replaced by a longitudinal rib formed at least partially on each longitudinal edge. Preferably, the protective part 4 comprises a pair of studs 42 at each end.

(48) As shown in some figures such as FIGS. 9, 10, 18 and 20, the support 3 comprises a coupling lug 38 configured to cooperate with the protective part 4, and arranged at the level of each end 31a, 32a. As shown in FIG. 20, each coupling lug 38 cooperates with the protective part 4 and more particularly with a pair of studs 42 by interlocking and/or by an at least partial shape matching. The coupling lug 38 comprises two symmetrical catches configured to block the protective part 5.

(49) In order to improve the preservation of sterility within the closed inner volume of the outer case 2, the closed end 21a of the body 21 has a housing adjusted to the first end 31a if the support 3. Similarly, the closed end 22a of the plug 22 has a housing intended to accommodate the end 32a of the support 3. Thus, when the support 3 is in the stowing position, the assembly of the first end 31a of the support 3 with the closed end 21a of the support 21 and the coverage of the second end 32a of the support 3 by the closed end 22a of the plug 22, guarantee the sterility of the packaged medical device 101. The assembly of the first end 31a of the support 3 with the closed end 21a of the body 21 is achieved by wedging and the closed end 22a of the plug 22 covers the second end 32a of the support 3. Advantageously, and as illustrated in FIG. 5, the closed end 21a of the body 21 comprises an inner rib 25 shaped so as to cooperate with a groove 36 formed on the first end of the support for example. Advantageously, the groove 36 formed on the first end 31a of the support 3 is the same one for cooperating with the inner rib 25 of the end of the body and for cooperating with the projecting lug 35 of the second end 32a.

(50) The medical device 101 wrapped in its pack 1 according to the invention form a medical device set 100. In this medical device set, the support 3 of the invention is in the stowing position, and the medical device 101 generally extends in the axis X-X of the support 3. As shown in particular in FIG. 7, the medical axis 101 is held by its center, which allows clearing the ends of the medical device and facilitating gripping and removal of the latter by an instrument for example as illustrated in FIGS. 21, 22 and 23. In particular, the removal of the medical device may be done without contact with the practitioner's gloves for example by means of a screwdriver (FIG. 21), by means of a specific clamp (FIG. 23), directly on a pre-inserted wire (FIG. 22).

(51) As illustrated in FIG. 24, the packing procedure would be as follows: the sterilized medical device is placed in the retaining member 37 of the support 3, the support 3 is covered by a protective part 4, the support 3 of the body 21 of the outer case 2 is covered, the plug 22 is disposed opposite the body 21 by aligning the index elements and the plug 22 is screwed until the thread of the plug 22 and the stop element 29 of the body 21 come into contact and the index elements 26a, 26b are aligned.

(52) In FIGS. 25 to 28, are illustrated the steps of removing the protective part 4 in order to access the medical device 101.

(53) In FIG. 25, the ends of the support are grasped with one hand and the protective part 4 is grasped with the other hand. Then, as illustrated in FIG. 26, a pressure is exerted on the first end 31a and on the second end 32a in a direction substantially perpendicular to the support 3 to make them converge beneath the support 3, the first portion 31 and the second portion 32 of the support 3 rotatably pivot at the level of the hinges in the form of film hinges 34, the third portion 33 remaining on its place. Then, the first end 31a and the second end 32a are joined together by making them cooperate so that they form a solid a stable support, as illustrated in FIG. 27. Finally, in FIG. 28, the protective part 4 may be removed by a simple translation/sliding.

(54) The description of the technical features of the invention shall not be limited to the disclosed figures and could integrate design variations such as the possibility of packaging medical devices with larger dimensions (for example by a homothety of the diameter/length of the case and of the support), or any other technical modification allowing improving the ergonomics, the simple use and the bulk management while complying with the features and the advantages set forth hereinbefore.

(55) Of course, the invention is not limited to the embodiments described and represented in the appended figures. Modifications are still possible, in particular with regards to the construction of the various elements or by substitution with technical equivalents, yet without departing from the scope of the invention.