Medical assembly comprising a medical article and a package containing said article

Abstract

The invention relates to a medical assembly, preferably a sterilized one, comprising a medical article (5) and a package containing said article, said package comprising a hollow support element (2) inside which said article (5) is free, a first protective element (3), called a stopper, which can be coupled to the support element (2) of said article, such that the support element (2) has a grip part (20) that protrudes from said stopper (3), and a second hollow protective element (4), called a cover. Said cover can be coupled to the stopper (3) in such a way as to delimit, in cooperation with said stopper (3), a chamber (8) inside which there extends said grip part (20) of the support element, and, in the state when the cover is coupled to the stopper, a part of the stopper (3) protrudes from the cover (4).

Claims

1. A medical package containing a medical article, comprising: a hollow support element in which the medical article is free and unattached to the hollow support element; a stopper configured_to be coupled to the hollow support element of the medical article in such a way that the hollow support element has a grip part that protrudes from the stopper, the grip part of the hollow support element being configured to be held by a hand of a person; a first chamber configured to enclose the medical_article, wherein the first chamber is delimited by the hollow support element on its own or in cooperation with the stopper; a hollow protective cover configured to be coupled to the stopper in such a way as to delimit, in cooperation with the stopper, a second chamber inside which there extends the grip part of the hollow support element, the hollow protective cover configured to be separated from the stopper, wherein when the hollow protective cover is coupled to the stopper, a part of the stopper protrudes from the hollow protective cover, and is configured to form a grip end of the stopper that is configured to be held by a hand of a person, when the hollow protective cover is separated from the stopper, wherein a part of the hollow support element is configured to be engaged by force inside the stopper, and, when the hollow protective cover is separated from the stopper, the hollow support element remains coupled to the stopper while the hollow support element is also separable from the stopper when a person holds the grip part of the hollow support element and pulls the hollow support element so as to separate it from the stopper.

2. The medical package of claim 1, wherein the stopper comprises an internal peripheral wall, and an external wall peripheral wall which surrounds the internal peripheral wall with clearance in order to define, between the peripheral internal and external walls, an annular space for engagement of that part of the hollow protective cover configured to be coupled to the stopper, the internal peripheral wall defining a space for engagement of that part of the hollow support element configured to be coupled to the stopper.

3. The medical package of claim 2, wherein an internal face of the internal peripheral wall of the stopper is provided with retaining means for retaining that part of the hollow support element engaged inside the space delimited by the internal peripheral wall of the stopper.

4. The medical package of claim 3, wherein the retaining means comprise lugs which are configured to be in bearing contact with the hollow support element in the state when the hollow support element is engaged in the stopper, and wherein the lugs are distributed on the internal peripheral face of the stopper, about the axis of the stopper, by being spaced apart at angles from one another.

5. The medical package of claim 4, wherein each lug comprises a ramp-forming part, directed toward the axis of the stopper starting from a bottom point of the ramp situated at the open end of the stopper to a top point of the ramp situated at the closed end of the stopper, in such a way that, when the hollow support element is engaged inside the space defined by the internal peripheral wall of the stopper, the hollow support element, by bearing on the ramp, pushes the lug radially and deforms the corresponding internal peripheral wall toward the external peripheral wall.

6. The medical package of claim 5, wherein the lugs form spacers for maintaining a radial distance between the hollow support element and the internal peripheral wall of the stopper, the spacing between the lugs defining a space for fluid communication between the inside of the internal peripheral wall of the stopper and the inside of the hollow protective cover.

7. The medical package of claim 2, wherein at least one of the external and internal peripheral walls of the stopper comprise screwing means for cooperating with complementary screwing means formed on the hollow protective cover.

8. The medical package of claim 7, wherein the internal face of the external peripheral wall of the stopper has a tapping that is able to cooperate with a thread formed on the external face of a peripheral wall of the hollow protective cover.

9. The medical package of claim 1, wherein the lugs form spacers for maintaining a radial distance between the hollow support element and the internal peripheral wall of the stopper, the spacing between the lugs defining a space for fluid communication between the inside of the internal peripheral wall of the stopper and the inside of the hollow protective cover.

10. The medical package of claim 1, wherein, when the hollow support element delimits on its own the first chamber enclosing the medical_article, the hollow support element is formed by at least two components that are configured to be coupled to/uncoupled from each other in order to form the first chamber enclosing the medical_article.

11. The medical package of claim 10, wherein the at least two components are configured to be coupled to/uncoupled from each other, by engagement with partial overlap, in order to form the first chamber enclosing the medical_article.

12. The medical package of claim 1, wherein, when the hollow support element delimits, in cooperation with the stopper, the first chamber enclosing the medical_article, the hollow support element delimits an open cavity configured to be closed by the stopper.

13. The medical package of claim 1, wherein the stopper has predefined locations permitting the positioning of at least two fingers of a person in order to allow him to grip the stopper in the area of the predefined locations.

14. The medical package of claim 1, wherein at least one of the hollow support element, the stopper, and the hollow protective cover has a part that is impermeable to bacteria but permeable to gases in order to permit gas sterilization of at least one of the first chamber and the second chamber.

15. The medical package of claim 14, wherein the part is formed by a membrane.

16. The medical package of claim 1, wherein the medical assembly is a sterilized one.

17. The medical package of claim 1, wherein the stopper can be coupled to the hollow support element of the medical_article by engagement with partial overlap.

18. The medical package of claim 1, wherein the hollow protective cover is able to be coupled to the stopper by engagement with partial overlap.

19. The method of unpacking as claimed in claim 1, wherein the hollow protective cover has predefined locations permitting the positioning of at least two fingers of a person in order to allow them to grip the hollow protective cover, in the area of the predefined locations.

20. A method of unpacking a medical article contained in a medical package of a medical as claimed in claim 1, wherein the method comprises the following steps: separation of the hollow protective cover from the stopper by a first person in order to uncover the hollow support element; gripping of the hollow support element by a second person; and separation of the hollow support element from the stopper held by the first person.

21. The method of unpacking as claimed in claim 20, wherein the method comprises the following additional step of opening the first chamber defined by the hollow support element in order to remove the medical_article therefrom.

22. The medical package of claim 21, wherein the method comprises the following additional step before the opening step of keeping the hallow support element, which encloses the medical_article, in a stand-by area pending the use of the medical article.

23. The method of unpacking as claimed in claim 20, wherein the method comprises, between the separation step and the gripping step, the following additional step in which the first person offers the second person the remaining package composed of the stopper and of the hollow support element, by presenting to them the end of the remaining package formed by the hollow support element, orienting the remaining package in such a way that the hollow support element is at a height lower than that of the stopper, such that the medical_article remains contained in the hollow support element during the separation of the hollow support element from the stopper, so as to avoid the medical_article falling to the ground.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

(1) The invention will be clearly understood from reading the following description of embodiments, with reference to the attached drawings in which:

(2) FIG. 1 is a view of a package according to the invention in a first embodiment, inside which a medical component is packed;

(3) FIGS. 2 to 4 are views of the package from FIG. 1 during a first unpacking step in which the cover is withdrawn by a first person, called the contaminated person, the remaining sub-assembly composed of the stopper and of the support element being held via the stopper by the hand of the contaminated person;

(4) FIGS. 5 and 6 are views of the sub-assembly of the package from FIG. 4 during a second unpacking step in which the stopper is withdrawn, remaining in the hand of the contaminated person, and the support element of the article is held by the hand of a second person called the clean person;

(5) FIG. 7 is a view of the support element from FIG. 5 during a third unpacking step in which the clean person separates the two components forming the support element in order to remove the medical component therefrom;

(6) FIG. 8 is a perspective view of the stopper of the package according to the first embodiment of the invention;

(7) FIG. 8A is a perspective view of a variant of the stopper of the package according to the invention, with an area for positioning of the fingers which is called an external area and is formed on that part of the stopper intended to protrude from the cover;

(8) FIG. 8B is a perspective view of another variant of the stopper of the package according to the invention, with an area for positioning of the fingers which is called an internal area and is formed on that part of the stopper intended to extend inside the cover.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS OF THE INVENTION

(9) A “dirty” or “contaminated” person is understood as a person working in non-aseptic conditions, who is likely to contaminate the articles he touches with his hands. Conversely, a “clean” person is understood as a person working in sufficiently aseptic conditions.

(10) With reference to the figures, and as has been mentioned above, the invention relates to a medical assembly comprising a medical article 5 and a package 1 containing said article 5 for the purpose of preserving the sterile nature of the article and with a view to unpacking said article in aseptic or almost aseptic conditions. Said article can be, for example, a solid component, such as a surgical screw, or any other type of article, in particular any other type of implant. In addition, said article can be a liquid or a powder. Said article and, preferably, the various parts of the package are sterilized as detailed below.

(11) Said package comprises a hollow support element 2 inside which said article 5 is free. In other words, said article 5 can move freely inside the support element 2. Said package also comprises a first protective element 3, called a stopper, which can be coupled to the support element 2 of said article 5 by engagement with partial overlap, in such a way that the support element 2 has a grip part 20 that protrudes from said stopper 3. Said grip part 20 corresponds to the free end part of the support element 2 which protrudes from said stopper 3. As is explained in detail below, said support element 2 delimits on its own, or in cooperation with the stopper 3, a first chamber 7 that encloses said article 5.

(12) Said package also comprises a second hollow protective element 4, called a cover. Said cover 4 is able to be coupled to the stopper 3, by engagement with partial overlap, in such a way as to delimit, in cooperation with said stopper 3, a second chamber 8 inside which there extends the grip end 20 of the support element 2. In the state when the cover 4 is coupled to the stopper 3, a part 30 of the stopper 3 protrudes from the cover 4.

(13) Said part 30 of the stopper corresponds to the free end of the stopper 3, opposite the end 31 of said stopper 3 that covers part of the support element 2 and forms a grip area. The end 40 of the cover 4 opposite the stopper 3 also forms a part for gripping the package opposite the end 30 of the stopper.

(14) Thus, each element of the package, namely the support element 2, the stopper 3 and the cover 4, has a grip end 20, 30, 40 in relation to its opposite end coupled to another element of the package. Said elements engage with each other in such a way as to define, by cooperation of two engaged elements, a chamber 7, 8 which is preferably impervious at least to bacteria. Thus, the engaged elements of the package define two chambers 7, 8, of which one 7 is defined between the stopper and the cover, accommodates the article and can be accessed only when opened, the other chamber 8 serving to protect the grip end 20 of the support element 2.

(15) Such a design of the package allows it to be manipulated without risk of contamination of the article contained in the presentation chamber, without having to let go of said article contained in the support element, while at the same time allowing said article to be quickly taken hold of, since the article is free in the support element.

(16) In the example illustrated in the figures, said support element 2 on its own delimits said first chamber 7 enclosing said article 5. For this purpose, said support element 2 is formed by at least two components 20, 21 that can be coupled to/uncoupled from each other, by engagement with partial overlap, in order to form said first chamber enclosing said article 5.

(17) An embodiment can also be provided according to which said support element 2 on its own delimits said first chamber 7 by being formed in one piece. Said support element 2 can thus be in the form of a closed and divisible one-piece hollow body, such as a divisible ampule, containing said article. In this case, the chamber 7 is opened by breaking said ampule.

(18) According to a variant that is not illustrated, said support element delimits, in cooperation with the stopper, said first chamber that encloses said article. In this case, said support element delimits an open cavity intended to be closed by said stopper.

(19) Preferably, the stopper 3 is formed by an elongate hollow body that is open at one end and closed at the other end. In the example illustrated in the figures, the cover 4 is also formed by an elongate hollow body that is open at one end and closed at the other end. The support element 2 is also in the form of an elongate hollow body that is closed at one end and open at the other end, or closed at both ends and formed by at least two components, depending on the embodiment chosen.

(20) The design of the stopper 3 and of the cover 4 in the form of an elongate body, in the manner of a test tube or of a tube closed at least at one end, provides the benefit of, on the one hand, a safe distance between the grip end 40 of the cover 4 and the grip end 30 of the stopper 3, and, on the other hand, a safe distance between the grip end 20 of the support element 2 and the grip end 30 of the stopper 3.

(21) Such a distance between the grip ends 30, 40 of the package makes it possible to limit the risk of contamination in the area of the grip end 20 of the support element 2 that extends in the chamber 8, when said chamber 8 is opened by separation of the cover 4 and the stopper 3.

(22) Said stopper 3, and if appropriate the cover 4, has (have) at least two predefined locations 32 that each permit the positioning of at least one finger of a person in order to allow him to grip said stopper or said cover by gripping between at least two fingers. Preferably, at least two of said predefined locations 32 are diametrically opposite with respect to the axis of the element, i.e. stopper 3 or cover 4, on which they are formed. In the example illustrated in FIGS. 1 to 8 and 8B, each location 32 is formed on a portion of the stopper that is intended to be covered by the cover 4. In this case, said location becomes accessible once the cover has been withdrawn.

(23) According to another embodiment of the stopper 3′ illustrated in FIG. 8A, said location 32 is formed on a portion of the stopper 3′ that is not intended to be covered by the cover.

(24) Advantageously, the stopper 3; 3′ has a sufficient length to allow the person to position his fingers on said stopper, and in particular to grip the stopper with a thumb, without risk of touching the support element 2.

(25) Said support element 2 and protective elements 3, 4 of the package engage each other, with partial overlap, by friction and/or by screwing. The means for coupling the elements to each other are explained in detail below.

(26) In the example illustrated in the figures, the stopper 3 and the cover 4 engage with each other by screwing, as do the parts 20, 21 of which the support element 2 is composed. Preferably, the thread and the tapping formed on the elements which engage with each other are configured in such a way as to allow said elements to be screwed together only once. In particular, provision can be made that the thread and/or the tapping deform during the screwing and unscrewing, such that renewed screwing of the two elements with each other is no longer possible.

(27) Alternatively, the partially overlapping engagement of said elements of the package could be achieved by simple friction, for example by elastic clamping or pressure. Such engagement by simple friction makes it possible to disengage said elements by means of one or each of the persons simply pulling an element of the package in a natural movement. Engagement by clips is also conceivable.

(28) In the example illustrated in FIGS. 1 to 8 and 8B, said stopper 3 also has at least one deformable part 31, preferably at least one deformable wing, allowing said stopper to be partially engaged inside the cover. Said part 31 is configured such that, on the one hand, when said deformable part 31 of the stopper is covered by the cover, said part 31 comes to bear against the internal face of the cover 4 in order to allow the stopper to be coupled to the cover by friction, and, on the other hand, such that said part 31 is able to deform in order to permit the separation of the cover 4 from the stopper 3.

(29) Said stopper 3 is formed by a hollow body open at one end and closed at the other end. The cover 4 is also formed by a hollow body open at one end and closed at the other end. The closed end of the stopper 3 defines a bottom part of the stopper. As is explained in detail below, said stopper 3 comprises means for coupling to the support element 2.

(30) In particular, said stopper 3 comprises a body substantially of revolution about an axis corresponding to the longitudinal axis of said stopper 3. The body of the stopper comprises a peripheral wall 320 called an internal wall, and a peripheral wall 340 called an external wall which surrounds said internal peripheral wall 320.

(31) The external peripheral wall 340 is substantially coaxial to the internal peripheral wall 320.

(32) Said external peripheral wall 340 surrounds said internal peripheral wall 320 with clearance in order to define, between said peripheral walls, an annular space 324 for insertion of that part of the cover 4 intended to be coupled to said stopper 3. Said part of the cover 4 intended to be coupled to said stopper 3 corresponds to the open end of the cover 4.

(33) On the external 340 and/or internal 320 peripheral walls, provision can be made to form screwing means, such as a tapping and/or thread, able to cooperate with complementary screwing means, such as a thread and/or tapping, formed on the peripheral wall of the cover 4.

(34) In particular, the internal face of the peripheral wall 340 called the external wall and/or the external face of the peripheral wall 320 called the internal wall can have a tapping and/or a thread in order to cooperate with a complementary thread and/or tapping formed on the external peripheral face and/or the internal peripheral face of the body of the cover 4.

(35) In the example illustrated in the figures, the internal face of the external peripheral wall 340 has a tapping able to cooperate with a thread formed on the external face of the peripheral wall of the cover 4.

(36) Provision can also be made that the distance between the external 340 and internal 320 peripheral walls of the stopper is configured such that the engagement of the cover 4 with the stopper 3 causes the peripheral wall of the cover 4 to be pinched between the external 340 and internal 320 peripheral walls of the stopper.

(37) In the example illustrated in the figures, the stopper 3 and the support element 2 engage with each other by force, that is to say by pressing an end part of the support element 2 into a corresponding hollow part of the stopper 3.

(38) In other words, the internal face of the internal peripheral wall 320 of the stopper 3 has retaining means 321 for retaining the part of the support element 2 engaged by force inside the space delimited by the internal peripheral wall 320 of the stopper 3.

(39) Advantageously, said retaining means 321 comprise lugs which are intended to be in bearing contact with the support element 2 in the state when said support element 2 is driven into the stopper 3. A good retention of the support element 2 with the stopper 3 is thus obtained before their separation with a view to opening said first chamber 7. In particular, each lug has a ramp-forming part configured such that the support element 2, which is engaged in the internal peripheral wall 320, pushes the lugs radially outward and thus deforms the corresponding internal peripheral wall 320 toward the external peripheral wall 340.

(40) More precisely, as is illustrated more particularly in FIGS. 8A and 8B, the lugs 321 are distributed on the internal peripheral face of the stopper, about the axis of said stopper 3, preferably being spaced apart at angles from one another.

(41) The presence of said lugs inside the internal peripheral wall 320 of the stopper makes it possible to retain the support element 2 engaged by force in the stopper 3, while also ensuring that, on such engagement of the support element 2 in the internal peripheral wall of the stopper, the internal peripheral wall 320 of the stopper is brought closer to the external peripheral wall 340 of said stopper, this being caused by the support element 2 bearing on the lugs 321.

(42) The closing together of the internal 320 and external 340 peripheral walls by elastic deformation reinforces the leaktightness of the join in the area of engagement between the cover 4 and the stopper 3. This is because the peripheral walls 320, 340 can thus pinch the peripheral wall of that part of the stopper 3 engaged in the space formed between said internal 320 and external 340 peripheral walls of the stopper.

(43) Thus, said retaining means 321 formed inside the internal peripheral wall 320 of the stopper 3 make it possible to improve not only the hold of the support element 2 with respect to the stopper 3, but also the leaktightness between the stopper 3 and the cover 4, of which the peripheral wall is pinched between said internal 320 and external 340 peripheral walls of the stopper 3.

(44) In the example illustrated in the figures, the hold between the cover 4 and the stopper 3 is ensured by the complementary screwing means, of the thread and tapping kind, formed on the cover 4 and the stopper 3, and the leaktightness between the cover 4 and the stopper 3 is obtained by pinching the peripheral wall of the cover 4 between said peripheral walls 320 and 340 of the stopper 3, resulting from the engagement of the support element 2 in the stopper 3 which elastically deforms the peripheral wall 320 toward the peripheral wall 340 of the stopper 3. The retention of the support element 2 in the stopper 3 is ensured by the lugs 321 which enclose the support element 2.

(45) In addition, the lugs 321 form spacers between the peripheral wall 320 and the support element 2, which spacers allow a radial distance to be maintained between the support element 2 and the peripheral wall 320. In addition, the spacing between the lugs 321 makes it possible to define a space for fluid communication between the inside of the peripheral wall 320 and the inside of the cover 4.

(46) A communication passage of this kind between the inside of the cover 4 and the inside of the peripheral wall 320 ensures that a sterilization gas injected into the cover 4, for example via a membrane permeable to gas and preferably impermeable to bacteria, is able to spread inside the volume delimited by the peripheral wall 320, in order to sterilize the two chambers 7 and 8 of the package, especially when the support element 2 is an open element, or when that end of the support element 2 engaged in the peripheral wall 320 has a membrane permeable to gas and preferably impermeable to bacteria.

(47) Provision can be made that the retaining means 321 for retaining the support element 2 with respect to the stopper 3 also comprise screwing means, for example of the tapping kind, which are able to cooperate with complementary screwing means, for example of the thread kind, which are formed on the external face of the peripheral wall of the support element 2.

(48) The combination of screwing means and of lugs thus makes it possible to combine a retention of the support element 2 with respect to the stopper 3 by screwing and also by friction, while maintaining the aforementioned advantages of the join between the stopper 3 and the cover 4.

(49) In addition, in the example illustrated in the figures, the internal peripheral wall 320 protrudes from the external peripheral wall 340 at the end opposite the bottom of the stopper 3.

(50) According to the stopper variants that are illustrated in FIGS. 8A and 8B, the stoppers 3′; 3″ also each have a hollow part which is provided with lugs and into which an end part of the corresponding support element is intended to be driven.

(51) The support element 2 and/or the stopper 3 and/or the cover 4 have a part, preferably formed by a membrane, that is impermeable to bacteria but permeable to gases in order to permit gas sterilization of said first chamber 7 and/or of said second chamber 8.

(52) With the package described above, it is possible to carry out a method of unpacking that comprises the following steps. This method is described with reference to FIGS. 1 to 8 in which the support element is composed of two components which can be coupled/uncoupled in order to delimit a closed cavity that encloses said article. As is illustrated in FIGS. 1 to 4, a first person, presumed to be in a contaminated area, separates the cover 4 from the stopper 3 in such a way as to uncover the support element 2, which remains away from the hands of the person who is presumed to be contaminated, since the hand of said person holds the remaining package by the stopper 3, that is to say at a distance away from the support element. The contaminated person can then offer to a second person, presumed to be in a clean area, the remaining package via the support element 2. Said clean person can then pull the support element 2 in order to cause the separation of said support element 2 from the stopper 3 held by the first person, who is presumed to be contaminated. Said “clean” person is, for example, the surgeon in the operating theater.

(53) If appropriate, the support element 2 which encloses the article 5 can be kept in a stand-by area pending the use of said article 5. Then said second person, or another person presumed to be clean, can open the first chamber 7 defined by said support element 2 by separating, in this case by unscrewing, the two components 20, 21 which form said support element, in order to take hold of said medical component.

(54) In the case not illustrated in the figures, where the support element directly forms the first chamber accommodating said article in cooperation with the stopper, the method described above is adapted such that the contaminated person offers to the second person, presumed to be in a clean area, the remaining package via the support element 2, by orienting said remaining package in such a way that the support element 2 is at a height lower than that of the stopper 3, such that said article 5 remains contained in the support element 2 during the separation of said support element 2 from the stopper 3, so as to avoid said article 5 falling to the ground.

(55) Thus, the medical component has not been touched or let go of during its unpacking. In addition, the chamber containing the medical component is opened only in a clean area.

(56) By virtue of the cover which delimits a chamber protecting the grip part 20 of the support element 2, the clean person touches a clean part of the package. This is because the dirty parts of the package, namely the stopper 3 and the cover 4, have remained in the hands of the dirty person. It is thus ensured that the hand of the person taking hold of the support element remains clean.

(57) Of course, in each of the embodiments, provision can be made that the separation of the cover and the stopper is carried out by two different persons in a contaminated area instead of by only one person, one of them holding an end of the stopper and the other holding an end of the cover.

(58) Preferably, the chambers 7 and 8 are impermeable at least to bacteria. Provision can be made that they are also impermeable to any fluid. Alternatively, provision can be made that one or other of them, preferably at least the chamber 7 for presentation of the article, is permeable only to gases in order to permit gas sterilization of the one or more chambers.

(59) Thus, according to a particular embodiment of the invention, provision can be made that at least part of the wall of the stopper 3 delimiting part of the chamber 7 for presentation of the article 5 is made of material permeable to gas but impermeable to bacteria, in order to permit gas sterilization of the chamber for presentation of the article, for example a medical component, for example with ethylene oxide or by steam. Such a design of the package allows the one or more chambers to be sterilized other than by radiation.

(60) Provision can thus be made that the stopper, at its end opposite the one partially covering the support element, is closed by a membrane designed for gas sterilization.

(61) The present invention is not in any way limited to the embodiments that have been described and illustrated, and instead a person skilled in the art will be able to apply any variant thereof that he sees fit.