Sealing disposable for a medical light application device

Abstract

The invention relates to a sealing disposable for a medical light application device, in particular for a pen-shaped light application device to provide light within an anatomical structure of a mammal, e.g. for providing curing light for a polymer composition to enable tissue repair. In particular, the invention relates to a sealing disposable ensuring sterile use of such medical light application device. Accordingly, a sealing disposable (10) for a medical light application device (100) is suggested, comprising a light transmissive pouch (12) defining a collapsible inner cavity (13), wherein the pouch (12) is configured as a sterile barrier between its inner cavity (13) and its exterior, wherein the pouch (12) is closed at a first longitudinal end portion (16) and comprises an opening (40) at a longitudinally opposing second longitudinal end portion (18), the opening (40) being configured for insertion of the medical light application device (100) into the inner cavity (13). The sealing disposable (10) furthermore comprises a sleeve (14) defining a longitudinally extending inner through-hole, wherein the sleeve (14) is configured as a sterile barrier between the inner through-hole and its exterior, wherein the sleeve (14) is at least partially accommodated within the opening (40) of the pouch (12) and comprises an enlarged portion (20) at least partially extending out of the pouch (12), wherein an inner diameter of the portion of the sleeve (14) extending out of the pouch (12) is larger than the largest diameter of the opening of the pouch (12) and wherein the sleeve (14) is removably connected to the second longitudinal end portion (18) of the pouch (12).

Description

[0001] Our Ref. Date

[0002] TI03P010WO December 12, 2024

[0003] Applicant:

[0004] Tissium S.A.

[0005] Sealing disposable for a medical light application device

[0006] Technical field

[0007] The invention relates to a sealing disposable for a medical light application device, in particular for a pen-shaped light application device to provide light within an anatomical structure of a mammal, e.g. for providing curing light for a polymer composition to enable tissue repair. In particular, the invention relates to a sealing disposable ensuring sterile use of such medical light application device.

[0008] Technological Background

[0009] Over the last decades, biomaterials have been widely used to replace and / or restore the function of traumatized or degenerated tissues or organs. For example, soft and compliant polymer composition that cure rapidly could be used to attach tissue surfaces together or prosthetic devices to tissue without the need for mechanical entrapment or fixation, thereby avoiding tissue compression and traumatism such as inflammation and scarring. Such biomaterials could find a broad range of applications for example in minimally invasive cardiac repair, peripheral vascular surgery, wound healing or in the repair of soft tissues, for example nerve repair. A number of biomaterials are known, including as examples fibrin glues, albumin-glutaraldehyde based compounds, cyanoacrylates, polyethylene glycol polymers, collagen-based adhesives or poly(glycerol-co-sebacate acrylate). These materials are typically polymer compositions that are applied as liquids to the site of interest, cured by chemical or physical cross-linking, and fixed to targeted site. According to some examples, cross-linking can be obtained by light. This photopolymerization has seen an important development, especially in adhesive and coating applications in vivo.

[0010] Current treatments of damaged tissue, such as nerve lesions, include reconstruction techniques, wherein a tubular structure in the form of a nerve guide or tissue wrap is provided. The provision of a tubular structure has the advantage of connecting the lesioned tissue, providing further mechanical support and structural stability, providing a tensionless repair, providing guidance to axonal growth limiting the risk of neuroma, reducing an inflammatory response to the site of the lesion, and / or limiting the extent of fibrous tissue development. In particular, such tubular structure may enable the bridging of a gap existing between lesioned nerve ends. Such tubular structure may be provided e.g. by autologous or allogenic venous structures or by artificially manufactured nerve conduits made of a biocompatible material.

[0011] In order to ensure that the lesioned tissue is secured within the tubular structure, a polymer composition may be applied, in particular at the longitudinally opposing openings of the tubular structure that have been used for insertion of the respective tissue end.

[0012] Alternatively, depending on the type of lesion and / or the required treatment, such polymer composition may also be applied directly to the damaged tissue (for example as vascular sealant used as an adjunct to sutures to achieve immediate hemostasis in peripheral vascular surgery).

[0013] The polymer composition is required to be cured within the damaged anatomical structure. Such curing is typically performed by light. For some uses where the damaged tissue is directly accessible, it is possible to deliver the required light in situ using a medical light application device in the form of a light-pen. The application of light may involve a direct contact of the medical light application device with the tissue to access the damaged tissue. Accordingly, it is necessary to guarantee sterility for the patient. Since the light-pen is typically a non-sterile device as it cannot be autoclaved and is not be suitable for ethanol immersion. Even if an outer surface has been appropriately cleaned and disinfected, a remaining risk of potential contamination may still exist.

[0014] Summary of the invention

[0015] Starting from the known prior art there is hence a need to further facilitate the sterile use of a medical light application device, in particular to enable safe in situ curing of a polymer composition, for example to enable safe repair of damaged internal anatomical structures such as nerve lesions or_to enable safe adjunct to sutures in vascular surgery.

[0016] According to the invention it has been recognized that the application of light to e.g. cure a polymer composition within a damaged anatomical structure is best performed in situ, i.e. directly at the target site. However, the inventors have recognized that this may result in problems with regard to sterility. This is because not all of the components of such light application device may be sterilized while at the same time said components are too expensive and complex to be considered as single-use items.

[0017] It is hence an object of the present invention to provide a means to enable an assembly of a medical light application device in a simple and reproducible manner while ensuring sterility during use and upon subsequent use. Said object is achieved by independent claim 1. Preferred embodiments are depicted in the dependent claims, the description, and the Figures.

[0018] Accordingly, a sealing disposable for a medical light application device is suggested, comprising a light transmissive pouch defining a collapsible inner cavity, the pouch being configured as a sterile barrier between its inner cavity and its exterior, wherein the pouch is closed at a first longitudinal end portion and comprises an opening at a longitudinally opposing second longitudinal end portion, and wherein the opening is configured for insertion of the medical light application device into the inner cavity. The sealing disposable furthermore comprises a sleeve defining a longitudinally extending inner through-hole. The sleeve is configured as a sterile barrier between the inner through-hole and its exterior, wherein the sleeve is at least partially accommodated within the opening of the pouch and comprises an enlarged portion at least partially extending out of the pouch. According to the invention, an inner diameter of the portion of the sleeve extending out of the pouch is larger than the largest diameter of the opening of the pouch, wherein the sleeve is removably connected to the second longitudinal end portion of the pouch.

[0019] By means of the sealing disposable, it is hence ensured that an inserted medical light application device, e.g. a light pen, including its electronics and light source is not in contact with the exterior of the pouch, such that potential contamination of the medical light application device may be prevented during use of the light application device. This has the advantage that handling of the light application device prior and after use may be facilitated, since the light application device may be simply cleaned and is not required to be provided in a sterile manner. By the same token, any germs that may nevertheless be present on the body, e.g. due to handling or preparation outside of a clean room prior to use, are isolated from the patient and the target tissue to be treated, such that safety of the treatment and patient is ensured.

[0020] On the other hand, the sealing disposable may be provided in a sterile condition. In this regard, the enlarged portion of the sleeve facilitates the insertion of the light application device into the inner cavity, such that its circumference is fully enclosed by the pouch and a light outputting portion is aligned with the closed end of the pouch. Based on the larger diameter of the sleeve, the insertion may be performed in an essentially contactless manner to such extent that the light application device does not contact the sleeve exterior and the pouch exterior. Thereby, contamination at the outer surface of the sealing disposable may be effectively prevented and sterile use of the light application device is ensured.

[0021] The sterile use is furthermore facilitated by the removable connection of the sleeve to the pouch. After insertion of the light application device into the inner cavity, e.g. by a non-sterile user, the sleeve may be removed from the pouch, such that any potentially contaminated inner surface of the sleeve may be removed and is no longer present during use of the assembled light application device. To facilitate use of the light application device, the opening of the pouch may be closed at its second longitudinal end, e.g. by folding and securing the excess pouch portion not covering the light application device.

[0022] The sleeve hence forms a sterile barrier towards the exterior during insertion of the light application device, such that a sterile user, i.e. a user with sterile gloves, may grab the exterior surface of the sleeve and / or pouch at the level of the second longitudinal end portion of the pouch to remove the sleeve in a safe and sterile manner. While the non-sterile light application device may hence contaminate the inner cavity of the pouch, the exterior of the pouch and the sterile gloves are maintained in a sterile state.

[0023] After the treatment and the operation of the light application device has been completed, the sealing disposable may be removed from the light application device, such that the light application device may be reused for a subsequent application or treatment. The provision of the sealing means as a low-cost sealing disposable, which is based on the pouch and the sleeve, has the advantage that it may be simply discarded and recycled.

[0024] Accordingly, the sealing disposable according to the present invention has the advantage that sterile conditions may be provided for a light application device in a cost-efficient manner and without requiring a laborious and / or complex assembly.

[0025] The sleeve may be essentially formed as an insert that is inserted into the opening of the pouch, e.g. a top portion of the pouch. Alternatively, it may also be provided that the sleeve is formed by an inner portion and an outer portion, wherein the outer portion surrounds the second longitudinal end portion to form a sandwich construction together with the inner portion. The configuration as an inner insert is advantageous to further reduce complexity of the sealing disposable and to facilitate manufacturing while this furthermore reduces the required amount of material.

[0026] On the other hand, a sandwich construction may provide a clamping mechanism for the pouch to provide an improved attachment. This may reduce the risk of premature removal or inadvertent disconnection of the sleeve. Furthermore, this may provide an improved force distribution to the second longitudinal end portion of the pouch upon removal, such that e.g. a more even portion of the second longitudinal end portion may be removed together with the removal of the sleeve.

[0027] The pouch is preferably light transmissive at least at the first longitudinal end portion to enable the application of light to the target tissue through the closed end of the pouch. Although the pouch may be light transmissive only at the closed end, the pouch is preferably formed entirely of a material being light transmissive to facilitate manufacturing and to enable inspection of the position of a light application device accommodated within the pouch. The pouch may be light transmissive to enable the output of light at one or more predefined wavelengths, wherein the wavelength may be selected based on the respective application, in particular a polymer composition to be cured. Preferably, the pouch is light transmissive for light being output by a light source of the light application device having a wavelength between 380 nm and 550 nm, preferably between 390 nm and 420 nm, in particular about 405 nm, so as to apply light in the range of blue light. This has been found to be particularly effective for curing or polymerization of a polymer composition, such as polymers that contain the photo-initiator trimethylbenzoyl diphenylphosphineoxide (TPO). Preferably, the pouch is formed of a transparent material.

[0028] At least the enlarged portion of the sleeve may be tapered or conically shaped. Such configuration provides that a gradual radial extension of the through-hole is provided, forming a funnel-like through-hole within the opening of the pouch. Thereby, it may be prevented that any contact between the light application device and the inner surface of the sleeve, during the insertion of the light application device into the pouch, results in a blocking of movement of the light application device or in a lateral movement potentially resulting in a loss of sterility of the exterior of the sleeve and / or sterile gloves of a user maintaining the sleeve in an open state. Contrary to a step-like configuration, the tapered or conical shape furthermore provides a smooth guiding surface towards the inner cavity of the pouch.

[0029] A sleeve portion adjacent to the enlarged portion may comprise a reduced tapering angle or may be formed as an essentially cylindrical portion. For example, the enlarged portion may be formed of a first portion extending out of the pouch and an adjacent second portion being accommodated within the pouch, wherein a third portion may extend from the second portion into the pouch in an essentially cylindrical manner or having a considerably reduced tapering compared with the enlarged portion. Such portion may facilitate that the exterior of the pouch is not inadvertently contaminated upon removal of the sleeve by providing a bridging section. Such bridging section may be provided between a portion of the inner cavity of the pouch that may have been in contact with the light application device, e.g. being adjacent to the sleeve, and a portion of the inner cavity that has been shielded from such contact by means of said sleeve portion and which is retained after removal of the sleeve.

[0030] By the same token, at least the second longitudinal end portion of the pouch may be tapered or conically shaped. Accordingly, the opening of the pouch may comprise a gradually increasing diameter towards the exterior or longitudinal end face of the pouch. Thereby, insertion of the sleeve comprising the enlarged portion may be facilitated.

[0031] The pouch may be particularly adapted to the shape and dimensions of the light application device that is to be accommodated within the pouch. The pouch and the insert may particularly comprise a circular or ellipsoid cross section along the longitudinal extension. Furthermore, a diameter of the inner cavity may be adapted to the outer diameter of the light application device. By adapting the shape and dimensions of the pouch to the light application device, insertion and adequate orientation of the light application device may be facilitated.

[0032] The portion of the sleeve being accommodated within the opening is preferably aligned with the adjacent portion of the second longitudinal end portion of the pouch. For example, a portion of the enlarged portion of the sleeve being accommodated within the opening may be in direct contact with the adjacent pouch. Alternatively, said portion may be loosely fitted into the opening with the exception of an attachment of the enlarged portion to the pouch, preferably extending along a circumferential line of the sleeve.

[0033] The alignment, in particular in case of a conical shape of the enlarged portion and a conical shape of the adjacent second longitudinal end portion of the pouch, ensures that a relative movement between the sleeve and the pouch may be prevented or at least does not result in an inadvertent contact between the inner surface of the sleeve and the outer surface of the pouch upon use of the sealing disposable together with a light application device.

[0034] To further facilitate the insertion of the light application device, e.g. a light pen, into the inner cavity of the pouch, a ratio between the smallest inner diameter and the largest inner diameter of the enlarged portion is preferably between 1 .0:1 .1 and 1 .0:2.0 or between 1 .0:1 .3 and 1 .0:1 .7. The largest inner diameter is thereby arranged at a portion of the enlarged portion extending out from the pouch while the smallest inner diameter is arranged within the opening of the pouch. A small increase in inner diameter of the through-hole, e.g. by a factor of 1.1 or 1 .2 compared with the smallest diameter, may already facilitate the insertion of the light application device.

[0035] Preferably, the increase in inner diameter is present with a factor of between 1 .3 and 1 .7, e.g. between 1 .4 and 1 .6. Such further increase in diameter not only further facilitates the insertion of the light application device through the through-hole into the inner cavity of the pouch. This also establishes an increased distance between the exterior or outer surface of the sleeve and the central axis of the opening. Accordingly, the risk of contamination of the exterior of the sleeve and pouch may advantageously be further reduced.

[0036] The smallest inner diameter of the enlarged portion may correspond to the smallest diameter of the opening of the second longitudinal end portion of the pouch. In other words, a diameter of the through-hole of the enlarged portion may be gradually reduced from the largest inner diameter at the outer end face of the sleeve towards the end of the enlarged portion of the sleeve in a direction of the first longitudinal end portion of the pouch. The essentially corresponding smallest diameter ensures that the opening of the pouch is not restricted by the sleeve and insertion of the light application device is not impaired. At the same time, this enables that an inserted light application device may enter the inner cavity without contacting the second longitudinal portion of the pouch, such that maintenance of the sterile exterior of the pouch may be further supported.

[0037] The largest inner diameter of the enlarged portion is preferably between 50 mm and 100 mm, in particular between 70 mm and 90 mm. The smallest inner diameter may be between 45 mm and 60 mm. By means of the corresponding dimensions, commonly sized light application devices may be inserted into the pouch, wherein the enlarged portion of the sleeve considerably facilitates the insertion of the light application device in an essentially sterile manner. The preferred dimensioning furthermore avoids that the enlarged portion inadvertently folds into the pouch, which the inventors found to occur when using excess dimensioning. The larger diameter furthermore provides that an improved spacing may be established between e.g. sterile gloves and a potentially contaminated light application device in the open state of the sleeve and the pouch.

[0038] By the same token, the longitudinal extension of the enlarged portion is preferably between 20 mm and 60 mm, preferably between 30 mm and 50 mm. Said preferred longitudinal extension provides that the inner surface of the pouch may be adequately shielded while simultaneously providing a guiding surface. In other words, proper insertion of the light application device may be facilitated and the pouch is protected over a predefined distance to facilitate sterile removal of the sleeve. Furthermore, such dimensions may prevent that the sleeve is inadvertently folded or collapsed into the inner cavity of the pouch.

[0039] Preferably, the enlarged portion is formed by a first portion extending out of the pouch and at least an adjacent second portion being arranged within the pouch. Accordingly, the sleeve may be formed as an insert that is essentially accommodated within the opening of the pouch, wherein only the first portion extends out of the opening. The sleeve may furthermore comprise a third portion adjacent to and extending from the second portion, which does not comprise an enlarged inner diameter of the through-hole. Instead, the inner diameter of the third portion may essentially correspond to the inner diameter of the inner cavity of the adjacent pouch portion.

[0040] In order to facilitate removal of the sleeve after insertion of the light application device while at the same time ensuring that the sleeve performs a function of a contamination barrier towards the adjacent pouch, the enlarged portion may be atached to an inner surface of the second longitudinal end portion of the pouch, wherein the removable connection is formed by a predefined circumferential breaking line arranged at the second longitudinal end portion of the pouch.

[0041] The atachment may e.g. be formed by a pressing heat seal from the adjacent portion of the pouch, wherein the attachment is preferably ring-shaped. This may facilitate that the adjacent portion of the pouch may be removed along the entire circumference at the level of the breaking line. The attachment may hence be provided at a longitudinal side of the breaking line in a direction away from the first longitudinal end portion of the pouch. In other words, the (circumferential) attachment and the breaking line are preferably spaced apart in a longitudinal direction, such that upon actuation of the breaking line, a corresponding portion of the pouch is removed together with the sleeve.

[0042] The breaking line may be provided as a perforation line, which maintains the arrangement of the sleeve relative to the pouch during insertion of the light application device in a stabile manner. On the other hand, the perforation line also enables that e.g. a tearing force being applied to the sleeve and the breaking line, in particular in a longitudinal direction, achieves a more uniform rupture of the pouch portion to maintain structural stability and sterility of the remaining pouch portion.

[0043] A sleeve portion adjacent to the enlarged portion may furthermore extend from the breaking line in a direction to the first longitudinal end portion. Such sleeve portion may correspond to the third sleeve portion described above. The provision of such further sleeve portion has the advantage that a distance between the potentially exposed pouch portion, e.g. being directly adjacent to the third sleeve portion in a direction towards the first longitudinal end portion, and a sterile portion at the end or rim portion of the pouch defined by the breaking line is established. Thereby, sterility at the top or open end of the pouch may be facilitated.

[0044] The breaking line is hence preferably arranged at the level of the end of longitudinal end of the enlarged portion being accommodated within the opening of the pouch. As described above, the enlarged portion may be formed by a first portion extending out of the pouch and an adjacent second portion being arranged within the pouch. The breaking line is hence preferably arranged at the level of the end of the second portion facing away from the first portion. In particular, the breaking line may be arranged at a junction of the second portion and a third portion of the sleeve extending from the second portion in longitudinal direction.

[0045] Such configuration may have the advantage that if a portion of the pouch being adjacent to the second portion of the sleeve is removed together with the sleeve, no potentially enlarged portion of the pouch is present while sterility of the hence defined rim portion of the pouch may be facilitated based on the longitudinal extension of the third sleeve portion. This also provides that an improved grip may be established to remove the sleeve without considerably impairing sterility at the level of the breaking line due to its longitudinal spacing towards the end face of the second longitudinal end portion of the pouch.

[0046] The sleeve is preferably collapsible. Accordingly, the sleeve may be transitionable between a closed state and an open state to respectively enable maintenance of sterility of the exterior and the insertion of the light application device. Preferably, the transitioning of the sleeve is provided along a fold aligned with a radial line extending through the center point of the opening. Thereby, a more even biasing may be provided towards the open state and it may be ensured that the sleeve and adjacent pouch are evenly deployed.

[0047] To facilitate the opening of the sleeve and the corresponding longitudinal end portion of the pouch, the enlarged portion of the sleeve may comprise a gripping portion extending away from the pouch and being configured to bias the sleeve into an open state. For example, the gripping portion may be formed as a radially flared circumferential rim portion. The rim portion provides that a sufficient radial extension of the sleeve and pouch portion may be achieved, such that the light application device may be easily inserted without establishing a manual contact between sterile gloves maintaining the sleeve and opening of the pouch in an open state and the potentially contaminated light application device. The rim portion furthermore provides that a direct actuation of the sleeve may be provided, which may provide an improved control.

[0048] Preferably, the gripping portion is formed by two tabs extending from the enlarged portion in a longitudinal direction and being arranged at radially opposing sides. The tabs may hence face each other and may be evenly distributed along the circumference of the sleeve. The provision of tabs as a gripping portion enables that an even larger distance to potentially contaminated surfaces may be provided during the insertion of the light application device. Furthermore, a direct contact to the enlarged portion of the pouch and the exterior of the pouch may be prevented.

[0049] A ratio between the longitudinal extension of the enlarged portion and the longitudinal extension of the tabs may be between 1 :1 .4 and 1 :2.2, preferably between 1 :1.6 and 1 :1 .9. For example, the longitudinal extension of the enlarged portion may be between about 30 mm and 50 mm while the longitudinal extension of each of the tabs is preferably between 60 mm and 80 mm. The preferred longitudinal extension was found to not only support and maintain sterile conditions for the light application device, but also provides sufficient precision control. Furthermore, the preferred longitudinal extension effectively prevents an intertwining of the tabs upon actuation and reduces the risk of an inadvertent removal of the sleeve caused by increased actuation forces to bias the sleeve into the open position.

[0050] The extension of each of the tabs in a circumferential direction may be between 10 percent and 40 percent of the largest diameter of the through-hole. For example, the extension or width may be between 10 mm and 30 mm. The preferred width of the tabs may support manual operation or actuation of the tabs, and may facilitate that the tabs are pulled in opposing radial directions to bias the sleeve into an open state. The preferred width, which may e.g. extend in a direction perpendicular to the longitudinal direction and radial direction, may furthermore provide an optical cue for medical personnel as an improved indication for the required handling steps. The tabs are preferably rounded at a junction with the enlarged portion. Thereby, sharp steps may be avoided, which may reduce the risk of inadvertently tearing the tabs from the enlarged portion of the sleeve. Furthermore, this may provide that an improved force distribution is established along the circumference of the sleeve upon the actuation of a pulling force in a radial direction.

[0051] The pouch may be formed of a flexible material, wherein the sleeve is formed of a material stiffer than the pouch material. By providing the stiffer sleeve, the biasing of the pouch and the sleeve into the open position may be considerably supported. At the same time, the sleeve may therefore provide an improved shielding of the adjacent pouch portion from any potential germs or contaminated surfaces. Furthermore, the provision of a stiffer sleeve may facilitate the removal of the sleeve portion from the pouch after the insertion of the light application device into the inner cavity, because the sleeve is attached to the second longitudinal end portion end may hence enable that an increased and more evenly distributed pulling force may be applied to the pouch portion that is preferably removed together with the sleeve.

[0052] Preferably, the sleeve is formed of a non-woven fabric, an autoclavable material, and / or a material being permeable to ethylene gas. For example, the sleeve may be formed of Tyvek or a similar material being formed e.g. by spun bond olefin fibers. By providing the sleeve from the preferred material, a more robust sleeve may be provided that is tear-resistant yet comprises sufficient flexibility to transition e.g. between an open state and a closed state. Furthermore, a compatibility with autoclaving procedures and / or ethylene gas procedures facilitates that the sleeve and the sealing disposable as a whole may be sterilized using established techniques, such that the production of the sealing disposable may be simplified. The preferred material, which is preferably polymer-based, e.g. polyethylene based, may furthermore enable that instructions necessary for handling the sealing disposable and, in particular, the sleeve, may be directly printed onto the sleeve, wherein the sleeve is preferably not transparent to further improve readability of said instructions or indications. The pouch may e.g. be formed of polyethylene or another polymer-based material that is preferably heat-seal compatible with the sleeve material.

[0053] Once the light application device has been inserted into the inner cavity and the sleeve has been removed from the pouch, the opening of the pouch is preferably closed and secured. Accordingly, the pouch may comprise a securing means arranged at the second longitudinal end portion or adjacent to the second longitudinal end portion, wherein the securing means extends from the pouch in a direction perpendicular to the longitudinal axis. The securing means may e.g. be provided as a tape, string, ring-shaped structure, or elastic band that is attached to the pouch and extends in a radially outward direction. The securing means may be applied or wrapped around the pouch, preferably after the second longitudinal end portion has been folded in a direction towards the first longitudinal end portion of the pouch. By providing the securing means, in particular a tape, at a predefined position at the pouch cumbersome fixations may be effectively prevented and assembly of the light application device within the sealing disposable may be further facilitated.

[0054] Thereby, the inner cavity is closed, e.g. at a top end at the level of the opening, by means of the fold and the compression provided by the securing means. The first longitudinal end portion of the pouch is already provided in a closed state prior to use of the sealing disposable, such that it may hence be ensured that the inner cavity is secured at each of the longitudinal end portions of the pouch. Accordingly, it may be prevented that any bodily fluids enter into the inner cavity or any potential contaminants exit the inner cavity of the pouch to maintain sterile conditions and functionality of the light application device during light application to the target tissue. The sealing or securing hence ensures that none of the components of the light application device are brought into direct contact with the target tissue or other bodily fluids, which facilitates that the inner components of the light application device are not contaminated and may be handled in a non-sterile manner after use.

[0055] The first longitudinal end portion, which is formed a closed and sealing end portion of the pouch, may comprise a cylindrical end, a tapered end, or a frustoconical end. Preferably, said end portion comprises a frustoconical end portion. The pouch may generally comprise a tube-like shape or essentially cylindrical shape. Alternatively, the pouch may also comprise a gradual reduction in inner diameter of the inner cavity, e.g. forming a (slightly) tapered shape.

[0056] The shape of the pouch and, in particular, it first longitudinal end portion may be particularly adapted to match the shape of a light outputting portion of the medical light application device in the inserted and accommodated state. The shape of the first longitudinal end portion and preferably the dimensioning may be adapted to provide an improved fit and prevent e.g. the occurrence of wrinkles, increased friction, and / or tilting of the light application device during or after insertion. Preferably, the pouch or at least its first longitudinal end portion are formed and dimensioned such that the light application device is accommodated within the inner cavity of the pouch by form-fitting or interference fit, wherein e.g. rotation and longitudinal displacement of the light application device relative to the pouch are at least impaired. Thereby, assembly of the light application device and the sealing disposable may be further facilitated and proper alignment of the light application device may be ensured.

[0057] Brief description of the drawings

[0058] The present disclosure will be more readily appreciated by reference to the following detailed description when being considered in connection with the accompanying drawings in which: Figure 1 shows a sealing disposable according to the invention in a schematic longitudinal section;

[0059] Figure 2 shows the sleeve of the sealing disposable according to Figure 1 in further detail;

[0060] Figure 3 shows an exemplary embodiment of the sealing disposable according to Figure 1 with a securing means in a side view;

[0061] Figure 4 shows the opening of the sealing disposable according to Figure 3 and the insertion of a light application device in a perspective top view;

[0062] Figure 5 shows the sealing disposable according to Figure 3 after insertion of the light application device and removal of the sleeve in a side view; and

[0063] Figures 6 shows the sealing disposable with the light application device according to Figure 5 with a secured second longitudinal end portion of the pouch.

[0064] Detailed of preferred embodiments

[0065] In the following, the invention will be explained in more detail with reference to the accompanying figures. In the Figures, like elements are denoted by identical reference numerals and repeated description thereof may be omitted in order to avoid redundancies.

[0066] In Figure 1 , a sealing disposable 10 is schematically depicted along a longitudinal section. As shown, the sealing disposable 10 comprises a shape having an essentially longitudinal extension. The sealing disposable 10 is formed of a pouch 12 and a sleeve 1 , which is at least partially accommodated within the pouch 12. The pouch 12 may have an essentially tube-like shape. The pouch 12 is formed as a continuous structure along its circumference and along its longitudinal extension so as to define an inner cavity 13 that is shielded from the exterior of the pouch 12. In other words, the pouch 12 or wall of the pouch 12 defining the inner cavity 13 forms a sterile barrier between its exterior and the inner cavity 13.

[0067] The pouch 12 comprises a first longitudinal end portion 16 and an opposing longitudinal end portion 18 and is slightly tapered towards the first longitudinal end portion 16. At the first longitudinal end portion 16 the pouch 12 comprises a frustoconical end, i.e. a conical portion that is truncated. The frustoconical end defines a flat end face, such that the pouch 12 is closed at the first longitudinal end portion 16. The frustoconical shape may be adapted to a shape of the light outputting portion of a light application device, such that the longitudinal end portion 16 may comprise a matching geometry and the light application device is not only adequately held within the pouch 12, but is also aligned with and preferably held by the adjacent wall portion of the pouch 12. The second longitudinal end portion 18 comprises a gradually enlarged radial extension and defines an opening. Within the opening, the sleeve 14 is at least partially accommodated. More particular, according to the present, non-limiting example, the sleeve 14 comprises an enlarged portion 20 being formed by a first sleeve portion 22, which extends out of the pouch 12 in a longitudinal direction, and a second sleeve portion 24, which is accommodated within the opening of the pouch 12. The enlarged portion 20 comprises a shape matching the adjacent portion of the pouch 12, such that the sleeve 14 may be in direct contact with the pouch 12. Adjacent to the second sleeve portion 24 is a third sleeve portion 26, which is essentially cylindrically shaped. Accordingly, the sleeve 14, which comprises an inner through-hole in the open state of the sleeve 14, may define a funnel shape that is held within the opening of the pouch 12.

[0068] In order to ensure that the sleeve 14 is not inadvertently removed from the pouch 12, which may impair sterile conditions at the exterior of the pouch 12, the sleeve 14 comprises a circumferential attachment 28, which is preferably formed by a heat seal between the adjacent pouch 12 and the sleeve 14. For example, the pouch 12 may be formed of a polyethylene-based material, which is heat pressed onto the sleeve 14, when the sleeve 14 is at least partially accommodated within the pouch 12. The attachment along the entire circumference ensures that the adjacent portion of the pouch 12 is shielded from any potential contaminants entering the inner cavity 13 via the through-hole of the sleeve 14 and the opening of the pouch 12.

[0069] Furthermore, the circumferential attachment 40 along the entire circumference is advantageous for removal of the sleeve 14 from the pouch 12 after insertion of a light application device into the inner cavity. In particular, this may result of a corresponding removal of the adjacent portion of the pouch 12, which is facilitated by a breaking line 30, which also extends along the entire circumference of the pouch 12 and is preferably formed as a predefined perforation line. Accordingly, after insertion of the light application device into the inner cavity 13, a pulling force may be applied to the sleeve 14 such that the breaking line 30 may be torn and the sleeve 14 together with the adjacent portion of the pouch 12 may be pulled from the pouch 12 at the level of its second longitudinal end portion 18.

[0070] As shown, the third sleeve portion 26 in this regard ensures that a portion of the pouch 12 at the second longitudinal end portion 18, which has previously has been shielded from a direct contact with the light application device and hence may be considered to be free of contaminants, remains in place. The removal of the sleeve 14 may be facilitated by the presence of two tabs 32, which extend from the enlarged portion 20 in a longitudinal direction and face each other at opposing sides of the sleeve 14, as better shown in Figure 4. The tabs 32 furthermore facilitate the opening of the pouch 12 and the sleeve 14 by enabling a radially outward biasing without requiring a direct contact of the enlarged portion 20 or the exterior of the pouch 12. Figure 2 shows the sleeve 14 of the sealing disposable 10 according to Figure 1 in further detail. In particular, the dimensioning of the enlarged portion 20 and the adjacent third sleeve portion 26 are more clearly depicted. Accordingly, the enlarged portion 20 essentially forms a gradually increasing inner diameter of the through-hole starting from the third sleeve portion 26 in a direction away from the pouch 12. At this end, the enlarged portion 20 comprises its smallest inner diameter 34, which is gradually increased to the largest inner diameter 36 at the opposing end of the enlarged portion 20. The inner diameter of the enlarged portion 20 may e.g. increase from between 50 mm and 55 mm to about 75 mm and 85 to facilitate the insertion of the light application device via the corresponding through-hole and opening into the inner cavity of the pouch 12.

[0071] Furthermore, Figure 2 shows that the tab 32 may have a larger longitudinal extension compared with the longitudinal extension of the enlarged portion. The larger gripping tabs 32 enable that a user may more easily bias the sleeve 14 into an open state and may more easily remove the sleeve 14 from the pouch 12 without being at risk of being in direct contact with the enlarged portion, inner through-hole surface, and exterior of the pouch 12 to be retained after removal of the sleeve 14.

[0072] In Figure 3 an exemplary embodiment of the sealing disposable 10 according to Figure 1 is shown in a side view, wherein the sealing disposable 10 comprises a securing means 38 in the form of a tape that is attached to and radially extends from an end of the second longitudinal portion 18 of the pouch 12 that is retained after removal of the sleeve 14. After removal of the sleeve 14 together with the adjacent portion of the pouch 12, the remaining portion of the second longitudinal end portion 18 may be folded towards the first longitudinal end portion 16, after which the securing means 38 may be wrapped around the pouch 12 and the light application device accommodated therein.

[0073] An example of the assembly of the light application device 100 and a sealing disposable 10 according to the invention is depicted in Figures 4 to 6. Accordingly, in a first step, a first sterile user 110, i.e. wearing sterile gloves and not having been in contact with the light application device 100 or any potential contaminants, may bias the sleeve 14 into an open state by applying a pulling force in radially opposing directions to the tabs 32, as shown in Figure 4. Accordingly, the sleeve 14 is biased into the open position, such that its through-hole is defined and the light application device may be inserted into the inner cavity via the through-hole and the opening 40 of the pouch 12.

[0074] To avoid potential contamination, the light application device 100 is inserted by another user, i.e. a non-sterile user 120, which is depicted without gloves to emphasize the difference in sterile conditions. As shown, the safe insertion of the light application device 100 is enabled by means of the enlarged portion 20 and the corresponding through-hole and opening 40, which allow for sufficient distance between the light application device 100 and the non-sterile user 120, on the one hand, and the sterile user 110 and the exterior of the pouch 12, on the other hand. Said distance may be even further increased by means of the tabs 32, as shown in Figure 4.

[0075] Figure 5 shows the sealing disposable 10 according to Figure 3 after insertion of the light application device 100 and removal of the sleeve 14 in a side view. As shown, the sleeve 14 is entirely removed from the pouch 12 and a portion of the pouch 12, which is adjacent to the breaking line 30, is removed from the second longitudinal end portion 18 as well.

[0076] The pouch 12 may then be folded towards the first longitudinal end portion 16 of the pouch, as shown in Figure 6. By means of the folding of the pouch 12, a longitudinal displacement of the light application device 100 may be impaired or even fully prevented, since the light application device 100 is positively held at the first longitudinal end portion 16. In other words, the light application device 100 accommodated within the inner cavity 13 may be form-fittingly held between the fold at the second longitudinal end portion 18 and the (truncated) end face of the first longitudinal end portion 16.

[0077] Furthermore, after folding of the pouch 12, the securing means 38, in particular a tape, extending from the second longitudinal end portion 18 may be wrapped around the folded portion and the light application device 100 to secure the light application device 100 within the inner cavity 13 and to form a seal around the top portion of the pouch, which is now oriented along the outer surface of the pouch 12 in a direction towards the first longitudinal end portion 16. Thereby, it may be prevented that any potential contaminants or germs may exit the inner cavity 13 of the pouch 12 and potentially contaminate the sterile user 1 10.

[0078] It will be obvious for a person skilled in the art that these embodiments and items only depict examples of a plurality of possibilities. Hence, the embodiments shown here should not be understood to form a limitation of these features and configurations. Any possible combination and configuration of the described features can be chosen according to the scope of the invention.

[0079] List of reference numerals

[0080] 10 Sealing disposable

[0081] 12 Pouch

[0082] 13 Inner cavity

[0083] 14 Sleeve

[0084] 16 First longitudinal end portion

[0085] 18 Second longitudinal end portion

[0086] 20 Elongated portion

[0087] 22 First sleeve portion

[0088] 24 Second sleeve portion

[0089] 26 Third sleeve portion

[0090] 28 Circumferential attachment

[0091] 30 Breaking line

[0092] 32 Tab

[0093] 34 Smallest inner diameter

[0094] 36 Largest inner diameter

[0095] 38 Securing means

[0096] 40 Opening

[0097] 100 Light application device

[0098] 1 10 Sterile user

[0099] 120 Non-sterile user

Claims

Claims1 . A sealing disposable (10) for a medical light application device (100), comprising: a light transmissive pouch (12) defining a collapsible inner cavity (13), the pouch (12) being configured as a sterile barrier between its inner cavity (13) and its exterior, wherein the pouch (12) is closed at a first longitudinal end portion (16) and comprises an opening (40) at a longitudinally opposing second longitudinal end portion (18), the opening (40) being configured for insertion of the medical light application device (100) into the inner cavity (13), and a sleeve (14) defining a longitudinally extending inner through-hole, the sleeve (14) being configured as a sterile barrier between the inner through-hole and its exterior, wherein the sleeve (14) is at least partially accommodated within the opening (40) of the pouch (12) and comprises an enlarged portion (20) at least partially extending out of the pouch (12), wherein an inner diameter of the portion of the sleeve (14) extending out of the pouch (12) is larger than the largest diameter of the opening of the pouch (12) and wherein the sleeve (14) is removably connected to the second longitudinal end portion (18) of the pouch (12).

2. The sealing disposable (10) according to claim 1 , wherein at least the enlarged portion (20) of the sleeve (14) is tapered or conically shaped.

3. The sealing disposable (10) according to claim 2, wherein a sleeve portion (26) adjacent to the enlarged portion (20) comprises a reduced tapering angle or is formed as an essentially cylindrical portion.

4. The sealing disposable (10) according to any of the preceding claims, wherein at least the second longitudinal end portion (18) of the pouch (12) is tapered or conically shaped.

5. The sealing disposable (10) according to any of the preceding claims, wherein the portion of the sleeve (24) being accommodated within the opening (40) is aligned with the adjacent portion of the second longitudinal end portion (18) of the pouch (12).

6. The sealing disposable (10) according to any of the preceding claims, wherein a ratio between the smallest inner diameter (34) and the largest inner diameter (36) of the enlarged portion (20) is between 1 .0:1 .1 and 1 .0:2.0 or between 1 .0:1 .3 and 1 .0:1.7.

7. The sealing disposable (10) according to claim 5, wherein the smallest inner diameter (34) of the enlarged portion (20) corresponds to the smallest diameter of the opening (40) of the second longitudinal end portion (18) of the pouch (12).

8. The sealing disposable (10) according to claim 6 or 7, wherein the largest inner diameter (36) of the enlarged portion (20) is between 50 mm and 100 mm, preferably between 70 mm and 90 mm, and / or wherein the smallest inner diameter (34) is between 45 mm and 60 mm.

9. The sealing disposable (10) according to any of the preceding claims, wherein the longitudinal extension of the enlarged portion (20) is between 20 mm and 60 mm or between 30 mm and 50 mm.

10. The sealing disposable (10) according to any of the preceding claims, wherein the enlarged portion (20) is formed by a first portion (22) extending out of the pouch (12) and at least an adjacent second portion (24) being arranged within the pouch (12).

11. The sealing disposable (10) according to any of the preceding claims, wherein the enlarged portion (20) is attached to an inner surface of the second longitudinal end portion (18) of the pouch (12) and wherein the removable connection is formed by a predefined circumferential breaking line (30) arranged at the second longitudinal end portion (18) of the pouch (12).

12. The sealing disposable (10) according to claim 11 , wherein a sleeve portion (26) adjacent to the enlarged portion (20) extends from the breaking line (30) in a direction to the first longitudinal end portion (16).

13. The sealing disposable (10) according to claim 11 or 12, wherein the breaking line (30) is arranged at the level of the end of longitudinal end of the enlarged portion (20) being accommodated within the opening (40) of the pouch (12).

14. The sealing disposable (10) according to any of the preceding claims, wherein the sleeve (14) is transitionable between a closed state and an open state along a fold aligned with a line extending through the center point of the opening (40).

15. The sealing disposable (10) according to any of the preceding claims, wherein the enlarged portion (20) of the sleeve (14) comprises a gripping portion extending away from the pouch (12) and being configured to bias the sleeve (14) into an open state.

16. The sealing disposable (10) according to claim 15, wherein the gripping portion is formed as a radially flared circumferential rim portion.

17. The sealing disposable (10) according to claim 15, wherein the gripping portion is formed by two tabs (32) extending from the enlarged portion (20) in a longitudinal direction and being arranged at radially opposing sides.

18. The sealing disposable (10) according to claim 17, wherein a ratio between the longitudinal extension of the enlarged portion (20) and the longitudinal extension of the tabs (32) is between 1 :1 .4 and 1 :2.2 or between 1 :1 .6 and 1 :1 .9.

19. The sealing disposable (10) according to claim 17 or 18, wherein the extension of each of the tabs (32) in a circumferential direction is between 10 percent and 40 percent of the largest diameter (36) of the through-hole.

20. The sealing disposable (10) according to any of the preceding claims, wherein the pouch (12) is formed of a flexible material and the sleeve (14) is formed of a material stiffer than the pouch material.21 . The sealing disposable (10) according to claim 20, wherein the sleeve (14) is formed of a non-woven fabric, an autoclavable material, and / or a material being permeable to ethylene gas.

22. The sealing disposable (10) according to any of the preceding claims, wherein the pouch (12) comprises a securing means (38) arranged at the second longitudinal end portion (18) or adjacent to the second longitudinal end portion (18), the securing means (38) extending from the pouch (12) in a direction perpendicular to the longitudinal axis.2023. The sealing disposable (10) according to any of the preceding claims, wherein the first longitudinal end portion (16) comprises a cylindrical end, a tapered end, or a frustoconical end.

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