A medical device for saving the prosthetic implant in the event of infection in breast surgery

Abstract

The present invention relates to a medical device for preserving a prosthetic breast implant in the event of post-surgical infection. The device is configured to ensure effective and homogeneous irrigation of the mammary pocket while simultaneously maintaining the original reconstruction volume and preventing tissue collapse. Said device comprises structural elements adapted to support the breast chamber atraumatically and distribution means allowing a 360-degree washing action. The invention thereby enables the salvage of the prosthetic implant without requiring removal, thus overcoming the limitations of conventional irrigation techniques.

Description

[0001] Title : "A medical device for saving the prosthetic implant in the event of infection in breast surgery"

[0002] DESCRIPTION

[0003] The patent application relates to a medical device for the purpose of saving the prosthetic reconstruction in the event of infection in breast surgery through the correct and ef fective washing, as well as maintenance of the original volume of the breast chamber .

[0004] The invention finds application in the sector of the production of devices for the treatment of infections in breast surgery .

[0005] The breast cancer is among the cancer pathologies which most closely match the world ' s female population . It is estimated that a woman on eight will undergo this pathology .

[0006] The gold standard for the treatment of cancer calls for the removal of the mammary gland, by means of an intervention of mastectomy, optionally adj udiced by radiotherapy or chemotherapy, and the subsequent reconstruction of the breast .

[0007] The reconstruction can be autologous , using the tissues of the same patient , or with prostheses . The prosthesis can be positioned immediately after the mastectomy or in a subsequent intervention .

[0008] Sometimes the reconstruction can also take place in two times through the use of a tissue expander, which can deform and gradually separate the tissues and create the volume required for the final prosthesis .

[0009] The prosthesis can be positioned under the most oral muscle or in a preponderant position, and can be partially or totally covered by a mesh of synthetic nature or biological matrices of various nature and derivation . In particular, the pre-oral reconstruction with complete winding of the prosthesis with a biological matrix is an increasingly widespread technique for its ability to prevent capsular countermeasure phenomena . These dies , in fact , mask the synthetic material of which the prosthesis is composed and are composed primarily of collagen, are recognised by the body as a binding material and integrate with the surrounding tissues , promoting tissue regeneration and a hard and natural reconstruction of the breast .

[0010] These reconstruction techniques , however, are not devoid of post-operative complications . I f not treated correctly, it can lead to the failure of the reconstruction, with heavy consequences on the patient and a greater expense by the health system . Among these the most common are the continuous and prolonged accumulation of serum in the peri-prosthetic zone , the said seroma, the formation of hematoma, deiscence , skin necrosis phenomena and the capstan, infections , contraction of the periprosthetic capsule and complications of aesthetic nature , such as rotation and movement of the prosthesis , visibility of the implant and the formation of wrinkling on the skin, said rippling .

[0011] Among these , infection is among the most critical . This involves , in the maj ority of cases , the removal of the silicone prosthesis and the failure of the reconstruction . It is estimated that the rate of infections following reconstruction varies between 2 and 35% .

[0012] Once the onset of infection has been encountered, the state of the art provides for a first administration by venous or oral administration of antibiotics with a wide range of action, in order to believe the pathogens that support it . however, this countermeasure is not always ef fective , in these cases , it is necessary to bring the patient back to the operating room, where the silicone plant is to be removed, and provide for the cleaning of the mammary pocket . The subj ect of the invention is an initial debridement of the infected material that is analyzed to correctly identi fy the pathogenic agent . Then the pocket is carried out with a mixture of saline solution and speci fic antibiotics .

[0013] One of the techniques used for the treatment of infection consists in washing for several days of the pocket with saline and / or antibiotic solution by means of a cannula inserted in the closed mammary pocket and subsequently drained by a second cannula or drainage . This treatment can be performed by the use of machines with negative pressure .

[0014] The ef fect of these washings is mainly the mechanical cleaning of the fabric, in order to remove how many times and infectious material possible . Once the cycle of washings is finished, the correct eradication of the infection occurs , and the mammary pocket is re-opened and a new prosthetic implant is inserted . This procedure is defined in the literature as " implant salvage" .

[0015] Said washing process , however, does not guarantee the cleaning of the entire breast chamber in an optimal way . The limit of said procedure lies in the cannula used for irrigation . In fact , it does not di f fuses the liquid to 360 degrees as desired, but rather invite the water to slide along a single path by gravity . Moreover, in the days of treatment , tissues tend to inevitably collapse and scar, thus sticking together and obliterating the space for the future positioning of a new prosthesis . This inevitably leads to the moment of insertion of the new system, to the need to surgically disconnect the fabrics together with each other, with the possibility of damaging them . Finally, the insertion of the new prosthetic implant is often several months after the resolution of the infection, with a consequent loss of the previously created volume .

[0016] Prior art .

[0017] The prior art comprises solutions having the purpose of keeping the skin skirt are stretched and supported, ensuring the opening of the mammary chamber, following mastectomy, suitably conceived for the purpose of performing the hemostasis and the evaluation of the viability of the subcutaneous tissue .

[0018] For example , the international patent application WO21024285 "medical devices , sel f-traumatic forms of wild type , for breast cancer surgery" , describes a retractor device comprising a first lower circular recess surface , a second circular recess surface located above the first hollow lower surface , at least three longitudinally extending elements associated with one end to said first hollow lower surface and at the opposite end to said second hollow lower surface so as to constitute a three- dimensional figure to support the mammary chamber, wherein the second hollow, upper surface , has a circumference lower than the first lower hollow surface and in which each of the at least three longitudinally extending elements define an arc .

[0019] In a preferred embodiment , the device obj ect of the aforementioned patent application may be provided with a light source which allows the visibility inside the mammary pocket in which it is accommodated .

[0020] The device of the type which is the obj ect of the international patent application WO21024285 mentioned above allows the production of a radial centri fugal force to the subcutaneous skirt in an atraumatic manner and can collapse on itsel f , by the action of manual compression by the surgeon, for easy insertion by means of surgical access .

[0021] However, this device does not have a system to ef fectively irrigate the mammary pocket .

[0022] This therefore represents a suitable solution for supporting the skin of the breast , given the stated structural features , the device thus produced does not represent a suitable solution for the simultaneous removal of the desired actions or the possibility of agile insertion and simpli fied in reduced form for subsequent three-dimensional development once inserted, supporting the skin shell and washing of the breast chamber .

[0023] At the state of the art there are known some solutions for the production of devices for the distribution of washing liquids in the event of infection, said devices being indicated in the following with the term " irrigator devices" .

[0024] For example , document US2023338637 describes the construction of an irrigating medical device of the mammary pocket . In particular, the invention described in the aforementioned document consists essentially of a flat and circular base , in the centre of which there is a box-shaped body with a circular base , said box-like body comprising a series of channels extending from the centre of the base towards the perimeter of the base itsel f . In particular, each channel has an angle of inclination with respect to the plane on which the diameter of the base lies .

[0025] In particular, the invention described in the aforementioned document is a proximal end of each channel in communication with the central circular box-like body and the central circular boxlike body is one or more tubes in which in at least one first tube the irrigation liquid is made to flow and at least one second tube is connected to a suction line .

[0026] In a preferential embodiment , each channel has , on its surface , a series of holes from which the irrigation liquid can flow . According to the invention described in the above-mentioned document , the device is inserted in the pocket to be subj ected to irrigation and is associated to the flow of irrigation liquid by means of the at least one first tube which reaches the central circular box body, and thus the channels achieving a vortex outflow in front of the inclination of each channel with respect to the diameter of the circular base .

[0027] The invention described in the above-mentioned document therefore allows the irrigation of the mammary pocket by means of vortex flows and consequent suction of the fluids , nevertheless , the device described in the aforementioned document carries out a washing from the bottom upwards , occluding and preventing, owing to the presence of the device itsel f , the washing of the base of the mammary pocket on which substantially the device itsel f rests or which is in proximity . A further disadvantage of the solution described in the aforementioned document is that the described device does not allow the support , even for several days , of the skin or muscle sheath, thus not allowing maintaining the original reconstruction volume .

[0028] The patent application EP3761963 describes the provision of a means for surgical repair and for repairing the soft tissues , said means comprising one or more active agents which are released over time and able to adapt to the biomechanical properties of tissue during healing thereof .

[0029] According to the description, the medium described in the aforementioned document can include one or a plurality of biotinylated layers and a bioabsorbable backing matrix attached to at least one of the biotinylated layers and having a plurality of particles configured to release an active agent over an extended period of time .

[0030] The particles may have a biodegradable portion configured to biodegradability or reorgani ze over time and release an active agent from the particle . In some examples , the particles could not biodegradably or could release an active agent through a di f ferent process , such as di f fusion through a membrane . The particles of the carrier matrix may include , for example , cyclodextrins , dendrimers , a gel , gold, liposomes , micelles , multivariate liposomes , microspheres , nanoparticles , prolapse , or the like .

[0031] The particles may have a plurality of non-concentric aqueous chambers , each chamber surrounded by a lipid membrane , at least one of the lipid membrane and the aqueous chamber containing a desired agent .

[0032] The solution described in the above-mentioned document therefore makes it possible to achieve the goal of the in situ release of agents for therapeutic purposes , however not allowing at the same time the support even for several days , of the skin skirt or the muscle , thus not allowing maintaining the original volume .

[0033] Le domande di brevetto US2024216122 " IMPLANTS ASSEMBLED FROM SKELETAL POLYHEDRON UNIT CELLS , COILED UNIT CELLS OR MESH UNIT CELLS" descrive la reali z zazione di una struttura di un impianto riassorbile utili z zato per creare volume e forma in tessuti molli con tessuto rigenerato , costituito da un reticolo formato da piu celle presentanti svariate forme che possono essere rivestite con innesto di grasso autologo .

[0034] La struttura descritta al documento summenzionato non e pertanto da considerarsi idonea allo scopo medico descritto in quanto non prevede la possibilita di rilascio in situ di agenti a scopo terapeutico .

[0035] Patent applications US2024216122 describes the construction of a structure of a reassortant implant used to create soft tissue volume and shape in soft tissues with regenerated tissue , consisting of a grating formed from a number of cells having a variety of shapes that can be coated with an autologous fat insert .

[0036] The structure described in the aforementioned document is therefore not to be considered suitable for the medical purpose described inasmuch as it does not provide for the possibility of in situ release of agents for therapeutic purposes .

[0037] Further examples of devices for making prosthetic implants provided with means for the delivery of agents to therapeutic purposes are described in documents US2011160854 which are described in breast implants : drug eluting reservoirs and methods therefor (US2020129259 ) Tissue compliance ers with integrated circuit and dielectric barrier properties . Both the solutions described in the documents mentioned above involve a series of disadvantages : in particular, the invention described in document US2011160854 describes the production of a system having means for the distribution of agents for therapeutic purposes , said means being reversibly integrated in the structure of the prosthesis and subsequently removed, a solution which does not allow a washing of the mammary chamber i f not once inserted the prosthesis . The solution described in document US2020129259 describes the production of an expander fitted with means for the insertion and drainage of liquids , the structure of which is particularly complex so as not to make it easy to fit easily into an intervention surgical access .

[0038] The purpose of out invention relative to this patent application is therefore that of producing a single medical device that is easily insertable into the mammary chamber by the surgical intervention access , which support for several days the cutaneous skin or muscle wall maintaining the original reconstruction volume , which prevents collapse of the breast chamber and the consequent bonding of the tissues , which ensures the correct washing of the pocket in order to believe the infection, and which allows the latter to save the prosthetic implant in the event of infection . Being the surgical access usually of 4-5 cm is intuitive as such a device has to have such characteristics as to be temporarily and easily reducible in terms of si ze , that is , compressible and collapsible on itsel f for easy insertion, and, once inserted into the mammary pocket , can deploy and develop in such a configuration as to allow the fabric to be supported by preventing the collapse and the adhesion between them .

[0039] In particular, the invention relative to this patent application consists of a medical device for saving the prosthetic implant in the case of infection in mammary surgery which performs the two key quiries :

[0040] Tissue support and maintaining the volume of the breast pocket ; Vigorous and ef fective irrigation of the breast pocket tissues due to a homogeneous 360-degree homogeneous washing .

[0041] The invention relative to this patent application is substantially comprised of at least four elements associated with one another in physical and mechanical continuity to form a single three-dimensional structure . In particular, the device forming the subj ect of the present patent application comprises :

[0042] - a first circular or elliptical crown,

[0043] - Said second circular or elliptical crown, said second circular or elliptical crown having a diameter smaller than the diameter of the first circular or elliptical crown, said second circular or elliptical crown being located above the first circular or elliptical crown,

[0044] - At least three tubular elements each of which is associated with a first end distal to the first circular or elliptical crown and at the distal end opposite the second circular or elliptical crown,

[0045] - At least one medium for distributing a fluid .

[0046] According to the invention which is the subj ect of the present patent application, the insertion of the at least three tubular elements with the first circular or elliptical crown is described by an angle comprised between 0 ° and 89 ° with respect to the perpendicular to the plane on which the first crown lies , and the trend of these tubular elements follows a spiral or levorotatory spiral profile , proj ected on a spherical dome .

[0047] According to the invention, the at least three tubular elements develop around the directrix perpendicular to the plane defined by the first ring gear and to describe a three-dimensional hollow dome structure which is adapted to prevent tissue collapse .

[0048] In a preferred embodiment , the device is made of elastomeric, polymeric or composite material . The surface of this device can be smooth or texturi zed with suitable surface treatments , it can also be formed of a solid, perforated or porous material .

[0049] The material has elastic mechanical properties such as to permit collapsing in a compact shape by applying a compression force by a single hand of the surgeon, suitable for insertion into the breast chamber through an approach of 4-5 cm, but suf ficient to support and maintain a distance between the tissues when the device returns to the original shape once the operator pressing action is concluded .

[0050] The device is inserted with the first parallel annulus and adj acent to the large-scale muscle in the case of a pre-oral chamber, parallel and adj acent to the co-state in the case of an underwater chamber .

[0051] Once its function is extinguished, it can be easily extracted given its intrinsic properties .

[0052] The positioning of the spiral profile of the tubular elements causes a ' pegs ' ef fect on the tissues , following their natural weight , autonomously adapting the vertical proj ection of the device on the basis of the load immediately and thus guaranteeing a state of mechanical quiet .

[0053] According to the invention, the at least one fluid distribution means is comprised of a solid body inside which is housed a mani fold, said mani fold being in turn associated with a series of channels with a section lower than the section of the mani fold, said channels extending in a radial direction with respect to the mani fold towards the outer surface of the fluid distribution medium .

[0054] In particular, each channel is associated with a distal end of the mani fold arranged inside the fluid distribution medium and at the opposite distal end, in correspondence with the outer surface of the fluid distribution medium, has an opening hereinafter called "hole " .

[0055] In a preferred embodiment , the at least one fluid distribution means consists of a hollow spherical body .

[0056] In a preferred alternative embodiment , the at least one means for distributing the fluid consists of a hollow ellipsoidal body .

[0057] In a preferred alternative embodiment , the at least one fluid distribution means is comprised of a hollow cylindrical body . In a further preferred embodiment , the at least one means for distributing the fluid consists of a hollow body having a circular or ellipsoidal section .

[0058] Regardless of the aforementioned embodiments , the fluid distribution means is associated with the first or second ring gear and has at least one connector, associated with the internally placed mani fold, for connection of the at least one fluid delivery means to the most common drainage tubes , cannulas and irrigation medical pumps already known in the state of the art and available on the market .

[0059] These elements act as a fluid source for the present device . The entry of the fluid can be guided by pressure by means of a pump or a drop .

[0060] The radial arrangement of the channels , combined with the supported pressure of the irrigation pump, favours irrigation with a very homogeneous shower effect , from top to bottom, homogeneous and supported, and with its mechanical action, permits washing of the mammary pocket to 360 degrees .

[0061] This device guarantees the support of the subcutaneous skirt in an atraumatic manner and can collapse on itsel f for easy insertion by means of surgical access . The breast chamber thus extended is ef fectively exposed to the washing ef fect .

[0062] The present invention, as previously described, ensures a total and homogeneous irrigation of the mammary pocket due to the arrangement of the holes in a radial manner and an agent from the top downwards .

[0063] Further features and advantages of the invention will become more apparent from the detailed description of a particular, but not exclusive embodiment , illustrated by way of non-limiting example in the attached drawings , in which :

[0064] FIG . 1 is a perspective view of the invention in a preferential embodiment ;

[0065] FIG . 2 . 1 is a perspective view of the invention in its uncollapsed state ; FIG. 2.2 is a perspective view of the invention in its uncollapsed state and held by the hand of an operator;

[0066] FIG. 2.3 is a perspective view of the invention in its collapsed state following the pressure exerted by the operator's hand.;

[0067] FIG. 3 is a side view of the invention in a preferential embodiment . ;

[0068] FIG. 4 represents a side view of the invention in a preferential embodiment ;

[0069] FIG. 5 shows a side view in section of the invention in a preferential embodiment.

[0070] With reference to the enclosed charts, the invention relative to this patent application is identified with numeral 100.

[0071] With reference to FIG. 3 and FIG. 4, the device (100) comprises a first circular or elliptical annulus having a circular section (101) , a second circular or elliptical crown having a circular section (102) , said second circular or elliptical crown (102) having a diameter smaller than the diameter of the first circular or elliptical crown (101) , said second circular or elliptical crown (102) being placed above the first circular or elliptical crown ( 101 ) .

[0072] The device (100) further comprises at least three tubular elements (103.1-103) . N) each of which is associated with a first end distal to the first circular or elliptical crown (101) at the distal end opposite to the second circular or elliptical crown (102) and at least one means for distributing a fluid (104) .

[0073] The insertion of the at least three tubular elements 103.1-103. N with the first circular or elliptical crown 101 is described by an angle alpha with respect to the perpendicular to the plane on which the first crown 101 lies, and the pattern of these tubular elements 103.1-103. N follows a spiral or levorotatory spiral profile, projected on a spherical dome.

[0074] With reference to FIG. 5, in a preferential embodiment, the fluid distribution means (104) consists of a solid body containing a collector device (105) which in turn is connected to a series of channels (106.1-106) . N, connected to a first end distal to the manifold 105 and extending radially from it to emerge towards the outer surface through an opening.

[0075] The fluid distribution medium (104) further comprises a connector (107) for connecting to a cannula or an irrigation pump that act as a source of the irrigation fluid.

[0076] In a preferred embodiment, the fluid distribution medium (104) is associated to the second crown (102 ) .

[0077] Regardless of the preferred embodiments described and without modifying the essential characteristic aspects, the device for saving the prosthetic implant in the case of infection in mammary surgery and realized as described allows an effective separation between two or more tissue flaps, preventing them from sticking together and does not compromise the integrity thereof, at the same time ensuring a complete washing and 360 degrees of the mammary pocket.

[0078] According to what is described, the invention relative to this patent application makes it possible to achieve the above mentioned objects in an advantageous manner..

[0079] In particular (FIG. 1, 2, 2.3) , the device (100) produced according to what is described can be easily insertable into the mammary chamber by the surgical intervention access, enables support of the skin skirt or the large harness for several days while maintaining the original reconstruction volume, prevents collapse of the breast chamber and the consequent sticking of the tissues, guarantees correct washing of the pocket in order to believe the infection, and finally it allows the saving of the prosthetic implant in case of infection.

[0080] As previously described, the surgical access usually is 4-5 cm, the device 100 constructed in accordance with the above description has characteristics such as to be temporarily and easily reducible in terms of size, that is, compressible and collapsible (FIG. 1, 2, 2.3) on itself for easy insertion, and, once inserted into the mammary pocket , can deploy and develop in such a configuration as to allow the fabric to be supported by preventing the collapse and the adhesion therebetween .

[0081] Given the menus characteristics , the device reali zed as described above allows at the same time a vigorous and ef fective irrigation of the tissues of the mammary pocket , thanks to a homogeneous washing of 360 degrees .

Claims

CLAIMS1. A medical device for preserving the prosthetic implant in the case of infection in mammary surgery, said device comprising a first circular or elliptical crown (101) , a second circular or elliptical crown (102) arranged above the first crown (101) , the second crown (102) having a diameter smaller than the diameter of the first crown (101) and comprising at least three tubular elements (103.1— 103. n) , each of said at least three tubular elements ( 103.1-103. n) being associated with a distal end to the first crown (101) and to the opposite distal end associated with the second crown (102) , said device being characterized in that: the insertion angle (a) of each tubular element relative to the first crown (101) is between 0° and 89° with respect to the perpendicular to the plane defined by the first crown ( 101 ) and the tubular elements ( 103.1-103. n) follow a spiral or levorotatory spiral profile projected onto a spherical dome and the device further comprises at least one fluid distribution means (104) .

2. Device according to claim 1 characterized in that the first crown (101) , the second crown (102) , the tubular elements ( 103.1-103. n) , and the at least one fluid distribution means (104) are made of an elastomeric or polymeric biomaterial .

3. Device as claimed in claim 1, characterized in that the fluid distribution means (104) comprises a solid body housing a manifold (105) , the manifold (105) being fluidly connected to a plurality of channels ( 106.1-106. n) having a smaller cross-section than the manifold (105) , the channels ( 106.1-106. n) extending radially from the manifold (105) towards an outer surface of the at least one fluid distribution means (104) .

4. Device according to the preceding claims, characterized in that each channel ( 106.1-106. n) has a proximal end connected to the manifold (105) and a distal end opening onto the outer surface of the at least one fluid distribution means (104) .

5. Device according to the preceding claims, characterized in that the at least one fluid distribution means (104) is associated with either the first crown (101) or the second crown (102) , and comprises at least one connector (107) fluidly connected to the manifold (105) .

6. Device according to the preceding claims, characterized in that the at least the at least one fluid distribution means (104) comprises a hollow spherical body.

7. The device according to the preceding claims, characterized in that the at least one means for distributing the fluid (104) comprises of a hollow ellipsoidal body.

8. Device according to claims 1,2, 3, 4, 5, 6 characterized in that the at least one fluid distribution means (104) comprises by a hollow cylindrical body.

9. Device according to claims 1,2, 3, 4, 5, 6 characterized in that the at least one means for distributing the fluid (104) comprises of a hollow body having a circular or ellipsoidal section.

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