WO2020132755A1 - Apparatus for containing and transporting an ex-vivo organ connected to a perfusion machine - Google Patents

Apparatus for containing and transporting an ex-vivo organ connected to a perfusion machine Download PDF

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Publication number
WO2020132755A1
WO2020132755A1 PCT/CL2018/050149 CL2018050149W WO2020132755A1 WO 2020132755 A1 WO2020132755 A1 WO 2020132755A1 CL 2018050149 W CL2018050149 W CL 2018050149W WO 2020132755 A1 WO2020132755 A1 WO 2020132755A1
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WO
WIPO (PCT)
Prior art keywords
organ
perimeter
perfusion
tray
container
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Application number
PCT/CL2018/050149
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Spanish (es)
French (fr)
Inventor
Rolando Arturo REBOLLEDO ACEVEDO
Pablo ACHURRA TIRADO
Original Assignee
Pontificia Universidad Catolica De Chile
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
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Application filed by Pontificia Universidad Catolica De Chile filed Critical Pontificia Universidad Catolica De Chile
Priority to PCT/CL2018/050149 priority Critical patent/WO2020132755A1/en
Publication of WO2020132755A1 publication Critical patent/WO2020132755A1/en

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Classifications

    • A—HUMAN NECESSITIES
    • A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
    • A01N—PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF; BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES; PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
    • A01N1/00—Preservation of bodies of humans or animals, or parts thereof
    • A01N1/02—Preservation of living parts

Definitions

  • the invention that is the subject of the present invention patent application refers to an apparatus for containing and transporting an ex vivo organ connected to a perfusion machine by means of at least two perfusion conduits, which allows the organ to be inserted or removed from a shipping container without disconnecting it from the infusion lines.
  • a transplant consists of moving an organ, tissue or a group of cells from one person (donor) to another (recipient), or from one part of the body to another in the same patient.
  • donor donor
  • recipient recipient
  • transplantable organs and tissues includes: lung, heart, kidney, liver, pancreas, intestine, stomach, skin, cornea, bone marrow, blood, bone, among others, the kidney being the most commonly transplanted organ worldwide.
  • Organ injury occurs primarily as a result of ischemia, and different organ preservation techniques serve to minimize this damage and improve organ function and survival.
  • Ischemia is the arrest or reduction of blood circulation through the arteries of a certain area, which involves a state of cellular suffering due to lack of oxygen and nutritional materials in the affected part, causing injuries that are particularly undesirable when it is intended an organ to be transplanted from a donor to a recipient.
  • cold ischemia time The standard technique for preserving donor organs for transplantation is cold, which is called the “cold ischemia time”, which is the time between extraction in the donor and implantation in the recipient.
  • a prolonged cold ischemia time is a risk factor for organ dysfunction and patient death.
  • Injuries caused by ischemia increase based on the amount of time an organ remains ex vivo.
  • a lung can typically be preserved ex vivo only for about 6 to about 8 hours before it becomes unusable for transplantation.
  • a heart can be preserved ex vivo for approximately 4 to 6 hours before it is unusable for transplantation.
  • hypothermic preservation techniques are cold preservation and preservation in a hypothermic perfusion machine.
  • Cold preservation is the most common method of preservation, and also the least expensive, consists of perfusing or internally washing the organ with a cold preservation solution immediately after extraction in the operating room itself. Subsequently, the same or similar preservation solution is used to bathe it and thus keep it stored in refrigerator at 4 ° C until implantation. Due to its extreme simplicity, this technique has a number of advantages, such as its almost universal availability and ease of transport, making it the most widely used preservation method. However, hypothermia alone is not sufficient for proper preservation, so it is necessary to irrigate the organ with special preservation solutions before storage.
  • the preservation technique in a hypothermic perfusion machine implies that, after the initial flushing that is performed during the perfusion in the operating room, the organ is inserted into a device that maintains a continuously or pulsatile controlled flow with cold preservation solution (0- 4 ° C). This flow allows a complete perfusion of the organ, as well as cleaning the circulatory stream from microthrombi and facilitating the elimination of final metabolic line products.
  • the perfusion machine is normally equipped
  • ex-vivo preservation which can keep the donor organ in a quasi-physiological state ready for transplantation, keeping it perfused with a solution containing red blood cells, normothermic, oxygenated and enriched with nutrients, during the transport between donor hospital and recipient hospital, thus reducing cold ischemia time.
  • This allows the removal of organs at a greater distance and also enables the resuscitation of marginal donors, thus expanding the availability of donors, which is always insufficient.
  • Ex vivo preservation is an effective physiological preservation technique of an organ outside its body of origin and provides important benefits compared to conventional approaches. For example, ex vivo physiological preservation allows for more careful monitoring, functional testing, evaluation, and therapy of the harvested organ. This, in turn, enables early detection and potential repair of defects in the harvested organ, further reducing the likelihood of organ failure after transplantation. The ability to perform and evaluate simple organ repairs also allows saving many organs with minor defects, while conventional transplant techniques force their disposal.
  • the systems currently developed do not allow the organ to be extracted from the container that transports them or placed inside it, maintaining the connection to the perfusion machine until the exact moment of the connection in the new body or disconnection from the donor body; although some existing solutions include the use of organ receiving trays to hold the organ inside the container, such as documents just cited, it also happens that once it is necessary to remove the organ to move it from the container to the operating table, the organ must be disconnected, since the cannulas or vials are attached to the container through its walls, so they could not be removed together and connected to the organ, being forced to disconnect for extraction from or to the container, increasing the time of possible ischemia.
  • organs require the same ideal transport conditions, because although some organs can be transported on a tray receiving constant irrigation within a controlled environment, there are other organs that require transporting completely submerged in special fluids, in addition to maintain connection with the perfusion machine; this is because they are much more sensitive and must remain in Protected environment to avoid direct contact with walls or support tray, so that when transported submerged an insulation and damping effect is generated.
  • the present invention overcomes the problems of the prior art by proposing an apparatus for containing and transporting an organ ex vivo allowing its connection with a perfusion machine.
  • the main objective of the present invention is to provide an apparatus for containing and transporting an ex vivo organ connected to a perfusion machine that provides the required humidity and temperature as stable as possible to decrease the period of ischemia.
  • Another object of the present invention is to provide an apparatus for containing and transporting an organ ex vivo by keeping it connected to a perfusion machine even when the organ is removed from the container.
  • Another object of the present invention is to provide an apparatus for containing and transporting an ex vivo organ connected to a perfusion machine that allows the organ to be held inside of the apparatus to carry out preparation maneuvers keeping it connected to said perfusion machine.
  • Still another objective of the present invention is to provide an apparatus that has means for temporarily fixing the perfusion lines to prevent the movements that occur from damaging the point of union between the lines and the organ.
  • Another objective of the present invention is to provide means that allow the safe evacuation of the overflow fluid. Still another object of the present invention is to provide means that prevent foaming in the overflow fluid.
  • the invention aims to provide an apparatus that allows the organ to be completely submerged in the container while maintaining its connection to the perfusion lines. Additionally, the invention aims to provide an apparatus that can contain more than one organ at a time.
  • Another object of the invention is to provide an apparatus for containing and transporting an ex vivo organ connected to a perfusion machine capable of containing the organ in a state completely submerged in a fluid.
  • Still another object of the invention is to provide an apparatus for containing and transporting an ex vivo organ connected to a perfusion machine, capable of itself containing the perfusion machine.
  • the present apparatus is for containing and transporting an ex vivo organ connected to a perfusion machine by means of at least two perfusion conduits (A), allowing the organ to be inserted or removed from a transport container without disconnecting it from the conduits perfusion.
  • fastening means comprise a connector in the form of a removable radial fixation clip that when fixed temporarily prevents axial displacement of the conduits and the removing it frees the ducts allowing the organ to be placed or removed from the container without disconnecting it from the perfusion machine.
  • the apparatus comprises different types of trays that directly support the organ, but regardless of the type of tray used, the apparatus provides the means for peripheral, temporary and removable holding of the perfusion lines, which in addition to being formed by clip-type connectors, are provided by guide channels arranged in the container, in which the perfusion lines are positioned. These guide channels are accompanied by pairs of perforations adjacent to each side of the guide channels, which are receivers of the radial fixing connector, which stabilizes the position of the conduits in relation to the container, preventing their axial displacement.
  • the container comprises a casing with an internal reservoir where the fluids to be recirculated fall, it also includes a system for direct support of the organ formed by trays and it includes a protective cover.
  • This casing is made up of a body of perimeter side walls that have a perimeter top edge, on the edge a front side and a back side are distinguished, which are wider than their side sides, since the channels are arranged on the front guides where the perfusion lines are positioned. From said upper perimeter edge, the internal reservoir projects into the housing.
  • the internal reservoir is formed by a cavity, which, as already mentioned, collects the fluids that fall from the trays with the organ and directs them to be recirculated through one of the perfusion lines that leave the perfusion machine, where This duct sucks up fluids.
  • the reservoir is formed by an inclined lower wall that facilitates or directs the fluids so that they are collected at the lowest point, being inclined downwards from the front side towards the rear side of the container;
  • This wall has rounded contours so that liquids flow and do not accumulate in the corners, and from these contours project the inner perimeter walls that have a stepped upper edge of the casing.
  • the internal reservoir has fluid recirculation means and antifoam means, where the recirculation means comprise a lower guide channel located in the rear half of the inclined wall, which has a curved path and a sloping bottom descending towards the central area. of the channel, where a coupling projection is provided in which one of the perfusion ducts is fixed, which extracts the drainage fluids that accumulate at the bottom of the reservoir, so when the fluids fall they are directed to the deepest area and They channel through the guide channel into the suction duct that hooks on the shoulder to secure its position.
  • the recirculation means comprise a lower guide channel located in the rear half of the inclined wall, which has a curved path and a sloping bottom descending towards the central area. of the channel, where a coupling projection is provided in which one of the perfusion ducts is fixed, which extracts the drainage fluids that accumulate at the bottom of the reservoir, so when the fluids fall they are directed to the deepest area and They channel through the guide channel into the suction
  • the antifoam means of the reservoir comprise a central projection of the upper wall curving downwards towards the inclined lower wall, whose highest area is close to the part from where the fluids fall, so that they fall into the reservoir flowing over it. Curved upper wall and do not free fall causing foam formation. Therefore, the antifoam central projection comprises grooves in the upper wall that receive the organ drainage fluid and ensure its direction at low speed towards the inclined lower wall.
  • the container also has a lower cavity where a temperature regulation means is provided, consisting of an electric plate, so that the apparatus provides temperature conditioning so that the fluids maintain the temperature provided by the perfusion machine.
  • a temperature regulation means consisting of an electric plate, so that the apparatus provides temperature conditioning so that the fluids maintain the temperature provided by the perfusion machine.
  • the apparatus comprises a direct organ support system made up of various types of tray that receive the organ during transport or preparation while keeping it connected to the perfusion lines.
  • the tray is rigid and deep, which comprises a lower wall joined in its contour to perimeter walls whose height defines the depth of the tray; it has a perimeter upper edge followed outwards by a perimeter channel that ends in a more external perimeter vertical projection on whose front side it has a central notch on the lower edge and two lateral notches on the upper edge, where the central notch projects inwards in the form of an inverted channel, this central notch being the one that receives the perfusion duct that goes to the bottom of the reservoir to suck the recirculation fluids, therefore the central notch is arranged on the lower edge;
  • the other lateral notches are arranged on the upper edge of the tray, since they allow the passage of the conduits that are directly connected to the organ and which are the essential conduits for maintaining the organ ex vivo in the perfusion system and prolong its useful life during the transfer to be transplanted.
  • This deep rigid tray includes a series of aligned minor drafts near the vertical perimeter upper edge, which are openings for evacuation of overfilling fluid, since this deep tray allows the organ to be moved in a fully submerged state in a fluid, in addition to being connected to the perfusion machine, thus achieving that those most delicate organs are protected against any rubbing with the tray, also maintaining a controlled conditioning of humidity and temperature.
  • the depth is not given by increasing the depth of the reservoir, since this is the same in all cases, but is achieved by increasing the height of the perimteral edge of the tray and, therefore, increases the height of the perimeter walls.
  • the deep tray can extend upward to increase its depth, complementing the containing cavity with the provision of the protective lid of the container.
  • the rigid tray is low and comprises a base plate with a stepped perimeter top contour having a front side, where the plate It comprises a recessed central area with drainage openings located in the center, through which the organ's irrigation fluids fall.
  • the low rigid tray On the front side of the low rigid tray it has a central notch on the lower edge and two lateral notches on the upper edge, where the central notch projects inwards in the form of an inverted channel, which, as in the other described embodiment, This central projection receives the perfusion duct that travels into the reservoir and sucks the drained fluids that are going to recirculate.
  • the plate of this rigid tray comprises two elongated slits flanked by separate lateral perforations, arranged close to the front side, which participate in the temporary fixation of the perfusion ducts that are directly connected to the organ.
  • the rigid tray does not have greater depth, conforming as a slightly curved platform, being part of the direct support system of the organ which, being at the upper height of the casing and not arranged inwards, forms this platform as a surface. where the surgeon can intervene the organ, either to prepare it, connect it to the ducts, evaluate it or other tasks corresponding to the transplant process.
  • a soft tray is included that gives protective support to the organ and that is placed above the low rigid tray, it is made of a soft and soft material, such as medical grade silicone, so that it constitutes a surface protective.
  • This soft tray comprises a shape similar to the low rigid tray, formed by a slightly concave plate with an upper surface, a radial flat perimeter edge through which it rests on the stepped edge of the rigid tray, where this edge has a perimeter projection and in it a front side is distinguished; the plate includes a recessed central area with drainage openings through which the irrigation fluid passes into the reservoir; while the upper surface of the plate comprises a plurality of slightly raised projections, which act as a non-slip surface, contributing to the positioning of the organ on the soft tray.
  • the soft tray comprises three notches on the front side of the radial plane perimeter edge, of which one is a major central notch extending into the center of the plate and two minor lateral notches running through the perimeter shoulder, where the major central notch it surrounds the projection of the rigid tray that goes inwards in the form of an inverted channel, through which the suction duct that goes to the bottom of the reservoir passes; meanwhile, the lateral notches allow the passage of the perfusion ducts that are directly connected to the organ that sits on this soft tray.
  • the plate of this soft tray comprises two major openings close to the front side, each one formed by an enlarged central area and two elongated extensions, where these openings participate in the installation of the peripheral, temporary and removable fastening means of the perfusion lines with respect to a container of the organ, formed by the connector in the form of a radial fixing clip; so that these openings allow the connector to fix the conduits to the low rigid tray that is below, allowing said conduits to be connected to the organ on the soft tray.
  • This radial fixing clip-shaped connector comprises a body formed by a main portion and folded flexible side portions, with free upper ends through which the user manipulates said connectors.
  • the main portion of the clip comprises a plate with a central draft that reveals the perfusion conduit on which it is placed; the plate also has a front and a rear skirt, where each skirt has a semicircular notch on its lower edge, this notch cooperating with the radial clamping of the perfusion duct in conjunction with the guide channels.
  • the aforementioned flexible portions of the connector extend in the form of a folded plane with internal vertical portions, which descend from the sides of the plate, and flexible external portions diverging towards the free upper ends from rounded lower edges that give it a elastic or flexible behavior.
  • the flexible outer portions have, on their outer face, a fixing projection and non-slip projections for fixing the user's fingers, where the fixing projection comprises a triangular profile with a horizontal upper side that acts as a stop to prevent the connector from Exit when it is placed over the conduit and inserted into the drafts adjacent to the guide channels through which the perfusion lines pass.
  • the connectors having the flexible folded portions, allow them to be inserted by pressure in the openings that accompany the guide channels and when they are removed, the user compresses them with each other by the free upper ends that the anti-slip projections have, causing that the triangular profile projections move with respect to the openings and stop retaining the connector, allowing its release when lifting it.
  • the container also has the aforementioned protective cover that participates in the closure of the apparatus and the protection of the organ; it comprises perimeter walls and an upper wall, where on its front side, the perimeter walls have a central semicircular notch and two elongated semicircular lateral notches arranged on its lower edge, which participate in the passage of the perfusion ducts towards the area of the trays or into the reservoir.
  • the cover is made of translucent material, revealing the transported organ inside without the need to open it to visually evaluate it; especially when it comes to the modality of use with the low tray, not deep, where the organ is practically above the upper surface of the casing.
  • auxiliary lifting parts that have the same guide channel and their lateral openings for the passage of the lateral perfusion ducts that are to be connected directly to the organ, where these auxiliary pieces raise the connection of the connectors so that the perfusion ducts line up longitudinally and enter the tray straight.
  • the apparatus can allow the movement of more than one organ at a time, so that the casing and the trays can have the guide channels and the notches on at least one of their sides, being able to connect more than one set of perfusion lines, one for each side. DESCRIPTION OF THE FIGURES
  • Figure 1 shows an isometric view of the apparatus with the perfusion lines (A).
  • Figure 2 shows an isometric view of the housing and connectors.
  • Figure 3 shows an exploded isometric view of the case, a tray, the connectors and the cover.
  • Figure 4 shows an isometric view of the housing.
  • Figure 5 shows a side sectional view of the housing.
  • Figure 6 shows a top isometric view of the housing.
  • Figure 7 shows a side sectional view of the housing, tray and cover.
  • Figure 8 shows an isometric view of the apparatus according to a first embodiment.
  • Figure 9 shows an isometric view of the tray according to the first embodiment.
  • Figure 10 shows a side sectional view of the tray according to the first embodiment.
  • Figure 11 shows an exploded isometric view of the housing, the rigid tray and the soft tray according to a second embodiment.
  • Figure 12 shows an isometric view of the low rigid tray according to a second embodiment.
  • Figure 13 shows an isometric view of the low soft tray according to a second embodiment.
  • Figure 14 shows an isometric of the connector.
  • Figure 15 shows a front elevation view of the connector.
  • Figure 16 shows an isometric view of the cover.
  • Figure 17 shows a front sectional view of the housing with the conduits and connectors installed.
  • Figure 18 shows an enlarged detail isometric view of the junction of the soft tray with the connector.
  • Figure 19 shows an enlarged detail isometric view of the junction of the soft tray, the low rigid tray and the connector.
  • Figure 20 shows an isometric view of the apparatus according to a third embodiment.
  • the present invention relates to an apparatus (1) for containing and transporting an ex vivo organ connected to a perfusion machine (not shown) by means of at least two perfusion conduits (A), which allows the organ to be inserted or removed from a transport container without disconnecting it from the infusion lines (A).
  • the section (1) comprises peripheral, temporary and removable holding means (300) of the perfusion lines (A) with respect to a container of the organ (10), where the means of clamp (300) comprise a connector (310) in the form of a removable radial fixing clip that when fixed temporarily prevents axial displacement of the ducts (A) and when removed frees the ducts (A) allowing the organ to be placed or removed from the container (10) without disconnecting it from the perfusion.
  • the means of clamp (300) comprise a connector (310) in the form of a removable radial fixing clip that when fixed temporarily prevents axial displacement of the ducts (A) and when removed frees the ducts (A) allowing the organ to be placed or removed from the container (10) without disconnecting it from the perfusion.
  • the peripheral, temporary and removable fastening means of the perfusion lines (A) comprise guide channels (301,302) where said lines (A) and a set of pairs of perforations (303) adjacent to each side of the guide channels (301,302), which are receiving the radial fixing connector (310) that stabilizes the position of the conduits in relation to the container (10) avoiding their axial displacement.
  • said container (10) comprises a housing (100) where the connectors (310) are coupled, an internal reservoir (110), a direct support system (200) of the organ and a protective cover ( 400).
  • the casing (100) is made up of a body of perimeter side walls (101), a perimeter top edge (102) with a front (103) and rear (104) side that are more wider than its lateral sides (105) and from said upper perimeter edge (102) the internal reservoir (110) is arranged.
  • Said internal reservoir (110), best shown in FIG. 5, is formed by an inclined lower wall (111) with rounded contours (112) attached to interior perimeter walls (113) with a stepped upper edge (114), where the wall inclined bottom (111) is oriented downward from the front side (103) towards the rear side (104) of the casing (100).
  • the internal reservoir (110) has fluid recirculation means and antifoam means; where the recirculation means comprise a lower guide channel (121) located in the rear half of the inclined wall (111) and is curved, bottom (122) sloping downward towards the central area (123) where a hook is provided (124) in which one of the perfusion conduits (A) is fixed, which extracts the drainage fluids that accumulate in the bottom of the reservoir (110); meanwhile, the antifoam means of the reservoir (110) comprise a central projection (131) of the upper wall (132) curving downwards towards the inclined lower wall (111), where the upper wall (132) comprises grooves (133) that receive the organ drainage fluid and gently and slowly direct it to the sloping lower wall (111).
  • the recirculation means comprise a lower guide channel (121) located in the rear half of the inclined wall (111) and is curved, bottom (122) sloping downward towards the central area (123) where a hook is provided (124) in which one of the perfusion conduits (A) is fixed, which
  • the casing (100) has a lower cavity (106) where a temperature regulation means consisting of an electrical plate (500) is provided.
  • the direct organ support system (200) comprises, according to one of the embodiments of the invention, illustrated in FIG. 8, FIG. 9 and FIG. 10, a deep rigid tray (210) that supports the organ , which is formed by a lower wall (211) joined in its contour to perimeter walls (212) whose height defines the depth of the tray, has a perimeter upper edge (213) followed outwards by a perimeter channel (214) that It ends in a perimeter vertical projection (215) on whose front side (216) it has a central notch (217) on the lower edge and two lateral notches (218) on the upper edge, where the central notch (217) projects inward.
  • the direct organ support system includes a soft tray (250) that provides protective support to the organ and which is placed on a low rigid tray (230) .
  • Said low rigid tray (230), best shown in FIG.12, comprises a plate (231) with a stepped perimeter upper contour (232) having a front side (233); the plate (231) comprises a recessed central area (234) with drainage openings (235); while said front side (233) has a central notch (236) on the lower edge and two lateral notches (238) on the upper edge, where the central notch (236) projects inwards in the form of an inverted channel (237) .
  • the plate (231) comprises two elongated slits (239) flanked by respective lateral perforations (240), arranged close to the front side (233).
  • the connector (310) in the form of a radial fixing clip that allows the perfusion lines to be fixed in the container comprises a body formed by a main portion (311) and portions flexible (320) folded with free upper ends (321), arranged one on each side of the main portion (311).
  • the main portion (311) comprises a plate with a central cutout (312), front and rear skirts (313), each with a lower notch (314) of semicircular shape.
  • the flexible portions (320) extend in a folded plane with vertical interior portions (322) and flexible exterior portions (323) diverging toward the free upper ends (321) from rounded lower edges (324).
  • the flexible outer portions (323) have, on their outer face (325) a fixing projection (326) and anti-slip projections (327); where the fixing projection (326) comprises a triangular 124 top horizontal profile (328) that acts as a stop to prevent the connector (310) from coming out when installed.
  • the protective cover (400) is translucent and comprises perimeter walls (401) and an upper wall (402), where at least one of the perimeter walls (401) has a semicircular central notch ( 403) and two elongated semicircular lateral notches (404) arranged on its lower edge.
  • the clip connectors (310) are inserted through their lower edges (324) into each pair of perforations (303) adjacent to each side of the guide channels (301,302) of the peripheral clamping means.
  • the connectors (310) are placed above the perfusion conduits (A) which in turn rest on the guide channels (301,302), where the lower notch (314) of the connectors (310) is in contact with the cylindrical body of the ducts, fixing them radially in position against said channels.
  • the clips (310) are inserted into each area enlarged center (262) of the major openings (261) of the soft tray (250) and in turn, as seen in FIG. 19, the connectors (310) are inserted into the lateral perforations (242) of the low rigid tray (230); as the perfusion conduit enters through the lateral notch (238) of the rigid tray (230) and the notch, it lands on the elongated slit (239) and the lateral notch (260) of the soft tray (250), to exit through the elongated extensions (263) and join the organ.
  • the perimeter edge (213) of the tray rises up above the upper edge (102) of the housing and the area where the guide channels are provided in said upper edge of the housing, it has auxiliary lifting parts (600) that have the same guide channel (601) and its lateral openings (602) where the connector (310) is inserted for the passage of the lateral perfusion lines (A) that are to be connected directly to the organ, where these auxiliary pieces raise the connection of the connectors so that the perfusion lines are longitudinally aligned and enter the tray straight.

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Abstract

The invention relates to an apparatus (1) for containing and transporting an ex-vivo organ connected to a perfusion machine by means of at least two perfusion tubes (A), which allows the organ to be placed in or removed from a transport container without disconnecting it from the perfusion tubes. The apparatus comprises temporary, removable peripheral securing means (300) for securing the perfusion tubes (A) with respect to a container (10) of the organ, wherein the securing means (300) comprise a connector (310) in the form of a radially fastening removable clip, which, when fastened, temporarily prevents the axial movement of the tubes and when removed, releases the tubes, thereby allowing the organ to be placed in or removed from the container without disconnecting it from the perfusion machine.

Description

APARATO PARA CONTENER Y TRANSPORTAR UN ÓRGANO EX-VIVO CONECTADO A UNA MÁQUINA DE PERFUSIÓN APPARATUS FOR CONTAINING AND TRANSPORTATION OF AN EX-LIVING ORGAN CONNECTED TO A PERFUSION MACHINE
MEMORIA DESCRIPTIVA DESCRIPTIVE MEMORY
La invención que es motivo de la presente solicitud de Patente de Invención se refiere a un aparato para contener y transportar un órgano ex- vivo conectado a una máquina de perfusión por medio de al menos dos conductos de perfusión, que permite poner o sacar el órgano desde un contenedor de transporte sin desconectarlo desde los conductos de perfusión. The invention that is the subject of the present invention patent application refers to an apparatus for containing and transporting an ex vivo organ connected to a perfusion machine by means of at least two perfusion conduits, which allows the organ to be inserted or removed from a shipping container without disconnecting it from the infusion lines.
DESCRIPCIÓN DEL ARTE PREVIO PREVIOUS ART DESCRIPTION
Un trasplante consiste en trasladar un órgano, tejido o un conjunto de células de una persona (donante) a otra (receptor), o bien de una parte del cuerpo a otra en un mismo paciente. Existen muchas razones por las cuales un paciente debe someterse a un trasplante; sin embargo, una de las razones más comunes es tratar de reemplazar algún órgano o tejido enfermo o lesionado y sustituirlo por uno sano. La lista de órganos y tejidos trasplantables incluye: pulmón, corazón, riñón, hígado, páncreas, intestino, estómago, piel, córnea, médula ósea, sangre, hueso, entre otros, siendo el riñón el órgano más comúnmente trasplantado a nivel mundial. A transplant consists of moving an organ, tissue or a group of cells from one person (donor) to another (recipient), or from one part of the body to another in the same patient. There are many reasons why a patient should undergo a transplant; However, one of the most common reasons is to try to replace a diseased or injured organ or tissue and replace it with a healthy one. The list of transplantable organs and tissues includes: lung, heart, kidney, liver, pancreas, intestine, stomach, skin, cornea, bone marrow, blood, bone, among others, the kidney being the most commonly transplanted organ worldwide.
La extracción, el almacenamiento y el trasplante de un órgano sólido de un donante alteran significativamente la homeostasis del medio interno del órgano y sus efectos se manifestarán en el grado en que recupere o no su función tras el trasplante. La lesión del órgano ocurre principalmente como resultado de la isquemia, y las diferentes técnicas de preservación de órganos sirven para minimizar este daño y mejorar la función y la supervivencia del órgano. La isquemia es la detención o disminución de la circulación de sangre a través de las arterias de una determinada zona, que comporta un estado de sufrimiento celular por falta de oxígeno y materias nutritivas en la parte afectada, causando lesiones que son particularmente indeseables cuando se pretende que un órgano se trasplante de un donante a un receptor. Extraction, storage, and transplantation of a solid organ from a donor significantly alter the homeostasis of the organ's internal environment and its effects will be manifested in the degree to which it recovers its function after transplantation. Organ injury occurs primarily as a result of ischemia, and different organ preservation techniques serve to minimize this damage and improve organ function and survival. Ischemia is the arrest or reduction of blood circulation through the arteries of a certain area, which involves a state of cellular suffering due to lack of oxygen and nutritional materials in the affected part, causing injuries that are particularly undesirable when it is intended an organ to be transplanted from a donor to a recipient.
La técnica estándar para preservación de órganos donantes para el trasplante es con frío, que se denomina“tiempo de isquemia fría” el que transcurre entre la extracción en el donante y el implante en el receptor. Un tiempo de isquemia fría prolongado es un factor de riesgo para disfunción del órgano y muerte del paciente. The standard technique for preserving donor organs for transplantation is cold, which is called the “cold ischemia time”, which is the time between extraction in the donor and implantation in the recipient. A prolonged cold ischemia time is a risk factor for organ dysfunction and patient death.
Las lesiones causadas por isquemia aumentan en función de la cantidad de tiempo que un órgano se mantiene ex vivo. Por ejemplo, un pulmón se puede preservar típicamente ex vivo solo durante aproximadamente 6 a aproximadamente 8 horas antes de que se vuelva inutilizable para el trasplante. Por lo general, un corazón puede conservarse ex vivo durante aproximadamente 4 a 6 horas antes de que sea inutilizable para el trasplante. Estos períodos de tiempo relativamente breves limitan el número de destinatarios a los que se puede llegar desde un sitio donante determinado, restringiendo así el conjunto de receptores para un órgano recolectado. Incluso dentro de los límites de tiempo, los órganos pueden sufrir daños significativos. Injuries caused by ischemia increase based on the amount of time an organ remains ex vivo. For example, a lung can typically be preserved ex vivo only for about 6 to about 8 hours before it becomes unusable for transplantation. Generally, a heart can be preserved ex vivo for approximately 4 to 6 hours before it is unusable for transplantation. These relatively short periods of time limit the number of recipients that can be reached from a given donor site, thus restricting the set of recipients for a collected organ. Even within time limits, organs can suffer significant damage.
Se han desarrollado técnicas que buscan prolongar el tiempo durante el cual un órgano puede conservarse ex vivo, las que reducen el riesgo de insuficiencia orgánica posterior al trasplante y aumentan las posibles reservas de donantes y receptores. Las técnicas de preservación hipotérmica más utilizadas en la actualidad son la conservación en frío y la preservación en máquina de perfusión hipotérmica. Techniques have been developed that seek to extend the time during which an organ can be conserved ex vivo, which reduce the risk of organ failure after transplantation and increase the possible reserves of donors and recipients. The most commonly used hypothermic preservation techniques are cold preservation and preservation in a hypothermic perfusion machine.
La conservación en frío es el método más habitual de preservación, y también el menos costoso, consiste en perfundir o lavar internamente el órgano con una solución de preservación fría inmediatamente después de la extracción en el propio quirófano. Posteriormente, se utiliza esa misma solución de preservación u otra similar para bañarlo y mantenerlo así almacenado en una nevera a 4°C hasta el momento del implante. Por su extremada simpleza, esta técnica presenta una serie de ventajas, como su disponibilidad casi universal y su facilidad de transporte, por lo que es el método de preservación más utilizado. Sin embargo, la hipotermia por sí sola no es suficiente para una adecuada preservación, por lo que es necesario irrigar el órgano con soluciones especiales de preservación antes de su almacenamiento. Cold preservation is the most common method of preservation, and also the least expensive, consists of perfusing or internally washing the organ with a cold preservation solution immediately after extraction in the operating room itself. Subsequently, the same or similar preservation solution is used to bathe it and thus keep it stored in refrigerator at 4 ° C until implantation. Due to its extreme simplicity, this technique has a number of advantages, such as its almost universal availability and ease of transport, making it the most widely used preservation method. However, hypothermia alone is not sufficient for proper preservation, so it is necessary to irrigate the organ with special preservation solutions before storage.
La técnica de preservación en máquina de perfusión hipotérmica implica que, tras el lavado inicial que se realiza durante la perfusión en quirófano, el órgano es introducido en un dispositivo que mantiene un flujo controlado de forma continua o pulsátil con solución de preservación fría (0-4°C). Este flujo permite una completa perfusión del órgano, así como limpiar de microtrombos el torrente circulatorio y facilitar la eliminación de productos metabó líeos finales. La máquina de perfusión normalmente está equipada The preservation technique in a hypothermic perfusion machine implies that, after the initial flushing that is performed during the perfusion in the operating room, the organ is inserted into a device that maintains a continuously or pulsatile controlled flow with cold preservation solution (0- 4 ° C). This flow allows a complete perfusion of the organ, as well as cleaning the circulatory stream from microthrombi and facilitating the elimination of final metabolic line products. The perfusion machine is normally equipped
Una técnica que busca superar esos problemas es la preservación ex-vivo, que puede mantener el órgano donante en un estado casi fisiológico listo para el trasplante, manteniéndolo perfundido con una solución que contiene glóbulos rojos, normotérmica, oxigenada y enriquecida con nutrientes, durante el transporte entre hospital donante y hospital del receptor disminuyendo así el tiempo de isquemia fría. Esto permite la extracción de órganos a mayor distancia y también posibilita la resucitación de donantes marginales, expandiendo así la disponibilidad de donantes, que siempre insuficiente. One technique that seeks to overcome these problems is ex-vivo preservation, which can keep the donor organ in a quasi-physiological state ready for transplantation, keeping it perfused with a solution containing red blood cells, normothermic, oxygenated and enriched with nutrients, during the transport between donor hospital and recipient hospital, thus reducing cold ischemia time. This allows the removal of organs at a greater distance and also enables the resuscitation of marginal donors, thus expanding the availability of donors, which is always insufficient.
La preservación ex vivo, es una técnica de preservación fisiológica efectiva de un órgano fuera de su cuerpo de origen y proporciona beneficios importantes en comparación con los enfoques convencionales. Por ejemplo, la conservación fisiológica ex vivo permite un monitoreo más cuidadoso, pruebas funcionales, evaluación y terapia del órgano recolectado. Esto, a su vez, permite la detección temprana y la reparación potencial de defectos en el órgano recolectado, reduciendo aún más la probabilidad de insuficiencia orgánica posterior al trasplante. La capacidad de realizar y evaluar reparaciones simples en el órgano también permiten salvar muchos órganos con defectos menores, mientras que las técnicas de trasplante convencional obligan a desecharlos. Ex vivo preservation is an effective physiological preservation technique of an organ outside its body of origin and provides important benefits compared to conventional approaches. For example, ex vivo physiological preservation allows for more careful monitoring, functional testing, evaluation, and therapy of the harvested organ. This, in turn, enables early detection and potential repair of defects in the harvested organ, further reducing the likelihood of organ failure after transplantation. The ability to perform and evaluate simple organ repairs also allows saving many organs with minor defects, while conventional transplant techniques force their disposal.
En el arte previo es posible ver claros ejemplos de estas soluciones, tal como lo divulgado en la patente norteamericana US 10076112 (B2) publicada el 18/09/2018 que se refiere a sistemas, métodos y dispositivos para el cuidado de órganos ex vivo; específicamente este documento describe un aparato para el transporte de órganos que incluye un contenedor del órgano y vías de conexión para realizar la perfusión. Al igual que lo mostrado en la patente europea EP2285211 (A4) publicada el 30/08/2017, que se refiere a un aparato para contener un órgano durante evaluación y preservación; como también en la patente europea EP2871947 (Bl) publicada el 05/09/2018 que se trata de un Kit de componentes para el traslado de órganos. In the prior art it is possible to see clear examples of these solutions, such as that disclosed in US patent US 10076112 (B2) published on 09/18/2018 that refers to systems, methods and devices for organ care ex vivo; specifically this document describes an organ transport apparatus that includes an organ container and connection pathways for perfusion. As shown in the European patent EP2285211 (A4) published on 08/30/2017, which refers to an apparatus for containing an organ during evaluation and preservation; as well as in the European patent EP2871947 (Bl) published on 09/05/2018 which is a Kit of components for the transfer of organs.
Aunque tales métodos y soluciones de preservación son útiles para prevenir el daño isquémico en los órganos, estos efectos beneficiosos se ven opacados por limitaciones prácticas y funcionales, que las soluciones existentes en el arte previo no son capaces de resolver. Por ejemplo, existe la necesidad de que el órgano permanezca el mayor tiempo posible conectado a la máquina de perfusión, muchas veces en el momento del trasplante el órgano debe ser intervenido justo antes de colocarlo en el nuevo organismo, por lo que requiere un posicionamiento adecuado para que el cirujano tenga acceso a él y pueda realizar la preparación, todo ese tiempo pueden ser minutos y si el órgano está desconectado de la máquina de perfusión, son minutos de riesgo de lesiones en el tejido. Although such preservation methods and solutions are useful in preventing ischemic organ damage, these beneficial effects are overshadowed by practical and functional limitations, which the solutions in the prior art are not capable of solving. For example, there is a need for the organ to remain connected to the perfusion machine for as long as possible, many times at the time of transplantation the organ must be operated on just before placing it in the new organism, therefore it requires proper positioning for the surgeon to have access to it and to perform the preparation, all that time can be minutes and if the organ is disconnected from the perfusion machine, there are minutes of risk of tissue injury.
Los sistemas actualmente desarrollados no permiten que el órgano pueda ser extraído desde el contenedor que los transporta o colocado dentro de él, manteniendo la conexión a la máquina de perfusión hasta el momento exacto de la conexión en el nuevo cuerpo o desconexión desde el cuerpo donante; si bien algunas soluciones existentes comprenden el uso de bandejas receptoras de órgano para sostenerlo dentro del contenedor, tal como los documentos recién citados, igualmente sucede que una vez que es necesario sacar el órgano para moverlo desde el contenedor hacia la mesa de operación, el órgano debe ser desconectado, pues las cánulas o vías están unidas al contenedor a través de sus paredes, por lo que no podrían ser extraídas en conjunto y conectadas con el órgano, viéndose obligados a su desconexión para la extracción desde o hacia el contenedor, aumentado el tiempo de posible isquemia. The systems currently developed do not allow the organ to be extracted from the container that transports them or placed inside it, maintaining the connection to the perfusion machine until the exact moment of the connection in the new body or disconnection from the donor body; although some existing solutions include the use of organ receiving trays to hold the organ inside the container, such as documents just cited, it also happens that once it is necessary to remove the organ to move it from the container to the operating table, the organ must be disconnected, since the cannulas or vials are attached to the container through its walls, so they could not be removed together and connected to the organ, being forced to disconnect for extraction from or to the container, increasing the time of possible ischemia.
Derivado de lo anterior se ve que otro problema tiene que ver con la accesibilidad al contenedor con sus conexiones a las vías o cánulas, pues para conectarlas al órgano primero se le debe introducir en el contenedor, posado en la bandeja, para luego conectarlo a las vías, tal cual se ve en los documentos del arte previo; en esas situaciones, el acceso al órgano es menos expedito de lo que se podría obtener si el órgano fuese conectado a las vías antes de introducirlo en el contenedor, de modo que cuanto más honda es la bandeja o cuanto más hondo en el contenedor se posiciona, mayor es la dificultad para acceder y manipular el órgano. Por ello, se hace indispensable una solución que permita un acceso al órgano que sea expedito y permita su conexión antes de ser colocado en el contenedor. Derived from the above, it is seen that another problem has to do with the accessibility of the container with its connections to the tracks or cannulas, since to connect them to the organ, it must first be introduced into the container, perched on the tray, and then connected to the ways, as seen in the documents of the prior art; In these situations, access to the organ is less expeditious than what could be obtained if the organ were connected to the tracks before inserting it into the container, so that the deeper the tray is or the deeper the container is positioned The greater the difficulty in accessing and manipulating the organ. Therefore, a solution that allows access to the organ that is expeditious and allows its connection before being placed in the container becomes essential.
Otro de los factores a tomar en cuenta es el movimiento relativo que se produce en el punto de conexión de las cánulas con el órgano que puede causar lesiones en el tejido, por lo que también es indispensable que una vez que las cánulas están unidas al órgano, exista una inmovilización de éstas; sin embargo, en el estado de la técnica no existen soluciones que aborden el problema de la estabilización de las vías o cánulas respecto de una bandeja móvil, principalmente porque no hay soluciones que incluyan una bandeja móvil. Another factor to take into account is the relative movement that occurs at the point of connection of the cannulas with the organ that can cause tissue injury, so it is also essential that once the cannulas are attached to the organ , there is an immobilization of these; however, there are no solutions in the state of the art that address the problem of stabilizing the tracks or cannulas with respect to a mobile tray, mainly because there are no solutions that include a mobile tray.
Por otro lado, no todos los órganos requieren las mismas condiciones ideales de transporte, pues si bien algunos órganos pueden transportarse sobre una bandeja recibiendo irrigación constante dentro de un entorno controlado, hay otros órganos que requieren ser transportados completamente sumergidos en fluidos especiales, además de mantener la conexión con la máquina de perfusión; esto se debe a que son mucho más sensibles y deben permanecer en ambiente protegido para evitar contacto directo con paredes o bandeja de soporte, de modo que al transportarlos sumergidos se genera un efecto de aislación y amortiguación. On the other hand, not all organs require the same ideal transport conditions, because although some organs can be transported on a tray receiving constant irrigation within a controlled environment, there are other organs that require transporting completely submerged in special fluids, in addition to maintain connection with the perfusion machine; this is because they are much more sensitive and must remain in Protected environment to avoid direct contact with walls or support tray, so that when transported submerged an insulation and damping effect is generated.
En el estado de la técnica no existe un aparato para el transporte de órganos ex vivo que permita ambas modalidades, es decir, transportar un órgano suspendido sumergido o transportar un órgano sostenido con irrigación constante; por ejemplo, la solicitud de patente norteamericana US2015342178 (Al) publicada el 03/12/2015 muestra una estructura de soporte y un contenedor para alojar un órgano, donde el contenedor es claramente una vasija honda donde se podría sumergir un órgano conectado a las cánulas de perfusión, sin embargo, esa solución carece de medios que permitan extraer el órgano desde el contenedor sin desconectarlo, pues las vías de perfusión pasan por las paredes del contenedor. In the state of the art there is no apparatus for the transport of organs ex vivo that allows both modalities, that is, transporting a submerged suspended organ or transporting a sustained organ with constant irrigation; for example, US patent application US2015342178 (Al) published on 12/03/2015 shows a support structure and a container to house an organ, where the container is clearly a deep vessel where an organ connected to the cannulas could be immersed For perfusion, however, this solution lacks the means to extract the organ from the container without disconnecting it, since the perfusion routes pass through the walls of the container.
Por lo anterior, la presente invención viene a superar los problemas del arte previo proponiendo un aparato para contener y transportar un órgano ex vivo permite su conexión con una máquina de perfusión. Therefore, the present invention overcomes the problems of the prior art by proposing an apparatus for containing and transporting an organ ex vivo allowing its connection with a perfusion machine.
DESCRIPCIÓN DE LA INVENCIÓN DESCRIPTION OF THE INVENTION
El principal objetivo de la presente invención es proveer un aparato para contener y transportar un órgano ex vivo conectado a una máquina de perfusión que provee la humedad y temperatura requerida lo más estable posible para disminuir el período de isquemia. The main objective of the present invention is to provide an apparatus for containing and transporting an ex vivo organ connected to a perfusion machine that provides the required humidity and temperature as stable as possible to decrease the period of ischemia.
Otro objetivo de la presente invención es proveer un aparato para contener y transportar un órgano ex vivo manteniéndolo conectado a una máquina de perfusión incluso cuando el órgano se saca desde el contenedor. Another object of the present invention is to provide an apparatus for containing and transporting an organ ex vivo by keeping it connected to a perfusion machine even when the organ is removed from the container.
Otro objetivo de la presente invención es proveer un aparato para contener y transportar un órgano ex vivo conectado a una máquina de perfusión que permite sostener el órgano dentro del aparato para realizar maniobras de preparación manteniéndolo conectado a dicha máquina de perfusión. Another object of the present invention is to provide an apparatus for containing and transporting an ex vivo organ connected to a perfusion machine that allows the organ to be held inside of the apparatus to carry out preparation maneuvers keeping it connected to said perfusion machine.
Aún otro objetivo de la presente invención es proveer un aparato que cuenta con medios de fijación temporal de los conductos de perfusión para evitar que los movimientos que se produzcan dañen el punto de unión entre los conductos y el órgano. Still another objective of the present invention is to provide an apparatus that has means for temporarily fixing the perfusion lines to prevent the movements that occur from damaging the point of union between the lines and the organ.
Otro objetivo de la presente invención es proveer medios que permitan la evacuación segura del fluido de desborde. Aún otro objetivo de la presente invención es proveer medios que eviten la formación de espuma en el fluido de desborde. Another objective of the present invention is to provide means that allow the safe evacuation of the overflow fluid. Still another object of the present invention is to provide means that prevent foaming in the overflow fluid.
También tiene como objetivo proveer un aparato que permite transportar el órgano sumergido completamente en el contenedor manteniendo su conexión a los conductos de perfusión. Adicionalmente la invención tiene como objetivo proveer un aparato que puede contener más de un órgano a la vez. It also aims to provide an apparatus that allows the organ to be completely submerged in the container while maintaining its connection to the perfusion lines. Additionally, the invention aims to provide an apparatus that can contain more than one organ at a time.
Otro objetivo de la invención es proveer un aparato para contener y transportar un órgano ex vivo conectado a una máquina de perfusión capaz de contener al órgano en estado completamente sumergido en un fluido. Another object of the invention is to provide an apparatus for containing and transporting an ex vivo organ connected to a perfusion machine capable of containing the organ in a state completely submerged in a fluid.
Aún otro objetivo de la invención es proveer un aparato para contener y transportar un órgano ex vivo conectado a una máquina de perfusión, capaz de contener en sí mismo a la máquina de perfusión. Así, el presente aparato es para contener y transportar un órgano ex- vivo conectado a una máquina de perfusión por medio de al menos dos conductos de perfusión (A), permite poner o sacar el órgano desde un contenedor de transporte sin desconectarlo desde los conductos de perfusión. Still another object of the invention is to provide an apparatus for containing and transporting an ex vivo organ connected to a perfusion machine, capable of itself containing the perfusion machine. Thus, the present apparatus is for containing and transporting an ex vivo organ connected to a perfusion machine by means of at least two perfusion conduits (A), allowing the organ to be inserted or removed from a transport container without disconnecting it from the conduits perfusion.
Comprende medios de sujeción periférica, temporal y removible de los conductos de perfusión respecto de un contenedor del órgano, donde los medios de sujeción comprenden un conector en forma de clip de fijación radial removible que al fijarse evita temporalmente el desplazamiento axial de los conductos y al removerlo libera a los conductos permitiendo colocar o sacar el órgano desde el contenedor sin desconectarlo desde la máquina de perfusión. It comprises peripheral, temporary and removable fastening means of the perfusion conduits with respect to an organ container, where the fastening means comprise a connector in the form of a removable radial fixation clip that when fixed temporarily prevents axial displacement of the conduits and the removing it frees the ducts allowing the organ to be placed or removed from the container without disconnecting it from the perfusion machine.
Como se describirá más adelante con mayor detalle, el aparato comprende diferentes tipos de bandejas que soportan directamente al órgano, pero independiente del tipo de bandeja que se use, el aparato provee los medios de sujeción periférica, temporal y removible de los conductos de perfusión, que además de estar formados por los conectores tipo clip, están dados por unos canales guía dispuestos en el contenedor, en los que se posicionan los conductos de perfusión. Esos canales guía van acompañados por pares de perforaciones adyacentes a cada lado de los canales guía, las que son receptoras del conector de fijación radial, que estabiliza la posición de los conductos en relación con el contenedor evitando su desplazamiento axial. As will be described later in greater detail, the apparatus comprises different types of trays that directly support the organ, but regardless of the type of tray used, the apparatus provides the means for peripheral, temporary and removable holding of the perfusion lines, which in addition to being formed by clip-type connectors, are provided by guide channels arranged in the container, in which the perfusion lines are positioned. These guide channels are accompanied by pairs of perforations adjacent to each side of the guide channels, which are receivers of the radial fixing connector, which stabilizes the position of the conduits in relation to the container, preventing their axial displacement.
El contenedor comprende una carcasa con un reservorio interno donde caen los fluidos que van a recirculación, comprende también un sistema de soporte directo del órgano formado por unas bandejas y comprende una cubierta protectora. Esta carcasa se conforma por un cuerpo de paredes laterales perimetrales que poseen un borde superior perimetral, en el borde se distingue un lado frontal y un lado posterior, los que son más anchos que sus lados laterales, pues en en el frontal se disponen los canales guías donde se posicionan los conductos de perfusión. A partir de dicho borde superior perimetral se proyecta hacia adentro de la carcasa el reservorio interno. The container comprises a casing with an internal reservoir where the fluids to be recirculated fall, it also includes a system for direct support of the organ formed by trays and it includes a protective cover. This casing is made up of a body of perimeter side walls that have a perimeter top edge, on the edge a front side and a back side are distinguished, which are wider than their side sides, since the channels are arranged on the front guides where the perfusion lines are positioned. From said upper perimeter edge, the internal reservoir projects into the housing.
El reservorio interno está formado por una cavidad, que como ya se mencionó, recoge los fluidos que caen desde las bandejas con el órgano y los direcciona para ser recirculados a través de uno de los conductos de perfusión que salen de la máquina de perfusión, donde este conducto succiona los fluidos. The internal reservoir is formed by a cavity, which, as already mentioned, collects the fluids that fall from the trays with the organ and directs them to be recirculated through one of the perfusion lines that leave the perfusion machine, where This duct sucks up fluids.
El reservorio está formado por una pared inferior inclinada que facilita o direcciona los fluidos para que se acopien en el punto más bajo, estando inclinada de manera descendente desde el lado frontal hacia el lado posterior del contenedor; esta pared es de contornos redondeados para que los líquidos fluyan y no se acumulen en las esquinas, y a partir de esos contornos se proyectan las paredes perimetrales interiores que cuentan con un borde superior escalonado de la carcasa. The reservoir is formed by an inclined lower wall that facilitates or directs the fluids so that they are collected at the lowest point, being inclined downwards from the front side towards the rear side of the container; This wall has rounded contours so that liquids flow and do not accumulate in the corners, and from these contours project the inner perimeter walls that have a stepped upper edge of the casing.
El reservorio interno cuenta con medios de recirculación de fluidos y con medios antiespuma, donde los medios de recirculación comprenden un canal guía inferior ubicado en la mitad posterior de la pared inclinada, el que es de recorrido curvo y de fondo inclinado descendente hacia la zona central del canal, donde se dispone un resalte enganche en el que se fija uno de los conductos de perfusión que extrae los fluidos de drenaje que se acumulan en el fondo del reservorio, así cuando los fluidos caen son dirigidos hacia la zona más profunda y se canalizan por el canal guía hacia el conducto de succión que se engancha en el resalte para asegurar su posición. The internal reservoir has fluid recirculation means and antifoam means, where the recirculation means comprise a lower guide channel located in the rear half of the inclined wall, which has a curved path and a sloping bottom descending towards the central area. of the channel, where a coupling projection is provided in which one of the perfusion ducts is fixed, which extracts the drainage fluids that accumulate at the bottom of the reservoir, so when the fluids fall they are directed to the deepest area and They channel through the guide channel into the suction duct that hooks on the shoulder to secure its position.
Por otro lado, los medios antiespuma del reservorio comprenden un resalte central de pared superior curva descendente hacia la pared inferior inclinada, cuya zona más alta está cercana a la parte desde donde caen los fluidos, de modo que estos caigan en el reservorio fluyendo sobre esta pared superior curva y no lo hagan en caída libre que provoca la formación de espuma. Por lo mismo, el resalte central antiespuma comprende hendiduras en la pared superior que reciben el fluido de drenaje del órgano y aseguran su direccionamiento a baja velocidad hacia la pared inferior inclinada. On the other hand, the antifoam means of the reservoir comprise a central projection of the upper wall curving downwards towards the inclined lower wall, whose highest area is close to the part from where the fluids fall, so that they fall into the reservoir flowing over it. Curved upper wall and do not free fall causing foam formation. Therefore, the antifoam central projection comprises grooves in the upper wall that receive the organ drainage fluid and ensure its direction at low speed towards the inclined lower wall.
El contenedor posee también una cavidad inferior donde se dispone un medio de regulación de la temperatura que consiste en una placa eléctrica, de modo que el aparato provea acondicionamiento de temperatura para que los fluidos mantengan la temperatura aportada por la máquina de perfusión. The container also has a lower cavity where a temperature regulation means is provided, consisting of an electric plate, so that the apparatus provides temperature conditioning so that the fluids maintain the temperature provided by the perfusion machine.
El aparato comprende un sistema de soporte directo del órgano formado por varios tipos de bandeja que reciben al órgano durante su transporte o preparación mientras se mantiene conectado a los conductos de perfusión. The apparatus comprises a direct organ support system made up of various types of tray that receive the organ during transport or preparation while keeping it connected to the perfusion lines.
En una de las realizaciones de esta invención la bandeja es rígida y honda, la que comprende una pared inferior unida en su contorno a paredes perimetrales cuya altura define la profundidad de la bandeja; posee un borde superior perimetral seguido hacia afuera por un canal perimetral que remata en un resalte vertical perimetral más externo en cuyo lado frontal presenta una muesca central en el borde inferior y dos muescas laterales en el borde superior, donde la muesca central se proyecta hacia dentro en forma de canal invertido, siendo esta muesca central la que recibe al conducto de perfusión que va hacia el fondo del reservorio para succionar los fluidos de recirculación, por ello la muesca central se dispone en el borde inferior; en cambio las otras muescas laterales se disponen en el borde superior de la bandeja, ya que ellas permiten el paso de los conductos que van conectados directamente con el órgano y que son los conductos imprescindibles para mantener el órgano ex vivo en el sistema de perfusión y prolongar su vida útil durante el traslado para ser transplantado. In one of the embodiments of this invention the tray is rigid and deep, which comprises a lower wall joined in its contour to perimeter walls whose height defines the depth of the tray; it has a perimeter upper edge followed outwards by a perimeter channel that ends in a more external perimeter vertical projection on whose front side it has a central notch on the lower edge and two lateral notches on the upper edge, where the central notch projects inwards in the form of an inverted channel, this central notch being the one that receives the perfusion duct that goes to the bottom of the reservoir to suck the recirculation fluids, therefore the central notch is arranged on the lower edge; On the other hand, the other lateral notches are arranged on the upper edge of the tray, since they allow the passage of the conduits that are directly connected to the organ and which are the essential conduits for maintaining the organ ex vivo in the perfusion system and prolong its useful life during the transfer to be transplanted.
Esta bandeja rígida honda comprende una serie de calados menores alineados cercanos al borde superior perimetral vertical, que son aberturas de evacuación de fluido de sobrellenado, pues esta bandeja honda permite que órgano pueda ser trasladado en estado sumergido completo en un fluido, además de estar conectado a la máquina de perfusión, logrando con esto que aquellos órganos más delicados, estén protegido contra algún roce con la bandeja, manteniendo igualmente un acondicionamiento controlado de humedad y temperatura. This deep rigid tray includes a series of aligned minor drafts near the vertical perimeter upper edge, which are openings for evacuation of overfilling fluid, since this deep tray allows the organ to be moved in a fully submerged state in a fluid, in addition to being connected to the perfusion machine, thus achieving that those most delicate organs are protected against any rubbing with the tray, also maintaining a controlled conditioning of humidity and temperature.
En el caso de las bandejas hondas, la profundidad no se da aumentado la profundidad del reservorio, pues este es el mismo en todos los casos, sino que se consigue aumentando la altura del borde perimteral de la bandeja y por ende, aumenta la altura de las paredes perimetrales. Así, en otra realización de la invención, la bandeja honda puede extenderse hacia arriba para aumentar su profundidad, complementando la cavidad contenedora con la disposición de la tapa protectora del contenedor. In the case of deep trays, the depth is not given by increasing the depth of the reservoir, since this is the same in all cases, but is achieved by increasing the height of the perimteral edge of the tray and, therefore, increases the height of the perimeter walls. Thus, in another embodiment of the invention, the deep tray can extend upward to increase its depth, complementing the containing cavity with the provision of the protective lid of the container.
En otra realización de la invención, la bandeja rígida es baja y comprende una placa de base con un contorno superior perimetral escalonado que tiene un lado frontal, donde la placa comprende una zona central rehundida con aberturas de drenaje ubicadas el centro, por donde caen los fluidos de irrigación del órgano. In another embodiment of the invention, the rigid tray is low and comprises a base plate with a stepped perimeter top contour having a front side, where the plate It comprises a recessed central area with drainage openings located in the center, through which the organ's irrigation fluids fall.
En el lado frontal de la bandeja rígida baja presenta una muesca central en el borde inferior y dos muescas laterales en el borde superior, donde la muesca central se proyecta hacia dentro en forma de canal invertido, que al igual que en la otra realización descrita, esta proyección central recibe el conducto de perfusión que viaja hacia el interior del reservorio y succiona los fluidos drenados que van a recirculación. On the front side of the low rigid tray it has a central notch on the lower edge and two lateral notches on the upper edge, where the central notch projects inwards in the form of an inverted channel, which, as in the other described embodiment, This central projection receives the perfusion duct that travels into the reservoir and sucks the drained fluids that are going to recirculate.
La placa de esta bandeja rígida comprende dos hendiduras alargadas flanqueadas por sendas perforaciones laterales, dispuestas cercanas al lado frontal, las que participan en la fijación temporal de los conductos de perfusión que van conectados directo al órgano. En esta realización, la bandeja rígida no tiene mayor profundidad, conformándose como una plataforma levemente curvada, siendo parte del sistema de soporte directo del órgano que al estar a la altura superior de la carcasa y no dispuesto hacia dentro, conforma esta plataforma como una superficie donde el cirujano puede intervenir el órgano, ya sea para prepararlo, conectarlo a los conductos, evaluarlo u otras tareas correspondientes al proceso de transplante. The plate of this rigid tray comprises two elongated slits flanked by separate lateral perforations, arranged close to the front side, which participate in the temporary fixation of the perfusion ducts that are directly connected to the organ. In this embodiment, the rigid tray does not have greater depth, conforming as a slightly curved platform, being part of the direct support system of the organ which, being at the upper height of the casing and not arranged inwards, forms this platform as a surface. where the surgeon can intervene the organ, either to prepare it, connect it to the ducts, evaluate it or other tasks corresponding to the transplant process.
En esta realización se incluye una bandeja blanda que da soporte protector al órgano y que se coloca por sobre la bandeja rígida baja, está fabricada de un material suave y blando, tal como una silicona de grado médico, de modo que se constituya como una superficie protectora. In this embodiment, a soft tray is included that gives protective support to the organ and that is placed above the low rigid tray, it is made of a soft and soft material, such as medical grade silicone, so that it constitutes a surface protective.
Esta bandeja blanda comprende una forma similar a la bandeja rígida baja, formada por una placa levemente cóncava con una superficie superior, un borde perimetral plano radial a través del cual se apoya en el borde escalonado de la bandeja rígida, donde este borde posee un resalte perimetral y en él se distingue un lado frontal; la placa comprende una zona central rehundida con aberturas de drenaje por donde pasa el fluido de irrigación hacia el reservorio; mientras que la superficie superior de la placa comprende una pluralidad de resaltes levemente levantados, los que actúan como superficie antideslizante, aportando en el posicionamiento del órgano sobre la bandeja blanda. This soft tray comprises a shape similar to the low rigid tray, formed by a slightly concave plate with an upper surface, a radial flat perimeter edge through which it rests on the stepped edge of the rigid tray, where this edge has a perimeter projection and in it a front side is distinguished; the plate includes a recessed central area with drainage openings through which the irrigation fluid passes into the reservoir; while the upper surface of the plate comprises a plurality of slightly raised projections, which act as a non-slip surface, contributing to the positioning of the organ on the soft tray.
La bandeja blanda comprende tres muescas en el lado frontal del borde perimetral plano radial, de las cuales una es una muesca central mayor que se extiende hacia el centro de la placa y dos muescas laterales menores que atraviesan el resalte perimetral, donde la muesca central mayor rodea a la proyección de la bandeja rígida que va hacia dentro en forma de canal invertido, por donde pasa el conducto de succión que se dirige hacia el fondo del reservorio; en tanto, las muescas laterales permiten el paso de los conductos de perfusión que van conectados directos al órgano que se posa sobre esta bandeja blanda. The soft tray comprises three notches on the front side of the radial plane perimeter edge, of which one is a major central notch extending into the center of the plate and two minor lateral notches running through the perimeter shoulder, where the major central notch it surrounds the projection of the rigid tray that goes inwards in the form of an inverted channel, through which the suction duct that goes to the bottom of the reservoir passes; meanwhile, the lateral notches allow the passage of the perfusion ducts that are directly connected to the organ that sits on this soft tray.
Por otro lado, la placa de esta bandeja blanda comprende dos calados mayores cercanos al lado frontal, cada uno formado por un área central ampliada y dos extensiones alargadas, donde estos calados participan en la instalación de los medios de sujeción periférica, temporal y removible de los conductos de perfusión respecto de un contenedor del órgano, formados por el conector en forma de clip de fijación radial; de modo que estos calados permiten que el conector fije los conductos a la bandeja rígida baja que está por debajo, dejando que dichos conductos sean conectados al órgano por sobre la bandeja blanda. On the other hand, the plate of this soft tray comprises two major openings close to the front side, each one formed by an enlarged central area and two elongated extensions, where these openings participate in the installation of the peripheral, temporary and removable fastening means of the perfusion lines with respect to a container of the organ, formed by the connector in the form of a radial fixing clip; so that these openings allow the connector to fix the conduits to the low rigid tray that is below, allowing said conduits to be connected to the organ on the soft tray.
Este conector en forma de clip de fijación radial comprende un cuerpo formado por una porción principal y porciones laterales flexibles plegadas, con extremos superiores libres por donde el usuario manipula a dichos conectores. La porción principal del clip comprende una placa con un calado central que deja a la vista el conducto de perfusión sobre el que es colocado; la placa cuenta también con un faldón frontal y uno posterior, donde cada faldón presenta una muesca de forma semicircular en su borde inferior, siendo esta muesca la que coopera con la sujeción radial del conducto de perfusión en conjunto con los canales guía. This radial fixing clip-shaped connector comprises a body formed by a main portion and folded flexible side portions, with free upper ends through which the user manipulates said connectors. The main portion of the clip comprises a plate with a central draft that reveals the perfusion conduit on which it is placed; the plate also has a front and a rear skirt, where each skirt has a semicircular notch on its lower edge, this notch cooperating with the radial clamping of the perfusion duct in conjunction with the guide channels.
Las mencionadas porciones flexibles del conector, se extienden en forma de un plano plegado con porciones verticales interiores, que descienden desde los laterales de la placa, y porciones exteriores flexibles divergentes hacia los extremos superiores libres a partir de unas aristas inferiores redondeadas que le dan un comportamiento elástico o flexible. The aforementioned flexible portions of the connector, extend in the form of a folded plane with internal vertical portions, which descend from the sides of the plate, and flexible external portions diverging towards the free upper ends from rounded lower edges that give it a elastic or flexible behavior.
Las porciones exteriores flexibles presentan, en su cara exterior, un resalte de fijación y unos resaltes antideslizantes para fijación de los dedos del usuario, donde el resalte de fijación comprende un perfil triangular de lado superior horizontal que actúa de tope para impedir que el conector se salga cuando está colocado por sobre el conducto e insertado en los calados adyacentes a los canales guía por donde pasan los conductos de perfusión. The flexible outer portions have, on their outer face, a fixing projection and non-slip projections for fixing the user's fingers, where the fixing projection comprises a triangular profile with a horizontal upper side that acts as a stop to prevent the connector from Exit when it is placed over the conduit and inserted into the drafts adjacent to the guide channels through which the perfusion lines pass.
En operación, los conectores al tener las porciones plegadas flexibles permiten que sean introducidos a presión en los calados que acompañan a los canales guía y al momento de removerlos, el usuario los comprime entre sí por los extremos superiores libres que tienen los resaltes antideslizantes, provocando que los resaltes de perfil triangular se desplacen respecto de los calados y dejen de retener el conector, permitiendo su liberación al alzarlo. El contenedor cuenta también con la mencionada cubierta protectora que participa en el cierre del aparato y la protección del órgano; comprende paredes perimetrales y una pared superior, donde en su lado frontal, las paredes perimetrales presentan una muesca central semicircular y dos muescas laterales semicirculares alargadas dispuestas en su borde inferior, las que participan en el paso de los conductos de perfusión hacia la zona de las bandejas o hacia el reservorio. In operation, the connectors, having the flexible folded portions, allow them to be inserted by pressure in the openings that accompany the guide channels and when they are removed, the user compresses them with each other by the free upper ends that the anti-slip projections have, causing that the triangular profile projections move with respect to the openings and stop retaining the connector, allowing its release when lifting it. The container also has the aforementioned protective cover that participates in the closure of the apparatus and the protection of the organ; it comprises perimeter walls and an upper wall, where on its front side, the perimeter walls have a central semicircular notch and two elongated semicircular lateral notches arranged on its lower edge, which participate in the passage of the perfusion ducts towards the area of the trays or into the reservoir.
La cubierta es de material translúcido, dejando ver en su interior el órgano transportado sin la necesidad de abrirlo para evaluarlo visualmente; en especial cuando se trata de la modalidad de uso con la bandeja baja, no profunda, donde el órgano queda prácticamente por sobre la superficie superior de la carcasa. The cover is made of translucent material, revealing the transported organ inside without the need to open it to visually evaluate it; especially when it comes to the modality of use with the low tray, not deep, where the organ is practically above the upper surface of the casing.
En el caso de la realización con la bandeja honda, donde el borde perimetral de la bandeja se alza hacia arriba por sobre el borde superior de la carcasa, la zona donde se disponen los canales guías en dicho borde superior de la carcasa, se cuenta con unas piezas auxiliares de alzado que cuentan con el mismo canal guía y sus calados laterales para el paso de los conductos de perfusión laterales que van a conectarse directo con el órgano, donde estas pieza auxiliares elevan la conexión de los conectores para que los conductos de perfusión queden alineados longitudinalmente y entren hacia la bandeja de manera recta. In the case of the embodiment with the deep tray, where the perimeter edge of the tray rises up above the upper edge of the housing, the area where the guide channels are arranged on said upper edge of the housing, there is auxiliary lifting parts that have the same guide channel and their lateral openings for the passage of the lateral perfusion ducts that are to be connected directly to the organ, where these auxiliary pieces raise the connection of the connectors so that the perfusion ducts line up longitudinally and enter the tray straight.
En otras realizaciones posibles de la invención, el aparato puede permitir el traslado de más de un órgano a la vez, de modo que la carcasa y las bandejas pueden disponer de los canales guías y las muescas en al menos uno de sus costados, pudiendo conectar más de un set de conductos de perfusión, uno por cada lado. DESCRIPCIÓN DE LAS FIGURAS In other possible embodiments of the invention, the apparatus can allow the movement of more than one organ at a time, so that the casing and the trays can have the guide channels and the notches on at least one of their sides, being able to connect more than one set of perfusion lines, one for each side. DESCRIPTION OF THE FIGURES
Para la realización de los objetos anteriores y relacionados, la invención puede realizarse en la forma ilustrada en los dibujos adjuntos; sin embargo, los dibujos son solo ilustrativos. Las variaciones se contemplan como parte de la invención, limitada únicamente por el alcance de las reivindicaciones. For the realization of the above and related objects, the invention can be carried out in the way illustrated in the attached drawings; however, the drawings are illustrative only. Variations are contemplated as part of the invention, limited only by the scope of the claims.
Así, una descripción detallada de la invención se llevará a cabo en conjunto con las figuras que forman parte integral de esta presentación, donde: Thus, a detailed description of the invention will be carried out in conjunction with the figures that form an integral part of this presentation, where:
La figura 1 muestra una vista isométrica del aparato con los conductos (A) de perfusión. Figure 1 shows an isometric view of the apparatus with the perfusion lines (A).
La figura 2 muestra una vista isométrica de la carcasa y los conectores. Figure 2 shows an isometric view of the housing and connectors.
la figura 3 muestra una vista isométrica en explosión de la carcasa, una bandeja, los conectores y la cubierta. Figure 3 shows an exploded isometric view of the case, a tray, the connectors and the cover.
La figura 4 muestra una vista isométrica de la carcasa. Figure 4 shows an isometric view of the housing.
La figura 5 muestra una vista en corte lateral de la carcasa. Figure 5 shows a side sectional view of the housing.
La figura 6 muestra una vista isométrica superior de la carcasa. Figure 6 shows a top isometric view of the housing.
La figura 7 muestra una vista en corte lateral de la carcasa, bandeja y cubierta. Figure 7 shows a side sectional view of the housing, tray and cover.
La figura 8 muestra una vista isométrica del aparato de acuerdo a una primera realización. Figure 8 shows an isometric view of the apparatus according to a first embodiment.
La figura 9 muestra una vista isométrica de la bandeja de acuerdo a la primera realización. Figure 9 shows an isometric view of the tray according to the first embodiment.
La figura 10 muestra una vista en corte lateral de la bandeja de acuerdo a la primera realización. Figure 10 shows a side sectional view of the tray according to the first embodiment.
La figura 11 muestra una vista isométrica en explosión de la carcasa, la bandeja rígida y la bandeja blanda de acuerdo a una segunda realización. La figura 12 muestra una vista isométrica de la bandeja rígida baja de acuerdo a una segunda realización. Figure 11 shows an exploded isometric view of the housing, the rigid tray and the soft tray according to a second embodiment. Figure 12 shows an isometric view of the low rigid tray according to a second embodiment.
La figura 13 muestra una vista isométrica de la bandeja blanda baja de acuerdo a una segunda realización. Figure 13 shows an isometric view of the low soft tray according to a second embodiment.
La figura 14 muestra una isométrica del conector. Figure 14 shows an isometric of the connector.
La figura 15 muestra una vista en elevación frontal del conector. Figure 15 shows a front elevation view of the connector.
La figura 16 muestra una vista isométrica de la cubierta. Figure 16 shows an isometric view of the cover.
La figura 17 muestra una vista en corte frontal de la carcasa con los conductos y conectores instalados. Figure 17 shows a front sectional view of the housing with the conduits and connectors installed.
La figura 18 muestra una vista isométrica en detalle aumentado de la unión de la bandeja blanda con el conector. Figure 18 shows an enlarged detail isometric view of the junction of the soft tray with the connector.
La figura 19 muestra una vista isométrica en detalle aumentado de la unión de la bandeja blanda, la bandeja rígida baja y el conector. Figure 19 shows an enlarged detail isometric view of the junction of the soft tray, the low rigid tray and the connector.
La figura 20 muestra una vista isométrica del aparato de acuerdo a una tercera modalidad. Figure 20 shows an isometric view of the apparatus according to a third embodiment.
DESCRIPCIÓN DETALLADA DE LA INVENCIÓN DETAILED DESCRIPTION OF THE INVENTION
La presente invención se relaciona con un aparato (1) para contener y transportar un órgano ex- vivo conectado a una máquina de perfusión (no ilustrada) por medio de al menos dos conductos (A) de perfusión, que permite poner o sacar el órgano desde un contenedor de transporte sin desconectarlo desde los conductos (A) de perfusión. The present invention relates to an apparatus (1) for containing and transporting an ex vivo organ connected to a perfusion machine (not shown) by means of at least two perfusion conduits (A), which allows the organ to be inserted or removed from a transport container without disconnecting it from the infusion lines (A).
De acuerdo a lo ilustrado en la FIG.l, el aparto (1) comprende medios de sujeción periférica, temporal y removible (300) de los conductos de perfusión (A) respecto de un contenedor del órgano (10), donde los medios de sujeción (300) comprenden un conector (310) en forma de clip de fijación radial removible que al fijarse evita temporalmente el desplazamiento axial de los conductos (A) y al removerlo libera a los conductos (A) permitiendo colocar o sacar el órgano desde el contenedor (10) sin desconectarlo desde la máquina de perfusión. According to what is illustrated in FIG. 1, the section (1) comprises peripheral, temporary and removable holding means (300) of the perfusion lines (A) with respect to a container of the organ (10), where the means of clamp (300) comprise a connector (310) in the form of a removable radial fixing clip that when fixed temporarily prevents axial displacement of the ducts (A) and when removed frees the ducts (A) allowing the organ to be placed or removed from the container (10) without disconnecting it from the perfusion.
Tal como se muestra en la FIG.2, los medios de sujeción periférica, temporal y removible de los conductos (A) de perfusión (no ilustrados) comprenden unos canales guía (301,302) donde se posicionan dichos conductos (A) y un conjunto de pares de perforaciones (303) adyacentes a cada lado de los canales guía (301,302), las que son receptoras del conector (310) de fijación radial que estabiliza la posición de los conductos en relación con el contenedor (10) evitando su desplazamiento axial. As shown in FIG. 2, the peripheral, temporary and removable fastening means of the perfusion lines (A) (not illustrated) comprise guide channels (301,302) where said lines (A) and a set of pairs of perforations (303) adjacent to each side of the guide channels (301,302), which are receiving the radial fixing connector (310) that stabilizes the position of the conduits in relation to the container (10) avoiding their axial displacement.
En referencia a la FIG.3, dicho contenedor (10) comprende una carcasa (100) donde se acoplan los conectores (310), un reservorio interno (110), un sistema de soporte directo (200) del órgano y una cubierta protectora (400). Referring to FIG. 3, said container (10) comprises a housing (100) where the connectors (310) are coupled, an internal reservoir (110), a direct support system (200) of the organ and a protective cover ( 400).
Así como se ilustra en la FIG.4, la carcasa (100) se conforma por un cuerpo de paredes laterales perimetrales (101), un borde superior perimetral (102) con un lado frontal (103) y posterior (104) que son más anchos que sus lados laterales (105) y a partir de dicho borde superior perimetral (102) se dispone el reservorio interno (110). As illustrated in FIG. 4, the casing (100) is made up of a body of perimeter side walls (101), a perimeter top edge (102) with a front (103) and rear (104) side that are more wider than its lateral sides (105) and from said upper perimeter edge (102) the internal reservoir (110) is arranged.
Dicho reservorio interno (110), mejor enseñado en la FIG.5, está formado por una pared inferior inclinada (111) de contornos (112) redondeados unidos a paredes perimetrales interiores (113) de borde superior escalonado (114), donde la pared inferior inclinada (111) se orienta descendente desde el lado frontal (103) hacia el lado posterior (104) de la carcasa (100). Tal como se aprecia en la FIG.6, el reservorio interno (110) cuenta con medios de recirculación de fluidos y medios antiespuma; donde los medios de recirculación comprenden un canal guía (121) inferior ubicado en la mitad posterior de la pared inclinada (111) y es de recorrido curvo, de fondo (122) inclinado descendente hacia la zona central (123) donde se dispone un enganche (124) en el que se fija uno de los conductos (A) de perfusión que extrae los fluidos de drenaje que se acumulan en el fondo del reservorio (110); en tanto, los medios antiespuma del reservorio (110) comprenden un resalte central (131) de pared superior (132) curva descendente hacia la pared inferior inclinada (111), donde la pared superior (132) comprende hendiduras (133) que reciben el fluido de drenaje del órgano y lo dirigen suave y lentamente hacia la pared inferior inclinada (111). Said internal reservoir (110), best shown in FIG. 5, is formed by an inclined lower wall (111) with rounded contours (112) attached to interior perimeter walls (113) with a stepped upper edge (114), where the wall inclined bottom (111) is oriented downward from the front side (103) towards the rear side (104) of the casing (100). As seen in FIG.6, the internal reservoir (110) has fluid recirculation means and antifoam means; where the recirculation means comprise a lower guide channel (121) located in the rear half of the inclined wall (111) and is curved, bottom (122) sloping downward towards the central area (123) where a hook is provided (124) in which one of the perfusion conduits (A) is fixed, which extracts the drainage fluids that accumulate in the bottom of the reservoir (110); meanwhile, the antifoam means of the reservoir (110) comprise a central projection (131) of the upper wall (132) curving downwards towards the inclined lower wall (111), where the upper wall (132) comprises grooves (133) that receive the organ drainage fluid and gently and slowly direct it to the sloping lower wall (111).
Así como se muestra mejor en la FIG.7, la carcasa (100) posee una cavidad inferior (106) donde se dispone un medio de regulación de la temperatura que consiste en una placa eléctrica (500). As is best shown in FIG. 7, the casing (100) has a lower cavity (106) where a temperature regulation means consisting of an electrical plate (500) is provided.
El sistema de soporte directo (200) del órgano comprende, de acuerdo a una de las realizaciones de la invención, ilustrado en la FIG.8, FIG.9 y FIG.10, una bandeja rígida (210) honda que da soporte al órgano, la que se forma por una pared inferior (211) unida en su contorno a paredes perimetrales (212) cuya altura define la profundidad de la bandeja, posee un borde superior perimetral (213) seguido hacia afuera por un canal perimetral (214) que remata en un resalte vertical perimetral (215) en cuyo lado frontal (216) presenta una muesca central (217) en el borde inferior y dos muescas laterales (218) en el borde superior, donde la muesca central (217) se proyecta hacia dentro en forma de canal invertido (219); comprende una serie de calados menores (220) alineados cercanos al borde superior perimetral vertical (213) que son aberturas de evacuación de fluido de sobrellenado. En otra realización de la invención, tal cual se ve en la FIG.ll, el sistema de soporte directo del órgano incluye una bandeja blanda (250) que da soporte protector al órgano y que se coloca por sobre una bandeja rígida baja (230). The direct organ support system (200) comprises, according to one of the embodiments of the invention, illustrated in FIG. 8, FIG. 9 and FIG. 10, a deep rigid tray (210) that supports the organ , which is formed by a lower wall (211) joined in its contour to perimeter walls (212) whose height defines the depth of the tray, has a perimeter upper edge (213) followed outwards by a perimeter channel (214) that It ends in a perimeter vertical projection (215) on whose front side (216) it has a central notch (217) on the lower edge and two lateral notches (218) on the upper edge, where the central notch (217) projects inward. inverted channel (219); it comprises a series of aligned minor drafts (220) close to the vertical perimeter upper edge (213) that are openings for evacuation of overfilling fluid. In another embodiment of the invention, as seen in FIG.ll, the direct organ support system includes a soft tray (250) that provides protective support to the organ and which is placed on a low rigid tray (230) .
Dicha bandeja rígida baja (230), mejor enseñada en la FIG.12, comprende una placa (231) con un contorno superior perimetral (232) escalonado que tiene un lado frontal (233); la placa (231) comprende una zona central rehundida (234) con aberturas de drenaje (235); mientras que dicho lado frontal (233) presenta una muesca central (236) en el borde inferior y dos muescas laterales (238) en el borde superior, donde la muesca central (236) se proyecta hacia dentro en forma de canal invertido (237). La placa (231) comprende dos hendiduras alargadas (239) flanqueadas por sendas perforaciones laterales (240), dispuestas cercanas al lado frontal (233). La bandeja blanda (250), tal cual se ilustra en la FIG.13, se forma por una placa (251) cóncava con una superficie superior (252), un borde perimetral plano radial (253) que tiene un lado frontal (254) y posee un resalte perimetral (255); comprende una zona central rehundida (256) con aberturas de drenaje (257) y una pluralidad de resaltes leves (258) dispuestos en la superficie superior (252) de la placa (251). También comprende tres muescas en el lado frontal (254) del borde perimetral plano radial (253), una muesca central mayor (259) que se extiende hacia dentro de la placa (251) y dos muescas laterales menores (260); en tanto la placa (251) comprende dos calados (261) mayores cercanos al lado frontal (254), cada uno formado por un área central ampliada (262) y dos extensiones alargadas (263). Tal como se aprecia en la FIG.14 y FIG.15, el conector (310) en forma de clip de fijación radial que permite fijar los conductos de perfusión en el contenedor, comprende un cuerpo formado por una porción principal (311) y porciones flexibles (320) plegadas con extremos superiores libres (321), dispuestas una a cada lado de la porción principal (311). La porción principal (311) comprende una placa con un calado central (312), faldones frontal y posterior (313), cada uno con una muesca inferior (314) de forma semicircular. Las porciones flexibles (320) se extienden en forma de plano plegado con porciones verticales interiores (322) y porciones exteriores flexibles (323) divergentes hacia los extremos superiores libres (321) a partir de unas aristas inferiores (324) redondeadas. Said low rigid tray (230), best shown in FIG.12, comprises a plate (231) with a stepped perimeter upper contour (232) having a front side (233); the plate (231) comprises a recessed central area (234) with drainage openings (235); while said front side (233) has a central notch (236) on the lower edge and two lateral notches (238) on the upper edge, where the central notch (236) projects inwards in the form of an inverted channel (237) . The plate (231) comprises two elongated slits (239) flanked by respective lateral perforations (240), arranged close to the front side (233). The soft tray (250), as illustrated in FIG. 13, is formed by a concave plate (251) with a top surface (252), a radial flat perimeter edge (253) having a front side (254) and it has a perimeter projection (255); it comprises a recessed central area (256) with drainage openings (257) and a plurality of slight projections (258) arranged on the upper surface (252) of the plate (251). It also comprises three notches on the front side (254) of the radial flat perimeter edge (253), a larger central notch (259) extending into the plate (251), and two minor side notches (260); while the plate (251) comprises two major openings (261) close to the front side (254), each one formed by an enlarged central area (262) and two elongated extensions (263). As seen in FIG. 14 and FIG. 15, the connector (310) in the form of a radial fixing clip that allows the perfusion lines to be fixed in the container, comprises a body formed by a main portion (311) and portions flexible (320) folded with free upper ends (321), arranged one on each side of the main portion (311). The main portion (311) comprises a plate with a central cutout (312), front and rear skirts (313), each with a lower notch (314) of semicircular shape. The flexible portions (320) extend in a folded plane with vertical interior portions (322) and flexible exterior portions (323) diverging toward the free upper ends (321) from rounded lower edges (324).
Las porciones exteriores flexibles (323) presentan, en su cara exterior (325) un resalte de fijación (326) y unos resaltes antideslizantes (327); donde el resalte de fijación (326) comprende un perfil triangular de 124ado superior horizontal (328) que actúa de tope para impedir que el conector (310) se salga cuando está instalado. The flexible outer portions (323) have, on their outer face (325) a fixing projection (326) and anti-slip projections (327); where the fixing projection (326) comprises a triangular 124 top horizontal profile (328) that acts as a stop to prevent the connector (310) from coming out when installed.
Tal cual se ve en la FIG.16, la cubierta protectora (400) es translúcida y comprende paredes perimetrales (401) y una pared superior (402), donde al menos una de las paredes perimetrales (401) presenta una muesca central semicircular (403) y dos muescas laterales semicirculares alargadas (404) dispuestas en su borde inferior. As seen in FIG. 16, the protective cover (400) is translucent and comprises perimeter walls (401) and an upper wall (402), where at least one of the perimeter walls (401) has a semicircular central notch ( 403) and two elongated semicircular lateral notches (404) arranged on its lower edge.
En uso del aparato, tal cual se ve en la FIG.17, los conectores (310) en forma de clip se introducen por sus aristas inferiores (324) dentro de cada par de perforaciones (303) adyacentes a cada lado de los canales guía (301,302) de los medios de sujeción periférica. Donde los conectores (310) se colocan por sobre los conductos (A) de perfusión que a su vez se posan en los canales guía (301,302), donde la muesca inferior (314) de los conectores (310) queda en contacto con el cuerpo cilindrico de los conductos fijándolos radialmente en su posición contra dichos canales. In use of the apparatus, as seen in FIG. 17, the clip connectors (310) are inserted through their lower edges (324) into each pair of perforations (303) adjacent to each side of the guide channels (301,302) of the peripheral clamping means. Where the connectors (310) are placed above the perfusion conduits (A) which in turn rest on the guide channels (301,302), where the lower notch (314) of the connectors (310) is in contact with the cylindrical body of the ducts, fixing them radially in position against said channels.
En la realización del aparato donde se dispone la bandeja rígida baja (230) en conjunto con la bandeja landa (250), tal cual se ve en la FIG.18, los conectores (310) en forma de clip se introducen dentro de cada área central ampliada (262) de los calados mayores (261) de la bandeja blanda (250) y a su vez, tal como se ve an la FIG.19, los conectores (310) se introducen dentro de las perforaciones laterales (242) de la bandeja rígida baja (230); en tanto el conducto de perfusión entra por la muesca lateral (238) de la bandeja rígida (230) y la muesca , se posa en la hendidura alargada (239) y la muesca lateral (260) de la bandeja blanda (250), para salir por las extensiones alargadas (263) y unirse al órgano. In the embodiment of the apparatus where the low rigid tray (230) is arranged together with the flat tray (250), as seen in FIG. 18, the clips (310) are inserted into each area enlarged center (262) of the major openings (261) of the soft tray (250) and in turn, as seen in FIG. 19, the connectors (310) are inserted into the lateral perforations (242) of the low rigid tray (230); as the perfusion conduit enters through the lateral notch (238) of the rigid tray (230) and the notch, it lands on the elongated slit (239) and the lateral notch (260) of the soft tray (250), to exit through the elongated extensions (263) and join the organ.
En el caso de la realización con la bandeja honda, tal cual se ve en la FIG.20, el borde perimetral (213) de la bandeja se alza hacia arriba por sobre el borde superior (102) de la carcasa y la zona donde se disponen los canales guías en dicho borde superior de la carcasa cuenta con unas piezas auxiliares de alzado (600) que cuentan con el mismo canal guía (601) y sus calados laterales (602) donde se inserta el conector (310) para el paso de los conductos (A) de perfusión laterales que van a conectarse directo con el órgano, donde estas pieza auxiliares elevan la conexión de los conectores para que los conductos de perfusión queden alineados longitudinalmente y entren hacia la bandeja de manera recta. In the case of the embodiment with the deep tray, as seen in FIG. 20, the perimeter edge (213) of the tray rises up above the upper edge (102) of the housing and the area where the guide channels are provided in said upper edge of the housing, it has auxiliary lifting parts (600) that have the same guide channel (601) and its lateral openings (602) where the connector (310) is inserted for the passage of the lateral perfusion lines (A) that are to be connected directly to the organ, where these auxiliary pieces raise the connection of the connectors so that the perfusion lines are longitudinally aligned and enter the tray straight.

Claims

REIVINDICACIONES
1. Aparato (1) para contener y transportar un órgano ex- vivo conectado a una máquina de perfusión por medio de al menos dos conductos de perfusión (A), que permite poner o sacar el órgano desde un contenedor de transporte sin desconectarlo desde los conductos de perfusión, CARACTERIZADO porque comprende medios de sujeción periférica, temporal y removible (300) de los conductos de perfusión (A) respecto de un contenedor del órgano (10), donde los medios de sujeción (300) comprenden un conector (310) en forma de clip de fijación radial removible que al fijarse evita temporalmente el desplazamiento axial de los conductos y al removerlo libera a los conductos permitiendo colocar o sacar el órgano desde el contenedor sin desconectarlo desde la máquina de perfusión. 1. Apparatus (1) for containing and transporting an ex vivo organ connected to a perfusion machine by means of at least two perfusion lines (A), which allows the organ to be put in or out of a transport container without disconnecting it from the perfusion lines, CHARACTERIZED in that it comprises peripheral, temporary and removable holding means (300) of the perfusion lines (A) with respect to an organ container (10), where the holding means (300) comprise a connector (310) in the form of a removable radial fixation clip that when fixed temporarily prevents axial displacement of the conduits and when removed frees the conduits allowing the organ to be placed or removed from the container without disconnecting it from the perfusion machine.
2. Aparato (1) de acuerdo a la reivindicación 1, CARACTERIZADO porque los medios de sujeción (300) periférica, temporal y removible de los conductos de perfusión comprenden unos canales guía (301,302) donde se posicionan los conductos de perfusión (A) y un conjunto de pares de perforaciones (303) adyacentes a cada lado de los canales guía (301,302), las que son receptoras del conector (310) de fijación radial que estabiliza la posición de los conductos en relación con el contenedor (10) evitando su desplazamiento axial. 2. Apparatus (1) according to claim 1, CHARACTERIZED in that the peripheral, temporary and removable holding means (300) of the perfusion lines comprise guide channels (301,302) where the perfusion lines (A) are positioned and a set of pairs of perforations (303) adjacent to each side of the guide channels (301,302), which are receivers of the radial fixing connector (310) that stabilizes the position of the conduits in relation to the container (10) avoiding their axial displacement.
3. Aparato (1), de acuerdo a la reivindicación 2, CARACTERIZADO porque dicho contenedor (10) comprende una carcasa (100) con un reservorio interno (110), un sistema de soporte directo (200) del órgano y una cubierta protectora (400). 3. Apparatus (1) according to claim 2, CHARACTERIZED in that said container (10) comprises a casing (100) with an internal reservoir (110), a direct support system (200) of the organ and a protective cover ( 400).
4. Aparato (1) de acuerdo a la reivindicación 3, CARACTERIZADO porque la carcasa (100) se conforma por un cuerpo de paredes laterales perimetrales (101), un borde superior perimetral 4. Apparatus (1) according to claim 3, CHARACTERIZED in that the casing (100) is formed by a body of perimeter side walls (101), a perimeter upper edge
1 (102) con un lado frontal (103) y posterior (104) que son más anchos que sus lados laterales (105) y a partir de dicho borde superior perimetral (102) se dispone el reservorio interno (110). one (102) with a front (103) and rear (104) side that are wider than its lateral sides (105) and from said upper perimeter edge (102) the internal reservoir (110) is arranged.
5. Aparato (1) de acuerdo a la reivindicación 4, CARACTERIZADO porque el reservorio interno (110) está formado por una pared inferior inclinada (111) de contornos (112) redondeados unidos a paredes perimetrales interiores (113) de borde superior escalonado (114). 5. Apparatus (1) according to claim 4, CHARACTERIZED in that the internal reservoir (110) is formed by an inclined lower wall (111) of rounded contours (112) joined to inner perimeter walls (113) of stepped upper edge ( 114).
6. Aparato (1) de acuerdo a la reivindicación 5, CARACTERIZADO porque la pared inferior inclinada (111) se orienta descendente desde el lado frontal (103) hacia el lado posterior (104) del contenedor (100). 6. Apparatus (1) according to claim 5, CHARACTERIZED in that the inclined bottom wall (111) is oriented downwards from the front side (103) towards the rear side (104) of the container (100).
7. Aparato (1) de acuerdo a la reivindicación 5, CARACTERIZADO porque el reservorio interno (110) cuenta con medios de recirculación de fluidos (120) y medios antiespuma (130), 7. Apparatus (1) according to claim 5, CHARACTERIZED in that the internal reservoir (110) has fluid recirculation means (120) and antifoam means (130),
8. Aparato (1) de acuerdo a la reivindicación 7, CARACTERIZADO porque los medios de recirculación (120) comprenden un canal guía (121) inferior ubicado en la mitad posterior de la pared inclinada (111). 8. Apparatus (1) according to claim 7, CHARACTERIZED in that the recirculation means (120) comprise a lower guide channel (121) located in the rear half of the inclined wall (111).
9. Aparato (1) de acuerdo a la reivindicación 8, CARACTERIZADO porque el canal guía (121) es de recorrido curvo, de fondo (122) inclinado descendente hacia la zona central (123) donde se dispone un enganche (124) en el que se fija uno de los conductos de perfusión (B) que extrae los fluidos de drenaje que se acumulan en el fondo del reservorio (110). 9. Apparatus (1) according to claim 8, CHARACTERIZED in that the guide channel (121) has a curved path, a bottom (122) inclined downwards towards the central area (123) where a hook (124) is arranged in the that one of the perfusion lines (B) is fixed, which extracts the drainage fluids that accumulate in the bottom of the reservoir (110).
2 two
10. Aparato (1) de acuerdo a la reivindicación 7, CARACTERIZADO porque los medios antiespuma (130) del reservorio (110) comprenden un resalte central (131) de pared superior (132) curva descendente hacia la pared inferior inclinada (111). 10. Apparatus (1) according to claim 7, CHARACTERIZED in that the antifoam means (130) of the reservoir (110) comprise a central projection (131) of upper wall (132) curving downwards towards the inclined lower wall (111).
11. Aparato (1) de acuerdo a la reivindicación 10, CARACTERIZADO porque el resalte central (131) comprende hendiduras (133) en la pared superior (132) que reciben el fluido de drenaje del órgano. 11. Apparatus (1) according to claim 10, CHARACTERIZED in that the central projection (131) comprises slits (133) in the upper wall (132) that receive the organ drainage fluid.
12. Aparato (1) de acuerdo a la reivindicación 1, CARACTERIZADO porque el contenedor (10) posee una cavidad inferior (106) donde se dispone un medio de regulación de la temperatura que consiste en una placa eléctrica (500). 12. Apparatus (1) according to claim 1, CHARACTERIZED in that the container (10) has a lower cavity (106) where a temperature regulation means consisting of an electrical plate (500) is provided.
13. Aparato (1) de acuerdo a la reivindicación 3, CARACTERIZADO porque el sistema de soporte directo (200) del órgano comprende una bandeja rígida (210) honda que da soporte al órgano. 13. Apparatus (1) according to claim 3, CHARACTERIZED in that the direct support system (200) of the organ comprises a deep rigid tray (210) that supports the organ.
14. Aparato (1) de acuerdo a la reivindicación 13, CARACTERIZADO porque la bandeja rígida honda (210) comprende una pared inferior (211) unida en su contorno a paredes perimetrales14. Apparatus (1) according to claim 13, CHARACTERIZED in that the deep rigid tray (210) comprises a lower wall (211) joined in its contour to perimeter walls
(212) cuya altura define la profundidad de la bandeja, posee un borde superior perimetral(212) whose height defines the depth of the tray, has a perimeter top edge
(213) seguido hacia afuera por un canal perimetral (214) que remata en un resalte vertical perimetral (215) en cuyo lado frontal (216) presenta una muesca central (217) en el borde inferior y dos muescas laterales (218) en el borde superior, donde la muesca central (217) se proyecta hacia dentro en forma de canal invertido (219). (213) followed outwards by a perimeter channel (214) ending in a perimeter vertical projection (215) on whose front side (216) it has a central notch (217) on the lower edge and two lateral notches (218) on the upper edge, where the central notch (217) projects inwards in the form of an inverted channel (219).
3 3
15. Aparato (1) de acuerdo a la reivindicación 14, CARACTERIZADO porque la bandeja rígida honda (210) comprende una serie de calados menores (220) alineados cercanos al borde superior perimetral vertical (213) que son aberturas de evacuación de fluido de sobrellenado. 15. Apparatus (1) according to claim 14, CHARACTERIZED in that the deep rigid tray (210) comprises a series of minor openings (220) aligned close to the vertical perimeter upper edge (213) that are overfill fluid evacuation openings .
16. Aparato (1) de acuerdo a la reivindicación 14, CARACTERIZADO porque la bandeja rígida baja (230) comprende una placa (231) con un contorno superior perimetral (232) escalonado que tiene un lado frontal (233), donde la placa (231) comprende una zona central rehundida (234) con aberturas de drenaje (235). 16. Apparatus (1) according to claim 14, CHARACTERIZED in that the low rigid tray (230) comprises a plate (231) with a stepped perimeter upper contour (232) having a front side (233), where the plate ( 231) comprises a recessed central area (234) with drainage openings (235).
17. Aparato (1) de acuerdo a la reivindicación 16, CARACTERIZADO porque en dicho lado frontal (233) presenta una muesca central (236) en el borde inferior (237) y dos muescas laterales (238) en el borde superior (239), donde la muesca central (236) se proyecta hacia dentro en forma de canal invertido (240). 17. Apparatus (1) according to claim 16, CHARACTERIZED because on said front side (233) it has a central notch (236) on the lower edge (237) and two lateral notches (238) on the upper edge (239) , where the central notch (236) projects inwards in the form of an inverted channel (240).
18. Aparato (1) de acuerdo a la reivindicación 16, CARACTERIZADO porque la placa (231) comprende dos hendiduras alargadas (241) flanqueadas por sendas perforaciones laterales (242), dispuestas cercanas al lado frontal (233). 18. Apparatus (1) according to claim 16, CHARACTERIZED in that the plate (231) comprises two elongated slits (241) flanked by respective lateral perforations (242), arranged close to the front side (233).
19. Aparato (1) de acuerdo a la reivindicación 13, CARACTERIZADO porque el sistema de soporte directo (200) del órgano incluye una bandeja blanda (250) que da soporte protector al órgano y se coloca por sobre la bandeja rígida baja (230). 19. Apparatus (1) according to claim 13, CHARACTERIZED in that the direct support system (200) of the organ includes a soft tray (250) that provides protective support to the organ and is placed over the low rigid tray (230) .
20. Aparato (1) de acuerdo a la reivindicación 18, CARACTERIZADO porque la bandeja blanda (250) comprende una placa (251) cóncava con una superficie superior (252), un borde perimetral plano radial (253) que tiene un lado frontal (254) y posee un resalte 20. Apparatus (1) according to claim 18, CHARACTERIZED in that the soft tray (250) comprises a concave plate (251) with an upper surface (252), a radial flat perimeter edge (253) having a front side ( 254) and has a projection
4 perimetral (255), una zona central rehundida (256) con aberturas de drenaje (257) y una pluralidad de resaltes leves (258) dispuestos en la superficie superior (252) de la placa (251). 4 perimeter (255), a recessed central area (256) with drainage openings (257) and a plurality of slight projections (258) arranged on the upper surface (252) of the plate (251).
21. Aparato (1) de acuerdo a la reivindicación 19, CARACTERIZADO porque la bandeja blanda (250) comprende tres muescas en el lado frontal (254) del borde perimetral plano radial (253), una muesca central mayor (258) que se extiende hacia dentro de la placa (251) y dos muescas laterales menores (259) 21. Apparatus (1) according to claim 19, CHARACTERIZED in that the soft tray (250) comprises three notches on the front side (254) of the radial plane perimeter edge (253), a larger central notch (258) that extends towards the inside of the plate (251) and two smaller lateral notches (259)
22. Aparato (1) de acuerdo a la reivindicación 19, CARACTERIZADO porque la placa (251) comprende dos calados (260) mayores cercanos al lado frontal (254), cada uno formado por un área central ampliada (261) y dos extensiones alargadas (262). 22. Apparatus (1) according to claim 19, CHARACTERIZED in that the plate (251) comprises two major openings (260) close to the front side (254), each formed by an enlarged central area (261) and two elongated extensions (262).
23. Aparato (1) de acuerdo a la reivindicación 1, CARACTERIZADO porque el conector (310) en forma de clip de fijación radial comprende un cuerpo formado por una porción principal (311) y porciones flexibles (320) plegadas con extremos superiores libres (321), dispuestas una a cada lado de la porción principal (311). 23. Apparatus (1) according to claim 1, CHARACTERIZED in that the radial fixing clip-shaped connector (310) comprises a body formed by a main portion (311) and folded flexible portions (320) with free upper ends ( 321), arranged one on each side of the main portion (311).
24. Aparato (1) de acuerdo a la reivindicación 24, CARACTERIZADO porque la porción principal (311) comprende una placa con un calado central (312), faldones frontal y posterior (313), cada uno con una muesca inferior (314) de forma semicircular. 24. Apparatus (1) according to claim 24, CHARACTERIZED in that the main portion (311) comprises a plate with a central cutout (312), front and rear skirts (313), each with a lower notch (314) of semicircular shape.
25. Aparato (1) de acuerdo a la reivindicación 24, CARACTERIZADO porque porque las porciones flexibles (320) se extienden en forma de plano plegado con porciones verticales interiores (322) y porciones exteriores flexibles (323) divergentes hacia los extremos superiores libres (321) a partir de unas aristas inferiores (324) redondeadas. 25. Apparatus (1) according to claim 24, CHARACTERIZED in that the flexible portions (320) extend in a folded plane with vertical inner portions (322) and flexible outer portions (323) diverging towards the free upper ends ( 321) from rounded lower edges (324).
5 5
26. Aparato (1) de acuerdo a la reivindicación 24, CARACTERIZADO porque las porciones exteriores flexibles (323) presentan, en su cara exterior (325) un resalte de fijación (326) y unos resaltes antideslizantes (327). 26. Apparatus (1) according to claim 24, CHARACTERIZED in that the flexible outer portions (323) have, on their outer face (325) a fixing projection (326) and anti-slip projections (327).
27. Aparato (1) de acuerdo a la reivindicación 27, CARACTERIZADO porque el resalte de fijación (326) comprende un perfil triangular de lado superior horizontal (328) que actúa de tope para impedir que el conector (310) se salga. 27. Apparatus (1) according to claim 27, CHARACTERIZED in that the fixing projection (326) comprises a triangular profile with a horizontal upper side (328) that acts as a stop to prevent the connector (310) from coming out.
28. Aparato (1) de acuerdo a la reivindicación 3, CARACTERIZADO porque la cubierta protectora (400) comprende paredes perimetrales (401) y una pared superior (402), donde al menos una de las paredes perimetrales (401) presenta una muesca central semicircular (403) y dos muescas laterales semicirculares alargadas (404) dispuestas en su borde inferior (405). 28. Apparatus (1) according to claim 3, CHARACTERIZED in that the protective cover (400) comprises perimeter walls (401) and an upper wall (402), where at least one of the perimeter walls (401) has a central notch semicircular (403) and two elongated semicircular lateral notches (404) arranged on its lower edge (405).
29. Aparato (1) de acuerdo a cualquiera de las reivindicaciones anteriores, CARACTERIZADO porque los conectores (310) en forma de clip se introducen por sus aristas inferiores (324) dentro de cada par de perforaciones (303) adyacentes a cada lado de los canales guía (301,302) de los medios de sujeción (300) periférica. 29. Apparatus (1) according to any of the preceding claims, CHARACTERIZED in that the clip-shaped connectors (310) are inserted through their lower edges (324) into each pair of perforations (303) adjacent to each side of the guide channels (301,302) of the peripheral clamping means (300).
30. Aparato (1) de acuerdo a cualquiera de las reivindicaciones anteriores, CARACTERIZADO porque los conectores (310) en forma de clip se introducen por sus aristas inferiores (324) dentro de cada área central ampliada (261) de los calados (260) mayores de la bandeja blanda (250) y a su vez dentro de las perforaciones laterales (242) de la placa (231) de la bandeja rígida baja (230) cuando está soportando a la bandeja blanda (250). 30. Apparatus (1) according to any of the preceding claims, CHARACTERIZED in that the clip-shaped connectors (310) are inserted by their lower edges (324) into each enlarged central area (261) of the openings (260) larger than the soft tray (250) and in turn within the lateral perforations (242) of the plate (231) of the low rigid tray (230) when it is supporting the soft tray (250).
6 6
31. Aparato (1) de acuerdo a cualquiera de las reivindicaciones anteriores, CARACTERIZADO porque los conectores (310) se colocan por sobre los conductos de perfusión (A) que se posan en los canales guía (301,302), donde cada muesca inferior (314) de los conectores (310) queda en contacto con el cuerpo cilindrico de los conductos fijándolos radialmente en su posición contra dichos canales. 31. Apparatus (1) according to any of the preceding claims, CHARACTERIZED in that the connectors (310) are placed above the perfusion lines (A) that rest on the guide channels (301,302), where each lower notch (314 ) of the connectors (310) remains in contact with the cylindrical body of the conduits, fixing them radially in position against said channels.
32. Aparato (1) de acuerdo a cualquiera de las reivindicaciones anteriores, CARACTERIZADO porque la carcasa comprende unas piezas auxiliares (600) en su lado frontal, que comprenden una placa alzada con un canal guía y calados a cada uno de sus lados. 32. Apparatus (1) according to any of the preceding claims, CHARACTERIZED in that the housing comprises auxiliary parts (600) on its front side, which comprise a raised plate with a guide channel and openings on each of its sides.
7 7
PCT/CL2018/050149 2018-12-27 2018-12-27 Apparatus for containing and transporting an ex-vivo organ connected to a perfusion machine WO2020132755A1 (en)

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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2012128696A1 (en) * 2011-03-23 2012-09-27 Vivoline Medical Ab Apparatus for maintaining a harvested organ viable and transportable
WO2015102524A1 (en) * 2013-12-30 2015-07-09 Vivoline Medical Ab Insert for an organ transport device
US20150342178A1 (en) * 2009-09-25 2015-12-03 Vivoline Medical Ab Container and supporting structure for housing an organ
CN108094403A (en) * 2017-11-30 2018-06-01 广东顺德工业设计研究院(广东顺德创新设计研究院) Isolated organ perfusion container
US20190082679A1 (en) * 2017-09-15 2019-03-21 The Cleveland Clinic Foundation Device for support of an organ ex vivo and method using such device

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20150342178A1 (en) * 2009-09-25 2015-12-03 Vivoline Medical Ab Container and supporting structure for housing an organ
WO2012128696A1 (en) * 2011-03-23 2012-09-27 Vivoline Medical Ab Apparatus for maintaining a harvested organ viable and transportable
WO2015102524A1 (en) * 2013-12-30 2015-07-09 Vivoline Medical Ab Insert for an organ transport device
US20190082679A1 (en) * 2017-09-15 2019-03-21 The Cleveland Clinic Foundation Device for support of an organ ex vivo and method using such device
CN108094403A (en) * 2017-11-30 2018-06-01 广东顺德工业设计研究院(广东顺德创新设计研究院) Isolated organ perfusion container

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