Density phase separation device.
Abstract
A mechanical separator for separating a sample of fluid in a first and second phase is described. The separator includes a float, a ballast assembly that can move longitudinally with respect to the float and a bellows structure. The bellows structure includes a first end, a second end and a deformable bellows between them. The float is attached to a part of the first end of the bellows structure and the ballast is joined to a part of the second end of the bellows structure. The float and bellows structure attached include an interference coupling between them that can be released. The float has a first density and the ballast has a second density that is greater than the first density of the float.

Term
4.3 yearsleft in the term
Expires 20 January 2031.
- Priority
- Filed
- Granted
- Today
- Expires
14 claims: 4 independent, 10 dependent
- 1REIVINDICACIONES 1. Un separador mecánico que comprende:una estructura de fuelle que comprende un primer extremo, un segundo extremo y un fuelle deformable entre los mismos;un flotador;y un conjunto de lastre que puede moverse longitudinalmente con respecto al flotador, comprendiendo el conjunto de lastre una primera sección de lastre y una segunda sección de lastre unida a la primera sección de lastre a través de una parte de la estructura de fuelle.
- 2El separador mecánico de la reivindicación 1, en donde el flotador tiene una primera densidad y el conjunto de lastre tiene una segunda densidad que es mayor que la primera densidad del flotador.
- 3El separador mecánico de la reivindicación 1, en donde el flotador se une a una parte del primer extremo de la estructura de fuelle y el conjunto de lastre se une a una parte del segundo extremo de la estructura de fuelle, comprendiendo además el flotador y la estructura de fuelle unidos un acoplamiento por interferencia entre los mismos que se puede liberar para mantener al flotador en relación fija con respecto a la estructura de fuelle.
- 4El separador mecánico de la reivindicación 3, en donde el acoplamiento por interferencia que se puede liberar está adaptado para liberarse con la centrifugación.
- 5El separador mecánico de la reivindicación 1, en donde la estructura de fuelle define un interior y el flotador se retiene de forma que pueda liberarse dentro de una parte del interior de la estructura de fuelle.
- 6El separador mecánico de la reivindicación 1, en donde la primera sección de lastre y la segunda sección de lastre están orientadas de forma opuesta alrededor de un eje longitudinal del separador mecánico.
- 7El separador mecánico de la reivindicación 1, en donde el flotador comprende una parte de cabezal que define una abertura a través de la misma para permitir el purgado de aire desde dentro del interior de un flotador al exterior del área del separador mecánico.
- 8El separador mecánico de la reivindicación 1, en donde la estructura de fuelle comprende una rendija de purgado que permite el purgado de aire desde el interior del flotador al exterior del área del separador mecánico.
- 9El separador mecánico de la reivindicación 1, en donde la estructura de fuelle comprende una rendija de purgado que permite el purgado de aire desde una cámara definida por un interior de la estructura fuelle y un exterior del flotador al exterior del área del separador mecánico.
- 10Un separador mecánico que comprende:un flotador;un conjunto de lastre que puede moverse longitudinalmente con respecto al flotador;y una estructura de fuelle que comprende un primer extremo, un segundo extremo y un fuelle deformable entre los mismos, en donde el flotador se une a una parte del primer extremo de la estructura de fuelle y el conjunto de lastre se une a una parte del segundo extremo de la estructura de fuelle, comprendiendo además el flotador y la estructura de fuelle unidos un acoplamiento por interferencia entre los mismos que se puede liberar para mantener el flotador en relación fija con respecto a la estructura de fuelle, en donde el conjunto de lastre comprende una pluralidad de secciones de lastre.
- 11El separador mecánico de la reivindicación 10, en donde el conjunto de lastre comprende una primera sección de lastre y una segunda sección de lastre unida a la primera sección de lastre a través de una parte de la estructura de fuelle.
- 12El separador mecánico de la reivindicación 10, en donde la primera sección de lastre y la segunda sección de lastre están orientadas de forma opuesta alrededor de un eje longitudinal del separador mecánico.
- 13Un conjunto de separación para permitir la separación de una muestra de fluido en la primera y segunda fases, que comprende:un tubo, que tiene al menos un extremo abierto, un segundo extremo y una pared lateral que se extiende entre los mismos;un cierre adaptado para sellar el acoplamiento con el extremo abierto del tubo, definiendo el cierre un rebaje;y un separador mecánico acoplado de forma que se pueda liberar con el rebaje, comprendiendo el separador mecánico: un flotador;un conjunto de lastre que puede moverse longitudinalmente con respecto al flotador;y una estructura de fuelle que comprende un primer extremo, un segundo extremo y un fuelle deformable entre los mismos, en el que el flotador se une a una parte del primer extremo mediante un acoplamiento por interferencia que se puede liberar entre los mismos para mantener el flotador en relación fija con respecto a la estructura de fuelle y el conjunto de lastre se une a una parte del segundo extremo, en donde el conjunto de lastre comprende una primera sección de lastre y una segunda sección de lastre unida a la primera sección de lastre a través de una parte de la estructura de fuelle.
- 14El conjunto de separación de la reivindicación 13, en donde la primera sección de lastre y la segunda 65 . ' sección de lastre están orientadas de forma opuesta alrededor de un eje longitudinal del separador mecánico.
Independent claims14
136 paragraphs in 7 sections, as filed
DIVISIONAL SUB-DIRECTOR OF PATENT FUND EXAMINATION MECHANICAL, ELECTRICAL AND INDUSTRIAL DESIGNS AND UTILITY MODELS PEDRO DAVID FRAGOSO LÓPEZ Original Chain:
PEDRO DAVID FRAGOSO LOPEZ | 00001000000405457619 | Tax Administration Service | 1052 || MX / 2019/59916 | MX / a / 2014/007859 | Normal patent title with divisional PCT | 1048 | SEF |
Digital stamp:
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MX 2019 59916
DENSITY PHASE SEPARATION DEVICE
CROSS REFERENCE WITH A RELATED APPLICATION
This application claims priority over U.S. Provisional Patent Application No. 61 / 082,365, filed on July 21, 2008, entitled Density Phase Separation Device, the full description of which is incorporated herein by reference.
BACKGROUND OF THE INVENTION
Field of the Invention
The object of the invention relates to a device and method for separating heavier and lighter fractions from a fluid sample. More particularly, this invention relates to a device and method for collecting and transporting fluid samples whereby the device and the fluid sample are subjected to centrifugation to cause separation of the heaviest fraction from the lightest fraction of the sample. of the fluid.
Description of Related Technique
Diagnostic tests may require the separation of a patient's whole blood sample into components, such as serum or plasma (the lightest phase component) and red blood cells (the heaviest phase component). Samples of whole blood are typically collected by venous puncture through a cannula or needle attached to a syringe or a collection tube of blood drawn. After collection, the separation of blood into serum or plasma and red blood cells is performed by rotating the syringe or a tube in a centrifuge. To maintain the separation, a barrier must be placed between the heaviest and lightest phase components. This allows separate components to be examined later.
A variety of separation barriers have been used in the collection devices to divide the area between the heaviest and lightest phases of a fluid sample. The vast majority of the devices used include thixotropic gel materials, such as polyester gels. However, today's polyester gel serum separation tubes require special manufacturing equipment both to prepare the gel and to fill the tubes. In addition, the shelf life of the product is limited. Over time, globules can be released from the gel mass and introduced into one or both of the components of separate phases. These globules can obstruct the measuring instruments, such as the probes of the instruments used during the clinical examination of the sample collected in the tube. Additionally, commercially available gel barriers can react chemically with analytes. Therefore, if certain drugs are present when the blood sample is taken, an adverse chemical reaction with the gel interface may occur.
Certain mechanical separators have also been proposed in which a mechanical barrier can be used between the heaviest and lightest phases of the fluid sample. Conventional mechanical barriers are placed between the heaviest and lightest phase components using differential buoyancy and high gravitational forces applied during centrifugation. For proper orientation with respect to serum and plasma samples, conventional mechanical separators typically require that the mechanical separator be fixed at the bottom of the tube closure such that blood filling occurs through or around the device. when coupled with the blood collection equipment. This fixation is needed to prevent premature movement of the separator during shipping, handling and blood collection. Conventional mechanical separators are fixed to the tube closure by a mechanical interlocking between the bellows component and the closure. Examples of devices are described in U.S. Patent Nos. 6,803,022 and 6,479,298.
Conventional mechanical separators have some significant drawbacks. As shown in Figure 1, conventional separators include a bellows 34 to provide a seal with the wall of the syringe or tube 38. Typically, at least a portion of the bellows 34 is housed in or in contact with a closure 32. As shown in Figure 1, when the needle 30 enters through the closure 32, the bellows 34 is pressed. This creates a vacuum 36 where blood can accumulate when the needle 30 is removed. This can result in problems of needle withdrawal, sample accumulation under the closure, prepropulsion of the device in which the mechanical separator is released. prematurely during blood collection, hemolysis, fibrin bandage and / or poor sample quality. In addition, the above mechanical separators are expensive and complicated to manufacture due to complicated multi-part manufacturing techniques.
Consequently, there is a need for a separator device that is compatible with conventional sampling equipment and reduces or eliminates the aforementioned problems of conventional separators. There is also a need for a separator device that is easy to use to separate a blood sample, minimize cross contamination of the heaviest and lightest phases of the sample during centrifugation, regardless of temperature during storage and transfer and Be stable against radiation sterilization.
SUMMARY OF THE INVENTION
The present invention is directed to an assembly and method for separating a fluid sample at a higher specific gravity phase and a lower specific gravity phase. Desirably, the mechanical separator of the present invention can be used with a tube and the mechanical separator is structured to move within the tube under the action of the centrifugal force applied to separate the parts of a fluid sample. More preferably, the tube is a sample collection tube that includes an open end, a closed end or a juxtaposed end and a side wall that extends between the open end and the closed or juxtaposed end. The side wall includes an outer surface and an inner surface and the tube also includes a closed device for fixing at the open end of the tube with a resealable partition. Alternatively, both ends of the tube can be opened and both ends of the tube can be sealed by elastomeric closures. At least one of the tube closures may include a resealable partition with a needle.
The mechanical separator can be arranged inside the tube in a situation between the upper closure and the lower part of the tube. The separator includes opposite upper and lower ends and includes a float, a ballast assembly and a bellows structure. The separator components are sized and configured to achieve an overall density for the separator that is between the densities of the phases of a fluid sample, such as a blood sample.
In one embodiment, the mechanical separator is adapted for the separation of a sample of fluid in a first and a second phase within a tube. The mechanical separator includes a float, a ballast assembly that can be moved longitudinally with respect to the float and a bellows structure. The bellows structure includes a first end, a second end and a deformable bellows between them. The float can be fixed to a part of the first end of the bellows structure and the ballast assembly can be fixed to a part of the second end of the bellows structure. The fixed float and the bellows structure also include an interference coupling between them that can be released. The float may have a first density and the ballast may have a second density greater than the first density of the float. The interference coupling that can be released can be set to release when the float exceeds a centrifugal force of at least 250 g.
The interference coupling that can be released from the mechanical separator can be adapted to be released with the longitudinal deformation of the bellows structure. The bellows structure can also define an interior and the float can be retained so that it can be released within a part of the interior of the bellows structure. The bellows structure can also include an inner flange and at least a part of the float can be retained inside the first end by the inner flange.
Optionally the mechanical separator float can include a neck part and the float can be retained so that it can be released within a part of the inside of the first end by mechanical interference from the inner flange and the neck part. In another configuration, the first end of the bellows structure may include an inner coupling part that faces inwardly and the float may include an outer coupling part for mechanical interface with the inner coupling part. The first end of the bellows structure may also include a pierceable head portion that has a structured puncture tip to resist deformation upon application of a puncture tip therethrough. The float may include a head part that defines an opening through which air is allowed to be purged from an inside of the float to the outside of the mechanical separator area.
Optionally, the bellows may include a purge slit to allow purging of air from inside the float to the outside of the area of the mechanical separator. The bellows may also include a purge slit to allow air purging from a chamber defined by an interior of the bellows and an exterior of the float to an outside of the area of the mechanical separator.
In another configuration, the ballast assembly includes a plurality of matched ballast sections, such as a first ballast section and a second ballast section attached to the first bellows section through a part of the bellows structure. The first ballast section and the second ballast section can be oriented opposite about a longitudinal axis of the mechanical separator. The mechanical separator can also include a float made of polypropylene, a ballast assembly made of polyethylene terephthalate and a bellows structure made of thermoplastic elastomer. The separation assembly includes a movable plug disposed within an interior of the float.
In another embodiment, the mechanical separator for the separation of a sample of fluid in the first and second phases within a tube includes a bellows structure having a first end, a second end and a deformable bellows therebetween. The mechanical separator also includes a float and a ballast assembly that can be moved longitudinally with respect to the float. The ballast assembly includes a first ballast section and a second ballast section that are attached to the first ballast section through a part of the bellows structure. The float may have a first density and the ballast assembly may have a second density greater than the first density of the float.
The float of the mechanical separator can be fixed to a part of the first end of the bellows structure and the ballast can be attached to a part of the second end of the bellows structure. The attached float and the attached bellows structure may further include an interference coupling between them that can be released. In one configuration, the bellows structure of the mechanical separator defines an interior and the float is retained so that it can be released within a part of the interior of the bellows structure.
In another configuration, the first ballast section and the second ballast section of the ballast assembly are oriented opposite about a longitudinal axis of the mechanical separator.
Optionally, the float may include a head part that defines an opening through which it allows air purging from the inside of the float to an outside of the area of the mechanical separator. The bellows may include a purge slit to allow purging of air from inside the float to an outside of the area of the mechanical separator. In addition, the bellows may include a purge slit to allow air purging from a chamber defined by an interior of the bellows and an exterior of the float to an outside of the area of the mechanical separator.
In another embodiment, a separation assembly includes a tube that allows the separation of a sample of fluid in the first and second phases, which has an open end, a juxtaposed end and a side wall that extends between them. A closure adapted to seal the coupling with the open end of the tube is also included. The closure defines a recess and a mechanical separator that are coupled so that they can be released into the recess. The mechanical separator includes a float, a ballast assembly that can be moved longitudinally with respect to the float and the bellows structure. The bellows structure includes a first end, a second end and a deformable bellows between them. The float can be attached to a part of the first end of the bellows structure and the ballast assembly can be attached to a part of the second end of the bellows structure. The attached float and the bellows structure also include an interference coupling between them that can be released. The float may have a first density and the ballast may have a second density greater than the first density of the float.
The bellows structure of the separation assembly can define an interior and the float can be retained so that it can be released within a part of the interior of the bellows structure. The release of the float from the first end of the bellows structure can release the mechanical separator from the closure recess. Optionally, the bellows structure includes a pierceable head part having a structured puncture tip to resist deformation after application of a puncture tip therethrough. The float may also have a head part that defines an opening and substantially includes a perimeter corresponding to a part of the puncture tip of the part of the pierceable head.
In another configuration, the ballast assembly of the separation assembly includes a first ballast section and a second ballast section attached to the first ballast section through a part of the bellows structure. The first ballast section and the second section can be oriented in opposition about a longitudinal axis of the mechanical separator.
Optionally, the float may include a head part that defines an opening whereby air purging from the inside of the float to the outside of an area of the mechanical separator is allowed. The bellows may include a purge slit to allow purging of air from inside the float to the outside of an area of the mechanical separator. The bellows may also include a purge slit to allow air purging from a chamber defined by an inside of the bellows and an outside of the float to the outside of an area of the mechanical separator. In another configuration, the separation assembly includes a movable plug disposed within the interior of the float.
In another embodiment, a method of assembling a mechanical separator includes the step of providing a subset having a first end and a second end. The subset includes a ballast arranged at least partially around the bellows structure and defining a pierceable head part. The method also includes the step of inserting a first end of the subset into the recess of a closure to provide a mechanical interface between the bellows structure and the closure. The method also includes the step of inserting a float at the second end of the subset.
In another embodiment of the present invention, a separation assembly to enable separation of a sample of fluid in the first and second phases includes a tube having at least one open end, a second end and a side wall extending between the same. The separation assembly also includes a closure adapted for a sealing coupling with the open end of the tube, with the closure defining a recess. A mechanical separator is coupled so that it can be released into the recess. The mechanical separator includes a float, a ballast assembly that can be moved longitudinally with respect to the float and a bellows structure. The bellows structure includes a first end, a second end and a deformable bellows between them. The bellows structure makes contact with a part of the recess of the closure in which the float is released from the bellows before the bellows is released from the recess after exposure of the separation assembly to a centrifugal force.
Optionally, the float is released from the bellows before the bellows is released from the recess after exposure of the separation assembly to a centrifugal force of at least 250 g.
In another embodiment of the present invention, a separation assembly to enable separation of a sample of fluid in the first and second phases includes a tube having at least one open end, a second end and a side wall extending between the same. The separation assembly also includes a closure adapted for sealing the coupling with the open end of the tube, with the closure defining a recess. A mechanical separator is coupled so that it can be released into the recess. The mechanical separator includes a float, a ballast assembly that can be moved longitudinally with respect to the float and a bellows structure. The bellows structure includes a first end, a second end and a deformable bellows between them. The bellows structure makes contact with a part of the closure recess, in which the float is released from the bellows to allow the mechanical separator to be released from the recess upon exposure of the separation assembly to a centrifugal force.
Optionally, the float is released from the bellows to allow the mechanical separator to be released from the recess after exposure of the separation assembly to a centrifugal force of at least 250 g.
The whole of the present invention is advantageous with respect to existing separation products using separation gel. In particular, the whole of the present invention will not interfere with analytes, while many gels interact with body fluids. Another attribute of the present invention is that the set of the present invention will not interfere with therapeutic drug monitoring analytes.
The assembly of the present invention is also advantageous over existing mechanical separators since the float provides mechanical interference with the bellows structure to prevent premature release of the mechanical separator from the closure. This minimizes the problems of removal of the needle device, of accumulation of the sample under closure, pre-propulsion of the device, hemolysis, fibrin coating, and / or poor quality of the sample. In addition, the pre-launch can be further minimized by prepressing the pierceable head of the bellows against the inside of the shutter.
Additionally, the assembly of the present invention does not require complicated extrusion techniques during manufacturing. The set of the present invention also does not occlude the conventional analysis probes as is common in the previous gel tubes.
The advantages and additional details of the invention will become clearer with the following detailed description when read in conjunction with the accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
Figure 1 is a view of a partial cross section of a conventional mechanical separator.
Figure 2 is an exploded perspective view of a mechanical separator assembly that includes a closure, a bellows structure, a ballast assembly, a float and a collection tube according to an embodiment of the present invention.
Figure 3 is a perspective view of the bottom surface of the closure of Figure 2.
Figure 4 is a cross-sectional view of the closure of Figure 2 taken along line 4-4 of Figure 3.
Figure 5 is a perspective view of the float of Figure 2.
Figure 6 is a front view of the float of Figure 2.
Figure 7 is a cross-sectional view of the float of Figure 2 taken along line 7-7 of Figure 6.
Figure 8 is a close-up of a cross-sectional view of the float of Figure 2 taken along section VIII of Figure 7.
Figure 9 is a top view of the float of Figure 2.
Figure 10 is a perspective view of a first part of the ballast assembly of Figure 2.
Figure 11 is a front view of the first part of the ballast assembly of Figure 2.
Figure 12 is a cross-sectional view of the first part of the ballast assembly of Figure 2 taken along line 12-12 of Figure 11.
Figure 13 is a top view of the first part of the ballast assembly of Figure 2.
Figure 14 is a perspective view of the bellows structure of Figure 2.
Figure 15 is a front view of the bellows structure of Figure 2.
Figure 16 is a cross-sectional view in the foreground of the bellows structure of Figure 2 taken along section XV of Figure 15.
Figure 17 is a top view of the bellows structure of Figure 2.
Figure 18 is a perspective view of an assembled mechanical separator including a float, a ballast assembly and a bellows structure in accordance with an embodiment of the present invention.
Figure 19 is a cross-sectional view of the mechanical separator of Figure 18 taken along line 19-19 of Figure 18.
Figure 20 is a front view of the mechanical separator of Figure 18.
Figure 21 is a cross-sectional view of the mechanical separator of Figure 18 taken along line 21-21 of Figure 20.
Figure 22 is a front view of an assembly including a tube having a closure and a mechanical separator disposed therein in accordance with an embodiment of the present invention.
Figure 23 is a front cross-sectional view of the assembly of Figure 22 having a needle accessing the inside of the tube and an amount of fluid supplied through the needle inside the tube according to an embodiment of the present invention.
Figure 24 is a front cross-sectional view of the assembly of Figure 23 having a needle removed therefrom during use and the spacer located separately from the closure according to an embodiment of the present invention.
Figure 25 is a front cross-sectional view of the assembly of Figure 24 having a mechanical separator that separates the less dense part of the fluid from the denser part of the fluid according to an embodiment of the present invention.
Figure 26 is a front cross-sectional view of the assembly having a mechanical separator and a closure coupled within a tube showing the needle in contact with the float structure according to an embodiment of the present invention.
Figure 2 7 is a cross-sectional view of the assembly of Figure 26 showing the uncoupled needle of the float from the bellows structure according to an embodiment of the present invention.
Figure 28 is a cross-sectional view of the assembly of Figure 27 showing the decoupled float of the bellows structure and the ballast assembly that is directed in a downward orientation in accordance with an embodiment of the present invention.
Figure 29 is a cross-sectional view of the assembly of Figure 27 showing the float redirected upwards in the mechanical separator according to an embodiment of the present invention.
Figure 3 0 is a cross-sectional view of the assembly having a mechanical separator and a closure coupled within a tube according to an embodiment of the present invention.
Figure 31 is a cross-sectional view of the assembly of Figure 30 showing the needle piercing the mechanical separator according to an embodiment of the present invention.
Figure 32 is a cross-sectional view of the assembly having a mechanical separator and a closure coupled within a tube according to an embodiment of the present invention.
Figure 33 is a cross-sectional view of the assembly of Figure 32 showing the mechanical separator partially displaced from the closure.
Figure 34 is a partial cross-sectional view of a mechanical separator having a movable plug disposed within the float according to an embodiment of the present invention.
Figure 34A is a partial cross-sectional view of the mechanical separator of Figure 34 in an initial position.
Figure 34B is a partial cross-sectional view of the mechanical separator of Figure 34A in a displaced position.
Figure 34C is a partial cross-sectional view of an alternative mechanical separator having a movable plug disposed within the float according to an embodiment of the present invention in an initial position.
Figure 34D is a partial cross-sectional view of the mechanical separator of Figure 34C in a displaced position.
Figure 35 is a front cross-sectional view of the float and a movable plug with a part of the bellows of Figure 34 in an initial position.
Figure 36 is a front cross-sectional view of the float and a movable plug with a part of the bellows of Figure 35 in a displaced position.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
For the purposes of the description hereinafter, the terms upper, lower, right, left, vertical, horizontal, upper, lower, lateral, longitudinal and similar spatial terms, if used, shall refer to Embodiments described as orientation of the figures in the drawings. However, it will be understood that many alternative embodiments and variations can be assumed except where expressly stated otherwise. It will also be understood that the specific embodiments and devices illustrated in the accompanying drawings and herein are simply exemplary embodiments of the invention.
As shown in the exploded perspective view of Figure 2, the mechanical separation assembly 40 of the present invention includes a closure 42 with a mechanical separator 44, for use in connection with a tube 46 to separate a fluid sample in the first and second phases inside tube 46. The tube 46 may be a sample collection tube, such as a sample collection tube that is used for in vitro diagnostics, clinical research, pharmaceutical research, proteomics, molecular diagnostics, chemical related diagnostic sample tubes, tubes collection of blood or other body fluid collection tube, coagulation sample tube, hematological sample tube and the like. Desirably, tube 46 is a collection tube of blood drawn. In one embodiment, tube 46 may contain additional additives as required for particular test procedures, such as anticoagulant agents, coagulating agents, stabilizing additives and the like. Such additives may be in liquid or particulate form and may be sprayed on the cylindrical side wall 52 of the tube 46 or be located at the bottom of the tube 46. The tube 46 includes a closed lower end 48, an open upper end 50 and a cylindrical side wall 52 extending therebetween. The side wall 52 includes an inner surface 54 with an inner diameter to which it extends substantially uniformly from the open upper end 50 to a location substantially adjacent to the closed lower end 48.
The tube 46 may be made of one or more of one of the following representative materials: polypropylene, polyethylene terephthalate (PET), glass or combinations thereof. The tube 46 may include single wall or multiple wall configurations. Additionally, tube 46 can be constructed in any practical size to obtain an appropriate biological sample. For example, the tube 46 may be of a size similar to conventional large volume tubes, small volume tubes or microtainer tubes, as are known in the art. In a particular embodiment, the tube 46 may be a conventional 3 ml tube for collecting collected blood, as is also known in the art. In another embodiment, the tube 46 may have a diameter of 16 mm and a length of 100 mm, with a blood collection capacity of 8.5 ml or 13 mm.
The open upper end 50 is at least partially structured to receive the closure 42 therein to form a liquid impermeable seal. The closure includes an upper end 56 and a lower end 58 structured to be received at least partially within the tube 46. The portions of the closure 42 adjacent to the upper end 56 define a maximum outer diameter that protrudes from the inner diameter a of the tube 46. As shown in FIGS. 2-4, the parts of the closure 42 at the upper end 56 include a central recess 60 defining a resealable perforable partition. The portions of the closure 42 extend downwardly from the lower end 58 which can be narrowed from a smaller diameter that is approximately equal to, or slightly smaller than the inside of the diameter a of the tube 46 to a larger diameter that is greater than the inner diameter a of the tube 46 adjacent to the upper end 56. Therefore, the lower end 58 of the closure 42 can be pressed into a part of the tube 46 adjacent to the open upper end 50. The inherent elasticity of the closure 42 can ensure a tight coupling with the inner surface of the cylindrical side wall 52 of the tube 46.
In one embodiment, the closure 42 may be formed of unit molded rubber or elastomeric material, having adequate dimensions and size to provide a tight coupling with the tube 46. The closure 42 can also be formed to define a lower recess 62 that is extend at the lower end 58. The lower recess 62 can be sized to receive at least a portion of the mechanical separator 44. Additionally, a plurality of arcuate flanges spaced apart from each other 64 can be extended around the lower recess 62 to retain therein at least partially the mechanical separator 44.
Again with respect to Figure 2, the mechanical separator 44 includes a float 66, a ballast assembly 68 and a bellows structure 70 such that the float 66 is coupled with a part of the bellows structure 70 and the assembly of ballast 68 is also coupled with a part of the bellows structure 70.
With respect to Figures 5-9, the float 66 of the mechanical separator is a generally tubular body 72 having an upper end 74, a lower end 76 and a passage 78 extending longitudinally therebetween. The upper end 74 may include a head part 80 separated from the generally tubular body 72 by a part of the neck 82. The float 66 is substantially symmetrical about the longitudinal axis L. In one embodiment, the outer diameter b of the tubular body 72 is smaller than the inner diameter a of the tube 46, shown in Figure 2.
The outer diameter c of the head portion 80 is typically smaller than the outer diameter b of the tubular body 72. The outer diameter d of the neck portion 82 is smaller than the outer diameter b of the tubular body 72 and is also smaller than the outer diameter c of the head part 80.
The head portion 80 of the float 66 includes an upper surface 84 that defines an opening 86 therethrough to allow air purging. In one embodiment, a plurality of openings may be arranged such as for example four openings 86a at a 90 ° angle to each other to allow air purging therethrough. As shown in a close-up view in Figure 8 taken along section VIII of Figure 7, the opening 86 may include a recess extending on the upper surface 84 or a projection extending upward from the upper surface 84. Part 86 may be substantially square or circular or may be continuous around float 66. Part 86 is typically recessed into the outer diameter c of head portion 80. In addition, the opening 8 6 of the head portion 80 of the float 66 can be structured to allow a puncture tip, shown in Figures 25-26, to pass therethrough.
With respect again to Figures 5-9, the upper surface 84 of the head part 80 may also include an inclined perimeter region 88 adjacent to the outer diameter c of the head part 80 having an inclination angle A. In a embodiment, the angle of inclination A is from about 15 degrees to about 25 degrees, such as about 20 degrees. In another embodiment, the head portion 80 may also include a bottom surface 90 adjacent to the neck portion 82. The bottom surface may also include an angle of inclination B from about 8 degrees to about 12 degrees, such as about 10 degrees .
The tubular body 72 of the float 66 may include a projection zone 94 adjacent to the neck portion 82. The projection zone 94 may include an inclined angle C from about 15 degrees to about 25 degrees, such as about 20 degrees. The lower end 76 of the float 66 may include a graduated part 96 having an outside diameter e that is smaller than the outside diameter b of the tubular body 82. In an alternative embodiment, the lower end 76 may be a reflection of the head portion 80, so that the float is symmetrical along a longitudinal axis.
In one embodiment, it is desirable that the float 66 of the mechanical separator 44 be made of a material having a lighter density than the liquid that is intended to be separated into two phases. For example, if it is desired to separate blood from a human being in serum and plasma, then it is desirable that the float 66 has a density of no more than about 0.902gm / cc. In another embodiment, the float 66 can be made of polypropylene.
As shown in Figure 2, the ballast assembly 68 of the mechanical separator 44 may include a plurality of ballast parts, such as a first part of the ballast 98 and a second part of the ballast 100. The first ballast section 98 and the second ballast section 100 can be oriented in opposition about a longitudinal axis Li of the mechanical separator 44. In one embodiment, the first part of the ballast 98 and the second part of the ballast 100 are symmetrical with each other and are mirror images thereof. Therefore, although only the first ballast section 98 is shown in Figures 1013, it is understood herein that the second part of the ballast 100 is a reflection of the first part of the ballast 98. Taken together in opposite orientation, the first part of the ballast 98 and the second part of the ballast 100 of the ballast assembly 68 have a substantially cylindrical shape. Alternatively, it is contemplated herein that the ballast assembly 68 may consist of more than two paired parts, that is, a first part of the ballast part 98 and a second part of the ballast 100. In one embodiment, the ballast assembly may comprise three paired ballast parts or four or more paired ballast parts.
As shown in Figures 10-13, the first part of the ballast 98 of the mechanical separator 44 includes a curved side wall 102 having an inner surface 104 and an outer surface 106. The curved side wall 102 has corresponding dimensions and curvature substantially to the dimensions and curvature of the inner surface 53 of the tube 46, shown in Figure 2, such that the first part of the ballast 98 can slide into the interior of the tube 46. The first part of the ballast 98 has an upper end 108 and a lower end 110 and an arc body 111 extending therebetween. The adjacent upper end 108 of the first part of the ballast 98 is a receiving recess 112 that is disposed within the outer surface 106 of the first part of the ballast 98. The receiving recess 112 can extend along the entire curvature of the upper end 108 of the outer surface 106. In one embodiment, the receiving recess 112 may be provided as a joint surface between the float 66 and the first part of the ballast 98 and / or the second part of the ballast 100 for double shot molding techniques. Optionally, a second receiving recess 114 may be included adjacent to the lower end 110 of the first part of the ballast 98. The first part of the ballast 98 also has an outer diameter h of the upper end 108 which is smaller than the outer diameter g of the arc body 111.
Referring again to Figures 10-13, the first part of the ballast 98 may include an inner retainer 118 extending from the inner surface 104 towards an inner defined by the curvature of the inner surface 104. The inner retainer 118 may have an angle of curvature D that extends along the inner surface 104 of the first part of the ballast 98. In one embodiment, the angle of curvature D is from about 55 degrees to about 65 degrees, such as about 60 degrees. In another embodiment, the inner seal 118 is oriented upwardly at an angle E from approximately degrees to approximately 50 degrees, such as approximately 4 5 degrees.
In another embodiment, it is desirable that the ballast assembly 68 of the mechanical separator 44 be made of a material having a heavier density than that of the liquid that is intended to be separated into two phases. For example, if it is desired to separate blood from a human being in serum and plasma, then it is desirable that the ballast assembly 68 has a density of at least 1,326 gm / cc. The ballast assembly 68 includes the first part of the ballast 98 and the second part of the ballast 100, which can have a density that is greater than the density of the float 66, shown in Figures 5-9. In one embodiment, the ballast assembly 68 can be made of PET. The first part of the ballast 98 and the second part of the ballast 100 can be molded or extruded as two separate pieces but manufactured at the same time in a single mold.
As shown in Figures 14-17, the bellows structure 70 of the mechanical separator 44 includes a first upper end 120, a second lower end 122 and a deformable bellows 124 arranged circumferentially therebetween. The first upper end 120 of the bellows structure 70 includes a perforable head part 126 that includes a substantially flat part 128 surrounded by a generally curved shoulder 130 so that it corresponds correspondingly to the shape of the lower body 62 of the closure 42, shown in Figures 2-4. In one embodiment, the substantially flat portion 128 can be curved with a nominal radius of approximately 1,905 cm. In one embodiment, the generally curved boss 130 has a curvature angle F from about 35 degrees to about 45 degrees, such as about 40 degrees. The substantially flat shaped part 128 may have any suitable dimension, however, it is preferable that the substantially flat part 128 has a diameter from about 0.724 cm to about 0.749 cm, the substantially flat part 128 of the pierceable head portion 126 is structured to allow a puncture tip, shown in Figures 25-26, such as a needle tip, needle cannula or probe to pass through it. In one embodiment, the pierceable head portion 126 is thick enough to allow the penetrating part of the puncture tip that is disposed therein to penetrate through it. From the removal of the puncture tip to the flat part 128 of the pierceable head portion 126, the pierceable head portion 126 is structured to reseal itself to provide a liquid impervious seal. The perforating head portion 126 of the mechanical separator 44 can be extruded and / or molded from a semi-hermetic material and elastically deformable, such as a thermoplastic elastomer. Optimally, the perforated flow portion 126 may be purged by a plurality of slits, such as the slits, created by a subsequent molding operation to purge the mechanical separator 44.
With reference to Figure 19, in one embodiment, the bellows bellow 124 may include purge slits 131 for purging in two locations, such as in the chamber created by the interior of the float 66 and the chamber created by the interior of the bellows bellows. 124 and the outside of float 66. These slits can be created by a subsequent molding process. During centrifugation, once the mechanical separator 70 is led from the closure 42 and the mechanical separator 70 is immersed in the fluid, the air is subsequently purged through the slits. The slits 131 can be arranged radially around the bellows deformadle 124 and can have a length from about 0.127 cm to about 0.191 cm, as measured by the inner surface of the bellows deformadle 124.
As shown in the foreground cross-sectional view of Figure 16 taken along section XV of Figure 15, the first upper end 120 of the bellows structure 70 defines an interior 132 and an interior surface 134 of the first upper end 120 adjacent to the pierceable head portion 126 which includes an inner coupling part 136 extending inside 132 of the first upper end 120. In one embodiment, the inner coupling part 136 is structured to couple the inner diameter of the float 66. The coupling of the inner coupling part 136 of the bellows structure 70 and the inner diameter of the separator, shown in Figure 8, provide a reinforcing structure for the pierceable head portion 126 of the bellows structure 70. In one embodiment, the perimeter 92 of the spacer 66 shown in Figures 6-9 substantially corresponds to the puncture tip of the pierceable head portion 126 of the bellows structure 70. Therefore, the first upper end 120 of the structure of bellows 70 may include a pierceable head portion 126 having a structured puncture tip to substantially resist deformation after application of a puncture tip, as shown in the
Figures 25-26, through it. The corresponding profiles of the pierceable head portion 126 of the bellows structure 70 and the head portion 80 of the float 66 make the pierceable head portion 126 of the present invention more stable and less likely to form a flare than the region punishable from existing mechanical separators. To further help limit the accumulation of the sample and the premature release of the separator 44 from the lower body 62 of the closure 42, the flat portion 128 of the pierceable head portion 126 may optionally include a thickened region, such as from about 0, 05 cm to approximately 0.203 cm thicker than other parts of the first upper end 120 of the bellows structure 70. In this way, the precompression of the mechanical separator 44 is further minimized by the precompression of the pierceable head against the inside of the closure 42.
Referring again to Figures 14-17, the inner surface 134 of the first upper end 120 of the bellows structure 70 also includes an inner flange 138 that extends inside 132 and is located between the pierceable head portion 126 and the deformable bellows 124. The inner edge 138 can be retained in a fastener that at least a part of the float 66, shown in Figures 5-9, can be released inside the interior 132 of the bellows structure 70. In another embodiment, the inner flange 138 can be retained so that at least a portion of the float 66 can be released, as shown again in Figures 5-9, inside the interior 132 of the first upper end 122 of the bellows structure 70 through a mechanical interface. The fixed float 66, shown in Figures 5-9, and the first upper end 120 of the bellows structure 70 provide an interference coupling therebetween that can be released to keep the float 66 in a fixed relationship with respect to the bellows structure 70. In one embodiment, the neck portion 82 of the float 66 and the inner flange 138 of the bellows structure 70 retain the float 66 at a mechanical interface with the bellows structure 70.
With respect to Figures 14-15, the deformable bellows 124 is longitudinally separated from the first upper end 120 of the bellows structure 70. The deformable bellows 124 can be located adjacent to the inner flange 138 but extends laterally outwards from an outer surface 144 of the bellows structure 70. The deformable bellows 124 is symmetrical about a longitudinal axis L<sub>2</sub> and includes an upper end 146, a lower end 148 and an inner recess extending therebetween. The deformable bellows 124 is provided for sealing the coupling of the bellows structure 70 with the cylindrical side wall 52 of the tube 46, as shown in Figure 2. The deformable bellows 124 can be made of any material sufficiently elastomeric to form a waterproof seal for liquids with the cylindrical side wall 52 of the tube 46. In one embodiment, the bellows is made of thermoplastic elastomer and has an appropriate dimensional thickness from about 0.038 cm to about 0.0635 cm. In one embodiment, the full bellows structure 70 is made of thermoplastic elastomer.
The deformable bellows 124 may have a generally toroidal shape having an outside diameter i that, in an unaltered position, slightly exceeds the inside diameter a of the tube 46, shown in Figure 2. However, the forces directed in opposition to the upper end 146 and the lower end 148 will extend the deformable bellows 124, simultaneously reducing the outlet diameter ia to a smaller dimension than
As shown in Figures 14-15, the second lower end 122 of the bellows structure 70 includes opposite dependent portions 140 extending longitudinally downward from the first upper end 120. In one embodiment, the opposite dependent portions 140 are connected to a ring at the lower end 142 which extends circumferentially around the structure of the bellows 70. In one embodiment, opposite dependent portions 140 define a reception space 150 structured to receive a portion of the ballast assembly 68 therein. In one embodiment, opposite dependent portions 140 define opposite reception spaces 150. A first part of the ballast 98 is structured so that it is received and fixed within a first reception space 150 and the second part of the ballast 100 is structured so that it is received and fixed within a second reception space 150. In one embodiment, the dependent portions 140 have an outer curvature G corresponding to the outer curvature of the first part of the ballast 98 and the second part of the ballast 100. The dependent portions 140 of bellows 70 can also be designed to be molded with ballast assembly 68, such as by double shot molding techniques. This may allow a link between the ballast assembly 68 and the bellows 70 along a surface of the dependent portions 140. This may allow the ballast assembly 68 to flex to open when the bellows 70 is stretched and subsequently to allow the float 66 to be inserted into the ballast assembly 68.
As shown in Figures 18-21, when assembling the mechanical separator 44 includes a bellows structure 70 having a first upper end 120, a second lower end 122 and a deformable bellows 124 therebetween. The float 66 is attached to a part of the first upper end 120 of the bellows structure 70 and of the ballast assembly 68, including the first part of the ballast 98 and the second part of the ballast 100, joins the second lower end 122 of the bellows structure 70. The first part of the ballast 98 and the second part of the ballast 100 can be joined through a part of the bellows structure 70, such as joined through a hanging part 140.
As shown in Figure 21, in one embodiment, the receiving recess 112 of the first part of the ballast 98 can be mechanically coupled with a corresponding projection 152 of the lower end ring 142 of the bellows structure 70. Also, the recess Corresponding receiving 112 of the second part of the ballast 100 can be mechanically coupled with a corresponding projection 152 of the lower end ring. As shown in Figure 20, the second receiving recess 114 of the first part of the ballast 98 can also be mechanically coupled with the lower tip 154 of the hanging part 140 of the bellows structure 70. Therefore, the first part of the ballast 98, the second part of the ballast 100 and the opposite dependent portions 140 of the bellows structure 70 form a cylindrical exterior having a diameter j that is smaller than the diameter a inside the tube 46 shown in Figure 2.
In this configuration, the float 66 provides a reinforcing support for the pierceable head portion 126 of the bellows structure 70 to minimize deformation and formation of a tip. The float 66 is limited within the interior 132 of the bellows structure 70 by the mechanical interface of the inner flange 138 of the bellows structure 70 with the neck portion 82 of the float 66.
As shown in Figure 19, the assembled mechanical separator 44 can be pressed into the lower recess 62 of the closure 42. This introduction is coupled to the flanges 64 of the closure 42 with the upper end 120 of the bellows structure 70. During Introduction, at least a part of the lower end 120 of the bellows structure 70 will be deformed to accommodate the contours of the closure 42. In one embodiment, the closure 42 does not deform substantially during the introduction of the mechanical separator 44 into the lower recess 62. In one embodiment, the mechanical separator 44 is coupled with the closure 42 by interference placement of the pierceable head portion 126 of the upper end 120 of the bellows structure 70 and the lower recess 62 of the closure 42. Optionally, a retaining ring (not shown) may be employed at the upper end 120 of the bellows structure 70 to further secure the mechanical separator 44 within closure 42.
With reference again to Figure 21, in use, the float 66 of the mechanical separator 44 is indicated to be restricted within the interior 132 of the bellows structure 70 by the mechanical interface of the inner flange 138 of the bellows structure 70 with the neck portion 82 of the float 66 until the mechanical separator is subjected to centrifugal acceleration forces, such as within a centrifuge. The presence of the float 66 prevents the upper part of the bellows structure 70 from becoming deformed and therefore prevents the mechanical separator 44 from being released from the closure 42. The mechanical separator 44 is locked inside the closure 42 until sufficient is generated. load g during centrifugation such that float 66 is removed from bellows 70 and released to mechanical separator 44 from closure 42.
With the application of centrifugal acceleration forces, the bellows structure 70, particularly the deformable bellows 124, is adapted to deform longitudinally due to the force exerted on the ballast 68. The ballast 68 exerts a force on the bellows 70 as a result the load g during centrifugation. The inner flange 138 deviates longitudinally due to the force exerted on it by the float 66, thereby allowing the part of the neck 82 of the float 66 to be released. When the float 66 is released from the bellows structure 70, it can be released to move within the mechanical separator 44. However, at least one part of the float 66 is restricted to pass through a lower end 156 of the mechanical separator 44 by contact with the inner retainer 116 of the first part of the ballast 98 and the inner retainer 116 of the second part of the 100 ballast. In one embodiment, the graduated part 96 of the float 66 passes through the lower end 136 of the mechanical separator 44, however, the tubular body 72 of the float is restricted to the interior of the mechanical separator 44 by the inner retainer 116 of the first part of the ballast 98 and inner seal 116 of the second part of ballast 100. After the mechanical separator 44 has been released from the closure 42, the mechanical separator 44 moves towards the fluid interface inside the tube 46. Once the mechanical separator 44 enters into the fluid contained within the tube 46, the float 66 it moves up again and is fixed on bellows 70.
In one embodiment, the ballast assembly 68 and the bellows structure 70 can be molded or extruded together as a subset, such as by two shot molding. The subset may include the ballast assembly at least partially arranged around the bellows structure 70 including a pierceable head portion 126. In another embodiment, the ballast assembly 68 and the bellows structure 70 can be molded or extruded together, such as by two shot molding, in a closure portion 42, as shown in Figure 19. Shape molding Joint the ballast assembly 68 and the bellows structure 70 reduces the number of manufacturing steps necessary to produce the mechanical separator 44. Alternatively, the ballast assembly 68 and the bellows structure 70 can be molded or extruded together, such as by two shot molding and subsequently inserted into the closure 42. The float 66 can then be inserted separately into the subset to move the mechanical interface between the bellows structure 70 and the closure 42. Alternatively, the float 66 can be inserted into the subset and then the combined float and subset can be inserted into the closure 42.
As shown in Figures 22-23, the mechanical separation assembly 40 includes a mechanical separator 44 and a closure 42 inserted in the open upper end 50 of the tube 46, such that the mechanical separator 44 and the lower end 58 of closure 42 remain inside tube 46. Optionally, the closure 42 may be at least partially surrounded by a protector, such as the Hemogard® Protector commercially available from Becton, Dickinson and Company, protecting the user from blood droplets in the closure 42 and the potential effects of blood aerosolization when the closure 42 is removed from the tube 46, as is known. During the introduction, the mechanical separator 44 includes the bellows structure 70, which will be tightly coupled inside the cylindrical side wall 52 and the open upper end of the tube 46.
As shown in Figure 23, a sample of liquid is supplied in the tube 46 by means of a puncture tip 160 that penetrates the partition of the upper end 56 of the closure 42 and the pierceable head portion 126 of the bellows structure 70. For illustrative purposes only, the liquid is blood. Blood will flow through the central passage 78 of the float 66 and to the closed lower end 48 of the tube 46. The puncture tip 160 will then be removed from the assembly. Upon removal of the puncture tip 160, the seal 42 will reseal itself. The pierceable head portion 126 will also reseal itself so that it is substantially impervious to fluid flow.
As shown in Figure 24, when the mechanical separation assembly 40 is subjected to an applied rotational force, such as centrifugation, the respective phases of the blood will begin to separate into a denser phase that moves towards the closed lower end. 58 of the tube 46 and a less dense phase that moves towards the upper open end 50 of the tube 46.
In one embodiment, the mechanical separation assembly 40 is adapted such that when subjected to an applied centrifugal force, the float 66 is released from the coupling with the bellows structure 70 before the bellows structure 70 is released from the recess bottom 62 of closure 42. Accordingly, the inner flange 138 of the bellows structure 70, shown in Figure 16 can be sufficiently deformed to allow at least a part of the float 66 to be released from the bellows structure 70 while the bellows structure 70 is coupled inside the lower recess 62 of the closure 42. The interference coupling that can be released from the float 66 and the bellows structure 70 can be adapted to release the float 66 from the bellows structure 70 when the mechanical separation assembly 40 is subjected to centrifugal forces above a centrifugation threshold . In one embodiment, the centrifugation threshold is at least 250 g. In another embodiment, the centrifugation threshold is at least 300 g. Once the mechanical separation assembly 40 is subjected to a centrifugal force applied above the centrifugation threshold and the interference coupling that can be released from the float 66 and the bellows structure 70 is disengaged, the mechanical separation assembly 40 is it can be decoupled, so that it releases the projecting coupling, from within the lower recess 62 of the closure 42, as shown in Figure 24. Optionally, the float release 66 of the bellows structure 7 0 allows the mechanical separation assembly 40 to be released from the lower recess 62 of the closure 42.
The mechanical separation assembly 40 is adapted to be retained within the lower recess of the closure during the pre-launch procedures, such as during the introduction of a needle for patient use through the pierceable head portion 126 of the bellows structure 70. In another embodiment, the mechanical separation assembly 4 0 is also adapted in such a way that the float 66 is retained in the interference coupling that can be released with the bellows structure 70 during the introduction of a non-use needle with patient to through the pierceable head portion 126 of the bellows structure 70. Accordingly, the interference coupling that can be released from the float 66 and the bellows structure 70 is sufficient to resist a pre-launch axial force applied substantially along the longitudinal axis L of the float 66, as shown in Figure 6 , and / or substantially along the longitudinal axis L<sub>2</sub> of the bellows structure 70, as shown in Figure 15. The interference coupling that can be released from the float 66 and the bellows structure 70 may be sufficient to resist at least 2,224 N. In another embodiment, the interference coupling which can be released from float 66 and the structure of bellows 70 may be sufficient to resist at least 11.12 N. The interference coupling that can be released from the float 66 and the bellows structure 70 of the mechanical separation assembly 40 is therefore sufficient to maintain the float coupling 66 and the bellows structure 70 with each other, and the mechanical separation assembly 40 within the lower recess 62 of the closure 42, during the introduction of a needle for patient use through the pierceable head portion 126 of the bellows structure 70. The interference coupling that can be released from the float 66 and the bellows structure 70 are also adapted to disengage the float 66 from the bellows structure 70 and the mechanical separation assembly 40 of the lower recess 62 of closure 42 with the centrifugal force applied above the centrifuge threshold.
During use, the applied centrifugal force will press the ballast assembly 68 of the mechanical separator 44 towards the closed lower end 58 of the tube 46. The float 66 will only be pressed towards the upper end 50 of the tube 46 after the mechanical separator 44 is has released from seal 42 and the mechanical separator is submerged in the fluid. When the mechanical separator 44 is still attached to the closure 42, both the float 66 and the ballast assembly 68 experience a force that acts to pull them towards the lower end of the tube 46. Accordingly, the ballast assembly 68 can be moved longitudinally with respect to float 66. This longitudinal movement generates a longitudinal deformation of the bellows structure 70. As a result, the bellows structure 70 and particularly the bellows bellows 124 will become longer and narrower and will be concentrically spaced inwardly from the inner surface of the cylindrical side wall 52. The force exerted by the float 66 on the inner flange 138 of the bellows structure 70 flexes the bellows structure 70 and, thus, the part of the float neck 66 is released. When the float 66 is disengaged from the inner flange 138 of the bellows structure 70, the upper end 120 of the bellows structure 70 elastically deforms in the longitudinal direction during the application of the centrifugal force. Accordingly, the upper end 120 of the bellows structure 70 will be disengaged from the closure 42. In one embodiment, the closure 42, particularly the flanges 64, is not dimensionally altered by the application of the centrifugal force and, consequently, does not deform.
As shown in Figure 24, in one embodiment, the negative buoyancy of the ballast assembly 68 opposes the positive buoyancy of the float 66 creating a differential force that causes the bellows structure 70 to contract by separating from the inner surface of the side wall of the tube 46. This elongation of the bellows structure 70 causes the purge slits 131 to open under load. Once the purge slits 131 are opened, the air trapped inside the mechanical separation assembly 40 can exit through the purge slits 131 in the tube to a location above the mechanical separation assembly 40. After centrifugation , the bellows structure 70 returns elastically to the position without deformation and the purge slits 131 are sealed again in the closed position.
The present design reduces pre-release by preventing the mechanical separator 44 from separating from the closure 42 as a result of the interaction of the needle with the head of the bellows structure 70. The mechanical separator 44 cannot be separated from the closure 42 until float 66 is released during centrifugation. In addition, the closure structure 42 creates a preload on a target area of the bellows structure 70, which helps minimize the formation of a tip in the bellows.
When the mechanical separator 44 is disengaged from the closure 42 and the diameter of the deformable bellows 124 is reduced, the components of the lighter phase of the blood can slide past the deformable bellows 124 and thus move upwards, and thus, the components of the heaviest phase of the blood can slide past the deformable bellows 124 and move down. As indicated above, mechanical separator 44 has an overall density between the densities of the separated phases of the blood.
As a consequence, as shown in Figure 25, the mechanical separator 44 will stabilize in a position within the tube 46 of the mechanical separation device 40 of such
<td>way that</td><td>components of</td><td>the phase</td><td>plus</td><td colspan="2">heavy 162 se</td>
<td>will place between</td><td>the separator</td><td>mechanical</td><td> 44</td><td>Y</td><td>the extreme</td>
<td>bottom closed</td><td>58 of tube 46,</td><td>While</td><td>what</td><td>the</td><td>components</td>
lighter phase 164 will be placed between the mechanical separator 44 and the upper end of the tube 50. After this stable state has been reached, the centrifuge will stop and the deformable bellows 124 will return elastically to its unaltered state and Hermetic coupling with the inside of the cylindrical side wall 52 of the tube 46.
Then the liquid phases formed for analysis will be accessed separately.
In an alternative embodiment, as shown in Figures 26-29, the application of the puncture tip 160 through the closure 42 of the mechanical separation assembly 40a puts it directly in contact with the float 66a. In this embodiment, the bellows structure 70a can be oriented to circumferentially surround a part of the float 66a to provide the hermetic coupling with the closure 42 and the side wall of the tube 46. As shown in Figure 27, the force of the puncture tip 160 is disengaged from the interference coupling that can be released between the spacer 66a and the bellows structure 70a, as described above, thereby allowing a liquid , such as blood, fill the mechanical separator 44a around the float 66a. As shown in Figure 28, with the float 66a ejected from the bellows structure 70a, the mechanical separator 44a is free to be launched from the closure 42 during accelerated rotation, such as centrifugation. As shown in Figure 29, once the mechanical separator 44a is disengaged from the closure, the natural buoyancy of the float 66a will press the float 66a to return to the bellows structure 70a as soon as the mechanical separator 44a enters the liquid inside. of the tube.
In yet another alternative embodiment as shown in Figures 30-31, similar to the description of Figures 26-29, the bellows structure 70b may include a perforable head portion 126b, similar to the configuration described above, with the exception that the pierceable head portion 126b is thick enough to allow the full puncture tip 200 of the needle 202 to be buried within the pierceable head portion 126b before contacting the spacer 66b. By allowing the puncture tip 200 to completely bury itself within the pierceable head portion 126b, the formation of a tip in the bellows or the accumulation of the sample within the deformed bellows is minimized. The float 66b can be made of a rigid, solid material. When the needle 202 advances further, the float 66b moves, allowing the liquid, such as blood, to flow around the float 66b and into the tube 204. During centrifugation, the float 66b will be coupled back to the bellows 79b.
In yet another embodiment, as shown in Figures 32-33, similar to the description in Figures 26-29, the bellows assembly 70c may include a pierceable head portion 126c having a thickened target area 71c to resist formation of a tip or deformation when applying a puncture tip (not shown) through it. By minimizing the effects of the formation of a tip in the bellows, premature decoupling of the mechanical seal separator is also minimized. Therefore, the application of centrifugal force, and not the coupling of the puncture tip with the mechanical separator, causes the ballast assembly 68c to move longitudinally, allowing the mechanical separator 44c to be released from the closure 42c. Optimally, a retaining ring can be placed around the bellows assembly 70c adjacent to the closure 42c to secure the mechanical separator 44c in place.
In accordance with yet another embodiment of the present invention, shown in Figure 34, a mechanical separator 600 may include a float 668, a bellows 670 and a ballast 672 as described herein. In one configuration, the float 668 can be provided with a movable plug 620 disposed within an inner part 622 of the float 668. In one embodiment, the mobile plug 620 may be formed of the same material of the float 668 and in another embodiment, the mobile plug 620 may be formed of a material that has substantially the same density as the density of the float 668. In another embodiment, the movable plug 620 can be inserted into an inner part 622 of the float 668 after the formation of the float 668.
In certain situations, a mechanical separator 600 that includes a float 668 having a movable cap 620 may be advantageous. For example, certain test procedures require that a sample be deposited in a sample collection container and the sample collection container is subjected to a centrifugal force to separate the lightest and heaviest phases within the sample, as described herein. Once the sample has been separated, the sample collection container and the sample disposed therein can be frozen, such as at temperatures of approximately -70 ° C and subsequently defrosted. During the freezing process, the heaviest phase of the sample can be expanded by forcing a sample column to advance upwards in the sample collection vessel and through a part of the inner part 622 of the float 668, so that in this way it interferes with the barrier placed between the lightest and heaviest phases. To minimize this effect of volumetric expansion, a movable plug 620 can be provided inside the inner part 622 of the float 668, as shown in Figure 34A.
Once the sample is separated into lighter and denser phases within the sample collection vessel (not shown), the sample can be frozen. During the freezing process, the densest part of the sample can expand upwards. To prevent the densest part of the sample from advancing upwards and interfering with the lighter phase and preventing the densest part of the sample from escaping from float 668, the movable plug 620 moves upward with the expansion of the plus phase. Dense sample, as shown in Figure 34B.
The mobile plug 620 can be adapted to advance with the expanded column of the densest material present inside the inner part 622 of the separator 668 during freezing. It has been anticipated herein that movable plug 620 can be limited to an upper limit by an upper portion 671 of bellows 670, shown schematically in Figures 34C-34D. In this configuration, the elasticity of the upper part 671 of the bellows 670 can act as a balloon that can be stretched to restrict the mobile plug 620 within the mechanical separator 600.
In accordance with yet another embodiment, the movable plug 620 can be provided with a transverse hole 623 that is substantially aligned with a transverse hole 624 provided on the float 668 in the initial position, shown in Figure 35 and substantially blocked by a part of block 625 of float 668 in the displaced position, as shown in Figure 36. In one embodiment, the transverse hole 624 of the movable plug 620 is disposed substantially perpendicular to the longitudinal axis R of the movable plug 668.
In this configuration, after sampling and during the application of centrifugal force to the mechanical separator, the air trapped inside the inner part 622 of the float 668 can be purged through the transverse hole 623 of the movable plug and the transverse hole 624 of float 668 and exit mechanical separator 600. Specifically, air can be purged between float 668 and bellows 670 as described herein. When the movable plug 620 advances upwards, the transverse hole 623 of the movable plug 620 is aligned with a blocking part 625 of the float 668 which prevents the sample from leaving the movable plug 620 and the inner part 622 of the float 668 through of cross hole 623.
The advance of the mobile cap 620 can be completely passive and in response to the freezing conditions of the sample applied externally. In certain examples, the movable cap 620 can also be provided to return to its initial position after subsequent defrosting of the sample.
Although the present invention has been described in terms of a mechanical separator disposed within the tube adjacent to the open end, it is also contemplated herein that the mechanical separator can be placed in the lower part of the tube, so that it is fixed to the bottom of the tube. This configuration can be particularly useful for plasma applications in which the blood sample does not coagulate, since the mechanical separator is able to move upward through the sample during centrifugation.
The mechanical separator of the present invention includes a float that engages or locks with a part of the bellows structure until the separator is subjected to an applied centrifugal force. Thus, in use, the mechanical separator of the present invention minimizes the pre-launch of the device and provides a more stable target area to the puncture tip interface to reduce the accumulation of the sample under closure. Additionally, the reduced space between the outside of the float and the inside of ballast minimizes the loss of trapped fluid phases, such as serum and plasma.
Although the present invention is described with reference to various different embodiments of a mechanical separator assembly and method of use, those skilled in the art can make modifications and alterations without departing from scope and spirit. Therefore, the description described above is intended to be illustrative and not restrictive.
Contents7
18 sheets
Sheet 1 Sheet 2 Sheet 3 Sheet 4 Sheet 5 Sheet 6 Sheet 7 Sheet 8 Sheet 9 Sheet 10 Sheet 11 Sheet 12 Sheet 13 Sheet 14 Sheet 15 Sheet 16 Sheet 17 Sheet 18
72 members in 11 offices
Priority claims4
| Document | Office | Kind | Date |
|---|---|---|---|
| 61082365 | United States of America | – | |
| 8236508 | United States of America | P | |
| 8236508 | United States of America | P | |
| US20080082365P | – | – | – |
Members72
| Document | Office | Kind | |
|---|---|---|---|
| AU2009274099A1 | Australia | A1 | |
| AU2009274104A1 | Australia | A1 | |
| CA2731076A1 | Canada | A1 | |
| CA2731156A1 | Canada | A1 | |
| CA2819470A1 | Canada | A1 | |
| WO2010011667A2 | World Intellectual Property Organization (WIPO) | A2 | |
| WO2010011672A2 | World Intellectual Property Organization (WIPO) | A2 | |
| WO2010011667A3 | World Intellectual Property Organization (WIPO) | A3 | |
| WO2010011672A3 | World Intellectual Property Organization (WIPO) | A3 | |
| US2010155319A1 | United States of America | A1 | |
| US2010160135A1 | United States of America | A1 | |
| MX2011000798A | Mexico | A | |
| MX2011000799A | Mexico | A | |
| EP2326421A2 | European Patent Office (EPO) | A2 | |
| EP2326422A2 | European Patent Office (EPO) | A2 | |
| CN102149471A | China | A | |
| CN102149472A | China | A | |
| JP2011528802A | Japan | A | |
| JP2011528803A | Japan | A | |
| AU2009274104B2 | Australia | B2 | |
| EP2326421B1 | European Patent Office (EPO) | B1 | |
| AU2009274099B2 | Australia | B2 | |
| EP2508260A1 | European Patent Office (EPO) | A1 | |
| EP2517792A1 | European Patent Office (EPO) | A1 | |
| EP2517793A1 | European Patent Office (EPO) | A1 | |
| ES2390171T3 | Spain | T3 | |
| EP2527039A2 | European Patent Office (EPO) | A2 | |
| EP2527039A3 | European Patent Office (EPO) | A3 | |
| JP2013029530A | Japan | A | |
| US8394342B2 | United States of America | B2 | |
| CA2731076C | Canada | C | |
| US2013164195A1 | United States of America | A1 | |
| EP2326422B1 | European Patent Office (EPO) | B1 | |
| EP2517793B1 | European Patent Office (EPO) | B1 | |
| CA2731156C | Canada | C | |
| EP2644274A1 | European Patent Office (EPO) | A1 | |
| ES2430638T3 | Spain | T3 | |
| EP2517792B1 | European Patent Office (EPO) | B1 | |
| PL2326422T3 | Poland | T3 | |
| JP5385384B2 | Japan | B2 | |
| ES2452534T3 | Spain | T3 | |
| EP2508260B1 | European Patent Office (EPO) | B1 | |
| JP5504323B2 | Japan | B2 | |
| PL2517792T3 | Poland | T3 | |
| US8747781B2 | United States of America | B2 | |
| CN102149472B | China | B | |
| ES2495431T3 | Spain | T3 | |
| JP5607621B2 | Japan | B2 | |
| CN102149471B | China | B | |
| CN104353511A | China | A | |
| JP2015045646A | Japan | A | |
| EP2644274B1 | European Patent Office (EPO) | B1 | |
| EP2527039B1 | European Patent Office (EPO) | B1 | |
| ES2545462T3 | Spain | T3 | |
| ES2548183T3 | Spain | T3 | |
| PL2644274T3 | Poland | T3 | |
| CA2819470C | Canada | C | |
| MX339263B | Mexico | B | |
| MX339267B | Mexico | B | |
| JP5923568B2 | Japan | B2 | |
| CN104353511B | China | B | |
| US9452427B2 | United States of America | B2 | |
| US2016367983A1 | United States of America | A1 | |
| US9700886B2 | United States of America | B2 | |
| US2017266662A1 | United States of America | A1 | |
| BRPI0916364A2 | Brazil | A2 | |
| BRPI0916368A2 | Brazil | A2 | |
| MX365966B | Mexico | B | |
| MX366109BThis record | Mexico | B | |
| US10350591B2 | United States of America | B2 | |
| BRPI0916364B1 | Brazil | B1 | |
| BRPI0916368B1 | Brazil | B1 |
Numbers
- Publication
- 366109
- Publication, DOCDB
- 366109
- Publication, EPODOC
- MX366109
- Application
- 2014007859
- Application, DOCDB
- 2014007859
- Application, EPODOC
- MX2014007859
Titles2
- Spanish
- DISPOSITIVO DE SEPARACION DE FASES POR DENSIDAD.
- English
- PHASE DENSITY SEPARATION DEVICE.
Classification
- CPC, 4
- B01L3/50215
- B01L2300/044
- B01L2300/048
- Y10T29/49826
- IPC, 1
- B01L3 14