• 专利附录
  • 专利说明
  • 权利要求
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    • 专利摘要:
    DEVICE (1a, 1b, 1c, 1d; 40) FOR EXTRACTING, STORING AND / OR PROCESSING BLOOD OR OTHER SUBSTANCES OF HUMAN OR ANIMAL ORIGIN, AND FOR APPLYING BLOOD COMPOUNDS OR OTHER BIOLOGICAL COMPOUNDS, comprising a body (2; 41) inside which a piston (3; 42) is able to move longitudinally and is separable, at least in part, where the body (2; 41) has an internal space (9; 51) that can be connected to the outside by middle of a channel (6; 50) at a first end (4; 48) of the body (2; 41), where the body (2; 41) and the piston (3; 43) can be locked longitudinally in at least one position to allow the creation of different degrees of vacuum. The device has multiple uses and is extremely versatile.
    公开号:BR112014031902B1
    申请号:R112014031902-2
    申请日:2013-07-02
    公开日:2021-01-12
    发明作者:Eduardo Anitua Aldecoa
    申请人:Biotechnology Institute, I Mas D.S.L.；
    IPC主号:
    专利说明:

    APPLICATION FIELD
    [001] The invention relates to a device to extract, store and / or process blood or other substances of human or animal origin, and to apply blood compounds or other biological compounds. Specifically, the invention relates to a single device with which blood can be drawn, into which blood can be processed, into which the blood or substances obtained can be stored, and from which the obtained substances can be applied. TECHNICAL STATUS
    [002] The extraction of small amounts of blood from a patient or animal and its further processing for the adequate therapeutic purpose is usually performed using vacuum tubes, closed with a perforated sealing cap. A butterfly needle is attached to the vacuum tube and inserted into the patient's vein. Once it is drawn into the vacuum tubes, blood is processed using methods that vary according to the medical application. For example, in many medical applications, blood is centrifuged so that it is separated into different fractions. Said centrifugation is generally carried out in vacuum tubes into which the blood was first drawn. Then, blood compounds obtained by centrifugation or, in general, processed blood compounds, usually need to be transferred to other containers for further processing or storage. For example, in the case of certain centrifuged compounds (such as platelet-rich plasma, if applied to the patient at a later stage) those compounds may need to be transferred to a syringe, in the event that they need to be applied to the patient or other means.
    [003] The transfer of blood or blood compounds from one container or device to another always involves the risk of the blood or blood compound being contaminated, for example, bacterial contamination.
    [004] Patent document CN101528243 entitled Plateletrich Plasma Separator and Platelet-rich Plasma Separation Method describes a platelet-rich plasma separator, comprising a first syringe and a second syringe. The first syringe comprises a first syringe cylinder provided with a first nozzle on which a blood collection needle can be mounted, a first detachable cap on the first nozzle, a first gasket for hermetically sealing the first syringe cylinder, where the first gasket moves inside the first syringe cylinder and a first plunger is detachably attached to the first gasket. The second syringe comprises a first hollow needle, which can be passed through the first gasket, a second syringe cylinder having a second nozzle on which the first hollow needle can be mounted, a second detachable cap on the second nozzle, a second gasket for sealing hermetically sealed the second syringe cylinder, said second gasket being displaceable within the second syringe cylinder and a second plunger detachably connected to the second gasket.
    [005] The patent US4906231 entitled Single-use Fillable Syringe refers to a disposable syringe comprising a plunger driven by a rod, the end of which is provided with an eccentric flap which by rotating the rod engages or disengages a cavity provided on the proximal face the plunger. During the filling step, the plunger is restricted to only move outward as needed for filling. For the injection to occur, the rod must be rotated to a second position in which the plunger is detached from the piston. In this position, the plunger is restricted so that it can only move inward as needed for injection. The plunger and stem include corresponding sets of ribs and retainers that cooperate in a rack action to restrict the direction of travel. This restriction means that the plunger can be pulled only once (to fill the syringe) and pushed only once (to expel liquid from the syringe).
    [006] Patent application US2008188828 entitled Airless Mixing with a By-pass Syringe deals with a transfer and mixing device that uses a bypass cartridge and a syringe. After mixing the dry component and the diluent in the bypass cartridge, the mixture can be passed to a syringe that includes a plunger having a fluid passage inside it with a hydrophobic membrane covering the passage. The mixture can be transferred back and forth between the bypass cartridge and the syringe through a small orifice for mixing, particularly in the case of microspheres kept in suspension.
    [007] An additional disadvantage of vacuum tubes is that they tend to gradually lose their vacuum. As a result, tubes that are stored for a period of time before being used to receive blood during an extraction may not be able to store as much blood as when they were first supplied due to the degree of vacuum inside it having been reduced. In addition, tubes that have been stored for a long time may have been contaminated as a potential result of air leaking into them.
    [008] The invention aims to offer a device that solves at least one of the problems mentioned above.
    [009] In other words, one of the aims of the invention is to provide a versatile device, offering a variety of uses and therefore to reduce the number of transfers between containers normally required in procedures involving the extraction, processing and storage of blood or blood compounds. blood.
    [010] It is also desirable to provide a device that reduces or eliminates the negative results caused by the loss of vacuum over time in blood extraction and blood storage devices. GENERAL DESCRIPTION OF THE INVENTION
    [011] It is an objective of this invention to provide a device to extract, store and / or process blood or other substances of human or animal origin, and to apply blood or other biological compounds, comprising a body within which a piston is capable to move longitudinally. The body is provided with a first end on which there is a channel that connects an internal space of the body located between the piston and the channel with the outside of the body. The body also comprises a second end through which the piston projects outwards. The internal space of the body is hermetically separated from the second end by means of the piston. The movement of the piston towards the first end where the channel is located allows the contents of the internal space to be expelled. In contrast, the movement of the piston towards the second end, opposite the channel, allows the vacuum in the internal space to be created.
    [012] In accordance with the invention, the aforementioned piston-body-based device has the specific feature that at least part of the piston is capable of being separated from the rest of the device so that the piston does not protrude out of the body. In addition, the device has mechanisms for unidirectional blocking of the piston, with the result that in the case of being blocked, the piston cannot move towards the first end of the body, although it can return towards the second end. The device also comprises a sealing element located at the first end, specifically so as to close the channel of the first end of the body in a sealed manner in the event that a needle is inserted into said channel. In other words, the sealing element ensures that the channel forms a sealed entry for a needle.
    [013] The features mentioned above make the device extremely versatile. First, the device can be used as a container into which a patient's blood is drawn, as long as the vacuum has been created in the device previously with the aid of the piston and the piston has been blocked so that the vacuum is maintained at the required level. In addition, when at least part of the piston is separated from the rest of the device, the device can function as a tube for storing compounds and even for processing compounds (for example, in a centrifugation process). In addition, the piston can be unlocked to allow it to move again towards the first end, with the result that the device can also function as a syringe. An additional advantage is the fact that, in the event that the device has several points at which the piston is blocked longitudinally in relation to the body, the degree of vacuum inside the device is adjustable.
    [014] The provision of a device with the ability to be converted from an initial body-piston unit to a tube-type container and vice versa results in significant improvements in some medical processes. First, it allows processes to be carried out with a smaller number of devices due to the fact that the device of the invention has a number of uses. In addition, for similar reasons, the number of transfers required between different devices is reduced, thus increasing biosafety.
    [015] An additional advantage of the invention is that the device performs ideally when used as an extraction or storage container, due to the fact that the device is provided with a piston that allows the creation of vacuum at any time and with an internal space tight. Vacuum can be created at the exact moment the device is to be used, ensuring that the vacuum level is ideal when the device is to be used and making the vacuum level adjustable. And, in the event that air enters the device, a vacuum can be created again in order to overcome this problem.
    [016] The sealing element can be internal to the body. In other words, it can be present permanently. Alternatively, the sealing element can be external to the body and connected to disconnected from the body. In other words, it may not be present on the device permanently. In addition, the sealing element can be pierceable so that it provides an airtight seal permanently and the device can operate without a needle. Alternatively, the sealing member may take the form of a ring with a through hole for insertion of a needle, so that it is hermetic only when a needle is inserted through said hole and fits against the ring. DESCRIPTION OF THE FIGURES
    [017] Details of the invention can be seen in the attached figures, not limiting:
    [018] Figures 1 and 2 show two perspective views of a first application of the device according to the invention.
    [019] Figure 3 shows a sectional view of the device, according to a vertical section plane that passes through the central longitudinal axis of the device.
    [020] Figure 4 shows a sectional view of a second application of a device according to the invention.
    [021] Figure 5 shows a sectional view of a third application of a device according to the invention.
    [022] Figure 6 shows a sectional view of a fourth application of a device according to the invention.
    [023] Figure 7 shows an application of an impeller element.
    [024] Figure 8 shows a sectional view of the device of Figure 6, to which the impeller element of Figure 7 has been connected.
    [025] Figure 9 shows a fifth application of the device according to the invention.
    [026] Figures 10 to 12 show a sixth application of the device according to the invention.
    [027] Figures 13A and 13B show a sequence for the preparation of a growth factor rich plasma (PRGF) in which the device of Figure 1 is used.
    [028] Figure 14 shows a seventh application of the device according to the invention.
    [029] Figure 15 shows an enlarged view of detail A in Figure 14.
    [030] Figure 16 shows an eighth application of the device according to the invention.
    [031] Figure 17 shows a sectional view of the device mentioned above, according to a vertical section plane comprising the central longitudinal axis of the device.
    [032] Figure 18 shows an enlarged sectional view of the second end of the body of Figure 17.
    [033] Figure 19 shows an enlarged sectional view of the first end of the body of Figure 17.
    [034] Figure 20 shows an optional external housing.
    [035] Figure 21 shows an optional internal disk.
    [036] Figure 22 shows the device of Figure 16, after the inner disk of Figure 21 and the outer shell of Figure 20 have been assembled.
    [037] Figure 23 shows an enlarged longitudinal sectional view of the area of the second end of the body of Figure 22.
    [038] Figure 24 shows an enlarged longitudinal sectional view of the area of the first end of the body of the device of Figure 22. DETAILED DESCRIPTION OF THE INVENTION
    [039] Figures 1 and 2 show two perspectives of a first application of a device (1a) according to the invention, to extract, store and / or process blood or other substances of human or animal origin, and to apply compounds of blood or other biological compounds. Said device (1a) comprises a body (2) within which a piston (3) is able to move longitudinally. The body (2) is provided with a first end (4) and a second end (5). The piston (3) protrudes outwards through the second end (5) and delimits, in a sealed way inside the body (2), an internal space (not shown in the figures). The internal space is connected to the outside by means of a channel (6) located in the area of the first end (4). The first end (4) preferably ends in a connector (7) which allows the device (1a) to be coupled to other devices. An example of an applicable connector (7) is a "Luer-Lock" or similar connection.
    [040] Figure 3 shows a sectional view of the device (1a) of the previous figures. The section was formed according to a vertical cutting plane that contains the central longitudinal axis (8) of the body (2). As shown in the figure, an internal space (9) is delimited inside the body (2), between the piston (3) and the channel (6). The piston (3) fits firmly into the internal walls of the body (2) to provide a sealed separation between the internal space (9) and the second end (5) of the body (2). In other words, the piston (3) seals hermetically or firmly the upper area (according to the position of the device in the figure) of the internal space (9). Opposite the piston (3) is the channel (6), which connects the internal space (9) of the body (2) to the outside of the body (2).
    [041] At least part of the piston (3) is capable of being separated from the rest of the device so that the piston (3) project does not protrude out of the body (2). This feature makes the device a versatile tool and also allows a single piston (3) to be shared by or used with multiple bodies (2). In this specific application, the piston (3) comprises a rod (10) and a tip (11), where the rod (10) is fixed to the tip (11) by means of a connection that can be disconnected and connected, in this case via a threaded connection. Said disconnectable and connectable union allows the rod (10) to be released from the tip (11) when necessary, and to be reconnected when necessary. This allows the device to be used as follows: first, with the rod (10) connected to the tip (11), the rod (10) can be pulled back - for example, by pulling an operable area (12) generally comprised on the rod (10) - to create a vacuum; a biological compound (for example, blood drawn from a patient) can then be transferred by vacuum to the device; the rod (10) can then be disconnected and removed to allow the device to be used as a tube, for example to store the compound or to process the compound (for example, by centrifugation); later, the rod (10) can be reconnected so that the device can be used as a syringe, ie the end of allowing the piston (3) to advance towards the channel (6) and expel the compound stored in the internal space (9). In addition, the provision of a joint that can be disconnected and connected allows the rod (10) to be reused with other devices and the vacuum to be repeated or adjustable.
    [042] In addition, the piston (3) comprises at least one locking surface (13a, 13b). In turn, the body (2) comprises at least one locking surface (14a, 14b) adapted to come into contact with a locking surface (13a, 13b) of the piston (3). The said contact between the corresponding locking surfaces (13a, 14a; 13b, 14b) is such that it provides a unidirectional locking of the piston (3), resulting in resistance being offered for the movement of the piston (3) towards the first end ( 4), while allowing the piston (3) to move back to the second end (5).
    [043] The device (1a) also comprises an internal and perforable sealing element (15) that allows to close the channel (6) of the first end (4) of the body (2) in a sealed way in the event of a needle or similar element be inserted into said channel (6). As the sealing element is internal and perforable, it is permanently present inside the body (2) and seals the channel (6) permanently. The internal space (9) is only communicated with the outside when a needle (such as a butterfly extraction needle) is inserted and punctures the sealing element (15). As a result of permanent sealing, a vacuum can be created in the internal space (9) at any time simply by pulling the piston (3). This allows you to recover vacuum conditions in the event of a small loss of vacuum caused, for example, by storing the device in improper conditions. In addition, the provision of an internal and perforable sealing element provides a permanently sealed and integrated device that can be used, for example, as a container into which blood is drawn, as a container into which it has plasma fractions. transferred, etc.
    [044] The combination of the features mentioned above makes the device extremely versatile. First, under normal conditions and by pulling the piston (3) back, a vacuum can be created in the internal space (9) of the body (2) allowing the device (1a) to be used to receive a substance by the effect of the vacuum (for example , to receive blood from the patient's vein). Second, when the piston (3) is blocked in the body (2), that is, prevented from moving towards the first end (4), part of the piston (3) can be separated to prevent the rest of the piston ( 3) protrudes out of the body (2), allowing the device (1a) to then be used as a tube, for example for storage, centrifugation, etc.
    [045] As shown in the figure, it is particularly interesting that a locking surface (13b) of the piston (3) is specifically comprised in the tip (11) of the piston (3). This allows the rod (10) to be disconnected from the piston (3) while the lock between the tip (11) and the body (2) is maintained by said locking surface (13b) of the tip (11) which is engaged on a surface of corresponding block (14b) of the body (2). The fact that the tip lock (11) is maintained when the rod (10) is removed allows the rod (10) to be used in succession on several devices and allows all devices, once the rod has been removed for use on the nearby device, be kept in identical conditions until all devices are ready to be processed.
    [046] Figure 4 shows a second application of the device (1b) according to the invention. In this case, the sealing element (16) is perforable and external, capable of being connected to the first end (4). For example, the sealing element (16) is a separating accessory. The fact that the sealing element (16) is external and can be connected and disconnected means that when the sealing element (16) is not present, other accessories can be connected to the first end (4) to allow the device (1b ) perform other functions. For example, a conventional syringe needle can be connected to the first end (4) to allow the device (1b) to be used as a syringe.
    [047] Figure 5 shows a third application of a device (1C) according to the invention. In this case, the sealing element (17) is internal and has the shape of a ring, and is located in the channel (6). The internal space (9) is permanently connected to the outside by the channel (6), and only when a needle is inserted into the channel and the outer walls of the needle contact in a sealed way against the sealing element (17) that the internal space (9) is sealed off from the outside. In order to illustrate this aspect, a needle drawn with dotted lines is shown inserted through the sealing element (17). This application is therefore characterized in that the vacuum can only be created in the internal space (9) when a needle is inserted through the channel (6). The advantage of this application is that only a very small amount of effort is required to insert the needle, as there is no need to pierce a piercing element. This allows, for example, the needle to require a sharp point. In addition, as long as the degree of interference between the ring seal and the needle is properly configured, the interior of the device can be as airtight or even more airtight than it would be using a pierceable element. In addition, in the event that the device is used repeatedly, the device (1b) suffers only minimal wear and remains equally capable of acquiring tightness.
    [048] Preferably, the piston (3) is capable of rotating within the body (2). In addition, at least one locking surface (14a, 14b) of the body (2) and at least one locking surface (13a, 13b) of the piston (3) are arranged in such a way that the locking is caused only in certain positions of rotation of the piston (3) in relation to the body (2), the piston (3) being free in relation to the body (2) in the remaining rotating positions. This allows the user to lock and unlock the piston advance (3) at the first end (4), when performing simple manipulation. When the user wants to use the device as a storage and processing tube, he pulls the piston back and rotates it until locking occurs. When the user wants to use it as a syringe he rotates the piston until it is unlocked and can move freely towards the first end.
    [049] Figure 6 shows a fourth application of a device (1d), according to the invention. In this case, the piston (3) comprises at least one breakable area (18) so that it can be manually broken into parts. In other words, some parts of the piston (3) can be separated from the rest of the piston (3) in a breakable and non-reconnectable way. This allows an application that avoids the reuse of the piston (3), which in certain circumstances may be of interest, for example, to prevent cross-contamination between patients.
    [050] For this application, the device (1d) has an accessory or impeller element (19), an example of which is shown in Figure 7. Said impeller element (19) comprises a first area (20) capable of pushing the piston (3) in order to overcome the piston advance resistance (3) offered by the lock between at least one locking surface (13a, 13b) of the piston (3) and the corresponding locking surface (14a, 14b) of the body (2) and therefore cause the piston (3) to advance towards the first end (4). The advance can be carried out, for example, in a second area (21) adapted for this purpose. The pusher element (19) allows the device (1d) to be used as a syringe once the piston (3) has been broken.
    [051] Preferably, the first area (20) of the impeller element (19) is capable of being connected to the piston (3) so that it can cause the piston to rotate (3). For example, in this application the first area (20) has grooves (22), containing a shape complementary to the shape of the broken piston (3). The broken piston can therefore be inserted in a small part of said grooves (22), and if a torque is applied to the impeller element (19), said torque is transferred to the piston (3). This allows the present application to have a piston (3) capable of being rotated. As a result, the piston (3) can also be designed, as in previous applications, to be locked in some rotating positions and unlocked in others.
    [052] In addition, the first area (20) of the impeller element (19) can be shaped in a complementary manner to the piston (3) so that the connection between the impeller element (19) and the piston (3) is actually obtained by the driving force itself. In other words, the positioning of the impeller element (19) behind the piston (3) and the impulsion of the impeller element (19) not only causes the piston to advance (3) but also improves the connection between both parts (3, 19).
    [053] In addition, the first area (20) of the impeller element (19) can be formed containing a mechanical connection with the piston (3) so that the connection between the impeller element (19) and the piston (3) allows that the piston (3) is not only pushed towards the first end (4), but also be pulled back to the second end (5). This allows the vacuum to be created inside the device at any time, if necessary.
    [054] Figure 9 shows an additional element that can be understood in the devices (1a, 1b, 1c, 1d). Said additional element is a manipulation tab (23), located on the second end (5) to allow the action of causing the piston (3) to move back towards the said second end (5). The manipulation tab (23) is connected to the rest of the body (2) in a disconnectable and connectable way, preferably by means of a thread (24), as shown in the figure. This allows the handling tab (23) to be disconnected from the body (2) once a vacuum has been created in the internal space (9) and the piston (3) and body (2) have been blocked, so that the manipulation tab (23) can be used with other devices, while maintaining the lock between the piston (3) and the body (2).
    [055] Figures 10, 11 and 12 show an additional optional feature of the invention, according to which the piston (3) comprises one or more guides (25) - two in the figures - which project radially from the piston (3 ). To aid understanding of the figures, the piston shaft (3) is shown only partially in Figure 10, and is omitted entirely from Figures 11 and 12. The guides (25) provide or act as a piston locking surface (13b) (3). In addition, the corresponding blocking surface (14b) of the body (2) takes the form of a transverse seating surface, the term transverse being understood as the surface containing a component in the radial direction of the body (2). The piston (3) is locked in relation to the body (2) when the guides (25) are supported on the locking surfaces (14b), as shown in Figures 10 and 11. The body (2) also comprises internal walls (27) , of which the distance from the central longitudinal axis (8) decreases in the direction of rotation in which the piston (3) must rotate in order to be released from the body (2) (which in the case shown in the figure is clockwise). Thus, as can be seen, when starting from a blocked situation like the one in Figure 11, the rotation of the piston (3) is caused in a blocking direction (clockwise), the guides (25) rotate in contact with the internal walls ( 27), and the decreasing distance between the inner walls (27) and the central longitudinal axis (8) causes the flaps (25) to flex inwards. A situation like the one shown in Figure 12 is eventually obtained where the guides (25) are flexed sufficiently inward to the locking surface (14b) of the body (2) to be released, the piston (3) thus becoming unlocked from the body (2) and being able to move towards the first end (4).
    [056] The invention also contemplates an optional technical resource applicable to cases in which the piston rod (10) and the piston tip (11) (3) are threaded together. Specifically, the body (2) can have at least one limiting element (26) against an area of the tip (11) that is able to come into contact when the tip (11) rotates in the direction opposite to the tightening direction of said union with screw thread. As a result, when the user wants to unscrew the rod (10) from the tip (11) and for this purpose produces a rotation of the rod (10) in the opposite direction to the tightening direction, the tip (11) eventually encounters the limiting element (26 ), which retains the tip (11) and prevents it from rotating together with the rod (10), thus allowing the rod (10) to be unscrewed from the tip (11). Figures 10, 11 and 12 show an application of this limiting element (26), which consists of a wall formed in a radial plane and against which the tip (11) comes into contact when it turns around the central longitudinal axis (8). In particular, the area of the tip (11) that comes into contact with the limiting element (26) is specifically comprised in a guide (25). In other words, it is the guide (25) that performs the dual function of longitudinally locking the tip (11) and restricting the rotation of the tip (11) in a direction opposite to that in which the rod (10) is tightened.
    [057] Figures 13A and 13B show an example of using a device according to the invention, which provides an understanding of its extreme versatility. A sequence for the preparation of a growth factor rich plasma (PRGF) in which the device (1a) of Figure 1 is used is shown. The sequence begins with a body (2) within which the tip (11) of a piston (3) is housed. In a first step, the piston rod (10) (3) is threaded to said tip (11). The rod (10) is then pulled back, causing the tip (11) to move inside the body (2) and a vacuum to be formed in the internal space (9) of the body (2). When the vacuum is created, the rod (10) is unscrewed from the tip (11), thus obtaining a tube-shaped device (1a) supplied with internal vacuum conditions. The blood is then drawn from the patient's vein into the internal space (9) of the device (1a), to which a suitable accessory is connected to the first end (4) of the body (2). When the body (2) is filled with blood (28), the separation of blood into different fractions, including a fraction (29) of red blood cells and a fraction (30) of platelet-rich plasma, is achieved for example by centrifugation device (1a) under suitable conditions. The device (1a) is then connected to a second device (1a '), by means of an intermediate closing device (31), with a vacuum having previously been created within the second device (1a'). The closing device (31) is capable of opening and closing the passage between the respective needles (32, 33), which are connected to each device (1a, 1a '), with the result that the passage of substances between the devices ( 1a, 1a ') can be allowed or prevented. The needle (32) in the example, which is connected to the first device (1a), does not have a sharp point like the sealing element (15) which is pre-pierced by a pointed needle (this pre-needle and the piercing step do not shown in the figures). When operated correctly, the closure device (31) then opens the passage between the needles (32, 33) and allows the vacuum effect transfer of the fraction (30) of the platelet-rich plasma from the first device (1a) to the second device (1a '), as shown in the first step of Figure 13B. The procedure is then repeated with a third device (1a '') containing blood fractions (29 and 30), with the result that the second device (1a ') contains fractions (30) of platelet-rich plasma from two devices (1a, 1a ''). Finally, the second device (1a ') is removed and the piston rod (10) (3) and the manipulation flap (23) are both connected, as a result of which the second device (1a') is ready for use like a syringe (a needle is not shown) as soon as the tip (11) of the piston (3) is released from the body (2).
    [058] Figures 14 and 15 show an alternative application of locking surfaces according to the invention. In this case, the piston (3) comprises a locking surface (13c) capable of coming into contact with a locking surface (14c) located on the inner wall of a conical intermediate part (34) of the body (2). The conical intermediate part (34) has limited longitudinal mobility in relation to the piston (3) and in relation to the rest of the body (2). When the piston (3) advances towards the first end (4), the friction between the interlocking surfaces (13c, 14c) causes the intermediate conical part (34) to advance a little towards the first end (4). As a result, the tapered outer wall (35) is pressed against the inner body wall (2), causing the intermediate tapered part (34) to be increasingly pressed against the piston (3), thus increasing friction between the locking surfaces. (13c, 14c). A cyclic phenomenon is therefore caused, resulting in a blockage between said blocking surfaces (13c, 14c) which prevents the piston (3) from advancing towards the first end (4). The piston (3) can be unlocked simply by pulling it back, in other words, in a direction towards the second end (5) of the body (2). This application allows the piston (3) to be locked in any longitudinal position in relation to the body (2), thus allowing a gradual vacuum to be created, where said vacuum can be varied continuously between the minimum and maximum volume.
    [059] Optionally, the device can be preloaded with a substance suitable for the type of treatment that must be performed with the device. For example, it can be preloaded with anticoagulant in the event that blood must be drawn into the device. The invention contemplates preloading during the manufacture of the device or by the user himself, depending on the requirements.
    [060] Figures 16 and 17 show respectively a perspective view and a sectional view of an eighth application of the device according to the invention, the section being carried out according to a vertical section plane containing the central longitudinal axis of the device . As in previous applications, the device (40) comprises a body (41) and a longitudinally movable piston (42). Figure 17 shows that the piston (42) again comprises a rod (43) and a ferrule (44). The rod (43) is connected to the tip (44) via a threaded connection (45) and therefore can be connected and disconnected from the tip (44). The tip (44) is composed of a tip body (46) and a cap (47). As in previous applications, the body (41) of the device (40) is again provided with a first end (48) in which there is a channel (50) that communicates an interior space (51) of the body (41), located between the piston (42) and the channel (50), with the outside of the body (41). In addition, the body (41) comprises a second end (49) through which the piston rod (43) protrudes outward. As in previous applications, the piston (42), more specifically the piston tip (44), comprises locking surfaces (52) intended to be engaged with the corresponding locking surfaces (53) at the second end (49) the body (41) when the piston (42) is fully pulled back inside the body (41) towards the second end (49); said engagement is not shown in Figure 17 because the piston (42) is shown only in half its travel between the first end (48) and the second end (49). The body (41) of the device (40) further comprises a sealing element (54) adapted to hermetically close the channel (50) of the first end (48). The device (40) also comprises a manipulation tab (55) to assist in the action of pulling the piston (42) back, that is, towards the second end (49) of the body (41), and to help push the piston (42) forward, that is, towards the first end (48) of the body (41). In this case, the manipulation tab (55) is not disconnectable, but preferably forms an integral part of the body (41).
    [061] Figure 18 shows an enlarged sectional view of the second end (49) of the body (41) of the previous figure, now shown in a situation where the locking surfaces (52) of the tip body (46) are engaged with the locking surfaces (53) of the body (41), offering resistance to the forward movement of the piston (42) towards the first end (48). In the present application, the locking surfaces (52) are internal elastic arms capable of slightly moving radially as indicated by the arrows in the figure and propelled elastically and radially inwards, in order to provide a snap effect when the user pulls the piston (42) back far enough to reach the situation shown in the figure. The popping effect provides an indication to the user that a vacuum has been successfully obtained inside the device.
    [062] Figure 19 shows an enlarged sectional view of the first end (48) of the body (41). In the area closest to the first end (48), the internal space (51) is bounded by an internal transverse wall (56) that has one or more holes (57, 58). A central through hole (58) is occupied and closed by a central area (59) of the sealing element (54), said sealing element (54), having the shape of a disc. Other through holes (57) are freely and externally closed by an outer area (60) of the sealing element (54). These other through holes (57) are designed to allow fluid to flow from the internal space (51) towards the outside under certain conditions which are explained below. On the face of the sealing element (54) opposite the inner wall (56), an internal trunk-conical bushing (61) is arranged. Said internal bushing (61) has an internal through hole that is partially occupied by the central area (59) of the sealing element (54) - said central area (59) being fitted in the through hole - and partially free, said part free being part of the channel (50). In a plane other than the cutting plane, the inner sleeve (61) is connected to the rest of the body (41) so that the inner sleeve (61) holds the sealing element (54) in place. The device further comprises a lid (62) which closes the first end (48) of the body (41). Said cover (62) has internal surfaces (63) adapted to press the outer area (60) of the sealing element (54) against the through holes (57), which close the holes. In other words, when the cover (62) is fixed as shown in the figure, a sandwich arrangement is formed in which the sealing element (54) is maintained between the inner wall (56) and, on the outside, the inner sleeve ( 61) and the inner surfaces (63) of the cover (62). The outer area of the cover (62) can allow the connection of other devices, as is the case with the current application where the said external area is a "Luer-Lock" type connection with a central hole (64) in communication with the channel (50). In this regard, it is contemplated that the cover (62) can have different designs to allow the connection of several devices. The device, in the situation shown in the figure, therefore works like the previous applications: the channel (50) that communicates the internal space (51) with the outside is closed by the sealing element (54), and the sealing element (54) allows the hermetic insertion of a needle in the direction of the internal space (51).
    [063] The device of the present application optionally comprises some additional components shown in Figures 20 and 21. Specifically, Figure 20 shows an external housing (65) adapted to fix the second end (49) of the body (41). The outer casing (65) comprises a body (66) that has a longitudinal through hole (67) designed to embrace the device body (41) and an inner space (68) shaped with a radial widening of the longitudinal through hole (67) . The outer casing (65) further comprises elastic arms (69), curved inwards with a greater curvature than the curvature of the outer walls of the body (41) of the device, in order to provide a hold of the outer casing (65) on the body ( 41). Finally, the outer casing (65) comprises internal protrusions (70) adapted to contact longitudinally with the internal walls of the body (41) of the device and with the handling tab (55), as will be shown below. In turn, Figure 21 shows an internal disc (71), provided with a threaded through hole (72) to allow the piston rod of the device (43) to pass through, as will be shown and also provided with an external face ( 73) which has small protuberances (74), a roughness or irregularity to help promote the rotation of the internal disc (71) through the rotation of the outer face (73) with the user's fingers. Finally, the internal disk (71) comprises angularly spaced visual marks (75) that provide a reference for the user.
    [064] Figure 22 shows the device (40) of Figure 16, with the inner disk (71) and the outer shell (65) already attached. The rod (43) has an external threaded contour whose thread is compatible with the threaded through hole thread (72) of the inner disc (71). The inner disc (71) is therefore connected by threading the rod (43) through the through hole (72) of the inner disc (71) to the tip (44). Once the inner disk (71) is positioned in place, the outer shell (65) is coupled radially to the inner disk (71), the inner disk (71) lodging in the inner space (68) of the outer shell (65) ). The outer shell (65) is then finally fixed to the body (41) by means of elastic arms (69).
    [065] Figure 23 shows an enlarged sectional view of the area of the second end (49) of the body (41) of the previous figure, in order to illustrate the functionality of the outer shell (65) and the inner disk (71). In the situation of the figure, the piston (42) is rotated enough to free the locking surfaces (52), as shown in the sectional view, this current sectional view having been performed according to a different longitudinal section plane than than in Figure 17. The outer shell (65) is connected to the body (41) so that the outer shell (65) is unable to move in the longitudinal direction. For example, in the present application, the outer casing (65) is unable to move longitudinally in one direction due to the presence of the inner disc (71) and is not able to move in the opposite direction due to longitudinal contact between the protuberances (70) and the device handling tab (55). The inner disc (71) is also prevented from moving longitudinally, due to the fixed presence of the outer shell (65) and the handling tab (55). Thus, when the user rotates the internal disc (71) due to the thread of the through hole with thread (72) at least partially combining with the external thread of the stem (43), the stem (43) is driven to move longitudinally in a forward or backward direction. The device therefore allows a simple and comfortable application of a liquid or other product contained in the internal space (51), since the user only needs to rotate the internal disk (71) to produce a forward movement of the piston (42), and therefore a forward movement of the liquid towards the first end (48) of the body. The visual marks (75) help to distribute exact doses of liquid, such as the angular distance between the visual marks (75) is directly related to the longitudinal displacement of the piston (42) and, therefore, to the volume of liquid extracted from the device.
    [066] The device of Figure 22 is prepared to be used to apply a liquid contained inside, for which the cap (62) has been removed and replaced by a filter accessory (76) provided with a needle (77). Figure 24 shows a longitudinal sectional view of the first end (48) of the body (41) and the filter accessory (76). In this case, the needle (77) of the filter accessory (76) does not pierce the sealing element (54) of the device in order to provide an outlet for the liquid. Instead, the sealing element (54) and the outer area (60), no longer in contact with the cover (62), can move longitudinally in relation to the through holes (57) of the inner wall (56). When the user moves the piston (42) to move forward, the pressure of the liquid in the through holes (57) increases and pushes the outer area (60), eventually causing it to separate from the through holes (57) and allow the liquid to escape through the through holes (57). In this particular application, for example, the liquid then flows through one or more internal channels of the filter accessory (76), not shown, passes through a filter membrane (78) that retains impurities and exits through the internal channel (79) the needle (77). In other words, according to the invention, the device opens automatically when the cover (62) is removed, partially releasing the sealing element (54), and the user applies sufficient pressure on the piston (42) for pressure increase and slightly open the sealing element (54).
    权利要求:
    Claims (20)
    [0001]
    1. DEVICE (1a, 1b, 1c, 1d; 40) FOR EXTRACTING, STORING AND / OR PROCESSING BLOOD OR OTHER SUBSTANCES OF HUMAN OR ANIMAL ORIGIN AND FOR APPLYING BLOOD COMPOUNDS OR OTHER BIOLOGICAL COMPOUNDS, which comprises a body (2; 41 ) within which a piston (3; 42) is able to move longitudinally, where the body (2; 41) is provided with a first end (48); in which a channel (6; 50) is provided that connects an internal space (9; 51) of the body (2; 41) located between the piston (3; 42) and the channel (6; 50) with the outside of the body (2; 41) and a second end (5; 49) through which the piston (3; 42) protrudes outward and which is hermetically separated from the internal space (9; 51) through the piston (3; 42 ), characterized by the fact that: - at least part of the piston (3; 42) is configured to be reversibly or irreversibly separated from the rest of the device so that the piston (3; 42) does not protrude out of the body (2 ; 41), the piston (3; 42) comprises at least one locking surface (13a, 13b, 13c; 52), the body (2; 41) comprises at least one locking surface (14a, 14b, 14c; 53 ) adapted to contact a locking surface (13a, 13b, 13c; 52) of the piston (3; 42) and provide a unidirectional locking of the piston (3; 42), according to the resistance offered to the piston (3 ; 42) which advances towards the prim end end (4; 48) provided that the piston (3; 42) is free to move back towards the second end (5; 49), where the device (1a, 1b, 1c, 1d; 40) further comprises a sealing element (15, 16, 17; 54) in, or adjacent to, the channel (6; 50) so that the set of said channel (6; 50) and said sealing element (15, 16, 17; 54) allows the removable insertion of a needle through it, where said sealing element is configured to fit said needle, so that a vacuum can exist in the internal space (9; 51).
    [0002]
    2. DEVICE (1a, 1c; 40), according to claim 1, characterized by the fact that the sealing element (15, 17; 54) is internal to the body (2; 41).
    [0003]
    3. DEVICE (1b), according to claim 1, characterized by the fact that the sealing element (16) is external and is capable of being connected to the first end (4).
    [0004]
    4. DEVICE (1a, 1b; 40), according to claim 2 or 3, characterized by the fact that the sealing element (15, 16; 54) is perforable.
    [0005]
    5. DEVICE (1c) according to claim 2 or 3, characterized by the fact that the sealing element (17) has a ring shape and is able to provide a seal against a needle inserted through it.
    [0006]
    6. DEVICE (1a, 1b, 1c, 1d; 40), according to claim 1, characterized by the fact that the piston (3; 42) is capable of rotating within the body (2; 41) and wherein at least one locking surface (14a, 14b; 52) of the body (2; 41) and at least one locking surface (13a, 13b; 53) of the piston (3; 42) are arranged so that the lock it occurs only in certain rotating positions of the piston (3; 42) in relation to the body, (2; 41), the piston (3; 42) being free in relation to the body (2; 41) in the remaining rotating positions.
    [0007]
    7. DEVICE (1a, 1b, 1c, 1d), according to claim 6, characterized by the fact that at least one piston locking surface (13b) is comprised in a projecting guide (25) radially from the piston (3) and in which at least one corresponding locking surface (14b) of the body (2) is comprised of a transverse seating surface, the body (2) having internal walls (27), the distance from which to the central longitudinal axis (8) decreases in the direction of rotation in which the piston (3) must rotate to release itself from the body (2) so that when the rotation of the piston (3) is produced in said direction the guides (25) they rotate in contact with the inner walls (27) and are flexed until the piston (3) is released in relation to the body (2).
    [0008]
    8. DEVICE (1a, 1b, 1c, 1d), according to claim 1, characterized by the fact that it comprises a handling tab (23), at the second end (5) of the body (2) to allow the action to take the piston (3) to move back towards said second end (5), where the handling tab (23) is connected to the body (2) in a disconnectable and connectable way.
    [0009]
    9. DEVICE (1d), according to claim 1, characterized by the fact that the piston (3) comprises at least one breakable area (18) so that it can be manually disassembled into separate parts.
    [0010]
    10. DEVICE (1d), according to claim 9, characterized in that it also comprises an impeller element (19) which has a first area (20) capable of pushing the piston (3) so that it can overcome the resistance to advance piston (3) offered by the lock between at least one locking surface (13a, 13b) of the piston (3) and the corresponding locking surface (14a, 14b) of the body (2), and which produces the piston advance ( 3) towards the first end (4).
    [0011]
    11. DEVICE (1d), according to claims 6 and 10, characterized by the fact that the first area (20) of the impeller element (19) is capable of being connected to the piston (3) so that it can take the piston (3) to rotate.
    [0012]
    12. DEVICE (1d), according to claim 10, characterized by the fact that the first area (20) of the impeller element (19) is provided with a complementary shape to that of the piston (3) so that the connection between the impeller element (19) and the piston (3) is caused by its impulsion.
    [0013]
    13. DEVICE (1d), according to claim 10, characterized by the fact that the first area (20) of the impeller element (19) is provided with a shape with a mechanical connection for the piston (3) so that the The connection between the impeller element (19) and also the piston (3) allows the piston (3) to be driven towards the first end (4) and the piston (3) to be pulled, causing it to return to the second end (5).
    [0014]
    14. DEVICE (1a, 1b, 1c; 40), according to claim 1, characterized by the fact that the piston (3; 42) comprises a rod (10; 43) and a ferrule (11; 44), where the rod (10; 43) is fixed to the tip (11; 44) by means of a connectable and disconnectable joint.
    [0015]
    DEVICE (1a, 1b, 1c, 40) according to claim 14, characterized in that at least one locking surface (13b; 52) of the piston (3; 42) is comprised in the tip (11; 44) of the piston (3; 42), so that when a corresponding locking surface (14b; 53) of the body (2; 41) is locked on said locking surface (13b; 52) of the tip (11; 44) , the piston rod (10; 43) can be disconnected by maintaining the lock between the tip (11; 44) and the body (2; 41).
    [0016]
    16. DEVICE (1a, 1b, 1c), according to claim 14, characterized by the fact that the union between the rod (10) and the tip (11) is threaded in a certain direction, and in which the body (2 ) has at least one limiting element (26) against an area of the tip (11) that is adapted to come into contact when the tip (11) rotates in the opposite direction to the given direction, thus allowing the rod (10) to be unscrewed from the tip (11).
    [0017]
    17. DEVICE (1a, 1b, 1c), according to claims 7 and 16, characterized by the fact that the area of the tip (11) that rises against the limiting element (26) is comprised in a guide (25).
    [0018]
    18. DEVICE, according to claim 1, characterized by the fact that the piston (3) comprises a locking surface (13c) capable of coming into contact with a locking surface (14c) located on the inner wall of a conical part intermediate (34) of the body (2), where said intermediate conical part (34) has limited longitudinal mobility in relation to the piston (3) and in relation to the rest of the body (2), and in which when the piston (3) advances towards the first end (4), friction between the locking surfaces (13c, 14c) causes the intermediate tapered part (34) to advance a little towards the first end (4) and be pressed against the piston (3 ), therefore increasing friction and allowing the vacuum in the internal space (9) to be adjusted continuously.
    [0019]
    19. DEVICE (40), according to claim 1, characterized by the fact that the internal space (51) is delimited in the area closest to the first end (48), by a transverse internal wall (56) provided with one or more more through holes (57) which are closed by an external area (60) of the sealing element (54), and which further comprises a cover (62) which closes the first end (48) of the body (41), where the said cover (62) comprises internal surfaces (63) adapted to press the external area (60) against the through holes (57) and close said through holes (57), where in the absence of the cover (62) the external area (60) ) of the sealing element (54) is longitudinally movable so that a sufficient increase in the pressure of a fluid contained in the internal space (51) can cause the external area (60) to separate from the through holes (57).
    [0020]
    20. DEVICE (40) according to claim 1, characterized in that it comprises an outer casing (65) that covers at least partially an inner disc (71) externally threaded on a piston rod (43), where the outer casing (65) and inner disc (71) show no relative longitudinal movement relative to the body (41), and a turn of the inner disc (71) produces a longitudinal movement of the stem (43).
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    法律状态:
    2018-12-04| B06F| Objections, documents and/or translations needed after an examination request according art. 34 industrial property law|
    2020-07-21| B06U| Preliminary requirement: requests with searches performed by other patent offices: suspension of the patent application procedure|
    2020-12-01| B09A| Decision: intention to grant|
    2021-01-12| B16A| Patent or certificate of addition of invention granted|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 02/07/2013, OBSERVADAS AS CONDICOES LEGAIS. |
    优先权:
    申请号 | 申请日 | 专利标题
    ES201200691A|ES2437541B1|2012-07-03|2012-07-03|Device for the extraction, storage and / or processing of blood or other substances of human or animal origin, and for the application of blood compounds or other biological compounds|
    ESP201200691|2012-07-03|
    PCT/ES2013/000156|WO2014006238A1|2012-07-03|2013-07-02|Device for the extraction, storage and/or treatment of blood or other substances of human or animal origin, and for the use of blood compounds or other biological compounds|
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