DE102004053529A1 - Blood withdrawal device for use by patient, has drive unit coupled with piston, which is movable in blood container, and detachable locking device, which prevents movement of piston by drive unit - Google Patents

Abstract

The device has a drive unit (4) coupled with a piston (3), which is movable in a blood container (2), where the piston can be moved by the drive unit. A detachable locking device (7) is provided in the container to prevent the movement of the piston by the drive unit. A stopper (62) is provided to limit a stroke of the piston. The stopper can be adjusted by a rotary motion of a dosing unit (6).

Description

The The invention relates to a device with which a user independently and by hand Blood or other body fluid can take.

Known For example, blood collection systems consist of a housing whose distal end is a needle, which is in the inside of the housing ends and which can be pierced with its protruding side into a body tissue. Also inside the case is an axially displaceable piston sealingly against the Inside of the housing is applied. The housing is open at its proximal end. Through the open end of the housing protrudes a piston rod from the container forth, which is connected to one side with the piston and on the one out of the case protruding side has a tangible element. For removal Blood gets the needle into the body tissue of the patient. For blood collection, the housing with held the one hand and with the other hand, the piston rod pulled out of the housing in the proximal direction, so that the piston is also moved in the proximal direction. Thereby arises within the housing between Piston and needle a negative pressure, allowing the blood to be withdrawn through the hollow needle in the said area can flow. A disadvantage of this arrangement is that the user both hands to Must use blood collection. An independent, personal blood collection a patient's arm, for example, is thus eliminated.

A The object of the invention is to provide a device with a patient is self-employed and by hand Can take blood without for the removal of both hands to use.

The Task is solved by claim 1. Advantageous developments arise from the dependent ones Claims.

The Invention relates to a device for taking body fluids, In particular blood, comprising a drive member, which in one with a container for receiving body fluid, in particular Blood, movable piston can be coupled, the piston can be moved by the drive member and wherein a releasable locking element is provided, which can prevent the piston from the drive member is moved. The piston is preferably automatically, that is without Supply of external force or energy from the drive member moves.

The Drive member may be an energy storage element. The energy can be stored in the energy storage element by the Energy storage element is elastically deformable and the energy for example by squeezing or pulling the energy storage element apart from a state low energy takes place in a higher energy state. The energy is preferably over a user from outside the Device introduced into the energy storage element and stored there. The energy storage element may, for example, a gas-filled, from the Surround sealed room, its volume when energized enlarged from its starting position or is reduced. By the volume change of the completed Space is supplied to this energy. The energy storage element is particularly preferably a spring, in particular a coil spring. Also, the spring is supplied with energy from outside by she is pulled apart or squeezed out of her relaxed state.

The container for receiving blood may be firmly connected to the device for using the device as a disposable blood collection system. Preferably however, the container is interchangeable with the device connectable, so that the device can be used as a reusable blood collection system. A preferred one Container can be designed such that attached to the distal end of a needle is or is attachable. The container may be open at its proximal end. The wall of the container preferably an annular, in particular an annular Cross-section on. In the container a piston is received, relative to the wall and / or to an inlet of the container is axially displaceable. The piston is preferably with his entire circumference sealing to the Behältniswandung. To the distal End of the container a pin can be attached. Furthermore, it is possible that the needle through the container is firmly recorded, so an integral part of the container forms.

It is also possible to attach the container with a container receptacle on the device. The receptacle receptacle can be a sleeve-shaped body which at least partially surrounds the receptacle. Preferably, the container receptacle forms an axial abutment to prevent falling out of the container from the device. The axial abutment may, for example, be attached to the distal end of the device. The need for blood collection needle can with a needle holder on a entspre attached portion of the container receptacle attached, screwed or releasably secured in another way. Furthermore, the needle may be firmly received in the container receptacle, so that the needle is an integral part of the receptacle receptacle. The container may include a septum through which the needle may penetrate into the interior of the container.

Of the Piston is coupled to the drive member so that the piston of the drive member can be moved. With a preferably releasable blocking element The piston can be prevented from being moved by the drive member becomes. Preferably, the blocking element engages in the drive member and / or in at least one of the components moved by the drive member one. The blocking element can also be attached to a component, in particular solvable be attached, opposite the, the drive member and the moving of the drive member components perform a relative movement. Such components are, for example, a housing, the container receptacle or the container itself, but not limited thereto.

Basically the device is designed so that the piston can perform a maximum stroke. The maximum stroke is characterized by the way the piston travels, when from the distal end of the container to the proximal one End of the container is moved, so that the piston just not out of the container, in particular Completely, is pulled out. Preferably, a stop is provided by for example, the maximum one that can be returned Path of the piston limited and thereby set the maximum stroke can be. Furthermore, it is preferable to provide a stop so that he is the returnable way the piston is limited so that it is less than the maximum stroke of the piston. As a result, a desired blood withdrawal amount can be set. In a preferred embodiment a stop can be provided which is adjustable, so that the stop can limit the stroke of the piston such that the Piston from its most distal position from no stroke to a maximum Execute hub can. Preferably, the stop is infinitely adjustable.

It It is conceivable that the attack only once, especially before first blood collection is adjustable. This can be used, for example, for persons who regularly the same amount of body fluid have to lose weight, set by a suitable person the stop and thus the removal amount become. A person who can stop the stroke can For example, a doctor, a pharmacist, a user or yourself to be another person.

In a further embodiment the attack is designed to be after each withdrawal of blood or body fluid is adjustable again. Thus, after or before each removal the removal quantity can be set.

At The device may be provided with a dosing, with which the Withdrawal of blood or body fluid can be adjusted. Preferably, the dosing member forms the Stop, which can limit the stroke of the piston. The dosing member is advantageously coupled to a component, opposite to the the drive member or driven by the drive member components perform a relative movement can. For example, the dosing member may be coupled to a housing of the device be. Preferably, the stop via a rotary movement of the dosing be set. An advantage is therefore a coupling of the dosing with the housing via coupling elements, the one rotational movement of the dosing member at least in an axial movement convert the stop. For example, dosing unit and housing are in one Thread engagement. In a preferred embodiment, the dosing member a dosing sleeve.

Generally Preferably, a dose indicator is provided with the stop is coupled. In particular, the dose indicator on the dosing and / or on the housing to be appropriate. In a preferred embodiment, a dose scale on the case appropriate. The individual values of the dose scale can be circulated in a spiral shape the housing to be appropriate. The slope of the spiral preferably corresponds the axial path, the stop during a revolution of the dosing travels. The dosing member may have an opening; in particular a window-like opening which is dimensioned so that a value of the scale can be read is. By rotation of the dosing moves the window-like opening along the spiral arranged values of the scale, the remaining dosing the Values of the scale are essentially hidden and a set value the removal quantity is only indicated by the window-like opening. at Coupling of the dosing with the housing with a thread as a coupling element it is advantageous if thread and the spiral from the scale values have the same slope. The spirally arranged values of the Scale can in another embodiment across from the window-like opening to be twisted.

In a further embodiment, the dosing member may perform a substantially axial movement relative to, for example, the housing. The dosing member can be in a purely frictional engagement with the housing. Advantageously, the friction between metering and housing is variable. This can be done by a betä tigbares element can be achieved, with which a coefficient of friction between, for example, the housing and the dosing member is changed. To set the removal amount, the coefficient of friction can be reduced and increased for blood collection, so that the stop can not be adjusted unintentionally due to the axial force of the drive member. The values of the dose scale would in this case be arranged substantially in the longitudinal direction.

A Axial movement of the piston can be achieved by means having a damping force can generate muted become. It is conceivable that the damping effect of the agent with decreasing distance of the piston from the stop increases or constant remains. However, it may also be advantageous if the damping effect the means decreases with decreasing distance of the piston from the stop. Generally advantageous means are provided which have a damping force can generate that of the driving force in the course of movement of the piston in addition to all unavoidable forces counteracts. The unavoidable opposing forces are essentially the friction forces exerted on the movement of the piston and from the inflow work the blood or the body fluid originating forces. By doing additionally to these counteracting forces inevitably occurring during the movement damping work the driving force is opposed, the resulting differential force from the generated driving force and all unavoidable counter forces as well the additional generated damping force be controlled much more precisely.

The damping is advantageously adjusted so that the blood or the Body fluid with preferably constant withdrawal rate is taken. In most applications it is the sampling rate constant when the piston is at constant speed moved in the removal direction. The removal direction is more advantageous Make a movement of the piston on the proximal end of the container. Accordingly, the damping force dependent on be generated by the speed of the piston. An acceleration elevated and a delay reduces the damping force; At constant speed of the piston, it can in both cases discussed above an increase or decrease in the damping force as well stay constant. Particularly preferred is a self-regulation.

In preferred embodiments takes the damping force in the course of movement of the piston at least once. Preferably is the over The stroke of the piston plotted course of the damping force the course of exerted by the drive member Driving force adapted. When consuming energy in the drive link increases the damping force in adaptation to the decrease in the driving force.

In an embodiment variant becomes the damping force characterized in that for movement of the piston, a volume change work due to an increase in the movement of the piston or shrinking chamber is to afford, in which a pressure equalization only delayed takes place. This system is self-regulating because it is a speed change a sign-like change the damping force causes. Such provided means, the damping force can produce an air damper be.

In a further embodiment is the damping force even a frictional force. Due to the structural design of the therefor Frictionally engaged components in this case becomes a friction based damping force also controlled. Preferably, damping force generating means provided, these means form a mechanical brake, the the damping force, in particular via mechanical Can generate friction.

Basically, one could the damping force generating Means also a magnetic damping element be.

The Locking element is in a locking engagement as described above. To make the blood sample, the blocking element should preferably one release the moving of the drive member components. The blocking element can, for example, with a trigger element released from a lock intervention become.

In an embodiment the blocking element can be releasable with a triggering element. The trigger element can be button-shaped be educated. Preferably, the button engages in a locking counter-element one. By pressing of the trigger element the locking engagement with the locking counter-element is released and the Movement of the piston allows. Preferably, the locking counter-element is formed on or through the housing. The locking counter-element may be, for example, a window-like opening, by a trigger element formed on or by the blocking element, in particular release button, through pressed the user can be.

In a further embodiment, the triggering element is formed on or by a protective element. The protective element may at least partially surround the attachable needle. The protective element may, for example, be a needle protection sleeve that is axially displaceable relative to the needle. In addition, the needle guard with a return element can be reset to its original position be. The starting position is understood to be the position of the protective element in which the needle is protected in such a way that unintentional puncturing by the needle point can be prevented. As a restoring element is preferably a spring, in particular a coil spring. The restoring element can be supported on the protective element and on a component of the device, against which the protective element is movable relative, in particular axially. Thereby, the restoring element can be biased during the movement of the protective element from its initial position, so that it can be reset by the return element to its original position.

In a particularly preferred embodiment the piston can be moved by a drive member of the drive member is driven, where at the output member the Piston takes along. Preferably, the output member is connected to the piston firmly connectable. The output member and the piston can in particular one piece be formed. For example, the output member forms the piston or the piston the output member. So that the drive member biased can be, it is preferred that the drive member is located on the Abtriebsglied and supported on a component, opposite to the drive member or one of the drive member moving components a relative movement can perform. In this embodiment preferably abuts the output member to the stop and thus limits the stroke of the Piston.

The The present invention has been explained with reference to several embodiments.

The individual devices of a device according to the invention for removal of body fluids or blood can also be meaningfully combined with each other. The invention is based on an embodiment explained with the help of the drawings. Show it:

1 a cross-sectional view of the device 2 .

2 a longitudinal section through the device according to the invention in an undosed and locked state,

3 the device off 2 in an undosed state and with a released blocking element,

4 a device after 2 or 3 in a metered state after removal,

5 a side view of the device 2 .

6 a side view of the device 4 .

7 a longitudinal section through an inventive device in egg nes undosed and locked state,

8th the device off 7 in a metered state and a released blocking element, and

9 the side view of the device 7 or 8th in a metered state, with the locking member in a locking engagement.

2 shows the device according to the invention in an undosed state, wherein the blocking element 7 is in a lockout. The device basically consists of a housing 1 , at the distal end of a dosing 6 in the form of a dosing sleeve 6 located. The dosing sleeve 6 is in threaded engagement with the housing 1 , For this purpose, the proximal end of the housing is approximately radially inward to a bushing 11 extending collar 73 educated. The bush 11 is rotationally symmetrical, with its axis coinciding approximately with the axis of the device. The bush 11 has on its inside an internal thread 12 on. Preferably, for the internal thread 12 a movement thread, in particular a trapezoidal thread used. At the dosing sleeve 6 is a dosing rod 61 formed, which has an external thread 65 has that with the internal thread 12 the liner 11 interacts. The dosing rod 61 indicates at its distal end, the end to which the dosing rod 61 with the dosing sleeve 6 is connected, opposite, a stop 62 on. The stop 62 can the stroke of the piston 3 limit.

The housing 1 is designed to be a container 2 can absorb, which serves to absorb a body fluid or blood. The container 2 is preferably interchangeable with the housing 1 connected, and performs apart from the replacement of the container 2 no relative movement to the housing 1 out. It is conceivable that the container 2 not interchangeable with the housing 1 can be connected, so that the entire device can be used only for a single removal. The container 2 has a needle at its distal end 21 on that as an integral part of the container 2 is included. At its proximal end is the container 2 open, allowing it to receive a driven element 5 in the form of a piston rod 5 suitable is. In the container 2 is an axially movable piston 3 taken, the sealing of the inner wall of the container 2 is applied.

The container 2 is in a container shot 9 taken up the container 2 surrounds. The container reception 9 is on the case 1 attached.

A drive member in the form of a spiral spring 4 is with the piston 3 coupled so that the spring 4 the piston 3 towards the proximal end of the device. For this purpose, the spring is supported 4 with one side on the container 2 from. This will be the container 2 firmly pressed into a stop, the container receptacle 9 forms. The other side of the spring 4 rests on a plate-shaped contact surface 51 off, on or through the piston rod 5 is formed. The piston rod 5 is designed so that at one of the drive member 4 caused movement of the pistons 3 is taken. These are piston rod 5 and pistons 3 with a fastener 52 connected. The fastener 52 may be a thread or a plug connection or a cone connection.

In the case 1 is also a blocking element 7 recorded, relative to the housing 1 , in particular axially, can be moved. Preferably, the blocking element 7 from the case 1 guided. To prevent the spring 4 uncontrolled the piston 3 drives, the blocking element can 7 the drive movement of the drive member 4 lock. For this one engages behind by the blocking element 7 formed radially inwardly projecting collar 73 the plate 51 , At the blocking element 7 is also a locking element 71 formed, which is designed swinging similar. The blocking element 7 is approximately sleeve-shaped. As in 1 can be seen, are located next to the locking element 71 Slots that the locking element 71 laterally from the blocking element 7 Separate, so that a swing-shaped section as a locking element 71 is formed. The locking element 71 can thus be flexible in the 2 swinging back and forth. At the distal end of the locking element 71 there is a catch 72 , the catch 72 engages in a locking counter element 91 a, in this embodiment by the container receptacle 9 is formed. The locking counter element 91 and the catch 72 each have a cooperating with the other part surface which extends approximately perpendicular to the axis of the device. The surfaces are each at the proximal end of the locking counter-element 91 and the latch 72 shaped. The catch 72 has a cross section tapering in the distal direction. The locking element 71 or the catch 72 and thereby the blocking element 7 can with a trigger element 81 that with the sloping surface of the latch 72 can be solved. The trigger element 81 is on or through a protective element 8th in the form of a needle protection sleeve 8th educated. The trigger element 81 located at the proximal end of the needle guard 8th , The needle protection sleeve 8th surrounds the container receptacle 9 and either through it or through the case 1 in particular axially guided. The needle protection sleeve 8th can relative to the housing 1 and / or to the receptacle receptacle 9 to be moved. A reset element 10 in the form of a spring 10 relies on the one hand on the receptacle receptacle 9 and on the other hand on the needle protection sleeve 8th from. This will cause the needle shield 8th according to their starting position 2 pressed a user against accidental puncture by the tip of the needle 21 to protect.

3 shows the device in an undosed state. By pushing back the needle protection sleeve 8th becomes the needle 21 released and the spring 10 curious; excited. Furthermore, the trigger element engages 81 acting as a tapered or thinner section than the remaining needle shield 8th is formed, in the inclined surface of the latch 72 and pressed as a result of the axial movement of the locking element 71 fixed latch 72 in approximately radially outward and thereby gives the blocking element 7 free. When releasing the locking element 71 or the latch 72 become a snap 72 and latching element 71 in one through the housing 1 formed groove 13 pressed. This allows the blocking element 7 , the piston rod 5 and the piston 3 through the spring 4 be moved in the proximal direction, if previously the dosing stop 62 has been moved from the zero dose position.

For dosing, the dosing 6 and with it the attack 62 from the piston 3 or the piston rod 5 moved away. The amount of body fluid or blood to be removed is determined by the distance that the stop 62 from the plate 51 after dosing. The desired dosage can be displayed via the dose display 63 according to the 5 or 6 be read. After the desired dose has been adjusted, the blocking element becomes 7 solved in the manner described above, so that the spring 4 the piston 3 , the piston rod 5 and the blocking element 7 from the most distal position of the piston 3 pushes towards the proximal end of the device until the plate 51 at the stop 62 strikes. It is in the container 2 between pistons 3 and needle 21 generates a negative pressure, the blood to be removed or the liquid to be removed in the container 2 to flow in.

4 shows the device according to the invention after a liquid removal.

According to 5 and 6 is the dosing sleeve 6 with a gripping surface 64 equipped that a Abrut the user's finger should prevent. This can be the grip surface 64 for example knurled or notched.

7 shows another embodiment of a device according to the invention, wherein the needle protection sleeve 8th missing and another release mechanism for the blocking element 7 is provided. In the 7 The device shown is also in a zero dose position. The blocking element 7 also has a latching element 71 and a catch 72 on. The catch 72 engages in a locking counter element 91 on or through the case 1 is formed. The locking counter element 91 is especially in window-like opening through the housing 1 , By pressing the trigger element 81 In about radially inward is the catch 72 out of engagement with the locking counter-element 91 emotional. This gives the blocking element 7 the movement of the components already described above for Flüssigkeitsenthanhme free.

8th shows the device in a state after the blood or fluid removal. In 9 is by means of the dosing sleeve 6 a dose 63 been discontinued. The trigger element 81 However, is still in the engagement with the locking counter-element 91 , By pressing the trigger element 81 the device is released for the removal of liquid.

1

casing

2

container

3

piston

4

Drive member; feather

5

Driven member; piston rod

6

dosing; dosing

7

blocking element

8th

Protection element; Needle guard

9

Container Recording

10

Return element; feather

11

liner

12

inner thread

13

groove

21

needle

51

Contact surface; Plate

52

Fastener; thread

61

metering

62

attack

63

dose display

64

grip

65

external thread

71

locking element

72

locking lug

73

collar

81

triggering element

91

Locking counter-element

Claims (22)

Device for taking blood, comprising a drive member ( 4 ) with one in a container ( 2 ) for receiving blood-moving pistons ( 3 ), wherein the piston ( 3 ) of the drive member ( 4 ) and wherein a releasable blocking element ( 7 ), which can prevent the piston ( 3 ) of the drive member ( 4 ) is moved. Device according to the preceding claim, characterized in that a stop ( 62 ) is provided, which is a stroke of the piston ( 3 ) can limit. Device according to the preceding claim, characterized in that a dosing member ( 6 ), which is the stop ( 62 ). Device according to the preceding claim, characterized in that the stop ( 62 ) via a rotary movement of the dosing member ( 6 ) can be adjusted. Device according to one of the preceding claims, characterized in that the stop ( 62 ) is infinitely adjustable. Device according to one of the four preceding claims, characterized in that the stop ( 62 ) is adjustable before a first blood sample, so that after a first blood sample, the change of the stop ( 62 ) is no longer possible. Device according to one of the preceding claims, characterized in that an output member ( 5 ) of the drive member ( 4 ), wherein the output member ( 5 ) the piston ( 3 ) takes along: Device according to one of the preceding claims, characterized in that an output member ( 5 ) with the piston ( 3 ) is firmly connected. Device according to one of the preceding claims, characterized in that the blocking element ( 7 ) by a triggering element ( 81 ) can be released from a lock intervention. Device according to one of the preceding claims, characterized in that a triggering element ( 81 ) on or by a protective element ( 8th ) which is an attachable needle ( 21 ) can at least partially surround. Device according to the preceding claim, characterized in that the protector lement ( 8th ) a needle protection sleeve ( 8th ) which is axially relative to the needle ( 21 ) is displaceable. Device according to the preceding claim, characterized in that the needle protection sleeve ( 8th ) is resettable with a return element in its initial position. Device according to one of claims 1 to 9, characterized in that the blocking element ( 7 ) is releasable with a release button. Device according to one of the preceding claims, characterized in that the drive member ( 4 ) is an energy storage element, in particular a spring. Device according to one of the preceding claims, characterized in that the blocking element ( 7 ) in a blocking counter element ( 91 ) can intervene. Device according to one of the preceding claims, characterized in that an axial movement of the piston ( 3 ) is attenuated by means capable of producing a damping force. Device according to the preceding claim, characterized in that the damping effect of the means with decreasing distance of the piston from a stop ( 62 ) increases. Device according to one of the preceding claims, characterized in that the means are provided which can generate a damping force which corresponds to the driving force in the course of a movement of the piston ( 3 ) counteracts in addition to all unavoidable counter-forces. Device according to one of the preceding claims, characterized characterized in that means are provided which have a damping force can generate said means being an air-damping element or a magnetic damping element are. Device according to one of claims 1 to 18, characterized that means are provided which can generate a damping force, wherein These means form a mechanical brake that reduces the damping force especially about can generate mechanical friction. Device according to one of claims 2 to 19, characterized in that a dose indicator ( 63 ) provided with the stop ( 62 ) is coupled. Device according to the preceding claim, characterized in that the dose indicator ( 63 ) on a dosing member ( 6 ) and / or on a housing ( 1 ) is attached.