Patent Application
20110046456
The invention relates to an assembly for providing continuous administration of a therapeutically working substance, such as insulin, or continuous reading of a component which assembly comprises a base part, which is to be fastened to a patients skin, to which an insertion device and delivery means are fastened. Delivery means normally comprises a reservoir and e.g. a pump, and the insertion device comprises means for inserting a penetrating member e.g. in the form of a cannula or a sensor.
WO 2007/071258 describes a medical device for delivering fluid comprising an injection part and a fluid delivery part where the fluid delivery part and the injection part can be separated and rejoined. The fluid delivery part comprises a reservoir, means for transport of liquid e.g. in form of a pump and a house in which the active units of the delivery part is placed. The injection part comprises: a base plate, a cannula part comprising a body with a through going opening provided with a cannula extending past the proximal side of the base plate and means for fixation of the base plate to the skin of the user e.g. in the form of a mounting pad. The delivery part and the injection part is assembled through a connector comprising a fluid path leading fluid from the reservoir to the through-going opening in the cannula part which fluid path comprises means for blocking access to the injection part when the connector is disconnected from the delivery part and/or the injection part. The embodiments illustrated in this document are quite complex and not easy to manufacture.
US 2007/0191772 discloses an infusion set assembly comprising an infusion device provided with a manual inserter i.e. the insertion needle is inserted by pushing the insertion needle into the patients skin. The infusion set assembly is desirably delivered to the user in a sterile package in a pre-assembled configuration as shown in
The object of the invention is to provide an assembly which solves the problem of positioning the penetrating member in connection with the inserter and of positioning the inserter in connection with the base part and thereby positioning the penetrating member in relation to the patient. If these actions are not performed correct, they each present a risk of contamination of the penetrating member or misplacement of the penetrating member and of incorrect positioning of the inserter and consequently infection at the insertion point or misplacement of the penetrating member can take place.
It is also an object of the invention to eliminate some of the problems experienced with the infusions assembly described in the prior art e.g. the penetrating part is not involved in the releasing of the inserter as this increases the risk of malfunction.
The problems are solved with a device according to claim 1 which device relates to an assembly comprising:
an inserter for insertion of a penetrating member into a patient,
a penetrating member attached to the inserter before use which penetrating member is provided with a through going opening forming a fluid connection between delivery means and a patient when the penetrating member is inserted,
a base part comprises a position shaped to receive the penetrating member where the penetrating member can be attached to the base part during use and fastening means which can provide for the base part to be attached to the patient,
where the inserter comprises inserter attachment means locking the inserter to the base part before and during insertion of the penetrating member which inserter attachment means can be unlocked so that the inserted can be removed from the base part after insertion of the penetrating member, the inserter attachment means comprises at least one protruding part and at least one corresponding opening. Either the at least one protruding part or the at least one corresponding opening part is positioned on a surface of the base part and the part corresponding to this protrusion or opening is positioned on a surface of the inserter.
When the inserter attachment means are positioned respectively on a surface of the inserter and on a surface of the base part the movement of the penetrating part from the start position inside the inserter to the end position in the base part will not be influenced by the disengagement of the inserter.
Normally there is more than one corresponding pair of protrusion and opening and then all attachment means on the inserter and respectively on the base part are facing in the same direction i.e. when the one or more corresponding pairs of protruding parts and openings are positioned only on one side of the base part, then the inserter can be disengaged from the base part by moving the whole inserter in one direction.
According to one embodiment the inserter is released from the base part i.e. the inserter attachment means are disengaged, by the interaction between a moving part of the inserter which moving part guides the insertion of the penetrating member from a first to a final position and a stationary part of the base part during insertion. The moving part of the inserter can move forward in a direction which is approximately perpendicular i.e. 90°±45°, normally 90°±15° to the direction of insertion of the penetrating member.
According to one of the embodiments according to the invention a further problem solved with such an assembly is that if it is provided with an automatic release mechanism the risk of displacing, e.g. partly or fully pulling out the penetrating member, is significantly reduced when removing the inserter from the base part.
An assembly according to claim 1 comprising an inserter for insertion of a penetrating member into a patient and a base part. The base part is provided with fastening means which can provide for the base part to be attached to the patient and the penetrating member is provided with a through going opening forming a fluid connection between delivery means and a patient when the penetrating member is inserted. The device is characterized in that the inserter comprises attachment means locking the inserter to the base part before and during insertion of the penetrating member.
According to one embodiment the attachment means can be unlocked so that the inserted can be removed from the base part after insertion of the penetrating member.
According to one embodiment the inserter is released from the base part by the interaction between a moving part of the inserter and a stationary part of the base part during insertion. “A stationary part” means that the part does not move in the same forward direction as the moving part, the stationary part might move in a direction perpendicular to the forward direction of the moving part. The interaction is to be understood as a physical contact which is reached at a specific time and place during the forward movement of the moving part, between a part of the moving part and a part of the inserter housing or a part stationary in relation to the inserter housing.
According to one embodiment the penetrating member is attached by a connection to the base part before and during insertion. Normally the connection will provide a permanent attachment of the penetrating member to the base part, i.e. the penetrating member is also attached to the base part after insertion. The connection can comprise a flexible material. This flexible material could e.g. be in the form of a tube providing a fluid path between the penetrating member and the base part. The word “flexible” can both mean that the material is elastic and that the material is soft and bendable.
According to another embodiment the inserter is released from the base part by applying a force to the inserter or a part of the inserter in a direction different from the direction of insertion of the penetrating member. Removal or detachment of the inserter can according to some embodiments not take place before the penetrating member is fully inserted in the base part i.e. the penetrating member is before insertion positioned partly inserted into the base part. The force can be applied in a direction which is approximately perpendicular i.e. 90°±45°, normally 90°±15° to the direction of insertion of the penetrating member.
According to a third embodiment the release of the inserter from the base part is at least partly provided by the release of a force in direction towards the base part. This force presses or pushes the base part toward the skin of the patient in order to prevent release of the base part and the penetrating member from the patient. The force can be provided by a spring unit exercising a force directed to a proximal surface of the inserter housing and a distal surface of the base part. That the surface is proximal means that it is turned toward the patient after insertion of the penetrating member and that the surface is distal means that it is turned away from the patient after insertion of the penetrating member.
The spring can be a leaf spring which at one end is fastened unreleasably to a part of the inserter and at the other end will touch the upper surface of the base part before the inserter is released from the base part.
According to a fourth embodiment the attachment means of the inserter comprise at least one protruding part corresponding to an opening in the base part. That the protruding part corresponds to the opening means that the protruding part fits closely into the opening, further the protruding parts normally have either a round or polygonal cross-section. The at least one protruding part can be inserted into the corresponding opening in a direction approximately parallel to the upper surface of the base part. That the direction is approximately parallel means that the insertion direction of the protruding part can deviate between 0° and 10° from the plane formed by the upper surface of the base part.
According to a fifth embodiment the attachment means comprise at least one hook formed by a part of the housing of the inserter. The at least one hook can be turned inward i.e. the hook is placed on an inner surface of the housing of the inserter and turned toward the centre of the housing. Further the at least one hook can face at least two protruding parts which are placed on a surface of the housing opposite the at least one hook. Also the at least one hook can face two protruding parts while at the same time the at least one hook is placed between the two protruding parts. When a single or double hook is placed between the opposite positioned protruding parts the inserter is fastened in a very stable triangular positioning.
According to one embodiment the penetrating member is provided with attachment means assuring that the penetrating member is unreleasably attached to the base part after insertion.
According to one embodiment either the penetrating member or the base part or both is/are provided with sealing means forming a fluid tight connection between the base part and the penetrating member and the base part is further provided with sealing means forming a fluid connection to the delivery means, preferably the penetrating member is provided with sealing means forming a fluid tight connection to the base part.
According to one embodiment the penetrating member is provided with sealing means along the edge of an opening forming the fluid connection to the base part. If the opening is round the sealing will have the form of an O-ring.
According with a sixth embodiment the base part is provided with a longitudinal opening extending from the upper surface of the connection part of the base part to the lower surface of the connection part of the base part, which opening corresponds to the profile of at least the non-penetrating end of the penetrating member. After insertion the penetrating part of the penetrating member is inserted below the patient's skin. “Corresponds” normally means that the two parts have a close fit where opening and the inserted member have the same shape. An outlet of a fluid path can open into the wall of the opening and when the penetrating member is inserted, an inlet to a fluid path of the penetrating member corresponds to the outlet of the fluid path.
According to one embodiment at least a part of the base part comprises a hard material provided with an adhesive surface on the proximal side of the device, i.e. the base part can be adhered to a patient's skin. The proximal side is the side of the device which is closest to the patient's skin, that the material is hard means that it can not be penetrated by an insertion needle and the material can not be compressed or expanded but might be bended if the thickness of the material allows it. The hard material can be provided with an opening through which the penetrating member can be inserted and the hard material can e.g. be a molded plastic material such as polypropylene.
According to one embodiment one penetrating member comprises a cannula part having a body made of a hard material having a soft or cutting cannula attached unreleasably. A cannula is a part providing a fluid path way right through a patient's skin; normally it is a hollow needle. If the cannula is soft it has to be inserted with a separate insertion needle and if the cannula is cutting it is itself able to cut through the patient's skin and need not be inserted with a separate insertion needle. Normally medication is transported to the patient via the fluid path way or blood or other liquid is transported from the patient. Preferably the body of the cannula part has an inner opening from which inner opening fluid is led to the cannula and this inner opening has at least one inlet through which fluid or a needle can enter the inner opening. The inner opening can have two inlets through which fluid or a needle can enter the inner opening.
According to one embodiment at least one penetrating member comprises a sensor part. A sensor part provides a contact right through the patient's skin, nothing physical needs to be transported normally only signals are transported between the end of the sensor which is in contact with the patient's blood and the end of the sensor which is in contact with a reader registering the signals.
According to one embodiment the assembly is delivered to the user in a sterile state where the penetrating member is in a retracted position in the inserter and the inserter is attached to the base part. “Sterile state” is a protected uncontaminated state in which the assembly can be stored ready for use. When the user receives the assembly the user will just have to unpack or otherwise reveal it and put it to use after e.g. first having cleaned the position on the patients skin where the penetrating member is to be inserted.
Embodiments of the invention will now be described with reference to the figures in which:
The
The inserter 10 holds the cannula part 7 before insertion and the insertion is initiated by pushing a handle 11.
The connector part 3 is kept in position by the surface plate 1. According to one embodiment the surface plate 1 and at least an outer cover of the connector part 3 is simply molded in one piece during manufacturing of the device. The connector part 3 forms a fluid path between e.g. a reservoir 6 of medication or a reservoir for liquid collected from the patient and a cannula part 7. Therefore the connector part 3 is provided with at least two openings, one opening at each end of the fluid path where the first opening 13 is an inlet or outlet opening receiving or delivering fluid to a reservoir 6 and the second opening 12 is an inlet or outlet opening receiving or delivering fluid to a cannula part 7 (see
In the following the first opening 13 will be referred to as “inlet” and the second opening 12 will be referred to as “outlet” although the direction of the flow through the fluid path is not significant for the invention.
The connection part 3 is further provided with a cannula opening 12A which accurately fits around a cannula part 7 i.e. the cannula opening 12A has the same shape or profile as the cannula part 7 and is just big enough to let the cannula part 7 pass through and then fit into the opening. When the cannula part 7 is fully inserted into the base part and the patient, then the upper surface i.e. the distal surface of the cannula part 7 is normally at level with or at a lower level than the outer surface of the connection part 3 surrounding the cannula opening 12A.
When the cannula part 7 has been fully inserted into the connection part 3, then an opening in a side surface of the body of the cannula part 7 corresponds to the opening 12 of the fluid path of the connection part 3 and fluid can flow from one part to the other.
A skilled person could easily suggest other methods for fastening of the inserter to the base part both mechanical methods and methods comprising adhesive surfaces.
In
The two release handles 9 are formed as s-shaped bands where one end is fastened hinge-like to the housing of the delivery part 8 and the first curve in the s-shape is slightly extending the outer surface of the housing of the delivery part whereas the second curve is free i.e. not attached to the housing of the delivery part 8 and is provided with a hook-like shape which can fold around a part 15 protruding from the distal surface of the base part. When the delivery part is locked to the base part both release handles 9 are folded round a protruding part 15, when the delivery part 8 is to be removed from the base part, the two opposite release handles 9 are pushed together whereby the hook-like parts of the release handles 9 are released from the protruding parts 15 of the base part, and the delivery part can be moved backwards i.e. in the direction away from the cannula part 7 and removed from the base part in this direction.
In
In
The fluid path of the connection part 3 is very short compared to the embodiment shown in
The housing 30 comprises guiding means 32 for the moving part 38 which allows the moving part 38 to move between two positions, guiding means 14 for the penetrating member 50 which allows the penetrating member 50 to move between two positions, and guiding means 34 for the activation part 40 which allows the activation part to move between two positions. The housing 30 is attached to the base part 100. This attachment is releasable. The attachment is provided by a connection which in this embodiment comprises a hinge 35 and a locking member 14, whereby the housing 30 and base part 100 are releasably connected. The hinge 35 comprises an at least partly rounded surface of a wall of the housing 30 which can pivot in relation to the base part 100. The locking member 14 of the housing 30 interacts with locking means 108 of the base part 100.
The letter “b” in
The housing 30 also comprises retention means 31. The retention means 31 hold the moving part 38 in a start position by engaging with locking means 28 on the moving part 38. According to this embodiment the retention means further provides a stop for the movement of the activation part 40.
The guiding means 13 for the moving part 38 provides a directional controlled movement of the moving part 38 in relation to the housing 30. The guiding means 13 are attached to or connected to or an integrated part of the inner surfaces of the housing 30 and will normally have the shape of longitudinal tracks corresponding to surfaces on the moving part 38. In the depicted embodiment, the moving part 38 can move parallel, i.e. horizontal to the base part 100, guided by the guiding means 13, the movement will normally be a sliding movement in a direction parallel to the surface of the base part 100, i.e. the movement is a longitudinal movement or a linear movement.
The guiding means 33 for the penetrating member 50 which are a part of or connected to or integrated with the housing 30 provides that the penetrating member 50 can only be moved in a well defined direction which direction is different from the direction of the moving member 38. In the embodiment the direction of movement of the penetrating member 50 is essentially perpendicularly to the direction of movement of the moving part 38. The guiding means 33 for the penetrating member 50 will normally be formed by inner surfaces of the housing 30, e.g. the guiding means 33 may comprise the inner surfaces of a hollow, cylindrical element wherein the penetrating member 50 can move between at least a forward and a retracted position along the longitudinal axis of said cylindrical element, comparable to the movement of a piston in a cylinder. Such a movement will be a sliding movement as the continuous contact between the inner surfaces of the cylindrical elements and the outer surfaces of the penetrating member 50 provides the guiding. Alternatively, the guiding means 33 of the penetrating member 50 can comprise one or more bars, governing the direction of movement of the penetrating member 50. As seen from the figures the guiding means 33 for the penetrating member 50 according to this embodiment can extend from the inner ceiling of the housing to the bottom part 100. The guiding means 33 of the penetrating member 50 are not attached to the base part 100 but might reach down and touch it or e.g. provide a support for the base part 100.
The guiding means 15 of the activation part 40 provides a directional controlled movement of the activation part 40 in relation to the housing 30. The guiding means 15 are attached to or integrated with the housing 30. In the depicted embodiment, the activation part 40 moves in parallel with, i.e. horizontal to the base part 100, guided by the guiding means 15 which according to this embodiment is provided as parts of the inner surfaces of the housing. The guiding means 15 might be formed as longitudinal tracks leading the activation part 40 in a well defined direction or simply the inner surfaces of the walls of the housing 30. Such a movement is normally a sliding movement as the guiding means 15 and the activation means are in continuous contact while moving in relation to each other. The movement will normally be a linear movement. The direction of movement of the activation part 40 is according to this embodiment identical to the direction of movement of the moving part 38 therefore the guiding means 15 of the activation part 40 can be the same as the guiding means 13 of the moving part 38 i.e. on set of guiding means 13, 15 provides the well defined and at least partly simultaneous movement of the moving part 38 and the activation part 40.
The moving part 38 is provided with transformation means 39 providing transformation of the movement of the moving part 38, which according to this embodiment is horizontal, into a movement of the penetrating member 50 in the insertion direction followed by a movement of at least the insertion needle of the penetrating member 50 in a direction of retraction. According to this embodiment the transformation means is shaped as an open V-shaped track in the moving part 38 which corresponds to a protruding cylindrical part 51 of the penetrating member 50. The V-shaped track 39 is sized to fit closely with the protruding part 51 of the penetrating member 50 in order to provide a well defined path for movement.
The moving part 38 comprises a releasing member 29 provides a separation of the housing 30, or at least a part of the housing 30, from the base part 100 by releasing the locking member 14 of the housing from the locking means 108 of the base part 100. Said release is provided by interaction of the releasing member 29 with a part of the housing 30, according to this embodiment it is the inner wall of the housing 30 opposite the activation means 40 where the linear movement of the activation means 40 would end if continued to the inner wall of the housing 30.
The housing comprises an elastic member 36 which upon release of the locking member 14 of the housing initiates removal of the housing 30 from the base part 100. According to the embodiment shown in
Insertion of the penetrating member 50 using the insertion device according to the invention 1 is provided by activation of the activation part 40. The activation part 40 is activated by pushing the part towards the housing 30. The activation part 40 comprises interaction means 41. The interaction means 41 interacts with the retention means 31 of the housing 30, thereby arresting the forward movement of the activation part 40. As can be seen in
The insertion device 1 is normally in a non-activated state before use, such as during transport or storage.
According to this embodiment a spring 45 is provided between the moving part 38 and the activation part 40. Normally the spring 45 will in a relaxed state during storing as this will normally prolong the time the product can be stored while still being fully functional, if the spring 45 is in a biased state during storing there is a risk that the performance of the product will rapidly decrease. As illustrated in
A function of the spring 45 is to provide energy for the penetration and/or retraction movement of the penetrating member 50 and/or parts of the penetrating member 50. If this energy is not provided by a spring 45 it has to be directly provided by the user of the device as the user provides a horizontal movement of the activation part 40 by pushing the activation part 40 towards the housing 30 and thereby a horizontal movement of the moving part 38.
The spring 45 of the illustrated embodiment store energy from the movement of the actuation of the of the activation part 40 as the spring 45 is biased through this movement. During actuation of the activation means 40 the moving part 38 is stationary. When the interaction means 41 of the activation means 40 gets into contact with the locking means 28, the moving part 38 is released from the stationary position and moved in a direction defined by the guiding means 13. The forward movement of the activation means 40 is stopped at the time where the interaction means 41 touches the retention means 31 of the housing 30. According to the embodiment of
As illustrated in
In one embodiment (not shown) the angle d is close to 90° i.e. d=90°, such an embodiment would in a drawing corresponding to
In another embodiment (shown in
As according to the embodiment of
This embodiment of the cannula part 7 is also provided with fastening means 23 and in this embodiment the fastening means 23 has the form of a protruding part 23 on the cannula part 7 which corresponds to a flexible part 23A on the stationary base part. The flexible part 23A can be pushed outward as indicated with an arrow at
The protruding part 38A on the moving part 38 is provided with a ramp. The ramp is an inclined surface placed on the forward side of the protruding part 38A in such a way that the front profile of the protruding part 38A forms an arrowhead.
The fastening means of this embodiment comprises a hinged part 14 which is fastened to the housing of the inserter 10. In the shown embodiment the hinged part 14 is actually made as a part of the housing as the hinged part 14 is created by making two cuts in the full height of the housing. The housing is normally made of a hard, molded plastic such as polypropylene and the relatively long shape of the hinged part 14 makes it very flexible i.e. the hinged part 14 is very pliant and it will be easy to push it outward from the relaxed position, the inward movement is blocked by the presence of the guiding means 33 for the penetrating member which in this embodiment is a cannula part 7. The hinged part 14 can also be made of a material which is different from the material of the housing of the inserter e.g. metal which are then attached to the housing in a rotatable manner.
The hinged part 14 is provided with two inward hooks (“inward” means that the hooks point toward the inside of the housing) at the lower or proximal end of the hinged part 14 and the two hooks lock the housing to the base part by catching a stationary protruding part 14B of the base part. As the two hooks are turned inward they are released from their locked position by being pushed outward i.e. away from the centre of the housing. The hinged part 14 is also provided with a contact member 14A having the form of a rounded plate of a rigid material placed inwards from the hinged part 14 around the guiding means 33 for the cannula part 7. When the moving part 38 moves from its start position to its end position the protruding member 38A which is placed on the trailing edge of the moving part 38 will hit the contact member 14A with the ramp surface and the contact member 14A will be forced outward and so will the hinged member 14 as the contact member 14A is attached unreleasably and rigidly to the hinged member 14.
The housing of the inserter also comprises two protruding parts having the form of rounded hooks 14PL and 14PR on the inside surface of the wall opposite the inward hooks of the hinged member 14. These protruding parts 14PL and 14PR fits into corresponding openings 14L and 14R of the base part close to the connector part 3. The openings in the base part are shown in
In order to detach the inserter 10 from the base part, the inserter 10 is pivoted around an axis provided by the upper surface of the openings 14L and 14R. The upper (distal) surface of the openings 14L and 14R provide a contact surface for the rounded hooks 14PL and 14PR along which contact surface the downward contact surface of the rounded hooks 14PL and 14PR can slide and thereby be forced out of the openings 14L and 14R when subjecting the inserter housing 10 to a rotational movement.
The rotatable movement is made possible at the lower or proximal surface of the housing of the inserter is inclined in relation to the upper surface 1 of the base part and therefore leaves room for the displacement of the housing 10, at the end of the rotational movement the lower (proximal), inclined surface of the inserter housing will normally rest against the patients skin.
Like the third embodiment the fourth embodiment of the inserter is provided with a moving part 38 (see
The fastening means of this embodiment comprises like the third embodiment of the inserter a hinged part 14 which is fastened to the housing of the inserter 10 and the hinged part 14 moves in the same way as described for the third embodiment of
The hinged part 14 is also provided with a contact member 14A having the form of a plate placed in a direction toward the centre of the inserter i.e. “inwards” from the hinged part 14 around the guiding means 33 for the cannula part 7. When the moving part 38 moves from its start position to its end position the protruding member 38A which is placed on the trailing edge of the moving part 38 will hit the contact member 14A with the ramp surface of the protruding member 38A and the contact member 14A will be forced outward and so will the hinged member 14 as the contact member 14A is attached unreleasably and rigidly to the hinged member 14.
According to the fourth embodiment the protruding members 14PL and 14PR are positioned on a flexible member 114. The protruding members 14PL and 14PR according to this embodiment have a rectangular profile but could also have e.g. a round or triangular profile. The protruding members 14PL and 14PR fits into openings 14P and 14L of the base part close to the connector part 3. These openings correspond to the rectangular protruding members 14PL and 14PR. When the fastening means in the form of the openings 14L and 14R on the base part are engaged with the corresponding fastening means in the form of the protruding members 14PL and 14PR on the inserter 10, the inserter 10 is prevented from moving in relation to the base part, both in the direction perpendicular to the surface plate 1 and in any direction parallel to the surface plate 1.
The flexible member 114 is attached to the housing or a part being stationary in relation to the housing 10 in such a way that the flexible member can move between two positions, a first position where the inserter is locked to the base part, and a second position where the inserter is released from the base part. Both
In order to bring the flexible member 114 from a first relaxed and locked position into a second and released position the flexible has to be subjected to a force large enough to be able to move the flexible member 114 to the second position.
When the positioning means 27 of the moving part 38 touch the flexible member 114, the flexible member 114 is pushed away from the connection part 3 of the base part, and the fastening means in the form of the protruding parts 14PL and 14PR are pulled out of the corresponding openings in the base part 14L and 14R. When the moving part 38 is in its end position, the integrated parts 38A and 27 will be at positions where both the hinge part 14 and the flexible member are pushed away from their relaxed and locked position which means it will be possible to remove the inserter from the base part when the moving part 38 is in its end position.
The flexible connection 16 either has to be long and flexible enough to reach between the cannula part and the connection part 3 in both a retracted position and a forward position or the flexible connection 16 has to be elastic and able to be extended in order to let the cannula part get into the retracted position. When the cannula part is in the retracted position it is placed inside an inserter (not shown), it could be an inserter of the type shown in any of the previous figures or it could be a completely different inserter which have the ability to hold the penetrating member to be inserted.
The flexible connection 16 attaches the penetrating member 7 unreleasably to the surface plate 1.
| Number | Date | Country | Kind |
|---|---|---|---|
| PA 2008 00185 | Feb 2008 | DK | national |
| Filing Document | Filing Date | Country | Kind | 371c Date |
|---|---|---|---|---|
| PCT/EP09/51380 | 2/6/2009 | WO | 00 | 11/10/2010 |
| Number | Date | Country | |
|---|---|---|---|
| 61027125 | Feb 2008 | US |
