Vented blood sampling device

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DESCRIPTION

Blood sampling device with discharge

BACKGROUND This description is related to the processes of air discharge and blood sampling with vascular access devices. Blood sampling is a common medical assistance procedure that involves the extraction of at least one blood sample from a patient. Blood samples are commonly taken from hospitalized patients, in domestic care and in emergency rooms with either finger pricks, heel pricks or venous puncture. Once collected, blood samples are analyzed through one or more levels of blood tests.

Blood tests determine the physiological and biochemical states of the patient, such as disease, mineral content, drug efficacy and organ function. Blood tests can be performed in a laboratory, at a distance away from the patient's location, or performed at the point of care, near the patient's location. An example of a point-of-care blood test is the routine testing of a patient's blood glucose levels, which involves the extraction of blood through a finger prick and the mechanical collection of blood in a diagnostic cartridge. After that the diagnostic cartridge analyzes the blood sample and provides the clinician with a reading of the patient's blood glucose level. Other devices that analyze blood gas electrolyte levels, lithium levels and ionized calcium levels are available. On the other hand, some point of attention devices identify markers for acute coronary syndrome (ACS) and deep vein thrombosis / pulmonary embolism (DVT / PE, deep vein thrombosis / pulmonary embolism).

Despite rapid progress in tests and diagnosis at the point of care, blood sampling techniques remain relatively unchanged. Blood samples are frequently drawn using hypodermic needles or vacuum tubes attached to a proximal end of a needle or catheter assembly. In some cases, clinicians collect blood from a catheter assembly that uses a needle and a syringe that is inserted into the catheter to draw blood from a patient through the inserted catheter. These procedures use needles and vacuum tubes as intermediate devices from which the blood sample typically collected before the test is removed. These processes are thus intensive devices, which use multiple devices in the process of obtaining, preparing and testing blood samples. On the other hand, each required device adds time and cost to the test process. Therefore, there is a need for more efficient devices and methods to sample and perform blood tests.

SUMMARY The present invention has been developed in response to problems and needs in the art that have not yet been fully resolved by the vascular access systems and methods currently available. Thus, these systems and methods are developed to provide a blood sampling device that can discharge air from an extravascular system and simultaneously collect a blood sample. In some embodiments, a blood sampling device replaces previous devices and procedures that took longer, used more parts and cost more than the present blood sampling device.

In one aspect of the invention, an extravascular system comprises: a body that has an internal internal passage that extends therethrough; a partition arranged inside the inner inner passage; a partition activator disposed within the internal internal passage proximal to the partition, the partition activator has an internal conduit extending therethrough; and a blood sampling device has a tube that is longer than a length of the septum activator and has a width less than or equal to a width of the inner duct of the septum activator, an interior of the tube is in fluid communication With a reservoir inside the blood sampling device, a discharge opening in fluid communication with the reservoir, the discharge opening allows air to pass through but not blood.

The implementation may include one or more of the following features. The tube of the blood sampling device can be selectively extended through the inner conduit of the septum activator and through a slit in the septum, the blood sampling device can be selectively coupled with the body. The partition can divide and substantially seal a distal chamber of the inner inner passage relative to a proximal chamber of the inner inner passage, and the partition can have one or more slits therein, the partition activator is movable from a position without activation in the chamber proximal to an activation position that extends through the septum slit inside the distal chamber. The blood sampling device may have a part of an outer geometry approximately equal to that of the internal internal passage of the body such that the blood sampling device can snap into the internal internal passage of the body. The blood sampling device may have a Luer connector that selectively locks each other with a Luer connector arranged in the body. The body can be a catheter assembly or a Luer access hole. The septum and body can form a fluid tight connection that

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circumscribes the partition. The reservoir may have a volume equal to or greater than about 0.1 ml. The tube may have a length greater than or equal to approximately 5 mm and a width less than or equal to approximately 3 mm. At least a part of the blood sampling device that defines the reservoir can be compressible and can decrease the internal volume of the reservoir when it is compressed.

In another aspect of the invention, a blood sampling device comprises: a body defining a reservoir therein; a tube extending from the body a distance greater than the length of a partition activator of a blood control valve, the tube has a width less than the interior width of the control inside the blood control valve, the interior of the tube is in fluid communication with the tank; and a discharge opening coupled to the body and forming a barrier surface of the reservoir, the discharge opening allows air to pass through but not blood.

The implementation may include one or more of the following features. The reservoir may have a volume equal to or greater than about 0.1 ml. The discharge opening may be air permeable and hydrophobic. At least one part of the body that defines the reservoir can be compressible and can decrease the internal volume of the reservoir when compressed. The tube may have a length greater than or equal to 5 mm.

In another aspect of the invention, an extravascular system comprises: a body that has an internal internal passage; a partition arranged inside the inner inner passage; a partition activator disposed within the internal internal passage proximal to the partition, the partition activator has an internal conduit extending therethrough; and a blood sampling device disposed at least partially within the internal internal passage of the body, the blood sampling device has a tube that extends through the inner conduit of the septum activator and through an opening in the partition, the blood sampling device has a reservoir in it in fluid communication with the tube and a discharge opening in fluid communication with the tank, the discharge opening lets through its air but not blood.

The implementation may include one or more of the following features. The partition can divide and substantially seal a distal chamber of the inner inner passage relative to a proximal chamber of the inner inner passage, and the partition can have one or more slits therein, the partition activator can be movable from a position without activation in the chamber proximal to an activation position that extends through the septum slit inside the distal chamber. A removable seal can be provided through the discharge opening that prevents air from passing through the discharge opening. The blood sampling device can be removably coupled with the body. The septum and body can form a fluid tight connection that circumscribes the septum.

These and other features and advantages of the present invention may be incorporated into certain embodiments of the invention and will become more fully apparent from the following description and the appended claims, or may be learned by the practice of the invention as it is practiced. explain later. The present invention does not require that all advantageous features and all the advantages described herein be incorporated into each embodiment of the invention.

BRIEF DESCRIPTION OF THE DIFFERENT VIEWS OF THE DRAWINGS In order to easily understand the manner in which the aforementioned and other features and advantages of the invention are obtained, a more particular description of the invention briefly described above will be prepared, by reference to specific embodiments thereof that are illustrated in the accompanying drawings. These drawings represent only typical embodiments of the invention and therefore should not be considered as limiting the scope of the invention.

Figure 1 is a perspective view of an extravascular system comprising a catheter assembly, intravenous tubes with a clamp, a hole and a blood sampling device with discharge, according to some embodiments. Figure 2 is a partial cross-sectional view of a hole having a blood control valve and a blood sampling device separated from the hole, according to some embodiments. Figure 3 is a partial cross-sectional view of a blood sampling device that has been inserted into the hole, according to some embodiments. Figure 4 is a cross-sectional view of a hole that is accessed with a separate device when the blood sampling device is removed from the hole, according to some embodiments. Figure 5 is a perspective view of a blood sampling device that is compressed and the blood dripping on a blood test strip, according to some embodiments. Figure 6 is a perspective view of a blood sampling device, according to some embodiments. Figure 7 is a perspective view of another blood sampling device, according to some embodiments.

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DETAILED DESCRIPTION OF THE INVENTION The presently preferred embodiments of the present invention will be better understood by reference to the drawings, where similar reference numbers indicate identical or functionally similar elements. It will be perfectly understood that the components of the present invention, as generally described and illustrated in the figures herein, could be arranged and designed in a variety of different configurations. Thus, the following more detailed description, as depicted in the figures, is not intended to limit the scope of the invention as claimed, but is only representative of the presently preferred embodiments of the invention.

Reference will now be made to Figure 1, which illustrates an extravascular system 20 with which a blood sampling device 42 can be used. It will be understood that the blood sampling device 42 is not limited to use within this illustrated extravascular system, but can be used with other extravascular systems, from a single needle, to more complex extravascular devices. The blood sampling device 42 may, in some configurations, reduce the number of components necessary to extract a diagnostic blood sample from a patient. This is because the blood sampling device 42 combines the ability to perform the processes of unloading the extravascular system 20 and collecting blood in a single device. Additionally, in some cases, the blood sampling device 42 and the hole 40 may eliminate the need for the clamp 38, as described below.

Figure 1 illustrates an extravascular system 20, such as the BD NEXIVA ™ Closed Intravenous Catheter System (IV) from Becton, Dickinson and Company, which can be accessed with a blood sampling device 42. The illustrated embodiment of the system 20 includes multiple vascular access devices, such as a needle connection cone 26 coupled to an insertion needle 32 that extends through a catheter assembly 24. The catheter assembly 24 includes a catheter adapter 28 that engages an peripheral catheter IV 30, on the needle, which extends therefrom. The insertion needle 32 is left inside the catheter assembly 24 until the catheter 30 is inserted and correctly placed into a patient's vascular system, at which time it is removed. In some embodiments, one or more needle tip guards 22 are incorporated into the needle connection cone 26 to protect the tip of the insertion needle 32 after it is removed from the catheter assembly 24.

In some configurations, an integrated extension tube 36 is coupled with catheter assembly 24, and provides fluid communication to it. The extension tube 36 can also be coupled to a hole 40 that provides access to the patient's vascular system through the extension tube 36 and the catheter assembly 24. The hole 40 can have various configurations, such as a single Luer hole adapter , a Luer Y adapter and like other known holes. In some cases, a clip 38 is used to selectively close the extension tube 36 to prevent flow through it. As shown, a blood sampling device 42 can be inserted into the hole 40.

While Figure 1 represents the blood sampling device 42 coupled to a hole 40 in an extension tube 36, the blood sample device 42 can be coupled to any hole 40 in fluid connection with the vascular system of a patient Such alternative holes could be located directly in catheter assembly 24, or more specifically in catheter adapter 28. In another extravascular system 20, the holes 40 may be coupled to an insertion needle 32, catheter 30 or other components of the extravascular system 20.

In some embodiments, the blood sampling device 42 discharges air from the catheter assembly 24 and the extension tube 36 before collecting a blood sample from it. When the catheter assembly 24 establishes fluid communication with a patient's vascular system, the internal blood pressure of the vascular system can force blood into the catheter assembly 24 and rise through the extension tube 36. In some cases, it is desirable to allow this blood to fill the catheter assembly 24 and the extension tube 36 in order to discharge air from the extravascular system 20 before the fluids are infused through this system into the patient. This process can reduce the likelihood of air infusing into the patient's vascular system.

Accordingly, the blood sampling device 42 includes a discharge opening 44 that is permeable to air, through which air passes from within the extravascular system 20. The discharge opening 44 is configured to allow air to pass but not blood. Blood entering the extravascular system 20 forces the air out of the discharge opening 44 as it enters the extravascular system 20 and fills the discharge opening 44 of the blood sampling device 42 with it. At this time, in some cases, the clamp 38 may close the extension tube 36 while the blood sampling device 42 and a separate vascular access device are removed, such as a line IV coupled to a fluid reservoir, it is coupled to hole 40 to start an IV therapy process. In other cases, as described below, a clamp 38 is not needed to prevent blood flow out of the hole 40.

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As described above, the blood sampling device 42 includes a discharge opening 44 that can allow the passage of air but not blood through it. The discharge opening 44 may include various materials and components that provide these properties. For example, in some embodiments, the discharge opening 44 includes glass, polyethylene terephthalate (PET), microfiber material and / or other synthetic material made of high density polyethylene fibers, such as DuPont TYVEK® material. The discharge opening 44 may be hydrophobic or hydrophilic. Other materials and components may also be used as a layer of the discharge opening or as the entire discharge opening to allow the discharge opening 44 to be hydrophobic and / or air permeable, according to some configurations.

In addition to discharging air from the extravascular system 20, the blood sampling device 42 may collect a blood sample therein which can be used for blood tests or other procedures. Accordingly, in some embodiments, the blood sampling device 42 includes a reservoir (shown in Figure 2 as 94) therein which can collect blood during the process that discharges and retains the blood after the device 42 Blood sampling is removed from hole 40. In some configurations, reservoir 94 has an internal volume of between about 0.1 ml to about 10 ml. In other configurations, reservoir 94 has an internal volume of between about 1 ml to about 5 ml. In still other configurations, the reservoir 94 has an internal volume that is more than 10 ml. Since the different blood tests required different amounts of blood, in some embodiments, the reservoir 94 is sized to retain an amount of blood needed for a specific blood test or for a specific number of blood tests. In some embodiments, a clinician is provided with a group of blood sampling devices 42 that have multiple blood sampling devices 42 of different sizes.

Reference is now made to Figure 2, which depicts a cross section of a hole 40 and a blood sampling device 42, according to some embodiments. As shown, the hole 40 comprises a body 70 that has an internal passage 66 extending therethrough. The internal passage 66 includes a proximal opening 76 of internal passage at the proximal end 78 of the body 70 into which a blood sampling device 42 can be inserted. The proximal end 78 of the body 70 may also include one or more Luer threads 72 that may allow a male Luer connector, such as a Luer male connector 134 of Figure 7, to connect to the proximal end 78 of the body 70. At the distal end 80 of the body 70 the extension tube 36 can be connected and aligned in fluid communication with the internal passage 66.

As shown, in some configurations, the hole 40 includes a blood control valve, which is a type of valve that includes a partition 50 and a partition activator 52. Septum activator 52 selectively drills through septum 50 to activate or open septum 50. The septum activator 52 moves distally through the septum 50 when a separate device 110 is inserted through the proximal internal passage opening 76 and distally forces the septum activator 52, as shown in Figure 4. The process of Drilling the partition 50 with the partition activator 52 is partially illustrated in Figure 5. Once the partition 50 is perforated, the fluid can be infused through the partition 50. In US Pat. Serial No. 13 / 042.103 presented on March 7, 2011, SYSTEM AND METHOD FOR PROVIDING A FLUSHABLE CATHETER ASSEMBLY (in this report the "Flushable Catheter Assembly reference") describes some examples not orifices of holes 40 having a blood control valve therein. In some configurations, the hole 40 may have any of the various configurations of blood control valves described in the Rinse Catheter Assembly reference. The Rinse Catheter Assembly reference and the patents on which it claims priority dependence also describe the use of a blood control valve in a catheter assembly 24. While the use of a blood sampling device 42 is generally described herein as being used with a hole 40 having a blood control valve within an internal internal passage 66 of body 70 of hole 40, it will be understood that the blood sampling device 42 may, in some configurations, used as an alternative or additionally with a catheter assembly 24 having a blood control valve within the internal internal passage of the body of the catheter assembly 24. Accordingly, in some configurations, the various embodiments of a blood sampling device 42 may be used as described herein with any of the various configurations of blood control valves in a catheter assembly described in the Reference of Catheter Set with Rinse and in Related References.

As shown in Figure 2, in some configurations, the blood control valve of the hole 40 includes a partition 50 disposed within a groove 74 in the inner inner passage 66 of the body 70. In some cases, between the partition 50 and The body 70 is disposed with one or more discharge channels to provide a channel for discharging air around the partition 50, as described in the Catheter Assembly with Rinse reference. The one or more channels can be used to discharge air from an extravascular system 20. In other cases, there are no discharge channels between the partition 50 and the body 70, but in this interface 54 an air tight connection is formed. The lack of discharge channels can impede the flow of air or blood around the partition 50. In such cases, air can be discharged from the extravascular system 20 through the discharge opening 44 of the blood sampling device 42.

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In some configurations, the partition 50 can also serve to divide the inner inner passage 66 into a distal chamber 82 and a proximal chamber 84 and provide a seal between these two chambers. A partition activator 52 can be arranged in the proximal chamber 84. In some embodiments, the partition activator 52 has an inner conduit 64 extending therethrough. The partition activator 52 may have one or more flow diversion channels 58 formed therethrough that allow fluid flow between the areas outside the partition activator 52 towards the inner conduit 64 to provide rinse capability within the internal internal passage 66 and within partition 52 activator.

Figure 2 also represents a blood sampling device 42 that can be inserted into the hole 40 to discharge air from the extravascular system 20 when the function of the septum activator 52 is avoided. In some configurations, a tube 90 of the blood sampling device 42 extends outside its body 92 a distance long enough to pass entirely and avoid the partition activator 52 when the blood sampling device 42 is connected to hole 40. Thus, in some cases, the length 100 of the tube 90 is greater than the length 60 of the partition activator 52. Additionally, in some cases, a width 104 of the tube 90 is smaller than an inner width 62 of the inner conduit 64 of the partition activator 52. In this way, the dimensions of this tube 90 can allow it to be inserted through the inner duct 64 of the partition activator 52 and pierce through the partition 50 without being inside and advancing the partition activator 52 forward. Accordingly, in some configurations, the outer geometry of the tube 90 approximates or is smaller than the inner geometry of the inner conduit 64 when the tube 90 is fully inserted through the inner conduit 64. Thus, for example, if the inner duct 64 narrows from a larger diameter to a smaller diameter, the outer geometry of the tube 90 can also be narrowed from a larger diameter to a smaller diameter or be smaller than another. so that the geometry of the inner duct 64. Accordingly, the outer geometry of the tube 90 can be shaped and sized with various configurations, to fit inside the inner duct 64 of the partition activator 52 when the tube 90 is fully inserted through the inner duct 64.

Reference will now be made to Figures 2 and 3 in some embodiments, the blood sampling device 42 may snap into the proximal inner passage opening 76 of the inner inner passage 66 of the hole 40. This connection may prevent leakage of air and blood outside the hole 40. This connection is formed between a distal part 102 of the body 92 of the blood sampling device 42 and the proximal part of the inner inner passage 66 of the hole 40. In some configurations, the outer geometry of the distal part 102 approximates the inner geometry of the proximal part of the inner inner passage 66. In some configurations, these geometries are substantially circular and the outer diameter 98 of the distal part 102 is approximately equal to the inner diameter 68 of the proximal part of the inner inner passage 66. In these and other configurations, the blood sampling device 42 may snap into the proximal opening 76 of the internal passage of the hole 40. In other configurations, as shown in Figure 7, the sampling device 42 Blood is connected to hole 40 through a threaded Luer connection instead of a snap fit connection. Similarly, other types of connections can be incorporated between the blood sampling device 42 and the hole 40.

Continuing with the reference to Figures 2 and 3, the blood sampling device 42 has a body 92 that defines a reservoir 94 therein which can be used to collect and retain a blood sample. When the blood sampling device 42 is fully inserted into the hole 40, the distal tip of the tube 90 extends through the one or more slits 56 of the partition 50. Thus, by crossing the partition 50, an air path is created through the interior 96 of the tube 90, through the reservoir 94 and outside the discharge opening 44. The discharge opening 44 can be in fluid communication with the tank 94 so that air can flow to the tank 94 and out of the discharge opening 44. This air path can allow air to be discharged from the extravascular system 20. In some configurations, the partition 50 may contact the outer surface of the tube 90 and prevent or substantially prevent the flow of air and blood between the tube 90 and the partition 50.

As described above, as air is discharged from the extravascular system 20, blood flows to the system and fills or substantially fills the reservoir 94. After a clinician acknowledges that the extravascular system 20 has been discharged and the reservoir 94 Once a blood sample has been collected, the clinician can remove the blood sampling device 42. When the tube 90 of the blood sampling device 42 is removed proximally through the partition 50, the one or more slits 56 of the partition 50 are sealed by sealing the proximal chamber 84 with respect to the distal chamber 82 and the blood contained therein . As mentioned before, in some cases, a clamp 38 is not required since the blood control valve can automatically seal the hole 40 before and after the blood sampling device 42 is inserted into the hole 40 .

Referring now to Figure 4, after removing the blood sampling device 42 from the hole 40, a separate device 110 can be coupled to the hole 40 to infuse a fluid through the hole 40 to the extravascular system 20. In some cases, The separate device 110 is a vascular access device, such as an intravenous fluid line. In some configurations, the separate device 110 includes a male Luer connector 134 that connects to the female Luer threads 72 of the hole 40. As shown, when the device

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apart 110 is inserted into the hole 40, a probe member 114 of the separate device 110 contacts the partition activator 52, forcing it forward through the partition 50, opening the partition 50. With the partition 50 open, the fluid can be infused through hole 40 to extravascular system 20.

Referring now to Figure 5, after removing the blood sampling device 42 from the hole 40, the collected blood 126 can be used for analysis and testing. Accordingly, in some configurations, the blood sampling device 42 is configured to eject at least a portion of the blood 126 from the reservoir 94. For example, in some embodiments, the blood sampling device 42 has a body 92 with a compressible part 120. A compressible part 120 may include any means for reducing the size of the reservoir volume in order to eject a sample of fluid within the reservoir 94. For example, the compressible portion 120 may comprise the entire body 92 that is flexible or semi-flexible. Or the compressible part 120 may be limited to a limited part of the body 92, which flecta. In a non-limiting example, a compressible part 120 is disposed between two or more rigid parts, such that the compressible part 120 is compressed when the more rigid parts are pressed inward 128. In some embodiments, to facilitate compression and compression. grip, body 92 includes hills or other grip members 122.

In some embodiments, the blood sampling device 42 is configured to eject blood 126 when it is compressed and retains blood 62 when it is not compressed. As such, when the blood sampling device 42 is removed from the hole 40, it retains blood therein (unless it is compressed), which prevents blood exposure to the clinician who removes the blood sampling device 42 blood. Thus, in some configurations, the inner dimensions of the tube 90 and / or the dimension of the tube opening 124 is shaped and sized to retain blood 126. The blood retention within the tube 90 is controlled, at least in part , by the inner perimeter of the tube 90, the surface tension of the blood, and the force in the blood 126 to flow out of the distal tube opening 124. Accordingly, the inner perimeter of the tube 90 can be designed such that within the reservoir 94 blood 126 is retained when the force of the blood 126 to flow out of the distal tube opening 124 is within a certain range, but allows for At least some blood flows out when blood pressure 126 exceeds this interval.

For example, in some cases, the inner dimensions of the tube 90 are substantially circular and the inner perimeter is less than or equal to about 2.0 mm with a diameter 60 less than or equal to about 0.6 mm. In these cases, the tube 90 allows blood retention against approximately the force of gravity. When the force in the blood 126 is greater than the force of gravity, some blood 126 may flow out of the distal tube opening 124. In other cases, a circular distal tube opening 124 with a diameter of approximately 0.3 mm can retain blood 126 therein against forces stronger than gravity, such as bumps, shocks and the movement of the filling device 42 blood samples. When the distal tube opening 124 has a very small inner perimeter, the force necessary to expel blood 126 can be very large.

Thus, in some embodiments, the inner perimeter of the tube 90 has an inner perimeter greater than or equal to about 0.3 mm, which when the inner perimeter of the tube 90 is a circular opening, corresponds to a diameter of about 0.1 mm Thus, in some configurations, the inner perimeter of the tube 90 has an inner perimeter between about 0.3 mm to about 2.0 mm. In some configurations, the inner perimeter of the tube 90 is approximately circular and has a diameter between about 0.1 mm to about 0.6 mm. In other embodiments, the inner perimeter of the tube 90 is not circular.

To eject blood 126 from the blood sampling device 42, the compressible part 120 or the compressible parts 120 can be compressed. This compression decreases the volume and increases the internal pressure of the reservoir.

94. As the internal pressure increases, it becomes larger than the forces that prevent blood 126 from flowing out of the tube 90, thereby causing blood 126 to flood out of the tube 90. The amount of blood 126 that is ejected from the Distal tube opening 124 may depend on the amount of force applied to the compressible portion 120. Blood 126 may be ejected on a blood test strip 130, in a diagnostic cartridge, or on another type of blood test / analysis device.

Figures 6 and 7 will now be mentioned. These figures represent specific embodiments of a blood sampling device 42. Figure 6 depicts a blood sampling device 42, similar to that of Figures 2 and 3 that can snap into the proximal internal passage opening 76 of a hole 40. As shown, the body 92 includes a or more compressible parts 120 and a grip notch 130. The grip notch 130 provides a visual and tactile indication of the place where a finger can be placed to effectively grasp and compress the compressible part 120. In some cases, another grip notch 130 is disposed on the opposite side of the body 92.

Figure 7 depicts a blood sampling device 42 that can be mutually locked with the Luer threads 72 of a hole 40. In some configurations, as shown, the body 92 includes an alternative distal body portion 132 comprising a connector threaded male Luer 134. This threaded male connector Luer 134 can be interconnected with the female connector Luer 72 of hole 40 to lock each other with the

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blood sampling device 42 thereto. This interconnection can provide additional strength and stability over other types of connections.

From the foregoing, it will be seen that these systems and methods are developed to provide an outlet device 42

5 of blood samples that can discharge air from an extravascular system 20 and simultaneously collect a blood sample 126. In some embodiments, a blood sampling device 42 replaces earlier devices and procedures that took longer, used more parts and They cost more than the present blood sampling device. The blood sampling device 42 may be inserted into a hole 40, left there while automatically discharging air from the extravascular system 20,

10 then withdrawn with a blood sample 126 automatically collected inside its internal reservoir 94.

The present invention can be embodied in other specific forms without leaving its structures, methods or other essential features as described herein extensively and as claimed below. The described embodiments must be considered in all aspects as illustrative and not restrictive. The reaching

fifteen of the invention is therefore indicated in the claims, rather than in the preceding description. All changes that come in the sense and the breadth of equivalence of the claims must be adopted within their scope.