GB2414186A

GB2414186A - Combination device for injection and blood sampling

Info

Publication number: GB2414186A
Application number: GB0411508A
Authority: GB
Inventors: David Wald
Original assignee: Individual
Current assignee: Individual
Priority date: 2004-05-22
Filing date: 2004-05-22
Publication date: 2005-11-23
Anticipated expiration: 2024-05-22
Also published as: GB2414186B; GB0411508D0

Abstract

A combination device for the simultaneous injection of a medical product through the skin and the delivery of a capillary blood sample to the skin surface for testing comprising; a hollow needle 1 and a solid lancet 9 embedded into a fixation plate 4 and a rigid, hollow collar 7 integrally moulded to the fixation plate 4 which connects the blunt end of the needle 3 to the spout of a syringe 8. The needle 1 and lancet 9 may be separated by a distance of 10-20 millimetres, parallel to each other and detachable. The needle 1 is preferably longer than the lancet 9. The device may have a protective cap and may be disposable. The device may be attached to a syringe 8 and may be operated by manual pressure or by means of a spring or other mechanical device.

Description

Combination device for injection and blood sampling

Summary of Invention

The present invention relates to a medical system for combining the injection of a medicinal product through a hollow needle to tissues beneath the skin with the delivery of a capillary blood sample to the skin surface in a single procedure. In particular, the present invention provides a single-use disposable device which simultaneously delivers an injection of a medicinal product to deep body tissues (such as muscle) and then withdraws a blood spot from the more shallow capillary-rich layer beneath the skin. The present invention has been made to overcome the need for two separate and sequential skin puncturing procedures when there is a requirement both for delivering a medicinal product by injection and obtaining a blood sample for testing.

Many medical procedures in use today require the delivery of a medicinal product into the subcutaneous layers of the skin or into the deeper muscle layers. This involves the use of a hollow needle (approximately I to 1 Ocm in length), in which the distal tip portion is cut into a bias (tapered) shape to give a sharp point for piercing the skin. Many needles are available for this purpose. The needles are generally connected to a syringe containing the medicinal product and are manually (or mechanically) introduced through the skin into the body tissue in which the medicinal product is to be delivered. The needles are generally designed to minimize trauma and bleeding at the skin surface, and are therefore not a reliable means of simultaneously drawing a blood spot sample. Moreover a blood sample from the needle puncture site may be contaminated by the injected medicinal product, making it unsuitable for testing.

Many medical procedures in use today require a relatively small sample of blood, in the range of O. 1 to 1 ml for testing. It is more cost effective and less traumatic to the patient to obtain such a sample by lancing or piercing the skin at a selected location (such as the finger, arm or leg), to enable the collection of 1 or 2 drops of blood, than by using a phlebotomist to draw a tube of venous blood. Many blood lancets are available for this purpose. A typical blood lances is cylindrical or trapezoid and has a - 2 solid sharpened point that is forced forward to cut through the skin (to a depth of approximately 0.5mm to 5mm below the skin surface) into the subcutaneous capillaries of the dermis. A blood spot then forms on the skin surface at the puncture site. Occasionally the skin around the puncture site needs to be massaged to squeeze a blood spot to the skin surface.

In clinical instances where patients require both an injection of a medicinal product and a capillary blood spot for testing (for example when administering an injected vaccine in children and also testing their blood glucose for diabetes) it would be desirable to have a single procedure that achieved both objectives. Current medical practice, in this situation, would require that two separate procedures, with two sequential skin punctures, be undertaken. This can be distressing and unacceptable to patients, particularly to children. The present invention has been made to combine the properties required both for the delivery of a medicinal product through a hollow needle together with the properties for producing a skin incision suitable for drawing a blood spot for testing, assembled together in a single device. The present invention therefore provides a means for delivering a medicinal product, for example by subcutaneous or intramuscular injection and obtaining a capillary blood sample for testing at the same time. The proposed device would be simpler than two separate procedures, less distressing for patients and would be more cost-effective.

To allow a better understanding of the device and its use there will now be given a description of the embodiments of the present invention with reference to the accompanying drawings, in which: Fig I is a side-on cross section view of the device connected to a syringe Fig 2 is an enlarged front view of the of the device in Fig 1 Fig 3 is an enlarged rear view of the device in Fig 1, without a syringe connected Fig 4 is a side-on cross section view of the device penetrating the skin and muscle.

Fig 5 is a side-on cross section view of the device penetrating the skin connected to a mechanical means of firing the lances blade.

The device which embodies the present invention will now be described. The device (figures I to 5) is designed to be used with a syringe containing a medicinal product. - 3

Many syringes are available for this purpose and the device is designed to be compatible with most generally available syringes.

Fig 1 illustrates a side-on view of the device. The device comprises a hollow needle 1, tapered at the distal end to form a sharp point 2. The proximal blunt end of the needle 3 is preferably embedded in a rigid fixation plate 4 although a detachable needle is also possible. The needle projects perpendicularly out from the fixation plate 4. The fixation plate 4 comprises two parts that are moulded together, consisting of an inner rigid fixation block 5 and an outer rigid insertion platform 6. The fixation block 5 anchors most of the distal blunt end of the hollow needle in place and also provides a surface that contacts with the skin when the needle is fully inserted into the body. The insertion platform 6 anchors the distal tip of the blunt end 3 of the hollow needle and also provides a surface against which the operator can apply forward manual pressure to the hollow needle when introducing the hollow needle through the skin. The fixation block 5 and insertion platform 6 may be made from any suitable material, for example plastic or metal.

The hollow cavity of the needle I connects at its blunt end 3 with a rigid hollow collar 7 into which fits a syringe 8. Also embedded in the fixation plate 5, is a lances 9. The lances is a solid (non-hollow) cylindrical or trapezoid rod with a sharp distal end 10 forming a point that penetrates the skin. The blunt end 11 of the lances is embedded in the fixation plate 4. The lances 9 projects perpendicularly out from the fixation plate 4 and is sited lateral to the hollow needle, by approximately a distance of 1 cm from the point at which the hollow needle is embedded in the fixation block 5. The lances 9 runs in a parallel orientation to the hollow needle 1.

Figure 2 shows an enlarged front view of the device to illustrate the spatial relationship between the tip of the needle 2 and the tip of the lances 10, which are approximately 1 cm from one another. Figure 3 is an enlarged rear end view of the device to illustrate the spatial relationship between the blunt ends of the hollow needle 3 and the lances 1 1, embedded within the fixation pate 4. As can be seen, the hollow cavity of the needle at its blunt end 3 connects with the hollow cavity of the collar 7 to allow the passage of medicinal product from a syringe to the tip of the hollow needle 2.

Figure 4 is a side-on cross section view of the device penetrating the skin, shown schematically also in cross-section, to provide a better illustration of the relationship between the hollow needle and the solid lances with respect to the skin structures that they penetrate and to provide a better appreciation of the use of the device. The operator introduces the needle through the skin surface at a selected site, such as the arm or the leg, under rapid forward pressure, using the insertion plate to distribute the forward pressure equally to the centrally positioned needle and the laterally positioned lances. The device is advanced until the fixation block 5 is flush with the skin surface 12. At this point the lances simultaneously pierces the skin, approximately I cm from the needle puncture site. The lances is short in relation to the needle so that when the device penetrates the skin and is advanced such that the surface of the fixation block 5 is in contact with the skin 12, the sharp tip of the needle 2 is positioned in the deeper tissue, such as muscle 13, and the shorter lances pierces the skin to a shallower depth in the capillary rich layers of the dermis 14.

Once the device is in position and the medicinal product has been injected the device is removed leaving a spot of capillary blood at the lances puncture site which can be used for testing. Gentle massage can be used to extract more blood from this site.

When not in use the device is enclosed in a protected rigid sheath, made of any suitable material such as plastic or metal. Preferably the device would be for single- use only and would be re-sheathed prior to disposal.

A range of lengths and widths (or circumferences) may be used for the hollow needle and the lances, depending on the size, age and fat distribution of the patient. The length of needle projecting from the surface of the insertion plate may be approximately 1 to 10 cm and the length of lances projecting from the surface of the insertion plate 6 may be approximately 0.5 to 5mm. In all embodiments of the device the needle is longer than the lances. The circumference (or width) of the needle may vary but is preferably less than that of the lances.

In the above described embodiments of the present invention the needle and lances of the device penetrate the skin under forward manual pressure provided by the operator and are then manually retracted by the operator once the medicinal product has been - 5 delivered. However, the present invention may also be applicable, in an alternative embodiment, for use where the penetration and retraction forces, for either the hollow needle or the lances, are provided by a spring-loaded mechanical means. Mechanisms for mechanically firing and retracting a lances (or needle) are straightforward known mechanisms that are in general use and may offer the advantage of a reduction in pain at the time of lances or needle insertion. Conventional spring-loaded mechanical devices comprise a body, a spring housed therein, a lances housed therein, a lances urged by a spring, a retaining mechanism to prevent the lances blade from projecting, and a push-type button on the surface of the housing for triggering the release of the lances blade and a recoil spring for retracting the lances blade back into a neutral position in the housing.

For example, Fig 6 illustrates an alternative embodiment in which the force for skin insertion of the lances blade is provided by a springloaded mechanism 15 contained in a housing 16, that may be activated by depression of a push type button on its top surface 17. Therefore, once the hollow needle is introduced manually through the skin and the fixation block 5 is flush with the skin surface 12, the syringe plunger 18 may be depressed to discharge the medicinal product. The syringe plunger, on its depression, may engage the push type button 17, to trigger the lances blade 9 to penetrate the skin from an enclosure 19 within the fixation block 5 and then may be rapidly retracted back into the enclosure 19, by the spring-loaded mechanism.

While the invention has been described and illustrated with reference to certain particular embodiments thereof, those skilled in the art will appreciate that various changes and modifications can be made therein without departing from the scope of the invention. - 6

Claims

Claims 1. A combination-use device for the simultaneous delivery of a

medicinal product by injection through the skin to body tissues and the delivery of a capillary blood sample to the skin surface for testing, the device comprising: A hollow needle, the blunt end integrally embedded into, and the sharp end protruding from, the centre of a rigid fixation plate; A solid lances, the blunt end integrally embedded into and the sharp end protruding from a lateral position of said rigid fixation plate; and A rigid hollow collar integrally moulded to said fixation plate and connecting the blunt end of said hollow needle to the spout of an injecting syringe.
2. A device according to claim I wherein said rigid fixation plate comprises an outer rigid platform and an inner rigid fixation block
3. A device according to claim I wherein said hollow needle and said solid lances are separated by a distance of approximately 1 0-20mm.
4. A device according to claim I wherein the hollow needle and lances are attachable to and detachable from the fixation plate.
5. A device according to claim 1 wherein said hollow needle and said solid lances are oriented perpendicularly to the fixation plate and run in a parallel orientation with respect to one another.
6. A device according to claim I wherein the protruding section of said hollow needle is longer than the protruding section of said lances blade.
7. A device according to any one of the preceding claims, wherein the device is housed in a protective cap prior to and after use.
8. A device according to any one of the preceding claims, wherein the device is disposable after use.
9. A device according to any one of the preceding claims, wherein the device can be attached to a syringe containing a medicinal product for injection.
10. A device according to any one of the preceding claims, wherein the device is operated by manual forward pressure to penetrate the skin surface.
11. A device according to any one of the preceding claims wherein the force for skin penetration and retraction of the hollow needle or lances is provided by a spring or other mechanical device means.
12. A device according to claims 9 and I 1 wherein the depression of a syringe plunger for delivering the medicinal product actuates the spring or other mechanical device means, for forcing and retracting the lances or needle into and out of the skin.
13. Use of a device according any one of the preceding claims to simultaneously deliver a medicinal product by needle injection through the skin to body tissues and to deliver a capillary blood sample to the skin surface for testing in a single procedure.
14. A Method of using a device according to any one of the preceding claims, to simultaneously deliver a medicinal product by needle injection through the skin to body tissues and to deliver a capillary blood sample to the skin surface for testing in a single procedure.