Skin cutter for painless extraction of small blood amounts

Surgery – Instruments – Cutting – puncturing or piercing

Patent

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606181, A61B 1732

Patent

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05997561&

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BRIEF SUMMARY
The present invention addresses a device for cutting skin to obtain small blood samples from human or animal tissue in an almost pain-free manner. It comprises a blade with a cutting edge having a length of less than 10 mm and an oscillator to make the blade oscillate essentially parallel to the cutting edge.
To take small amounts of blood from the finger or the earlobe for diagnostic purposes, one uses lancets which are pricked into the corresponding body part either manually or with the aid of a simple apparatus by the doctor or lab personnel. It is a matter of fact that the lancet has to be sharp and sterile. Otherwise, there are no particularly high demands to be met by the doctors' offices as blood samples are collected from individual patients in greater time intervals and the procedure is carried out by specially trained staff.
The requirements are significantly higher when blood lancet devices are used which are to be operated by the patient. They are necessary to allow patient groups that are at a particular risk to regularly determine certain analytical blood values by home monitoring.
This applies in particular to diabetics who regularly and frequently have to monitor their blood glucose level to keep it within certain levels by adjusting the amount of insulin to be injected which depends on food intake, physical activity, and other factors. This is of utmost importance for the health of these patients to avoid delayed serious damage such as blindness and amputation of body parts.
For this reason, one has developed easy to handle and relatively inexpensive analytical systems which usually comprise blood test strips and a corresponding evaluation instrument. Although the possibility of performing an easy and relatively inexpensive analysis is available to every patient today, the self-monitoring of blood glucose levels has still not reached the desired general acceptance among diabetics. The main reason being the pain that accompanies the pricking procedure when taking the blood sample.
Prior art knows lancet devices where a spring-propelled lancet pricks the tissue at a very high speed. Blood emerges from the so-created wound which can then be used for diagnostic purposes. Devices of this kind are known, for example from U.S. patents U.S. Pat. No. 4,203,446 and U.S. Pat. No. 4,895,147. There is a great variety of such devices with differently ground lancets and different spring mechanisms available on the market. Experiments have shown, however, that the pain caused by this kind of device cannot be lowered under a limit which the user clearly identifies as being unpleasant. What makes it even more difficult in the case of diabetics is that the test must be carried out frequently; the affected skin parts such as the finger tips and earlobes develop cornifications which in turn require deeper penetration levels thus causing more pain during pricking.
Numerous different blood lancet devices have been developed that are suitable to generate the wound necessary to collect the blood specimen in a simple and relatively pain-free manner. Examples are described in patents U.S. Pat. No. 4,442,836, U.S. Pat. No. 4,469,110, U.S. Pat. No. 4,535,769, and U.S. Pat. No. 4,924,897. Blood sampling device for driving a lancet and lancets are made to match one another and are also referred to as blood collection systems. Despite some progress, the pain caused by the cutting procedure when using blood lancet device designed for patient use is still too great.
The pain sensed during cutting could be reduced in blood lancet devices where the needle is guided in a controlled manner (U.S. Pat. No. 4,824,879 and U.S. Pat. No. 5,318,584). The devices of this kind are known as controlled guidance systems, as opposed to ballistic systems where the lancet, propelled by a spring, contacts the skin surface in a relatively uncontrolled manner.
It was, hence, an object of the present invention to propose a device which causes less pain during blood sampling as is the case with prior arts systems. It was another object of the inv

REFERENCES:
patent: 4750489 (1988-06-01), Berkman et al.
patent: 5318584 (1994-06-01), Lange et al.
patent: 5613978 (1997-03-01), Harding

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