CA2245574A1 - Skin cutter for painless extraction of small blood amounts - Google Patents
Skin cutter for painless extraction of small blood amounts Download PDFInfo
- Publication number
- CA2245574A1 CA2245574A1 CA002245574A CA2245574A CA2245574A1 CA 2245574 A1 CA2245574 A1 CA 2245574A1 CA 002245574 A CA002245574 A CA 002245574A CA 2245574 A CA2245574 A CA 2245574A CA 2245574 A1 CA2245574 A1 CA 2245574A1
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- Canada
- Prior art keywords
- blade
- tissue
- movement
- less
- cutting edge
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Abandoned
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/150007—Details
- A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
- A61B5/150381—Design of piercing elements
- A61B5/150442—Blade-like piercing elements, e.g. blades, cutters, knives, for cutting the skin
- A61B5/150458—Specific blade design, e.g. for improved cutting and penetration characteristics
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/150007—Details
- A61B5/150015—Source of blood
- A61B5/150022—Source of blood for capillary blood or interstitial fluid
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/150007—Details
- A61B5/150053—Details for enhanced collection of blood or interstitial fluid at the sample site, e.g. by applying compression, heat, vibration, ultrasound, suction or vacuum to tissue; for reduction of pain or discomfort; Skin piercing elements, e.g. blades, needles, lancets or canulas, with adjustable piercing speed
- A61B5/150106—Means for reducing pain or discomfort applied before puncturing; desensitising the skin at the location where body is to be pierced
- A61B5/150137—Means for reducing pain or discomfort applied before puncturing; desensitising the skin at the location where body is to be pierced by vibration
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/150007—Details
- A61B5/150175—Adjustment of penetration depth
- A61B5/15019—Depth adjustment mechanism using movable stops located inside the piercing device housing and limiting the travel of the drive mechanism
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
- A61B5/15101—Details
- A61B5/15103—Piercing procedure
- A61B5/15107—Piercing being assisted by a triggering mechanism
- A61B5/15113—Manually triggered, i.e. the triggering requires a deliberate action by the user such as pressing a drive button
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
- A61B5/15101—Details
- A61B5/15115—Driving means for propelling the piercing element to pierce the skin, e.g. comprising mechanisms based on shape memory alloys, magnetism, solenoids, piezoelectric effect, biased elements, resilient elements, vacuum or compressed fluids
- A61B5/15117—Driving means for propelling the piercing element to pierce the skin, e.g. comprising mechanisms based on shape memory alloys, magnetism, solenoids, piezoelectric effect, biased elements, resilient elements, vacuum or compressed fluids comprising biased elements, resilient elements or a spring, e.g. a helical spring, leaf spring, or elastic strap
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
- A61B5/15101—Details
- A61B5/15115—Driving means for propelling the piercing element to pierce the skin, e.g. comprising mechanisms based on shape memory alloys, magnetism, solenoids, piezoelectric effect, biased elements, resilient elements, vacuum or compressed fluids
- A61B5/15121—Driving means for propelling the piercing element to pierce the skin, e.g. comprising mechanisms based on shape memory alloys, magnetism, solenoids, piezoelectric effect, biased elements, resilient elements, vacuum or compressed fluids comprising piezos
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
- A61B5/15101—Details
- A61B5/15126—Means for controlling the lancing movement, e.g. 2D- or 3D-shaped elements, tooth-shaped elements or sliding guides
- A61B5/15132—Means for controlling the lancing movement, e.g. 2D- or 3D-shaped elements, tooth-shaped elements or sliding guides comprising tooth-shaped elements, e.g. toothed wheel or rack and pinion
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
- A61B5/15186—Devices loaded with a single lancet, i.e. a single lancet with or without a casing is loaded into a reusable drive device and then discarded after use; drive devices reloadable for multiple use
- A61B5/15188—Constructional features of reusable driving devices
Abstract
A skin cutter is disclosed for painlessly extracting small blood amounts from human or animal tissue. A blade (13) is made to vibrate by means of an oscillator (14, 32), is slowly lowered into the tissue and withdrawn again. In a first embodiment, the blade vibrates substantially in a parallel direction to the cutting edge of the blade and to the surface of the tissue. In the second embodiment, the blade vibrates substantially in the perpendicular direction to the surface of the tissue. The advantage of the disclosed devices is that the pain caused by pricking is reduced.
Description
CA 0224~74 1998-08-03 BOE~INGER MANNEEIM GMBH 4317/00 Cutting device for skin for obtaining small blood samples in almost pain-free ~ er 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 essenti~lly 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 m~nll~lly 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 dem~n~1~ to be met by the doctors' offlces 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 blin~1ness 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 431700.ENG
CA 0224~74 1998-08-03 reached the desired general acceptance among diabetics The main reason being the pain that accompanies the pricking procedure when ta~ing 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 US patentsUS-4,203,446 and US-4,895, 147. There is a great variety of such devices with differently ground lancets and different spring mech~nisms 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 comifications 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 US-~,442,836, US 4,469,110, US-4,535,769, and US-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 (US-4,824,897 and US-5,3 18,584). 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 invention to provide a blood lancet where the penetration depth can be reproduced in a more precise and improved manner than is the case with known devices.
CA 0224~74 1998-08-03 The object was accomplished in accordance with the invention in that the skin is penetrated in a manner where there is no pressure wave directed perpendicular to the skin and where a relatively small amount of pain receptors is activated due to precise guidance and a relatively small penetration depth of the lancet/blade. This can be achieved in that the skin is penetrated/opened in a procedure that is carried out ess~nti~lly parallel to the skin surface.
This cutting procedure causes si~nific~ntly less pain than pricking.
In accordance with the invention, the pain sensed when obtaining small amounts of blood is reduced in that a rapid oscillating movement is superimposed on the movement (usually a linear movement) of the blade that is necessary to enter the tissue. The excursion of the blade generated by this oscill~ting movement can principally be transverse to the tissue or essentially perpendicular to the tissue. With respect to these two embo-~imf~nts7 two different blade types have proven to be expedient so that the embodiments are described separately hereinafter.
When coupling a slow pricking movement with an osrill~ting movement, it is advantageous that despite an extremely high relative movement of the blade with respect to the skin, a pressure wave affecting deeper layers of the blade is almost completely avoided since the excursion ofthe blade is very smail despite the high speed (preferably ranging around 10-200 llm) and there is virtually no pressure component being generated perpendicular to the tissue surface. The blade "falls" into the skin. The penetration principle is, hence, based on a cutting procedure which can be carried out by an "oscill~ting" blade without a significant pressure component running perpendicular to the direction of movement. Owing to the small stroke of the blade, the cut is limited to very small ~limen.sions and, hence, easy to control.
Coupling a slow blade movement with an oscill~ting movement leads to cutting procedures which cause less pain than do the methods for obtaining small blood samples known from prior art.
Time-con.s lming tests have shown that the disadvantages of the blood lancets known in prior art are likely due to the p~infilllness of the skin penetration process which is essentially ~31700.ENG
CA 0224~74 1998-08-03 caused by the activation of pain receptors and their afferent signals. When the lancet arrives on the tissue a pressure wave is generated that propagates predoll~il.anlly in the direction of movement. This pressure wave precedes the moving blade and thus activates additional pain receptors which would not be activated during penetration and cutting if the lancet would e~cec~1te a mere cutting and ripping process. Avoiding a pressure wave when the lancet hits the skin can, hence, significantly reduce the pain sensation. Moreover, the llnri~finPd penetration depth and the uncontrolled movements of the lancet are likely to be additional reasons for unnecessaly high pain sensation when using known systems.
The device of the invention can be further improved when the skin opening is kept as small as possible, preferably smaller than 1.5 mm, more preferably smaller than 1 mm, and when the cutting movement is carried out in a controlled manner.
rt is also important that the site opening be generated in a controlled movement and not in an uncontrolled "rip". Ripping the tissue would lead to a corresponding pressure wave and/or pulling of the tissue which then causes pain. Advantageous movements are those w~re the blade is guided such that ro-wald and backward movements are uniform. It is also advantageous to control the movement such that the forward movement upon reaching a predefined dead point changes into a backward movement.
The following figures are given to describe the invention in greater detail.
~i~ure 1: Principal interaction between penetration depth and cutting width when using pointed lancets Fi~ure 2: Arrangement of blade and tissue with respect to one another Figure 3: Manually operated vampire blood lancet ~igure 4: Blood lancet with spring as propelling meçh~nism l~igure 5: Blood lancet with an eccentric disk as a propelling mechanism 431700.E~JG
CA 0224~74 1998-08-03 Figure 6: Blade types Figure 7: Cross sections of blades Figure 8: Principal representation of a Mucke-type blood lancet Figure 9: Manually operated blood lancet of the Mucke-type Figure 10: System of coordinates for d~fining directions of movement Figure 11: Representation ofthe interaction between projection depth (A), deformation (D) and penetration depth (E) In order to define the directions of movement of the lancet, Figure 10 shows a system of coordinates. The tissue surface is located in the XZ-plane. In order to penetrate the tissue, the lancet must carry out a movement with a Y-component, i.e. a movement having a component perpendicular to the tissue surface. In the case shown here, the cutting edge (2) is located on the Z-axis while the blade (1) is located within the XY-plane. The blade can now be guided perpendicularly, i.e. in direction of the negative Y-axis, into the tissue; or it can be moved in a plane E' which is tilted with respect to the XY-plane. The description ,~ess~nti~lly perpendicular to the tissue surface" when used with respect to the direction of movement should also include movements which are tilted by, e.g. 30~, with respect to the XY-plane. In a first embodiment the blade is made to oscillate transversely to the direction of movement. In the system of coordinates of Figure 10, this is an oscill~ting movement of the blade in direction Z.
The present invention is further directed to a process for obtaining small volumes of blood by a process where an os-.ill~ting blade is being moved in direction towards the tissue to be penetrated, is being lowered into the tissue in a direction primarily vertical to the skin surface and is being retracted out of the tissue. This can be accomplished by an active movement of the blade in direction towards the tissue as well as by an active movement of 43 1 700.ENG
CA 0224~74 1998-08-03 the tissue. Furthermore it is not necessary that the blade is already in oscillation while contacting the tissue surface. It is also possible to start oscillation of the blade after contact between blade and tissue has been established.
In almost all parts of its body, the human being possesses epithelial skin where blood sampling with lancets is not possible at all or very difficult as this type of skin, owing to its high retraction properties, will close imm~ tely after pricking or cutting so that the blood emerging from the blood vessels cannot reach the surface of the skin or is released into subcutaneous tissue parts causing micro-hematomas. Skin parts that are suitable for obtaining blood samples include the tips of fingers and toes and the earlobes. On his finger and toe tips the human being possesses ridged skin. The top layer of this skin is the epidermis with a thickness of 0.1 to 0.5 mm. Below the epidermis is the corium consisting of the stratum papillare and the stratum reticulare. Below the corium is the subcutis. The upper part of the corium and the stratum papillare are of particular importance for obtaining small amounts of blood in almost pain-free manner. The stratum papillare features a finely woven net of blood vessels and pain receptors located closely together. In this part of the tissue the blood vessels can be divided into capillaries and microvessels. Capillaries are shaped like hair needles reflected in the papillae of the skin. Arterial blood rises from the inside of the tissue to the curvature in the hair needle to release oxygen to the surrounding tissue; it is then via the venous system cond~lcted back into deeper layers of tissue in the form of venous blood. Within the present invention it has been found that due to anatomic properties, it suffices to penetrate the epidermis and cut open a few hair needle-like blood vessels of the papillary layer and/or cut open a few microvessels located in this region of the tissue to obtain an amount of blood that is sufficient to satisfy the diagnostic purpose (appr.
5 ,ul - 30 ~1).
Prior art lancets, however, penetrate the corium much deeper and in an uncontrolled manner, i.e. with heavy movements perpendicular to the propelling direction. The reason for this can be understood from Figure 1. In order to generate a wound of width d on the surface of the corium, the tip of the lancet must enter the corium at a depth h. With the technology known from prior art, this depth h can only be reduced when a lancet with a 431700.ENG
CA 0224~74 1998-08-03 flatter tip is selected, i.e. redllr.ing the h/d-ratio. More blunt lancets, however, cause more pain during pricking as was shown in experiments.
** The first embodiment (Vampire) In accordance with the invention, the pricking pain is reduced in that the blade is made to oscillate a high rate while the oscill~ting blade is lowered into the tissue are relatively slow speed, preferably slower than 2 km/h. In a first embodiment of the invention, the blade is oscillated ess~nti~lly parallel to the cutting edge.
Figure 2 shows the principal arrangement of blade and tissue. The blade (1) shown has a cutting edge (2) which executes an osçill~ting movement in direction toward the double arrow shown in the figure. When the blade, while osçill~ting, approaches the epidermis, it is capable of penetrating it without causing ~i~nific~nt pain. Due to the osçill~tin~ movement, the epidermis is then cut open; as compared to currently available pricking lancets, it is now possible to lower the blade into epidermis and corium at a much slower speed. From Figure 2 it can be seen that this embodiment uses a blade type where a sufflciently wide piece d of the tissue is cut open while the penetration depth of the corium remains very small. Owing to the arrangement of the hair-needle-like blood vessels and other microvessels found in this region within the corium, said vessels are effectively cut open by the oscill~tin~? movement of the blade. A cutting width d of 300 to 900 ~lm is already sufficient in order to obtain a sufficient amount of blood. For obtaining larger amounts of blood it is in accordance with the invention of course also possible to use correspondingly longer blades.
* * * The oscillator In order to allow the blade to enter the tissue in an almost pain-free manner, experience has shown it to be important that the blade oscillate essentially parallel to the cutting edge at frequency above 500 Hz. The cutting device in accordance with the invention could further be significantly improved by raising the oscillation frequency to above 700 Hz. Particularly effficient cutting is achieved with frequencies in the kilo-Herz range or above 900 Hz. Pain sensation during cutting is significantly infl~lenced by the oscillation amplitude. Experiments 431700.ENG
CA 0224~74 1998-08-03 have shown that the amplitude should be below 500 ~lm. A preferred amplitude is one below 300 ~m, particularly prere~led below 250 llm. Oscillators to implement the described requirements include in particular piezo elements, ultrasonic ceramics, electrodynamical transformers as well as mechanical transformers. Piezo elements have proven particularly well as oscillators which execute changes in length upon application of an electrical voltage.
As these changes usually amount to only one or a few ,um, it is necessary to have a me-~h~nic~l transformation to achieve larger amplitudes. This can be accomplished by a piezo element coupled to one end of a bar and a blade coupled to the other end. The bar should have a low weight in order to ~ e a damping of the oscillation. The bar is preferably made of a ridgid material in order to achieve a proper energy transfer from the oscillator onto the blade. Bar and piezo element are properly coupled to a mass. It is, however, also possible to advantageously use a stack of piezo elements where the changes in length of the individual elements are added up.
Mechanical transformers which lead to an oscillation of the blade are so called spring-mass-oscillators, which can be accomplished with a tuning fork, for example, at the one arm of which there is attached the blade or a device to hold the blade. It has shown to be particularly useful to operate the oscillator at a resonance frequency since the amplitude of the blade is high under such conditions.
*** The blade Blades with a cutting edge of less than 10 mm have proven to be suitable for cutting devices designed to obtained small blood samples. Cutting edges with a length between 0.2 to 2 mm, preferably 0.4 to 1.5 mm have proven to be suitable for obtaining blood samples ranging around 100 tll. Cutting edges of 0.5 to 1.0 mm in length are particularly suitable.
Materials such as steel that are commonly used in prior art lancets haven proven well for the blades. Generally, it is also possible to use metals, glasses, ceramic materials and plastics.
Particularly well suited are plastics which can be processed by injection molding and which are ridgid enough after cooling down. When using suitable injection molding forms a separate process step for sharpening the blade can be avoided. Experiments have shown it 43 1700.ENG
CA 0224~74 1998-08-03 to be advantageous to coat the blades with substances which reduce friction between blade and tissue. By red~lc ing the friction between blade and tissue, it is possible to avoid the ~.~nsrel- of me-~hRnical energy into the tissue and, hence, pain caused by heat. In a particularly pler~llt;d embodiment bar and blade are a mechanical unit which can be ~x~hs~nged. In the medical field it is desirable due to hygienic reasons to have a disposable unit which can be exch~nged after each cutting process. Bar and blade can be made from different materials, however, it is prer~lled that both are made from the same material.
*** The m~nll~lly operated blood lancet Figure 3 shows a blood lancet in accordance with the invention. Said lancet comprises a housing cont~ining the blade and the oscillator. The housing has an outer cover (10) which serves to handle the device. Inside the cover there is a bar (12) to which the blade (13) is attached. A piezo crystal (14) connectecl to bar (12) is activated via an electronic oscillation generator (15) such that blade (13) executes osçill~ting movements essentially parallel to the cutting edge (13a). In the example shown here, another cover (11) is located inside the outer cover (10) where it can be moved such that the portion of the blade which projects out of the outer cover ( 10) can be adjusted. An axis ( 18) connects bar ( 12) with cover ( 1 1 ) such that this end of the bar is attached to a mass. At its bottom end, cover ( 10) is provided with a contact surface (16) which is m~n~l~lly placed onto the tissue. The portion by which the blade projects beyond the contact surface, hence, defines the depth of the cut in the tissue. The invention proposes that the cutting devices feature an adjusting unit to define the m~imllm and minimllm distances by which the blade can project beyond the contactsurface. The adjusting range of this interval is preferably selected such that its lower limit is longer than 200 ,um while its upper limit is smaller than 2500 ~lm This adjusting range is preferably set between 0.5 and 2.0 mm or, even more ple~relled, between 0.7 and 1.3 mm.
For proper performance of the device it is important that the bar ( 12) be made of a material that exhibits a sufficiently high modulus of elasticity to transfer the energy of the piezo oscillation to the blade (13). Suitable materials for the bar are, for example, glass, spring steel, plastics and ceramics. Moreover, it is also important that the weight of the oscillating components (bar and blade) is small in comparison to the weight on the opposite site of the 431700.ENG
CA 0224~74 1998-08-03 piezo element. In figure 3 the piezo element is coupled via a connecting piece (1 la) to the inner cover (11). It is particularly advantageous to operate the apparatus such that bar and blade oscillate at resonance frequency.
** The spring-operated blood lancet Figure 4 shows examples of embodiments where the manual movement which is necessary with the appa. ~ s shown in Figure 3, is replaced by the effect of a spring element (20).
Spring (20) is connected to guide rail (21) which has a recess for a lever (22) to engage.
Lever (22) is provided with a push-button located outside the housing. When pressing the push-button, the lock is released and the inner cover (11) is moved relative to the outer cover. Blade (13) is thus moved outside the outer cover. By varying the distance X between the edge of the inner cover (11) and the inside of the contact surface (16) in the initial position, it is possible to adjust the cutting depth by which the blade penetrates the tissue.
This can be accomplished, for example, by varying the length of the outer cover, e.g. with the aid of a screw. Additional options to vary the penetration depth are known from US-4,895,147 and US-5,318,584. The arrangement can also be selected such that the blade is fixed in its position while the skin contact surface is provided on the front side of a cover which is mounted to an adjustable abutment in a spring-supported manner.
The unit for adjusting the penetration depth is preferably configured such that it can be set at given levels. At least in the above given levels, the m~imllm distance between the individual levels is appr. 0.4 mm and the minimllm distance is appr. 0.2 mm, preferably û.3 mm. This range can, of course, also exceed the maximum values to allow deeper penetration, e.g. to account for the relatively small amount of subjects where the above mentioned small penetration depth does not provide a sufficient amount of blood (e.g. due to an excessively thick horn layer). For an exact adjllstnntont of the penetration depth, it is also important to have such a precise positioning of the blade in its holder that it is possible to reproduce the position of the blade end in diredion to the pricking movement relative to the blade holder when several blades are s~lcces~ively mounted to the blade holder.
43 1700.EN~
CA 0224~74 1998-08-03 Owing to the advantageous properties of the device in accordance with the invention of displacing/compressing the tissue only very little before penetration, it is possible to achieve a very good reproducibility of the cutting depth which is significantly improved(< +/- 0.1 mm) over presently available systems. Due to these very good penetration properties of the device of the invention, individual variation with respect to the skin turgor and/or skin density are now only of secondary importance. This is accomplished in that the tissue opposite the blade is not compressed upon first contact with the forwardly propelled blade; in.~te~rl, the penetration/cutting does not begin until the blade arrives on the skin.
Figure 4a shows an embodiment where the inner cover (11) is shown together with a configuration of oscillator, bar and blade which is slightly modified with respect to figure 4.
The piezo crystal (14) and the blade (13) are disposed on di~elen~ sides with respect to axis (18). By this configuration an oscillation of the blade is being accomplished in the way of a chopping-blade. This type of movement has a comparent parallel to the cutting edge as well as a component vertical thereto. An oscillation of the bar around the axis creates a movement of the blade on a part of a circle.
Figure 11 shows the interaction between the width at which the lancet projects from the cutting device and the penetration depth ofthe tissue. Figure 1 lA shows the initial position of the system where the blade ( 1 ) is completely located inside the housing (5 1 ) and the housing is pressed onto a part of the skin (50). Figure 1 lB shows a condition where the blade displaces the skin without cutting it. Deformation of the skin is identified as (D).
Figure 1 lC shows a condition where the blade has already cut open the skin. The depth (A) at which the blade projects out of the housing results in a deformation (D) and a penetration depth (E) in the tissue. Deformation (D) can be subject to great deviation within one individual and between dirrelenl individuals so that the penetration depth can also greatly vary while the projection depth is constant; a fact which is not desired. In devices according to the present invention, the d~rol,lla~ion (D) is very small due to the reasons listed above;
the deviations of (D) are, hence, also very small. With a defined projection depth (A) the penetration depth (E) into the skin can, hence, be exactly predet~rmined.
43 1 700.1~NG
CA 0224~74 1998-08-03 Easy procedures allow the user to precisely set the desired penetration depth. The adjusting range preferably covers unnsu~lly deep penetration levels between 0.5 and 2.0 mm, with a range between 0.7 mm and 1.3 mm being of particular importance. The amount of blood necess~ry for an analysis usually ranges between 1 and 50 ,ul, more frequently between 5 and 30 ~1; as the invention has shown, this amount can already be obtained for the majority of individuals at penetration levels where pain is siy,nificantly reduced, provided the penetration level can be easily reproduced at a certain, ic~ntic~l setting of the instrument.
With an idçntic~l setting of the cutting device given, the depth of the cut generated in succes.,ive cutting procedures should deviate by less than 0.15 mm, preferably 0.1 mrn and particularly pler~"ed 0.05 mm.
*** The eccentric disc-operated blood lancet Figure 5A shows a blood lancet where the bar (12) holding the blade (13) is mounted to a weight (41). The weight (41) is located inside an inner cover (23) which in turn is located moveably inside the outer cover (10). The bar (12) which is rigidly connected to the weight (41), e.g. in glued or screwed connection, runs across the weight (41). In the bar (12) there is integrated a piezo element (14) which causes the bar (12) and the blade (13) to oscillate.
An enlargement (42) surrounding the opening where the blade emerges can be advantageously provided at the contact surface (16) of the device which is pressed onto the skin. Purpose of this enlargement is to put the part of the skin to be cut open under tension and fix it in position. It has proven to be advantageous if this enlargement (4Z) projects past the contact surface (16) by 0.2 to 0.3 mrn.
Figure 5A also shows an advantageous drive unit for moving the blade into the tissue. This drive unit features an eccentric disk (25) to which a lever (26) is mounted via an axis;
another axis connects said lever in turn to the bar ( 12). Figure 5B is a rear view of the eccentric disk. On this side said disk has a toothed wheel (27) which is driven via a toothed rod (28). It is an advantage of the device shown in Figure 5 that when the user presses down the toothed rod (28) the blade is lowered into the tissue and again retracted. Since the user must execute only one single movement, the h~nllling of the device is further f~cilit~terl A spring element (29) can be provided to retract the toothed rod back into its 431700.ENG
CA 0224~74 1998-08-03 original position. When the tooth rod is pressed down, the spring element is compressed to then move the toothed rod back into its original position. It can also be advantageous to provide some idle for the toothed wheel (27) so that the eccentric disk (25) does not rotate and the blade is not lowered again into the tissue when the toothed rod is retracted into its original position.
Figure 5C shows the rod (12) with an integrated piezo element (14). The piezo element is configured such that when en electric alternating voltage is applied, it carries out changes in length along its longitl~clin~l axis. These length changes then causes the lever to be bent as is known analogously from bimetallic strips. Mechanical oscillation of the bar ( 12) can be generated by applying electrical signals having a suitable frequency.
*** The blade types Figure 6 shows three embodiments of blades which are pl ere,led in accordance with the invention. Figure 6A shows a trapezoidal blade with a straight cutting edge. Figure 6B
shows a blade as used in chopping knifes while the blade shown in Figure 6C has a pointed tip. Each of these 3 blade types can have different cross sections. Figure 7 shows two possible cross sections A and B taken along section line aa' Each of the blades shown in Figures 6A through 6C could have one these cross sections. A section line is indicated in Figures 6A to 6C to further illustrate this.
The basic shapes of the blades include trapezoids, circles, semi-circles, squares, polygons, pointed tips or chopping blade-type blades. The following taper options are possible:
- circul,lrelell~ial ground - facet ground and - ground on both sides ** The second embodiment (Mucke) The invention also encomp~cses an embodiment where the blade is made to oscillate perpendicularly to the tissue surface. In this embodiment, owing to the oscill~ting movement ~31700.ENG
CA 0224~74 1998-08-03 the microscopic movements of the blade and the movements for introducing the blade into the tissue run es.s~nti~lly parallel. In this embodiment it is also advantageous to employ pointed blades and blades with several edges. The latter type can also be achieved with facet grinding.
With this type of device there can be used pin pointed needles which preferably have a facet ground.
The "Mucke"-type device preferably uses a rigid coupling between oscillator and blade which avoids a lateral movement or oscillation of the blade and employs a vertical oscillation with respect to the tissue surface. The oscillation amplitude vertical to the skin surface is set to be smaller than 300 !lm, preferably smaller than 100 llm and particularly p~erelled smaller as 50 llm. For example mechanical oscillators, electrodynamic transformers and piezo elements can be employed as oscillators.
*** Sch~m~tic representation Figure 8 is a schematic representation showing the implementation of this secondembodiment. Bar (30) is movable disposed on a sleeve (31). A piezo crystal (32) to transfer oscillations to blade (33) is disposed on bar (30). In this embodiment, the piezo crystal is arranged such that the oscillations generate a movement of the blade (33) in longitudinal direction of the bar in accordance with the double-arrow displayed above the bar. It is of importance that the weight of the oscill~tin~ pieces (bar and blade) is small compared to the mass disposed on the other side with respect to the oscillator (which means on side of the bar). In order to carry out a tissue section, the piezo crystal (32) is first made to oscillate;
the blade is then lowered into the tissue by moving bar (30). Af'~er generating a sufficiently large cut, the bar (30) is moved in opposite direction and the blade (33) is pulled back out of the tissue. Pointed tips have proven well for this embodiment. Especially advantageous are flat blades with cross sections as shown in Figures 7A and 7B. Experiments have also shown that the oscillation frequency of the blade transverse to the tissue surface should be above 100 Hz to In;l~ i7e pain sensation during cutting. By increasing the frequency to 43 1 700.1~NG
-CA 0224~74 1998-08-03 above 500 Hz, pain sensation can be further reduced. The amplitude of the osçill~tin~
movement should for the same reason be below 100 llm, preferably below 50 llm.
The oscillation of blade (33) necessary for proper operation ofthe device is achieved with the aid of a suitable geometric arrangement of the masses which generates a so-called resonance step-up of the amplitude.
The s~h-sm~tic repres~nt~tinn of the apparatus shown in Figure 8 can be combined, for example, with the driving mech~ni~m~ for moving the blade transversely to the tissue surface as described in Figures 4 and 5.
** The manual pricking aid Figure 9 shows a particularly simple embodiment where a battery-operated electronic oscillation generator (15) is located within a housing (40). This oscillation generator (15) causes the piezo crystal (32) to oscillate. In this embodiment the blade is directly coupled to the piezo crystal. The user moves the blade (33) to the tissue to be cut open and carries out a cut at the desired depth.
43 1 700.ENG
, CA 02245574 1998-08-03 List of reference numerals (1) blade (2) cutting edge (10) outer cover (11) inner cover (1 la) connecting piece (12) bar (13) blade (14) piezo crystal (15) electronic oscillation generator (16) contact surface (17) battery (18) axis (19) weight (20) spring element (21) guide with recess (22) lever (23) guide element (24) rubber (25) eccentric disk (26) lever rod (27) toothed wheel (28) toothed rod (29) spring element (30) bar (31) sleeve (32) piezo crystal (33) blade (40) housing (41) weight (42) enlargement 43 1 700.ENG
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 m~nll~lly 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 dem~n~1~ to be met by the doctors' offlces 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 blin~1ness 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 431700.ENG
CA 0224~74 1998-08-03 reached the desired general acceptance among diabetics The main reason being the pain that accompanies the pricking procedure when ta~ing 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 US patentsUS-4,203,446 and US-4,895, 147. There is a great variety of such devices with differently ground lancets and different spring mech~nisms 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 comifications 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 US-~,442,836, US 4,469,110, US-4,535,769, and US-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 (US-4,824,897 and US-5,3 18,584). 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 invention to provide a blood lancet where the penetration depth can be reproduced in a more precise and improved manner than is the case with known devices.
CA 0224~74 1998-08-03 The object was accomplished in accordance with the invention in that the skin is penetrated in a manner where there is no pressure wave directed perpendicular to the skin and where a relatively small amount of pain receptors is activated due to precise guidance and a relatively small penetration depth of the lancet/blade. This can be achieved in that the skin is penetrated/opened in a procedure that is carried out ess~nti~lly parallel to the skin surface.
This cutting procedure causes si~nific~ntly less pain than pricking.
In accordance with the invention, the pain sensed when obtaining small amounts of blood is reduced in that a rapid oscillating movement is superimposed on the movement (usually a linear movement) of the blade that is necessary to enter the tissue. The excursion of the blade generated by this oscill~ting movement can principally be transverse to the tissue or essentially perpendicular to the tissue. With respect to these two embo-~imf~nts7 two different blade types have proven to be expedient so that the embodiments are described separately hereinafter.
When coupling a slow pricking movement with an osrill~ting movement, it is advantageous that despite an extremely high relative movement of the blade with respect to the skin, a pressure wave affecting deeper layers of the blade is almost completely avoided since the excursion ofthe blade is very smail despite the high speed (preferably ranging around 10-200 llm) and there is virtually no pressure component being generated perpendicular to the tissue surface. The blade "falls" into the skin. The penetration principle is, hence, based on a cutting procedure which can be carried out by an "oscill~ting" blade without a significant pressure component running perpendicular to the direction of movement. Owing to the small stroke of the blade, the cut is limited to very small ~limen.sions and, hence, easy to control.
Coupling a slow blade movement with an oscill~ting movement leads to cutting procedures which cause less pain than do the methods for obtaining small blood samples known from prior art.
Time-con.s lming tests have shown that the disadvantages of the blood lancets known in prior art are likely due to the p~infilllness of the skin penetration process which is essentially ~31700.ENG
CA 0224~74 1998-08-03 caused by the activation of pain receptors and their afferent signals. When the lancet arrives on the tissue a pressure wave is generated that propagates predoll~il.anlly in the direction of movement. This pressure wave precedes the moving blade and thus activates additional pain receptors which would not be activated during penetration and cutting if the lancet would e~cec~1te a mere cutting and ripping process. Avoiding a pressure wave when the lancet hits the skin can, hence, significantly reduce the pain sensation. Moreover, the llnri~finPd penetration depth and the uncontrolled movements of the lancet are likely to be additional reasons for unnecessaly high pain sensation when using known systems.
The device of the invention can be further improved when the skin opening is kept as small as possible, preferably smaller than 1.5 mm, more preferably smaller than 1 mm, and when the cutting movement is carried out in a controlled manner.
rt is also important that the site opening be generated in a controlled movement and not in an uncontrolled "rip". Ripping the tissue would lead to a corresponding pressure wave and/or pulling of the tissue which then causes pain. Advantageous movements are those w~re the blade is guided such that ro-wald and backward movements are uniform. It is also advantageous to control the movement such that the forward movement upon reaching a predefined dead point changes into a backward movement.
The following figures are given to describe the invention in greater detail.
~i~ure 1: Principal interaction between penetration depth and cutting width when using pointed lancets Fi~ure 2: Arrangement of blade and tissue with respect to one another Figure 3: Manually operated vampire blood lancet ~igure 4: Blood lancet with spring as propelling meçh~nism l~igure 5: Blood lancet with an eccentric disk as a propelling mechanism 431700.E~JG
CA 0224~74 1998-08-03 Figure 6: Blade types Figure 7: Cross sections of blades Figure 8: Principal representation of a Mucke-type blood lancet Figure 9: Manually operated blood lancet of the Mucke-type Figure 10: System of coordinates for d~fining directions of movement Figure 11: Representation ofthe interaction between projection depth (A), deformation (D) and penetration depth (E) In order to define the directions of movement of the lancet, Figure 10 shows a system of coordinates. The tissue surface is located in the XZ-plane. In order to penetrate the tissue, the lancet must carry out a movement with a Y-component, i.e. a movement having a component perpendicular to the tissue surface. In the case shown here, the cutting edge (2) is located on the Z-axis while the blade (1) is located within the XY-plane. The blade can now be guided perpendicularly, i.e. in direction of the negative Y-axis, into the tissue; or it can be moved in a plane E' which is tilted with respect to the XY-plane. The description ,~ess~nti~lly perpendicular to the tissue surface" when used with respect to the direction of movement should also include movements which are tilted by, e.g. 30~, with respect to the XY-plane. In a first embodiment the blade is made to oscillate transversely to the direction of movement. In the system of coordinates of Figure 10, this is an oscill~ting movement of the blade in direction Z.
The present invention is further directed to a process for obtaining small volumes of blood by a process where an os-.ill~ting blade is being moved in direction towards the tissue to be penetrated, is being lowered into the tissue in a direction primarily vertical to the skin surface and is being retracted out of the tissue. This can be accomplished by an active movement of the blade in direction towards the tissue as well as by an active movement of 43 1 700.ENG
CA 0224~74 1998-08-03 the tissue. Furthermore it is not necessary that the blade is already in oscillation while contacting the tissue surface. It is also possible to start oscillation of the blade after contact between blade and tissue has been established.
In almost all parts of its body, the human being possesses epithelial skin where blood sampling with lancets is not possible at all or very difficult as this type of skin, owing to its high retraction properties, will close imm~ tely after pricking or cutting so that the blood emerging from the blood vessels cannot reach the surface of the skin or is released into subcutaneous tissue parts causing micro-hematomas. Skin parts that are suitable for obtaining blood samples include the tips of fingers and toes and the earlobes. On his finger and toe tips the human being possesses ridged skin. The top layer of this skin is the epidermis with a thickness of 0.1 to 0.5 mm. Below the epidermis is the corium consisting of the stratum papillare and the stratum reticulare. Below the corium is the subcutis. The upper part of the corium and the stratum papillare are of particular importance for obtaining small amounts of blood in almost pain-free manner. The stratum papillare features a finely woven net of blood vessels and pain receptors located closely together. In this part of the tissue the blood vessels can be divided into capillaries and microvessels. Capillaries are shaped like hair needles reflected in the papillae of the skin. Arterial blood rises from the inside of the tissue to the curvature in the hair needle to release oxygen to the surrounding tissue; it is then via the venous system cond~lcted back into deeper layers of tissue in the form of venous blood. Within the present invention it has been found that due to anatomic properties, it suffices to penetrate the epidermis and cut open a few hair needle-like blood vessels of the papillary layer and/or cut open a few microvessels located in this region of the tissue to obtain an amount of blood that is sufficient to satisfy the diagnostic purpose (appr.
5 ,ul - 30 ~1).
Prior art lancets, however, penetrate the corium much deeper and in an uncontrolled manner, i.e. with heavy movements perpendicular to the propelling direction. The reason for this can be understood from Figure 1. In order to generate a wound of width d on the surface of the corium, the tip of the lancet must enter the corium at a depth h. With the technology known from prior art, this depth h can only be reduced when a lancet with a 431700.ENG
CA 0224~74 1998-08-03 flatter tip is selected, i.e. redllr.ing the h/d-ratio. More blunt lancets, however, cause more pain during pricking as was shown in experiments.
** The first embodiment (Vampire) In accordance with the invention, the pricking pain is reduced in that the blade is made to oscillate a high rate while the oscill~ting blade is lowered into the tissue are relatively slow speed, preferably slower than 2 km/h. In a first embodiment of the invention, the blade is oscillated ess~nti~lly parallel to the cutting edge.
Figure 2 shows the principal arrangement of blade and tissue. The blade (1) shown has a cutting edge (2) which executes an osçill~ting movement in direction toward the double arrow shown in the figure. When the blade, while osçill~ting, approaches the epidermis, it is capable of penetrating it without causing ~i~nific~nt pain. Due to the osçill~tin~ movement, the epidermis is then cut open; as compared to currently available pricking lancets, it is now possible to lower the blade into epidermis and corium at a much slower speed. From Figure 2 it can be seen that this embodiment uses a blade type where a sufflciently wide piece d of the tissue is cut open while the penetration depth of the corium remains very small. Owing to the arrangement of the hair-needle-like blood vessels and other microvessels found in this region within the corium, said vessels are effectively cut open by the oscill~tin~? movement of the blade. A cutting width d of 300 to 900 ~lm is already sufficient in order to obtain a sufficient amount of blood. For obtaining larger amounts of blood it is in accordance with the invention of course also possible to use correspondingly longer blades.
* * * The oscillator In order to allow the blade to enter the tissue in an almost pain-free manner, experience has shown it to be important that the blade oscillate essentially parallel to the cutting edge at frequency above 500 Hz. The cutting device in accordance with the invention could further be significantly improved by raising the oscillation frequency to above 700 Hz. Particularly effficient cutting is achieved with frequencies in the kilo-Herz range or above 900 Hz. Pain sensation during cutting is significantly infl~lenced by the oscillation amplitude. Experiments 431700.ENG
CA 0224~74 1998-08-03 have shown that the amplitude should be below 500 ~lm. A preferred amplitude is one below 300 ~m, particularly prere~led below 250 llm. Oscillators to implement the described requirements include in particular piezo elements, ultrasonic ceramics, electrodynamical transformers as well as mechanical transformers. Piezo elements have proven particularly well as oscillators which execute changes in length upon application of an electrical voltage.
As these changes usually amount to only one or a few ,um, it is necessary to have a me-~h~nic~l transformation to achieve larger amplitudes. This can be accomplished by a piezo element coupled to one end of a bar and a blade coupled to the other end. The bar should have a low weight in order to ~ e a damping of the oscillation. The bar is preferably made of a ridgid material in order to achieve a proper energy transfer from the oscillator onto the blade. Bar and piezo element are properly coupled to a mass. It is, however, also possible to advantageously use a stack of piezo elements where the changes in length of the individual elements are added up.
Mechanical transformers which lead to an oscillation of the blade are so called spring-mass-oscillators, which can be accomplished with a tuning fork, for example, at the one arm of which there is attached the blade or a device to hold the blade. It has shown to be particularly useful to operate the oscillator at a resonance frequency since the amplitude of the blade is high under such conditions.
*** The blade Blades with a cutting edge of less than 10 mm have proven to be suitable for cutting devices designed to obtained small blood samples. Cutting edges with a length between 0.2 to 2 mm, preferably 0.4 to 1.5 mm have proven to be suitable for obtaining blood samples ranging around 100 tll. Cutting edges of 0.5 to 1.0 mm in length are particularly suitable.
Materials such as steel that are commonly used in prior art lancets haven proven well for the blades. Generally, it is also possible to use metals, glasses, ceramic materials and plastics.
Particularly well suited are plastics which can be processed by injection molding and which are ridgid enough after cooling down. When using suitable injection molding forms a separate process step for sharpening the blade can be avoided. Experiments have shown it 43 1700.ENG
CA 0224~74 1998-08-03 to be advantageous to coat the blades with substances which reduce friction between blade and tissue. By red~lc ing the friction between blade and tissue, it is possible to avoid the ~.~nsrel- of me-~hRnical energy into the tissue and, hence, pain caused by heat. In a particularly pler~llt;d embodiment bar and blade are a mechanical unit which can be ~x~hs~nged. In the medical field it is desirable due to hygienic reasons to have a disposable unit which can be exch~nged after each cutting process. Bar and blade can be made from different materials, however, it is prer~lled that both are made from the same material.
*** The m~nll~lly operated blood lancet Figure 3 shows a blood lancet in accordance with the invention. Said lancet comprises a housing cont~ining the blade and the oscillator. The housing has an outer cover (10) which serves to handle the device. Inside the cover there is a bar (12) to which the blade (13) is attached. A piezo crystal (14) connectecl to bar (12) is activated via an electronic oscillation generator (15) such that blade (13) executes osçill~ting movements essentially parallel to the cutting edge (13a). In the example shown here, another cover (11) is located inside the outer cover (10) where it can be moved such that the portion of the blade which projects out of the outer cover ( 10) can be adjusted. An axis ( 18) connects bar ( 12) with cover ( 1 1 ) such that this end of the bar is attached to a mass. At its bottom end, cover ( 10) is provided with a contact surface (16) which is m~n~l~lly placed onto the tissue. The portion by which the blade projects beyond the contact surface, hence, defines the depth of the cut in the tissue. The invention proposes that the cutting devices feature an adjusting unit to define the m~imllm and minimllm distances by which the blade can project beyond the contactsurface. The adjusting range of this interval is preferably selected such that its lower limit is longer than 200 ,um while its upper limit is smaller than 2500 ~lm This adjusting range is preferably set between 0.5 and 2.0 mm or, even more ple~relled, between 0.7 and 1.3 mm.
For proper performance of the device it is important that the bar ( 12) be made of a material that exhibits a sufficiently high modulus of elasticity to transfer the energy of the piezo oscillation to the blade (13). Suitable materials for the bar are, for example, glass, spring steel, plastics and ceramics. Moreover, it is also important that the weight of the oscillating components (bar and blade) is small in comparison to the weight on the opposite site of the 431700.ENG
CA 0224~74 1998-08-03 piezo element. In figure 3 the piezo element is coupled via a connecting piece (1 la) to the inner cover (11). It is particularly advantageous to operate the apparatus such that bar and blade oscillate at resonance frequency.
** The spring-operated blood lancet Figure 4 shows examples of embodiments where the manual movement which is necessary with the appa. ~ s shown in Figure 3, is replaced by the effect of a spring element (20).
Spring (20) is connected to guide rail (21) which has a recess for a lever (22) to engage.
Lever (22) is provided with a push-button located outside the housing. When pressing the push-button, the lock is released and the inner cover (11) is moved relative to the outer cover. Blade (13) is thus moved outside the outer cover. By varying the distance X between the edge of the inner cover (11) and the inside of the contact surface (16) in the initial position, it is possible to adjust the cutting depth by which the blade penetrates the tissue.
This can be accomplished, for example, by varying the length of the outer cover, e.g. with the aid of a screw. Additional options to vary the penetration depth are known from US-4,895,147 and US-5,318,584. The arrangement can also be selected such that the blade is fixed in its position while the skin contact surface is provided on the front side of a cover which is mounted to an adjustable abutment in a spring-supported manner.
The unit for adjusting the penetration depth is preferably configured such that it can be set at given levels. At least in the above given levels, the m~imllm distance between the individual levels is appr. 0.4 mm and the minimllm distance is appr. 0.2 mm, preferably û.3 mm. This range can, of course, also exceed the maximum values to allow deeper penetration, e.g. to account for the relatively small amount of subjects where the above mentioned small penetration depth does not provide a sufficient amount of blood (e.g. due to an excessively thick horn layer). For an exact adjllstnntont of the penetration depth, it is also important to have such a precise positioning of the blade in its holder that it is possible to reproduce the position of the blade end in diredion to the pricking movement relative to the blade holder when several blades are s~lcces~ively mounted to the blade holder.
43 1700.EN~
CA 0224~74 1998-08-03 Owing to the advantageous properties of the device in accordance with the invention of displacing/compressing the tissue only very little before penetration, it is possible to achieve a very good reproducibility of the cutting depth which is significantly improved(< +/- 0.1 mm) over presently available systems. Due to these very good penetration properties of the device of the invention, individual variation with respect to the skin turgor and/or skin density are now only of secondary importance. This is accomplished in that the tissue opposite the blade is not compressed upon first contact with the forwardly propelled blade; in.~te~rl, the penetration/cutting does not begin until the blade arrives on the skin.
Figure 4a shows an embodiment where the inner cover (11) is shown together with a configuration of oscillator, bar and blade which is slightly modified with respect to figure 4.
The piezo crystal (14) and the blade (13) are disposed on di~elen~ sides with respect to axis (18). By this configuration an oscillation of the blade is being accomplished in the way of a chopping-blade. This type of movement has a comparent parallel to the cutting edge as well as a component vertical thereto. An oscillation of the bar around the axis creates a movement of the blade on a part of a circle.
Figure 11 shows the interaction between the width at which the lancet projects from the cutting device and the penetration depth ofthe tissue. Figure 1 lA shows the initial position of the system where the blade ( 1 ) is completely located inside the housing (5 1 ) and the housing is pressed onto a part of the skin (50). Figure 1 lB shows a condition where the blade displaces the skin without cutting it. Deformation of the skin is identified as (D).
Figure 1 lC shows a condition where the blade has already cut open the skin. The depth (A) at which the blade projects out of the housing results in a deformation (D) and a penetration depth (E) in the tissue. Deformation (D) can be subject to great deviation within one individual and between dirrelenl individuals so that the penetration depth can also greatly vary while the projection depth is constant; a fact which is not desired. In devices according to the present invention, the d~rol,lla~ion (D) is very small due to the reasons listed above;
the deviations of (D) are, hence, also very small. With a defined projection depth (A) the penetration depth (E) into the skin can, hence, be exactly predet~rmined.
43 1 700.1~NG
CA 0224~74 1998-08-03 Easy procedures allow the user to precisely set the desired penetration depth. The adjusting range preferably covers unnsu~lly deep penetration levels between 0.5 and 2.0 mm, with a range between 0.7 mm and 1.3 mm being of particular importance. The amount of blood necess~ry for an analysis usually ranges between 1 and 50 ,ul, more frequently between 5 and 30 ~1; as the invention has shown, this amount can already be obtained for the majority of individuals at penetration levels where pain is siy,nificantly reduced, provided the penetration level can be easily reproduced at a certain, ic~ntic~l setting of the instrument.
With an idçntic~l setting of the cutting device given, the depth of the cut generated in succes.,ive cutting procedures should deviate by less than 0.15 mm, preferably 0.1 mrn and particularly pler~"ed 0.05 mm.
*** The eccentric disc-operated blood lancet Figure 5A shows a blood lancet where the bar (12) holding the blade (13) is mounted to a weight (41). The weight (41) is located inside an inner cover (23) which in turn is located moveably inside the outer cover (10). The bar (12) which is rigidly connected to the weight (41), e.g. in glued or screwed connection, runs across the weight (41). In the bar (12) there is integrated a piezo element (14) which causes the bar (12) and the blade (13) to oscillate.
An enlargement (42) surrounding the opening where the blade emerges can be advantageously provided at the contact surface (16) of the device which is pressed onto the skin. Purpose of this enlargement is to put the part of the skin to be cut open under tension and fix it in position. It has proven to be advantageous if this enlargement (4Z) projects past the contact surface (16) by 0.2 to 0.3 mrn.
Figure 5A also shows an advantageous drive unit for moving the blade into the tissue. This drive unit features an eccentric disk (25) to which a lever (26) is mounted via an axis;
another axis connects said lever in turn to the bar ( 12). Figure 5B is a rear view of the eccentric disk. On this side said disk has a toothed wheel (27) which is driven via a toothed rod (28). It is an advantage of the device shown in Figure 5 that when the user presses down the toothed rod (28) the blade is lowered into the tissue and again retracted. Since the user must execute only one single movement, the h~nllling of the device is further f~cilit~terl A spring element (29) can be provided to retract the toothed rod back into its 431700.ENG
CA 0224~74 1998-08-03 original position. When the tooth rod is pressed down, the spring element is compressed to then move the toothed rod back into its original position. It can also be advantageous to provide some idle for the toothed wheel (27) so that the eccentric disk (25) does not rotate and the blade is not lowered again into the tissue when the toothed rod is retracted into its original position.
Figure 5C shows the rod (12) with an integrated piezo element (14). The piezo element is configured such that when en electric alternating voltage is applied, it carries out changes in length along its longitl~clin~l axis. These length changes then causes the lever to be bent as is known analogously from bimetallic strips. Mechanical oscillation of the bar ( 12) can be generated by applying electrical signals having a suitable frequency.
*** The blade types Figure 6 shows three embodiments of blades which are pl ere,led in accordance with the invention. Figure 6A shows a trapezoidal blade with a straight cutting edge. Figure 6B
shows a blade as used in chopping knifes while the blade shown in Figure 6C has a pointed tip. Each of these 3 blade types can have different cross sections. Figure 7 shows two possible cross sections A and B taken along section line aa' Each of the blades shown in Figures 6A through 6C could have one these cross sections. A section line is indicated in Figures 6A to 6C to further illustrate this.
The basic shapes of the blades include trapezoids, circles, semi-circles, squares, polygons, pointed tips or chopping blade-type blades. The following taper options are possible:
- circul,lrelell~ial ground - facet ground and - ground on both sides ** The second embodiment (Mucke) The invention also encomp~cses an embodiment where the blade is made to oscillate perpendicularly to the tissue surface. In this embodiment, owing to the oscill~ting movement ~31700.ENG
CA 0224~74 1998-08-03 the microscopic movements of the blade and the movements for introducing the blade into the tissue run es.s~nti~lly parallel. In this embodiment it is also advantageous to employ pointed blades and blades with several edges. The latter type can also be achieved with facet grinding.
With this type of device there can be used pin pointed needles which preferably have a facet ground.
The "Mucke"-type device preferably uses a rigid coupling between oscillator and blade which avoids a lateral movement or oscillation of the blade and employs a vertical oscillation with respect to the tissue surface. The oscillation amplitude vertical to the skin surface is set to be smaller than 300 !lm, preferably smaller than 100 llm and particularly p~erelled smaller as 50 llm. For example mechanical oscillators, electrodynamic transformers and piezo elements can be employed as oscillators.
*** Sch~m~tic representation Figure 8 is a schematic representation showing the implementation of this secondembodiment. Bar (30) is movable disposed on a sleeve (31). A piezo crystal (32) to transfer oscillations to blade (33) is disposed on bar (30). In this embodiment, the piezo crystal is arranged such that the oscillations generate a movement of the blade (33) in longitudinal direction of the bar in accordance with the double-arrow displayed above the bar. It is of importance that the weight of the oscill~tin~ pieces (bar and blade) is small compared to the mass disposed on the other side with respect to the oscillator (which means on side of the bar). In order to carry out a tissue section, the piezo crystal (32) is first made to oscillate;
the blade is then lowered into the tissue by moving bar (30). Af'~er generating a sufficiently large cut, the bar (30) is moved in opposite direction and the blade (33) is pulled back out of the tissue. Pointed tips have proven well for this embodiment. Especially advantageous are flat blades with cross sections as shown in Figures 7A and 7B. Experiments have also shown that the oscillation frequency of the blade transverse to the tissue surface should be above 100 Hz to In;l~ i7e pain sensation during cutting. By increasing the frequency to 43 1 700.1~NG
-CA 0224~74 1998-08-03 above 500 Hz, pain sensation can be further reduced. The amplitude of the osçill~tin~
movement should for the same reason be below 100 llm, preferably below 50 llm.
The oscillation of blade (33) necessary for proper operation ofthe device is achieved with the aid of a suitable geometric arrangement of the masses which generates a so-called resonance step-up of the amplitude.
The s~h-sm~tic repres~nt~tinn of the apparatus shown in Figure 8 can be combined, for example, with the driving mech~ni~m~ for moving the blade transversely to the tissue surface as described in Figures 4 and 5.
** The manual pricking aid Figure 9 shows a particularly simple embodiment where a battery-operated electronic oscillation generator (15) is located within a housing (40). This oscillation generator (15) causes the piezo crystal (32) to oscillate. In this embodiment the blade is directly coupled to the piezo crystal. The user moves the blade (33) to the tissue to be cut open and carries out a cut at the desired depth.
43 1 700.ENG
, CA 02245574 1998-08-03 List of reference numerals (1) blade (2) cutting edge (10) outer cover (11) inner cover (1 la) connecting piece (12) bar (13) blade (14) piezo crystal (15) electronic oscillation generator (16) contact surface (17) battery (18) axis (19) weight (20) spring element (21) guide with recess (22) lever (23) guide element (24) rubber (25) eccentric disk (26) lever rod (27) toothed wheel (28) toothed rod (29) spring element (30) bar (31) sleeve (32) piezo crystal (33) blade (40) housing (41) weight (42) enlargement 43 1 700.ENG
Claims (42)
1. Device for obtaining small blood samples from human or animal tissue in an almost pain-free manner, comprising - a blade (1, 13) having a cutting edge (2) with a length of less than 10 mm, and - an oscillator which makes the blade oscillate essentially parallel to the cutting edge.
2. Device according to claim 1, having a housing in which there are disposed a blade and an oscillator and having contact surface (16) for establishing contact with a skin surface, said contact surface having an opening which is large enough for the blade and stroke of the oscillation movement.
3. Device according to claim 1 and 2 where the skin contact surface is configured such that an enlargement (42) runs around the edge of the opening which puts theskin under tension and fixes it in position.
4. Device according to claim 1, where the enlargement (42) projects beyond the contact surface by 0.2 to 0.3 mm.
5. Device according to claim 1, where the oscillation of the oscillator is coupled to the blade via a bar (12).
6. Device according to claim 5, where a piezo element (14) is integrated into the bar and changes in the length of said piezo element with respect to the longitudinalaxis of said bar are created by an alternating voltage applied to the piezo element.
7. Device according to claim 5, where bar and blade form an exchangeable mechanical unit.
8. Device according to claim 7, where bar and blade are made from the same material and form a one piece unit.
9. Device according to one of the claims 1 or 2, where the cutting edge of the blade has a length of 0.2 to 2.0 mm, preferably 0.4 to 1.5 mm, particularly preferred 0.5 to 1.0 mm.
10. Device according to one of the claims 1 or 9 where the frequency of the oscillation is above 500 Hz, preferably above 700 Hz, particularly preferred above 900 Hz.
11. Device according to one of the claims 1, 9 or 10 where the amplitude of the oscillation is below 500 µm, preferably below 300 mm, particularly preferred below 250 µm.
12. Device according to claim 2 where the blade (13) is movable perpendicular to the cutting edge (13a), so that in a first position, the cutting edge is disposed inside the housing and, in a second position, it projects beyond the contact surface (16).
13. Device according to claim 1, 2, or 12 where a propelling mechanism (25, 26) moves the blade (13) perpendicularly to the cutting edge.
14. Device according to one of the claims 1 or 2, where the blade (13) is attached to a spring-loaded element (20) and where upon releasing the spring tension, said blade is moved transversely to the cutting edge.
15. Device according to one of the claims 1 or 2 where the blade is fixed perpendicular to the tissue and the skin contact surface is provided on a sleevewhich is mounted at an adjustable spring stop, through which the maximum penetration depth of the blade into the tissue is set.
16. Device according to claim 13 or 14, where the propelling mechanism or the spring element moves the blade perpendicularly to the cutting edge at a speed of less than 2 km/h, preferably less than 0.5 km/h, particularly less than 0.2 km/l.
17. Device according to claim 2, where the length by which the blade maximally projects past the contact surface during cutting can be set and the setting covers an interval whose lower limit is greater than 200 µm and whose upper limit is smaller than 2500 µm.
18. Device according to claim 1 where the blade has one of the following basic shapes - trapezoid - circle or semi-circle - square - polygon - pointed tip - chopping knife shape
19. Device according to claim 1, where the blade has one of the following grindings:
- circumferential ground - facet ground and - ground on both sides
- circumferential ground - facet ground and - ground on both sides
20. Device according to claim 1 where the oscillator comprises a piezo crystal (14), an ultraceramics element or an electrodynamic transformer or a mechanically excitedelement as an oscillating element and said oscillating element is activated via an electronic (15, 17) or mechanical oscillation generator.
21. Device according to claim 1, where the blade is made to oscillate by a mechanical oscillator.
22. Device according to claim 1, where the blade is made from a plastic which can be processed in an injection molding process.
23. Method of cutting skin tissue for obtaining blood samples of less than 50 µl from human or animal tissue in an almost pain-free manner comprising the following steps:
- causing the blade (13, 33) having a cutting edge of less than 10 mm to oscillate essentially parallel to the cutting edge, - moving the blade toward the tissue to be cut open - moving the blade essentially perpendicularly into the tissue, and - retracting the blade from the tissue.
- causing the blade (13, 33) having a cutting edge of less than 10 mm to oscillate essentially parallel to the cutting edge, - moving the blade toward the tissue to be cut open - moving the blade essentially perpendicularly into the tissue, and - retracting the blade from the tissue.
24. Method according to claim 23, where the oscillation movement comprises a component parallel to the cutting edge as well as a component vertical thereto.
25. Method according to claim 24, where the blade moves on the segment of a circle during oscillation.
26. Method according to claim 23 where the oscillating frequency is above 200 Hz, preferably above 500 Hz, particularly preferred above 900 Hz.
27. Method according to claim 23 where forward and retracting blade movement are carried out manually.
28. Method according to claim 23 where the blade movement is carried out by a moving means (25, 26) and the speed of moving it into the tissue is less than 2 km/h, preferably less than 1 km/h, particularly preferred less than 0.5 km/h.
29. Method according to claim 23 where the blade is retracted from the tissue along a path that runs in the cutting channel.
30. Method according to claim 23 where the blade is guided in a depth under the tissue surface which is less than 2500 µm, preferably less than 1800 µm, particularly preferred less than 1200 µm.
31. Device for skin for obtaining small blood samples from human or animal tissue in an almost pain-free manner, comprising - a blade (33) with a pointed cutting edge - an oscillator (32) which makes the blade oscillate essentially parallel to the tissue surface at a frequency between 10 Hz and 10 kHz.
32. Device according to claim 31, where the blade is a needle.
33. Device according to claim 31 where the frequency of the oscillating movement is greater than 500 Hz, preferably above 700 Hz, particularly preferred above 1000 Hz, however, below 10 kHz.
34. Device according to claim 31 where the amplitude of the oscillating movement is below 300 µm, preferably below 100 µm, particularly preferred below 50 µm.
35. Device according to claim 31, having a moving means (25,26) for moving the blade essentially perpendicularly to the tissue surface and controlling said movement such that upon arriving at a defined dead point the forward movement is converted into a retracting movement.
36. Device according to claim 31, having a moving means (25, 26) for moving the blade essentially perpendicularly to the tissue surface and having a guide (10,23, 41) to control the movement of the blade into the tissue (forward movement) and the movement of the blade out of the tissue (retracting movement) thus that the path described by the blade when executing both of said movements is essentiallythe same.
37. Device according to claim 31 where the blade is mounted to a spring-loadedelement (20) and where the blade upon releasing the spring tension is moved essentially perpendicularly to the cutting edge.
38. Device according to claim 35 or 37 where the blade speed generated by the movement or the spring element is less than 1 km/h, preferably less than 0.5 km/h, particularly preferred less than 0.2 km/h.
39. Device according to claim 31, where the blade has several pointed cutting edges.
40. Method of cutting skin for obtaining small blood samples in an almost pain-free manner from human or animal tissue, comprising the following steps:
- causing a blade (33) with a pointed tip to oscillate essentially vertical to the tissue surface at an oscillating frequency of more than 10 Hz, - moving the blade toward the tissue to be cut open - lowering the blade into the tissue - retracting the blade from the tissue
- causing a blade (33) with a pointed tip to oscillate essentially vertical to the tissue surface at an oscillating frequency of more than 10 Hz, - moving the blade toward the tissue to be cut open - lowering the blade into the tissue - retracting the blade from the tissue
41. Method according to claim 40 where the blade is lowered into the tissue at a speed of less than 1 km/h, preferably less than 0.5 km/h, particularly preferred less than 0.2 km/h.
42. Method according to claim 40 where the blade is lowered below the tissue surface at a depth of less than 2500 µm, preferably less than 1800 µm, particularly preferred less than 1200 µm.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| DE19604156.2 | 1996-02-06 | ||
| DE19604156A DE19604156A1 (en) | 1996-02-06 | 1996-02-06 | Skin cutting device for taking pain-free small amounts of blood |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA2245574A1 true CA2245574A1 (en) | 1997-08-14 |
Family
ID=7784581
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA002245574A Abandoned CA2245574A1 (en) | 1996-02-06 | 1997-02-04 | Skin cutter for painless extraction of small blood amounts |
Country Status (14)
| Country | Link |
|---|---|
| US (2) | US5997561A (en) |
| EP (1) | EP0879017B1 (en) |
| JP (1) | JP2001503284A (en) |
| KR (1) | KR19990082310A (en) |
| CN (1) | CN1214623A (en) |
| AT (1) | ATE261702T1 (en) |
| AU (1) | AU1600697A (en) |
| CA (1) | CA2245574A1 (en) |
| DE (2) | DE19604156A1 (en) |
| ES (1) | ES2217387T3 (en) |
| MX (1) | MX9806339A (en) |
| TW (1) | TW347315B (en) |
| WO (1) | WO1997028741A1 (en) |
| ZA (1) | ZA97926B (en) |
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-
1996
- 1996-02-06 DE DE19604156A patent/DE19604156A1/en not_active Withdrawn
-
1997
- 1997-02-04 TW TW086101302A patent/TW347315B/en active
- 1997-02-04 JP JP52813297A patent/JP2001503284A/en active Pending
- 1997-02-04 WO PCT/EP1997/000501 patent/WO1997028741A1/en active IP Right Grant
- 1997-02-04 US US09/117,527 patent/US5997561A/en not_active Expired - Fee Related
- 1997-02-04 CN CN97193301A patent/CN1214623A/en active Pending
- 1997-02-04 AU AU16006/97A patent/AU1600697A/en not_active Abandoned
- 1997-02-04 CA CA002245574A patent/CA2245574A1/en not_active Abandoned
- 1997-02-04 AT AT97902323T patent/ATE261702T1/en not_active IP Right Cessation
- 1997-02-04 EP EP97902323A patent/EP0879017B1/en not_active Expired - Lifetime
- 1997-02-04 KR KR1019980706040A patent/KR19990082310A/en not_active Application Discontinuation
- 1997-02-04 DE DE59711425T patent/DE59711425D1/en not_active Expired - Lifetime
- 1997-02-04 ES ES97902323T patent/ES2217387T3/en not_active Expired - Lifetime
- 1997-02-05 ZA ZA97926A patent/ZA97926B/en unknown
-
1998
- 1998-08-06 MX MX9806339A patent/MX9806339A/en unknown
-
1999
- 1999-10-13 US US09/417,480 patent/US6210421B1/en not_active Expired - Fee Related
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|---|---|
| ZA97926B (en) | 1998-08-19 |
| KR19990082310A (en) | 1999-11-25 |
| MX9806339A (en) | 1998-10-31 |
| DE59711425D1 (en) | 2004-04-22 |
| EP0879017B1 (en) | 2004-03-17 |
| WO1997028741A1 (en) | 1997-08-14 |
| JP2001503284A (en) | 2001-03-13 |
| DE19604156A1 (en) | 1997-08-07 |
| AU1600697A (en) | 1997-08-28 |
| CN1214623A (en) | 1999-04-21 |
| EP0879017A1 (en) | 1998-11-25 |
| ES2217387T3 (en) | 2004-11-01 |
| US5997561A (en) | 1999-12-07 |
| TW347315B (en) | 1998-12-11 |
| ATE261702T1 (en) | 2004-04-15 |
| US6210421B1 (en) | 2001-04-03 |
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| Date | Code | Title | Description |
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| FZDE | Discontinued |