MXPA98004004A - Device for taking fluid samples corpora - Google Patents

Device for taking fluid samples corpora

Info

Publication number
MXPA98004004A
MXPA98004004A MXPA/A/1998/004004A MX9804004A MXPA98004004A MX PA98004004 A MXPA98004004 A MX PA98004004A MX 9804004 A MX9804004 A MX 9804004A MX PA98004004 A MXPA98004004 A MX PA98004004A
Authority
MX
Mexico
Prior art keywords
sleeve
ring
stimulator
skin
sampling device
Prior art date
Application number
MXPA/A/1998/004004A
Other languages
Spanish (es)
Inventor
G Duchon Brent
S Douglas Joel
N Roe Jeffrey
Radwanski Ryszard
Original Assignee
Roche Diagnostics Operations Inc
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Roche Diagnostics Operations Inc filed Critical Roche Diagnostics Operations Inc
Publication of MXPA98004004A publication Critical patent/MXPA98004004A/en

Links

Abstract

The present invention relates to samples of body fluid from an incision in the skin by placing a ring against the skin and repeatedly applying a force of elastic pressure to the ring, whereby the stimulating surface of the ring presses a ring of skin and body tissue into the ring. a relationship surrounding the incision to expel body fluid from the incision. The surface of the stimulator is inclined at an angle of 10 to 65 °, the width of the surface of the stimulator is 5 to 20 mm, and an internal diameter of the surface of the stimulator is not less than 6.0

Description

DEVICE FOR TAKING SAMPLES OF BODY FLUIDS DESCRIPTION OF THE INVENTION The present invention relates to lancet devices and methods for obtaining samples of blood and other body fluids for analysis or processing. Many medical procedures used today require a relatively small blood sample in the range of 5-50 μl. It is more economical and less painful for the patient to obtain that sample when cutting with a lancet or perforating JU 10 the skin in a desired location, such as the finger to allow the collection of 1 or 2 drops of blood, than when using a phlebotomist to extract a venous blood tube. With the advent of home-use tests such as self-monitoring of blood glucose, a procedure is required simple that can be done in any conformation by a person who needs the test. Conventionally used lancets generally have a rigid body and a sterile needle protruding from one end. The lancet can be used to pierce the skin, allowing the collection of a blood sample from the orifice created, the blood is transferred to a testing or collection device. The most common is that the blood is taken from the tips of the fingers, where the supply is generally excellent. However the density of the nerves in this region causes significant pain in many patients Taking alternate samples, such as the lobes of the ear and limbs, is sometimes practiced to reach places that are less sensitive. These sites are also prone to provide excellent blood samples and make it difficult to transfer blood directly to the test devices. Repeated perforation in limited surface areas (such as fingertips) results in callus formation. This leads to greater difficulty for? .10 draw blood and more pain. To reduce the anxiety of puncturing the skin and associated pain, many devices pushed with a spring have been developed. The following two patents are representatives of the devices that were developed in the 1580s for use with home diagnostic test products. Cornell et al. in U.S. Pat. do not. 4,503,856 * describes a lancet injector pushed with a spring. The reusable device is coupled with a disposable lancet. The lancet holder can be held in a retracted position. When the user makes contact with the releaser, a spring causes the lancet to pierce the skin at high speed and then retract. Speed is important to reduce the pain associated with perforation. 25 Levin et al. in U.S. Pat. do not. 4,517,978 describes an instrument for taking blood samples. ? T This device, which is also pushed with a spring, uses a standard disposable lancet. The design allows easy and precise placement against the tip of a finger so that the impact location can be easily determined. After the lancet pierces the skin, a spring retracts the lancet to a secure position within the device. In institutional settings, it is often desirable to collect the patient sample and then »- 10 enter it into a test device in a controlled manner. Some blood glucose monitoring systems, for example, require that the blood sample be applied to a test device that is in contact with a test instrument. In those cases, putting your finger on a patient directly to the test device causes some risk of contamination of the blood of a previous patient. With these systems, particularly in hospitals, in common "^ Cutting a sample with a lancet to a patient - in a micropipette by means of capillary action and then transfer the sample from the pipette to the test device. Haynes in U.S. Pat. do not. No. 4,920,977 discloses a blood collection assembly with a lancet and a microcollection tube. This device incorporates a lancet and a container container in a single device. The cut with lancet and collection are two separate activities, but the device is a single disposable unit suitable for ^ situation in which it is desired to collect a sample before use. Similar devices are described by Sarrine in U.S. Pat. do not. 4,360,016 and O'Brien in the U.S. Patent do not. 4,924,879. Jordan et al in U.S. Pat. do not. 4,850,973 AND NO. 4,858,607 disclose a combined device that can alternatively be used as an injection device in the form of a syringe and a lancet device with a disposable solid needle lancet ^ - ^ 10, depending on the configuration. Lange et al, in U.S. Pat. do not. 5,318,584 discloses a blood lancet device for drawing blood for diagnostic purposes. This invention uses a Rotary / slider drive system to reduce pain. The depth of drilling is easily and precisely adjusted by the user. ~ jß Suzuki et al. in U.S. Pat. do not. 5,368,047, Dombrowski in U.S. Pat. do not. 4,654,513 and Ishibashi in U.S. Pat. do not. 5,320,607 each describe blood samplers of the suction type. These devices develop the suction between the point of perforation and the end of the device when the lancet support mechanism retracts after piercing the skin. A meeting Flexible around the end of the device helps seal the end around the drilling point until the proper sample is removed from the drilling point or the user removes the device. García et al. in U.S. Pat. do not. 4,637,403 and Haber et al. in U.S. Pat. do not. 4,637,403 and Haber et al. in U.S. Pat. do not. 5,217,480 describes combined lancet and blood collection devices that use a diaphragm to create a vacuum over the site of the wound. _ Erickson et. in U.S. Pat. do not. 4 m * ± Q 5,582,184 describes means to collect and measure bodily fluids. This system uses a coaxial syringe and a capillary tube disposed within a spacer member. The separating member limits the depth of the syringe penetration, and compresses the body tissue around the syringe while the syringe is in the skin, to improve the flow of interstitial fluid to the incision. However, it will be appreciated that the incision will have to be closed against the syringe limiting any advantages that may be obtained. The single-use devices have been developed for single use tests, for example home cholesterol tests and for institutional use to eliminate cross-contamination between patients by the use of multiple patients. Cross an et al. in U.S. Pat. do not. 4,869,249 and Swierczek in U.S. Pat. do not. 5,402,798, also discloses disposable lancet devices single use only. U.S. Pat. do not. 5,421,816; 5,445,611 and 5,458,140 describe as a replacement for invasive sampling, the use of ultrasound to act as a pump to extract interstitial fluid directly through intact (undrilled) skin. However, the amount of fluid that can be obtained in this way is very limited. The above patents are mentioned for reference. w «« / l? Even with so many improvements that have been made, the pain associated with perforation is an important point for many patients. The need for blood sampling and the fear of associated pain is also a major obstacle for the millions of diabetics diagnosed, who do not monitor properly blood glucose due to associated pain. In addition, lancet drilling to obtain a blood sample for other diagnostic applications is becoming more common and less painful, minimal invasive devices are needed to improve those applications and make those more acceptable technologies. An object of the present invention, therefore, is to provide a device and method for obtaining a sample of body fluid through the skin that is virtually painless and minimally invasive. In addition, known lancet devices include manually operable buttons to trigger the mechanism W lancet driver once the user has placed the device against their skin. Because the user knows the precise moment in which the lancet will be fired, there is a tendency for the user to move or lift the device at the time of shooting, which can lead to inconsistent skin penetration or possibly lack of penetration. Therefore, another object of the invention is to provide a lancet device that eliminates such tendency on the part of the patient. iQ user. In addition, known carriers for the disposable lancets are configured to allow the disposable part to be inserted and removed only through its lower end. This requires a user to grab a portion bottom of the scrap to push it up or pull it down. Since the needle projects from a lower end of the discarded part, the user's hand will be in the immediate vicinity of the needle and thus exposed to a potential accident and / or contamination. Also the disposable part is retains in the carrier by means of a friction fit. Due to the normal manufacturing tolerances, it is difficult to ensure a sufficiently narrow fit of the disposable part; There may be a tendency to wobble, increasing the pain caused during the drilling stage. Therefore, it is another object of the invention the provide a lancet carrier that eliminates the aforementioned disadvantages ™. Another object of this invention is to provide a method that can result in a sample of blood or interstitial fluid, depending on the sampling point and the depth of penetration used. Although there are currently no commercial devices using interstitial fluid (ISF), there are active efforts to establish the correlation of analytes, such as glucose, in ISF compared to whole blood. If ISF could be easily obtained and the correlation established, ISF can preferably be as a sample since there is no interference from the adjustment of red blood cells or hematocrit required. Another object of the invention is to provide a method that can extract a small but adjustable sample, this is 3 μl for a test device and 8 μl for another device, as appropriate. The present invention relates to a sampling device for sampling blood or interstitial fluids.
The device consists of a manually graspable sleeve defining a longitudinal axis, a carrier adapted to hold the piercing means, such as a lancet or a laser for example, to produce an incision in the skin, and a ring projecting from a longitudinal forward end of the sleeve and mounted for longitudinal movement in relationship to the manga. The ring includes a front stimulator surface adapted to make contact with a surface of the skin. An elastically deforragable force transmitting element is operably placed between the sleeve and the ring to transmit a force from the sleeve to the ring in response to the forward movement of the sleeve in relation to the ring, to press the surface of the stimulator against the surface of the skin, the surface of the - ^ stimulator is set to press a shaped portion ^^ 10 of the skin and body tissue placed in a position surrounding the incision in the skin, causing the incision to swell and the side of the incision to open, thereby expelling the body fluid from the skin. incision. Alternatively, the device may omit the carrier, with which perforation would be done with a separate device. Preferably all parts of the device are in one piece and are assembled together without the aid of separate fasteners. The ring preferably constitutes an inner ring, the device further comprising an outer ring placed in a telescopic relationship around the inner ring. The outer ring projects forward from the sleeve and can move longitudinally with respect to the manga A spring elastically pushes the outer ring towards ahead. The outer ring is movable longitudinally in * relation to the sleeve and the inner ring. The invention also relates to a device having a stimulating surface inclined in relation to a plane oriented perpendicular to the axis. The tilt is radially inward and longitudinally backward. The inclination in relation to the plane is from 10 to 65 degrees. The width of the surface of the stimulator is preferably approximately 5 to 20 mm. An inner diameter of the stimulator surface is preferably not less than about 6.0 mm. BRIEF DESCRIPTION OF THE DRAWINGS The objects and advantages of the invention will be apparent from the following detailed description of a preferred embodiment thereof in relation to the accompanying drawings in which similar numbers refer to similar elements and in which: Figure 1 is a side elevational view of a sampling device according to the present invention; Figure 2 is a longitudinal sectional view through a tip assembly according to the invention; with a disposable part mounted on it; Figure 3 is a front perspective view of a frame component of a sampling device; Figure 4 is a longitudinal sectional view taken through the frame shown in Figure 3; Figures 5, 6 and 7 are views exploded in perspective of the tip assembly; Figure 8 is a rear perspective view of an outer ring component of the tip assembly; Figure 9 is an exploded view in perspective of a hammer assembly of the sample taker according to the invention; Figure 10 is an exploded perspective view of the hammer assembly and the frame of Figure 3; Figure 11 is an exploded view in perspective of the frame and sleeve components of the sample taker; Figure 12 is an exploded view in perspective of the entire sample taker; and Figures 13A-13I are longitudinal sectional views taken through the sample taker showing a sequence of operation thereof. A minimum invasive sampling device 10 shown in the figures (for example see Figures 1 and 13A) includes a tubular sleeve 12 in which a tubular frame 14 is telescopically placed.1 Sleeve 12 and frame 14 define a common longitudinal axis A, the frame 14 includes an open front end adapted to receive a detectable lancet tip assembly 16 (see also FIG. figure 2) serving to carry the disposable lancet member r 15 (hereinafter called "disposable") and to stimulate the skin piercing point, as will be explained below. Also mounted on the frame 14 is a hammer 18 for moving the disposable part forward in the direction of piercing the skin, a manual handle 20 for retracting the hammer back and forth to a cocked position (this is pushed forward). , and a plurality ^ fr 10 of springs to achieve proper movement of the parts described above. The tip assembly 16 includes an inner ring 22, an outer ring 24, an adapter 26, an outer ring spring 28, a carrier 30, and a carrier spring 32.
The inner ring 22 includes a generally hollow cylindrical body having a wing projecting radially outwards 34 near its front end, and a pair of mounting legs projecting rearward 36 at its rear end. Each leg 36 includes a level rear surface 38 inclined obliquely in relation to the axis A, each surface 38 forms a hook having a forward pointing shoulder 40. A forward pointing front surface 42 of the inner ring is inclined obliquely in axis relation for reasons that are going away to explain in more detail below.
The outer ring 24 consists of a body * generally hollow cylindrical including circumferentially spaced recesses 46 at its outer periphery to allow a user to more easily take up the tip assembly 16 as will be explained. An inner surface of the outer ring 24 includes axial channels 47 (Figure 8) for reasons to be discussed. A forward facing front surface 48 of the outer ring 24 is oriented obliquely in relation to the axis A as will be described later. The fin The projecting radially inward 50 is disposed in the outer ring 24 at a point spaced behind the bottom surface 48. The inner ring 22 is adapted to fit coaxially within the outer ring 24, the ring spring 15 being outer 28 inserted into the fin 50. The carrier 30 is adapted to fit inside the ring 22, the carrier spring 32 being seated in an internal shoulder pointing rearwardly 52 of the inner ring. A radially outer fin 54 positioned on the rear end 20 of the carrier 30 rests on a rear end of the carrier spring. The inner surface of the carrier 20 has a reduced diameter at its lower end to form a seat 56 on which the disposable part 15 rests afterwards. to be inserted forward through the top end of the carrier The disposable 15 may have any desirable configuration, but preferably consists of a one-piece plastic body molded around a metal lancet 53. The body has a generally X-shaped cross section formed by four ribs 55 which is thinned in the direction in which the front ends of the ribs 55 rest on the seat 56 of the carrier 30. The body also includes an integrally molded cap 57 (see FIG. 13C) that can be twisted and broken to expose the lancet 53 after the disposable has been installed in the tip assembly 16 (Figure 13D). The adapter 26 includes a cylindrical divided skirt 60 that fits telescopically inside the outer ring. The skirt 60 includes axial ribs 62 that fit into the channels 47 of the outer ring 24 to lock the outer ring and the adapter together to rotate in common. At its upper end the adapter 26 includes a shoulder pointing rearwardly, projecting radially inwardly 64 (see FIG. 13B) that supports the shoulder 40 of the legs 36 of the inner ring 22 when the adapter 26 is pressed into those legs. At the rear end of the adapter is the outwardly projecting fin structure that includes a pair of diametrically opposed shoulders, which point towards W forward 70 (a shoulder 7Q is shown in Figure 7) that is inclined obliquely with respect to the axis A.
Preferably, the shoulders 70 extend along a generally elliptical path »Located circumferentially between shoulders 7Q are a pair of radially outwardly pointing struts 72 (a shoulder 72 is shown in Figure 7) that are also inclined obliquely with respect to the K axis, ^ 10 for example extending along an elliptical trajectory that is axially displaced with respect to the trajectory of the shoulders 70. Thus diametrically opposed axial spaces 74 are formed between the shoulders 70, 72) a space 74 is shown in Figure 7), to allow the adapter is attached to frame 14, as will be explained. The frame 14 has a generally tubular hollow shape and includes a front portion 8Q having a larger diameter than a back portion 82 (see Figures 3 and 4). The rear end of the front portion includes a pair of handles 84 * see figure 4). After the adapter 26 has been inserted into the lower position 80 of the frame 14 with the handles located behind the shoulder pointing to the rear 72 of the adapter (as shown in shaded lines in FIG. 7), the rotation of the adapter in FIG. an address in the clockwise in figure 12 will provoke that the forward pointing shoulders 7Q of the adapters engage in the upper portions of the respective handles 84 to cause the adapter 26 and the frame 14 to converge axially and lock together, made by means of a shaped coupling. threaded The frame 14 further includes a spring finger 90 having a shoulder pointing haca forward 92 (Figure 4) to engage a shoulder pointing back 94 located on an inner surface of the sleeve 12 (Figure 13a) to ^ 10 retain the frame 14 within the sleeve 12. In addition the frame 14 includes a clasp handle 96 spaced radially outwardly with respect to a rear section of the rear portion 92 of the frame 14, as can be seen in figure 13. The clasp handle 96 is slidable within a notch of longitudinal bracket 98 formed on an inner surface of the sleeve 12, and is arranged to retain the hammer 18 in a cocked state »The hammer 18 is slidably mounted within the frame 14 and includes a front recessed surface 10Q and a pair of rear mounting arms 102 having hooks configured to lock in a snap fit to a retention 1Q4 that is slidably mounted in the frame (see Figures 9 and 13A). The hammer 18 further includes a 1Q6 clasp member having a shoulder pointing towards forward 1Q8 placed to hook the hook handle of the frame 14 when the hammer is hammered. The member of ^^ bracket 1Q6 is slidable within bracket notch 98 to prevent rotation of the hammer. Extending forward through the opening back 110 formed on the rear end of the frame 14 there is a button 11q tab 20, the tab 111 includes a pair of spring legs 112"The front ends of the spring legs 112 form hooks 114 are ^ placed to attach a front end of a collar 120 that ^^ 10 is disposed on the outer periphery of the hammer 18 »A button spring 122 acts between the retainer 1Q4 and the collar 120, and a hammer spring 124 acts between the rear part of the frame 14 and the retainer 104. A spring of sleeve 126 acts between a forward pointing shoulder 15 128 of sleeve 12 and a rearwardly pointing shoulder 13Q of frame 14 »A retaining member 132 (figures 12, 13A) is pressed into frame 134 of frame 14, the member retained 132 includes a central opening beveled back 136 to 20 prevent the disposable portion 15 to move back (see figure 13C) in the event that the sampler 10 is maintained with s front end directed upward, Assembly of Sampler To assemble the apparatus described above, the parts 25 of the tip assembly 16 are first assembled together to the insert the inner ring 22 into the outer ring 24 and place the spring of the outer ring 28 in the spring ring 22. Then the carrier spring 32 is placed in the inner ring 22 and the adapter 26 of the carrier 30 is placed 5 under pressure in the legs 36 of the inner ring »The main body is assembled by sliding the collar 12Q on the hammer 18 and inserting the button spring 122 on the hammer» The retainer 1Q4 is then pressed into the mounting brackets 102 of the hammer 18 for ^ * " '10 capture between them the button spring 122, spring hammer 124 is then inserted into the retenedar 104, the sub-assembly resulting spring 105 is then inserted into the frame 14 (see figure 10) with the member of bracket 1Q6 aligned with bracket notch 98 »Spring of the sleeve 126 and the sleeve 12 are then placed on the frame and the button 2Q is inserted through the rear opening 11Q of the frame in such a way that its spring legs 112 travel through the detent 104 the button spring 122 and are trapped in the blank 120 »2Q The retaining member 132 is inserted in the recess 134 formed in the frame 14, and the tip assembly 16 is installed in the rear of the frame until the flap handles 84 of the frame engage the adapter shoulders 72 lock the 84 handles and end the tip assembly inside the frame.
Use of the sample taker i. In order to use the apparatus the tip assembly 16 is removed by rotating the outer ring 24 and the adapter 26 counterclockwise in Figure 7, 5 and a disposable part 15 is inserted forward through the rear part of the carrier 30 »Then, the tip assembly is reinstalled (Figures 13C), and the lid 57 of the disposable is manually twisted and broken (Figure 13D) to expose the lancet 53. The button 20 is then pulled towards back to make the hammer 18 pulled back (figure 13D) »The bracket member 1Q6 of the hammer travels upward beyond the clasp handle 96» When this happens, the button spring 122 and the hammer spring 124 they are compressed Then releasing the button 20, the button spring 122 pulls the batten 20 forward, and the hammer spring 124 pushes the hammer forward until the shoulder 108 of the clasp member embeds the gripper handle 96 (Fig. 13E) » The ahara hammer is in a cocked portion » The front surface 48 of the outer ring 24 is now placed against the skin of the wearer S, and the wearer, by taking the sleeve 12 pushes the sleeve 12 towards the skin of the wearer S, consequently the outer ring 24 travels backward relative to the inner ring 22, causing the spring of the ring 28 is compressed, This will play until the surface 2Q front 42 of the inner ring 22 makes contact with the ^ L skin surface S (figure 13F). The additional downward force in the sleeve 12 causes the sleeve 12 to travel forward in relation to the frame 14, when the crimping member 106 is engaged and moved inward by means of a 15Q portion of the inner surface of the sleeve 12, with which the bracket member 106 is released from the clasp handle 96, This allows the previously compressed hammer spring 124 to move the hammer 1Q forward against the ^ * - 1Q rear end of the disposable part 15 (Figure 13G), with which the disposable part, together with the carrier 3Q, move forward, causing the spring of the carrier 32 to be compressed, as the disposable part 15 travels forward, the lancet 53 pierces the surface of the skin and forms an incision I therein, after which the spring of the carrier 32 immediately retracts the carrier 3Q and the disposable part 15 (FIG. 13H), The forward force that is applied to the sleeve 12 is transmitted to the inner ring 22 through the sleeve spring compressed 126, the frame 14, and the adapter 26 »The front surface 42 of the inner ring 22 thus presses a ring-shaped portion of the skin and the body tissue surrounding the incision I, causes the incision to be inflate by separating the parts of the incision. So the Fatal fluid as blood to interstitial fluid is trapped by the tissue body and skin and is pressurized in such a way that it travels towards ^ w up through the open end of the incision. That is, the surrounding ring of skin and depressed tissue restricts the flow of fluid out of the incision, 5 When the forward force of sleeve 12 is stopped (Figure 131) the sleeve is retracted by means of the sleeve spring 126, causing the force applied by the inner ring 22 to be released penetrates the skin »In accordance with this, the sides of incision I close, the fresh fluid (previously blocked by the oppressed skin and body tissue) flow into the incision to replace the fluid that has been expelled from the incision »As a force is reapplied forward to the sleeve and thus the inner ring (see Figure 13H ), the action described above is repeated, and more fluid is pushed up through the incision »Eventually, this pumping action results in the formation of a drop B with a suitable dimension of the body fluid capable of serving as a sample» Although the front face of the inner ring 22 is describes a generally annular shape, it could have another configuration such as oval or polygonal, whereby the oppressed body weaving ring would have a similar configuration, Certain optimum dimensional characteristics of the frontal surface, this is the surface of the stimulator 42, of the inner ring 22, to maximize the flow of recoverable fluid. In this regard, the angle of inclination a of the face 42 with respect to a plane P extending perpendicular to the axis A should be from about 1- to 65 °, more preferably 25 to 65 ° (see figure 13F), a width of the face 42 (this is the outer diameter of the inner ring minus its inner diameter) should be approximately 5 mm approximately 20 mm. The inner diameter of the surface 42 should be less than about 6 »Q mm, and not more than about 12.Q mm, By tilting the surface of the stimulator 42 within the range of angles given, it has been ensured that a sufficient increase of body fluid displaced by the surface will flow towards the incision, By making the inner diameter is not less than 6, QQ mm, the surface 42 will not tend to make contact and smear the drop of blood B of the appropriate sample size (this is 3 microliters.) »By applying the" pumping "force forward of the sleeve 12 to the inner sleeve through the middle of an elastic force transmission member, this the sleeve spring 126, the force is applied during a Waiting period during forward movement of sleeve 12 in relation to frame 14, This allows more blood or interstitial fluid to be confined around incision I to be pushed forward »Except for needle 53 and the springs 28, 32, 122, 124 and 126, the parts of the sampling device 10 are formed , preferably of plastic. All plastic parts have ^ a one-piece structure (this is to avoid sticking the segments forming a part), Also all the plastic parts are joined together in the absence of fasteners separate, for example half pair of snap coupling or by means of threaded coupling (this is in the case of attachment of adapter 26 to frame 14) »This greatly simplifies the construction of the sample-taking device and reduces its cost of manufacture »^. It will be appreciated that the device 10 provides for automatic firing of the hammer in response to the pressure of the device against the skin. This eliminates any tendency of the user to deflect the device upward at the time of the shot because the user is not aware of the shot, and ensures that penetrations will be obtained with a constant depth from one operation to the other. The ability to load and unload a discarded part in the tip assembly 16 by means of an upper end thereof means that the user can keep his hands away from the lancet. This protects against accidental injuries, arguably half of a lancet. contaminated »Fixation at four points of the waste part within the carrier, defined by the four projections 55 of the disposable part, creates a stable, motion-free assembly of the disposable part 25 within the carrier» Thus the disposable part does not tend to move laterally during a procedure of * perforation, reducing the amount of dollar that will be experienced by the user »The ability of the device to pump fluids Such bodily such as blood to interstitial fluid to the surface of the skin allows the device to be used to pierce the skin in areas in which the body is less susceptible to feeling damage, such as the breaststroke. has been described In relation to its preferred embodiment, those skilled in the art will appreciate that additions, modifications, substitutions and aminations may be made that have not been specifically described without departing from the spirit and scope of the invention as defined in the appended claims.

Claims (6)

  1. CLAIMS * 1.- A sampling device for sampling interstitial tissue bleeding, consisting of »a manual grip sleeve defining a longitudinal axis; a carrier adapted to hold a perforating half of the skin to produce an incision in the skin; a ring projecting from a longitudinal front end of the sleeve and mounted with long-term movement "10 in relation to the sleeve the ring includes a front stimulator surface adapted to make contact with the surface of the skin; and an elastically defarmable force transmitting element disposed between the sleeve and the ring to transmit 15 a force from the sleeve to the ring in response to forward movement of the sleeve in relation to the ring, to press the stimulator surface against the surface of the skin, the surface of the stimulator is configured to press an annular portion of the skin and the body tissue 2Q placed in a surrounding relationship to an incision in the skin, causing the incision to swell and the sides of the incision to open, thereby expelling the fluid from the incision. 2 - The sample taking device according to claim 1, wherein the ring constitutes a ring 25 inside, the device also includes an outer ring placed in a telescopic relationship around the inner ring, the outer ring projects forward from the sleeve and can move longitudinally relative to the sleeve, and a spring that elastically pushes the outer ring downward, the outer ring can move longitudinally in relation to the sleeve; and a spring that resiliently pushes the outer ring outward, the outer ring moves longitudinally relative to the sleeve, and the inner ring, 3, - The sampling device according to claim 2, which further includes a mounted frame in the sleeve for its movement length in relation thereto, a trigger mounted on a frame for its longitudinal movement, the frame and the trigger together define a bracket structure to releasably lock the trigger in a hammered state pushed with the spring, the bracket structure can be released in response to backward movement of the frame relative to the sleeve, 4, - Sampling device according to claim 3, further including an adapter connected to the ring by means of a snap coupling, and connected to the frame by means of a bayonet coupling, 5. The sampling device according to the claim 1 in which the surface of the stimulator is inclined in relation to the plane oriented perpendicular to the axis, the inclination is radially inward and longitudinally backward, the inclination in relation to the plane is 10 to 65 degrees. 6. The sampling device according to claim 5, wherein the width of the stimulator surface is from about 5 mm to 20 mm. The sampling device according to claim 6, wherein the inside diameter of the
  2. The surface of the stimulator is not more than about 6.0 mm, 8"- The sampling device according to claim 7 in which the inner diameter is not greater than about 12.0 mm. 15 - The sampling device according to claim 1, wherein the width of the stimulating surface is from about 5 to 20. The sampling device according to claim 9 wherein the diameter inside of the
  3. The stimulator surface is approximately 6.0 to 12.Q mm 11 »- The sample-taking device according to claim 1, wherein the inner diameter of the stimulator surface is not less than about 6, Q mm» 25 12, - The sampling device according to the claim 11 in which the inner diameter is not * greater than about 12.0mm, 13. The sampling device according to claim 1, further comprising a frame mounted on the sleeve and movable longitudinally in relation to the sleeve; an adapter attached to the frame and carrying the ring and the carrier; a necklace placed in the frame; a retainer arranged in the frame in a separate backward relationship of the collar; a coil spring placed so 10 operable between the retainer and the collar; a hammer that has % an extreme butt joined to retain; a hammer spring positioned to push forward the hammer towards the carrier; a hammer button on the hand hammer that has a rear hand grip that projects from 15 the frame and sleeve and a front end attached to the collar; the frame forms a stop to releasably lock the hammer in a cocked state. 14. The sample-taking device according to claim 13, wherein the ring and the adapter form 2Q a first independent coupling of a separate retain; the adapter and the hastidor form a second independent coupling of a separate retainer; the hastidor and the sleeve form a third independent coupling of a separate retainer; the hammer and the retainer make a quarter 25 independent coupling of a separate retainer; and the hoton of coarse and silent form a fifth coupling * independent of the separate retainer »15. The sampling device according to claim 14 in which each of the first, third, fourth and fifth coupling 5 in a snap coupling» 16.- The sampling device according to the rei indication 1, in combination with a lancet mounted on the carrier; a support mounted on the sleeve behind the 10 carrier to prevent backward movement of the lancet »17.- The sampling device for samples of blood or interstitial fluid, consisting of a manual grip sleeve that defines an axis 15 longitudinal; and a ring projecting from an extreme longitudinal front of the sleeve and mounted with long-end movement in relation to the sleeve, the ring includes a front stimulator surface adapted to contact the 20 surface of the skin, in which the surface of the stimulator is inclined in relation to a plane perpendicular to the axis, the inclination is radially inward and longitudinally backward, the inclination in relation to the plane is 10 to 165 °, a width of the stimulator surface is 25 approximately 5 to 20 mm; an inside diameter of the
  4. Stimulator surface is not less than about 6.Q * 18, - A sampling device according to claim 17 further including a carrier adapted to hold the skin piercing means to produce an incision in the skin, 19 - A sampling device for taking samples of blood or interstitial fluid, which consists of: a manual grip sleeve that defines an axis 10 longitudinal; a ring projecting from a longitudinal front end of the sleeve and mounted with long-end movement in relation to the sleeve the ring includes a front stimulator surface adapted to make contact with the sleeve. 15 surface of the skin; and an elastically deformable force transmitting element disposed between the sleeve and the ring to transmit a force from the sleeve to the ring in response to forward movement of the sleeve in relation to the ring, for
  5. By pressing the stimulating surface against the surface of the skin, the surface of the stimulator is configured to press an annular portion of the skin and the body tissue placed in a surrounding relationship to an incision in the skin, causing the incision to swell and the sides of the incision 25 are opened, with which the liquid is expelled from the incision. ai 2Q, - Sampling device according to claim 19 in which the stimulating surface is inclined in relation to a plane oriented perpendicular to the axis, the inclinations radially inward and 5 longitudinally rearward, the inclination in relation to the plane is from 10 to 65 degrees, 21. The sampler device according to claim 19 wherein the width of the stimulator surface is from about 5 to 2Q mm, 10 22"- The sampler device according to Claim 19 in which the inner diameter of the surface of the stimulator is not less than about 6 »Q mm» 23.- The sampling device in accordance with 15 claim 19 in which the surface of the stimulator is inclined in relation to a plane oriented perpendicular to the axis, the inclination is radially inward and longitudinally backward, the inclination relative to the plane is 10 to 65 °, a width of the surface of the 20 stimulator is about 5 to 20 mm, an inner diameter of the stimulator surface is na greater than about
  6. 6.0 mm »
MXPA/A/1998/004004A 1997-11-21 1998-05-20 Device for taking fluid samples corpora MXPA98004004A (en)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US08975978 1997-11-21

Publications (1)

Publication Number Publication Date
MXPA98004004A true MXPA98004004A (en) 1999-06-01

Family

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