JP4048219B2 - Body fluid sampling device - Google Patents

Description

  BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a lancing device and relates to a method for collecting blood and other bodily fluid samples from the body for analysis or processing.

  Many medical procedures used today require relatively small blood samples in the 5-50 microliter range. Compared to using a phlebotomist to collect venous blood, this is done by incising or puncturing the skin at a selected location such as a finger so that one or two drops of blood can be collected. Obtaining such a sample is more cost effective for the patient and requires less trauma. With the advent of home testing such as self-management of blood glucose levels, there is a demand for a simple method that can be arbitrarily set by a person who needs the test.

  Usually, the lancet used has a rigid body and a sterile needle protruding from one end. This lancet is used to puncture the skin and can collect a blood sample from the resulting opening. The collected blood is transferred to a test device or a collection device. In general, blood is often collected from a fingertip, and the fingertip is an excellent source of blood. However, fingertips are very painful for many patients due to the concentration of nerves. Sampling at other locations, such as the earlobe and limbs, is sometimes performed because it allows access to insensitive locations. However, these positions make it difficult to provide an excellent blood sample and make it difficult to send blood directly to the test apparatus.

  Repeated incisions in a limited surface area (such as the tip of a finger) will result in a hard skin. This makes it more difficult to collect blood and increases pain.

  Many spring loaded devices have been developed to relieve the anxiety of puncturing the skin and the associated pain. The next two patents are representative of such devices and were developed in the 1980s for use with home diagnostic test products.

  Cornell et al U.S. Pat. No. 4,503,856 describes a spring loaded lancet syringe. A reusable device is connected to the disposable lancet. The lancet holder is locked in the retracted position. When the user touches the release, the spring inserts the lancet through the skin at high speed and then retracts. This speed is important to reduce the pain associated with puncture.

  US Pat. No. 4,517,978 to Levin et al. Describes a blood sampling device. This device is also spring loaded and uses a standard disposable lancet. This device design allows easy and accurate positioning at the tip of the finger, so that the impact location can be easily determined. After the lancet is inserted through the skin, the lancet is retracted to a safe position in the device by a rebound return spring.

  In the institutional context, it is often desirable to collect a sample from a patient and then introduce the sample into the test device in a controlled manner. Some blood glucose management systems require, for example, adding a blood sample to a test device that is in contact with the test equipment. In such a situation, bringing the patient's finger directly to the test device has some risk of contamination by the blood of the previous patient. In such a system, particularly in a hospital environment, the patient's skin is incised, a sample is collected in a micropipette by capillary action, and then the sample is sent from the pipette to a test device.

  Haynes US Pat. No. 4,920,077 describes a blood collection device having a lancet and a micro collection tube. This device incorporates a lancet and a collection vessel in a single device. Although incision and collection are two separate actions, the device is a regular single-use unit, although sample collection prior to use is desirable. Similar devices are described in Sarrine US Pat. No. 4360016 and O'Brien US Pat. No. 4,924,879.

  Jordan et al., U.S. Pat. Nos. 4,849,873 and 4,858,607 disclose combination devices that can be selectively used, depending on configuration, as a syringe-type injector and as a cutting device using a disposable solid needle lancet. ing.

  Lange et al U.S. Pat. No. 5,318,584 describes a blood lancet device for collecting blood for diagnostic purposes. The present invention uses a rotary sliding transmission system to reduce incision pain. The puncture depth can be easily and precisely adjusted by the user.

  U.S. Pat. No. 5,368,447 to Suzuki et al., U.S. Pat. No. 4,654,513 to Dombrowski, and U.S. Pat. No. 5,320,607 to Ishibashi et al. Each describe an aspiration blood sampling device. These devices generate suction between the incision position and the end of the device when the lancet holding mechanism is retracted after being inserted into the skin. A flexible gasket around the end of the device helps seal the end around the puncture location until sufficient sample is aspirated from the puncture location, i.e., the user pulls the sample into the device.

  U.S. Pat. No. 4,637,403 to Garcia et al. And U.S. Pat. No. 5,217,480 to Haber et al. Disclose a combination of a lancing device using a diaphragm and a blood collection device to generate a negative pressure over the lesion location. .

  US Pat. No. 5,582,184 to Erickson et al. Describes a means for collecting and measuring bodily fluids. This system uses coaxial injection capillaries disposed within the spacer member. The spacer member limits the depth of injection penetration and compresses body tissue around the injection tube while the injection tube is in the skin to improve the flow of intervening fluid to the incision. However, the incision tends to close the injection tube, limiting the benefits of wrinkles achieved.

  Single use devices have also been developed for single use testing, i.e. for home cholesterol measurement and for institutional applications to eliminate contamination from use in large numbers of patients. US Pat. No. 4,869,249 to Crossman et al. And US Pat. No. 5,402,798 to Swierczek also disclose disposable single use lancing devices.

  U.S. Pat. Nos. 5,418,816, 5,456,611, and 5,458,140 are super pumps that act like a pump to sample intervening fluid directly from the complete skin (uncut skin) instead of taking samples that penetrate the body. Disclose the use of sound waves. However, the amount of fluid obtained by this method is very limited.

The inventions disclosed in the aforementioned patents are incorporated herein.
Even with many of these already developed devices, dissection-related distress remains significant distress for many patients. Although blood sampling is necessary, the associated painful fear is a major obstacle for the millions of diabetics diagnosed, who are well controlled for blood sugar levels due to the pain associated with the study I can't. In addition, it is normal to make an incision to obtain a blood sample for other diagnoses, to suit these applications and make these techniques more acceptable, there is less pain, A device with minimal penetration is desired.

  Accordingly, it is an object of the present invention to provide an apparatus and method for obtaining a sample of bodily fluid that is practically painless and has minimal penetration.

  In addition, known lancing devices have a manual button for the user to place the device on their skin and trigger the lancet drive mechanism. Because the user knows the exact moment to trigger the lancet, at the moment of the trigger, the user will tend to pull or raise the device suddenly and the penetration into the skin will not match or penetrate There is a fear of not. Accordingly, another object of the present invention is to obtain a lancing device that eliminates such a tendency on the user side.

  Furthermore, known carriers that support disposable lancets are configured to be inserted and removed only from the lower end of the disposable member. Therefore, in order to push the disposable member upward or pull downward, the user needs to grasp the lower part of the disposable member. Since the needle protrudes from the lower end of the disposable member, the user's hand is in close proximity to the needle and thus faces potential injury and / or contamination. Also, the disposable member is typically held in the carrier by friction fit. With normal manufacturing tolerances, it is difficult to fit the disposable member tightly enough. As such, disposable members tend to wobble, and this increases the suffering experienced during the incision process.

Accordingly, another object of the present invention is to obtain a lancet carrier in which the above-mentioned drawbacks are eliminated.
An additional object of the present invention is to secure the lancing device by preventing the lancet drive mechanism from being ready for firing until the disposable member has been inserted.

Another object of the present invention is to provide a method for obtaining a blood or intervening fluid sample according to the sample location and the penetration depth utilized. Currently, there are no commercially available devices that utilize intervening fluids (ISFs), and active efforts are being made to establish interrelationships of analytical values such as blood glucose levels within ISF compared to whole blood. If the ISF can be easily obtained and the correlation established, the ISF is suitable as a sample because there is no interference with red blood cells, ie, the necessary hematocrit adjustment.
Another object of the present invention is a method by which a small amount of an adjustable sample, i.e., an appropriate value, such as 3 microliters in one test device and 8 microliters in the other test device can be taken. To get.

  Another object of the present invention is to obtain a method that can collect a sample collected and easily provide it to a test apparatus regardless of the position of the sample on the body. This method helps control infection control because many patients do not contact a single test device and only a sampling device with a disposable patient contact is contacted with the test device. Alternatively, the disposable part of the test device may be physically coupled to the sampling device so that the sample can be brought directly to the test device during sampling. If so, the test device may be read in the test instrument, or the test system can be integrated into the sampling device and the test device can provide a direct result displayed for the patient.

  Still another object of the present invention is to provide a reusable sampling device and a device for sampling with a minimum penetration depth, comprising a disposable lancet and a sample collection device.

  One aspect of the invention is an incision device for incising the skin to collect blood or intervening fluid. The device comprises a housing. A lancet carrier is mounted adjacent to the front end of the housing to move longitudinally relative to the housing. In order to push the lancet carrier forward to incise the skin, a hammer mechanism is provided which can be prepared to be fired by a spring. A latch is provided to hold the hammer mechanism in a release ready position so that it can be released. The latch release mechanism includes a skin contact portion that moves backward in response to being pressed against the skin, and a latch release portion that releases the latch in response to the backward movement of the skin contact portion. Yeah.

  In another aspect of the present invention, a safety mechanism is provided, which is normally placed in a safe position that prevents the hammer mechanism from being ready for launch, and also allows the hammer mechanism to be ready for launch. Therefore, the safety mechanism can be moved to the non-safe position in response to the installation of the lancet carrier in the housing.

  In another aspect of the invention, a disposable lancet includes a body that houses a skin incision member and a capillary tube. After incising the skin, a pusher member for pressing the capillary tube forward relative to the main body is provided in order to suck fluid from the incised skin.

  Yet another aspect of the present invention relates to the combination of a disposable lancet and its carrier. The carrier includes a sleeve adapted to be mounted within the housing. The sleeve has an inner surface that forms a through passage extending from the upper end to the lower end of the sleeve. A disposable lancet is seated in the through-passage. The inner surface is shaped so that the disposable lancet can be inserted and removed only through the upper end. At least one upwardly facing shoulder is provided on the inner surface, and a disposable lancet is supported on the shoulder. The present invention also relates to the lancet carrier itself.

  Another aspect of the invention relates to a sampling device for sampling bodily fluids. The sampling device comprises a housing defining a longitudinal axis and an incision forming means for forming an incision through the surface of the skin. Attach a stimulating member to the front end of the housing and point it towards the incision to form a drop of bodily fluid at the open end of the incision and surround the skin against the skin to press the body fluid outward through the incision In order to sink the annular body tissue, the stimulation member can be allowed to sink into the skin.

  A pusher member is provided for moving the capillary forward relative to the carrier to aspirate body fluid.

  A method aspect of the present invention includes abutting the front end of the housing against the surface of the skin of the user's body and forming an incision through the surface of the skin. Press the housing against the surface of the skin, repeatedly sink the annular body tissue in a relationship that surrounds the incision, push the body fluid outward through the incision, toward the incision, and at the open end of the incision Form drops of bodily fluids. The capillary is projected forward relative to the carrier, and the tip of the capillary is inserted into a drop of body fluid.

  The objects and advantages of the present invention will become apparent from the following detailed description of the preferred embodiment, taken in conjunction with the accompanying drawings, in which like parts are designated with like numerals.

  The minimal penetrating sampling device 10 shown in FIG. 1 has a tubular housing 12 formed from two half shells 12A, 12B (see FIGS. 9 and 10) attached to each other. The housing 12 defines a longitudinal axis A and a lower open end 14 that can accommodate a removable lancet carrier unit 16. This carrier unit serves to support a disposable lancet member 150 (hereinafter referred to as “disposable member”), and serves to stimulate the skin puncture position, as will be described next.

  In addition, a hammer 18 for moving the disposable member downward in the direction of insertion into the skin, a manual handle 20 for raising the hammer to a firing preparation position (ie, a position pressed downward), and this on the skin surface The interposer 22 for automatically releasing the hammer in response to manually pressing the device, the manual pusher 24 for pressing the blood-containing capillary downward, and the above-mentioned pieces are properly installed and moved A plurality of springs are attached in the housing 12 (see FIG. 3A).

  The interposer 22 shown in FIGS. 3 and 12 is movable in the longitudinal direction within the housing 12, and has a lower cylindrical portion 30 and an upper cylindrical portion 32. The diameter of the lower cylindrical portion is larger than the diameter of the upper cylindrical portion. A small shoulder 34 is thus formed which faces upwards. A pair of diametrically opposed slits 36 are formed in the lower cylindrical portion 30 to allow the carrier unit 16 to slide upwardly into the housing 12.

  A slot 40 is formed in the upper cylindrical portion 32, and three guide ribs 42 (see FIG. 10) parallel to the longitudinal direction and integrally formed on the inner surface of the half shell 12B of the housing are projected from the slot 40. The central rib 42 is much shorter than the other two ribs 42, resulting in a space in which the end of the capillary can be fitted, as will be described below. Another slot 44 is separated from the slot 40 by 90 degrees, a trigger projection 46 is formed on the wall of the slot 44, and an inclined upper cam surface 47 is provided on the trigger projection 46, as will be described below. The upper cam surface 47 causes the hammer 18 to be released from the firing preparation position.

  A coil compression spring 45 is disposed between the shoulder 47 formed on the pusher 24 and the upper end of the interposer 22, and presses the interposer 22 downward.

  The manual pusher 24 shown in FIG. 5 is movable in the vertical direction, and a knob 52 is provided on the semi-cylindrical portion 50 of the pusher so as to protrude radially outward from its upper end. The knob 52 is dimensioned so that the knob 52 can slide along a longitudinal slot 53 formed in the housing 12. A lock rib 56 protruding radially inward from the lower end of the inner surface 54 of the semi-cylindrical portion 50 is provided, and an operating rib 58 is further provided. Through the slot 40 formed in the interposer 22, the lock rib 56 and the actuating rib 58 are protruded radially inward.

  As shown in FIGS. 4 and 11, the operation rib 58 extends downward between the guide ribs 42 of the housing 12.

  The hammer 18 shown in FIGS. 7 and 8 can move longitudinally within the housing 12 and includes a top wall 70 having an upper opening 72 so that the handle 20 can be mounted therein. The upper portion 74 of the hammer 18 houses a coil compression spring 76 (see FIG. 3A). As will be described below, this compression spring acts as a return spring that acts between the hammer and the handle 20. The lower portion of the hammer 18 includes a latch arm 82 and a pair of parallel longitudinal impact legs 80 straddling the guide rib 42 of the housing 12. The latch arm 82 is separated from one of the legs 80, and the lock rib 56 is accommodated therebetween (see FIGS. 3A and 4). A finger piece 84 directed radially outward is provided at the lower end of the latch arm 82, and the top of the finger piece 84 is defined by an inclined cam driven surface 86. As will be described next, when the hammer 18 is pulled up to the firing preparation position (see FIG. 3E), the finger piece 84 is vertically moved through a stop 88 protruding radially inward from the inner surface of the housing 12. When moved, the latch arm 82 is radially flexible.

  The coil compression spring 90 acts between the upper wall 92 of the housing 12 and the top wall 70 of the hammer 18 and presses the hammer downward (see FIG. 3A). A coil compression spring 93 surrounding the spring 90 acts between the upper wall 92 and the upper edge 94 of the pusher 24 to press the pusher downward.

  The carrier unit 16 has the adapter 100 shown in FIGS. The adapter 100 is substantially cylindrical and is arranged so that it can be inserted and removed within the stimulation sleeve 102. A coil compression spring 104 is inserted between the lower end edge of the adapter 100 and the annular flange 106 protruding radially inward from the inner surface of the sleeve 102. The adapter 100 has a plurality of longitudinal slots 107 that divide the adapter into a plurality of spring fingers 108. Two of the spring finger pieces 108 have a circumferential groove 110 formed in the upper part thereof. In order to releasably mount the adapter in the housing 12, the circumferential groove 110 is shaped so as to accommodate the protrusion 112 formed integrally on the inner surface of the half shells 12A, 12B of the housing. That is, when a downward force is applied to the adapter, the spring finger is bent and the adapter can be removed from the housing 12.

The adapter 100 has three keys 113 protruding outward in the radial direction.
The keys 113 are arranged so as to engage with the respective side surfaces 114 of the protrusions 115 formed on the inner surfaces of the half shells 12A and 12B of the housing. Only when the adapter is in one particular circumferential direction, the key 113 and the side surface 114 are oriented so that the adapter can be inserted into the housing 12. For the reason described below, the vertical keyway 117 is formed on the inner surface of the adapter.

  An inner ring 116 is attached so that it can be inserted into and removed from the sleeve 102. A shoulder 118 projecting radially outward is provided near the lower end of the inner ring, and a shoulder 120 projecting radially inward is provided near the upper end. A shoulder 118 is disposed so as to abut the lower end of the flange 106. An annular recess is provided in the ring 116, and a snap projection is formed between the annular recess so that the radial projection of the adapter 100 can be accommodated in the annular recess (see FIG. 2).

  The lancet carrier 130 shown in FIGS. 13 to 16 is positioned in the axial direction inside the adapter 100 and the ring 116. The lancet carrier 130 is generally in the shape of a cylindrical sleeve that has a vertical through passage 131 that allows the disposable member 150 to be inserted downward into the vertical through passage when the carrier unit 16 is removed from the housing 12. To get. A coil compression spring 132 is applied between the radially outer flange 134 of the lancet carrier 130 and the radially inner shoulder 120 formed on the ring 116.

  In order to guide the disposable member, the lancet carrier is provided with a pair of guide inclined surfaces 140 that are inclined downward and formed upward on the inner surface of the lancet carrier. The lower ends of these inclined guide surfaces 140 intersect to form a recess 142 that opens upward. These inclined guide surfaces and recesses form an upwardly facing seat that supports the disposable member. A key 133 projecting radially outward is formed on the upper annular flange 135 of the carrier 130. The key 133 is inserted into the keyway 117 of the adapter 100, and the position of the carrier 130 in the circumferential direction with respect to the adapter is determined.

  A disposable member 150 is shown in FIGS. 2 and 11 and has a generally cylindrical body 152 having a needle 154 protruding from the lower end. Three bosses 156 projecting radially outward from the outer peripheral edge of the disposable member are provided spaced apart in the circumferential direction and the vertical direction. That is, a lower boss 156 and a pair of upper bosses 158 arranged at the same height above the lower boss are provided. When the disposable member is viewed in the longitudinal direction, the three bosses are spaced apart from each other in the circumferential direction. When the disposable member is dropped onto the upper end of the lancet carrier 130 (see FIG. 2), the two upper protrusions engage with the two guide inclined surfaces 140 to guide the downward movement of the disposable member, and the lower boss 156 To enter the recess 142 (see also FIG. 13).

  Further, the disposable member is provided with a slot 160 extending longitudinally along the disposable member. A plurality of pairs of opposing holding finger pieces 162 are arranged in the slot 160. As shown by phantom lines in FIG. 11, the shape of the holding finger 162 is determined so that the capillary 164 can be gripped and held in a direction parallel to the longitudinal axis of the disposable member. For reasons explained next, when the unit 16 is inserted into the housing 12, the cooperation between the projections 156, 158 of the disposable member and the guide inclined surface 140 of the lancet carrier 130 causes the operating finger 58 of the pusher 24 to operate. On the other hand, the capillaries can be positioned by being arranged in the axial direction.

  The handle 20 (see FIGS. 3A and 4) has a pair of longitudinally extending lift fingers 170 that project downward through the top wall 70 of the hammer 18. The lower end of the lift finger piece constitutes a leg 172 protruding outward in the radial direction to which the lower end of the spring 76 is crimped. A knob 174 that can be grasped by hand is placed on top of the handle so that the handle can be raised.

  To illustrate the operation of the lancing device 10, attention is first drawn to FIG. 3A showing the device 10 without the disposable member 150 attached to the carrier unit 16.

  In order to install the disposable member, the carrier unit 16 is pulled downward from the housing, and the disposable member 150 is dropped into the carrier 130 (see FIG. 2). In that way, the bosses 156, 158 of the disposable member move along the guide ramp surface 140 of the lancet carrier until the lower boss 156 of the disposable member reaches rest in the recess 142 of the carrier. That

As a result, the capillary 164 of the disposable member is oriented to a special relationship with the unit 16.
Next, the unit 16 is pressed vertically upward into the front end of the housing 12 until the groove 110 formed in the spring finger 108 of the adapter 100 snaps onto the protrusion 112 of the housing 12, and the unit 16 is moved to a predetermined position. (See FIG. 3B).

Due to the relationship between the adapter key 113 and the side 115 of the projection 114 formed on the housing 12, the adapter can be inserted in only one circumferential (rotational) relationship with respect to the housing 12. Furthermore, since the circumferential relationship between the lancet holder 130 and the adapter 100 is preset by the engagement between the key 133 of the holder 130 and the key groove 117 of the adapter, the upper end of the capillary 164 is connected to the pusher 24. It can be reliably arranged on the actuating fingers, ie actuating ribs 58. Since the upper end of the capillary protrudes slightly upward past the upper end of the disposable member 150 (see FIG. 3B), the upper end of the capillary pushes the actuating rib 58 and thus the entire pusher 24 slightly upward. 3A, when the disposable member 150 is not attached to the carrier unit 16, the lock rib 56 of the pusher 24 is at the same level as the stopper 88 of the housing 12. However, when the disposable member 150 is attached, the upper end of the capillary 164 is The actuating rib 58, and hence the pusher 24, is pushed slightly upward, and the lock rib 56 provided integrally with the pusher 24 is raised to a level higher than the stop 88 of the housing.

  If the protective sheath S covers the needle 54 (see FIG. 2), the user pulls out the protective sheath, and then grasps the knob 174 of the handle 20 and pulls it upward (see FIG. 3C).

  As a result, the spring 76 is compressed between the leg 172 of the lift finger piece 170 and the top wall 70 of the hammer 18. When the spring 76 is compressed to a point where it cannot be compressed any further, the hammer 18 will rise when the handle 20 is further raised. Therefore, as a result, the inclined cam follower surface 86 at the top of the latching finger piece 84 engages with the trigger projection 46 and the lower side of the latch 88, causing the latching arm 82 to bend radially inward and beyond the projection 46. The finger piece 84 is then passed over the stop 88. Finally, the finger piece 84 moves past the stop 88 and snaps radially outward, thereby preventing the lowering movement of the finger piece and thus the lowering movement of the hammer by the top of the stop 88 (see FIG. 3C). ).

If the locking rib is not raised beforehand, the latching finger piece cannot be bent radially outward. Therefore, unless the disposable member 150 is installed, the lock rib 56 reliably prevents the hammer 18 from being installed in the loading position, that is, the firing preparation position.
Since the hammer 18 is raised, the spring 90 is compressed at the same time, thereby pressing the hammer 18 downward.

  When the handle 20 is released, the spring 76 pushes the handle downward until the handle leg 172 comes to rest on the shoulder 180 projecting radially inward of the handle 18 that is currently raised (see FIG. See 3D). This causes knob 174 to remain slightly elevated by a distance D from its previous position, and this slight elevation of the knob serves to provide a visual indication that the hammer is in the fire ready position (loading position).

  When the stimulation sleeve 102 is pressed downward against the user's skin (see FIG. 3E), the sleeve 102 moves upward against the pressing force of the spring 104, and against the pressing force of the spring 45. The interposer 22 and its trigger projection 46 are raised. Since the trigger protrusion 46 is circumferentially displaced with respect to the stop 88, this protrusion can contact the lower side of the latching finger piece 84, and the protrusion 46 exerts a cam action on the latching finger piece 84, The latching finger piece 84 is removed from the stop 88 and moved radially inward. As a result, the hammer 18 and its impact leg 80 are moved downward against the pressing force of the spring 76 toward the disposable member 150 by the pre-compressed spring 90 (see FIG. 3F), and the pressing force of the spring 132 is increased. In contrast, the disposable member 150 and the carrier 130 are pressed downward, thereby penetrating the needle into the skin, ie, incising the skin. The carrier 130 and the disposable member 150 are immediately retracted upward by the action of the spring 132. Since the hammer 18 is immediately retracted by the spring 76, such retraction of the carrier and the disposable member is possible. Therefore, the puncture action, that is, the incision action and the lancet retraction are performed as a substantially continuous movement.

The user then repeatedly moves the housing 12 up and down, thereby keeping the stimulation sleeve 102 in contact with the skin and repeatedly pressing the stimulation sleeve 102 with the spring 45 to the surface of the skin (like blood). Repeatedly open and close the wound to pump out the fluid. About pumping out this blood-like fluid, the application incorporated herein (agent processing number 018176-060)
Explained in great detail.

  That is, each time a downward force is applied, the end face of the outer stimulation sleeve acts to depress the wound, i.e. the skin placed in an encircling relationship with the incision I, and the annular part of the body tissue, Inflate the wounded area while pulling and releasing the side of the wound. Accordingly, fluid such as blood or intervening fluid intervening between tissues is captured and pressurized. Thus, the fluid moves upwards through the open end where the inflated wound is pulled. This is because the sinking skin and the annulus surrounding the body tissue limit the outward flow of fluid.

  When the downward force is released, the side of the wound closes and fresh fluid flows towards the wound area instead of the fluid forced through the wound upward. When the downward force is applied again, the above action is repeated and additional fluid is forced through the wound. This “pumping” action finally forms a suitably large drop B of bodily fluid.

Although the end face of the sleeve 102 is shown to be generally annular, it may be other forms such as oval or polygonal, in which case the annulus of body tissue to be pressed will be of a similar form.

  When a sufficiently large drop B of fluid develops on the surface of the skin (see FIG. 3G), the user applies a downward force F to the knob 52 of the pusher 24 to push the pusher against the pressing force of the spring 38 and its operation The rib 58 is moved downward. Accordingly, the capillary 164 is pressed downward until the lower end of the capillary 164 protrudes from the bottom of the housing 12. At this point, the lower end of the capillary is located in a drop of blood and draws blood into the capillary by capillary action. The pusher 24 can be released, so that the spring 38 moves the pusher 24 upward.

  The strip material 200 is then brought into contact with the bottom of the capillary (see FIG. 3H) and a fluid sample is withdrawn for analysis.

The user holds the sleeve 102 and pulls out the carrier unit 16 in order to perform the next puncture operation, that is, the incision operation and the sample collection operation. The disposable member 150 can then be lifted from the carrier 130 and discarded so that a new disposable member can be inserted.
Except for the needle 154 and the springs 93, 90, 45, 76, 104, 132, it is preferred that the piece of the lancing device 10 be made of plastic.

  The device 10 can trigger the hammer automatically in response to pressing the device against the skin. This eliminates the tendency of the user to push the device suddenly upward at the moment of the trigger and ensures a certain depth of penetration from one puncture operation to the next puncture operation.

  The ability of the device of the present invention to prevent the hammer from preparing to fire until the disposable member is placed can reliably prevent the disposable member from moving forward in an accident when installing the carrier unit. Such an accident will occur if the hammer is already ready to fire during installation of the carrier unit. Thus, according to the present invention, the user is protected against accidental damage.

  The ability of the device of the present invention to extrude a capillary to collect a fluid sample simplifies the sampling operation and minimizes the necessary direct manual manipulation of the capillary.

In practice, there is no need for direct contact with the capillary when using the device of the present invention. This aspect of the invention does not require the use of a lancet to make the incision. A known type of pneumatic or hydraulic syringe that injects pressurized gas or pressurized liquid into the skin at the location where the lancet is used to make the incision can be used. Such automatic injectors are commercially available from Becton-Dickinson, for example for injecting insulin. To sample a body fluid by removing insulin and simply injecting a gas (eg air or nitrogen) or a liquid (eg water) at a pressure of about 2.1 kg / cm ² (30 psi) or higher Incisions can be made in the skin. It is advantageous to mix small particles with the gas to facilitate the tissue dissection action. The particles can be composed of carbon particles with a diameter of 1 micron to 0.25 mm (0.01 inch).

  The ability to attach and remove a disposable member from the upper end of the carrier unit means that the user can hold his hand away from the needle. This will certainly prevent accidental injury from possibly contaminated needles. By mounting the disposable member in the carrier at three points so as to be defined by the three protrusions of the disposable member, the disposable member can be stably mounted in the carrier unit without moving. Therefore, the disposable member does not tend to move to the side during the puncturing process, that is, the incision process, thereby reducing the pain experienced by the user.

  As described in a co-pending patent application (agent processing number 018176-060), the ability of this device to pump blood or bodily fluids such as intervening fluids down to the surface of the skin, As such, the device can be used to puncture or cut the skin in areas of the body that are less painful.

  Although the present invention has been described in terms of preferred embodiments, the present invention is not intended to depart from the scope of the invention as set forth in the appended claims, and is not specifically described herein. Will be apparent to those skilled in the art.

It is a side view of this incision apparatus. It is a side view of the disposable member currently inserted in the lancet carrier unit shown by the longitudinal cross-sectional view. It is a longitudinal cross-sectional view of the cutting device of the present invention shown in various operating positions. It is a longitudinal cross-sectional view of the cutting device of the present invention shown in various operating positions. It is a longitudinal cross-sectional view of the cutting device of the present invention shown in various operating positions. It is a longitudinal cross-sectional view of the cutting device of the present invention shown in various operating positions. It is a longitudinal cross-sectional view of the cutting device of the present invention shown in various operating positions. It is a longitudinal cross-sectional view of the cutting device of the present invention shown in various operating positions. It is a longitudinal cross-sectional view of the cutting device of the present invention shown in various operating positions. It is a longitudinal cross-sectional view of the cutting device of the present invention shown in various operating positions. It is a longitudinal cross-sectional perspective view of this cutting device. It is the perspective view seen from the bottom part of the pusher member by this invention. It is the perspective view seen from the bottom part of the adapter member by this invention. It is the perspective view seen from the bottom part of the hammer member by this invention. It is the other perspective view seen from the bottom part of the hammer member shown in FIG. FIG. 3 is a perspective view of a half of a housing according to the present invention. FIG. 6 is a perspective view of the other half of the housing according to the present invention. FIG. 2 is a perspective view of a disposable member according to the present invention, showing a capillary tube in phantom. It is the perspective view seen from the bottom part of the interposer member by this invention. It is a side view of the disposable carrier member by this invention which showed the protrusion of the disposable member in the installed state with the virtual line. It is the perspective view seen from the other angle of the disposable carrier shown in FIG. FIG. 14 is a cross-sectional perspective view of the carrier member of FIG. 13. It is the perspective view seen from the bottom part of the carrier member of FIG.

Claims (2)

In a bodily fluid sampling device that samples bodily fluids,
A housing defining a longitudinal axis;
A lancet carrier mounted in the housing for forming an incision through the surface of the skin and supporting a disposable lancet having a skin incision member and a capillary separately, and an incision comprising a driving means for driving the lancet carrier Forming means;
A stimulating member attached to the front end of the housing, for forming a body fluid drop at the open end of the skin incision, pushing the body fluid outwardly through the incision toward the incision A stimulating member capable of sinking to the skin to sink the annular body tissue in a surrounding relationship to the skin,
Body fluid sampling device, characterized in that it comprises a pusher member for moving said capillary tube forwardly relative to the lancet carrier for aspirating body fluids. The lancet carrier is mounted adjacent to the front end of the housing so as to be movable longitudinally relative to the housing;
Said drive means, said lancet carrier for forming an incision on the surface of the skin and driven forward, driven backwards substantially continuous movement according to claim 1 which has a structure to retract the lancet from the incision Body fluid sampling device.

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