CN100361623C - Method and apparatus for body fluid sampling - Google Patents
Method and apparatus for body fluid sampling Download PDFInfo
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- CN100361623C CN100361623C CNB2003801081646A CN200380108164A CN100361623C CN 100361623 C CN100361623 C CN 100361623C CN B2003801081646 A CNB2003801081646 A CN B2003801081646A CN 200380108164 A CN200380108164 A CN 200380108164A CN 100361623 C CN100361623 C CN 100361623C
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Abstract
A device for use with a penetrating member driver to penetrate tissue is provided. A plurality of penetrating members are coupled to a single cartridge and are operatively couplable to the penetrating member driver. The penetrating members are movable to extend radially outward from the cartridge to penetrate tissue. A plurality of analyte sensors are coupled to the single cartridge and are positioned on the cartridge to receive body fluid from a wound in the tissue created by the penetrating member.
Description
Technical field
Known joint-cutting device in medical and health care product industry is used for skin puncture so that produce the blood that is used to analyze.Usually, be used for one of this analysis liquid of bleeding and obtain like this, promptly by forming little otch at finger tip, thereby produce minor cut or wound, this minor cut or wound produces little drop of blood on skin surface.
Background technology
Joint-cutting method early comprises by syringe needle or razor and punctures or cut skin.Present method is utilized the joint-cutting device, and this joint-cutting device comprises a plurality of springs, cam and piece actuator, so that drive lancet.These all comprise cantilever spring, barrier film, helical spring and the gravity plummet that is used for drive lancet.Device can be held against skin, and carries out mechanical excitation so that the emission lancet.Regrettably, the pain of being followed when each use known technology carries out joint-cutting makes that patient is unwilling to test.Except when driver when impacting the end of emitter retainer to the vibratory stimulation of skin, known spring biasing device also may excite lancet, this lancet carries out resonance oscillations facing to patient's tissue, thereby because recoil causes repeatedly punctures.This recoil of lancet and repeatedly the puncture be to make patient observe a major obstacle of structural glucose monitoring system.
Another obstacle that makes patient follow this method is that known joint-cutting technology can natural birth hemopoietic stream.Except as above-mentioned pain, patient may need to carry out repeatedly the joint-cutting incident so that obtain blood sample, because use known joint-cutting technology can not produce nature blood reliably.Therefore, pain will need the more number of times of trial to double in order successfully to produce the nature blood flow owing to patient.Between the different user of joint-cutting device, different skin thickness may cause producing Different Results aspect the success rate of pain, blood flow and acquisition blood.Known devices is seldom considered these skin thickness difference.
Another obstacle of following glucose monitoring is that each joint-cutting incident all has a lot of steps and inconvenience.The diabetic that much depends on insulin may need 5 to 6 blood sugar levels of test every day oneself.In common glucose method of testing, need more step, from carrying out joint-cutting to extruding blood, blood being coated on the test strip, and obtaining measured value from test strip, a lot of diabetics are reluctant the blood sugar level of testing them continually like that image is recommended.The patient that elderly patients and motion function are degenerated is difficult to lancet is packed in the emitter apparatus, blood is sent to maybe will be approached test strip on the test strip and insert in the slit of glucose meters.In addition, also may make by the size of crossing the wound groove that known system stays patient on one's body and must or worry that the patient of the healing of wound groove is unwilling to test their glucose level with the active patient of hands.
Summary of the invention
The present invention provides solution for some above-mentioned shortcoming at least.Specifically, some embodiments of the present invention provide many lancets scheme, so that measure the level of the analyte in the health.The present invention can adopt high density (density) design about the penetrating parts number in the chuck.The present invention can provide the indicator of the shock point of lancet or penetrating parts, and this lancet or penetrating parts are used for from organizing the body fluid of sampling.The embodiment of the invention will satisfy at least a portion in the these and other objects described here.
In an enforcement of the present invention, the device that uses together with body fluid sampling device is provided, this body fluid sampling device is used for extracting body fluid from the region of anatomy.This device comprises the chuck (cartridge) with a plurality of cavitys.This device can comprise a plurality of penetrating parts, and each penetrating parts to small part is arranged in the cavity of chuck, wherein, and the penetrate tissue that stretches out of the opening thereby this penetrating parts can be slided from the chuck.This device also can comprise a plurality of detection of analytes parts and a plurality of chamber.Each chamber can link to each other with a cavity, and this chamber arranges that along the periphery of chuck wherein at least one detection of analytes parts forms the part of a wall of one of a plurality of chambers.
In one embodiment, this device also can comprise the body fluid allotter that is positioned at least a portion detection of analytes parts top, so that impel body fluid flow to a detection part.Each penetrating parts can have the tip, and wherein at least one most advanced and sophisticated original position is in chamber.These detection of analytes parts can be electrochemical.In one embodiment, at least one chamber is included in the lip-deep opening of this chamber, wherein can see detection of analytes parts by this opening.
In another embodiment, the invention provides a kind of device that uses with body fluid sampling device, this body fluid sampling device is used for extracting body fluid from the region of anatomy.This device comprises the chuck with a plurality of sample chambers and a plurality of penetrating parts, and each penetrating parts to small part is arranged in the sample chambers of single chuck, wherein, and the penetrate tissue that stretches out of the opening thereby this penetrating parts can be slided from this chuck.Can comprise a plurality of detection of analytes parts.It is adjacent substantially with the periphery of this chuck that this chamber can be arranged to, and wherein, at least one these detection of analytes parts forms the part of a wall of one of a plurality of sample chambers.
With reference to the remainder and the accompanying drawing of description, can more be expressly understood the features and advantages of the present invention.
Description of drawings
Fig. 1 is that expression is used for skin puncture so that obtain the perspective view of the system embodiment of blood sample;
Fig. 2 is the plane graph that the replaceable penetrating parts chuck of system forms the part of parts;
Fig. 3 is the view of section view end along the line 3-3 among Fig. 2;
Fig. 4 is the view of section view end along the line 4-4 among Fig. 2;
Fig. 5 is the perspective view of the device of the parts of formation system and the functional unit that is used as chuck, has represented that the penetrating parts accelerator rotates along the downward direction pivot;
Fig. 6 A is the view that is similar to Fig. 5, has represented how chuck rotates or advance;
Fig. 6 B is how expression penetrating parts accelerator allows the progressive sectional side view of chuck;
Fig. 7 A and 7B are respectively the views that is similar to Fig. 6 A and 6B, have represented the pivot rotation in opposite direction of penetrating parts accelerator, so that engage with a penetrating parts of selecting in chuck;
Fig. 8 A and 8B are respectively the views that is similar to Fig. 7 A and 7B, have represented how the penetrating parts accelerator makes selected penetrating parts motion so that skin puncture;
Fig. 9 A and 9B are respectively the views that is similar to Fig. 8 A and 8B, have represented how the penetrating parts accelerator makes penetrating parts return its initial position;
Figure 10 is the block diagram of the functional part of indication device; And
Figure 11 is the end-view of the chuck of the optional embodiment of expression, and this chuck can bonding better sterile barrier (barrier).
Figure 12 is the cutaway view with embodiment of feature of the present invention.
Figure 13 is the cutaway view of embodiment when work with feature of the present invention.
Figure 14 is the cutaway view that expression is coated on a low-friction coating on the penetrating parts contact surface.
Figure 15 is the cutaway view that expression is applied to a coating on the penetrating parts contact surface, and this coating has increased friction, and has increased the microcosmic contact area between penetrating parts and penetrating parts contact surface.
Figure 16 has represented the part of penetrating parts chuck, and this penetrating parts chuck has annular shape, and the penetrating parts slit of a plurality of radial directed is arranged, and the distal side edge of driver part is arranged in the penetrating parts slit.
Figure 17 is and the partial longitudinal section that the coating penetrating parts is arranged that has coating penetrating parts contact surface to contact.
Figure 18 has represented to have the joint-cutting device embodiment of feature of the present invention.
Figure 19 is the perspective view of the part of penetrating parts chuck substrate, and this substrate has a plurality of penetrating parts slits and driver part guide slit, and this driver part guide slit is radially inwardly arranged, and alignd with this penetrating parts slit.
Figure 20-22 has represented penetrating parts chuck (analysing and observe), driver part, penetrating parts and the patients fingers tip in three successive stages of joint-cutting circulation.
Figure 23 has represented to have the penetrating parts embodiment of feature of the present invention.
Figure 24 is the exploded view of a part of the penetrating parts chuck of Figure 12.
Figure 25 and 26 has represented to be arranged in the multilamellar sterile barrier above the penetrating parts slit, and in the joint-cutting circulation, this sterile barrier is penetrated by the far-end of penetrating parts.
Figure 27 and 28 has represented the driver part embodiment that is connected with driver, wherein, driver part comprises the cutting part with sharpened edge, and this sharpened edge is arranged in the joint-cutting circulation and cuts the sterile barrier of wearing the penetrating parts slit, so that driver part is contacted with penetrating parts.
Figure 29 and 30 has represented the embodiment of penetrating parts slit (vertically analysing and observe) and driver part, this penetrating parts slit has the sloping portion of the far-end that is arranged in it, this driver part has the cut edge at its far-end, is used for cutting in joint-cutting circulation wearing sterile barrier.
Figure 31-34 has represented the driver part slit in the penetrating parts chuck, and wherein, at least a portion of driver part slit has tapered opening, and the lateral dimension of this tapered opening is bigger than the driver part bottom at driver part slit top.
Figure 35-37 has represented the embodiment of penetrating parts chuck and penetrating parts driver part, and wherein, the penetrating parts driver part has wheel profile (contoured) chuck, and this chuck is arranged to clamp the penetrating parts axle.
Figure 38 and 39 has represented to have the part of the joint-cutting device of lid, and this lid can be opened, so that expose the cavity of penetrating parts chuck, is used to take out the penetrating parts chuck that uses up, and inserts new penetrating parts chuck.
Figure 40 and 41 has represented to have in both sides the penetrating parts chuck of penetrating parts slit.
Figure 42-44 has represented to have the end-view and the perspective view of the penetrating parts chuck of a plurality of penetrating parts slits, and these penetrating parts slits are formed by the corrugated surface of penetrating parts chuck.
Figure 45-48 has represented the embodiment of penetrating parts and driver part, and wherein, this penetrating parts has the axle with slit, and this driver part has projection, and this projection is arranged to the slit coupling with the penetrating parts axle.
Figure 49 is the perspective view of chuck of the present invention.
Figure 50 and 51 has represented the zoomed-in view of the different chucks of periphery.
Figure 52 is the perspective view of the bottom side of chuck.
Figure 53 A has represented the vertical view of chuck and perforator and pusher assembly.
Figure 53 B is the perspective view of an embodiment of perforator plate.
Figure 54 A-54G has represented the sequence of motion of perforator plate, chuck and chuck pusher.
Figure 55 A-55B has represented the cutaway view of system of the present invention.
Figure 56 A has represented the perspective view of system of the present invention.
Figure 56 B-56D has represented the view after the part of mechanism is in the present invention removed.
Figure 57-65B has represented optional embodiment of the present invention.
Figure 66-68 has represented other embodiment of chuck of the present invention.
Figure 69 A-69L has represented the sequence of motion of the optional embodiment of chuck of the present invention.
Figure 70-72 has represented to be used for the view of sampling module of the chuck of another embodiment of the present invention.
Figure 73 has represented to have the chuck of sterile barrier and detection of analytes component layer.
Figure 74-78 has represented another embodiment of the detection of analytes parts that are connected with chuck.
Figure 79-84 has represented to be used for the optional structure of chuck of the present invention.
Figure 85 has represented the perspective view of an embodiment of a system of the present invention.
Figure 86 is the sketch map of the system of the optional embodiment of the present invention.
Figure 87 A-87B has represented the chuck of another embodiment of the present invention.
Figure 88 has represented to have the chuck of a set of analytes detection part.
Figure 89-90 has represented to be used for the embodiment of illuminator of the present invention.
Figure 91-96 expression is used for the another embodiment of the optical means of detection of analytes.
Figure 97 is illustrated in the figure that changes penetrating parts speed in the different piece of tissue.
Figure 98 represents the cutaway view of the light source that register driver is used.
Figure 99 and 100 expressions have the cutaway view of the housing of the light source that register driver uses.
Figure 101 and 102 expressions wherein a part are the housings of being made by transparent material.
Figure 103 represents based on chuck of the present invention, sterile barrier and substrate.
The perspective view of Figure 104-105 expression one embodiment of the present of invention.
The perspective view of the downside of Figure 106-107 expression one embodiment of the invention.
Figure 108 and 109 expressions are according to top view and the bottom view of the another embodiment of chuck of the present invention.
Figure 110 and 111 expressions top perspective view and bottom perspective view according to still another embodiment of the invention.
Figure 112 represents to be used for the additional embodiment used with the present invention.
Figure 113-115 expression is according to each view of the another embodiment of chuck of the present invention and detection of analytes parts.
Figure 116 and 117 expressions are according to top view and the bottom view of the another embodiment of chuck of the present invention.
Figure 118-119 expression is used for the additional embodiment used with the present invention.
Figure 120 represents to use view under the top of chuck of the body fluid allotter on the detection of analytes parts.
Figure 121-the 123rd is according to the perspective view of the another embodiment of chuck of the present invention.
Figure 124-125 expression is according to implement of the present invention.
Figure 126-the 128th, the figure of the sensitivity of expression detection of analytes parts.
Figure 129 represents to have the embodiment of the chuck of a plurality of detection of analytes parts.
The various structures of Figure 130-132 expression detection of analytes parts group.
Figure 133 table is in the chuck that is suitable for holding single penetrating parts and has a plurality of detection of analytes parts.
The specific embodiment
The invention provides the multiple analyte detection part that is used for bodily fluid sampling.Particularly, some embodiments of the present invention provide multiple analyte detection part and thorniness blood needle method, are used for measuring the analyte level of health.The present invention can adopt high density designs.It can use the lancet than known lancet smaller szie (such as but not limited to diameter or length).Device can be used for repeatedly cutting incident, and does not need to remove disposable product from device.The present invention also provides improved detected energy.These and other in this article at least a portion of described purpose will realize by embodiments of the invention.
Should be known in that the general description of front and the detailed description of back are example and indicative, is not the desired the present invention of restriction.Should be known in that when being used for description and accessory claim singulative " ", " one " comprise a plurality of objects, unless clearly in context point out not to be like this.Therefore, for example " a kind of material " can comprise mixtures of material, and " chamber " can comprise a plurality of chambers.Therefore, the list of references of being quoted is whole reference here, unless their content with obviously conflict described in this description.
In description and claim subsequently, a plurality of terms will be defined as has the following meaning:
The meaning of " selection " or " selectively " is that described subsequently situation may take place or may not take place, and therefore, this explanation comprises the example of this situation generation and the example that this situation does not take place.For example, when device when selectively comprising the feature that is used for the analyzing blood sample, its meaning is that this analytical characteristic has, and also may not have, and therefore, this explanation comprises that device has the structure of analytical characteristic and the structure of this analytical characteristic not.
" detection of analytes parts " are meant that use (alone or in combination) test chemical reagent and method, electrical testing circuit and method, physical testing component and method, optic test component and method and biological test reagent and method produce the information about blood sample.These methods are known in this field, and for example can be based on following instruction: Tietz Textbook of ClinicalChemistry, 3d ED, Sec.V, pp.776-78 (Burtis﹠amp; Ashwood, Eds., W.B.Saunders Company, Philadelphia, 1999); Authorize the U.S. Patent No. 5997817 (on December 7th, 1999) of Chrismore etc.; Authorize the U.S. Patent No. 5059394 (on October 22nd, 1991) of Phillips etc.; Authorize the U.S. Patent No. 5001054 (on March 19th, 1991) of Wagner etc.; And authorize U.S. Patent No. 4392933 (July 12 nineteen eighty-three) of Nakamura etc. etc., the content of these documents is incorporated herein by reference.The detection of analytes parts can be included in the test in the sample testing chamber of electrochemical properties of test blood, perhaps they can comprise the Optical devices of the optical characteristics (for example oxygen saturation levels) that is used to detect blood, and perhaps they can comprise the biological reagent (for example antibody) that is used to detect blood characteristics (for example antigenic existence).The detection of analytes parts can comprise with blood or other body fluid in the biological detection or the reaction reagent material of analyte (for example glucose) reaction, like this, produce the appropriate signals relevant, and can read by the reading machine device with the existence of analyte.By non-limiting example, when the detection of analytes parts participate in when the reading machine device provides function about the appropriate signals of blood sample, these detection of analytes parts can " link to each other " with chamber or other structure, in " being installed in " this chamber or other structure or " " be connected " with this chamber or other structure.The detection of analytes parts can also comprise nano wire detection of analytes parts, and are as described herein.The detection of analytes parts can use potential determination method, coulometry method or other to be used for the method for check and analysis thing level single or in combination.
Accompanying drawing 1-11 has represented an embodiment of system 10, is used for the puncture tissue so that obtain blood sample.System 10 can comprise: removable chuck 12; And install 14, be used for removably receiving chuck 12, and be used to operate the parts of chuck 12.
With reference to Fig. 1 and 2, chuck 12 can comprise a plurality of penetrating parts 18 together.Chuck 12 can be disc format, and the opening that outer circular surface 20 is arranged and form inner circular surface 22.A plurality of grooves 24 are formed in the plane surface 26 of chuck 12.Each groove 24 is an elongated shape, and extends radially outwardly from the central point of chuck 12.Each groove 24 forms and passes outer circular surface 20.Although not shown, should be known in that groove 24 is formed on the whole circumference of plane surface 26.Shown in Fig. 3 and 4, each groove 24 is narrow more the closer to chuck 12 central spot, and more wideer a little away from central spot.Groove 24 can be molded in the chuck 12, in chuck 12 machining or use that other method that can be used for the medical treatment device manufacturing is forged, punching press or formation.
In the present embodiment, the far-end 27 that each penetrating parts 18 has slender body 26 and fines away, this far-end 27 has sharp-pointed tip 30.This penetrating parts 18 has circular cross-section, and diameter in the present embodiment is about 0.315mm.The all outer surfaces of penetrating parts 18 all has identical coefficient of friction.Penetrating parts can be (but not necessary) exposed lancet.Lancet is " exposing ", and the meaning is not have projecting shape or molded parts on it, these parts can with other complementary structure engage.Common lancet comprises bigger plastic molded component, and these parts are used for convenient the joint.Unfortunately, this adnexa has increased size and cost.In the most basic meaning, exposed lancet or exposed penetrating parts are the tinsels with pointed end.When enough hour of its diameter, the tip can penetrate under situation about needn't fine away.Exposed lancet can be crooked, and this also thinks exposed lancet.In one embodiment, Luo Lu lancet can be made by a kind of material.
In the present embodiment, each penetrating parts 18 lays respectively in each groove 24.The sharpened distal end 27 that penetrating parts 18 makes them radially outward refers to from the central point of chuck 12.The near-end of each penetrating parts 18 can carry out engaging of interference engagement with the relative side of respective grooves 24, as shown in Figure 3.Other embodiment of chuck 12 can not adopt such interference engagement.As non-limiting example, they can use broken bonding agent that penetrating parts 18 is fixed on the chuck 12 releasedly.As shown in Figure 4, the part in the more distally of penetrating parts 18 does not engage with the relative side of groove 24, because the spacing between side is bigger.
In the present embodiment, device 14 can comprise housing 30, starter push button 32, penetrating parts motion sub-component 34, chuck advance sub-component 36, battery 38, capacitor 40, microprocessor controller 42 and switch 44.Housing 30 can have bottom 46 and lid 48.Lid 48 is fixed on the bottom 46 by hinge 50.Recess 52 is arranged at bottom 46.Circular open 54 in bottom 46 has been determined the external boundary of recess 52, and the levelling bench 56 of bottom 46 has been determined the substrate of recess 52.
In use, the lid 48 of present embodiment pivots to the position shown in Fig. 1.Chuck 12 upsets also are arranged in the recess 52.Plane surface 26 is resisted against on the levelling bench 56, and circular open 54 and outer circular surface 20 contacts, and planar moves so that prevent chuck 12.Then, lid 48 rotates along direction 60 pivots, and sealing chuck 12.
With reference to the embodiment shown in the figure 5, penetrating parts motion sub-component 34 comprises lever 62, penetrating parts accelerator 64, linear actuators 66 and spring 68.Other suitable actuator is including, but not limited to revolving actuator, and as described in the U.S. Patent application No.10/127395 (lawyer's code No.38187-2551) of common transfer and common pending trial, its applying date is on April 19th, 2002.Lever 62 pivotally is fixed on the bottom 46.But button 32 is located at the place, approximated position outside the bottom 46, and is connected with an end of lever 62 by the axle 70 that passes bottom 46.Penetrating parts accelerator 64 is installed on the opposite end of lever 62.The user edge is upward to 66 pressing buttons 32, and like this, axle 70 makes end lever 62, that be connected with it along rotating to pivot upward.Rotate along the downward direction pivot opposite end of lever.Spring 68 is between button 32 and base 40, and compression when pressing button 32, will make button 32 move downward and make the penetrating parts accelerator along the direction opposite with the direction 64 pivotally supported power that makes progress so that produce.
With reference to figure 6A and 6B, in this particular example, button motion to the position shown in Fig. 5 also makes and contacts with terminal 76 on being fixed on bottom 46 at the terminal on the axle 20 74.Contact between terminal 74 and 76 represents that button 32 pressed fully.By pressing button 32, chuck 12 can rotate under the situation of not interfering with penetrating parts accelerator 64.Therefore, the chuck device subsystem 36 that advances comprises pinion 80 and stepper motor 82.This stepper motor 82 is fixed on the bottom 46.This pinion 80 is fixed on the stepper motor 82, and rotates by stepper motor 82.Indented joint on the inner circular surface 22 of tooth on the pinion 80 and chuck 12.The rotation of pinion 80 makes chuck 12 rotate around its central point.Terminal 74 when 76 contact at every turn, stepper motor 82 operations so that make chuck 12 rotations by certain discrete angle, this discrete angle equals the angle intervals from penetrating parts 18 centrages to adjacent penetrating parts centrage.Therefore, selected penetrating parts 18 moves to above the penetrating parts accelerator 64, shown in Fig. 6 B.Forcing down subsequently of button 32 will make subsequently adjacent penetrating parts 18 move to the position on penetrating parts accelerator 64.
Then, the pressure on user's release-push is shown in Fig. 7 A.The power that is produced by spring 68 or other elastomeric element will make button 32 move along downward direction 76.Axle 70 pivotally is fixed on the lever 62, and like this, axle 70 makes end lever 62, that be connected with it move downward.The opposite end of lever 62 makes penetrating parts accelerator 64 along rotating to 80 pivots upward, and shown in Fig. 7 B, the part of sterile barrier 28 is worn out at the edge 82 of penetrating parts accelerator 64, and contacts with the downside surface physics of penetrating parts 18.
With reference to figure 8A, linear actuators 66 comprises the coil 86A and retreat coil 86B and the magnetisable iron core in this coil 86A and 86B of advancing separately.Coil 86A and 86B are fixed on the bottom 46, and iron core 90 can move in coil 86A and 86B.In case penetrating parts accelerator 64 is positioned at the position shown in Fig. 7 A and the 7B, electric current is to supplying with the coil 86A that advances.According to electromagnetic general principle, electric current among the pro-inlet wire circle 86A produce act on unshakable in one's determination 90, along the power of direction 88.
Bearing 91 is fixed on the lever, and penetrating parts accelerator 64 has the slit 92 on bearing 91.Slit 92 makes penetrating parts accelerator 64 to move along direction 88 with respect to lever 62, and like this, the power that produces on iron core makes penetrating parts accelerator 64 move along direction 88.
The edge 82 of penetrating parts accelerator 64 has the coefficient of friction more much higher than the base of chuck 12.The more great friction coefficient at edge helps to produce the higher relatively frictional force F3 on the downside surface that acts on penetrating parts 18.The relatively more low-friction coefficient of base produce on the uper side surface that acts on penetrating parts 18 relatively than less friction F4.Difference between power F3 and F4 is the composite force that penetrating parts is quickened along direction 88 with respect to chuck 12.The penetrating parts motion is to throw off the interference engagement shown in Fig. 3.Exposed penetrating parts 18 is moved, and need not form any bonding part on penetrating parts.On the contrary, present device uses the plastic body that is molded on each penetrating parts usually, so that help the operation penetrating parts.The motion of penetrating parts 18 makes its pointed end be passed in bottom 46 lateral openings 90.Therefore, the pointed end 30 of penetrating parts 18 moves to the position that it is stretched out from the home that retreats bottom 46 from opening 90.Utilize acceleration, the high-speed motion of penetrating parts to make sharp tip 30 penetrate people's skin.Then, can from human body, gather blood sample, be generally used for the diabetes analysis.
Below with reference to Fig. 9 A and 9B, after penetrating parts is quickened (such as, but be not limited to: afterwards less than 0.25 second), leading to the failure of current of accelerating coil 86A, electric current supply retreats coil 86B.Unshakable in one's determination 90 with penetrating parts accelerator 64 92 motions in opposite direction.Then, penetrating parts accelerator 64 makes exhausted penetrating parts enter its initial position, promptly with Fig. 7 B in identical position.
The button of pushing subsequently as shown in Figure 5 will repeat once described processing, but at adjacent aseptic penetrating parts.Aseptic penetrating parts subsequently can be used equally, all uses up to all penetrating parts, promptly after chuck 12 changes a whole circle.In the present embodiment, do not allow chuck 12 to change second circle, so that prevent to use the penetrating parts of in last circle, having used and having polluted.The unique method that the user can continue operative installations 14 is: uncap 48 as shown in Figure 1, take out used chuck 12, and change exhausted chuck with another chuck.When the detection of detector (not shown) is taken out chuck and is changed with another chuck.Such detector can be (but being not limited to) optical pickocff, electrically contact pick off, bar code reader etc.
Figure 10 has represented that electric parts can interconnective functionally in the present embodiment mode.Battery 38 is to capacitor 40 and controller 42 power supplies.Terminal 76 is connected with controller 42, and like this, when pressing button 32, controller will be discerned.Capacitor independently by switch (such as, but be not limited to field-effect transistor) march forward coil 86A, retreat 82 power supplies (voltage and current) of coil 86B and stepper motor.The control of all controlled device 42 of switch 44A, B, C.Memorizer 100 is connected with controller.One group of instruction is stored in the memorizer 100, and can be read by controller 42.Controller 42 will be by top explanation as can be known with other function that terminal 76 and switch 44A, B, C make up.
Figure 11 has represented to have the structure of another embodiment of the chuck of penetrating parts.Chuck 112 has corrugated structure and a plurality of penetrating parts 118, in the groove 124 of these penetrating parts 118 in being formed at chuck 112 opposite sides. Sterile barrier 126 and 128 is installed in the top of penetrating parts 118 and the bottom of penetrating parts 118 respectively.This structure provides the big surface that is used to install sterile barrier 126 and 128.Whole penetrating parts in a side are at first used, and make chuck 112 upsets then, and use the penetrating parts at opposite side.The additional aspect of this chuck is also introduced in Figure 42-44.
Below with reference to Figure 12-13, will introduce in more detail below based on friction, be connected and drive the method for this lancet or penetrating parts with lancet that exposes or exposed penetrating parts.Described herein any embodiment of the present invention can be used these methods.As shown in figure 12, surface 201 contacts with penetrating parts 202 physics.Surface 203 also contacts with penetrating parts 202 physics.In embodiments of the present invention, surface 201 is a rustless steel, and penetrating parts 202 is a rustless steel, and surface 203 is for having applied the rustless steel of politef.
Figure 13 has represented an embodiment who in use connects based on friction.Vertical force 206 can vertically be applied on the surface 201, thereby it is pressed against on the penetrating parts 202.Therefore, penetrating parts 202 abutment surfaces 203.Vertical force 206 is transmitted by surface 201 and penetrating parts 202, thereby also acts between penetrating parts 202 and the surface 203.Surface 203 keeps rigidity or static with respect to the target of lancet.Utilize classical static friction model, the surface 201 and penetrating parts 202 between maximal friction equal the surface 201 and penetrating parts 202 between coefficient of friction multiply by the surface 201 and penetrating parts 202 between vertical force.In the present embodiment, the surface 203 and penetrating parts 202 between maximal friction equal the surface 203 and penetrating parts 202 between coefficient of friction multiply by the surface 203 and penetrating parts 202 between vertical force.Because less than the coefficient of friction between surface 201 and penetrating parts 202, therefore the maximum static friction force that can form at the interface of maximum static friction force rate between surface 203 and penetrating parts 202 that the interface between surface 201 and the penetrating parts 202 can form is higher at the coefficient of friction between surface 203 and the penetrating parts 202.
Vertically be applied on the surface 201 by driving force shown in the arrow 207 and vertical force 206.Horizontal force is the summation of driving force 207 and the frictional force that forms on the interface of surface 201 and penetrating parts 202 (this frictional force is along the directive effect opposite with driving force 207) in the summation of the power of surface on 201.Because the surface 203 and penetrating parts 202 between coefficient of friction less than the surface 201 and penetrating parts 202 between coefficient of friction, therefore, when driving force 207 surpasses can be by the maximum static friction force of the supporting of the interface between surface 203 and the penetrating parts 202 time just, penetrating parts 202 and surface 201 will keep static toward each other, and can think and be equivalent to parts.Because the coefficient of friction between surface 201 and penetrating parts 202 is high enough to prevent relative motion between them, therefore surface 201 and penetrating parts 202 can be thought parts.
In one embodiment, coefficient of friction between surface 201 and penetrating parts 202 is approximately 0.8, equal the coefficient of friction between two stainless steel surfaces, and the coefficient of friction between surface 203 and penetrating parts 202 is approximately 0.04, equals the coefficient of friction between stainless steel surfaces and ptfe surface.The value of vertical force 206 is 2 newton.When using these values, the maximal friction that the interface between surface 201 and penetrating parts 202 can support is 1.6 newton, and the maximal friction that the interface between surface 203 and penetrating parts 202 can support is 0.08 newton.When driving force 207 surpasses 0.08 Newtonian time, surface 201 and penetrating parts 202 will begins together with respect to surface 203 acceleration.Equally, when driving force 207 surpassed 1.6 newton and penetrating parts 202 and runs into rigid barrier, surface 201 will be with respect to penetrating parts 202 motions.
For example surface 201 will be in the peak acceleration situation with respect to another state of penetrating parts 202 motions.In one embodiment, the quality of penetrating parts 202 is 8.24 * 10
-6Kg.Therefore, penetrating parts 202 will need 194,174m/s
2Acceleration (equal about 19,800N/m so that surpass frictional force between penetrating parts 202 and surface 201
2).Do not limit any specific embodiment or operating principle, adopt other method can adopt yet based on the connection that rubs.For example, penetrating parts 202 can be utilized interference engagement and engage with adapter, so that produce frictional engagement with these parts.
Figure 14 has represented the polytetrafluorethylecoatings coatings on stainless steel surfaces 203 in detail.Should be known in that surface 203 can be coated with other material, such as, but be not limited to: Telfon , silicon, polymer or glass.This coating can be coated on the whole penetrating parts, only be coated on the portions of proximal, only be coated on the distal part, only be coated in and most advanced and sophisticatedly go up, only be coated on some other parts, perhaps above-mentioned some or all some combination.Figure 15 has represented to be applied to the lead paint (doping) on the surface 201, and when penetrating parts 202 pressed this surface 201, this surface adapted with penetrating parts 202 on microcosmic.These embodiment of penetrating parts and other apply embodiment and can use with described driving method herein.
The shape and the structure on surface 201 and surface 202 can be different from shown in Figure 12-15.For example, the surface 201 can be a wheel surface, and this wheel surface makes penetrating parts 202 advance with respect to surface 203 or retreat when rotated.Surface 201 other adaptation materials that will be coated with outside the deleading are such as, but be not limited to plastics.Can also be coated with microgranule such as, but be not limited to bortz powder, perhaps make the surface that texture is arranged, so that improve the coefficient of friction of surface 201 and penetrating parts 202.Following material be made or be coated with in the surface 202 can by following material: the copolymer of copolymer, ethylene and the CTFE of diamond, PEP, perfluoro alkoxy (perfluoroalkoxy), ethylene and politef or be lower than other material of the coefficient of friction of the material that is used for surface 201 and penetrating parts 202 with the coefficient of friction of penetrating parts 202.
With reference to Figure 16, substrate 210 parts of penetrating parts chuck penetrating parts chuck embodiment are expressed as has a plurality of penetrating parts slits 212, and these penetrating parts slits 212 are radially arranged, and cut in the top surface 214 of substrate.Driver part 216 is expressed as has distal side edge 218, and this distal side edge 218 is arranged in the penetrating parts slit 212 of substrate 210.The distal side edge 218 of driver part 216 is arranged under the situation of frictional force minimum and slides in penetrating parts slit 212, but closely cooperates with this penetrating parts slit 212, so that reduce the transverse movement in the joint-cutting circulation.
Figure 17 has represented the partial longitudinal section of the distal part 220 of cated penetrating parts 222.Cated penetrating parts 222 has core segment 224, coating 226 and tapered distal end part 228.A part of also having represented cated driver part 230, it has coating 234, and this coating 234 has penetrating parts contact surface 236.Penetrating parts contact surface 236 forms interface 238 with the outer surface 240 of cated penetrating parts 222.The feature coefficient of friction of interface 238 will depend in part on the material of penetrating parts coating 226 and driver part coating 234 and select.When silver is used as penetrating parts and driver part coating 226 and 236, with the coefficient of friction that produces about 1.3 to about 1.5.Other material can be used for coating 226 and 236, so that obtain suitable coefficient of friction.For example, gold, platinum, rustless steel and other material also can be used for coating 226 and 236.Hope is used combination of different materials for coating 226 and 236.For example, an embodiment can comprise silver that is used for penetrating parts coating 226 and the gold that is used for the driver part coating.The coefficient of friction of some embodiment of interface 238 is about 1.15 to about 5.0, particularly about 1.3 to about 2.0.
The embodiment of penetrating parts 222 can have about 200 to about 400 microns outside lateral dimension or diameter, particularly about 275 to about 325 microns.The embodiment of penetrating parts 222 can have about 10 to about 30 millimeters length, particularly about 15 to about 25 millimeters.Penetrating parts 222 can be made such as, but be not limited to rustless steel etc. by the high-strength alloy of any appropriate.
Figure 18 is the perspective view with joint-cutting device 242 of feature of the present invention.Penetrating parts chuck 244 is arranged in above the driver 246, and this driver 246 is connected with driver part 248 by connector rod 250.Penetrating parts chuck 244 has: a plurality of penetrating parts slits 252, these penetrating parts slits 252 with radial arrangements in the top surface 254 of the substrate 256 of penetrating parts chuck 244.The far-end 253 of penetrating parts slit 252 is arranged on the outer surface 260 of substrate 256.The sterile barrier 258 (representing with partial cutaway) that can break is arranged on the top surface 254 of substrate 256 and on a plurality of penetrating parts slits 252.This sterile barrier also is arranged in above the outer surface 260 of substrate 256, so that hermetic penetrant parts slit prevents to pollute before the joint-cutting circulation.The distal part of penetrating parts 262 is expressed as from penetrating parts chuck 244 along patients fingers that 264 directions extend radially out.
Figure 19 has represented to be used for the part of the substrate 256 of joint-cutting device 242 in more detail, does not wherein arrange sterile barrier (for the ease of diagram).Substrate 256 comprises a plurality of penetrating parts slits 252, these penetrating parts slits 252 and corresponding driving parts slit 266 radially aligneds.Driver part slit 266 has optional taper to introduce structure, and structure can make things convenient for driver part 248 in driver part 248 moves downward process to driver part slit 266 and the penetrating parts slit 252 alignment is introduced in this taper.The size of penetrating parts slit 252 and structure are configured to receive penetrating parts disposed therein 262, and allow penetrating parts 262 axially-movable in penetrating parts slit 252, do not have tangible transverse movement simultaneously.
With reference to Figure 18, in use, the penetrating parts chuck 242 and the driver 246 of present embodiment are arranged to operating structure again.Joint-cutting circulation beginning, driver part 248 is passed down through sterile barrier 258, and enters in the penetrating parts slit 252.Then, the penetrating parts contact surface of driver part contacts with the outer surface of penetrating parts 262, and distad drives towards patients fingers 264, as described in the embodiment in the earlier in respect of figures 20.At the penetrating parts contact surface of driver part 248 and the coefficient of friction between the penetrating parts 262 greater than the coefficient of friction between the inner surface of penetrating parts 262 and penetrating parts slit 252, therefore, driver part 248 can distad drive penetrating parts 262 and pass sterile barrier 258 and enter in the patients fingers 264, simultaneously between driver part 248 and penetrating parts 262 without any relative motion or there is not obvious relative motion.
With reference to figure 20-22, joint-cutting circulation sequence list is shown and is used for joint-cutting device 242, and this joint-cutting device 242 has penetrating parts chuck 244 another embodiment shown in Figure 23 and 24.The substrate 256 of the penetrating parts chuck 242 shown in Figure 23 and 24 has a plurality of penetrating parts slits 252, and these penetrating parts slits 252 have open top 268, and 268 outer surfaces 260 that radially do not extend to substrate 256 are opened at this top.Like this, penetrating parts slit 252 can seal by second sterile barrier 272 that is arranged in first sterile barrier 270 on substrate 256 top surfaces 254 and be arranged on the outer surface 260 of substrate 256.Penetrating parts outlet opening 274 is arranged in the far-end of penetrating parts slit 252.
With reference to Figure 20, be expressed as penetrating parts 262 and be in the starting position (in penetrating parts slit 252) that nearside retreats again.The outer surface of penetrating parts 276 contacts with the penetrating parts contact surface 278 of driver part 248.Coefficient of friction between the outer surface 276 of the penetrating parts contact surface 278 of driver part 248 and penetrating parts 262 is greater than the coefficient of friction between the inner surface 280 of penetrating parts 262 and penetrating parts slit 252.Then, the distad driving force shown in arrow among Figure 10 282 is applied on the driver part 248 by driving adapter 250, and penetrating parts is extruded and enters in the patients fingers 264 from penetrating parts outlet opening 274.Then, shown in arrow among Figure 22 284, nearly the side setback force is applied on the driver part 248, and penetrating parts 262 withdraws from and is retracted in the penetrating parts slit 252 from patients fingers 264.
Figure 25 and 26 has represented at the embodiment that carries out the multilamellar sterile barrier 258 of breakthrough process by penetrating parts 62.Should be known in that this barrier 258 can be used for any embodiment of the present invention.Sterile barrier 258 shown in Figure 25 and 26 is two-layer sterile barrier 258, and when penetrating parts 262 was passed and left sterile barrier 258, this sterile barrier 258 helped making penetrating parts 262 to keep aseptic.In Figure 25, the far-end 286 of penetrating parts 262 applies axial force along the inner surface 288 that distal direction faces toward the ground floor 290 of sterile barrier 258, thereby makes ground floor 290 distortion of sterile barrier 258.The distortion 291 of ground floor 290 applies deformation force to the second layer 292 of sterile barrier 258 again.The second layer of sterile barrier is arranged to have the hot strength lower than ground floor 290.Therefore, because the far-end 286 by penetrating parts 262 is applied to the strain on the ground floor 290, the second layer 292 lost efficacy before ground floor 290, as shown in figure 26.After the second layer 292 lost efficacy, it retreated from the crushed element 291 of ground floor 290, shown in the arrow among Figure 26 294.As long as the inner surface 288 and the outer surface 296 of ground floor 290 were aseptic before the second layer 292 loses efficacy, penetrating parts 262 will keep aseptic so, because it passes this ground floor 290 when the ground floor ultimate failure.This multilamellar sterile barrier 258 can be used for described any embodiment herein.Multilamellar sterile barrier 258 can also comprise three layers or more multi-layered.
With reference to Figure 27 and 28, the embodiment that has represented the driver part 300 that is connected with driver 302 among the figure, wherein, driver part 300 comprises cutting part 304, this cutting part 304 has sharp edges 306, this sharp edges 306 is arranged in cuts the sterile barrier 258 of wearing penetrating parts slit 252 in the joint-cutting cyclic process, so that driver part 300 is contacted with penetrating parts.Optional stop pin 308 on cutting part 304 can be arranged to engage with the top surface of substrate, so that prevent that cutting part 304 is with respect to driver part 300 distal motion in the joint-cutting circulation.
Figure 29 and 30 has represented the embodiment of penetrating parts slit 316 with sectional side elevation, and this penetrating parts slit 316 has sloping portion 318, and this sloping portion 318 is arranged in far-end 320 places of penetrating parts slit.Driver part 322 is expressed as the part and is arranged in the penetrating parts slit 316.Driver part 322 has in the cut edge 324 at its far-end 326 places, is used for cutting in joint-cutting circulation wearing sterile barrier 328.Figure 30 has represented to cut the cut edge 324 of wearing sterile barrier 328 in joint-cutting circulation, and Qie Ge sterile barrier 328 324 is peeled off from the cut edge simultaneously.
Figure 31-34 has represented the driver part slit in the substrate 330 of penetrating parts chuck, and wherein, at least a portion of driver part slit has tapered opening, and this tapered opening is bigger in driver part slit bottom at the lateral dimension ratio at substrate top surface place.Figure 31 has represented to have the substrate 330 of penetrating parts slit 332, and the whole length along penetrating parts slit 332 is taper to this penetrating parts slit 332 at import 334 places at top surface 336 places of substrate 330.In this structure, penetrating parts slit and driver part slit (not shown) will be continuous along the whole length connected sum of slit 332.Also can select, the substrate 338 shown in Figure 32 and 33 can have driver part slit 340, this driver part slit 340 and corresponding penetrating parts slit 342 axial separation.For this structure, driver part slit 340 can have pyramidal structure, and penetrating parts slit 342 can have straight wall construction.In addition, this structure also can be used for corrugated substrate 346 embodiment, as shown in figure 34.In Figure 34, driver part 348 is arranged in the driver part slit 350.Penetrating parts contact surface 352 is arranged on the driver part 348.Contact surface 352 has pyramidal structure, and this pyramidal structure will help making driver part 348 and driver part slit 350 lateral alignment.
Figure 35-37 has represented the embodiment of penetrating parts chuck 360 and driver part 362, and wherein, driver part 362 has profile clevis head 364, and this chuck 364 is arranged to clamp penetrating parts axle 366.In Figure 35, driver part 362 and penetrating parts axle 366 represent that with cross-sectional figure simultaneous wheels profile chuck 364 is arranged in around the penetrating parts axle 366.Pivoting point 368 is arranged between the profile clevis head 364 and taper compression slots 370 of driver part 362.Compression voussoir 372 is expressed as and is arranged in the taper compression slots 370.Compression voussoir 372 inserts in the compression slots 370 (shown in arrow 374) will force profile clevis head 364 closed and clamp this penetrating parts axle 366 around penetrating parts axle 366, shown in arrow 376.
Figure 36 has represented driver part 362, and this driver part 362 is in the penetrating parts slit 378 of penetrating parts chuck 360 position around penetrating parts axle 366.Driver part can drive with reference to other driver part and the described method of driver embodiment by top.Figure 37 is the sectional side elevation that is arranged in the penetrating parts axle 366 in the penetrating parts slit 378. Arrow 380 and 382 has been represented the motor path of driver part 362 in the joint-cutting circulation in normal way.In the joint-cutting circulation, shown in arrow 380, driver part passes optional sterile barrier (not shown) and enters penetrating parts slit 378 downwards.Then, the profile clevis headring of driver part carries out clamping around penetrating parts axle 366, and travels forward along distal direction, enters in patient's the skin so that drive penetrating parts, shown in arrow 382.
Figure 38 and 39 has represented the part of joint-cutting device 390, and this joint-cutting device 390 has lid 392, and this lid 392 can be opened, so that expose penetrating parts chuck cavity 394, is used to take out exhausted penetrating parts chuck 396 and inserts new penetrating parts chuck 398.Along direction pressing button 400 shown in the arrow 402 driver part 404 will be raise from the surface of penetrating parts chuck 396.The rising of lid 392 will be along the arm of direction activation lever shown in the arrow 410 408, and this lever arm 408 applies tensile force along direction shown in the arrow 414 to cable 412 again.This action retracts driver part from penetrating parts chuck 396, like this, penetrating parts chuck 396 can take off from joint-cutting device 390.Then, new penetrating parts chuck 398 can insert in the joint-cutting device 390, and with above-mentioned steps conversely, so that make driver part be positioned at above the penetrating parts chuck 398 and be in operating position.
Figure 40 and 41 has represented penetrating parts chuck 420, and this penetrating parts chuck 420 has at the top side 424 of penetrating parts chuck 420 and the penetrating parts slit 422 on the bottom side 426.Compare with the single face penetrating parts chuck of same diameter D, this makes the penetrating parts chuck 420 of diameter D can store the penetrating parts of using twice.
Figure 42-44 has represented the end-view and the perspective view of penetrating parts chuck 430, a plurality of penetrating parts slits 432 that this penetrating parts chuck 430 has the corrugated surface 434 by penetrating parts chuck 430 to form.Penetrating parts 436 is arranged in the both sides of penetrating parts chuck 430.In Figure 44, sterile barrier 438 be expressed as be arranged in penetrating parts slit 432 above.
Figure 45-48 has represented the embodiment of penetrating parts 440 and driver part 442, wherein, penetrating parts 440 has the transverse slot 444 in penetrating parts axle 446, and driver part 442 have be arranged to penetrating parts axle 446 in the projection 448 of transverse slot 444 coupling.Figure 45 has represented to have the projection 448 of pyramidal structure, and the pyramidal structure of the transverse slot 444 in this projection 448 and the penetrating parts axle 446 cooperates.Figure 46 has represented the optional embodiment when projection 448 has straight wall side, and this straight wall side is arranged to cooperate with the straight wall side of the transverse slot 444 shown in Figure 46.Figure 47 has tapered protrusion 448, and this tapered protrusion 448 is arranged between the transverse slot bottom of projection 448 end and penetrating parts axle 446 and leaves tip-clearance 450.
Figure 48 has represented to be used for driver part 442 is locked in mechanism 452 on the penetrating parts axle 446, there is lever arm 454 in this mechanism 452, this lever arm 454 has the optional bearing 456 at first end, 458 places, and this bearing 456 is arranged in the guide slit 459 of driver part 442.Lever arm 454 has pivoting point 460, and this pivoting point 460 is arranged between second end 462 of first end 458 of lever arm 454 and lever arm 454.Second end 462 and spring members 464 substrate 466 between second end that be arranged in lever arm 454 of biasing force by being arranged in lever arm 454.Biasing force along direction shown in the arrow 458 forces the outer surface of the penetrating parts contact surface 470 of driver part 442 against penetrating parts 446, forces the projection 448 of driver part 442 to be pressed in the transverse slot 444 of penetrating parts axle 446 in addition.
With reference to Figure 49, but will introduce another optional embodiment of the replaceable chuck 500 of the penetrating parts (not shown) that is suitable for holding a plurality of self-movements below in more detail.Although chuck 500 is expressed as the neighboring with chamfering, should be known in seldom chamfering and do not have chuck 500 embodiment of chamfering also can be used for any embodiment of the present invention described here.The penetrating parts that is connected with chuck can be not have the outer, molded parts as shown in common lancet or the exposed lancet or the exposed elongated member of molded body member slidably.Exposed design has reduced cost, and has simplified the manufacturing that is used for penetrating parts of the present invention.Penetrating parts can be return and remain in the chuck, and like this, they can not be used again.In case all penetrating parts were all used, then available new chuck is changed this chuck.Lancet or penetrating parts can be packed in the exhausted chuck fully, have therefore reduced the probability that patient contacts with this waste product.
As shown in figure 49, chuck 500 can comprise a plurality of cavitys 501 that are used to hold penetrating parts.In the present embodiment, this cavity 501 can have the longitudinal opening 502 that links to each other with it.Cavity 501 can also have transverse opening 503, thereby penetrating parts can radially outward be left from chuck.As shown in figure 49, the radial outside of cavity part can narrow down.The top of this narrowed areas also can seal or push, so that make top 505 closures, and has determined closing any opening 506, as shown in figure 50.Also can select, narrow zone 504 can keep the open top structure, but in certain embodiments, can not break at this paper tinsel above gap, thereby prevents the penetrating parts rising or protrude upward chuck.Narrow 504 can be used as the supporting member and/or the guiding piece of penetrating parts.Figure 51 has represented that opening 506 can have different shape, such as, but be not limited to: the combination of circle, rectangle, triangle, hexagon, square or any or whole aforementioned shapes.Be used for the next-door neighbour vicinity that other microfluid, opening capillaceous 507 (being represented by dotted lines) also can be included in opening 506.In some optional embodiment, this opening 507 can be arranged to one heart or with other formal ring around this opening 506.
Introduce the bottom side of chuck 500 in more detail below with reference to Figure 52.This figure has represented a lot of features on a chuck 500.Should be known in that chuck can comprise, not have or whole these features, but they are shown among Figure 52 all, so that explain.The bottom side can comprise pit or the hole 510 near the inner rim place, so that with the chuck appropriate location, so that engage and/or make forward gear (shown in Figure 56 B and the 56C) can make chuck 500 rotations with the penetrating parts anchor clamps.Pit or hole 511 can be formed at the bottom side of chuck 500 along diverse location, and can take different shape, such as, but be not limited to: the combination of circle, rectangle, triangle, hexagon, square or any or whole aforementioned shapes.Groove 512 also can form along the inner surface of chuck 500, so that help to make chuck alignment and/or rotation.Certainly, should be known in that some feature also can be arranged in the top side of chuck and be in the zone that the cavity 501 of can't help to adorn penetrating parts occupies.Also can comprise groove 513 along the neighboring of chuck.These grooves 513 can be used to collect the excess stock (not shown) of sterile barrier 28, and this sterile barrier can be used to cover the sloping portion 514 of chuck.In the present embodiment, chuck has flat top surface and around the inclined surface in the outside.When being welded on paper tinsel shape sterile barrier above the inclined surface, because surface (at this moment being 45 degree) changes, so paper tinsel is folding.This produces excess stock.Groove or groove 513 are the positions that are used for this excess stock.Place these grooves 513 interior 45 degree inclined surfaces that can cross to strain this material downwards on paper tinsel.Although the surface is expressed as 45 degree in the present embodiment, should knows also and can adopt other angle.For example, the surface can be to 90 degree arbitrarily angled between (with respect to horizontal direction) at about 3 degree.In certain embodiments, the surface can be cut into square.The surface can not have chamfering.The surface also can be curved surface, and perhaps it can be the combination on various inclined surfaces, curved surface and straight surface, perhaps is above-mentioned some or all combination in any.
Introduce order when chuck 500 indexings and the driving penetrating parts below with reference to Figure 53-54.Should be known in that under the situation that does not break away from spirit of the present invention some step described here can make up or the change order.The order of these steps provides the vertical and horizontal movement that is used for present embodiment, so that penetrating parts is installed on the driver.
As previously mentioned, each cavity on chuck can seal separately by paper tinsel lid or other aseptic closed material so that keep aseptic, when use or just when using before.In the present embodiment, penetrating parts discharged from their gnotobasis before driving just, and was loaded in the emitter mechanism so that use.Discharged penetrating parts and will make the penetrating parts in the present embodiment to drive under the situation that needn't pierce through any aseptic closed material before emission from gnotobasis, this closed material may make the most advanced and sophisticated rust of penetrating parts or pollutant are placed on the penetrating parts in the process of destination organization operation in penetrating parts.Several different methods can realize this purpose.
Figure 53 A has represented an embodiment of penetrating parts releasing device, and in the present embodiment, this penetrating parts releasing device is a perforated plate 520, and for ease of explaining, this perforated plate 520 adopts perspective fashion to represent.This perforated plate 520 can comprise: first 521 is used to pierce through the sterilizable material that covers longitudinal opening 502; And second portion 522, be used to pierce through the material that covers transverse opening 503.Slit 523 allows the penetrating parts anchor clamps to pass perforated plate 520, and engages with the penetrating parts that places chuck 500.The second portion 522 of perforated plate descends so that engage with the sterile barrier that is inclined to about 45 degree gradients.Certainly, the gradient of barrier can change.Perforated portion 522 at first contacts with the rear portion of anterior capsule cave sterile barrier, and when it reduces, crackle will extend under each side direction, and barrier pressure is low to moderate the bottom of front cavity.At first break, and barrier is depressed, and clears out of passage substantially with perforated portion 522 back edge that contact, barrier.These features are clearer expression in Figure 53 B.Perforated portion 521 can comprise the blade section along centrage.When perforated portion descends, blade can with the center-aligned of cavity, thereby sterile barrier is cut into two parts.Then, the wider portion of perforator 521 is pushed into downwards on the barrier, and like this, they are parallel to the side alignment of cavity.This has produced complete accessible path in the whole longitudinal opening of cavity, that be used for anchor clamps.In addition, shown in Figure 53 B and 54A, a plurality of protruding 524 are positioned to engage with cam (Figure 55 A), and this cam is realized boring a hole in proper order and other of perforated plate 520 and chuck pusher 525 moves both vertically.From force producer (not shown) driving shaft 526 be used to drive penetrating parts 527.
Below with reference to Figure 54 A-F, the release of penetrating parts and loading are realized in the following sequence.Figure 54 A has represented the release and the loader mechanism that remain static, and wherein, dirty exposed penetrating parts 527 remains in the penetrating parts anchor clamps 530.This is the unit state between twice joint-cutting incident.When patient begins to start another joint-cutting incident, before actual joint-cutting incident, remove exhausted penetrating parts just, and load new penetrating parts.Patient by operation setting lever or slider so that start up process, thereby begin to load new penetrating parts.Be provided with lever can mechanically actuated so that make cam (seeing Figure 55 A) rotation, this cam makes perforated plate 520 and 525 motions of chuck pusher.Various mechanism can be used to connect slider so that cause the rotation of chuck.In another embodiment, stepper motor or other prime mover (such as, but be not limited to pneumatic actuator, hydraulic actuator etc.) are used to drive loading sequence.
Figure 54 B has represented an embodiment of penetrating parts anchor clamps 530 in more detail.Penetrating parts anchor clamps 530 can be the tuning fork shape, have along the sharp edges of the leg inboard that contacts with penetrating parts.In certain embodiments, penetrating parts can have slit, recess is arranged or be other shape, so that receive the penetrating parts anchor clamps.When anchor clamps 530 are pushed on the penetrating parts downwards, leg elasticity is launched, so that penetrating parts (such as, but be not limited to exposed elongated metal wire, do not have molded on it or otherwise be installed in adnexa on this penetrating parts) is blocked in friction.In certain embodiments, penetrating parts is made by homogeneous material, do not have molded, bonding, glued joint or otherwise be attached to any adnexa on this penetrating parts.
In certain embodiments, anchor clamps 530 can be cut the sidepiece of penetrating parts.In one embodiment, penetrating parts is about 300 microns wide, and the groove that is formed in the penetrating parts sidepiece by knife-edge is that about 5-10 micron is dark, and quite little.In this particular example, with the longitudinal axis along elongated penetrating parts penetrating parts is compared from the power that anchor clamps take off, blade makes device can use very little insertion force that anchor clamps are stuck on the penetrating parts.Therefore, reduced the danger that penetrating parts is thrown off in the driving process.Anchor clamps 530 can be made by various materials, these materials such as, but be not limited to: high strength carbon steel (this carbon steel is heat-treated, so that increase hardness), pottery, have substrate, composite reinforced plastics, elastomer, polymer and the sintering metal of diamond coatings.In addition, steel can carry out surface treatment.Anchor clamps 130 can have the higher power of clamping, and on solenoid or other driver less frictional resistance are arranged simultaneously.
Shown in Figure 54 C, operating sequence starts from promoting perforated plate 520 downwards.This causes opening next aseptic cavity 532.In certain embodiments, this motion of perforated plate 520 may cause fettering dirty penetrating parts, is used once more so that prevent it.This constraint can realize by the projection on the perforated plate, and this projection makes that penetrating parts is crooked or penetrating parts pushed in the groove in the chuck that this groove is held in place penetrating parts by interference engagement.Shown in Figure 53 B and 54C, perforated plate 520 has projection or perforator, and this projection or perforator form longitudinal opening 502 and the transverse opening 503 that penetrates on the chuck.First 521 perforator, that open cavity 532 forms the sterile barrier that at first punctures, and promotes, compresses or otherwise make the lateral movement of aseptic closed material towards longitudinal opening 502 then.The second portion 522 of perforator exports 503 places in transverse opening or penetrating parts and promotes sterile barrier downwards, like this, when penetrating parts when tissue site drives, its any material that can not puncture.
Below with reference to Figure 54 D, chuck pusher 525 engages with cam 550 (not shown), and beginning is pushed to downwards on the chuck 500.Perforated plate 520 can also move downwards with chuck 500, and the maximum that is pushed into it downwards up to it is to upper/lower positions, and penetrating parts anchor clamps 530 keep vertically static simultaneously.Leaving this connection that penetrating parts anchor clamps 530 move downward will make penetrating parts take off from anchor clamps.Perforated plate 520 is pushed against on the penetrating parts by projection 534 (Figure 55 A) substantially, keep penetrating parts with chuck, penetrating parts anchor clamps 530 are left in chuck 500 and perforated plate 520 reductions simultaneously, and in the present embodiment, these penetrating parts anchor clamps 530 keep vertically static.When chuck during with respect to clamp movement, this makes exhausted penetrating parts peel off from anchor clamps 530 (Figure 45 D).
At this moment, shown in Figure 54 E, perforated plate 520 is upwards return, and chuck 500 promotes to leave anchor clamps 530 fully downwards.At this moment, removed obstacle and be in rotatable position, chuck 500 advance a capsule cave or cavity make the aseptic penetrating parts of the new release in cavity 532 align with penetrating parts anchor clamps 530 in the direction, shown in Figure 54 F.Because finger piece engages with hole or pit 533 on the chuck, so chuck is rotated, shown in Figure 54 A.In certain embodiments, these pits 533 do not pass completely through chuck 500.In a further embodiment, these pits are the holes that pass completely through.Chuck has a plurality of than small rut 533 near the chuck center on top surface along internal diameter.In one embodiment, sterile barrier prescinds, so that do not cover these pits 533.Certainly, should be known in that these holes can be positioned at the bottom, sidepiece or other can be near on the surfaces.These pits 533 have two purposes.Other bonding feature that this device can have one or more locator pins, stationary pin or can not move.In the present embodiment, chuck is just lowerd in place, and in this position, anchor clamps 530 are clamped penetrating parts.In order to make the box indexing, chuck raises to break away from these pins or other bonding feature, be rotated, and these pins of loweing is used for next position.Rotary apparatus is by using two finger pieces: one is static pawl, and another is the slip finger piece.They engage with hole 533.Finger piece is driven by slider, and this slider can drive automatically, is perhaps driven by the user.This can by machinery, by the electricity or other power set carry out.In the halfway of stroke, finger piece can engage with chuck and rotate around chuck.More complete explanation is as seen in conjunction with the explanation of Figure 56 B-56C.
Below with reference to Figure 54 G, when the alignment of aseptic penetrating parts, chuck 500 is shown in arrow 540 and discharge, and recovery contacts with penetrating parts anchor clamps 530.New penetrating parts 541 is inserted in the anchor clamps 530, and this device performs the preparation of launching penetrating parts once more.For the present invention, after emission and between twice joint-cutting incident, exposed lancet or penetrating parts 541 are held in place by anchor clamps 530, thereby prevent penetrating parts protrusion or skid off from chuck 500 unexpectedly.
Certainly, should be known in and under the situation that does not break away from spirit of the present invention, can change the foregoing description.For example, penetrating parts 541 can be arranged in the placement location in the chuck 500 before emission.Shown in Figure 55 A, penetrating parts can be kept by the narrow 542 of chuck, thereby produces the interference engagement of the near-end of clamping penetrating parts.When static and the friction of mould or chuck keep penetrating parts, thereby prevent to slide before and after the penetrating parts.Certainly, also can adopt other method that keeps penetrating parts.Shown in Figure 55 B, before emission, penetrating parts anchor clamps 530 can be released part 542 with penetrating parts 541.Penetrating parts 541 can remain on this position, up to being driven by the solenoid that is connected with the penetrating parts anchor clamps or other force producer.Cam face 544 can be used for penetrating parts is pulled out part 542.This mechanical cam surface can be connected with the mechanical slider that is driven by patient, and this machinery slider can be thought force producer separately.Therefore, from patient's energy penetrating parts is pulled out, pull out the situation of penetrating parts with solenoid or electric drive and compare, this has reduced the consumption of device battery.The penetrating parts small distance (approximately 1mm or littler) that can travel forward from its placement location very is so that pull out penetrating parts from the resting position anchor clamps.After penetrate tissue, penetrating parts can be returned chuck, and finally is arranged in placement location.Although not necessary, this also can be undertaken by the power that patient provides.In one embodiment, lancet is not placed in the placement location, up to start the processing of loading new penetrating parts by patient.In another embodiment, in the action identical, carry out pulling out from placement location with the penetrating parts driving.Return placement location and also can think continuous action.
Figure 55 A has represented to be used to coordinate the cam of motion of perforated plate 520 and an embodiment on other surface.For example, in the present embodiment, cam 550 is circular, and engages with projection 524 and chuck pusher 525 on the perforated plate 520.Say that relatively Figure 55 A also more clearly shows projection 534, when penetrating parts anchor clamps 530 left penetrating parts, this projection 534 helped to make penetrating parts to remain in the chuck 500.Detent face 552 with cam 550 rotations can be used to prevent that cam from rotating backward.Being used for the rising load/unload penetrating parts, chuck 500 and perforated plate 50 and reducing can be by various cam faces, spring like the mode Mechanical Driven known to those skilled in the art.Some embodiment can also use the electric or magnetic device to load, unload and discharge exposed penetrating parts., perforated plate 520 moves, removes or remove paper tinsel or other gnotobasis closure member although being expressed as downward perforation, but should be known in that other method is such as, but be not limited to peeling off, spur, tear or the combination of one or more these methods can being used to remove paper tinsel or aseptic closure member.For example, in a further embodiment, perforated plate 520 can be positioned at the bottom side of chuck, and upwards perforation.In a further embodiment, it is vertically static that chuck can keep, and other parts are such as, but be not limited to penetrating parts anchor clamps and perforated plate motion, so that aseptic penetrating parts is loaded on the penetrating parts anchor clamps.
Figure 55 B has also represented the further feature that this device can comprise.Can comprise exciting button 560, so that the user drives penetrating parts.Can comprise front-end interface 561, so that make patient can place their finger that is used for joint-cutting or other destination organization.Interface 561 can be taken off, so that clean or change.Can comprise visual displays 562, so that to patient's display device state, joint-cutting character, error report etc.
Below with reference to Figure 56 A, also can be included on the housing so that load the mechanical slider 564 of new penetrating parts by patient's use.Can also connect slider 564, so that on the joint-cutting device, drive LCD or visual displays.So that make the chuck indexing, slider 564 all right conversion electron elements show so that begin except energy source is provided.The user can use display to select the joint-cutting degree of depth or further feature.Display can return dormancy once more, drives once more by the motion of slider 564 up to it.The bottom side of housing 566 also can be hinged, perhaps can otherwise take off, so that chuck 500 can be inserted in the device.Chuck 500 can utilize current being used for that the technology in CD or other dish insertion Disc player is inserted.In one embodiment, pallet can be arranged, this pallet can outwards launch, so that receive or take out chuck.Pallet can be retracted in the device, this device in, it can raise, reduce or otherwise carry in place, for use in the penetrating parts driver.In other embodiments, device can have slit, and chuck can locally insert in this slit, and at this moment, machinery inserts chuck help fully, and chuck is loaded in the correct position of device inside.Disc player on this device and the automobile is similar.Insertion/the ejection of these Disc players and loading attachment use gear, pulley, cable, pallet and/or other parts, and they can be used for the present invention.
Below with reference to Figure 56 B, this figure provides the more detailed view of an embodiment of slider 564.In this embodiment, slider 564 will at first motion shown in arrow 567.In order to finish circulation, patient will make slider return its original position or initial start position, shown in arrow 568.Slider 564 has arm 569, and this arm moves with slider, so that make cam 550 rotations, and engages with part 522.The motion of slider 564 also with finger piece 570 mechanical connections, this finger piece 570 engages with pit 571 on the chuck 500.This finger piece 570 is by synchronously making chuck 500 rotations as spurring in the arrow 572 be shown ins plane identical with chuck.Should be known in that in certain embodiments finger piece 570 promotes (rather than pulling) so that chuck is rotated along correct direction.Finger piece 570 can also be used for engaging with detent face 706, shown in Figure 66, so that make the chuck rotation.Finger piece 570 can also comprise comprising and moves both vertically, so that match with the rising and the reduction of chuck 500.The motion of finger piece 570 can also for example stepper motor or other device that is used to obtain to move provide power by electric actuator.Figure 56 B has also represented part encoder 573, that be used for position probing.
Below with reference to Figure 56 C, represented another view of slider 564 and arm 569 among the figure.Arm 569 motion is so that engages with part 522, and shown in arrow 575, and this makes cam 550 rotate, shown in arrow 577.In this particular example, cam 550 rotates about 1/8 circle along with each pulling of slider 564.When slider 564 returned its original or start position, arm 569 was crossed part 522.The motion of slider makes that also cam face 544 can be around pivoting point 579 rotations.Elastomeric element 580 can be connected with cam face 544, makes this cam face 544 rotation counterclockwise with convenient arm 569 when the direction of arrow 577 is moved.Pin 5800 will keep contacting with arm 569.When cam face 544 rotation, first surface 582 will contact with the pin 583 on the anchor clamps piece 584, and will sell 583 and retract, so that penetrating parts is stopped in the connection or narrow 542 of chuck 500, shown in Figure 55 A.When arm 569 returned the home position, cam face 544 back rotated, the rotation of second surface 586 clockwise directions, and promote penetrating parts forward, so that from narrow 542, discharge, thereby form position shown in Figure 55 B.Should be known in certain embodiments, lancet from part 542 release and/or stop in the part 542 and can provide power by driver 588, and do not adopt the mechanical assistance of cam face 544.
In another embodiment of chuck device, can on chuck, comprise mechanical features, like this, can only in one way chuck be loaded on the device.As non-limiting example, in the embodiment of 50 penetrating parts of a maintenance, chuck can have 51 capsule caves or cavity.When loading attachment, the 51st capsule cave will enter and excite the position, be used for making anchor clamps to place the position of chuck thereby provide, and penetrating parts do not discharged from gnotobasis simultaneously.In anchor clamps 530, zero position is at capsule cave or cavity inside, and this is that a capsule cave can be the reason of sky.Certainly, some embodiment can make anchor clamps 530 be positioned to clamp penetrating parts when time in device 500 charging apparatus, and patient is very fast subsequently that self is carried out joint-cutting, thereby makes the penetrating parts can aseptic closure member is outside not to be polluted owing to being exposed to for a long time.This zero position can be beginning and end position.Chuck can also be fluted, so as with device on bump bonds, be used to make the penetrating parts can only be thereby also provide with the method for a direction loading or unloading.Basically, chuck 500 can have key or the slit that links to each other with device, and like this, chuck 500 can only insert or take out along a direction.For example, shown in Figure 56 D, chuck 592 can have key shape slit 593, the outline of this key shape slit 593 and projection 594, and like this, chuck 592 can only take off by slit 593 is alignd with projection 594 in beginning or end position.Should be known in that other key technology also can use, and slit or key can be positioned at periphery or other position of chuck 592, be used for so only allowing chuck being inserted or taking out along the direction of or selected number.
Below with reference to Figure 57, represented to hold the cutaway view of another embodiment of the cavity 600 of penetrating parts among the figure.Cavity 600 can comprise concave portions 602, is used to make anchor clamps 530 enough to penetrate in the cavity deeply, so as with penetrating parts 541 frictional engagement.Penetrating parts can also be packed in the groove 604, and before driving and afterwards, this groove 604 is held in place penetrating parts.In the driving process, penetrating parts 541 raises so that leave groove 604, and comes out by opening 506.
Below with reference to Figure 58, will introduce another version of system of the present invention below.Figure 58 has represented joint-cutting system 610, and wherein, penetrating parts makes the most advanced and sophisticated radially inner side that points to of their sharpening.Patient's finger or other tissue pass centre bore 611 and insert, so that by parts 612 punctures.Operate in mode identical described in basic and Figure 54 A-G with the penetrating parts anchor clamps 530 that driving force generator 613 connects.Perforated portion 521 and 522 is operated in essentially identical mode, so that penetrating parts is discharged from aseptic closure member.Perforated portion 522 can be arranged on the inner rim of device, and at this moment, the penetrating parts outlet is positioned on this inner rim, and therefore, aseptic closed material is removed from the passage of penetrating parts outlet.
Below with reference to Figure 59, introduce another version of joint-cutting of the present invention system below.In the embodiment shown in Figure 53-54, near penetrating parts, and at least a portion of drive system is arranged in the plane different with chuck 500 to penetrating parts anchor clamps 530 from top.Figure 59 has represented an embodiment, and wherein, penetrating parts driver 620 is in the plane identical with penetrating parts 622 substantially.Adapter 624 engages with the crooked or L shaped part 626 of parts 622.Chuck 500 can rotate, so that new penetrating parts is engaged with adapter 624, does not need to make chuck or adapter to move both vertically simultaneously.Next penetrating parts rotates to the position in the slit on adapter 624.The narrow of chuck is as the penetrating parts guiding piece near the penetrating parts far-end, so that penetrating parts is alignd when leaving chuck.
Below with reference to Figure 61, represented the chuck 640 that uses with plane inner driver 620 among the figure.Chuck 640 comprises sky slit 642, and this sky slit makes chuck arrange in place with respect to driver 620.In this embodiment, this sky slit 642 can make adapter 644 be positioned to engage with untapped penetrating parts 645, and this penetrating parts 645 can be rotated in place, shown in arrow 646.Shown in Figure 61, chuck 640 can also be designed to only to seal penetrating parts, need the part (promptly in fact may penetrate in-house part) that keeps aseptic.Shown in Figure 61, the portions of proximal 647 of penetrating parts exposes.The portions of proximal of this exposure can be about 70% of a penetrating parts.In another embodiment, it can be penetrating parts about 69% to about 5% between.Chuck 640 can also comprise (but not necessary) seal convexity 648.These projectioies 648 are connected with chuck 640 releasedly, and when chuck rotation so that remove from chuck 640 by extracting tool 649 when making penetrating parts place effective penetrating parts position.Before parts 645 drive gnotobasis is broken, and parts do not penetrate aseptic closed material, this aseptic closed material may make tip rust in the driving process of penetrating parts.Rupturable encapsulant 650 can be applied on the parts, so that seal up the interior circumferential portion of chuck.
Another embodiment that is used for chuck of the present invention below with reference to Figure 62 introduction.This chuck 652 comprises tapering part 654, is used to make adapter 655 can enter cavity 656.Narrow 657 guiding penetrating parts 658.Adapter 655 can have (but must not have) active chuck 659, and this active chuck 659 engages, so that clamp penetrating parts 658.Allowing adapter to enter cavity 656 can make penetrating parts keep alignment in the driving process better.This tapering part 654 can be used for any chuck embodiment described here.
Be used for linear chuck of the present invention below with reference to Figure 63 introduction.Although the present invention has represented to be used for radial chuck, the joint-cutting system also can be used for the chuck of other shape.Figure 79-83 has represented can be used for other chuck of different shape of the present invention.Figure 63 has been provided by 660 some 662 sterility protections that provide for penetrating parts of chuck.But, chuck 660 has base 664, and penetrating parts 665 can place on this base 664.This provides the protection of certain level to penetrating parts in processing procedure.Base 664 can also form provides slit 666, penetrating parts 667 can remain in this slit 666.Slit 666 can also be suitable for having tapering part 668.These structures go for any embodiment described here, and for example chuck 652.
Below with reference to Figure 64 A-64C, various different devices are expressed as the sterile sealing spare that is used to discharge the transverse opening 503 that covers chuck 500.Figure 64 A has represented rotary piercing device 670, and this rotary piercing device 670 has projection 672, and this projection 672 makes sterile barrier perforation, thereby produces opening 674, and penetrating parts can with under the situation that the sterile barrier material contacts not left from this opening 674.Figure 64 B has represented vertical rotary apparatus 676, and this vertical rotary apparatus 676 has the projection 678 that is shaped, and this projection will be bored a hole downwards along sterile barrier 679 when effectively exciting the position rotating to.Figure 64 C has represented perforator 680, and this perforator 680 is positioned to make barrier 682 perforation when chuck is reduced on the perforator 680.The chuck rotation, perforator 680 rotates with this chuck.When chuck rotated to correct position and raises, perforator 680 was loaded with elastic load or otherwise is arranged to return the position that engages with the sterile barrier that covers next untapped penetrating parts.
Introduce the another kind of punch block mechanism that is used for perforated plate 520 below with reference to Figure 65 A-65B.Device shown in Figure 53-54 has such mechanism, and this mechanism at first bores a hole, and makes the penetrating parts rotation of release or indexing then and in place.In the present embodiment, chuck at first rotates, and anchor clamps and perforator are moved downward simultaneously.Figure 65 A has represented an embodiment of perforator 685, and this perforator 685 has first 686 and second portion 687.Shown in the cutaway view of Figure 65 B, penetrating parts anchor clamps 690 are positioned at perforator 685 inside.Therefore, sterile barrier penetrates to be integrated in and makes in penetrating parts and the step that anchor clamps 690 engage.Perforator 685 can comprise slit 692, and this slit 692 can extend upward the part 694 of anchor clamps 690.Transverse opening 695 is provided, and penetrating parts can be left from this transverse opening.In certain embodiments, perforated portion 687 does not comprise perforator 686, but depends on some other mechanism, for example as shown in Figure 64 A-64C, so that force down to the barrier material that covers transverse opening 503.
Introduce another embodiment of chuck of the present invention below with reference to Figure 66.Figure 66 has represented to have a plurality of cavitys 702 and the chuck 700 of deflector or finger piece 704 separately.The end of protection cavity 702 can be divided into the independent finger piece (for example a finger piece has a cavity) on the periphery of dish.Each finger piece 704 can be covered (not shown for the ease of expression) by paper tinsel and seal respectively, so that keep aseptic, when using.Along the bossed step part 706 of the inner rim of chuck 700, so that produce the ratchet type of mechanism.Shown in Figure 67, penetrating parts 708 can be packed in each cavity.Penetrating parts can place on the bump 710.Narrow 712 is clamped the portions of proximal of penetrating parts 708.Each cavity can comprise wall part 714, and after penetrating parts was used, this penetrating parts 708 can be pressed in this wall part 714.Figure 68 has represented penetrating parts anchor clamps 716, and these penetrating parts anchor clamps 716 reduce so that engage with penetrating parts 708A.For the ease of expression, expression does not cover the sterile barrier of each cavity.
Introduce the sequence of steps of the penetrating parts be used for driving chuck 700 below with reference to Figure 69 A-69L.Should be known in that in other embodiments under the situation that does not break away from spirit of the present invention, step can make up or reduce.Last penetrating parts to be used can be stayed going-back position, is caught by anchor clamps 716.The end of protection cavity 704 can deflect down by the driving of front.The manipulable mechanism of user such as, but be not limited to: thumb wheel, lever, crank, slider etc., this mechanism makes new penetrating parts 720 enter transmitting site, shown in Figure 69 A.Mechanism raises bar, this allow protection cavity return it, the initial position in the dish plane.
In the embodiment shown in Figure 69 B, penetrating parts guiding piece 722 forces down the paper tinsel that is passed in rear portion, capsule cave, so that " facing to (home) " penetrating parts and control the down suction.For easy diagram, be used to make the driving device of penetrating parts guiding piece 722 and other mechanism kinematic not shown.They can be spring, cam or other device, and they can make parts shown in the figure reduce and motion.In certain embodiments, chuck 700 can raise or reduce, so as with penetrating parts guiding piece 722 and other means for engaging.
Shown in Figure 69 C, colter or aseptic closure member releasing device 724 reduce, so that engage with chuck 700.In certain embodiments, dish or chuck 700 risings that can partly make progress, up to colter or scraper plate 724 sterile barriers 726 that puncture, this sterile barrier 726 can be that paper tinsel covers.
Below with reference to Figure 69 D, colter 724 is removed paper tinsel from front portion, capsule cave, and it is installed on the chuck 700.Colter 724 radially inwardly drives, and cuts sterile barrier, and in the colter front with the chip coiling.When the anterior angle of colter and horizontal direction are about 55 when spending, paper tinsel curls naturally and forms tight volume.The angle of colter can be approximately between the 60-40 degree, preferably near 55 degree.In certain embodiments, paper tinsel can be removed by this way, and like this, penetrating parts does not need any aseptic closed material that punctures in emission process.
Below with reference to Figure 69 E, anchor clamps 716 can reduce, so that engage with the penetrating parts and the lancet and means 720 that expose.Also can select, dish or chuck 800 can raise, and firmly are pressed in the anchor clamps 716 up to penetrating parts 720.Although not shown at this, the penetrating parts driver or the actuator of present embodiment can remain in the horizontal plane identical with penetrating parts.
Shown in Figure 69 F, bar 730 can force down to the protection cavity outer end 732 on so that make its deflection, it leaves the path of penetrating parts like this.In the present embodiment, bar 730 forms and allows exposed penetrating parts 720 to pass.The bar (for example only contacting with a side or the part of end 732) that should be known in other shape and orientation can be used for engaging with end 732.
Below with reference to Figure 69 G, electrical solenoid or other electronics or feedback control driver can radially outward drive anchor clamps 716, thereby make it carry exposed penetrating parts 720.Exposed penetrating parts is stretched out from containment vessel, and penetrates the finger above the hole that is arranged in actuator or the skin of other tissue site.Suitable penetrating parts driver as common transfer the possession of and the U.S. Patent application No.10/127395 (lawyer's case No.38187-2551) of common pending trial described in, the applying date of this U.S. Patent application is on April 19th, 2002.
Below with reference to Figure 69 H, solenoid or other suitable penetrating parts driver retreat to going-back position exposed penetrating parts 720, and it stops at this going-back position, up to the next joint-cutting circulation of beginning.
Below with reference to Figure 69 I, bar 730 can discharge, and like this, end 150 is returned and chuck 800 coplanar structures.
Shown in Figure 69 J, anchor clamps 716 can radially outward drive exhausted exposed penetrating parts, up to fine away most advanced and sophisticated at cavity 732 places, outer end or near imbed in the plastic wall 714, thereby the penetrating parts of fixed-contamination.
Shown in Figure 69 K and 69L, colter 724, anchor clamps 716 and penetrating parts guiding piece 722 can be thrown off with exposed penetrating parts 720.Also can select, should be known in that advancement mechanism can make chuck 700 reduce from anchor clamps 716.Lid paper tinsel most advanced and sophisticated and at the place, opposite end in the plastics limits by embedding, exhausted penetrating parts is peeled off from anchor clamps.Dish or chuck 700 can rotate, the position below aseptic penetrating parts new, sealing is in trigger mechanism.
Below with reference to Figure 70 and 71, the purpose of some embodiment of the present invention is to comprise blood sampling and detection in this penetrating parts driving device.In this embodiment, driving mechanism (anchor clamps 738 and serpentine pipe drive coil 739) can be used for penetrating parts is pressed into skin, and obtains blood sample in conjunction with this joint-cutting incident when blood sample is formed at finger surface.In first embodiment shown in Figure 70, there is the microfluid module 740 of detection of analytes parts chemistry and checkout gear 742 (Figure 71) to be connected on the axle of penetrating parts 720.Above-mentioned driving circulation also can driver module 740, and like this, it places on the finger surface, obtains blood when returning from wound with convenient penetrating parts.Module 740 can remain on finger surface or other tissue site, and up to the rear end 744 of anchor clamps 738 arrival microfluid modules 740, at this moment, module also is retracted in the housing.In the present embodiment, module 740 remain on the finger time quantum can according to end 744 localized distances and in returning stroke anchor clamps engage the time quantum that is spent with it and change.Then, be full of the module 740 (when module remains on the puncture tissue site, filling) of blood by carrying out detection of analytes such as, but be not limited to optics or Electrochemical Detection.
Blood can be full of in the tube chamber, and penetrating parts is in this separate space, and perhaps module can have the sample chambers of determining separately at penetrating parts separate space sidepiece.The detection of analytes parts also can be arranged near the middle part just, perhaps retreat from the module opening that receives blood a little, like this, still have the blood of less capacity will arrive the detection of analytes parts.In certain embodiments, therefore detection of analytes parts and visual displays and other interface can provide the reading of analyte level on device, do not need simultaneously device and test strip are inserted in the independent reader device.Shown in Figure 71, lid 746 also can be for transparent, so that allow light by carrying out optical detection.The detection of analytes parts can adopt low capacity, for example less than about 1 microlitre sample,, are more preferably less than about 0.3 microlitre preferably less than about 0.6 microlitre, and most preferably be less than 0.1 microlitre sample.
In another embodiment shown in Figure 72, according to direction, detecting element 760 can directly print or be formed at the top side of the bottom of penetrating parts chuck 700.Then, exposed penetrating parts is passed the hole 762 in the plastic cover and is driven, and subsequently blood sample is sucked in the radial cavities.Then, electrochemistry or the optical detection apparatus that is used for detection of analytes can be operated (Figure 72).Also have, cavity 766 can have transparent part, so that light can be passed through, thereby carries out optical detection.In one embodiment, a lot of miniature detection of analytes parts field can be arranged on the base plate of radial cavities (shown in Figure 72), perhaps on the microfluid module shown in Figure 71, so that can bleed and carry out a plurality of tests on the single analyte of liquid forming one, so that improve accuracy and the precision of measuring.But be not limited to this mode, can also comprise additional detection of analytes parts field or zone, be used for demarcating or other purpose.
Introduce another embodiment of chuck of the present invention below with reference to Figure 73.Figure 73 has represented an embodiment of chuck 800, and this chuck 800 removably inserts and is used to drive in the device of penetrating parts, so that skin puncture or tissue.Chuck 800 has a plurality of penetrating parts 802, and these penetrating parts 802 can drive separately or selectively, and like this, penetrating parts 802 can be protruding from chuck, shown in arrow 804, so that penetrate tissue.In the present embodiment, chuck 800 can based on have a plurality of penetrating parts (such as, but be not limited to: 25,50,75,100...) flat disc, these penetrating parts radial arrangement are on dish or chuck 800.Should know, although chuck 800 is expressed as dish or dish type housing, but under the situation that does not break away from spirit of the present invention (arranging a plurality of penetrating parts), also can adopt the chuck of other shape or structure so that individually or in combination engage with the penetrating parts driver.
Each penetrating parts 802 can be included in the cavity 806 in the chuck 800, the pointed end radial outward of penetrating parts simultaneously, and each penetrating parts can be in the plane identical with chuck.This cavity 806 can be molded in this chuck, punching press, forging or otherwise form.But be not limited to this mode, the end of cavity 806 can be divided into the independent finger piece (for example is used for a cavity) on the periphery of dish.The given shape of each cavity 806 can be designed to be fit to the size or the shape of penetrating parts wherein, perhaps is suitable for arranging the space of detection of analytes parts 808.Such as, but be not limited to, cavity 806 can have V-arrangement cross section, U-shaped cross section, C tee section, multistage cross section or other cross section.Make the penetrating parts 802 can be by leaving so that the opening of penetrate tissue 810 also can have different shape, such as, but be not limited to: circular open, square or rectangular aperture, U-shaped opening, only allow narrow openings that penetrating parts passes through, have the opening, slit in bigger gap, structure or other shape shown in Figure 75 at sidepiece.
In this embodiment, after driving, penetrating parts 802 is returned in the chuck, and can remain in the chuck 800 in the mode that can not reuse.Such as, but be not limited to: exhausted penetrating parts can be returned in the chuck, and is held in place by emitter, up to joint-cutting incident next time.When joint-cutting next time, emitter can be thrown off with exhausted penetrating parts, chuck 800 rotates or the extremely next penetrating parts that cleans of indexing simultaneously, like this, keeping the cavity of exhausted penetrating parts to be positioned at can not be by the approaching position of user (promptly being rotated away from the penetrating parts exit opening).In certain embodiments, the tip of exhausted penetrating parts can be pressed in the protection retainer, and this protection retainer is held in place penetrating parts after use.All used out-of-dately when all penetrating parts, perhaps under time or situation that the user sees fit, chuck 800 can be changed by new chuck 800.
Still with reference to the embodiment among Figure 73, chuck 800 can be provided for the gnotobasis of penetrating parts by sealing member, paper tinsel, lid, polymer or the similar material that is used for sealed cavity, and is provided for closed area that penetrating parts is placed in one.In the present embodiment, paper tinsel or sealant 820 are applied on the surface of chuck 800.Sealant 820 can be made by different materials, such as, but be not limited to metal forming or other encapsulant, hot strength and other character perhaps can be arranged, they can provide sealing, gnotobasis, up to penetrating sealant by suitable device or penetrating device, device that this is suitable or penetrating device provide power predetermined or selected size to open the gnotobasis of sealing.Lid cavity 806 can be by layer 820 and independent sealed, like this, a cavity open the aseptic that can not influence adjacent or other cavity in chuck 800.As shown in the embodiment of Figure 73, sealant 820 can be the planar materials that is bonded on the top surface of chuck 800.
According to the direction of chuck 800 in the penetrating parts drive assembly, sealant 820 can be on the surface of top surface, side surface, basal surface or other position.Illustrate and illustrate the embodiment of Figure 73 for convenience, layer 820 is arranged on the top surface of chuck 800.Keep the cavity 806 of penetrating parts 802 to seal, therefore produce the gnotobasis that is used for penetrating parts by paper tinsel layer 820.Paper tinsel layer 820 can seal a plurality of cavitys 806, perhaps only seals the cavity of selected number as required.
In another feature of Figure 73, chuck 800 can selectively be included in a plurality of detection of analytes parts 808 on the substrate 822, and this substrate 822 can be installed on the basal surface of chuck 800.Substrate can be made with the material that keeps detection of analytes parts 808 by being suitable for being installed on the chuck, such as, but be not limited to: polymer, paper tinsel or other material.Shown in Figure 73, substrate 822 can keep a plurality of detection of analytes parts, such as, but be not limited to: approximately other combination of 10-50,50-100 or detection of analytes parts.This helps the assembling of detection of analytes parts 808 and chuck 800 and integrated.These detection of analytes parts 808 make it possible to form integrated bodily fluid sampling system, wherein, penetrating parts 802 is created in the wound road in the destination organization, and this wound produces body fluid, this body fluid flows in the chuck, is used for carrying out detection of analytes by at least one detection of analytes parts 808.Substrate 822 can comprise detection of analytes parts arbitrary number, that be suitable for check and analysis thing in the chuck with a plurality of cavitys 806.In one embodiment, a plurality of detection of analytes parts 808 can be printed on the single substrate 822, and this substrate 822 is bonded on the chuck more then, so that make and the simplification assembling.Detection of analytes parts 808 can be electrochemical properties.Detection of analytes parts 808 can also comprise enzyme, dyestuff or other detector, and they will react in being exposed to the suitable analysis thing time.In addition, detection of analytes parts 808 can comprise transparent optical window, and this window makes that light can be by entering in the body fluid, so that carry out analyte analyzation.The number of detection of analytes parts 808, position and type can suitably change, and part is based on the susceptiveness of number, detection of analytes parts calibration request and the detection of analytes parts of the design of chuck, analyte to be measured.When chuck 800 uses a kind of detection of analytes modular construction (in this detection of analytes modular construction, the detection of analytes parts are on the substrate that is installed on the chuck bottom) time, through hole (shown in Figure 76), wicking element, capillary tube or other device can be arranged on chuck 800, so that make body fluid flow to detection of analytes parts 808, thereby analyze from chuck.In other structure, detection of analytes parts 808 can print, form or otherwise be located immediately in the cavity that holds penetrating parts 802, perhaps are located in the zone on the chuck surface that receives blood behind the joint-cutting.
Use sealant 820 and substrate or detection of analytes component layer 822 can be so that the manufacturings of these chucks 10.For example, single sealant 820 can be bonding, install or otherwise be connected with chuck 800, shown in arrow 824, so that seal a plurality of cavitys 806 simultaneously.The thin slice 822 of detection of analytes parts also can be bonding, install or otherwise is connected with chuck 800, shown in arrow 825 so that the while a plurality of detection of analytes parts are provided on chuck.In the manufacture process of one embodiment of the invention, chuck 800 can be equipped with penetrating parts 802, the temporary layer (not shown) of (this substrate 822 will be contained on this bottom afterwards) seals by layer 820 with in the bottom, so that be provided for the sealed environment of penetrating parts.Then, this assembly with interim bottom sterilizes.After sterilization, assembly is delivered to cleaning room (or this assembly is in cleaning room or in the environment that is equal to), and in this cleaning room, interim bottom will be removed, and the substrate 822 with detection of analytes parts will be connected with chuck, shown in Figure 73.This method allows use may damage the accuracy of the detection of analytes parts on the substrate 822 or the processing and/or the temperature of function comes the chuck assembly with penetrating parts 802 is sterilized.As a non-limiting example, follow whole chuck 800 and can be placed in another sealed container (such as, but be not limited to bag, bag, plastic pattern container made etc.), so that help contact, improve durability, and/or feasible more easily manipulation.
In certain embodiments, can use a plurality of sealants 820 to come sealed cavity 806.In certain embodiments, multilamellar can be arranged on each cavity 806, half of cavity or some selected parts can be sealed by one deck, and second half of cavity or selected part can be by other thin slice or layer sealings, and difform cavity can use different sealant etc.Sealant 820 can have different physical properties, near the sealant that for example covers penetrating parts 802 the chuck end can have different colours such as, but be not limited to redness, so that before chuck should be changed, the available penetrating parts of user has dropped to had only 10,5 or other number to user indication (but when visual observation time).
Introduce the microfluid embodiment of the detection of analytes parts 808 that are used for chuck 800 below with reference to Figure 74 and 75.Illustrate for convenience, the shape of cavity 806 is simplified to single wedge-type shape.Should be known in also and can use more complicated shape, such as, but be not limited to shown in Figure 73.Figure 74 has represented conduit 826, and this conduit 826 helps body fluid is inhaled to detection of analytes parts 808.In the present embodiment, two detection of analytes parts 808 are expressed as in cavity 806.This just is used to represent purpose, because as required, cavity 806 can have only detection of analytes parts, and the detection of analytes parts of other number are arbitrarily perhaps arranged.The body fluid that enters cavity 806 also will be attracted to detection of analytes parts 808 by the capillarity of groove 826 when being full of the part cavity.These detection of analytes parts 808 can all carry out identical analysis, can carry out dissimilar analyses separately, perhaps can be two kinds of combinations (some pick offs carry out identical analysis and other carry out other analysis).
Figure 75 has represented the fragmentary, perspective view of cavity 806.Penetrating parts 802 (being represented by dotted lines) is packed in the cavity 806, and can pass penetrating parts exit opening 830 and protruding, shown in arrow 832.The position at the tip of penetrating parts 802 can change, such as, but be not limited to close penetrating parts exit opening or spaced apart with this outlet.Most advanced and sophisticated position with respect to detection of analytes parts 808 can change, and such as, but be not limited to leaving detection of analytes parts or spaced apart, perhaps puts together with detecting the thing parts, perhaps near the detection of analytes parts.Then, fluid can enter cavity 806, and by conduit 826 guiding.Shown in Figure 75, conduit 826 is at open-topped groove.Conduit 826 can be that whole groove has open top, and perhaps it can some have the sealing top, thereby forms tube chamber, and perhaps groove can seal, except the opening near penetrating parts exit opening 830 places.Should be known in that the groove that uses a surface to expose can obtain capillarity.In certain embodiments, detection of analytes parts 808 are near penetrating parts exit opening 830, and like this, detection of analytes parts 808 may not need capillarity groove or conduit to attract body fluid, shown in Figure 78.
Shown in Figure 75 and 76, cavity 806 can comprise substrate 822, and this substrate 822 is connected with the basal surface that comprises detection of analytes parts 808 of cavity 806.By making detection of analytes parts 808 be positioned at the bottom side of chuck 800, shown in the embodiment among Figure 76, chuck 800 can comprise at least one through hole 834, makes body fluid lead to the passage of detection of analytes parts 808 from cavity 806 so that provide.The size of through hole 834, position, shape and further feature can change according to the number of cavity 806 and the detection of analytes that provides parts 808.In other embodiments, wicking element etc. can be used for by through hole 834 body fluid being inhaled to detection of analytes parts 808 from groove 826.
Below with reference to Figure 77, different slots and detection of analytes modular construction on single chuck have been represented among the figure.Just in order to represent purpose, single chuck can not comprise all these structures to these structures.Some embodiment can use detection part arbitrarily single or in combination.But, should know, the detection of analytes modular construction can customize each cavity, such as, but be not limited to: use the detection of analytes parts of different numbers and position according to the joint-cutting variable (such as, but be not limited to joint-cutting event times, the types of analytes that will measure of every day, the test position of wanting joint-cutting, horny layer hydration or other joint-cutting parameter) relevant with cavity.As non-limiting example, detection part can shift near towards the outer rim of dish, more on sidewall, and combination in any, or like that.
Figure 77 has represented the penetrating parts 802 in cavity 838, and three detection of analytes parts 808 are arranged in this cavity.For easy diagram, omitted penetrating parts 802 in remaining cavity, like this, can more easily see the detection of analytes modular construction.Cavity 840 has conduit 826, and this conduit 826 has two detection of analytes parts 808.Cavity 842 has conduit 844, and this conduit 844 is connected with single analyte detection part 808.Cavity 846 and 848 has one and two detection of analytes parts 808 respectively.Detection of analytes parts 808 in these cavitys can directly be arranged in the penetrating parts exit of chuck, perhaps substantially in the penetrating parts exit.Also can adopt other detection of analytes modular construction, such as, but be not limited to: with one or more detection of analytes arrangements of components on the sidewall of cavity, with particular arrangement (linear arrangement for example, rounded projections arranged, square arrangement etc.) with the detection of analytes arrangements of components on sidewall or basal surface, use detection of analytes parts (for example electrochemistry and the optics of mixed type, perhaps some other combination), (for example perhaps make detection of analytes parts mixed positioning, on the substrate of at least one detection of analytes parts below chuck, and at least one detection of analytes parts is in cavity).
Figure 78 has represented the embodiment of chuck 800, wherein, and near the far-end of detection of analytes parts 850 seat cavitys 806.Detection of analytes parts 850 can form, deposit or otherwise be installed on the chuck 800.In another embodiment, analyzing and testing parts 850 can be well or the pits that the bottom is arranged, and this bottom is fully transparent, so as to make the optical analysis quality testing survey parts can detect be deposited in the well or fluid that pit is interior in analyte.Well or pit also can comprise some analyte reagent, when body fluid places this well, and this analyte reagent will react (fluorescence, change color or other detectable character is arranged).In another embodiment, detection of analytes parts 850 can be replaced by through hole, and this through hole allows fluid to pass through.Detection of analytes parts 808 on substrate 822 can be installed in the bottom side of chuck 800, and the fluid that enters leads to detection of analytes parts 808 downwards from cavity 806.
As mentioned above, detection of analytes parts 808 can also be arranged near the module opening that receives blood just, perhaps retreat from the module opening a little, and like this, low volume blood also will arrive the detection of analytes parts.Detection of analytes parts 808 can be used for low volume, for example less than about 1 milliliter of sample,, are more preferably less than about 0.3 milliliter preferably less than about 0.6 milliliter, and most preferably be less than about 0.1 milliliter of sample.Detection of analytes parts 808 can directly print or be formed at the bottom of penetrating parts chuck 800.In one embodiment, a plurality of miniature detection of analytes parts field can be arranged on the base plate of radial cavities or on the microfluid module, so that can carry out a plurality of tests to the single analyte of the liquid of singly bleeding, so that improve accuracy and the precision of measuring.But be not limited to this mode, also can comprise additional detection of analytes parts field or zone, so that demarcate or other purpose.
Introduce other embodiment of chuck 800 below with reference to Figure 79-84.Figure 79 has represented to have the chuck 860 of semicircular in shape.Figure 80 has represented to be the chuck 862 of local curve shape.Figure 80 has represented that also chuck 862 can be stacked to different structure, such as, but be not limited to vertically, horizontal direction or other direction.Figure 81 has represented to have the chuck 864 of basic rectilinear form.Figure 82 has represented a plurality of chucks 864, and these chucks 864 are arranged to from the center 866 and radially outward stretch out.Each chuck can be on sliding part (not shown for simplification), and this sliding part makes chuck 864 radially outward to slide, so that align with the penetrating parts emitter.After use, chuck 864 866 slides and to return towards the center, and whole assembly rotates shown in arrow 868, so that make new chuck 864 be in the position that is used for the penetrating parts driver.Figure 83 has represented another embodiment, and wherein, a plurality of chucks 800 can stacking, for use in penetrating parts driver (seeing Figure 85).Driver can move into it self is alignd with each chuck 800, and perhaps chuck can move into they self are alignd with driver.Figure 84 has represented another embodiment, and wherein, a plurality of chuck 864 links together by flexible support, so that be specified to one group.Roller 870 can be used to make chuck 864 to move to the position that is driven by penetrating parts driver 872.
Below with reference to Figure 85, represented to use an embodiment of the device 880 of radial chuck 800 among the figure with penetrating parts driver 882.Wheel profile surface 884 is positioned near the penetrating parts exit opening 886, thereby makes patient their finger can be arranged in the position that is used for joint-cutting.Although not shown, device 880 can comprise that people can read or the visual displays of other type, so that to user's transmit mode.Display also can be represented the analyte level measured or other measured value or to user's feedback, do not need simultaneously with device 880 or separately test strip insert independent analyte reader device.Device 880 can comprise processor or other logic circuit, is used to drive penetrating parts or is used for Measurement and analysis thing level.Chuck 800 can in the charging apparatus 880, this top shell can hinged or removably be connected with bottom shell by the top shell of device for opening.Chuck 800 can also use loading attachment and in the drawn-back device 880, and this loading attachment is at the loading attachment that is similar to use in Disc player etc. in the design.In this embodiment, device can have slit (being similar to the CD Player in the automobile), and this slit allows chuck 800 is inserted in the device 880, the position or other position that are used to operate in the automatic again charging apparatus of this chuck.Loader mechanism can mechanically provide power or provide power by electricity.In certain embodiments, except slit, loader mechanism can use loading pallet.Slit can be arranged as higher on housing, and like this, chuck 800 will have enough gaps to come in the charging apparatus, then above falling to penetrating parts driver 882.Chuck 800 can have indicator mark or indexing device, and it makes chuck 800 when putting into device 880 and loader mechanism or registration mechanism proper alignment.Chuck 800 can place on the radial platform, and therefore this platform provides to be used to make chuck to advance, so that the method that untapped penetrating parts is engaged with the penetrating parts driver around 882 rotations of penetrating parts driver.Chuck 800 can form certain contour shape on its bottom side or other surface, such as, but be not limited to being formed with groove, groove, towing pad, optical markings etc., so that handle chuck and/or make the chuck indexing.These shapes or surface also can change, so that indicate this chuck almost not have untapped penetrating parts, indicate only remaining 5 penetrating parts or indicate some other chuck state indication as required.
Introduced appropriate method and the device that is used to load penetrating parts in the U.S. Patent application (lawyer's case 38187-2589 and 38187-2590) of aforementioned common transfer, common pending trial, they are included in herein by reference for this reason.Common transferring the possession of, introducing in the U.S. Patent application (lawyer 38187-2601 and 38187-2602) of common pending trial and be used for the appropriate device that engages and be used to remove the protective material that is connected with the penetrating parts cavity with penetrating parts, so they are incorporated herein by reference.For example, in the embodiment of Figure 78, paper tinsel or sealant 820 can cavity extends and cover this cavity along inclined surface 892 extension downwards by crossing along top surface 890, so that the gnotobasis of sealing is provided, is used for wherein penetrating parts and detection of analytes parts.The piercing element of introducing in U.S. Patent application (lawyer 38187-2602) has piercing element, therefore push paper tinsel to cavity sidepiece or other position at the shaped portion of this element back, like this, penetrating parts 802 can drive, and body fluid can flow in the cavity.
Introduce another embodiment of joint-cutting of the present invention system below with reference to Figure 86.Can comprise radial chuck 500, for use in penetrating parts driver 882.Penetrating parts can outwards drive, shown in arrow 894.A plurality of detection of analytes parts are present on the coiled material 895, and this coiled material 895 is arranged near the penetrating parts outlet.Coiled material 895 can advance, and shown in arrow 896, like this, exhausted detection of analytes parts leave effective site.Coiled material 895 can also be replaced by the dish that keeps a plurality of detection of analytes parts, and wherein, detection of analytes parts dish (not shown) is oriented in basic and the vertical plane, chuck 500 planes.Detection of analytes parts dish can also for not with parallel plane other angle of chuck 500 so that can rotate, and new, untapped detection of analytes parts are arranged in proper order with respect to chuck 500, the new penetrating parts of not using.
Below with reference to Figure 87 A, chuck 500 provides the high density that is used for joint-cutting system packaging system.This form makes patient to load a large amount of penetrating parts by single chuck, remains basic hand-held device simultaneously.Certainly, this chuck 500 also can be used for non-hand-held device.This chuck 500 provides the very high test density of volume each time.For the chuck embodiment that also comprises the detection of analytes parts except penetrating parts (for example chuck 800), density also can be measured as the form of the density of detection of analytes parts in once and penetrating parts.In another embodiment, density can be expressed as the form of detection of analytes parts each time.For example, by the physics volume that obtains an embodiment or always seal, can make this number divided by penetrating parts number or test number.This result is each penetrating parts or each volume of testing in the box-like formula.For example, in one embodiment of the invention, the total measurement (volume) of chuck 500 is defined as 4.53 cubic centimetres.In this embodiment, chuck 500 keeps 50 penetrating parts.Make this volume divided by 50, the volume of each test is 0.090 cubic centimetre.The scope that common test set for example rouses is 0.720 or 0.670 cubic centimetre, and it just is equipped with the volume of a plurality of test strip.This does not comprise penetrating parts, as present embodiment 800.Therefore, present embodiment is higher substantially density.Even have penetrating parts and analyzing and testing parts and the device of low-density a little in 0.500 cubic centimetre of scope, also improve greatly than known devices, do not comprise penetrating parts because be used for the above-mentioned numeral of known devices, just the packing of each test strip.
Each penetrating parts (perhaps may be penetrating parts and detection of analytes parts sometimes) can have the packing density in chuck 500 or occupy volume.In different embodiment, each penetrating parts in chuck 500 packing density or occupy volume and can be no more than about 0.66cm
3, 0.05cm
3, 0.4cm
3, 0.3cm
3, 0.2cm
3, 0.1cm
3, 0.075cm
3, 0.05cm
3, 0.025cm
3, 0.01cm
3, 0.090cm
3, 0.080cm
3Deng.These numerals can be the volumes that is used for penetrating parts separately, perhaps are used for the combination of penetrating parts and detection of analytes parts.In other words, the required volume of each penetrating parts is no more than 0.66cm
3/ penetrating parts, 0.05cm
3/ penetrating parts, 0.4cm
3/ penetrating parts, 0.3cm
3/ penetrating parts, 0.2cm
3/ penetrating parts, 0.1cm
3/ penetrating parts, 0.075cm
3/ penetrating parts, 0.05cm
3/ penetrating parts, 0.025cm
3/ penetrating parts, 0.01cm
3/ penetrating parts, 0.090cm
3/ penetrating parts etc.Therefore, when the overall package volume of chuck is defined as X, and chuck is when comprising Y penetrating parts, penetrating parts and test zone or other unit 395, and each unitary volume is no more than 0.66cm
3, 0.05cm
3, 0.4cm
3, 0.3cm
3, 0.2cm
3, 0.1cm
3, 0.075cm
3, 0.05cm
3, 0.025cm
3, 0.01cm
3, 0.090cm
3, 0.080cm
3Deng.
Introduce another embodiment of chuck of the present invention below with reference to Figure 87 B.Figure 87 B has represented the cutaway view of conical chuck, and this taper shape chuck has penetrating parts, and in one embodiment, this penetrating parts is oriented motion radially outward, shown in arrow 897.In another embodiment, penetrating parts can be oriented radially inwardly motion, shown in arrow 895.Anchor clamps can be positioned to engage with penetrating parts from the inner surface of chuck or outer surface.
Below with reference to Figure 88, nano wire also is used to produce the low analysis by measure quality testing that is used for chuck 800 and surveys parts.U.S. Provisional Patent Application No.60/433 at common transfer, common pending trial, other details of nano wire device have been introduced among 286 (the lawyer's case No.38187-2605), the applying date of this U.S. Provisional Patent Application is December in 2002 13 days, and the document is whole to be incorporated herein by reference.Nano wire detection of analytes parts 898 can be included in the cavity 806 that holds penetrating parts 802.They can be arranged on the base plate or basal surface of cavity 806, in some or all the combination in any on the wall, on top surface or in these probabilities.Detection of analytes parts 898 can be designed to the different ranges of sensitivity, so that improve the overall sensitivity of one group of such detection of analytes parts.Realize this purpose method can including, but not limited to: use different size nano wire, change the number of nano wire or change glucoseoxidase on nano wire or the amount of other glucose detection material.Therefore these nano wire detection of analytes parts can be designed to use low volume body fluid for each sample owing to their size.In certain embodiments, each detection of analytes parts uses the body fluid samples of receiving liter capacity less than about 500 exactly.In certain embodiments, each detection of analytes parts uses the body fluid samples of receiving liter capacity less than about 300 exactly.In certain embodiments, each detection of analytes parts use exactly less than about 50 receive liter capacity body fluid samples, less than about 30 receive liter capacity, less than about 10 receive liter capacity, receive liter capacity and less than about 5 less than about 1 body fluid samples of receiving liter capacity.In certain embodiments, the detection of analytes parts of assembled arrangement use less than 300 body fluid of receiving liter and realize analysis measurement.
Introduce another embodiment of the present invention below with reference to Figure 89.Figure 89 has represented to be used for the embodiment that the optical analysis quality testing is surveyed the optical lighting system 910 of parts (Figure 91), and this optical analysis quality testing is surveyed parts and can be contacted with body fluid samples.Total system can comprise a plurality of detection of analytes parts, and these detection of analytes parts have: some optical indicator; Light source 912 is used to provide the light that shines on the detection of analytes parts; At least one photodetector 914; One processor (not shown).The detection of analytes component exposed is in the fluid sample of unknown component.A plurality of detection of analytes parts can be arranged to a series of detection of analytes parts that are exposed in a kind of fluid sample, the target of each group is a kind of specific analyte, and can comprise the chemical drugs of specific analyte, this chemical drugs is special to interact with a kind of analyte that will analyze, and does not interact with some other analyte.Each detection of analytes parts can also have the different sensitivity scope, so that make the overall sensitivity maximum of a series of such detection of analytes parts.Light source 912 makes rayed at least one detection of analytes parts, interacts so that cause light.Difference in the detection of analytes parts may cause the difference in the light interaction.Photodetector detects the light that is undertaken by the detection of analytes parts and interacts.The processor analysis is interacted by the light that the detection of analytes parts carry out, so that consider the interactional interference of light between analyte, thereby determines the concentration of the suitable analysis thing in fluid.
Still with reference to the embodiment of Figure 89, light source 912 can be (but being not limited to) LED.Optionally LED 915 also can be used for the present invention.Light, illumination or excitation energy from LED 912 move along the path by pin-and-hole 916, light filter 917 and lens 918.Then, light and spectroscope 919 (such as, but be not limited to dichroic mirror or be used for other device of beam split) contact.Then, light is guided lens 920 into, shown in arrow 921.Lens 920 focus light on the detection of analytes parts (Figure 91).This excitation energy can cause detectable optics indication from the detection of analytes parts.Such as, but be not limited to: fluorescence can be able to be reflected by lens 920 convex (bay).This energy arrives lens 922 by spectroscope 919, and then, this energy is received by detector 914, shown in arrow 923.Detector 914 is measured this energy, and sends this information to the processor (not shown), so that determine analyte level.Illuminator 910 can also be included in the battery 924 on the panel surface.In this particular example, penetrating parts 925 by force producer 926 (such as, but be not limited to: solenoid) drive, this penetrating parts can be used to obtain fluid sample.Device can also comprise ratchet and other exposed lancet or penetrating parts 928.
Below with reference to Figure 90, represented to be used for another embodiment of the illuminator 910 of chuck 929 among the figure.Chuck 929 is similar with chuck 800.Chuck 929 is single chuck, has a plurality of penetrating parts and a plurality of optical analysis quality testing to survey the parts (not shown).Chuck 929 also comprises a plurality of optical clear parts 930 (this optical clear part 930 can be but be not limited to window etc.), is used to make the cavity from the bright chuck 929 of the illumination of LED 912.In one embodiment, each cavity of chuck 929 can comprise at least one transparent part 930.This makes that light can produce power, and this energy can be read by detection of analytes parts 914.Chuck 929 can use driver 882 to drive penetrating parts, and chuck 929 can rotate, shown in arrow 931.
Below with reference to Figure 91, represented the cutaway view of the similar embodiment of illuminator among the figure.This system 932 is active 912, and lens 933 and excitation light filter 934 are arranged.In one embodiment, 934 of this excitation light filters allow excitation energy to pass through.This light filter 934 allows excitation energy to lead to dichroic mirror 935, but makes it can not return source 912.Excitation energy reflects downwards, shown in arrow 936.Lens 937 make energy focus on the optical analysis quality testing and survey on the parts 938.Fluorescence can 939 by dichroic mirror 935 and lead to fluorescence filters 940.In one embodiment, 940 of fluorescence filters allow fluorescence can by and lead to lens 941.Therefore, detector 914 can only receive the fluorescence energy from detection of analytes parts 938.Certainly, should be known in that light filter can change over permission and be passed through by the kind of energy that detection of analytes parts 938 produce.In certain embodiments, can not use light filter.Dichroic mirror 935 can be Bk7 substrate, 63x40x8mm.Light filter can also be the Bk7 substrate, is approximately 40mm diameter and about 6mm thickness.Lens 933,937 and 941 can be achormat:bfl=53.6, and the work aperture is 38mm.
Introduce another embodiment of illuminator 942 below with reference to Figure 92.This system does not use spectroscope or dichroic mirror.But source or LED 912 and detector 914 all have the straight line of alignment optical detection of analytes parts 938.In the present embodiment, a plurality of elements combination are in single housing.For example, lens 943, lens 944 and light filter 945 combinations, and lens 946, lens 947 and light filter 948 also make up.
Below with reference to Figure 93, represented among the figure in housing 950, with the cutaway view of system like the system class of Figure 89.LED 912 sends light to reflecting mirror 919, arrives panel surface by light path 951, element 924.Finger inlet 952 makes it possible to obtain sample, and sample longshore current body path 953 is flowed so that analyze.Processor 954 can be connected with detector 914, so that analyze this result.
Below also will be with reference to system like the system class of Figure 94 introduction and Figure 90.The figure shows the chuck 929 that is used for driver 882.This can carry out radial design, and wherein, penetrating parts extends radially outwardly, shown in arrow 955.Driver 882 can have connector part, and this connector part moves back and forth, shown in arrow 956.Figure 95 and 96 also provides the view of system like the system class with Figure 89.Figure 95,96 embodiment can comprise supplementary lens or the light filter that can be used for improving energy measuring.
Below with reference to Figure 97, the skin layer that pierces through finger when lancet is during up to desired depth, importantly the velocity variations scattergram.More particularly, the speed of the lancet of the different phase by thrusting track is shown in Figure 97.In this embodiment, the Phase I correspondence be horny layer, the Phase correspondence be epidermis and Phase I correspondence be corium.In each stage (and in the process in this stage), can select to keep existing speed, increase existing speed or reduce existing speed.According to cuticular thickness, can adopt 360 of four frontier inspection method of determining and calculating and per inch decoding bars, 29 some places monitorings in 6 some places in 9 some places in the horny layer of this embodiment, the epidermis and the corium and change speed.Produce the number of the monitoring point that is used to specify displacement of previous discussion although note the embodiment of driver discussed here, also can adopt other driver that higher or lower resolution may be provided and the embodiment of position sensor.
For the purpose of this non-limiting example is discussed at present, think that skin has three different zones or organized layer: horny layer SC (Phase I), epidermis E (Phase) and corium D (Phase I).In one embodiment, lancet or penetrating parts 10 accelerate to the first required speed.In the driving process, can be scheduled to or calculate this speed by processor.This processor also can be used for controlling the lancet speed in the tissue.Lancet 10 impacts skin and begins to pierce through horny layer under this speed.Because horny layer is very hard, so in this embodiment, can adopts the maximal rate of penetrating parts 10 so that pierce through this layer effectively, and can keep this constant airspeed to pass this layer up to lancet.When lancet pierces through horny layer, may need to apply power so that keep this first speed to lancet driver 12.Average cuticle thickness is about 225 μ m.The position sensor 14 of this embodiment adopts four frontier inspection method of determining and calculating, can 225/17 or about 13 some places carry out the check and the feedback of velocity information.In another embodiment, can improve by horny layer and pierce through efficient impacting after-acceleration.If lancet does not reach target velocity or required speed before impact, can adopt acceleration.Figure 97 has represented that the speed of each organized layer on the lancet track increases (arrow (a)), keeps the result of (arrow (b)) or minimizing (arrow (c)).
When arriving epidermis E (Phase), the embodiment of a method can make speed reduce (arrow (c)) so that reduce extruding this second organized layer from first speed.Therefore in this non-limiting example, this lancet 10 can have the second required speed littler than first speed.The speed that reduces in second organized layer can reduce the pain of being experienced by the mechanoreceptor neuron in the skin corium (the 3rd organized layer).But do not organizing on the skin corium under the situation of squeezing effect, lancet speed can keep constant so that effectively pierce through (be second speed can keep identical with first speed).In another embodiment, the speed in second organized layer is increased from first speed.
At Phase I, lancet or penetrating parts 10 can arrive blood vessel and thrust blood vessel so that produce blood.The nerve that selected VELOCITY DISTRIBUTION can influence the 3rd organized layer at an easy rate distributes and the pain that produces in the joint-cutting process thus.Can select the 3rd required speed in one embodiment.Can select this speed so that the nerve stimulation minimum is kept thrusting efficient simultaneously.An embodiment comprises from second speed and reduces this speed so that reduce pain, and increases this speed before just will thrusting blood vessel.The step of tachometric survey that may be used for the above-mentioned position sensor of corium is about 58 steps.By using, user can be determined best speed/thrust distribution.The distribution that has the minimum pain amount and produce successful blood sample when joint-cutting may be programmed in this device.
Now, user is by testing various settings and by the degree of depth that is used for optimizing on the mechanical emitter is set, and is secured in required setting according to the joint-cutting comfortableness.The embodiment of this device and method discussed here provide multiple VELOCITY DISTRIBUTION (Figure 97), can optimize this distribution being used for controlled joint-cutting by user, and can comprise: the speed of thrusting of control lancet when lancet is in skin; When lancet is in skin, assign to regulate the VELOCITY DISTRIBUTION of lancet according to the one-tenth of this skin layer; Come joint-cutting according to precise region VELOCITY DISTRIBUTION based on the variation of the cell type that is passed down through epidermis and corium from skin surface; Cut with required speed and to wear any organized layer and for this speed of each layer variation.This can comprise by cuticular maximal rate, reconciles the speed by epidermis so that reduce shock wave to the pain pick off in the corium, and regulating can the stimulation pain receptor so that effectively thrust blood vessel by the speed of corium.Other details can find in the U.S. Patent application sequence No.10/420535 (lawyer's case No.38187-2664, the applying date is on April 21st, 2003) of common transfer, common pending trial, and is incorporated herein by reference.
Below with reference to Figure 98, another embodiment of the present invention is described.Some embodiments of the present invention can provide the accurate method that is positioned at the sampled point on the health.As non-limiting example, can adopt light beam.In addition, light beam can be used for the indication be ready to the sampling.In another embodiment, folded light beam can be used to equip device or actual this device that drives of use.Arbitrary these embodiment can be used for using with arbitrary described chuck and/or joint-cutting system.
Shown in the embodiment of Figure 98, light source 1000 can be used for light beam is projected the surface of skin or tissue.Can adopt a plurality of light sources.Light source comprises the light source of glimmering luminous or other type of (but being not limited to) white heat, light emitting diode, fluorescence, electricity.In most of embodiment, light source 1000 is with the visible spectral emissions radiation of human eye.Light source 1000 also can be with other wavelength emission radiation, for example (but being not limited to) ultraviolet, infrared ray or the like, and detect by independent detector means.An example can be similar to the device of Figure 99.Although the embodiment of Figure 98 adopts a plurality of light sources 1000, be to be understood that some embodiment can only adopt single source 1000.
In the embodiment of Figure 98, can setting element so that light is directed to the target area of health.This can realize by the light source that employing has a built-in calibrating installation (such as, but be not limited to lens).Another method of direct light is to make light draw by the one or more holes 1002 in the device.End cap can be set or front end 1003 is helped finger locating.Other method is to adopt the form of optical fiber or light pipe technology to make light beam on health.The light pipe technology can have built-in lens (such as, but be not limited to traditional or Fresnel).Shown in Figure 98, lancet or penetrating parts 1004 are sent by opening 1006.This device can comprise the adapter 1008 that connects driver and penetrating parts 1004.Electric wire or lead 1010 can be used to transmit power with driving light source 1000.The quantity that is to be understood that light beam can change.Light beam can be the light (such as, but be not limited to circle, point, X, chart, sign etc.) of, two or more independent light beams or successive ring or other shape, so that the labelling shock point.Light source 1000 also can throw the light of different colours.As non-limiting example, the light of first color can be used for aiming, and is aimed at correctly or adopt during in required target the light of second color when device.For example, begin to use HONGGUANG, when device is used green glow when accurately being aimed at.Two Different Light 1000 can be used to provide the light of different colours.
Below with reference to Figure 99, attachment device can be so that optical diode or similar pick off 1020 detect the reflected light from light source 1000, this can be used for a plurality of purposes, and for example aiming is used for device driven, determines skin characteristic or utilizes reflected signal to start the joint-cutting operation.In the embodiment of Figure 99, the light that optical fiber 1022 can be used for transporting from light source 1000 is used for emission.
In one embodiment, by detecting the detector signal that AC connects, can be at quite high frequency downconverts system light beam, this frequency can strengthen detecting operation.The reflection of aligned bundle can be used for detecting the region of anatomy near.Modulation can provide a kind of method that resists the ambient light intensity level, this ambient light intensity level can phonily indicate the region of anatomy near.Light emission is to sampled point S place, if drive lancet or penetrating device, then this lancet or penetrating device can form wound.
Below with reference to Figure 100, in this embodiment, shown in light source 1000 do not need to be arranged in the front of chuck 500.Be to be understood that light source 1000 can have eclipsed structure, wherein light source can be on chuck, below or the side.Light source 1000 can use with device that only holds a penetrating parts 1004 or the device that holds a plurality of penetrating parts.Carrying out with light source 912 among some embodiment of detection of analytes or measurement, light source 912 also can be provided for aiming at the light of purpose by light chain 1042 (such as, but be not limited to optical fiber, mirror or lens).For easy explanation, expression is not used to make light source 912 to realize other optics of analysis measurement function in Figure 100.
Below with reference to the embodiment in Figure 100 and 101, the part 1050 of shell 1052 can be transparent to be convenient to see finger with by joint-cutting the time with convenient finger locating.Embodiment among Figure 101 provides sizable transparent region, and the embodiment among Figure 102 provides the transparent region of close joint-cutting position, and this zone is the form of the window of circle, annular, square, rectangle, polygon, other shape.Be to be understood that arbitrary light beam embodiment, transparent outer cover embodiment and other device that is used to aim at can combine with arbitrary the embodiment disclosed herein or by the embodiment that reference is included in this.
Below with reference to Figure 103, another embodiment of the present invention is described.Figure 103 represents chuck 1100, has the layer 1102 of a plurality of detection of analytes parts 1104 and the decomposition view of sterile barrier 1106.Detection of analytes parts 1104 on layer 1102 can have lead or the adapter 1108 that extends along layer 1102.In certain embodiments, these leads 1108 extend to the interior week of layer 1102 always.In other embodiments, lead 1108 can not extend to the interior week of layer 1102 always.Shown in arrow 1110 and 1112, layer 1102 can be connected the device that uses with joint-cutting device 880 to be formed for chuck 1100 with sterile barrier 1106.In most embodiment, make sterile barrier 1106 be connected on the chuck 1100 before the penetrating parts (not shown) be contained in the chuck 1100.Be to be understood that detection of analytes parts 1104 can be low capacity electrochemical analyte detection parts, for example described in the disclosed PCT application WO02/02796, this application is quoted in full at this.Disposable detection of analytes parts can comprise supporting material, electric conductor and electrode system are placed on this supporting material, this electrode system comprises antielectrode and the working electrode that forms from conversion zone, and the dielectric insulation layer that covers supporting material and electric conductor is recessed so that form the biologic components that contacts and be used for the discriminatory analysis thing of manostat device and electrode system.The conversion zone of disposable detection of analytes parts comprises the electronics transmission medium and the electrically conductive material of distillation a little.The electrode system of detection of analytes parts is covered by polymeric protective layer.The invention still further relates to a kind of method of in body fluid samples, determining analyte by the detection of analytes parts, adopt the complex of distillation a little electronics to be sent to the electrically conductive material from enzyme, and employing detection of analytes parts are determined the analyte concentration in body fluid or body fluid samples as the electronics transmission medium in electrochemical sensor.The detection of analytes parts can be used to provide enough readings, based on no more than about 600 receiving liter, 500 receive liter, 400 receive liter, 300 receive liter, 200 receive liter, 100 receive liter, 50 receive liter, 25 receive liter, 20 receive liter, 15 receive liter, 10 receive liter, 5 receiving and rise or still less volume.As non-limiting example, in another embodiment, the size of analyte detection can be from 1 * 1mm or 0.5 * 0.5mm.
Below with reference to the embodiment among Figure 104, shown in the chuck 1114, cavity 1116 has the length of prolongation and has penetrating parts and clamps or put area 1118.Before driving, should the penetrating parts (not shown) be held in place zone 1118.This zone 1118 also can be used for after driving penetrating parts being held in place.Chuck 1114 also can have the groove that forms in interior week along this chuck.These grooves can be used for the combination of localized purpose, the rotation purpose of chuck or these two kinds or other reason.For non-circular structure, along the wall formation groove of the opening that passes through non-circular chuck.
Figure 105 is the guide wire of alternative shape of chuck 1114.Peripheral shape along this chuck 1114 becomes chamber 1122.In one embodiment, come blood or other body fluid of the wound of free joint-cutting formation to be integrated in this chamber 1122.Can there be conduit 1124 to guide body fluid into opening 1126.In one embodiment, detection of analytes parts (not shown) can occupy this opening 1126.In certain embodiments, the detection of analytes parts form the diapire of opening 1126 rather than occupy this opening 1126.In certain embodiments, on the bottom side of chuck 1114, there is not the fluid bearing structure.
Below with reference to the embodiment in Figure 106 and 107, represented to be used for the structure of chuck 1114 bottom sides.In this embodiment, opening 1126 leads to the fluid conduit 1128 in chuck 1114 bottom sides.Can select the length of conduit 1128 to be large enough to hold to be enough to be full of substantially the volumetric blood of the fluid mass 1130 of expansion.As non-limiting example, can construct conduit 1128 so that hold volume at least about 1.5 μ l, 1.4 μ l, 1.3 μ l, 1.2 μ l, 1.1 μ l, 1.0 μ l, 0.9 μ l, 0.8 μ l, 0.7 μ l, 0.6 μ l, 0.5 μ l, 0.4 μ l, 0.3 μ l, 0.2 μ l, 0.1 μ l, 0.05 μ l or 0.01 μ l.As another non-limiting example, before fluid entered zone 1130, conduit 1128 also can be thought the volume that keeps no more than about 1.5 μ l, 1.4 μ l, 1.3 μ l, 1.2 μ l, 1.1 μ l, 1.0 μ l, 0.9 μ l, 0.8 μ l, 0.7 μ l, 0.6 μ l, 0.5 μ l, 0.4 μ l, 0.3 μ l, 0.2 μ l, 0.1 μ l, 0.05 μ l or 0.01 μ l.In another embodiment, the amount required according to different detection parts is no more than 1.5 μ l, 1.4 μ l, 1.3 μ l, 1.2 μ l, 1.1 μ l, 1.0 μ l, 0.9 μ l, 0.8 μ l, 0.7 μ l, 0.6 μ l, 0.5 μ l, 0.4 μ l, 0.3 μ l, 0.2 μ l, 0.1 μ l, 0.05 μ l or 0.01 μ l from the fluidic amount of conduit 1128 inflow regions 1130.In one embodiment, detection of analytes parts (not shown) can occupy zone 1130 or corresponding with regional 1130 on the position.When fluid was full of fluid conduit 1128 and inflow region 1130, the unexpected expansion of width made fluid pour zone 1130, preferably volume be enough to be full of substantially this zone or at least volume be enough to make the detection of analytes parts to produce reading.Zone 1130 can keep the volume of about 1.5 μ l, 1.4 μ l, 1.3 μ l, 1.2 μ l, 1.1 μ l, 1.0 μ l, 0.9 μ l, 0.8 μ l, 0.7 μ l, 0.6 μ l, 0.5 μ l, 0.4 μ l, 0.3 μ l, 0.2 μ l, 0.1 μ l, 0.05 μ l or 0.01 μ l.In certain embodiments, zone 1130 volumes that are used to keep are less than the volume that can remain in the conduit 1128 a little before fluid arrives zone 1130.In a non-limiting example, this volume can be about 0.01 μ l, 0.05 μ l or 0.1 μ l or still less.Outlet 1132 can be connected so that handle any fluidic overflow with fluid mass 1130 fluids of expansion.Outlet 1132 reconnects with cavity 1116 on the opposite side of chuck.
Figure 108 and 109 expressions are based on another embodiment of the present invention.The embodiment split shed 1134 that Figure 108 represents shifts near the periphery of chamber 1122 more.Similarly, in certain embodiments, chuck 1114 can support conduit or structure without any flow.The detection of analytes parts can occupy this opening 1134, the bottom side that forms opening 1134 or both certain combinations.Figure 108 has also represented to be used for gathering from sterile barrier the groove 1136 of too much material.The embodiment split shed 1134 that Figure 109 represents opens directly in the zone 1138 of expansion.There is not conduit fluid to be brought into the zone 1138 of expansion.In this embodiment, three detection of analytes parts 1140,1142 and 1144 can be associated with each zone 1138.Be to be understood that in arbitrary embodiment of the present invention single or multiple detection of analytes parts can be associated with each zone (for example zone 1138).Be to be understood that in arbitrary embodiment of the present invention the detection of analytes parts can carry out identical analysis, different analysis or the combination in any of these two kinds of analyses.
Below with reference to the embodiment among Figure 110, rib 1146 is arranged across the opening in the chamber 1,150 1148.Arrange chamber 1150 so that hold freely to cut the body fluid of the wound that produces.This rib 1146 can form from multiple material (such as, but be not limited to cycloolefin or other plastics well known in the art).In certain embodiments, this rib can be made hydrophilic or the peripheral region can be made hydrophilic by surface treatment.In one embodiment, this rib 1146 can be made extremely thin, about 100 microns rank.This rib 1146 also can have other thickness (for example less than about 200 microns or less than about 300 microns).Be to be understood that in one embodiment rib 1146 can form one with chuck or install or be connected on this chuck after forming chuck.The detection of analytes parts can occupy opening 1148, the bottom side that forms opening 1148 or both certain combinations.These detection of analytes parts can form, are configured to or formalize and hold the fluid that diffuses out from rib 1146.In certain embodiments, there is not the fluid bearing structure in the bottom side of chuck.
Figure 111 has represented the bottom side of an embodiment of chuck 1152.For easy description, make rib 1146 look thicker than reality.Tiny part 1154 is set.The detection of analytes parts can occupy corresponding to the part in the zone 1154 of the opening 1148 with rib 1146, be full of zone 1154 substantially, supporting surface 1154 arranges or is arranged to can be used for holding fluid from opening 1146.In certain embodiments, the basal surface of analyte sensor formation chamber 1150 also can be considered to " wall " of this chamber.When assembling chuck 1152 (and having pierced through sterile barrier), the detection of analytes parts can be seen by opening 1148.In certain embodiments, outlet conduit 1156 can be configured to guide too much fluid into outlet 1158 by opening 1160.In other embodiments, do not have outlet conduit 1156, too much blood or body fluid just are full of chamber 1150 or flow to slit 1162 (shown in Figure 110).
Figure 112 has represented to have the bottom side of the chuck of two different fluid structures, and this different fluid structure can be single or be used in combination.Embodiment on the right comprises the zone 1164 that the size owing to opening 1166 reduces to form.Can control the size of this opening 1166 according to the amount that the detection of analytes parts are analyzed required blood or body fluid.In each embodiment, the amount of this blood or body fluid can be less than about 1.0 μ l, 0.9 μ l, 0.8 μ l, 0.7 μ l, 0.6 μ l, 0.5 μ l, 0.4 μ l, 0.3 μ l, 0.2 μ l, 0.1 μ l, 0.05 μ l or 0.01 μ l.
Figure 113 has represented according to view under the top of an embodiment of chuck 1152 of the present invention.In some constructions, in chamber 1150, rib 1146 is set so that fluid is passed in detection of analytes parts 1140,1142 and 1144.In certain embodiments, on the bottom side of chuck, there is not the fluid bearing structure.As non-limiting example, the detection of analytes parts of Shi Yonging can utilize the fluid that is no more than about 1.0 μ l, 0.9 μ l, 0.8 μ l, 0.7 μ l, 0.6 μ l, 0.5 μ l, 0.4 μ l, 0.3 μ l, 0.2 μ l, 0.1 μ l, 0.05 μ l or 0.01 μ l that analysis is provided in the present embodiment.In certain embodiments, the employed Fluid Volume of all analyte parts that is connected with each sample chambers 1150 can utilize the fluid that is no more than about 1.0 μ l, 0.9 μ l, 0.8 μ l, 0.7 μ l, 0.6 μ l, 0.5 μ l, 0.4 μ l, 0.3 μ l, 0.2 μ l, 0.1 μ l, 0.05 μ l or 0.01 μ l that analysis is provided.Adopt the detection of analytes parts as WO02/02796 described in, employed detection of analytes parts can utilize to be no more than and about 20 receive liter, 15 receive liter, 10 receive liter, 5 receive liter and volume still less provides analysis in the present embodiment.For example parts 1143 and these detection parts of 1148 also can arrange in groups 1145,1147 and 1149.As non-limiting example, these detection of analytes parts can be based on electrochemical and utilize current measurement (ampiometric) technology to come the Measurement and analysis thing.These detection of analytes parts can be printed on a plurality of surfaces, including, but not limited to glass, pottery and plastics.These detection of analytes parts can comprise prints hydrophilic conduit, and this conduit adopts the hydrophilic layer that has with the very little corresponding to size of volumetric blood purposes (height of 50-100 micron).
Figure 114 is the close-up illustration of an embodiment with chuck of a plurality of detection of analytes parts.In this view, represented penetrating parts 1168.In one embodiment, penetrating parts 1168 can originate in this position in the chamber 1150 before joint-cutting.Behind joint-cutting, this penetrating parts 1168 can be returned this position.In another embodiment, penetrating parts 1158 can advance to the position shown in Figure 114 with non-joint-cutting speed, stops, and follows with this penetrating parts of joint-cutting speed drive so that penetrate tissue.In one embodiment, sample chambers 1150 can only have two detection of analytes parts 1142 and 1144.In other embodiments, can comprise other detection of analytes parts 1140,1148 or 1143 (all are all represented with diplopia).
Figure 115 represents an embodiment of chuck 1152 bottom sides.In this embodiment, because detection of analytes parts 1140,1142,1143,1144 and 1148 can be arranged in the zone 1154, so represented these parts.Lead and adapter 1108 can be connected on the detection of analytes parts.Be to be understood that arbitrary detection of analytes parts disclosed herein or known in the art can be used for using with the present invention.
Below with reference to Figure 116 and 117, another embodiment of the present invention is described.In the embodiment of this chuck, comprise that a plurality of fluid transmission devices 1170 and 1172 are used to force the fluid into a plurality of openings 1174,1176 and 1178.In this embodiment, transmission device can form one with chuck.Detection of analytes parts 1180 in this embodiment and 1182 direction are perpendicular to opening 1174,1176 and 1178.
Below with reference to Figure 118 and 119, the cavity that uses with chuck according to the present invention and the multiple structure of opening have been represented.These structures can be used alone or in combination on chuck.Cavity 1116 can have the exit opening 1184 in the position shown in Figure 118.As shown in the embodiment relevant with slot # 4, some embodiment can have the chamber 1150 that extended configuration is arranged.In another embodiment, do not comprise opening 1186, the unique method of fluid being guided into the bottom side is by an opening 1184, this opening 1184 can shown in be used for the optional position of cavity 1116.In another embodiment, the detection of analytes parts can directly be arranged in the cavity 1116, do not use opening (for example 1184 or 1186) with these detection of analytes parts of direct fluid and rely on.These detection of analytes parts can be arranged in any position (at side surface, basal surface or the like) in the cavity 1116.
Figure 119 has represented the bottom side structure, has the label of each relevant position that is used for shown in Figure 118.In the structure relevant with slot #, opening 1186 directly is connected with the open area, and this open area is corresponding to the detection of analytes position component.
Below with reference to Figure 120, another embodiment of the present invention is described.This embodiment has propagation element 1190 and at least one detection of analytes parts below element 1190, and this propagation element 1190 forms the diapire of chamber 1150.As non-limiting example, this element 1190 has the structure of net, fabric or " chain first " type.Shown in Figure 120, penetrating parts 1168 can have the original position in chamber 1150.This propagation element 1190 can be made of a variety of materials, including, but not limited to nitrocellulose polymers, celluloid, detest water porous type nylon, polysulfones and Merlon.These elements 1190 can be barrier films in certain embodiments, and can directly be cast by solution at the top of sensitive zones usually.Can construct these elements 1190 by morphology, its mode makes and can guide on the pick off from the effusive blood in joint-cutting place and with all blood flow or plasma fraction stream by wicks.Can change porosity control and surface treatment so that the speed of control flowing velocity (direction is passed through on side direction or edge) or lateral propagation.Also can make this element be fit to filtering particles (for example erythrocyte).In addition, this element 1190 can be to utilize the polymer that detects chemical mixing or utilize other material that detects chemical mixing.This element 1190 can occupy the whole zone, a part, certain geometry (circle, rectangle, square, shape with opening, 8 fonts, cross shape, grill-shaped etc.) of analyte sensor top or the combination in any of one or more these structures.
Below with reference to Figure 121 and the 122 another embodiment that describe according to chuck of the present invention.The chuck 1200 of Figure 121 comprises a plurality of grooves 1202 in the opening that is formed in this chuck.These grooves 1202 can be used for a plurality of purposes, including, but not limited to chuck 1200 is positioned in the joint-cutting device, perhaps are used to the purpose of rotating so that change the position of the cavity 1116 that aligns with the penetrating parts discharger.The hub (not shown) that can cooperate with above-mentioned opening can be the rotary apparatus that is used to control cavity 1116, and arranges that penetrating parts is used for engaging with emitter.
In one embodiment, chuck 1200 can comprise preceding support region 1208 and the back support region 1210 that is used to guide penetrating parts.The length of back support region 1210 enough makes penetrating parts can form wound in destination organization, and can not lose contact or guiding from back support region 1210.This provides more controls of thrusting the path that penetrating parts is adopted.This cavity provides the enough spaces that are used for the penetrating parts anchor clamps, so that hold the employed stroke of anchor clamps, thereby penetrating parts is advanced so that contact tissue.In certain embodiments, can use middle guide support 1212.In this embodiment, anchor clamps can be clamped the rear section of penetrating parts, and the while, two supporting members remained on " front " of anchor clamps, and the stroke zone of cavity 1116 is to the latter half of chuck (in one embodiment) is mobile at least, shown in arrow among Figure 123 1213.As non-limiting example, as required adjustment stroke in case occupy above cavity 1116 1/2, less than 1/3 or less than 1/4 cavity.Can comprise that narrow 1218 keeps this penetrating parts when not driving penetrating parts with box lunch.
Shown in Figure 122, can open the part 1220 on the chuck 1200 or push this part so that close the top surface (although still have make the opening of penetrating parts process) of forward support.The rear portion of cavity 1116 can narrow down so that penetrating parts is held in place.This part 1220 also can be used to handle the flash of light relevant with production process (flash).
Below with reference to Figure 124 and 125, embodiments of the invention can comprise external member, and this external member has comprised arbitrary penetrating parts executor 1230 disclosed herein.External member can also comprise uses indication (IFU), and above-mentioned arbitrary method has been set forth in this indication.Alternatively, external member can also comprise chuck, and this chuck holds a plurality of penetrating parts.This chuck 1232 can be arbitrary embodiment described herein.Usually, set components can be packaged in bag P or other traditional medicine device bag, such as, but be not limited to case, dish, pipe or like that together.In many examples, chuck is disposable.Chuck 1232 self can be contained in the independent bag or container, inserts then among the container P.In certain embodiments, use indication can be printed on the container P.In a non-limiting example, container P can only hold executor 1230 and not hold chuck 1232.
Below with reference to Figure 125, embodiments of the invention can comprise external member, and this external member only comprises chuck 1232.Also can comprise and use indication.In certain embodiments, can comprise a plurality of chucks 1232 (representing) with diplopia.Any element in these figure or described in this application other element can be individually or with combination in any be arranged among the container P.
The sensitivity that typical detection of analytes parts have optimization range.Figure 126 has described the sensitivity of typical glucose sensor with respect to the concentration of glucose in body fluid samples.Shown in Figure 126, it is accurate in limited range only that glucose sensor detects concentration of glucose.The about 3mM of the optimum sensitivity of most of pick offs (millimole or micromole mole/mL or 3mmol/L).For high glucose level or range of blood sugar, the precision of pick off reduces.For LG level or range of blood sugar, the precision of pick off also reduces.Can regulate the scope of pick off so that cover high glucose level or the LG level, but this not suitable solution, because sacrificed in the glucose range before adjusting even more precision.Inaccurate meeting in the glucose readings of muting sensitivity scope causes severe complications, and for example the too much insulin of patient injection is in body.
Below with reference to Figure 127 one embodiment of the present of invention are described.Figure 127 has represented the figure of the sensitivity of a plurality of glucose analysis quality testings survey parts 1222,1224,1226 and 1228.As seen, the preferred sensitivity of each detection of analytes parts is at different analyte concentrations.The zone of these preferred sensitivity can be overlapping.In glucose monitoring, this point is particularly useful, can distribute different sensitivity because this structure makes, so as to survey with respect to single traditional analysis quality testing parts increase the sensitivity coverage.Because sensitivity can cover the concentration range of expansion now, the group with detection of analytes parts of different sensitivity scope has improved precision.Accordingly, in one embodiment of the invention, a plurality of detection of analytes parts with different sensitivity are used on the identical body fluid samples.
Shown in Figure 128, even only have the performance that the embodiment of the detection of analytes parts of two different sensitivity scopes also can improve the detection of analytes parts.Optionally, in other embodiments, can the operational analysis quality testing survey the group of parts, wherein all detection of analytes parts in a group have the identical range of sensitivity, but have the different ranges of sensitivity at detection of analytes parts on the same group not.This provides advantage redundant and statistics because the measurement in a scope can with compare at another detection of analytes parts on the same group mutually, these detection of analytes parts are measured glucose in this same concentrations scope.
Below with reference to Figure 129, the group 1242 of detection of analytes parts (for example those described in the WO02/02796) can be used in the chuck 1229 with a plurality of lancets or penetrating parts 1240, and and driver 1236 use together.Simple in order to describe, only represented in a plurality of penetrating parts 1240.The group 1242 of detection of analytes parts can be arranged in lancet outlet 1230 near so that the body fluid of extruding from patient can arrive this group at an easy rate.This group 1242 can be positioned at module 1229 basal surface, on the side surface, on the top surface, be installed on the independent material layer, then this material layer is installed on this module 1229 or these certain possible combinations arbitrarily.Group 1242 can be used so that body fluid is guided to the detection of analytes parts together with microfluid conduit or pipe.Group 1242 can have multiple for increasing the useful structure of glucose monitoring precision.For example, group 1242 can have circular structure, rectangular configuration (NxM, wherein N and M are integers), triangular construction, concentric structure or other design.Suitable sample modular design can find in the U.S. Provisional Patent Application sequence No.60/422988 (lawyer's case No.38187-2601, the applying date is on November 1st, 2002) of common transfer, common pending trial; In the U.S. Provisional Patent Application sequence No.60/424429 (lawyer's case No.38187-2602, the applying date is on November 6th, 2002) of common transfer, common pending trial, find; In the U.S. Provisional Patent Application sequence No.60/428084 (lawyer's case No.38187-2604, the applying date is on November 20th, 2002) of common transfer, common pending trial, find.
In order to make it possible to use a plurality of detection of analytes parts to be used for glucose monitoring in the environment of every day, the volume that is used for the body fluid of each detection of analytes parts need reduce from traditional level.From the angle of reality, be limited from patient's the effusive naturally blood flow volume of each joint-cutting wound.Extracting too many blood is unpractical for patient, and can limit patient can with the number of times of being ready to sample.Accordingly, blood that each detection of analytes parts is required or body fluid are few more, and the detection of analytes parts that can use on blood that obtains by existing joint-cutting technology or body fluid samples are many more.By example but be not determinate method, each the glucose monitoring parts in an embodiment of detection of analytes parts group can use and be less than about 500 and receive the blood flow volume that rises.In other embodiments, each detection of analytes parts uses and is less than about 300 and receives liter.In other embodiment, each detection of analytes parts uses and is less than about 50 and receives liter, be less than about 30 and receive liter, be less than about 10 and receive liter, be less than about 5 and receive to rise and be less than about 1 and receive liter.Shown in Figure 130, the group 1238 of these detection of analytes parts 1140 is connected with lead.Figure 131 and 132 has represented to be suitable for other set constructor of the present invention.
Figure 133 has represented another embodiment, has wherein represented to be used to keep the chuck 1300 of single penetrating parts.Print plastics or other overlay, a plurality of low capacity detection of analytes parts 1140 are installed on the chuck 1300 simultaneously.Body fluid is introduced in the sample chambers 1302, wherein the analyte of parts 1140 detections in body fluid.Certainly be to be understood that the detection of analytes parts that other number can be installed to plate 1304, are not limited at the embodiment shown in this Figure 133.
Although with reference to specific embodiment introduction of the present invention and represented the present invention, but it will be appreciated by those skilled in the art that under the situation that does not break away from the spirit and scope of the present invention and can carry out various variations, change, improvement, replacement, deletion or interpolation program and rules.For example, for any the foregoing description, the penetrating parts driving device can change with respect to the position of penetrating parts or chuck.For any the foregoing description, the penetrating parts tip can expose (promptly in emission process, penetrating parts do not puncture penetrating parts closure member or protective foil) in the driving process.For any the foregoing description, in emission process, penetrating parts can be the penetrating parts of exposing.For any the foregoing description, before emission, penetrating parts can be the penetrating parts of exposing, because this can be so that penetrating parts be obviously tightr.In certain embodiments, penetrating parts can form elbow, carry out bending, form texture, forms or carry out other processing so that actuator operated at near-end or proximal region place.Penetrating parts can be arranged to fluted or groove, so that be connected with anchor clamps.Groove or groove can form along the elongated portion of penetrating parts.For any the foregoing description, cavity can be at the bottom or the top of chuck, and anchor clamps are at opposite side simultaneously.In certain embodiments, the detection of analytes parts can be printed on top, bottom or the sidepiece of cavity.In emission process, the front end of chuck can contact with the user.Identical drivers can be used to penetrating parts is moved forward and backward.The diameter of penetrating parts and length are suitable for obtaining volumetric blood described here.The penetrating parts driver can also be in basic and chuck same level.Driver can be used through hole or other opening, so that engage with the near-end of penetrating parts, enters tissue and leaves tissue thereby drive penetrating parts along path.
May be used to any embodiment of the present invention in any feature described in the application or any list of references described here.For example, device of the present invention also can make up with injection penetrating parts or the syringe needle described in the U.S. Patent application No.10/127395 (lawyer's case No.38187-2551, the applying date is on April 19th, 2002) of common transfer, common pending trial.The detection of analytes parts that are used for detecting the existence of paper tinsel also can be included in the joint-cutting device.For example, used out-of-dately in the past when cavity, paper tinsel or sterile barrier will be bored a hole.Whether the detection of analytes parts can detect cavity is new, perhaps not based on the state of barrier.Should be known in that in optional embodiment sterile barrier can be designed so that the to puncture sterile barrier of this thickness can not make the most advanced and sophisticated rust of penetrating parts.The joint-cutting device can also use improved driving mechanism.For example, the solenoid force generator can improve, so that attempt to improve the size of the power that solenoid produces under given electric current.Being used for solenoid of the present invention can have 5 coils, and in this embodiment, iron core is roughly the size of two coils.A kind of variation is to increase the outer metallic shell of coil or the thickness of winding.By increasing thickness, magnetic flux will increase.Iron core can separate; Can also use two less iron cores, and depart from 1/2 coil pitch.This allows more iron cores near coil, will speed up at this coil place iron core.This produces more, unshakable in one's determination incident near coil, thereby produces system more efficiently.
In another optional embodiment, the anchor clamps in protection cavity the inner can and use the back to keep penetrating parts in transportation, thereby have omitted the feature of using paper tinsel, protection end or other parts to keep exhausted penetrating parts.The feature of other advantage of some of described embodiment and additional embodiment comprises: same mechanism is used for sending exhausted penetrating parts to storage area; A large amount of penetrating parts (for example 25,50,75,100,500 or more penetrating parts) can be contained on dish or the chuck; Need be around the molding of lancet; Simplified the manufacturing of many penetrating parts device by using chuck; Under the situation of additional structural features, operating exposed metallic rod silk, enter tissue so that drive them; Keep point-device guiding (laterally be better than 50 microns, and vertical direction being better than 20 microns); And provide have independent cavity/slit, be used for new and stocking system exhausted penetrating parts.The size of the housing of joint-cutting device also can be arranged to be fit to ergonomics.In one embodiment, the width of joint-cutting device is about 56mm, and length is about 105mm, and thickness is about 15mm.In addition, some embodiment of the present invention can be used for the force producer or the driving mechanism of non-electricity.For example, punching machine and the method that is used for penetrating parts is discharged from aseptic closure member go for the emitter based on spring.The anchor clamps that utilize friction to connect also can adopt other actuation techniques.
The present invention also can comprise other optional feature.For example, for any the foregoing description, the penetrating parts driving device can change with respect to the position of penetrating parts or chuck.For any the foregoing description, the penetrating parts tip can expose (promptly in emission process, penetrating parts do not puncture penetrating parts closure member or protective foil) in the driving process.In emission process, penetrating parts can be the penetrating parts of exposing.Identical drivers can be used to penetrating parts is moved forward and backward.The different detection of analytes parts that detect different concentration of glucose scopes, different analytes etc. can make up and be used for each penetrating parts.Non-potential measurement technology also can be used for detection of analytes.For example, the direct electron migration that is adsorbed on the glucoseoxidase molecule on the carbon nanotube powder microelectrode can be used to measure glucose level.In certain embodiments, the detection of analytes parts can form concordant with chuck, thereby do not form " well ".In some other embodiment, the detection of analytes parts can form basic concordant with chuck surface (in 200 microns or 100 microns).In all methods, the silk growth of nanometer range can realize by chemical vapour deposition (CVD).In whole embodiment of the present invention, preferred nano wire is a nanotube.Be used for any method that glucoseoxidase or other detection of analytes material are deposited on nano wire or the nanotube be may be used to the present invention.In addition, for some embodiment, above shown in arbitrary chuck can be configured to there is not arbitrary penetrating parts, chuck only is an analyte detection apparatus like this.In addition, the index of chuck can be as follows: promptly adjacent cavity can be to use continuously or use in order.As non-limiting example, the cavity that can use in order and be separated by this means that chuck will pass through two circulations before each or all substantially cavitys all are used.As another non-limiting example, what the next one used can be outer, 4 outer or N the cavitys that cavity is outer of cavity of 3 cavitys.This makes at the cavity that holds least recently used penetrating parts and holds between the cavity of the new penetrating parts that next will use can bigger interval.The application's cross-reference: the common transfer and the U.S. Patent application No.10/323622 (lawyer's case No.38187-2606) of common pending trial, the applying date is December in 2002 18 days; The common transfer and the U.S. Patent application No.10/323623 (lawyer's case No.38187-2607) of common pending trial, the applying date is December in 2002 18 days; And common the transfer and the U.S. Patent application No.10/323624 (lawyer's case No.38187-2608) of common pending trial, the applying date is December in 2002 18 days.The application also relates to the U.S. Patent application No.10/335215 of common transfer and common pending trial; 10/335258; 10/335099; 10/335219; 10/335052; 10/335073; 10/335220; 10/335252; 10/335218; 10/335211; 10/335257; 10/335217; 10/335212; 10/335241; 10/335183; 10/335082; 10/335240; 10/335259; 10/335182; (lawyer's case No.38187-2633 to 38187-2652), their applying date is December in 2002 31 days.Above-mentioned application all is incorporated herein by reference.According to purpose of the present invention and practice, can estimate result's variation or difference.Therefore, the present invention is determined by the scope of following claim, and the reasonably extensive interpretation of this claim.
Claims (14)
1. device that uses with body fluid sampling device, this body fluid sampling device are used for extracting body fluid from the region of anatomy, and described device comprises:
Chuck, this chuck has a plurality of cavitys;
A plurality of penetrating parts, each penetrating parts to small part are contained in the described cavity of this chuck, and wherein penetrating parts can be slided so that the opening from described chuck stretches out, thus penetrate tissue;
It is characterized in that described device also comprises:
One processor is used for controlling the speed of penetrating parts at tissue, and the conciliation to the penetrating parts speed of passing epidermis is provided, to reduce to impose on the shock wave of the pain sensation pick off in the corium; And
A plurality of detection of analytes parts.
2. device according to claim 1 also comprises:
One in a plurality of chambers, each chamber and described cavity links to each other, and described chamber is arranged along the periphery of described chuck;
Wherein at least one described detection of analytes parts has formed the part of a wall of one of described a plurality of chambers, and the volume of each described chamber is not more than 1 microlitre.
3. device according to claim 1, this device also comprises: fluid transmission device, this fluid transmission device be positioned at the described detection of analytes parts of at least a portion above so that force one of described detection part of direction of flow.
4. device according to claim 2, wherein: described penetrating parts respectively has a tip, and wherein at least one tip has the original position in described chamber.
5. device according to claim 1, wherein: described detection of analytes parts are electrochemical.
6. device according to claim 1, wherein: described detection of analytes parts have the different ranges of sensitivity, and when these parts were used on the body fluid samples, the different ranges of sensitivity had increased the overall sensitivity scope of the group of these parts.
7. device according to claim 1, wherein: described detection of analytes parts can provide analysis, one of no more than following volume of volume that this analysis needs: 20,15,10 and 5 receive liter.
8. device according to claim 2, wherein: at least one described chamber is included in a lip-deep opening of this chamber, wherein can see described detection of analytes parts by described opening.
9. device according to claim 2, wherein: at least one described chamber is included in a lip-deep opening of this chamber, and a described detection of analytes arrangements of components is in this opening, so that this opening opens directly on this detection part.
10. device according to claim 1, this device also comprises: construct fluid transmission device into the net, this fluid transmission device is positioned at the top of described detection of analytes parts.
11. device according to claim 2 also comprises:
Wherein, described chamber is arranged to adjacent substantially with the periphery of described chuck;
Wherein, at least one described detection of analytes parts forms the part of a wall of one of described a plurality of sample chambers, and the volume of each chamber is not more than 1 microlitre.
12. device according to claim 11, this device also comprises a plurality of ribs, and each rib links to each other with one of described sample chambers.
13. device according to claim 2 also comprises:
Wherein, each chamber is arranged to adjacent substantially with the periphery of described chuck;
At least one opening in a described sample chambers is guided fluid one of into described detection of analytes parts along the fluid passage, and the volume of each chamber is not more than 1 microlitre.
14. device according to claim 13, wherein said fluid passage comprises conduit, and the size of this conduit can keep being no more than 1 microlitre.
Applications Claiming Priority (10)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US42298802P | 2002-11-01 | 2002-11-01 | |
| US60/422,988 | 2002-11-01 | ||
| US60/424,429 | 2002-11-06 | ||
| US60/428,084 | 2002-11-20 | ||
| US60/433,286 | 2002-12-13 | ||
| US10/323,624 | 2002-12-18 | ||
| US10/420,535 | 2003-04-21 | ||
| US10/423,851 | 2003-04-24 | ||
| US10/429,196 | 2003-05-02 | ||
| US60/473,088 | 2003-05-23 |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1735370A CN1735370A (en) | 2006-02-15 |
| CN100361623C true CN100361623C (en) | 2008-01-16 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CNB2003801081646A Expired - Fee Related CN100361623C (en) | 2002-11-01 | 2003-11-03 | Method and apparatus for body fluid sampling |
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| Country | Link |
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| CN (1) | CN100361623C (en) |
Families Citing this family (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP2384694A1 (en) | 2010-05-05 | 2011-11-09 | Roche Diagnostics GmbH | Method for producing a membrane ring or test strip ring |
| TW201212887A (en) * | 2010-07-08 | 2012-04-01 | Sanofi Aventis Deutschland | Eliciting a blood sample |
| CN104144645B (en) * | 2012-01-10 | 2017-07-07 | 赛诺菲-安万特德国有限公司 | Blood analyser |
| US20140358034A1 (en) * | 2012-01-10 | 2014-12-04 | Sanofi-Aventis Deutschland Gmbh | Cartridge |
| CN106248434A (en) * | 2015-05-19 | 2016-12-21 | 亚诺法生技股份有限公司 | Liquid collection device and method for manufacturing liquid collection device |
| CN105487593A (en) * | 2016-01-13 | 2016-04-13 | 广州埃克森生物科技有限公司 | Sample sucking key mechanism of blood analyzer |
| CN109030796B (en) * | 2018-06-26 | 2024-07-30 | 山东卓越生物技术股份有限公司 | Medical test card and test device thereof |
Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5318583A (en) * | 1992-05-05 | 1994-06-07 | Ryder International Corporation | Lancet actuator mechanism |
| CN1223847A (en) * | 1998-01-22 | 1999-07-28 | 泰尔茂株式会社 | Body-fluid inspection device |
| US6036924A (en) * | 1997-12-04 | 2000-03-14 | Hewlett-Packard Company | Cassette of lancet cartridges for sampling blood |
| CN1429087A (en) * | 2000-03-02 | 2003-07-09 | 英弗尼斯医疗技术公司 | Combined lancet and electrochemical analyte-testing apparatus |
-
2003
- 2003-11-03 CN CNB2003801081646A patent/CN100361623C/en not_active Expired - Fee Related
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5318583A (en) * | 1992-05-05 | 1994-06-07 | Ryder International Corporation | Lancet actuator mechanism |
| US6036924A (en) * | 1997-12-04 | 2000-03-14 | Hewlett-Packard Company | Cassette of lancet cartridges for sampling blood |
| CN1223847A (en) * | 1998-01-22 | 1999-07-28 | 泰尔茂株式会社 | Body-fluid inspection device |
| CN1429087A (en) * | 2000-03-02 | 2003-07-09 | 英弗尼斯医疗技术公司 | Combined lancet and electrochemical analyte-testing apparatus |
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| CN1735370A (en) | 2006-02-15 |
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