Title of Invention	METHOD AND APPARATUS FOR PRODUCING AN INTERACTIVE VIRTUAL MOVIE
Abstract	THE INVENTION RELATES TO A SYSTEM FOR PRODUCING AN INTERACTIVE VIRTUAL MOVIE, WHICH SIMULTES THE WALKING OF A USER WITHIN A REAL SITE AND EXPLORING THE SAME, WHICH COMPRISES: (A) A MOVABLE PLATFORM (202) HAVING POSITION AND ORIENTATION UNIT 204 FOR OBTAINING AT ANY GIVEN TIME POSITION AND ORIENTATION OF THE PLATFORM 202, AND PROVIDING THE SAME TO AN IMAGING UNIT 201; (B)IMAGING UNIT 201 FOR CREATING A NODE (15-18) ANY TIME WHEN SOME FIRST MINIMAL CONDITIONS ARE MET, OBTAINING IMAGE DATA, AND ASSOCIATING SAID IMAGE DATA AND ITS ORIENTATION WITH THE NODE LOCATION, THEREBY FORMING A NODE PACKAGE; (C)DATA UNIT (275) FOR: (c.1) RECEIVING NODE PACKAGES FROM THE IMAGING UNIT (275) ; (c.2)CALCULATING NEIGHBORHOOD BETWEEN NODES; (c.3)REGISTERING LINKS BETWEEN FOUND NEIGHBORING NODES,INCLUDING REGISTERING FOR EACH LINK ENTRY AND EXIT DIRECSTIONS TO AND FROM NODES; (c.4) CALCULATING POSSIBLE MERGING AND/OR ELIMINATING OF NODES; (c.4) saving in a database (302) withih the data unit a linked graph as formed by (c.1)-(c.4) above, said linked graph beingsaid virtual movie.

Title of Invention

METHOD AND APPARATUS FOR PRODUCING AN INTERACTIVE VIRTUAL MOVIE

Abstract

THE INVENTION RELATES TO A SYSTEM FOR PRODUCING AN INTERACTIVE VIRTUAL MOVIE, WHICH SIMULTES THE WALKING OF A USER WITHIN A REAL SITE AND EXPLORING THE SAME, WHICH COMPRISES: (A) A MOVABLE PLATFORM (202) HAVING POSITION AND ORIENTATION UNIT 204 FOR OBTAINING AT ANY GIVEN TIME POSITION AND ORIENTATION OF THE PLATFORM 202, AND PROVIDING THE SAME TO AN IMAGING UNIT 201; (B)IMAGING UNIT 201 FOR CREATING A NODE (15-18) ANY TIME WHEN SOME FIRST MINIMAL CONDITIONS ARE MET, OBTAINING IMAGE DATA, AND ASSOCIATING SAID IMAGE DATA AND ITS ORIENTATION WITH THE NODE LOCATION, THEREBY FORMING A NODE PACKAGE; (C)DATA UNIT (275) FOR: (c.1) RECEIVING NODE PACKAGES FROM THE IMAGING UNIT (275) ; (c.2)CALCULATING NEIGHBORHOOD BETWEEN NODES; (c.3)REGISTERING LINKS BETWEEN FOUND NEIGHBORING NODES,INCLUDING REGISTERING FOR EACH LINK ENTRY AND EXIT DIRECSTIONS TO AND FROM NODES; (c.4) CALCULATING POSSIBLE MERGING AND/OR ELIMINATING OF NODES; (c.4) saving in a database (302) withih the data unit a linked graph as formed by (c.1)-(c.4) above, said linked graph beingsaid virtual movie.

Full Text	WO 2004/041088 PCT/US2003/034456 METHOD OF LANCING SKIN FOR THE EXTRACTION OF BLOOD BACKGROUND OF THE INVENTION Field_of the Invention The presenl invention relates, in general, to a method of lancing skin and, more particulaily, to an improved method wherein the lancing element is removed after creating an incision and then blood is channeled up the lancing element to a sensor element. located at a proximal end of the lancing clement. Background of the Invcntion In in-situ testing of blood glucose, a glucose meter is placed against the skin and blood is sampled and measured without moving the meter. In one method of in-situ testing, a glucose sensor strip is combined with a. luncing clement positioned at a distal end thereof, the glucose sensor strip is then positioned in a meter adapted to launch the strip and lancing element combination toward the skin where the lancing element forms an incision. Blood or other bodily fluids such as, fot example, interstitial fluid, may then be extracted from the incision and moved to the glucost sensor strip where it can be measured using, for example, on electrochemical process. When lancing skin using an in-situ lest strip, it is desirable to ensure that blood be transferred efficiently from the incision to the test strip, using as little blood as possible. Efficient transfer of blood from the incision means that more of the blood is actually used to lest for anslyte (e.g. glucose) levels, reducing the total blood required and, therefore, the incision size required for the lest Smaller intisions are particularly desirable because, in general, it is desirable to reduce the pain experienced by the user. Further, smaller incisions generally heal faster and art out as likely to re-open once healed. 1 WO 2004/041088 PCT/US2003/03456 Thus, when using an in-situ test, it is desirable to create an incision which is very small while maximising the amount of blood generated by that incision. A number of factors influence the amount of blood generated by a particular incision, Mary of those factors cannot be controlled. One of the factors which reduces, the amount of blood available at a particular incision is the tendency of the incision to seal around the lancing element if the lancing element is left in the wound. It would, therefore, be advantageous to develop a-method of lanting which increases the amount of blood available for testing at a particular incisbn sits. It would further be advantageous to develop a method of lancing which increases the amount of blood available for lancing by pieveniing the wound from mscaling during the testing process. It would further he advantageous to develop a method of lancing which increases the amount 01 blood available for lancing by preventing the wound from sealing around the lancinig elcment during the testing process. SUMMARY OF THE INVENTION In a method according to the present invention, a lancing tip is first inserted and then is netracted completely out of the lance wound site, The lancing tip is then positioned adjacent the wound opening and blood is chmneled to a test strip integrated with the lance. In a method of lancing skin according to the present invention, the lancing element is inserted through an outer surface of the skin to obtain a sample of blood. In one embodiment of ths invention, the method includes using a lancing instrument having a sharpened end and a fluid channel extending from the sharpened end to a sensor attachtd to a proximal end of the lancing instrument, forcing the sharpened tip of the lancing element into the skin to a first predclemined depth, wherein the sharpened tip creates an incision in the skin surface and a wound below the skin surface, and completely with drawing the lancing element, including the sharpened tip. After completely withdrawing tip sharpened tip from the incision, blood, is drawn through the channel to the sensor. 2 WO 2004/041088 PCT/US2003/034456 In a method of lancing skin according to the present invention, the lancing element is inserted through an outer surface of the skin to obtain a sample of blood. In one embodiment of the invention, the method includes providing pressure an the skin in a region surrounding the incision site (i.e. the sits where the incision is to be mads). Theo using a laucing inilnimtait having a sharpened end and a fluid channel extending from the sharpened and to a sensor attached to a proximal end of the lancing instrument, forcing the sharpened tip of the lancing element into the skin to a first predetermined depth, wherein the sharpened tip creates an incision in the skin surface and a wound below the skin surface and oampletely withdrawing the lancing elemeni, including the sharpened tip. After completely withdrawing the sharpened tip from the incision, and blood is drawn through the channel to the sensor. In a method of lancing skin in accordance with the present invention, as set forth above, the method may further include providing a milking ring wherein the pressure in the region surrounding the incision site is exerted by the milking ring. The milking ring is positioned on the skin prior to the step of forcing the sharpened tip into the skin and may be maintained throughout the remainder of the procedure. In this embodiment of the invention, the milking ring provides a pressure sufficient to facilitate the flow of bodily fluids into the channel after the reinsertion of the lancing lip into the wound. In one embodiment of the invention, the milking ring provides a pressure in a range of approximately 0.5 to 1.5 pounds. In a method of lancing skin in accordance with the present invention, as set forth above the method may farther include providing a milking ring wherein the pressure is the region, surrounding the incision site is exerted by the milikng ring. The milking ring is positioned on the skin prior to the step of forcing the sharpened tip into the skin and may be maintained thoughout the remainder of the procedure. In this embodiment of the invention, the milking ring provides a pressure sufficient to facilitate the flow of bodily fluids into the channel after the reinsertion of the lancing tip into the wound, in one embodiment of the invention, the milking ring provides a pressure in a range of approximately 0.5 to 1.5 pounds. In a further embodiment of the present invention, the method may include positioning the milking ring against the skin for a predetermined period of time prior to launching the lancing 3 WO 2004/041088 PCT/US2003/034456 element In a further embodiment of the present invention, the predetemined period of time may be thrce seconds or more. BRIEF DESCRIPTION OF THE DRAWINGS The novel features of the invention are set forth with particularity in the appended claims. A better understanding of the features and advantages of the present invention will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the invention are utilized, and the accompanying drawings of whtch: Figure 1 is a perspective view of a, lancing element and strip for use in a method according to the present invention. Figure 2 is a perspective view of the top layer of a lancing element and strip for use in a method according to the present invention. Figure 3A is a peispective view of a lancing element tip immediately before penetration of the surface of the skin. Figure 3B is a side view of the lancing element illustrated in Figure 3A. Figure 3C is a perspective view of a lancing element as the tip of the lancing element begins to penetrate the surface of the skin. Figure 3D is a side view of the lancing clement as the lip of the lancing element begins to penetrate the surface of the skin. Figure 3E is a perspective view of the lancing element as it reaches its full depth of penetration beneath the surface of the skin. 4 WO 2004/041088 PCT/US2003/034456 Figure-3F is a side view of the lancing, clement as it reaches its full depth of penetration beneath the surface of the skin. Fig 3G is a side view of the fancing efement after it is full wilhdrawn from the skin- Figure 3I is a perspective view of the lancing element as it renters the surface a f the skin through the incision created during the first entry. Fignre 3J is a side: view of the lancing element as it lerentecs the surface of the skin through the incision created during the first entry. Figure 3K is a pretspectivc view showing the lancing element being used to draw blood from a forcarm. DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS OF THE INVENTION Figure 1 is a perspective view of a lancing element and strip for use in a method according to the present invention. in Figure 1, lancing element 15 is connected to sensor strip 100, Sensor strip 100 maybe, for example, a glucose sensor strip which uses electrochemistry to measure the smotint of glucose in a bodily fluid, such as, for example, blood or milerstitial fluid. In Figure 1, lancing clement furfber includes lancing tip 22. Sensor strip 100 further includes first electrode contact 10, adhesive layer 11, conductive snbstraie 12, vent bole 13, analyte sensing layer 14, second electrode contact 17, insulating substrate 18, insulating layer 20, registration bole 23 and working electrode 36. Figure 2 is a petspective view of the top layer of a lancing clement and strip for use in a method acoording to the present invention. In Figure 2 top layer is formed of conductive substrate 12. In the embodiment illustrated in Figure 2, conductive; substrate 12 includes vent 5 WO 2004/041088 PCT/US 2003/034456 bole 13 and registration bole 23. In Figure 2, lancing element includes lancing tip 22. channel tip 24 and fill channel 21. One embodiment of a lancing element and sensor strip Suitable for use in a method according to the present invention may be described with reference to Figure 1 and 2. In the embodiment illustrated in Figures 1 and 2, sensor ship 100 includes first electrode contact 10, wherein first electrode contact may be screen printed on an insulating substrate 18, and a second electrode contact 17, wherein said second electrode contact comprises s portion of conductive- substrate 12 which is contiguous with top reference electrode 19 and lancing element 15. In the embodiment of the lancing element and sensor strip illustrated in Figures 1 and 2, the orientation of said first electrode contact 10 and second electrode contact 17 are arranged such that an anslyte measurement meter, such as,for example, a glucose meter (not shown) can establish electrical contact with senscir strip 100. in the illustrated embodiment, the electrodes are arranged on the same side of msulaling substrate 18 to facilitate contact of both dectrodes at this proximal end of sensor strip 100. Sensor strip 100 is manufictured using adhesive layer 11 to attach. insuleting substate 18 to conductive substrate 12- Adhesive layer 11 could be implemented in a number of ways, including using pressure sensitive-material, beat activated material, or UV cured double sided adhesive material. Cooductive stibstmte 12 may be, for example, a conductive substrate that is B sheet of cloctrioally conduttivc material such as gold or plated stainless steel. The geometry of conductive substrate 12 may be formed by, for example, stumping; process or phopo-ctching. In the embodiment illustrated in Figures 1 and 2, lancing element 15 may be manufactured as an integral part of conductive substrate 12. Vent bole 13, may be formed by, for example punching through conductive layer 12. Vent hole 13 is used to facilitate the transport of bodily fluid up lancing element 15 and across analyte sensing layer 14. Registration bole 23 may be formed during the stamping process of making conductive substrate 12. 6 WO 2004/041088 PCT/US2003/034456 in one embodiment of the invention, analyse sensing layer 14 may be, for example, a glucose sensing layer, including an enzyme, a buffer, and a redox mediator. Analyte sensing layer 14 may preferably be deposited on top of working eloctrods 36. Where snalyte sensing layer 14 is used to dstect the presence and concentration of giucose in a bodily fluid, at least a portion of glucose sensing layer 14 dissolves in the bodily fluid and is used to convert the glucose concentration into an electrically measured parameter which is proportional to the glucose-concentration in the sample. In the embodiment illustraled in Figures 1 and 2, lancing element 15 has a proximal and distal end and the proximal end is integrated with the top reference electrode 19 and said distal end is integrated with a lancing tip 22 and channel tip 24. The lancing element is formed by the process of stamping or photo-eiching a conductive material sheet end bending it to the geometty shown in Figure 2. In one embodiment, lacing tip 22 and channel tip 24 are slightly offset by about 0-005 to 0.20", the design of lancing element 15 is adapted to assist in improving skini separation. The geometry illustrated in Figares 1 and 2 may enhance fluid egress because it helps sprfcad and open a skin wound. In the embodiment illustrated in Figures 1 and 2, the lancing element 15 is congiguous with the top reference electrode 19 and electrode contact 17. In the embodiment of the invention illustrated in Figure 2, lancing element 15 includes fill chatmd 2lt wherein capillary fill channel 21 facilitates the flow of body fluid from the wound to the analyte scnsing layer 14. Fill channel 21 may facilitate the flow of bodily fluids by, for example, wicking or capiliary action. In the embadimait illustrated in Figures 1 and 2 fill channel 21 has an open geometiy which facilitates the wicking of viscous satuples and provides for simpler manufacturing techniques when compared with closed capillary channels. In the emhodiment of sensor suip 100 illustrated in Figure 1, insulating substrate 18 coosists of material such as polyester or ceramic on which a conductive material can be prints onto the insulating layer through silk-screening, sputtering, or elcctroi-less deposition. Conductive material deposited on insulating Euhstrate 18 forms first electrode contact 10 and 7 W0 2004/041088 PCT/US2003/034456 working electrode 36. Insulating layer 20 may be, for example, screen printed to form a boundary for the electrode contact 10 and the bottom working electrode. Figure 3A is a perspective view of a lancing element tip imediately before penetration of the surface of the skin. More particularly, Figure 3A is a perspective view of a lance 15 before lancing tip 22 penetrates skin surface 30, Figure 3B is a side view of the lancing element illustrated in Figure 3A- More particularly Figure 3B is side view of lancing element 15 before lancing tip 22 penetrates skin surface 30. In Figures 3A and 3B, milking ring 31 iS placed against skin surface 30, causing skin surface 30 to bulge in to milking opening 32, Milking ring 32 may be, for example. a substrate with a bole drilled through it which could be, for example, a plastic such as polystyrene poiyethylene, polycarbonate, polyester, or the like. The diameter of opening 32 of said milting ring may be, for example, in the range of between 3,5 and 12 mm. in operation, the milking ring 31 may be applied with gentle pressure onto a fingertip, forearm, or other suitable site such that the skin surface 30 forms a raised mound within milting ring 31. In a one embodiment of a method according to the present invention, milking ring 31 is applited to skin surface 31 with a pressure of approximately 0,5 to 1.5 pounds of applied pressure. To one embodiment of a method according to the present invention, the use of a milking ring is- intended to facilitate the collection of bodily fluids by applying a pressure around the incision site to provide a driving force for expressing fluid from the wound site. Figure 3C is a perspective view of a lanoing element as the tip of the lancing element begins to penetrate the surface of the skin. As lancing tip 22 enters skin surface 30, deflecting sion surface 30 away from lancing tip 22 until skin surface 30 is punctured, forming an incision 37 in skin surface 30, enabling lancing element 15 to enter subcutaneous region 33. Figure 3D is a side view of the landng element as the tip of the lancing clement begins to penetrate the surface of the skin, Moie particularly;, Figure 3D is a side view of lancing element 15 as lencing tip 22 enters imcision 37 in skin surface 30. Figure 3E is a perspective view of the lancing element as it rcaches its full depth of penetration bencalh the surface of the skis. More particularly, Figure 3E is a perspective 8 WO 2004/041088 PCT/US2003/034456 view of lancing element 15 after lancing tip 22 has reacliud its full depth of pcnetrasion into subcutaneous region 33. Figure 3F is a side view of the lancing element 15 as it reaches its full depth of penetration beneath the surface of the skin. More particularly, Figure 3F is a side view of lancing element 15 after lancing tip 22 has reached its full depth, of penetration into subcutaneous region 33. At full penetration, lanciisg tip 22 reaches a depth of DI - The actual value of Dl for a particular application will depend upon a number of factors, including the bodily fluid being extracted. For example, if the bodily fluid being extracted is blood, the depth Dl will be greater than if the bodily fluid being extracted, is interstitial fluid (i.e. 1SF). in one embodiment of the present inveaiicn, penetration depth D1 may be, for example, in the range of 0.25 to 1.5 mm deep. In a method according to the present invention, insertion of lancing element 15 throught skin surface 30 creales an incision 37 in addition to severing subcutaneous tissue and capillaries and providing fill channel 21 with access to the bodily fluid to be sampled, wheiher blood or interstitial fluid Thus, with lancing element 15 positioned as shown in Figure3E and 3F, bodily fluid will flow through fill channcl 21 and into sensor strip 100. However, leaving lancing element 15 positioned as iIllustrated in Figures 3E and 3F will not provide an optimal flow of bodily fluid through fill channel 21. The reasons for the limited flow may include, for example, the blocking of lanced capillaries by the location of lancing element 15 which may, for example, prevent the capillaries or interstitial fluid from flowing freely and pooling in the wound created by lancing element 15. Fig 3G is a perspective -view of the lancing etement after if. is fully with drawn from the skin. More particularly, Figure 3G is a perspective view of lancing element 15 after lencing lip 22 has been withdrawn completely from incision 37. Fig 3H is a side view of the- lancing element 15 after it is fully withdrawn from sion surface 30. In a method according to the present invention, fully withdrawing lancing element 15 from incision 37 creates an open the wound 38 below incision 37 Which fecilitates expression of bodily fluid into wound 38. By folly removing lancing element 15 from the wound in accordance with the method of the present invention, bodily fluids flow mofc readily into wound 38. If lancing element 15 is not completely removed from wound 38, blood and/or interstitial fluid flow may be impeded, 9 WO 2004/041088 PCT/US2003/034456 One possible explanation for the limited blood flow is the possibility that the partially retracted lancing element. 15 may still effectively block severed capillarise because of the resiliency of the skin. After the initial skin streochtng during the penetration-event, the skin might revert back to its initial position abound lancing element 15, Thus, in the method according to the present invention it is important that lancing element 15 be fully removed from wound 38 after the initial penetration to allow bodily fluid to pool in wound 38. Figure31 is a perspective view of the lancing element as it re-enters the surface of the skin through the incision created during the first entry. More particularly, Figure 31 is a perepectivc view of lancing element 15 after lancing tip 22 has been re-inserted through incision 37 into wound 38. Figure 3J is a side view of the latticing element as it re-enters the stirfafle of the skin through the incision created during the first entry. More particularly. Figure 3J is a side view of lancing element 15 positioned within wound 38 such that channel tip 24 is below skin surfecs 30. Figure 3K. is a perspective view showing the landng element being used to draw blood from a forearm. More particularly. Figure 3K. is a. perspective view of a lancing device 15 being used in a method seconding to the present invention to draw bodily fluids from a forearm 40 of a human being. In a method of lancing skin in accordance with the present invention, as set forth above, the method may further include using milking ring. 31 to exert the pressure in the region surrounding incision 37 exerted by milking ring 31. Milking ring 31 is posttidned on the skin prior to the step of forcing the lancing tip 22 into the skin and may be maintained throughout the remainder of the procedure. In this embodiment of the invention the milking ring31 provides a pressure sufficient to facilitate the flow of bodily fluids into fill channel 21 after the reinsertion of lancing tip 22 into wound 38. in One embodiment of the invention, milking ring 31 provides a pressure in a range of approximately 0,5 to 1.5 pounds. In a further embodiment of the present invention, the method may include positioning the milking ring 51 against the skin for a predetermined period of line prior to launching the lancing element in a futher embondiment of the present invention, the predetermined period of time may be three seconds or more. 10 WO 2004/041088 PCT/US2003/034456 It will be recognized that eqirivalent structures may be substituted for the structures- illustrated and described herein and that the described embodiment of the invention is not the only structure which may be employed to implement the claimed invention. As one example of an equivalent structure which may be used to implement the present-invention, a- lancing element may be used which, does not include a channel tip, with the channel exlcnding from the distal end of the lancing element to the working, electrode. While preferred embodiments of the present invention have been shown and described herein, it will be obvious to those skilled in the art that such embodiments are provided by way of example, only. Ntrnerous variations, changes, and substitutions will now occur to hose skilled in the art without departing from the invention. It should be understood that various alternatives to the embodiments of the invention described herein: may be employed in practicing the invention. It is intended that the following claims define the scope of the invention and that methods and structures -within the scope of these claims and their equivalents be covered thereby. 11 l. A method of extracting blood from an outer surface of skin, the method comprising the steps of: providing a lancing instrument having a sharpened tip and a channel adjscent to said sharpened tip to a sensor attached to a proximal end of said lancing instrument; forcing said sharpened tip into said skin to a first predetermiritd dtpth below said outer surface, wherein said sharpened tip creates an incision in said skin surface; completely withdrawing said sharpened tip from said incision; and drawing blood through said channel to said sensor. 2. A method as claimed in claim 1, wherein said first predetermined depth is in the range of approximately 0-25 to 1 ,5mm. 3. A method as claimed in claim 1, further comprising the steps of providing pressure on said skin in a region surrounding said incision. 4. A method as claimed in claim 3 whierin said pressure is exerted by a milking ring positioned on said skin prior to said step of forcing said sharpened tip into said skin. 5. A method as claimed in claim 4 wherein said milking ring provides a pressure sufficient to facilitate the flow of bodily fluids into said channel. 12 The prescnt invention reclacs to a thethod of lancing.skin through an outer surface of said skin to obtain a sample of blood. the method proving a lancing instrument having a sharpened end and a channnel extendting from adjaccnt said sharperse and in a sensor accahed in a proximul of said lancing instumernt forcing said sharpened tip into said skin to a first predeemiires dcpth below said outer surface wherein said shorpened tip creates an incision in said skin surface: the completely withdrawing said shaipened tipi from the incision, and drawing blood through said channel to the sensor.

Full Text

WO 2004/041088 PCT/US2003/034456
METHOD OF LANCING SKIN FOR THE EXTRACTION OF BLOOD
BACKGROUND OF THE INVENTION
Field_of the Invention
The presenl invention relates, in general, to a method of lancing skin and,
more particulaily, to an improved method wherein the lancing element is removed after
creating an incision and then blood is channeled up the lancing element to a sensor element.
located at a proximal end of the lancing clement.
Background of the Invcntion
In in-situ testing of blood glucose, a glucose meter is placed against the skin
and blood is sampled and measured without moving the meter. In one method of in-situ
testing, a glucose sensor strip is combined with a. luncing clement positioned at a distal end
thereof, the glucose sensor strip is then positioned in a meter adapted to launch the strip and
lancing element combination toward the skin where the lancing element forms an incision.
Blood or other bodily fluids such as, fot example, interstitial fluid, may then be extracted
from the incision and moved to the glucost sensor strip where it can be measured using, for
example, on electrochemical process.
When lancing skin using an in-situ lest strip, it is desirable to ensure that blood
be transferred efficiently from the incision to the test strip, using as little blood as possible.
Efficient transfer of blood from the incision means that more of the blood is actually used to
lest for anslyte (e.g. glucose) levels, reducing the total blood required and, therefore, the
incision size required for the lest Smaller intisions are particularly desirable because, in
general, it is desirable to reduce the pain experienced by the user. Further, smaller incisions
generally heal faster and art out as likely to re-open once healed.
1

WO 2004/041088 PCT/US2003/03456
Thus, when using an in-situ test, it is desirable to create an incision which is
very small while maximising the amount of blood generated by that incision. A number of
factors influence the amount of blood generated by a particular incision, Mary of those
factors cannot be controlled. One of the factors which reduces, the amount of blood available
at a particular incision is the tendency of the incision to seal around the lancing element if the
lancing element is left in the wound.
It would, therefore, be advantageous to develop a-method of lanting which
increases the amount of blood available for testing at a particular incisbn sits. It would
further be advantageous to develop a method of lancing which increases the amount of blood
available for lancing by pieveniing the wound from mscaling during the testing process. It
would further he advantageous to develop a method of lancing which increases the amount 01
blood available for lancing by preventing the wound from sealing around the lancinig elcment
during the testing process.
SUMMARY OF THE INVENTION
In a method according to the present invention, a lancing tip is first inserted
and then is netracted completely out of the lance wound site, The lancing tip is then
positioned adjacent the wound opening and blood is chmneled to a test strip integrated with
the lance.
In a method of lancing skin according to the present invention, the lancing
element is inserted through an outer surface of the skin to obtain a sample of blood. In one
embodiment of ths invention, the method includes using a lancing instrument having a
sharpened end and a fluid channel extending from the sharpened end to a sensor attachtd to a
proximal end of the lancing instrument, forcing the sharpened tip of the lancing element into
the skin to a first predclemined depth, wherein the sharpened tip creates an incision in the
skin surface and a wound below the skin surface, and completely with drawing the lancing
element, including the sharpened tip. After completely withdrawing tip sharpened tip from
the incision, blood, is drawn through the channel to the sensor.
2

WO 2004/041088 PCT/US2003/034456
In a method of lancing skin according to the present invention, the lancing
element is inserted through an outer surface of the skin to obtain a sample of blood. In one
embodiment of the invention, the method includes providing pressure an the skin in a region
surrounding the incision site (i.e. the sits where the incision is to be mads). Theo using a
laucing inilnimtait having a sharpened end and a fluid channel extending from the sharpened
and to a sensor attached to a proximal end of the lancing instrument, forcing the sharpened tip
of the lancing element into the skin to a first predetermined depth, wherein the sharpened tip
creates an incision in the skin surface and a wound below the skin surface and oampletely
withdrawing the lancing elemeni, including the sharpened tip. After completely withdrawing
the sharpened tip from the incision, and blood is drawn through the channel to the sensor.
In a method of lancing skin in accordance with the present invention, as set
forth above, the method may further include providing a milking ring wherein the pressure in
the region surrounding the incision site is exerted by the milking ring. The milking ring is
positioned on the skin prior to the step of forcing the sharpened tip into the skin and may be
maintained throughout the remainder of the procedure. In this embodiment of the invention,
the milking ring provides a pressure sufficient to facilitate the flow of bodily fluids into the
channel after the reinsertion of the lancing lip into the wound. In one embodiment of the
invention, the milking ring provides a pressure in a range of approximately 0.5 to 1.5 pounds.
In a method of lancing skin in accordance with the present invention, as set
forth above the method may farther include providing a milking ring wherein the pressure is
the region, surrounding the incision site is exerted by the milikng ring. The milking ring is
positioned on the skin prior to the step of forcing the sharpened tip into the skin and may be
maintained thoughout the remainder of the procedure. In this embodiment of the invention,
the milking ring provides a pressure sufficient to facilitate the flow of bodily fluids into the
channel after the reinsertion of the lancing tip into the wound, in one embodiment of the
invention, the milking ring provides a pressure in a range of approximately 0.5 to 1.5 pounds.
In a further embodiment of the present invention, the method may include positioning the
milking ring against the skin for a predetermined period of time prior to launching the lancing
3

WO 2004/041088 PCT/US2003/034456
element In a further embodiment of the present invention, the predetemined period of time
may be thrce seconds or more.
BRIEF DESCRIPTION OF THE DRAWINGS
The novel features of the invention are set forth with particularity in the
appended claims. A better understanding of the features and advantages of the present
invention will be obtained by reference to the following detailed description that sets forth
illustrative embodiments, in which the principles of the invention are utilized, and the
accompanying drawings of whtch:
Figure 1 is a perspective view of a, lancing element and strip for use in a method according to
the present invention.
Figure 2 is a perspective view of the top layer of a lancing element and strip for use in a
method according to the present invention.
Figure 3A is a peispective view of a lancing element tip immediately before penetration of
the surface of the skin.
Figure 3B is a side view of the lancing element illustrated in Figure 3A.
Figure 3C is a perspective view of a lancing element as the tip of the lancing element begins
to penetrate the surface of the skin.
Figure 3D is a side view of the lancing clement as the lip of the lancing element begins to
penetrate the surface of the skin.
Figure 3E is a perspective view of the lancing element as it reaches its full depth of
penetration beneath the surface of the skin.
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WO 2004/041088 PCT/US2003/034456
Figure-3F is a side view of the lancing, clement as it reaches its full depth of penetration
beneath the surface of the skin.
Fig 3G is a side view of the fancing efement after it is full wilhdrawn from the skin-
Figure 3I is a perspective view of the lancing element as it renters the surface a f the skin
through the incision created during the first entry.
Fignre 3J is a side: view of the lancing element as it lerentecs the surface of the skin through
the incision created during the first entry.
Figure 3K is a pretspectivc view showing the lancing element being used to draw blood from a
forcarm.
DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS
OF THE INVENTION
Figure 1 is a perspective view of a lancing element and strip for use in a method
according to the present invention. in Figure 1, lancing element 15 is connected to sensor
strip 100, Sensor strip 100 maybe, for example, a glucose sensor strip which uses
electrochemistry to measure the smotint of glucose in a bodily fluid, such as, for example,
blood or milerstitial fluid. In Figure 1, lancing clement furfber includes lancing tip 22. Sensor
strip 100 further includes first electrode contact 10, adhesive layer 11, conductive snbstraie
12, vent bole 13, analyte sensing layer 14, second electrode contact 17, insulating substrate
18, insulating layer 20, registration bole 23 and working electrode 36.
Figure 2 is a petspective view of the top layer of a lancing clement and strip for use in
a method acoording to the present invention. In Figure 2 top layer is formed of conductive
substrate 12. In the embodiment illustrated in Figure 2, conductive; substrate 12 includes vent
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WO 2004/041088 PCT/US 2003/034456
bole 13 and registration bole 23. In Figure 2, lancing element includes lancing tip 22. channel
tip 24 and fill channel 21.
One embodiment of a lancing element and sensor strip Suitable for use in a method
according to the present invention may be described with reference to Figure 1 and 2. In the
embodiment illustrated in Figures 1 and 2, sensor ship 100 includes first electrode contact 10,
wherein first electrode contact may be screen printed on an insulating substrate 18, and a
second electrode contact 17, wherein said second electrode contact comprises s portion of
conductive- substrate 12 which is contiguous with top reference electrode 19 and lancing
element 15.
In the embodiment of the lancing element and sensor strip illustrated in Figures 1 and
2, the orientation of said first electrode contact 10 and second electrode contact 17 are
arranged such that an anslyte measurement meter, such as,for example, a glucose meter (not
shown) can establish electrical contact with senscir strip 100. in the illustrated embodiment,
the electrodes are arranged on the same side of msulaling substrate 18 to facilitate contact of
both dectrodes at this proximal end of sensor strip 100.
Sensor strip 100 is manufictured using adhesive layer 11 to attach. insuleting substate
18 to conductive substrate 12- Adhesive layer 11 could be implemented in a number of ways,
including using pressure sensitive-material, beat activated material, or UV cured double sided
adhesive material. Cooductive stibstmte 12 may be, for example, a conductive substrate that
is B sheet of cloctrioally conduttivc material such as gold or plated stainless steel. The
geometry of conductive substrate 12 may be formed by, for example, stumping; process or
phopo-ctching. In the embodiment illustrated in Figures 1 and 2, lancing element 15 may be
manufactured as an integral part of conductive substrate 12. Vent bole 13, may be formed by,
for example punching through conductive layer 12. Vent hole 13 is used to facilitate the
transport of bodily fluid up lancing element 15 and across analyte sensing layer 14.
Registration bole 23 may be formed during the stamping process of making conductive
substrate 12.
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WO 2004/041088 PCT/US2003/034456
in one embodiment of the invention, analyse sensing layer 14 may be, for example, a
glucose sensing layer, including an enzyme, a buffer, and a redox mediator. Analyte sensing
layer 14 may preferably be deposited on top of working eloctrods 36. Where snalyte sensing
layer 14 is used to dstect the presence and concentration of giucose in a bodily fluid, at least a
portion of glucose sensing layer 14 dissolves in the bodily fluid and is used to convert the
glucose concentration into an electrically measured parameter which is proportional to the
glucose-concentration in the sample.
In the embodiment illustraled in Figures 1 and 2, lancing element 15 has a proximal
and distal end and the proximal end is integrated with the top reference electrode 19 and said
distal end is integrated with a lancing tip 22 and channel tip 24. The lancing element is
formed by the process of stamping or photo-eiching a conductive material sheet end bending
it to the geometty shown in Figure 2. In one embodiment, lacing tip 22 and channel tip 24 are
slightly offset by about 0-005 to 0.20", the design of lancing element 15 is adapted to assist
in improving skini separation. The geometry illustrated in Figares 1 and 2 may enhance fluid
egress because it helps sprfcad and open a skin wound. In the embodiment illustrated in
Figures 1 and 2, the lancing element 15 is congiguous with the top reference electrode 19 and
electrode contact 17.
In the embodiment of the invention illustrated in Figure 2, lancing element 15
includes fill chatmd 2lt wherein capillary fill channel 21 facilitates the flow of body fluid
from the wound to the analyte scnsing layer 14. Fill channel 21 may facilitate the flow of
bodily fluids by, for example, wicking or capiliary action. In the embadimait illustrated in
Figures 1 and 2 fill channel 21 has an open geometiy which facilitates the wicking of viscous
satuples and provides for simpler manufacturing techniques when compared with closed
capillary channels.
In the emhodiment of sensor suip 100 illustrated in Figure 1, insulating substrate 18
coosists of material such as polyester or ceramic on which a conductive material can be
prints onto the insulating layer through silk-screening, sputtering, or elcctroi-less deposition.
Conductive material deposited on insulating Euhstrate 18 forms first electrode contact 10 and
7

W0 2004/041088 PCT/US2003/034456
working electrode 36. Insulating layer 20 may be, for example, screen printed to form a
boundary for the electrode contact 10 and the bottom working electrode.
Figure 3A is a perspective view of a lancing element tip imediately before
penetration of the surface of the skin. More particularly, Figure 3A is a perspective view of a
lance 15 before lancing tip 22 penetrates skin surface 30, Figure 3B is a side view of the
lancing element illustrated in Figure 3A- More particularly Figure 3B is side view of lancing
element 15 before lancing tip 22 penetrates skin surface 30. In Figures 3A and 3B, milking
ring 31 iS placed against skin surface 30, causing skin surface 30 to bulge in to milking
opening 32, Milking ring 32 may be, for example. a substrate with a bole drilled through it
which could be, for example, a plastic such as polystyrene poiyethylene, polycarbonate,
polyester, or the like. The diameter of opening 32 of said milting ring may be, for example,
in the range of between 3,5 and 12 mm. in operation, the milking ring 31 may be applied
with gentle pressure onto a fingertip, forearm, or other suitable site such that the skin surface
30 forms a raised mound within milting ring 31. In a one embodiment of a method according
to the present invention, milking ring 31 is applited to skin surface 31 with a pressure of
approximately 0,5 to 1.5 pounds of applied pressure. To one embodiment of a method
according to the present invention, the use of a milking ring is- intended to facilitate the
collection of bodily fluids by applying a pressure around the incision site to provide a driving
force for expressing fluid from the wound site.
Figure 3C is a perspective view of a lanoing element as the tip of the lancing element
begins to penetrate the surface of the skin. As lancing tip 22 enters skin surface 30, deflecting
sion surface 30 away from lancing tip 22 until skin surface 30 is punctured, forming an
incision 37 in skin surface 30, enabling lancing element 15 to enter subcutaneous region 33.
Figure 3D is a side view of the landng element as the tip of the lancing clement begins to
penetrate the surface of the skin, Moie particularly;, Figure 3D is a side view of lancing
element 15 as lencing tip 22 enters imcision 37 in skin surface 30.
Figure 3E is a perspective view of the lancing element as it rcaches its full depth of
penetration bencalh the surface of the skis. More particularly, Figure 3E is a perspective
8

WO 2004/041088 PCT/US2003/034456
view of lancing element 15 after lancing tip 22 has reacliud its full depth of pcnetrasion into
subcutaneous region 33. Figure 3F is a side view of the lancing element 15 as it reaches its
full depth of penetration beneath the surface of the skin. More particularly, Figure 3F is a
side view of lancing element 15 after lancing tip 22 has reached its full depth, of penetration
into subcutaneous region 33. At full penetration, lanciisg tip 22 reaches a depth of DI - The
actual value of Dl for a particular application will depend upon a number of factors,
including the bodily fluid being extracted. For example, if the bodily fluid being extracted is
blood, the depth Dl will be greater than if the bodily fluid being extracted, is interstitial fluid
(i.e. 1SF). in one embodiment of the present inveaiicn, penetration depth D1 may be, for
example, in the range of 0.25 to 1.5 mm deep.
In a method according to the present invention, insertion of lancing element 15
throught skin surface 30 creales an incision 37 in addition to severing subcutaneous tissue and
capillaries and providing fill channel 21 with access to the bodily fluid to be sampled,
wheiher blood or interstitial fluid Thus, with lancing element 15 positioned as shown in
Figure3E and 3F, bodily fluid will flow through fill channcl 21 and into sensor strip 100.
However, leaving lancing element 15 positioned as iIllustrated in Figures 3E and 3F will not
provide an optimal flow of bodily fluid through fill channel 21. The reasons for the limited
flow may include, for example, the blocking of lanced capillaries by the location of lancing
element 15 which may, for example, prevent the capillaries or interstitial fluid from flowing
freely and pooling in the wound created by lancing element 15.
Fig 3G is a perspective -view of the lancing etement after if. is fully with drawn from
the skin. More particularly, Figure 3G is a perspective view of lancing element 15 after
lencing lip 22 has been withdrawn completely from incision 37. Fig 3H is a side view of the-
lancing element 15 after it is fully withdrawn from sion surface 30. In a method according to
the present invention, fully withdrawing lancing element 15 from incision 37 creates an open
the wound 38 below incision 37 Which fecilitates expression of bodily fluid into wound 38.
By folly removing lancing element 15 from the wound in accordance with the method of the
present invention, bodily fluids flow mofc readily into wound 38. If lancing element 15 is not
completely removed from wound 38, blood and/or interstitial fluid flow may be impeded,
9

WO 2004/041088 PCT/US2003/034456
One possible explanation for the limited blood flow is the possibility that the partially
retracted lancing element. 15 may still effectively block severed capillarise because of the
resiliency of the skin. After the initial skin streochtng during the penetration-event, the skin
might revert back to its initial position abound lancing element 15, Thus, in the method
according to the present invention it is important that lancing element 15 be fully removed
from wound 38 after the initial penetration to allow bodily fluid to pool in wound 38.
Figure31 is a perspective view of the lancing element as it re-enters the surface of the
skin through the incision created during the first entry. More particularly, Figure 31 is a
perepectivc view of lancing element 15 after lancing tip 22 has been re-inserted through
incision 37 into wound 38. Figure 3J is a side view of the latticing element as it re-enters the
stirfafle of the skin through the incision created during the first entry. More particularly.
Figure 3J is a side view of lancing element 15 positioned within wound 38 such that channel
tip 24 is below skin surfecs 30. Figure 3K. is a perspective view showing the landng element
being used to draw blood from a forearm. More particularly. Figure 3K. is a. perspective view
of a lancing device 15 being used in a method seconding to the present invention to draw
bodily fluids from a forearm 40 of a human being.
In a method of lancing skin in accordance with the present invention, as set
forth above, the method may further include using milking ring. 31 to exert the pressure in the
region surrounding incision 37 exerted by milking ring 31. Milking ring 31 is posttidned on
the skin prior to the step of forcing the lancing tip 22 into the skin and may be maintained
throughout the remainder of the procedure. In this embodiment of the invention the milking
ring31 provides a pressure sufficient to facilitate the flow of bodily fluids into fill channel 21
after the reinsertion of lancing tip 22 into wound 38. in One embodiment of the invention,
milking ring 31 provides a pressure in a range of approximately 0,5 to 1.5 pounds. In a
further embodiment of the present invention, the method may include positioning the milking
ring 51 against the skin for a predetermined period of line prior to launching the lancing
element in a futher embondiment of the present invention, the predetermined period of time
may be three seconds or more.
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WO 2004/041088 PCT/US2003/034456
It will be recognized that eqirivalent structures may be substituted for the structures-
illustrated and described herein and that the described embodiment of the invention is not the
only structure which may be employed to implement the claimed invention. As one example
of an equivalent structure which may be used to implement the present-invention, a- lancing
element may be used which, does not include a channel tip, with the channel exlcnding from
the distal end of the lancing element to the working, electrode. While preferred embodiments
of the present invention have been shown and described herein, it will be obvious to those
skilled in the art that such embodiments are provided by way of example, only. Ntrnerous
variations, changes, and substitutions will now occur to hose skilled in the art without
departing from the invention. It should be understood that various alternatives to the
embodiments of the invention described herein: may be employed in practicing the invention.
It is intended that the following claims define the scope of the invention and that methods and
structures -within the scope of these claims and their equivalents be covered thereby.
11

l. A method of extracting blood from an outer surface of
skin, the method comprising the steps of:
providing a lancing instrument having a sharpened tip and a
channel adjscent to said sharpened tip to a sensor attached to a
proximal end of said lancing instrument;
forcing said sharpened tip into said skin to a first
predetermiritd dtpth below said outer surface, wherein said
sharpened tip creates an incision in said skin surface;
completely withdrawing said sharpened tip from said
incision; and
drawing blood through said channel to said sensor.
2. A method as claimed in claim 1, wherein said first
predetermined depth is in the range of approximately 0-25 to
1 ,5mm.
3. A method as claimed in claim 1, further comprising the
steps of providing pressure on said skin in a region surrounding
said incision.
4. A method as claimed in claim 3 whierin said pressure is
exerted by a milking ring positioned on said skin prior to said
step of forcing said sharpened tip into said skin.
5. A method as claimed in claim 4 wherein said milking ring
provides a pressure sufficient to facilitate the flow of bodily
fluids into said channel.
12

The prescnt invention reclacs to a thethod of lancing.skin through an outer surface of said skin to obtain a sample of
blood. the method proving a lancing instrument having a sharpened end and a channnel extendting from adjaccnt said sharperse and
in a sensor accahed in a proximul of said lancing instumernt forcing said sharpened tip into said skin to a first predeemiires
dcpth below said outer surface wherein said shorpened tip creates an incision in said skin surface: the completely withdrawing said
shaipened tipi from the incision, and drawing blood through said channel to the sensor.

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Patent Number

221728

Indian Patent Application Number

00994/KOLNP/2005

PG Journal Number

27/2008

Publication Date

04-Jul-2008

Grant Date

03-Jul-2008

Date of Filing

26-May-2005

Name of Patentee

MENTORWAVE TECHNOLOGIES LTD.

Applicant Address

10 MASKIT STREET, P.O.BOX 4039, HERZLIA 46140

Inventors:

#	Inventor's Name	Inventor's Address
1	ROYZ GADI	9 SHPRINTZAK STREET, 64738 TEL-AVIV
2	AMIRA RONY	63 EMEK HA'ELA STREET, 71700 MODI'IN

PCT International Classification Number

G06T 15/70

PCT International Application Number

PCT/IL2003/000990

PCT International Filing date

2003-11-24

PCT Conventions:

#	PCT Application Number	Date of Convention	Priority Country
1	60/428,699	2002-11-25	U.S.A.