최소 단어 이상 선택하여야 합니다.
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다음과 같은 기능을 한번의 로그인으로 사용 할 수 있습니다.
NTIS 바로가기다음과 같은 기능을 한번의 로그인으로 사용 할 수 있습니다.
DataON 바로가기다음과 같은 기능을 한번의 로그인으로 사용 할 수 있습니다.
Edison 바로가기다음과 같은 기능을 한번의 로그인으로 사용 할 수 있습니다.
Kafe 바로가기국가/구분 | United States(US) Patent 등록 |
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국제특허분류(IPC7판) |
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출원번호 | US-0335142 (2002-12-31) |
등록번호 | US-7374544 (2008-05-20) |
발명자 / 주소 |
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출원인 / 주소 |
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대리인 / 주소 |
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인용정보 | 피인용 횟수 : 195 인용 특허 : 1019 |
These and other objects of the present invention are achieved in a body fluid sampling system for use on a tissue site that includes an electrically powered drive force generator. A penetrating member is operatively coupled to the force generator. The force generator moves the member along a path ou
These and other objects of the present invention are achieved in a body fluid sampling system for use on a tissue site that includes an electrically powered drive force generator. A penetrating member is operatively coupled to the force generator. The force generator moves the member along a path out of a housing having a penetrating member exit, into the tissue site, stops in the tissue site, and withdraws out of the tissue site. An analyte detecting member is positioned to receive fluid from a wound created by the penetrating member. The detection member is configured to determine a concentration of an analyte in the fluid using a sample of less than 1 mL of the fluid.
What is claimed is: 1. A body fluid sampling system for use on a tissue site, the system comprising: a controllable, electrically powered drive force generator; a penetrating member operatively coupled to said controllable, electrically powered drive force generator, said controllable, electrically
What is claimed is: 1. A body fluid sampling system for use on a tissue site, the system comprising: a controllable, electrically powered drive force generator; a penetrating member operatively coupled to said controllable, electrically powered drive force generator, said controllable, electrically powered force generator moving said penetrating member along a path out of a housing having a penetrating member exit, into said tissue site, stopping in said tissue site, and withdrawing out of said tissue site; and a sample chamber that includes electrodes, has a volume no greater than 1 μL and has an analyte sensor, the sample chamber being positioned to receive fluid from a wound created by said penetrating member, and the analyte sensor and determine a concentration of an analyte in a fluid using a sample of less than 1 μL of the fluid, wherein when the penetrating member is removed from the sample chamber, the electrodes remain in the sample chamber and the volume of the sample chamber is less than 1 μL and a penetrating member sensor coupled to said controllable, electrically powered drive force generator and to a programmable processor, the penetrating member sensor configured to provide information relative to a depth of penetration of a penetrating member through a skin surface, the programmable processor operatively programmed with software that has control instructions for the controllable, electrically powered drive force generator to keep a wound tract created by a penetrating member open for a sufficient time to provide for spontaneous flow of blood for sample capture into an associated sample chamber, wherein the control instructions are selected from at least one of, penetration depth of a penetrating member, velocity of a penetrating member, velocity of a penetrating member in or out of target tissue and a dwell time of a penetrating member in the tissue site. 2. The system of claim 1, wherein the depth of penetration is about 100 to 2500 microns. 3. The system of claim 1, wherein the depth of penetration is 500 to 750 microns. 4. The system of claim 1, wherein the depth of penetration is no more 1000 microns beyond a stratum corneum thickness of a skin surface. 5. The system of claim 1, wherein the depth of penetration is no more 500 microns beyond a stratum corneum thickness of a skin surface. 6. The system of claim 1, wherein the depth of penetration is no more 300 microns beyond a stratum corneum thickness of a skin surface. 7. The system of claim 1, wherein the depth of penetration is less than a total of a stratum corneum thickness of a skin surface and 400 microns. 8. The system of claim 1, wherein the penetrating member sensor is further configured to provide an indication of velocity of a penetrating member. 9. The system of claim 1, wherein the active penetrating member moves along a linear path into the tissue. 10. The system of claim 1, wherein the active penetrating member moves along an at least partially curved path into the tissue. 11. The system of claim 1, wherein the processor includes a memory for storage and retrieval of a set of penetrating member profiles utilized with the penetrating member driver. 12. The system of claim 1, wherein the processor is utilized to monitor position and speed of a penetrating member as the penetrating member moves in a first direction. 13. The system of claim 1, wherein the processor is utilized to adjust an application of force to a penetrating member to achieve a desired speed of the penetrating member. 14. The system of claim 1, wherein the processor is utilized to adjust an application of force to a penetrating member when the penetrating member contacts a target tissue so that the penetrating member penetrates the target tissue within a desired range of speed. 15. The system of claim 1, wherein the processor is utilized to monitor position and speed of a penetrating member as the penetrating member moves in the first direction toward a target tissue, wherein the application of a launching force to the penetrating member is controlled based on position and speed of the penetrating member. 16. The system of claim 15, wherein the processor is utilized to control a withdraw force to the penetrating member so that the penetrating member moves in a second direction away from the target tissue. 17. The system of claim 16, wherein in the first direction the penetrating member advances through the target tissue at a speed that is different than a speed at which the penetrating member withdraws from the target tissue. 18. The system of claim 16, wherein in the first direction the penetrating member advances through the target tissue at a speed that is greater than a speed at which the penetrating member withdraws from the target tissue. 19. The system of claim 16, wherein the average velocity of the penetrating member during a tissue penetration stroke in the first direction is 100 to 1000 times greater than the average velocity of the penetrating member during a withdrawal stroke in a second direction. 20. The system of claim 15, wherein a speed of a penetrating member in the first direction is the range of 2.0 to 10.0 m/sec. 21. The system of claim 15, wherein a speed of a penetrating member in the first direction is the range 0.05 to 60 m/sec. 22. The system of claim 15, wherein a speed of a penetrating member in the first direction is the range 0.1 to 20.0 m/sec. 23. The system of claim 15, wherein a speed of a penetrating member in the first direction is the range 1.0 to 10.0 m/sec. 24. The system of claim 15, wherein a speed of a penetrating member in the first direction is the range 3.0 to 8.0 m/sec. 25. The system of claim 15, wherein a dwell time of the penetrating member in the target tissue below a skin surface is in the range of 1 microsecond to 2 seconds. 26. The system of claim 1, wherein a dwell time of the penetrating member in the a target tissue below a skin surface is in the range of 500 milliseconds to 1.5 second. 27. The system of claim 1, wherein a dwell time of the penetrating member in a target tissue below a skin surface is in the range of 100 milliseconds to 1 second. 28. The system of claim 1, further comprising a cartridge having one of said penetrating members. 29. The system of claim 1, further comprising: a plurality of cartridges integrated in a cassette, each of said cartridges having one of said penetrating members. 30. The system of claim 29, wherein each cartridge has an exit port, and upon launch each penetrating member exits from the exit port. 31. The system of claim 29, wherein unused cartridges are stored in a linear stack. 32. The system of claim 29, further comprising a flexible support member coupling said cartridges together to define an array. 33. The system of claim 29, wherein each of said cartridges has one of said analyte detecting members. 34. The system of claim 29, wherein: each of said cartridges has one of said analyte detecting members; each of said cartridges defines a lumen at least partially housing one of said penetrating members; wherein each of said analyte detecting members are positioned to receive body fluid entering the lumen from a wound on the tissue site created by the penetrating member. 35. The system of claim 29, wherein: each of said cartridges has one of said analyte detecting members; wherein each of said penetrating members moves outward from an exit port on said cartridges to penetrate tissue; wherein each of said analyte detecting members are positioned to receive body fluid entering the exit port from a wound on the tissue site created by the penetrating member. 36. The system of claim 1, wherein the penetrating member sensor includes an optical encoder. 37. The system of claim 1, wherein the sample chamber has an opening for transport of a body fluid into the sample chamber, the sample chamber being sized to receive no more than 0.75 μL of the body fluid. 38. The system of claim 1, wherein the sample chamber has an opening for transport of a body fluid into the sample chamber, the sample chamber being sized to receive no more than 0.5 μL of the body fluid. 39. The system of claim 1, wherein the sample chamber has an opening for transport of a body fluid into the sample chamber, the sample chamber being sized to receive no more than 0.25 μL of the body fluid. 40. The system of claim 1, wherein the sample chamber has an opening for transport of a body fluid into the sample chamber, the sample chamber being sized to receive no more than 0.1 μL of the body fluid. 41. The system of claim 1, wherein a plurality of penetrating members are provided, each of a penetrating member of the plurality of penetrating members having a packing density of no more than 1.0 cm3/penetrating member. 42. The system of claim 41, wherein each of a penetrating member and an associated sample chamber have a combined packing density of no more than 1.0 cm3. 43. The system of claim 41, wherein each of a penetrating member and an associated sample chamber have a combined packing density of no more than 0.75 cm3. 44. The system of claim 41, wherein each of a penetrating member and an associated sample chamber have a combined packing density of no more than 0.5 cm3. 45. The system of claim 41, wherein each of a penetrating member and an associated sample chamber have a combined packing density of no more than 0.25 cm3. 46. The system of claim 41, wherein each of a penetrating member and an associated sample chamber have a combined packing density of no more than 0.1 cm3. 47. The system of claim 1, wherein a plurality of penetrating members are provided, each of a penetrating member of the plurality of penetrating members having a packing density of no more than 0.75 cm3/penetrating member. 48. The system of claim 1, wherein a plurality of penetrating members are provided, each of a penetrating member of the plurality of penetrating members having a packing density of no more than 0.5 cm3/penetrating member. 49. The system of claim 1, wherein a plurality of penetrating members are provided, each of a penetrating member of the plurality of penetrating members a packing density of no more than 0.25 cm3/penetrating member. 50. The system of claim 1, wherein a plurality of penetrating members are provided, each of a penetrating member of the plurality of penetrating members having a packing density of no more than 0.1 cm3/penetrating member. 51. The system of claim 1, further comprising: a seal formed by a fracturable material between the penetrating member and the cartridge, the seal being positioned at a distal port or a proximal port of the cartridge. 52. The system of claim 1, further comprising a second fracturable seal located at the distal port or proximal port of cartridge. 53. The system of claim 1, further comprising at least three fracturable seals between the penetrating member and the cartridge. 54. The system of claim 1, wherein the penetrating member is an elongate member without molded attachments. 55. The system of claim 1, wherein the penetrating member is a microneedle having a lumen therein. 56. The system of claim 1, further comprising: a penetrating member transport device for moving each of a penetrating member into a position aligned with the penetrating member driver. 57. A body fluid sampling system for use on a tissue site, the system comprising: a controllable, electrically powered drive force generator; a plurality of cartridges each containing a penetrating member, each of said cartridges coupled together to define a flexible array; a transport device for moving each of said cartridges into a launch position operatively coupling said penetrating member to the force generator; an analyte detecting member positioned to receive fluid from a wound created by said penetrating member, said detection member configured to determine a concentration of an analyte in the fluid using a sample of less than 1 μL of the fluid; and a programmable processor operatively programmed with software that has control instructions for the controllable, electrically powered drive force generator to keep a wound tract created by a penetrating member open for a sufficient time to provide for spontaneous flow of blood for sample capture into an associated sample chamber, wherein the control instructions are selected from at least one of, penetration depth of a penetrating member, velocity of a penetrating member, velocity of a penetrating member in or out of target tissue and a dwell time of a penetrating member in the tissue site. 58. A body fluid sampling system for use on a tissue site, the system comprising: a controllable, electrically powered drive force generator; a penetrating member having an elongate portion without a molded attachment and operatively coupled to said force generator; a sterility enclosure covering at least a tip of said penetrating member, said sterility enclosure removed from said penetrating member prior to actuation of the member and positioned so that the penetrating member will not contact said enclosure during actuation; an analyte detecting member positioned to receive fluid from a wound created by said penetrating member, said detection member configured to determine a concentration of an analyte in the fluid using a sample of less than 1 μL of the fluid; and a programmable processor operatively programmed with software that has control instructions for the controllable, electrically powered drive force generator to keep a wound tract created by a penetrating member open for a sufficient time to provide for spontaneous flow of blood for sample capture into an associated sample chamber, wherein the control instructions are selected from at least one of, penetration depth of a penetrating member, velocity of a penetrating member, velocity of a penetrating member in or out of target tissue and a dwell time of a penetrating member in the tissue site. 59. A body fluid sampling system for use on a tissue site, the system comprising: a controllable, electrically powered drive force generator; a penetrating member having an elongate portion without a molded attachment and operatively coupled to said force generator; a sterility enclosure creating a sterile environment around at least a tip of said penetrating member, said penetrating member breaching said sterile environment during actuation; an analyte detecting member positioned to receive fluid from a wound created by said penetrating member, said detection member configured to determine a concentration of an analyte in the fluid using a sample of less than 1 μL of the fluid; and a programmable processor operatively programmed with software that has control instructions for the controllable, electrically powered drive force generator to keep a wound tract created by a penetrating member open for a sufficient time to provide for spontaneous flow of blood for sample capture into an associated sample chamber, wherein the control instructions are selected from at least one of, penetration depth of a penetrating member, velocity of a penetrating member, velocity of a penetrating member in or out of target tissue and a dwell time of a penetrating member in the tissue site.
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