Method and apparatus for penetrating tissue
View Patent ↗A tissue penetrating system includes a plurality of penetrating members each having a tip. A penetrating member driver is coupled to the plurality of penetrating members. A support is provided with a plurality of openings. Each opening receives a penetrating member. Each tip of a penetrating member is uncovered during launch of a penetrating member by the penetrating driver member. A user interface is configured to relay at least one of, skin penetrating performance or a skin penetrating setting.
1. A tissue penetrating system, comprising:
a plurality of penetrating members each with a tip;
at least one seal maintaining each of a penetrating member in a sterile environment prior to launch of a penetrating member to a tissue site;
a penetrating member driver coupled to the plurality of penetrating members;
a support with a plurality of openings, each opening receiving a penetrating member and being sealed by the at least one seal prior to launch of a penetrating member, wherein that portion of the at least one seal is at least partially removed from an opening associated with a penetrating member about to be launched to provide that each tip of a penetrating member being launched without contacting the at least one seal; and
a disposable housing said penetrating member, said disposable having a first and a second seal formed at a distal end and a proximal end of said disposable respectively to maintain a sterile environment around a portion of the penetration member prior to penetrating member actuation; and
an user interface coupled to a processor, wherein in response to an input at the user interface by a user the processor provides an input to the penetrating member driver to relay a penetrating member parameter selected from at least one of, penetrating member depth of penetration, penetrating member velocity, penetrating member braking, or penetrating member retraction from a tissue site.
2. The system of claim 1 , wherein the processor is configured to change a direction and magnitude of force exerted on a penetrating member as it penetrates or advances through the target tissue.
3. The system of claim 1 , further comprising:
a penetrating member sensor configured to detect a penetrating member position during target tissue penetration.
4. The system of claim 1 , wherein the at least one output is selected from, a penetration event of a penetrating member, number of penetrating members remaining, time of day, alarm, penetrating member trajectory waveform profile information, force for last penetration event, the last penetration event, how or low battery status, analyte status, time to change cassette status, jamming malfunction, and system status.
5. The system of claim 1 , wherein the user interface is selected from an LED, an LED digital display, an LCD display, a sound generator, a buzzer, and a vibrating device.
6. The system of claim 1 , wherein a housing is selected from at least one of, a telephone, a watch, a PDA, electronic device, medical device, point of care device and a decentralized diagnostic device.
7. The system of claim 6 , further comprising:
an input device coupled to the housing, the input device selected from one or more pushbuttons, a touch pad independent of the display device, or a touch sensitive screen on a visual display.
8. The system of claim 1 , further comprising:
a data exchange device for coupling the tissue penetrating system to support equipment.
9. The system of claim 1 , further comprising:
a data exchange device for coupling the tissue penetrating system to support equipment selected from one of the following: personal computer, modem, PDA and a computer network.
10. The system of claim 1 , wherein the user interface includes a real time clock and one or more alarms a user can set for reminders of when a next target tissue penetration event is needed.
11. The system of claim 1 , wherein the user interface is coupled to receive signals from a human interface processor separate from the processor coupled to the penetrating member driver.
12. The system of claim 11 , wherein the user interface processor has a sleep mode and runs intermittently to conserve power.
13. The system of claim 11 , wherein the user interface processor has logic that provides an alarm time set for a first subset of days and a second alarm time set for a second subset of days.
14. The system of claim 13 , wherein the first subset of days is Monday thru Friday and the second subset of days is Saturday and Sunday.
15. The system of claim 1 , further comprising:
a memory for storing at least one of, a number of penetrating members used, number of target tissue penetrating events, time and date of the last selected number of target tissue penetrating events, time interval between alarm and target tissue penetrating event, stratum corneum thickness, time of day, energy consumed by a penetrating member driver to drive a penetrating member into the target tissue, depth of penetrating member penetration, velocity of the penetrating member, a desired velocity profile, velocity of the penetrating member into the target tissue, velocity of the penetrating member out of the target tissue, dwell time of the penetrating member in the target tissue, a target tissue relaxation parameter, force delivered on the target tissue, dwell time of the penetrating member, battery status, system status, consumed energy, speed profile of the penetrating member as the penetrating penetrates and advances through the target tissue, a tissue target tissue relaxation parameter, information relative to contact of a penetrating member with target tissue before penetration by the penetrating member, information relative to a change of speed of a penetrating member as in travels in the target tissue, information relative to consumed sensors and information relative to consumed penetrating members.
16. A tissue penetrating system, comprising:
a plurality of penetrating members each with a tip;
a penetrating member driver coupled to the plurality of penetrating members;
a disposable housing said penetrating member, said disposable having a first and a second seal formed at a distal end and a proximal end of said disposable respectively to maintain a sterile environment around a portion of the penetration member prior to penetrating member actuation;
a support having a plurality of openings, each opening receiving a penetrating member;
a penetrating member sensor coupled to the plurality of penetrating members, the penetrating member sensor configured to provide information relative to a depth of penetration of a penetrating member through a skin surface; and
an user interface coupled to a processor, wherein in response to an input at the user interface by a user the processor provides an input to the penetrating member driver to relay a penetrating member parameter selected from at least one of, penetrating member depth of penetration, penetrating member velocity, penetrating member braking, or penetrating member retraction from a tissue site.
17. The system of claim 16 , wherein the processor is configured to change a direction and magnitude of force exerted on a penetrating member as it penetrates or advances through the target tissue.
18. The system of claim 16 , wherein the at least one output is selected from, a penetration event of a penetrating member, number of penetrating members remaining, time of day, alarm, penetrating member trajectory waveform profile information, force for last penetration event, the last penetration event, how or low battery status, analyte status, time to change cassette status, jamming malfunction, and system status.
19. The system of claim 16 , wherein the user interface is selected from an LED, an LED digital display, an LCD display, a sound generator, a buzzer, and a vibrating device.
20. The system of claim 16 , wherein a housing is selected from at least one of, a telephone, a watch, a PDA, electronic device, medical device, point of care device and a decentralized diagnostic device.
21. The system of claim 20 , further comprising:
an input device coupled to the housing, the input device selected from one or more pushbuttons, a touch pad independent of the display device, or a touch sensitive screen on a visual display.
22. The system of claim 16 , further comprising:
a data exchange device for coupling the tissue penetrating system to support equipment.
23. The system of claim 22 , further comprising:
a data interface configured to couple the tissue penetrating system to support equipment with a data interface.
24. The system of claim 16 , further comprising:
a data exchange device for coupling the tissue penetrating system to support equipment selected from one of the following: personal computer, modem, PDA and a computer network.
25. The system of claim 24 , further comprising:
a data interface configured to couple the tissue penetrating system to support equipment with a data interface.
26. The system of claim 16 , wherein the user interface includes a real time clock and one or more alarms a user can set for reminders of when a next target tissue penetration event is needed.
27. The system of claim 16 , wherein the user interface is coupled to receive signals from a human interface processor separate from the processor coupled to the penetrating member driver.
28. The system of claim 27 , wherein the user interface processor has a sleep mode and runs intermittently to conserve power.
29. The system of claim 27 , wherein the user interface processor has logic that provides an alarm time set for a first subset of days and a second alarm time set for a second subset of days.
30. The system of claim 29 , wherein the first subset of days is Monday thru Friday and the second subset of days is Saturday and Sunday.
31. The system of claim 16 , further comprising:
a memory for storing at least one of, a number of penetrating members used, number of target tissue penetrating events, time and date of the last selected number of target tissue penetrating events, time interval between alarm and target tissue penetrating event, stratum corneum thickness, time of day, energy consumed by a penetrating member driver to drive a penetrating member into the target tissue, depth of penetrating member penetration, velocity of the penetrating member, a desired velocity profile, velocity of the penetrating member into the target tissue, velocity of the penetrating member out of the target tissue, dwell time of the penetrating member in the target tissue, a target tissue relaxation parameter, force delivered on the target tissue, dwell time of the penetrating member, battery status, system status, consumed energy, speed profile of the penetrating member as the penetrating penetrates and advances through the target tissue, a tissue target tissue relaxation parameter, information relative to contact of a penetrating member with target tissue before penetration by the penetrating member, information relative to a change of speed of a penetrating member as in travels in the target tissue, information relative to consumed sensors and information relative to consumed penetrating members.