Method and apparatus for penetrating tissue
View Patent ↗A body fluid sampling system for use on a tissue site has a housing and a penetrating member driver at least partially within the housing. At least one cartridge is in the housing. The cartridge includes an analyte sensor in a sample chamber configured to receive body fluid from a wound in tissue created by a penetrating member. A penetrating member is associated with the sample chamber. Each penetrating member, and its associated sample chamber, has a combined occupied volume of no more than about 5.0 cm 3 . The penetrating member is at least partially co-located with the analyte sensor in the sample chamber. The sample chamber receives body fluid from a wound in tissue created by a penetrating member, and the analyte sensor determines analyte levels using a body fluid sample of less than about 1 microliter. A transport mechanism engages the cartridge. The penetrating member is operatively engaged with the penetrating member driver when moved into position by the transport mechanism. The driver provides the force to advance the penetrating member. A user interface on the housing displays information to a user.
1. A body fluid sampling system for use on a tissue site, the system comprising:
a controllable electromagnetic based penetrating member driver;
a disposable positionable in a housing of the body fluid sampling system;
a plurality of penetrating members, each of a penetrating member and an associated sample chamber having a combined occupied volume of no more than about 5.0 cm 3 , the plurality of penetrating members and associated sample chambers being positioned in the disposable;
a transport mechanism configured to engage the disposable to carry the plurality of penetrating members on top of a belt, and move the plurality of penetrating members in its entirety position to provide that one of the penetrating members is coupled to the controllable electromagnetic driver for launch of the penetrating member; and
a human interface at the housing of the body fluid sampling system and providing at least one output selected from at least one of, number of penetrating members available, number of penetrating members used, actual depth of penetrating member penetration in a tissue site, stratum corneum thickness in the case where the tissue site is the skin and an area below the skin, force delivered on tissue site, energy used by driver to drive penetrating member into tissue site, dwell time of penetrating member, battery status of body fluid sampling system, status of body fluid sampling system, amount of energy consumed by body fluid sampling system, speed profile of a penetrating member, information relative to contact of penetrating member with tissue site before penetration by penetrating member and information relative to a change of speed of penetrating member as in travels in tissue site.
2. The system of claim 1 , further comprising:
a processor coupled to the penetrating member driver and 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 human 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 the 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 1 , 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 8 , further comprising:
the data interface configured to couple the tissue penetrating system to support equipment with a data interface.
10. The system of claim 1 , further comprising:
a data exchange device for coupling the tissue penetrating system to support equipment selected from at least one of: personal computer, modem, PDA and a computer network.
11. The system of claim 1 , wherein the human 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.
12. The system of claim 1 , wherein the human interface is coupled to receive signals from a human interface processor separate from a processor coupled to the penetrating member driver.
13. The system of claim 12 , wherein the human interface processor has a sleep mode and runs intermittently to conserve power.
14. The system of claim 1 , further comprising:
a memory coupled to the human interface 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.
15. The system of claim 1 , wherein the human interface 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.
16. The system of claim 5 , wherein the first subset of days is Monday thru Friday and the second subset of days is Saturday and Sunday.
17. A body fluid sampling system for use on a tissue site, the system comprising:
a controllable electromagnetic based penetrating member driver;
a disposable;
a plurality of penetrating members, each of a penetrating member and an associated sample chamber having a combined occupied volume of no more than about 5.0 cm 3 and being positioned in the disposable;
a transport mechanism configured to engage the disposable and to carry the plurality of penetrating members on top of a belt, and move the plurality of penetrating members in its entirety in order to place one of the penetrating members to be in a position of engagement with the controllable electromagnetic based penetrating member driver when moved into position by said transport mechanism; and
a user interface at a housing of the body fluid sampling system configured to relay at least one of, number of penetrating members available, number of penetrating members used, actual depth of penetrating member penetration in a tissue site, stratum corneum thickness in the case where the tissue site is the skin and an area below the skin, force delivered on tissue site, energy used by driver to drive penetrating member into tissue site, dwell time of penetrating member, battery status of body fluid sampling system, status of body fluid sampling system, amount of energy consumed by body fluid sampling system, speed profile of a penetrating member, information relative to contact of penetrating member with tissue site before penetration by penetrating member and information relative to a change of speed of penetrating member as in travels in tissue site.
18. A body fluid sampling system for use on a tissue site, the system comprising:
a controllable electromagnetic based penetrating member driver;
a disposable positionable in a body fluid sampling system housing;
a plurality of penetrating members, each of a penetrating member and an associated sample chamber having a combined occupied volume of no more than about 5.0 cm 3 ;
a transport mechanism configured to engage the disposable and to carry the plurality of penetrating members on top of a belt, and move the plurality of penetrating members in its entirety in order to place one of the penetrating members in a position to be engaged with the controllable electromagnetic penetrating member driver when moved into position by said transport mechanism; and
a human interface at a housing of the body fluid sampling system and providing at least one output selected from at least one of, number of penetrating members available, number of penetrating members used, actual depth of penetrating member penetration in a tissue site, stratum corneum thickness in the case where the tissue site is the skin and an area below the skin, force delivered on tissue site, energy used by driver to drive penetrating member into tissue site, dwell time of penetrating member, battery status of body fluid sampling system, status of body fluid sampling system, amount of energy consumed by body fluid sampling system, speed profile of a penetrating member, information relative to contact of penetrating member with tissue site before penetration by penetrating member and information relative to a change of speed of penetrating member as in travels in tissue site.