Tissue penetration device
First Claim
1. A method of lancing the tissue of a patient comprising:
- (a) providing a tissue penetration element having a tip configured to penetrate tissue and a shaft portion;
(b) disposing the tissue penetration element in proximity to the tissue of the patient;
(c) driving the tissue penetration element distally towards the tissue of the patient;
(d) making contact between the tip and the tissue of the patient;
(e) advancing the tip into the tissue during a penetration stroke to a position of maximum inward displacement;
(f) displacing the tissue penetration element proximally over a withdrawal stroke at an average velocity that is substantially lower than an average velocity of the tissue penetration element during the penetration stroke; and
(g) removing the tip from the tissue.
4 Assignments
0 Petitions
Accused Products
Abstract
A tissue penetration device and method of using same. The tissue penetration device may optionally include sampling and analyzing functions, which may be integrated. An embodiment provides control of a lancet used for sampling blood. Electric field coils or solenoids may drive the lancet using electromagnetic force. Advancement and retraction of a lancet may be controlled by a feedback loop monitoring the position and velocity of the lancet embodiments of the lancet driver can be configured to follow a predetermined tissue lancing profile. Embodiments of the invention include a lancet and method for using a lancet to maintain the patency of the wound tract once the lancet has cut into the skin.
-
Citations
353 Claims
-
1. A method of lancing the tissue of a patient comprising:
-
(a) providing a tissue penetration element having a tip configured to penetrate tissue and a shaft portion;
(b) disposing the tissue penetration element in proximity to the tissue of the patient;
(c) driving the tissue penetration element distally towards the tissue of the patient;
(d) making contact between the tip and the tissue of the patient;
(e) advancing the tip into the tissue during a penetration stroke to a position of maximum inward displacement;
(f) displacing the tissue penetration element proximally over a withdrawal stroke at an average velocity that is substantially lower than an average velocity of the tissue penetration element during the penetration stroke; and
(g) removing the tip from the tissue. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8)
-
-
9. A method of lancing the tissue of a patient comprising:
-
(a) providing a tissue penetration element having a tip configured to penetrate tissue and a shaft portion;
(b) disposing the tissue penetration element in proximity to the tissue of the patient;
(c) driving the tissue penetration element distally towards the tissue of the patient;
(d) making contact between the tip and the tissue of the patient;
(e) advancing the tip into the tissue during a penetration stroke to a position of maximum inward displacement;
(f) allowing the tissue penetration element to settle upon reaching the point of maximum inward penetration for about 1-200 milliseconds, wherein no driving force is imposed on the tissue penetration element while settling;
(g) displacing the tissue penetration element proximally over a withdrawal stroke at an average velocity that is substantially lower than an average velocity of the tissue penetration element during the penetration stroke; and
(h) removing the tip from the tissue.
-
-
10. A method for lancing tissue comprising:
-
(a) selecting a desired lancing velocity profile from a set of alternative lancing velocity profiles having characteristic phases for lancet advancement and retraction;
(b) lancing a user according to said selected profile;
(c) determining a lancing velocity profile trait during each of said characteristic phases; and
(d) optimizing said profile for subsequent lancing based upon said profile trait as a function of the characteristic phases for lancet advancement and retraction. - View Dependent Claims (11, 13, 14)
-
-
12. A method for lancing tissue of 10 wherein the profile trait comprises blood volume obtained from said user.
-
15. A method for lancing tissue comprising:
-
(a) selecting a desired lancing velocity profile from a set of alternative lancing velocity profiles having characteristic phases for lancet advancement and retraction; and
(b) lancing a user according to said selected profile.
-
-
16. A method for lancing tissue comprising:
-
(a) providing a lancing device comprising;
a lancet having a shaft with a proximal driver head and a distal lancing end;
a controllable driver coupled to said lancet for longitudinal displacement of said lancet; and
a position feedback loop for monitoring the longitudinal displacement of said lancet and for modulating the controllable driver to provide a predetermined tissue lancing profile having characteristic phases for lancet advancement and retraction;
(b) selecting a desired lancing velocity profile from a set of alternative lancing velocity profiles having characteristic phases for lancet advancement and retraction; and
(c) lancing a user according to the selected lancing velocity profile.
-
-
17. A method of lancing the tissue of a patient comprising:
-
(a) providing a tissue penetration element having a tip configured to penetrate tissue;
(b) disposing the tissue penetration element in proximity to the tissue of the patient;
(c) initiating a lancing cycle including advancing the tip into the tissue during a penetration stroke and displacing the tissue penetration element proximally over a withdrawal stroke; and
(d) acquiring tissue data based on an interaction between the tissue penetration element and the tissue during at least a portion of the lancing cycle. - View Dependent Claims (18, 19, 20)
-
-
21. A method for lancing tissue comprising:
-
(a) selecting a desired lancet velocity profile from a set of alternative lancet velocity profiles;
(b) lancing a user according to said selected profile;
(c) determining whether the lancing of the user generated a blood sample result from said user;
(d) determining whether the lancing had success of obtaining a blood sample from the user;
(e) determining whether the lancing caused pain to the user;
(f) storing information regarding the blood sample result, said blood volume, and said pain determinations; and
(g) optimizing said profile for subsequent lancing procedures for the user.
-
-
22. A lancing device comprising:
-
means for penetrating tissue to obtain a blood sample;
means for driving said means for penetrating tissue; and
means for controlling said means for driving to provide a selectable lancing velocity profile. - View Dependent Claims (23, 24)
-
-
25. A method of lancing the skin of a patient comprising withdrawing a lancet from the skin of the patient at a velocity sufficiently slow to allow blood flowing from severed blood vessels to flow into a channel in the patient'"'"'s skin created by the lancet distal tip to follow the distal tip of the lancet out of the wound channel and flow to a surface of the skin.
-
26. A method of lancing the skin of a patient comprising withdrawing a lancet during a withdrawal stroke at a maximum velocity of up to about 0.02 meter per second.
-
27. A method of lancing the tissue of a patient comprising:
-
(a) providing a tissue penetration element having a tip configured to penetrate tissue and a shaft portion;
(b) disposing the tissue penetration element in proximity to the tissue of the patient;
(c) driving the tissue penetration element distally towards the tissue of the patient;
(d) making contact between the tip and the tissue of the patient;
(e) advancing the tip into the tissue during a penetration stroke to a position of maximum inward displacement;
(f) allowing the tissue penetration element to settle upon reaching the point of maximum inward penetration for at least about 1 millisecond with no driving force imposed on the tissue penetration element; and
(g) displacing the tissue penetration element proximally over a withdrawal stroke and removing the tip from the tissue. - View Dependent Claims (28, 29, 30)
-
-
31. A method of lancing the tissue of a patient comprising:
-
(a) providing a tissue penetration element having a tip configured to penetrate tissue and a shaft portion;
(b) disposing the tissue penetration element in proximity to the tissue of the patient;
(c) driving the tissue penetration element distally towards the tissue of the patient;
(d) making contact between the tip and the tissue of the patient;
(e) advancing the tip into the tissue during a penetration stroke to a position of maximum inward displacement;
(f) applying force to the tissue penetration element necessary to hold the tissue penetration element substantially stationary and prevent retrograde motion of the tissue penetration element the point of maximum inward penetration for at least about 1 millisecond; and
(g) displacing the tissue penetration element proximally over a withdrawal stroke and removing the tip from the tissue. - View Dependent Claims (32)
-
- 33. A controllable lancet driver configured to exert a driving force on a lancet during a lancing cycle comprising a drive force generator and a controller coupled to the drive force generator capable of changing the direction and magnitude of force exerted on the lancet during the lancing cycle.
-
37. A tissue penetration device, comprising:
-
a) a magnetic source that produces a controllable magnetic field in a magnetically active region adjacent the magnetic source;
b) a magnetic member disposed at least partially in the magnetically active region;
c) a permanent magnet disposed at a proximal end of the magnetically active region for zeroing the position of the magnetic member while the tissue penetration device is inactive. - View Dependent Claims (38, 39, 40)
-
-
41. A tissue penetration device, comprising:
-
a) a magnetic source that produces a controllable magnetic field in a magnetically active region adjacent the magnetic source;
b) a magnetic member disposed at least partially in the magnetically active region;
c) a sharpened member configured to penetrate tissue which is coupled to the magnetic member; and
d) a position sensor configured to measure the position of the sharpened member. - View Dependent Claims (42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62)
-
-
63. A lancing device for obtaining a blood sample from a patient, comprising:
-
a) a magnetic source that produces a controllable magnetic field in a magnetically active region adjacent the magnetic source;
b) a magnetic member disposed at least partially in the magnetically active region; and
c) a lancet coupled to the magnetic member. - View Dependent Claims (64, 65, 66, 67, 68, 69, 70)
-
-
71. A controllable electromagnetic driver for driving a lancet and obtaining a sample of blood from a patient, comprising:
-
a) a magnetic source that produces a controllable magnetic field in a magnetically active region adjacent the magnetic source;
b) a magnetic member disposed at least partially in the magnetically active region and configured to be coupled to a lancet;
c) a position sensor configured to measure the position of the magnetic member; and
d) a processor which is electrically coupled to the magnetic source and configured to control the magnitude of the magnetic field in the magnetically active region based on feedback from the position sensor.
-
-
72. A controllable electromagnetic driver for driving a lancet and obtaining a sample of blood from a patient, comprising:
-
a) a driver coil pack having a proximal end and a distal end comprising a plurality of adjacent electric coils with each coil being comprised of an electrical conductor wound about an axial lumen of each coil with the axial lumens of the coils in a coaxial configuration;
b) an elongate coupler shaft having a proximal end and a distal end disposed within an axial lumen of the driver coil pack;
c) a magnetic member secured to a distal portion of the elongate coupler shaft and configured to slide axially within the axial lumen of the driver coil pack;
d) a position sensor disposed at adjacent the driver coil pack, comprising an optical reader and an optical flag secured to a proximal section of the coupler shaft with the optical flag configured to slide axially adjacent the optical reader and to measure the position of the coupler shaft relative to the position sensor and driver coil pack;
e) a processor which is electrically coupled to the electrical conductors of the plurality of adjacent electric coils and position sensor and which is configured to control a magnitude of a magnetic field in the axial lumen of the driver coil pack by controlling the amount of electrical current flowing through the electrical conductor of each coil based on closed loop feedback position data from the position sensor; and
f) a lancet coupler secured to the distal end of the coupler shaft and configured to be coupled to a lancet.
-
-
73. A flat coil tissue penetration device, comprising:
-
a) a magnetic source that produces a first magnetic field in a first magnetically active region and a second magnetic field in a second magnetically active region;
b) a flat coil secured to a translation substrate and having a leading segment disposed at least partially within the first magnetically active region and a trailing segment disposed at least partially within the second magnetically active region; and
c) a sharpened member configured to penetrate tissue and mechanically coupled to the translation substrate. - View Dependent Claims (74, 75, 76, 77)
-
-
78. A moving coil tissue penetration device, comprising:
-
a) a magnetic source that produces a magnetic field in a magnetically active region;
b) a cylindrical coil secured to a translation substrate and disposed at least partially within the magnetically active region; and
c) a sharpened member configured to penetrate tissue and mechanically coupled to the translation substrate. - View Dependent Claims (79, 80)
-
-
81. A method of lancing for obtaining a sample of blood from a patient, comprising:
-
a) providing a lancing device for obtaining a blood sample from a patient, comprising;
a magnetic source that produces a controllable magnetic field in a magnetically active region adjacent the magnetic source, a magnetic member disposed at least partially in the magnetically active region, and a lancet coupled to the magnetic member;
b) disposing the lancet device adjacent tissue of the patient; and
c) activating the magnetic source to produce a magnetic field in the magnetically active region generating a magnetic force between the magnetic field and the magnetic member and driving the lancet into the patient'"'"'s tissue. - View Dependent Claims (82)
-
- 83. A lancet driver comprising an electric energy source having electric field coils.
-
89. A lancing device for obtaining a blood sample from a patient, comprising:
-
a) a driver coil pack comprising a proximal end, a distal end, an axial lumen, an inner coil with increased wraps per inch in a distal direction and an outer coil which longitudinally overlaps the inner coil and which has increased wraps per inch in a proximal direction;
b) a magnetic member disposed at least partially within the axial lumen; and
c) a lancet coupled to the magnetic member.
-
- 90. A lancet driver comprising a force generating member and a velocity control system.
-
102. A lancing device comprising:
-
a lancet having a shaft with a proximal driver head and a distal lancing end;
a controllable driver coupled to said lancet for longitudinal displacement of said lancet; and
a position feedback loop for monitoring the longitudinal displacement of said lancet and for modulating the controllable driver to provide a predetermined tissue lancing profile having characteristic phases for lancet advancement and retraction. - View Dependent Claims (103, 104, 105, 106, 107, 108, 109)
-
-
110. A method for lancing tissue to obtain a blood sample comprising:
-
providing a tissue penetration element;
coupling said tissue penetration element to a controllable driver for advancement and retraction of said tissue penetration element; and
controlling the advancement and retraction of the tissue penetration element by modulating the controllable driver to vary the advancement and retraction as a function of relative position and motion of the tissue penetration member.
-
-
111. A lancing device comprising a feedback loop that includes a light detecting sensor and a light emitter for monitoring the relative position of a lancet, the lancet comprising a reflective surface on a proximal end such that the light emitter emits light that is reflected from the reflective surface to the sensor.
-
112. A lancing device comprising a feedback loop having an electromagnetic sensor for monitoring the relative position of at least one magnetically permeable region disposed on a region that is coupled to a lancet.
-
113. A method of controlling a lancet velocity profile, comprising:
-
a) measuring a velocity of a moving lancet at a known position;
b) compare the measured velocity of the lancet with an appropriate velocity for the lancet at the known position; and
c) applying a force to the lancet to adjust the velocity of the lancet. - View Dependent Claims (114, 115, 116)
-
-
117. A method of controlling electromagnetic lancet driver, comprising:
-
a) measuring a first position of a lancet of the lancet actuator;
b) apply force to the lancet to induce motion in the lancet;
c) measure a second position of the lancet;
d) determine a velocity of the lancet from change of position versus a change in time with regard to the first and second position of the lancet; and
e) adjust the force on the lancet to achieve a desired velocity of the lancet.
-
-
118. A method of controlling movement of a lancet, comprising:
-
applying force to the lancet to thereby cause the lancet to move in a first direction toward a target;
monitoring position and speed of the lancet as the lancet moves in the first direction;
adjusting the application of force to the lancet as the lancet moves in the first direction to achieve a desired speed of the lancet; and
adjusting the application of force to the lancet when the lancet contacts the target so that the lancet penetrates the target within a desired range of speed. - View Dependent Claims (119)
-
-
120. A system that controls movement of a lancet, comprising one or more processors that execute program instructions and receive a data set, wherein the program instructions are executed to cause the processor to:
-
cause force to be applied to the lancet to thereby cause the lancet to move in a first direction toward a target;
monitor position and speed of the lancet as the lancet moves in the first direction;
adjust the application of force to the lancet as the lancet moves in the first direction to achieve a desired speed of the lancet;
adjust the application of force to the lancet when the lancet contacts the target so that the lancet penetrates the target within a desired range of speed. - View Dependent Claims (121, 122)
-
-
123. A program product for use in a processor that executes program steps recorded in a computer-readable media to perform a method for controlling movement of a lancet, the program product comprising:
-
a recordable media;
a program of computer-readable instructions executable by the processor to perform operations comprising;
causing force to be applied the lancet to thereby cause the lancet to move in a first direction toward a target;
monitoring position and speed of the lancet as the lancet moves in the first direction;
adjusting the application of force to the lancet as the lancet moves in the first direction to achieve a desired speed of the lancet;
adjusting the application of force to the lancet when the lancet contacts the target so that the lancet penetrates the target within a desired range of speed.
-
-
124. A system that controls movement of a lancet, the system comprising
one or more processors that execute program instructions and receive a data set, wherein the program instructions cause the system to perform operations including: -
applying a launching force to the lancet so that the lancet moves in a first direction toward a skin target;
controlling the application of the launching force to the lancet to thereby control the movement of the lancet as it moves in the first direction toward the skin target; and
applying a withdraw force to the lancet so that the lancet moves in a second direction away from the target. - View Dependent Claims (125, 126, 127, 128, 129, 130)
-
-
131. A method of controlling a lancet velocity profile, comprising:
-
a) measuring a velocity of a moving lancet; and
b) applying a braking force to the lancet to adjust the velocity of the lancet. - View Dependent Claims (132)
-
-
133. A program product for use in a processor that executes program steps recorded in a computer-readable media to perform a method for controlling movement of a lancet, the program product comprising:
-
a recordable media;
a program of computer-readable instructions executable by the processor to perform operations comprising;
applying a launching force to the lancet so that the lancet moves in a first direction toward a skin target;
controlling the application of the launching force to the lancet to thereby control the movement of the lancet as it moves in the first direction toward the skin target; and
applying a withdraw force to the lancet so that the lancet moves in a second direction away from the target.
-
- 134. A program product as defined in claim 134, wherein applying a launching force to the lancet comprises energizing a coil to create a magnetic field that attracts a magnetic member disposed on the lancet to thereby cause the lancet to move in the first direction toward the skin target.
-
139. A method of determining contact between a tip of a lancet and target tissue of a patient comprising:
-
(a) providing a lancing device comprising a lancet driver having a position sensor and a processor that can determine the relative position and velocity of the lancet based on measuring relative position of the lancet with respect to time;
(b) measuring a magnitude of deceleration of the lancet during at least a portion of the inward cutting stroke of the lancing cycle and comparing the magnitude of the measured deceleration to a known value of deceleration; and
(c) determining contact if the magnitude of the measured deceleration is sufficiently greater than the magnitude of the known value of deceleration. - View Dependent Claims (140, 141)
-
-
142. A method of measuring tissue elasticity comprising:
-
(a) providing a lancing device comprising a lancet driver having a position sensor and a processor that can determine the relative position and velocity of a lancet based on measuring relative position of the lancet with respect to time;
(b) driving the lancet into tissue with the lancet driver to a position of maximum penetration and removing substantially all force imparted from the lancet driver to the lancet; and
(c) measuring an elastic recoil displacement of lancet in a proximal direction due to elastic recoil of target tissue. - View Dependent Claims (143)
-
-
144. A method of measuring penetration depth of a lancet during a lancing cycle comprising:
-
(a) driving the lancet toward the patient'"'"'s target tissue;
(b) measuring a contact point of the lancet with the target tissue;
(c) advancing the lancet into the target tissue to a position of maximum penetration and removing substantially all force imparted from the lancet driver to the lancet at the position of maximum penetration;
(d) measuring the elastic recoil displacement of the lancet in a proximal direction due to elastic recoil of target tissue after force from lancet driver is removed; and
(e) subtracting the magnitude of elastic recoil displacement from the magnitude of lancet displacement measured from the contact point to the position of maximum penetration. - View Dependent Claims (145, 146, 147)
-
-
148. A method of lancing the tissue of a patient to a known predetermined depth of penetration comprising:
-
(a) providing tissue elasticity information for the patient comprising an average elastic recoil displacement value for the patient'"'"'s target tissue for a lancing cycle;
(b) driving the lancet toward the patient'"'"'s target tissue;
(c) measuring a contact point of the lancet with the target tissue;
(d) advancing the lancet into the target tissue from the contact point over a displacement equal to the sum of the average elastic recoil displacement value and the desired tissue penetration depth. - View Dependent Claims (149, 150, 151)
-
-
152. An agent injection device capable of injecting an agent to a known predetermined tissue depth, comprising:
-
(a) an injection member having an elongate injection shaft with an outlet port configured to dispense an agent at a controllable time;
(b) a controllable driver coupled to the elongate injection shaft and configured to drive the injection member into target tissue; and
(c) a velocity control system in communication with the controllable driver and configured to control the velocity of the elongate injection shaft. - View Dependent Claims (153, 154, 155, 156, 157, 158, 159, 160)
-
-
161. A method of injecting an agent into the tissue of a patient at a known predetermined depth, comprising:
-
(a) driving an elongate injection shaft having an outlet port configured to dispense an agent at a controllable time toward the patient'"'"'s target tissue;
(b) determining a contact point between a distal extremity of the elongate injection shaft and the target tissue;
(c) advancing the elongate injection shaft into the target tissue from the contact point over a displacement equal to the sum of an elastic recoil displacement value for the target tissue, the distance between a distal extremity of the elongate injection shaft and the outlet port, and the desired tissue depth of injection for agent deposition; and
(d) injecting the agent. - View Dependent Claims (162, 163, 164, 165, 166, 167, 168, 169)
-
-
170. A method of injecting an agent into a patient'"'"'s target tissue at a desired injection depth, comprising:
-
(a) driving an elongate injection shaft having an outlet port configured to dispense an agent at a controllable time toward the patient'"'"'s target tissue;
(b) advancing the elongate injection shaft into the target tissue from a contact point between the elongate injection shaft and the target tissue over a displacement greater than the desired injection depth to a position of maximum penetration;
(c) withdrawing the injection shaft in a proximal direction to the desired penetration depth; and
(d) injecting the agent. - View Dependent Claims (171, 172, 173, 174, 175, 176, 177, 178, 179, 180, 181, 182, 183)
-
-
184. A lancet driver configured to follow a predetermined lancet velocity profile with an average velocity of an inward penetration stroke of a lancet being substantially greater than an average velocity of the withdrawal stroke of the lancet.
- 185. A lancet comprising a sharpened distal tip, a shaft portion and a proximal drive head that has a transverse dimension that is substantially larger than a transverse dimension of the shaft portion adjacent the proximal drive head.
-
192. A lancet belt comprising:
-
a first belt tape having a longitudinal axis and an adhesion material disposed on an adhesion side of the tape;
a second belt tape having a longitudinal axis disposed on the adhesion side of the first tape with the longitudinal axes of the first belt tape and second belt tape being substantially parallel;
a plurality of lancets disposed between the first belt tape and the second belt tape with longitudinal axes of the lancets being substantially orthogonal to the longitudinal axes of the first and second belt tapes.
-
- 193. A method for sampling blood comprising lancing to create a wound tract and bracing the wound tract.
-
196. An apparatus for sampling blood comprising:
-
a lancet; and
a flow control disposed on the lancet for bracing a wound tract created by the lancet. - View Dependent Claims (197)
-
-
198. A method of sampling blood comprising puncturing skin to create a wound tract and bracing said wound tract with a biodegradable structure to permit a controlled sample of blood to exit said wound tract.
-
199. A lancet module comprising
a module body portion configured to be mechanically registered and secured adjacent a lancet driver; - and
a lancet comprising a sharpened distal tip and shaft portion which is slidably disposed within the module body portion. - View Dependent Claims (200, 201, 202, 203, 204, 205, 206)
- and
- 207. A lancet module comprising a module body portion having a lancet channel and a lancet slidably disposed within the lancet channel and a cover sheet disposed over the lancet and lancet channel capturing the lancet shaft in the lancet channel.
-
213. A sampling module comprising:
-
a module body portion configured to be mechanically registered and secured adjacent a lancet driver;
a lancet comprising a sharpened distal tip and shaft portion which is slidably disposed within the module body portion; and
a sample reservoir in fluid communication with a sampling site of the module body portion. - View Dependent Claims (214, 215, 216, 217, 218, 219, 220, 221, 222)
-
-
223. A sampling module comprising:
-
a module body portion;
a lancet comprising a sharpened distal tip and shaft portion which is slidably disposed within a lancet channel of the module body portion; and
a sample reservoir which has an analytical region with sample sensors disposed within the analytical region the sample reservoir being in fluid communication with a sampling site of the module body portion.
-
- 224. A sampling module comprising a module body portion having a lancet channel, a lancet slidably disposed within the lancet channel, a cover sheet disposed over the lancet and lancet channel capturing the lancet shaft in the lancet channel, and a sample reservoir for collection of a sample obtained by lancing a patient with the lancet.
-
235. A sampling device comprising:
-
a lancet for obtaining a blood sample from a user, said lancet having a distal end and a proximal end;
a reservoir for collecting the blood sample adjacent to the distal end of said lancet;
a lancet driver attached to the proximal end of said lancet; and
a sensor on said sampling device for detecting said user and initiating a lancing cycle. - View Dependent Claims (236, 237, 238, 239, 240, 241)
-
-
242. A method of sampling comprising:
-
providing a sampling module having a lancet disposed within a lancet channel, a sample reservoir and an orifice on a surface of the sampling module in fluid communication with the sample reservoir;
coupling the lancet of the sampling module to a lancet driver;
activating a lancing cycle by having a patient place target tissue over a sensor which detects the target tissue and initiates the lancing cycle;
lancing the target tissue to obtain a sample of blood;
collecting said sample of blood through the orifice. - View Dependent Claims (243)
-
-
244. A method of sampling comprising:
-
loading a disposable sampling module into a lancing device with a lancet disposal within a lancet channel which has an orifice on a surface of said sampling module;
initiating a lancing cycle by prompting a user sensor on said lancing device;
activating said lancing cycle by having a patient place a finger over an ergonomically contoured area located on said surface such that said finger overlaps with said orifice;
lancing the finger to obtain a sample of blood;
collecting said sample of blood through said orifice; and
informing said user to remove said finger from the ergonomically contoured active sampling area. - View Dependent Claims (245)
-
-
246. A method of sampling comprising:
-
loading a disposable sampling module having a lancet into a lancing device;
initiating a lancing cycle and activating a user sensor on said lancing device by placing a piece of skin on a surface of said sampling module;
lancing said skin to obtain a blood sample; and
collecting said blood sample. - View Dependent Claims (247)
-
-
248. A method of sampling comprising:
-
loading a disposable sampling module having a lancet into a lancing device;
initiating a lancing cycle and activating a user sensor on said lancing device by placing a piece of skin on a surface of said sampling module;
lancing said skin to obtain a blood sample;
collecting said blood sample; and
- View Dependent Claims (249, 250, 251, 252, 253)
-
-
254. A tissue penetration sampling device for collecting blood from the skin of a patient, the device comprising:
-
a sampling module having a sampling site, the sampling site having a sample input port. a sample reservoir in fluid communication with the sample input port, a lancet maintained within the sampling module, the lancet having a lancet tip adjacent the sample input port, and a lancet driver coupled to the lancet to drive the lancet tip through the opening to lance the skin when the lancet driver is actuated, the device being configured to allow actuation of the lancet driver, lancing of the skin, collection of the blood, and movement of the blood to the sample reservoir seamlessly by forming a substantially airtight seal at the opening when the skin is firmly pressed against the sampling site. - View Dependent Claims (255)
-
-
256. A sampling module for use in collecting blood from the skin of a patient, comprising
a body portion, a sampling site on the body portion defining a sample input port, the sampling site shaped to conform to the skin and to form a substantially airtight seal with the skin, a lancet disposed in the body portion, the lancet having a lancet tip adjacent the sample input port, wherein the lancet is operable to send the lancet tip through the opening to lance the skin of the patient, and a reservoir in fluid communication with the sample input port, the sampling acquisition module configured to allow seamless sampling of the blood, and integrated lancing of the skin, collection of the blood through the sample input port, and movement of the blood to the sample reservoir.
-
257. A method of collecting blood from the skin of a patient, the method comprising:
-
a) contacting the skin of the patient with a blood sampling device, and b) performing a single initiating act resulting in the blood sampling device lancing the skin, collecting blood from the skin, and moving blood to a reservoir within the sampling device. - View Dependent Claims (258, 259, 260)
-
- 261. A sampling module belt comprising a plurality of sampling modules having a module body portion with a lancet channel and a lancet slidably disposed within the lancet channel and a cover sheet disposed over the lancet and lancet channel capturing the lancet shaft in the lancet channel with the plurality of sampling modules interconnected in a linear array by a flexible belt member.
-
264. A lancet belt cartridge comprising:
-
(a) a lancet belt comprising a plurality of lancets releasably secured to a flexible belt tape substantially orthogonal to a longitudinal axis of the belt tape; and
(b) a supply canister disposed about an unused portion of the lancet belt. - View Dependent Claims (265)
-
-
266. A lancet belt cartridge comprising:
-
(a) a lancet belt comprising;
a first belt tape having a longitudinal axis and an adhesion material disposed on an adhesion side of the tape;
a second belt tape having a longitudinal axis disposed on the adhesion side of the first tape with the longitudinal axes of the first belt tape and second belt tape being substantially parallel;
a plurality of lancets disposed between the first belt tape and the second belt tape with longitudinal axes of the lancets being substantially orthogonal to the longitudinal axes of the first and second belt tapes;
(b) a supply canister disposed about an unused portion of the lancet belt; and
(c) a receptacle canister configured to accept and store used lancets.
-
-
267. A lancet module cartridge, comprising a plurality of lancet modules interconnected in an array and configured for sequential use.
-
268. A lancet module cartridge comprising:
-
(a) a lancet module belt comprising a plurality of lancet modules interconnected in an array by a flexible member; and
(b) a supply canister that is disposed about an unused portion of the lancet module belt. - View Dependent Claims (269)
-
-
270. A lancet module cartridge comprising:
-
(a) a lancet module belt comprising a plurality of lancet modules having a module body portion with a lancet channel and a lancet slidably disposed within the lancet channel and a cover sheet disposed over the lancet and lancet channel capturing the lancet shaft in the lancet channel with the plurality of lancet modules interconnected in a linear array by a flexible belt member. (b) a supply canister that is disposed about an unused portion of the lancet module belt; and
(c) a receptacle canister that is configured to store a used portion of the lancet module belt.
-
- 271. A sampling module cartridge comprising a plurality of sampling modules interconnected in an array and configured for sequential use.
-
273. A sampling module cartridge comprising:
-
(a) a plurality of sampling modules interconnected in an array by a flexible member; and
(b) a supply canister that is disposed about an unused portion of the sampling module belt. - View Dependent Claims (274, 275)
-
-
276. A sampling module cartridge comprising:
-
(a) a sampling module belt comprising a plurality of sampling modules having a module body portion with a lancet channel, a lancet slidably disposed within the lancet channel, a cover sheet disposed over the lancet and lancet channel capturing the lancet shaft in the lancet channel, and a sample reservoir for collection of a sample obtained by lancing a patient with the lancet with the plurality of sampling modules interconnected in a linear array by a flexible belt member;
(b) a supply canister that is disposed about an unused portion of the sampling module belt; and
(c) a receptacle canister that is configured to store a used portion of the sampling module belt.
-
-
277. An apparatus for collecting blood from a patient'"'"'s skin, the apparatus comprising a cartridge including a plurality of sampling modules, each sampling module comprising a sampling input port,
a lancet having a tip, the tip adjacent the sampling input port, the lancet maintained within the cartridge and operable to extend the lancet tip through the sampling input port to pierce the patient'"'"'s skin positioned adjacent the sampling input port, and an analytical region in fluid communication with the sampling input port, the analytical region associated with sample sensors.
-
280. A method of collecting and testing a series of blood samples, the method comprising:
-
a) providing a sampling module cartridge and a reader device, the sampling module cartridge including a plurality of sampling modules, each sampling module adapted to perform a single blood sampling cycle of lancing, collection of a blood sample, and testing of the blood sample;
b) coupling the sampling module cartridge to the reader device;
c) initiating the blood sampling cycle and obtaining a first blood sample;
d) testing the first blood sample obtained;
e) advancing the sampling cartridge to bring another sampling module online;
f) initiating another blood sampling cycle and obtaining a second blood sample; and
g) testing the second blood sample. - View Dependent Claims (281, 282, 283, 284, 285)
-
-
286. A tissue penetration sampling device comprising a controllable lancet driver operatively coupled to a cartridge of sampling modules.
- 287. A sampling module cartridge comprising a plurality of sampling modules disposed within a cartridge housing and configured for serial use by a lancet driver.
- 290. A cartridge for use in sampling, comprising a sampling cartridge body having a plurality of sampling module portions, a lancet cartridge body having a plurality of lancet module portions with the sampling cartridge body and lancet cartridge body being disposed adjacent each other in an operative configuration such that each lancet module portion can be readily aligned in a functional arrangement with each sampling module portion.
-
310. A method of detecting the arrival of a biomolecular fluid in the local environment of a thermal sensor, the method comprising:
-
a) obtaining a first signal from the thermal sensor prior to arrival of the biomolecular fluid in the local environment;
b) obtaining a second signal from the thermal sensor as the biomolecular fluid arrives in the local environment; and
c) relating the first signal with the second signal to detect the arrival of the biomolecular fluid. - View Dependent Claims (311, 312, 313, 314, 315, 316, 317, 318, 319)
-
-
320. A method for determining the start time of a rate-based assay, comprising:
-
a) obtaining a first signal from a thermal sensor prior to arrival of the biomolecular fluid in the local environment;
b) obtaining a second signal from the thermal sensor as the biomolecular fluid arrives in the local environment; and
c) relating the first signal with the second signal to determine the start time of the rate-based assay. - View Dependent Claims (321, 322, 323, 324, 325, 326, 327)
-
-
328. A method for detecting a dynamic change in the local environment of a detector element arising from a biomolecular fluid arriving at or near the local environment, comprising:
-
a) applying a current to the detector element to raise the temperature of the local environment prior to contact with the biomolecular fluid, b) receiving a first signal from the detector element prior to arrival of the biomolecular fluid;
c) receiving a second signal from the detector element as the sample or fluid arrives at the local environment; and
d) relating the first signal with the second signal to detect a dynamic change in the local environment. - View Dependent Claims (329, 330, 331, 332, 333, 334, 335)
-
-
336. A method for determining the start time of a rate-based assay, comprising:
-
a) Applying a current to a detector element having a local environment to raise the temperature of the local environment prior to the arrival of the biomolecular fluid at the local environment, b) obtaining a first signal from the detector element prior to arrival of the biomolecular fluid at the local environment;
c) obtaining a second signal from the detector element as the biomolecular fluid arrives at the local environment; and
d) relating the first signal with the second signal to determine the start time of the rate-based assay. - View Dependent Claims (337, 338, 339, 340)
-
-
341. A lancing system comprising
a controllable driver having a proximal end and a distal end with a distal end of a coupler shaft disposed at the distal end of the controllable driver; -
a ratchet drive mechanism operably disposed at the distal end of the controllable driver; and
a plurality of lancets configured to be sequentially advanced by the ratchet drive mechanism into a coupled configuration with the coupler shaft of the controllable driver. - View Dependent Claims (342, 343, 344, 345, 346, 347, 348, 349, 350, 351, 352)
-
-
353. A driver coupler for coupling a lancet to a lancet driver comprising a coupler body portion having a proximal end, a distal end and a lateral slot with at least one abutment within the lateral slot at a distal end of the lateral slot which intrudes into the lateral slot to form an area of reduced width at the distal end of the lateral slot relative to a portion of the lateral slot proximal thereto.
Specification