Tissue penetration device

• US 20130096533A1
• Filed: 12/03/2012
• Published: 04/18/2013
• Est. Priority Date: 06/12/2001
• Status: Active Grant

• Current Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Original Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Inventors: Freeman, Dominique M., Alden, Don
• Granted Patent: US 8,845,550 B2
• Time in Patent Office: Days
• US Class Current: 604/506
• CPC Class Codes: A61B 17/32093 for skin incisions
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150061 Means for enhancing collection
• CPC Class Codes: A61B 5/150068 by tissue compression, e.g. with specially designed surface of device contacting the skin area to be pierced
• CPC Class Codes: A61B 5/150099 by negative pressure, other than vacuum extraction into a syringe by pulling on the piston rod or into pre-evacuated tubes
• CPC Class Codes: A61B 5/150152 by an adequate mechanical impact on the puncturing location
• CPC Class Codes: A61B 5/150167 Adjustable piercing speed of skin piercing element, e.g. blade, needle, lancet or canula, for example with varying spring force or pneumatic drive
• CPC Class Codes: A61B 5/150175 Adjustment of penetration depth
• CPC Class Codes: A61B 5/15019 Depth adjustment mechanism using movable stops located inside the piercing device housing and limiting the travel of the drive mechanism mechanisms using distal end caps A61B5/150183, mechanisms at the piercing element carrier proximal end A61B5/150198
• CPC Class Codes: A61B 5/150213 Venting means
• CPC Class Codes: A61B 5/150221 Valves
• CPC Class Codes: A61B 5/150358 Strips for collecting blood, e.g. absorbent optical reagent test strips G01N21/8483; chemical reagent test strips G01N33/4875, G01N33/52
• CPC Class Codes: A61B 5/150427 Specific tip design, e.g. for improved penetration characteristics
• CPC Class Codes: A61B 5/150503 Single-ended needles hollow piercing element tip design A61B5/150396, needle sets for catheters A61M25/06, needles for bringing media into the body A61M5/32
• CPC Class Codes: A61B 5/150572 Pierceable protectors, e.g. shields, caps, sleeves or films, e.g. for hygienic purposes
• CPC Class Codes: A61B 5/15113 Manually triggered, i.e. the triggering requires a deliberate action by the user such as pressing a drive button
• CPC Class Codes: A61B 5/15117 comprising biased elements, resilient elements or a spring, e.g. a helical spring, leaf spring, or elastic strap
• CPC Class Codes: A61B 5/15123 comprising magnets or solenoids
• CPC Class Codes: A61B 5/15146 Devices loaded with multiple lancets simultaneously, e.g. for serial firing without reloading, for example by use of stocking means. multiple simultaneous cutting or piercing A61B5/150977
• CPC Class Codes: A61B 5/15151 : Each piercing element being stocked in a separate isolated compartment
• CPC Class Codes: A61B 5/15153 : Multiple piercing elements stocked in a single compartment
• CPC Class Codes: A61B 5/15163 : Characterized by propelling the piercing element in an axial direction relative to the disc
• CPC Class Codes: A61B 5/15169 : Characterized by a rolled strip
• CPC Class Codes: A61B 5/15171 : Characterized by propelling the piercing element perpendicular to the direction of movement of the strip
• CPC Class Codes: A61B 5/15176 : Stocking means comprising cap, cover, sheath or protection for aseptic stocking
• CPC Class Codes: A61B 5/15178 : Stocking means comprising separate compartments or units for new and for used piercing elements separate compartments for used piercing elements in piercing devices A61B5/15184
• CPC Class Codes: A61B 5/15184 : Piercing device comprising a separate compartment or unit for used piercing elements separate compartments for used piercing elements in stocking means A61B5/15178
• CPC Class Codes: A61B 5/15186 : Devices loaded with a single lancet, i.e. a single lancet with or without a casing is loaded into a reusable drive device and then discarded after use; drive devices reloadable for multiple use
• CPC Class Codes: A61B 5/157 : Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: A61M 2005/004 : Magazines with multiple needles directly inserted into an injection or infusion device, e.g. revolver-like magazines
• CPC Class Codes: A61M 5/158 : Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
• CPC Class Codes: A61M 5/46 : having means for controlling depth of insertion
• CPC Class Codes: B01L 2200/10 : Integrating sample preparation and analysis in single entity, e.g. lab-on-a-chip concept
• CPC Class Codes: B01L 2300/0663 : Whole sensors
• CPC Class Codes: B01L 2300/18 : Means for temperature control
• CPC Class Codes: B01L 3/5027 : by integrated microfluidic structures, i.e. dimensions of channels and chambers are such that surface tension forces are important, e.g. lab-on-a-chip B01L3/5023 takes precedence; micromixers B01F33/30; microreactors for synthesis B01J19/0093; microcapillary devices in general B81B1/00
• CPC Class Codes: B01L 3/502715 : characterised by interfacing components, e.g. fluidic, electrical, optical or mechanical interfaces
• CPC Class Codes: B01L 3/50273 : characterised by the means or forces applied to move the fluids micropumps F04B19/006, of the membrane type F04B43/043
• CPC Class Codes: B01L 3/502746 : characterised by the means for controlling flow resistance, e.g. flow controllers, baffles B01L3/502738 takes precedence
• CPC Class Codes: G01N 33/4905 : Determining clotting time of blood by chemical methods G01N33/86, C12Q1/56
• CPC Class Codes: G01N 33/557 : using kinetic measurement, i.e. time rate of progress of an antigen-antibody interaction

Abstract

An agent injection device is provided that is capable of injecting an agent to a known predetermined tissue depth. An injection member has an elongate injection shaft with an outlet port configured to dispense an agent at a controllable time. A controllable driver is coupled to the elongate injection shaft and is configured to drive the injection member into target tissue. A velocity control system is in communication with the controllable driver and is configured to control the velocity of the elongate injection shaft.

Claims

1. 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) 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;

(c) injecting the agent; and

(d) accurately delivering the agent to a specific depth within a skin or tissue layer and provide for localized agent delivery.

2. The method of claim 1, further comprising:

using a rapid insertion velocity to the specific depth to reduce pain of insertion of the needle into the skin.

3. The method of claim 1, further comprising:

using a position feedback loop of a controllable driver coupled to the elongate injection shaft.

4. The method of claim 1, further comprising:

using an agent injection module that has a reservoir.

5. The method of claim 1, further comprising:

using a plurality of agent injection modules; and

providing a series of metered doses of the agent.

6. 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.

7. The method of claim 6, wherein the elastic recoil displacement value comprises an average elastic recoil displacement value for the patient'"'"'s target tissue for a tissue penetration cycle.

8. The method of claim 6, wherein determining the contact point of the elongate injection shaft with the target tissue comprises measuring the deceleration of the elongate injection shaft.

9. The method of claim 6, wherein determining the contact point of the elongate injection shaft with the target tissue comprises using a known fixed distance from a starting position of the elongate injection shaft to the target tissue, a position sensor configured to measure the position of the elongate injection shaft, and measuring the distance traveled by the elongate injection shaft from the starting position during an injection cycle to determine the contact point.

10. The method of claim 6, further comprising:

providing an average inelastic recoil displacement value for the patient'"'"'s target tissue for a lancing cycle; and

advancing the elongate injection shaft into the target tissue from the contact point over a displacement equal to the sum of the average elastic recoil displacement value, the distance from the distal extremity of the elongate injection shaft to the outlet port, the inelastic recoil displacement value of the patient'"'"'s target tissue and the desired tissue depth for agent deposition.

11. The method of claim 10, wherein the value of the magnitude of the average inelastic recoil displacement value is about 100 to about 200 microns.

12. The method of claim 6, wherein the elongate injection shaft comprises a hypodermic needle.

13. The method of claim 6, wherein the depth of injection can be achieved to an accuracy of better than about 200 microns.

14. The method of claim 13, wherein the depth of injection can be achieved to an accuracy of better than about 40 microns.

15. 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.

16. The method of claim 15, further comprising determining the contact point between the elongate injection shaft and the target tissue during an injection cycle.

17. The method of claim 16, wherein determining the contact point of the elongate injection shaft with the target tissue comprises measuring the deceleration of the elongate injection shaft during an the injection cycle.

18. The method of claim 16, wherein determining the contact point of the elongate injection shaft with the target tissue comprises using a known fixed distance from a starting position of the elongate injection shaft to the target tissue, a position sensor configured to measure the position of the elongate injection shaft, and measuring the distance traveled by the elongate injection shaft from the starting position during an injection cycle to determine the contact point.

19. The method of claim 15, further comprising allowing the elongate injection shaft to settle during a settling phase after reaching the position of maximum penetration with substantially no force applied to the injection shaft during the settling phase and the patient'"'"'s target tissue elastically recoiling during at least a portion of the settling phase.

20. The method of claim 15, wherein the elongate injection shaft is withdrawn in a proximal direction from the position of maximum penetration over a displacement equal to the magnitude of the displacement from the contact point to the position of maximum penetration less the desired penetration depth.

21. The method of claim 15, wherein the injection shaft is driven into the patient'"'"'s target tissue to a depth that is greater than the sum of a known elastic recoil value of the patient'"'"'s target tissue and the desired injection depth.

22. The method of claim 15, wherein the displacement of the injection shaft from the point of contact to a depth of maximum penetration of about 1 to about 5 mm.

23. The method of claim 15, wherein determining the contact point of the elongate injection shaft with the target tissue comprises measuring the deceleration of the elongate injection shaft during an injection cycle.

24. The method of claim 15, wherein determining the contact point of the elongate injection shaft with the target tissue comprises using a known fixed distance from a starting position of the elongate injection shaft to the target tissue, a position sensor configured to measure the position of the elongate injection shaft, and measuring the distance traveled by the elongate injection shaft from the starting position during an injection cycle to determine the contact point.

25. The method of claim 15, wherein the value of the magnitude of the elastic recoil of the patient'"'"'s target tissue is about 0.2 to about 2.0 mm.

26. The method of claim 15, wherein the elongate injection shaft comprises a hypodermic needle.

27. The method of claim 15, wherein the depth of injection can be achieved to an accuracy of better than about 200 microns.

28. The method of claim 27, wherein the depth of injection can be achieved to an accuracy of better than about 40 microns.