TISSUE PENETRATION DEVICE

• US 20150126962A1
• Filed: 09/29/2014
• Published: 05/07/2015
• 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 9,427,532 B2
• Time in Patent Office: Days
• US Class Current: 604/506
• CPC Class Codes: A61B 5/1411 by percutaneous method, e.g. by lancet
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150152 by an adequate mechanical impact on the puncturing location
• CPC Class Codes: A61B 5/150175 Adjustment of penetration depth
• CPC Class Codes: A61B 5/150305 Packages specially adapted for piercing devices or blood sampling devices kits for diabetes A61M5/003; packaging in general B65D
• CPC Class Codes: A61B 5/150427 Specific tip design, e.g. for improved penetration characteristics
• CPC Class Codes: A61B 5/150946 Means for varying, regulating, indicating or limiting the speed or time of blood collection
• CPC Class Codes: A61B 5/15123 comprising magnets or solenoids
• CPC Class Codes: A61B 5/15151 Each piercing element being stocked in a separate isolated 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 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: A61B 5/442 Evaluating skin mechanical properties, e.g. elasticity, hardness, texture, wrinkle assessment
• 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 2005/005 Magazines with multiple ampoules directly inserted into an injection or infusion device, e.g. revolver-like magazines containing ampoules with or without needles
• CPC Class Codes: A61M 2005/206 With automatic needle insertion
• CPC Class Codes: A61M 5/20 Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically A61M5/142 , A61M5/46 take precedence; hypodermic projectiles F42B12/54
• CPC Class Codes: A61M 5/2425 by compression of deformable ampoule or carpule wall
• CPC Class Codes: A61M 5/46 having means for controlling depth of insertion

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:

driving an elongate injection shaft using an electronic driver, the elongated injection shaft having an outlet port configured to dispense an agent at a controllable time toward the patient'"'"'s target tissue;

providing programmable control of the electronic driver for a desired velocity of the injection shaft;

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;

injecting the agent; and

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 the 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:

driving an elongate injection shaft having an outlet port configured to dispense an agent at a controllable time toward the patient'"'"'s target tissue;

determining a contact point between a distal extremity of the elongate injection shaft and the target tissue;

providing programmable control of the electronic driver for a desired velocity of the injection shaft;

advancing the elongate injection shaft into the target tissue from the contact point; and

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:

driving an elongate injection shaft having an outlet port configured to dispense an agent at a controllable time toward the patient'"'"'s target tissue;

providing programmable control of the electronic driver for a desired velocity of the injection shaft;

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;

withdrawing the injection shaft in a proximal direction to the desired penetration depth; and

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.