Method and apparatus for penetrating tissue

• US 9,072,842 B2
• Filed: 07/31/2013
• Issued: 07/07/2015
• Est. Priority Date: 04/19/2002
• Status: Expired due to Fees

• Current Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Original Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Inventors: Freeman, Dominique M.
• Primary Examiner(s): TOWA, RENE T
• Application Number:
  US13/955,369
• Publication Number:
  US 20130317429A1
• Time in Patent Office: 706 Days
• Field of Search: 600/573, 600575-579, 600/583, 606181-183, 604/19, 604/117, 604/187, 604/191, 604/212
• US Class Current: 1/1
• CPC Class Codes: A61B 5/1411 by percutaneous method, e.g. by lancet
• CPC Class Codes: A61B 5/1427 Multiple blood sampling, e.g. at periodic or pre-established intervals
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14865 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
• 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 5/150167 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 5/150221 Valves
• CPC Class Codes: A61B 5/150343 Collection vessels for collecting blood samples from the skin surface, e.g. test tubes, cuvettes sampling from within body cavities A61B5/150015, A61B5/150045
• 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 5/150412 Pointed piercing elements, e.g. needles, lancets for piercing the skin blade-like piercing elements A61B5/150442
• 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 5/150755 Blood sample preparation for further analysis, e.g. by separating blood components or by mixing
• CPC Class Codes: A61B 5/15087 short range, e.g. between console and disposable using implanted devices A61B5/150877
• CPC Class Codes: A61B 5/151 Devices specially adapted for taking samples of capillary blood, e.g. by lancets , needles or blades
• 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 5/15123 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 5/15194 : fully automatically retracted, i.e. the retraction does not require a deliberate action by the user, e.g. by terminating the contact with the patient's skin
• CPC Class Codes: A61B 5/157 : Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: A61B 5/6886 : Monitoring or controlling distance between sensor and tissue
• CPC Class Codes: A61M 5/3295 : Multiple needle devices, e.g. a plurality of needles arranged coaxially or in parallel

Abstract

A tissue penetrating system has a housing member. A plurality of penetrating members are positioned in the housing member. A tissue stabilizing member is coupled to the housing. A penetrating member sensor is coupled to the plurality of penetrating members. The penetrating member sensor is configured to provide information relative to a depth of penetration of a penetrating member through a skin surface.

Claims

1. A medicament delivery system, comprising:

a housing member;

one or more penetrating members positioned in a cartridge;

a controllable driver configured to be coupled to the one or more penetrating members;

a processor configured to be coupled to each penetrating member and the controllable driver, the processor customizing a user'"'"'s profile in response to user input information, the processor providing for localization of an injection of a medicament, the processor allowing the user to rank the results of penetrating event configured to customize a user profile;

a database that stores information relative to penetrating events, with the processor calculating profile traits, in response to circumstances or parameters for a lancing input by a user.

2. The system of claim 1, further comprising:

a cartridge positionable in the housing member.

3. The system of claim 1, wherein the user profile is used to determine at least one of an amount of medicament delivered, when a medicament is delivered, and a phase of penetrating member movement for medicament delivery.

4. The system of claim 1, wherein the processor and controllable driver provide for targeted delivery of the medicament.

5. The system of claim 1, wherein the processor and controllable driver provide for an ability to accurately deliver medicament to a specific depth within a skin or tissue layer to minimize wastage of medicament.

6. The system of claim 1, wherein the processor and controllable driver provide for the ability to deliver a medicament to a precise depth.

7. The system of claim 1, further comprising:

a feedback loop coupled to the processor and controllable driver.

8. The system of claim 7, wherein the feedback loop in operation provides for accurate control of medicament delivery.

9. The system of claim 1, further comprising:

a medicament container.

10. The system of claim 1, wherein a medicament container is a collapsible canister configured to be coupled to a penetrating member and actuatable by the controllable driver.

11. The system of claim 10, wherein a medicament injection module houses the medicament to be injected.

12. The system of claim 1, further comprising:

a plurality of medicament injection modules.

13. The system of claim 12, wherein the plurality of medicament injection modules are positioned in a cartridge.

14. The system of claim 12, wherein the plurality of medicament injection modules provide a series of metered doses.

15. The system of claim 14, wherein the metered doses provide for a long-term medication need.

16. The system of claim 13, wherein the medicament injection modules and the one or more penetrating members are housed in the cartridge.

17. The system of claim 16, wherein the cartridge is disposable.

18. The system of claim 1, wherein the controllable driver and processor provide for an ability to precisely determine a position or penetration depth of the one or more penetrating members.

19. The system of claim 1, wherein the one or more penetrating members is a hypodermic needle.

20. The system of claim 1, wherein each of a one or more penetrating members is coupled to a coupler.

21. The system of claim 3, wherein the processor and controllable driver provide for medicament delivery at a point of maximum penetration of the one or more penetrating members.

22. The system of claim 3, wherein the processor and controllable driver provide for medicament delivery during a retraction of the one or more penetrating members.

23. The system of claim 3, wherein the processor and controllable driver provide for medicament delivery during insertion of the one or more penetrating members.

24. The system of claim 9, wherein a plate is disposed at a distal end of the medicament container.

25. The system of claim 24, wherein the plate is sealed and secured to a shaft of the one or more penetrating members to prevent leakage of the medicament from the medicament container.