Appartus and method for penetration with shaft having a sensor for sensing penetration depth

• US 20100228194A1
• Filed: 04/26/2010
• Published: 09/09/2010
• Est. Priority Date: 03/30/1998
• Status: Active Grant

• Current Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Original Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Inventors: Schulte, Thomas, Freeman, Dominique
• Granted Patent: US 8,439,872 B2
• Time in Patent Office: Days
• US Class Current: 604/117
• CPC Class Codes: A61B 18/14 Probes or electrodes therefor
• CPC Class Codes: A61B 2018/00738 Depth, e.g. depth of ablation
• CPC Class Codes: A61B 2018/00755 Resistance or impedance
• CPC Class Codes: A61B 2018/00875 Resistance or impedance
• CPC Class Codes: A61B 2018/126 bipolar
• CPC Class Codes: A61B 2018/1425 Needle
• CPC Class Codes: A61B 2090/062 penetration depth
• CPC Class Codes: A61B 5/053 Measuring electrical impedance or conductance of a portion of the body
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/15003 for venous or arterial blood
• CPC Class Codes: A61B 5/150137 by vibration enhancing collection by vibration A61B5/150175
• 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 5/150389 Hollow piercing elements, e.g. canulas, needles, for piercing the skin
• 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 5/15117 comprising biased elements, resilient elements or a spring, e.g. a helical spring, leaf spring, or elastic strap
• CPC Class Codes: A61B 5/15121 comprising piezos
• CPC Class Codes: A61B 5/15125 comprising a vacuum or compressed fluids
• CPC Class Codes: A61B 5/15128 comprising 2D- or 3D-shaped elements, e.g. cams, curved guide rails or threads comprising tooth-shaped elements A61B5/15132
• 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: A61M 5/46 : having means for controlling depth of insertion

Abstract

An apparatus having a shaft that can sense the depth of penetration, for penetrating into an object (the substrate). The substrate being penetrated has impedance that varies according to the depth under a surface of the substrate. The shaft has a tip for penetration and has conductive ends near to the tip of the shaft. A change of impedance of material of the object between the conductive ends can be sensed to provide information on the depth of penetration. A processor can be provided external to the object being penetrated by the shaft to gather and process the impedance information to determine whether the desired depth has been achieved.

Claims

1. A tissue penetrating device for sampling body fluid from a patient and for use with a penetrating member, the device comprising:

an electrical driver coupled to provide force that moves said penetrating member along a path into the tissue;

a sensing device for use in controlling motion of the penetrating member to penetrate the skin of the patient to a desired depth of penetration that is sufficient to create a wound from which blood flows from the wound and into an interior of the tissue penetrating device for blood analysis, wherein at least a portion of the sensing device is coupled to move with the penetrating member as the penetrating member advances into the tissue;

a controller electrically coupled to the electrical driver and sensing device, the controller configured to receive a signal from the sensing device to control the electrical driver and a motion of the penetrating member to reduce over-penetration by the penetrating member with reduced patient discomfort.

2. The device of claim 1, further comprising:

an electronic feedback loop circuit in electrical communication with the sensing device and the controller to inhibit penetrating member penetration once a penetration depth of the penetrating member has been sensed by the sensing device.

3. The device of claim 1, wherein the controller is configured to provide for the penetrating member to enter a tissue site through a skin surface at a velocity greater than an exit velocity from the tissue site.

4. The device of claim 1, wherein the controller provides control of the electronic driver such that when a desired depth of penetration at the tissue site by the penetrating has been achieved the electronic driver is stopped automatically.

5. The device of claim 1, wherein the electrical driver includes a motor.

6. The device of claim 1, wherein the controller includes a microprocessor.

7. The device of claim 6, wherein the controller has logic for directing the electrical driver to provide force to drive the penetrating member into tissue and to provide force to withdraw the penetrating member from tissue.

8. A tissue penetrating device for sampling body fluid from a patient and for use with a penetrating member, the device comprising:

an electrical driver coupled to provide force that moves said penetrating member along a path into the tissue;

a sensing device for use in controlling motion of the penetrating member to penetrate the skin of the patient to a desired depth of penetration that is sufficient to create a wound from which blood flows from the wound and into an interior of the tissue penetrating device for blood analysis, wherein at least a portion of the sensing device is coupled to move with the penetrating member as the penetrating member advances into the tissue;

a controller electrically coupled to the electrical driver and sensing device, the controller having logic for directing the electrical driver to provide force to drive the penetrating member into tissue and to provide force to withdraw the penetrating member from tissue, the controller configured to receive a signal from the sensing device to control the electrical driver and a motion of the penetrating member to reduce over-penetration by the penetrating member with reduced patient discomfort.

9. The device of claim 8, further comprising:

an electronic feedback loop circuit in electrical communication with the sensing device and the controller to inhibit penetrating member penetration once a penetration depth of the penetrating member has been sensed by the sensing device.

10. The device of claim 9, wherein the controller is configured to provide for the penetrating member to enter a tissue site through a skin surface at a velocity greater than an exit velocity from the tissue site.

11. The device of claim 8, wherein the electrical driver in combination with the controller provides an electronic stop to stop travel of the penetrating member in the tissue site.

12. A method of lancing the tissue of a patient using a tissue penetrating device, comprising:

providing a penetrating member device comprising an electrical driver coupled to provide force to a penetrating member;

activating the electrical driver;

driving the penetrating member into a tissue site of a patient, wherein the electrical driver provides force to move said penetrating member into the tissue;

using a controller electrically coupled to the electrical driver to control a motion of the penetrating member relative to the tissue site;

sensing the depth of penetration of the penetrating member after the penetrating member has been driven into the tissue site with the sensing device and controlling the activation of the electrical driver with the controller based on the depth of penetration of the penetrating member; and

using the controller and a signal from the sensing device to control the electrical driver and a motion of the penetrating member to reduce over-penetration by the penetrating member in the tissue site with reduced patient discomfort.

13. The method of claim 12, further comprising:

using the electrical driver to stop the penetrating member in the tissue site; and

using the electrical driver to withdraw the penetrating member from the tissue

14. The method of claim 13, further comprising:

using the electrical driver to stop the penetrating member in the tissue site.

15. The method of claim 12, further comprising:

sensing a depth of penetration of the penetrating member after the penetrating member has been driven into the tissue site with the sensing device and controller providing activation of the electrical driver based on the depth of penetration of the penetrating member.

16. The method of claim 12, further comprising:

obtaining a body fluid sample, wherein the sample is obtained by removing the penetrating member from the tissue site.

17. The method of claim 12. wherein the penetrating member is a non-hollow, elongate member.

18. The method of claim 12, further comprising:

using the electrical driver to stop the penetrating member in the tissue site with interaction from the sensing device and the controller.

19. The method of claim 12, further comprising:

using an electronic feedback loop circuit in electrical communication with the sensing device and the controller for controlling motion of the penetrating member.

20. The method of claim 12, further comprising:

using logic from the controller for directing the electrical driver to provide force to drive the penetrating member into the tissue site and force to withdraw the penetrating member from the tissue site.

21. A tissue penetrating device for sampling blood from the skin of a patient, the device comprising:

an electrical driver configured to provide drive force to a penetrating member, wherein said penetrating member is coupled to a sensing device;

a controller electrically coupled to the electrical driver and configured to control a motion of the penetrating member to penetrate the skin of the patient to a desired depth of penetration that is sufficient to create a wound from which blood flows from the wound without flowing through the penetrating member and into an interior of the tissue penetrating device for blood analysis with reduced patient discomfort from the creation of the wound;

an electronic feedback loop in electrical communication with the controller for inhibiting penetrating member penetration once a desired penetration depth of the penetrating member has been reached and control the electrical driver and a motion of the penetrating member to reduce over-penetration by the penetrating member with reduced patient discomfort sensed by the sensing device member; and

wherein the electrical driver is used to stop the penetrating member in the tissue site.

22. The device of claim 21, wherein the electrical driver includes a motor.

23. The device of claim 21, wherein the controller includes a microprocessor.

24. A tissue penetrating device for sampling blood from a tissue site of a patient, comprising,

an electrical driver including a sensing device, said electrical driver providing drive force, and configured to be coupled to and drive a penetrating member for penetrating a skin surface of a patient, wherein motion of the penetrating member results in motion of at least one component of the sensing device relative to the housing;

a controller coupled to the electrical driver and configured to control a motion of the penetrating member;

an electronic feedback loop circuit in electrical communication with the sensing device and the controller for inhibiting penetration of the penetrating member when a desired penetration depth of the penetrating member has been sensed by the sensing device member to penetrate the skin of the patient to a desired depth of penetration in the tissue site with reduced patient discomfort from the creation of the wound; and

wherein using the electrical driver is used to stop the penetrating member in the tissue.

25. The device of claim 24, wherein the electrical driver includes a motor.

26. The device of claim 24, wherein the controller includes a microprocessor.

27. A method of sampling blood from a patient, the method comprising:

activating an electrical driver;

driving a penetrating member coupled to the electrical drive through a skin surface of a patient into a tissue site;

sensing a depth of penetration of the penetrating member after the penetrating member has been driven into the tissue site; and

controlling activation of the electrical driver in response to a depth of penetration of the penetrating member in the tissue site that is determined with a sensing device member;

penetrating the skin to a desired depth of penetration at a tissue site to create a wound from which blood flows from the wound without flowing through the penetrating member and into an interior of the tissue penetrating device for blood analysis with reduced patient discomfort from the creation of the wound.

28. The method of claim 27, further comprising:

obtaining the body fluid sample, wherein the sample is obtained only by removing the penetrating member from the tissue.

29. The method of claim 27, wherein the penetrating member is a non-hollow, elongate member.

30. The method of claim 27 further comprising:

using the electrical driver to stop the penetrating member in the tissue site.

31. The method of claim 27 further comprising:

using the electrical driver to withdraw the penetrating member from the tissue site.