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

• US 6,391,005 B1
• Filed: 03/30/1998
• Issued: 05/21/2002
• Est. Priority Date: 03/30/1998
• Status: Expired due to Term

• Current Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Original Assignee: Agilent Technologies, Inc.
• Inventors: Simons, Tad Decataur, Lum, Paul, Melton, Hewlett E. Jr., Greenstein, Michael
• Primary Examiner(s): Seidel, Richard K.
• Assistant Examiner(s): Rodriguez, Cris L
• Application Number:
  US09/050,853
• Time in Patent Office: 1,513 Days
• Field of Search: 604/117, 604/116, 604/49, 604/51, 604/52, 604/65, 604/66, 604/67, 604/264, 604/272, 604/22, 604/46, 604/500, 604/503, 604/165.04, 600/382, 600/398, 600/399, 600/506, 600/547, 600/576, 600/583, 600/300, 600/554, 600/373, 600/546, 600/582, 600/568, 600/372, 606/181
• 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. An apparatus for penetrating into tissue which has impedance that varies according to the depth of tissue, comprising:

a shaft comprising;

(i) a shaft body with a tip for penetration; and

(ii) first and second conductors proximate to the tip such that a change of electrical impedance of material of the between the first and second conductors can be sensed to provide information on the depth of penetration; and

electronic circuit associated with the shaft for determining the change in electrical impedance between the first and second conductors, said electronic circuit providing an electrical signal to automatically drives said shaft as a function of said electrical impedance.

2. The apparatus according to claim 1 further comprising a first conductor line leading from the first conductors to the electronic circuit and a second conductor line leading from the second to the electronic circuit, the shaft comprising an electrical insulator interposing between the first conductor and the second conductor.

3. The apparatus according to claim 2 wherein the first conductor line is on one side of the shaft and the second conductor line is on a second side of the shaft to prevent the two conductor lines from electrically contacting each other.

4. The apparatus according to claim 1 further comprising a channel in the shaft extending from the tip for conducting fluid from the tip through the shaft.

5. The apparatus according to claim 4 wherein the shaft has a center line and the second conductor is proximate to the central line and the shaft comprising an electrical insulator interposing between the first conductor and the second conductor.

6. The apparatus according to claim 5 wherein the electrical insulator is a tube, the first conductor is a conductive layer encircling the insulator tube, and the second conductor extending inside the insulator tube, and wherein the electronic circuit is located remote from the tip.

7. The apparatus according to claim 4 wherein the shaft body comprises a metallic tube, an electrically insulating layer coated on the metallic tube and a conductor layer coated on the electrically insulating layer, the conductor layer being in electrical communication with the first conductor and the electronic circuit and the metallic tube being in electrical communication with the second conductor and the electronic circuit, and wherein the electronic circuit is located external to the tissue when the shaft has penetrated the tissue.

8. The apparatus according to claim 4 further comprising a reservoir operatively connected to the shaft in fluid communication with the channel to receive fluid therefrom.

9. The apparatus according to claim 1 wherein the shaft body has a size of a hypodermic needle for penetrating the skin of a patient.

10. The apparatus according to claim 1 further comprising a mechanical driver operatively associated with the shaft for driving the shaft into the body by incremental steps.

11. An apparatus having a shaft for penetration into tissue which has impedance that varies according to the depth of tissue penetrated comprising:

(a) a shaft having a size of that of a hypodermic needle, with a sharp tip for penetration;

(b) An impedance sensor connected to the shaft and including;

first and second conductors proximate to the sharp tip such that a change of impedance of material of the tissue between the first and second conductors can be sensed to provide information on the depth of penetration;

electronics for determining said change in impedance;

first and second lines extending along the shaft to connect the conductors to the electronics; and

an electrical insulator interposing between the first conductor and the second conductor; and

(c) mechanical driver operatively contacting the shaft for incrementally driving the shaft, the driving action being affected by said change of impedance.

12. A method for driving a shaft into tissue comprising:

(a) driving a shaft to penetrate into tissue having a surface and material with electrical impedance varying with depth of tissue penetrated; and

(b) sensing the electrical impedance of the material in the tissue proximate the tip of the shaft during penetration to determine whether desired depth has been achieved and automatically modifying the driving action of an electrically controlled driver with an electrical signal based on the electrical impedance sensed by an electrical circuit.

13. The method according to claim 12 further comprising driving the shaft incrementally with a driver.

14. The method according to claim 13 further comprising reciprocatively driving the shaft to penetrate the tissue.

15. The method according to claim 12 further comprising stopping the driving action when a desired depth of penetration has been sensed.

16. The method according to claim 12 wherein the shaft has a channel therein and further comprising allowing fluid to flow from the tissue through the shaft to sample the fluid.

17. A method for inserting a needle-sized shaft through the skin and underlying tissue comprising:

(a) driving a needle-sized shaft to penetrate into said tissue through the skin;

(b) electrically sensing the electrical impedance of said tissue from an electronic circuit to determine whether desired penetration depth has been achieved; and

(c) automatically stopping the advance of the needle-sized shaft when the desired depth has been achieved based on an electrical signal provided to an electrically controlled driver by said electronic circuit.

18. The method according to claim 17 further comprising using an electrical driver to drive the needle-sized shaft incrementally and electrically stopping the electrical driver when the desired depth has been achieved.

19. An apparatus having a shaft for penetrating into tissue which has impedance that varies according to the depth of tissue penetrated comprising:

a shaft comprising;

(i) a shaft body with a tip for penetration; and

(ii) first and second conductors proximate to the tip such that a change of impedance of material of the tissue between the first and second conductors can be sensed to provide information on the depth of penetration; and

a mechanical driver associated with the shaft for driving the shaft into the body by incremental steps.

20. A method for driving a shaft into ti'"'"'sue, comprising:

(a) driving a shaft having a tip to penetrate into tissue having a fluid therein;

(b) sensing the impedance of the material in the tissue proximate the tip of the shaft during penetration to determine whether desired depth has been achieved and automatically modifying the driving action based on the impedance sensed by an electronic circuit, said electronic circuit providing an electrical signal to modify said driving action; and

allowing fluid to flow from the tissue through a channel in the shaft to sample the fluid.