Medical tool for reduced penetration force with feedback means

• US 8,870,865 B2
• Filed: 11/08/2012
• Issued: 10/28/2014
• Est. Priority Date: 06/29/2007
• Status: Active Grant

• Current Assignee: Actuated Medical, Inc.
• Original Assignee: Actuated Medical, Inc.
• Inventors: Frankhouser, Paul L., Park, Brian M., Mulvihill, Maureen L.
• Primary Examiner(s): DOUGHERTY, SEAN PATRICK
• Application Number:
  US13/672,497
• Publication Number:
  US 20130072856A1
• Time in Patent Office: 719 Days
• Field of Search: 600573-584, 606/169, 606181-185, 604/22
• US Class Current: 606/42
• CPC Class Codes: A61B 10/025 for taking bone, bone marrow or cartilage samples
• CPC Class Codes: A61B 17/3401 Puncturing needles for the peridural or subarachnoid space or the plexus, e.g. for anaesthesia local anaesthesia A61M19/00
• CPC Class Codes: A61B 17/3403 Needle locating or guiding means guides for suture needles A61B17/0482; guiding or tracking by nuclear magnetic resonance G01R33/285
• CPC Class Codes: A61B 17/3415 for introducing tubes or catheters, e.g. gastrostomy tubes, drain catheters A61B17/3417 takes precedence; body piercing catheter guide needles A61M25/06
• CPC Class Codes: A61B 17/3423 Access ports, e.g. toroid shape introducers for instruments or hands access sites for liquids A61M39/0247
• CPC Class Codes: A61B 17/3476 Powered trocars, e.g. electrosurgical cutting, lasers, powered knives
• CPC Class Codes: A61B 2017/0011 piezoelectric
• CPC Class Codes: A61B 2017/00115 with audible or visual output
• CPC Class Codes: A61B 2017/00123 and automatic shutdown
• CPC Class Codes: A61B 2017/32007 with suction or vacuum means
• CPC Class Codes: A61B 2017/320089 node location
• CPC Class Codes: A61B 2017/3413 guided by ultrasound
• CPC Class Codes: A61B 2090/064 for measuring force, pressure or mechanical tension
• CPC Class Codes: A61B 34/20 Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
• CPC Class Codes: A61M 2005/1585 Needle inserters
• CPC Class Codes: A61M 2205/581 by audible feedback
• CPC Class Codes: A61M 2205/582 by tactile feedback
• CPC Class Codes: A61M 2205/583 by visual feedback
• CPC Class Codes: A61M 25/065 Guide needles
• CPC Class Codes: A61M 37/0092 using ultrasonic, sonic or infrasonic vibrations, e.g. phonophoresis
• CPC Class Codes: A61M 5/00 : Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests vaccination appliances for veterinary use A61D1/025 ; tube connectors, tube couplings, valves or branch units specially adapted for medical use A61M39/00; containers specially adapted for medical or pharmaceutical purposes A61J1/00; combinations of vial and syringe for mixing or transferring their contents A61J1/20; holders for containers for collecting, storing or administering blood or medical fluids A61J1/16
• 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 5/20 : 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 5/3287 : Accessories for bringing the needle into the body; Automatic needle insertion A61M5/20, A61M5/31525 take precedence

Abstract

A medical device for reducing the force necessary to penetrate living being tissue using a variety of reciprocating motion actuators, including piezoelectric, voice coil, solenoids, pneumatics or fluidics. The reciprocating actuator drives a penetrating member, such as a needle, through the tissue at a reduced force while the device detects the passage of the penetrating member through the tissue. Upon passage of the penetrating member through the tissue, electrical power to the reciprocating actuator is automatically terminated. One exemplary method for detecting this passage is via a fluid-containing syringe that is coupled to a channel within the penetrating member. Once the penetrating member tip has passed through the living tissue, the fluid within the syringe no longer experiences any pressure and a plunger within the syringe displaces indicating passage of the penetrating member tip. This motion can provide direct tactile feedback to an operator of the medical device or can automatically open a switch providing electrical power to the medical device. Alternatively, a pressure transducer can also monitor the pressure within the penetrating member channel and automatically activate the switch to cut off the electrical power.

Claims

1. A medical device for penetrating living being tissue, said device comprising:

a penetrating member which is vibrated to reduce force needed to penetrate living being tissue;

a driving actuator coupled to said penetrating member and causing said vibration when energized; and

an electrical power cut off automatically de-energizing said medical device when said penetrating member has passed through said living being tissue,

wherein said driving actuator comprises;

a distal end coupled to said penetrating member;

a first channel extending to said distal end;

at least one piezoelectric element for converting electrical energy into oscillatory motion when energized, wherein a third channel extends through said at least one piezoelectric element such that said at least one piezoelectric element is disposed circumferentially completely around a length of said third channel; and

a second channel having a first end in communication with said first channel and a second end positioned at an exterior surface of said actuator, and

wherein said distal end and said penetrating member are displaced in oscillatory motion when said at least one piezoelectric element is energized.

2. The medical device of claim 1 wherein said at least one piezoelectric element is adapted for vibrating at a frequency to produce sinusoidal displacement of said penetrating member.

3. The medical device of claim 1

wherein said first channel and said third channel are in fluidic communication.

4. The medical device of claim 1 wherein said penetrating member further comprises a channel, and said first channel is in communication with said channel of said penetrating member.

5. The medical device of claim 1 wherein said driving actuator is a Langevin actuator.

6. The medical device of claim 5 wherein said distal end of said Langevin actuator defines an anti-node.

7. The medical device of claim 1 wherein said second channel extends radially from a longitudinal axis of said actuator and is centered at a location defining a zero-node.

8. The medical device of claim 1, wherein said driving actuator further comprises an anchor having a fourth channel, wherein the fourth channel extends longitudinally through the anchor, said fourth channel being in fluidic communication with said first and third channels.

9. The medical device of claim 1 wherein said second end of said second channel defines a side port for providing fluid communication with, or passage of a catheter within, said penetrating member.

10. The medical device of claim 1 further comprising a bolt disposed in said third channel, wherein said third channel has a circular cross-section.

11. The medical device of claim 10 wherein said bolt is hollow.

12. A medical device for penetrating living being tissue, said device comprising:

a penetrating member which is vibrated to reduce force needed to penetrate living being tissue,

a driving actuator coupled to said penetrating member and causing said vibration when energized, wherein said driving actuator has at least one piezoelectric element wherein a channel extends through said at least one piezoelectric element such that said at least one piezoelectric element is disposed circumferentially completely around a length of said channel; and

an electrical power cut off automatically de-energizing said medical device when said penetrating member has passed through said living being tissue,

wherein an exterior surface of said driving actuator comprises a side port for providing fluid communication with, or passage of a catheter within, said penetrating member.

13. A medical device for penetrating living being tissue, said device comprising:

a penetrating member which is vibrated to reduce force needed to penetrate living being tissue,

a driving actuator coupled to said penetrating member and causing said vibration when energized, wherein said driving actuator has at least one piezoelectric element wherein a piezoelectric element channel extends through said at least one piezoelectric element such that said at least one piezoelectric element is disposed circumferentially completely around a length of said piezoelectric element channel;

an electrical power cut off automatically de-energizing said medical device when said penetrating member has passed through said living being tissue; and

a fluid-containing syringe coupled to said driving actuator, said fluid-containing syringe comprising a moveable biasing element disposed therein, wherein said biasing element is in fluid communication with a channel within said penetrating member, said biasing element providing an indicator when said penetrating member has passed through said living being tissue.

14. The medical device of claim 13, further comprising

a needle attachment fitting coupled to said penetrating member and to the driving actuator,

wherein said biasing element comprises a moveable plunger disposed in said fluid-containing syringe, and

wherein said fluid-containing syringe is coupled to a port of said attachment fitting.

15. The medical device of claim 14 wherein said plunger is used to aspirate matter from said living being via said medical device.

16. The medical device of claim 13, wherein said biasing element provides one of a visual, audible, or tactile indication that said penetrating member has passed through the living being tissue.

17. The medical device of claim 13 wherein said biasing element activates said electrical power cut off.

18. The medical device of claim 13, wherein the driving actuator comprises a port in fluid communication with said channel of said penetrating member, and the fluid-containing syringe is coupled to said actuator via said port.

19. A medical device for penetrating living being tissue, said device comprising:

a penetrating member which is vibrated to reduce force needed to penetrate living being tissue,

a driving actuator coupled to said penetrating member and causing said vibration when energized, wherein said driving actuator has at least one piezoelectric element wherein a channel extends completely through said at least one piezoelectric element such that said at least one piezoelectric element is disposed circumferentially completely around a length of said channel;

an electrical power cut off automatically de-energizing said medical device when said penetrating member has passed through said living being tissue; and

a loss of resistance pump system interfaced with said driving actuator, said loss of resistance pump comprising a visual indicator that automatically indicates entry of said penetrating member within a desired bodily area.

20. The medical device of claim 19 wherein said visual indicator comprises an LED.