Device and method for precise subcutaneous placement of a medical instrument

• US 4,804,054 A
• Filed: 06/01/1987
• Issued: 02/14/1989
• Est. Priority Date: 06/01/1987
• Status: Expired due to Fees

• Current Assignee: Intelligent Medicine, Inc. (Peninsula Holdings Group Ltd.)
• Original Assignee: Intelligent Medicine, Inc. (Peninsula Holdings Group Ltd.)
• Inventors: Carroll, Gary T., Howson, David C., Pauley, J. Donald
• Primary Examiner(s): Jaworski, Francis J.
• Assistant Examiner(s): MANUEL, GEORGE C
• Application Number:
  US07/055,986
• Time in Patent Office: 624 Days
• Field of Search: 128/303.18, 128/303.19, 128/1.3, 128/1.4, 128/1.5, 128/639, 128/1 R, 128/DIG. 12, 604/158, 604/160, 604/174, 604/891, 604/152, 604/67, 604/48
• US Class Current: 128/898
• 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: A61M 2039/0232 having means for facilitating the insertion into the body
• CPC Class Codes: A61M 2039/0238 having means for locating the implanted device to insure proper injection, e.g. radio-emitter, protuberances, radio-opaque markers
• CPC Class Codes: A61M 2039/0244 having means for detecting an inserted needle
• CPC Class Codes: A61M 2205/3523 using telemetric means
• CPC Class Codes: A61M 39/0208 Subcutaneous access sites for injecting or removing fluids transcutaneous access sites A61M39/0247; implantable infusion devices A61M5/14276
• CPC Class Codes: A61M 5/427 Locating point where body is to be pierced, e.g. vein location means using ultrasonic waves, injection site templates

Abstract

A device and method for precise placement of a medical instrument for fluid delivery at, or withdrawal of fluid from, a predetermined location in a body is disclosed. A sensor, such as a proximity detector or electrically conductible circuitry, is implanted into the body adjacent to a predetermined location, which location preferably has an implanted reservoir thereat, for sensing the position of a medical instrument having an open end portion inserted into the reservoir to enable delivery of medicament into the reservoir or, in the alternative, to remove fluid from the reservoir. A signal indicative at least of a sensed desired positioning of the instrument is generated and used to assure that the instrument has been properly positioned, with additional circuitry also being provided to enable location of the implanted reservoir for positioning of the instrument prior to insertion into the body.

Claims

1. A system for monitoring medical instrument placement with respect to a reservoir in a body to ensure accurate positioning of an opening in an inserted end portion of said instrument at a preselected location with respect to reservoir, said system comprising:

electrical means positioned outside said body for providing an electrical power output;

signal generating means positioned outside said body connected with said electrical means for receiving said electrical power output to thereby supply output signals;

sensing means separate from connection with said instrument and adapted to receive said output signals from said signal generating means, said output signals being modified in accordance with the position of said instrument with respect to said reservoir, to thus utilize said signals to provide an electrical output indicative of at least a predetermined desired positioning of said inserted end portion of said instrument at said preselected location within said body;

signaling means connected with said sensing means to receive said electrical output therefrom and responsive thereto provide an electrically induced output signal; and

indicating means receiving said output signal from said signaling means and utilizing said output signal to provide an indication at least that said desired positioning of said inserted end portion of said instrument at said preselected location is then established.

2. The system of claim 1 wherein said inserted end portion of said instrument includes a metallic material, and wherein said sensing means includes an electrically inductive coil said output indicative of a predetermined desired position of said inserted end portion of said instrument being provided upon insertion of said end portion to attain a predetermined position with respect to said coil.

3. The system of claim 2 wherein said sensing means includes an oscillator and said coil is included in said oscillator, and wherein said signaling means includes signal modulation means for varying said output signal in response to said output from said sensing means.

4. The system of claim 1 wherein said indicating means includes microprocessor means for processing said electrically induced output signal from said signaling means.

5. The system of claim 1 wherein said instrument effects fluid delivery therethrough, wherein said body has reservoir means placed therein at said preselected location for one of receipt of said fluid through said opening in said inserted end portion of said instrument and maintaining said fluid therein for withdrawal of said fluid through said opening in said inserted end portion of said instrument, and wherein said reservoir means includes fluid passageway means for passage of said fluid between said reservoir means and said body.

6. The system of claim 1 wherein said inserted end portion of said instrument is made of electrically conductive material and wherein said sensing means includes first and second electrically conductive means, said sensing means providing said output indicative of said predetermined desired position of said inserted end portion of said instrument when said inserted end portion is in electrical contact with both said first and second conductive means.

7. The system of claim 1 wherein said sensing means provides outputs indicative of proximity of said inserted end portion of said instrument to said preselected location within said body.

8. A system for locating matter at a predetermined position within a body, which position is accessible through a medical instrumentality insertable into said body, said system comprising:

reservoir means positioned at said predetermined position within said body for receiving and maintaining said matter thereat;

first electronic means contiguous to said reservoir, said first electronic means including sensing means separate from connection with said medical instrumentality for sensing the position of said instrumentality relative to said reservoir means and signaling means connected with said sensing means for providing an electrical signal indicative at least of positioning of said instrumentality within said reservoir means;

second electronic means positioned outside said body, said second electronic means including signal processing means for sensing said electrical signal provided by said signaling means and indicating means for indicating to a user of said instrumentality said positioning of said instrumentality within said reservoir means responsive to said electrical signal sensed by said signal processing means; and

electrical signal generating means positioned outside said body for activating said first and second electronic means of said system.

9. The system of claim 8 wherein said signaling means includes means for providing a signal indicative of the proximity of said instrumentality to said reservoir means and wherein said indicating means of said second electronic means includes means for indicating to a user of said instrumentality said proximity of said instrumentality to said reservoir means.

10. The device of claim 8 wherein said sensing means is a proximity detector for sensing the positioning of said instrumentality relative to said reservoir means.

11. The device of claim 8 wherein said reservoir means includes a first section for receiving said instrumentality therethrough while remaining substantially impervious to passage of matter from said body therethrough, and a second section for storing said matter received through said instrumentality, said second section being adapted for metered delivery of said matter from said second section to said body.

12. A device for locating and establishing placement relative to a desired location in a body of a medical instrumentality insertable into said body for effecting fluid delivery to said desired location, said device comprising:

first means implanted within said body and contiguous to said desired location, said first means including first electronic sensing means for sensing inductance changes caused by positioning of said instrumentality inserted into said body relative to said desired location and signaling means for providing an electrically induced signal indicative of said inductance changes; and

second means movably positionable outside said body, said second means including second electronic sensing means for sensing the position of said first means relative to a location on said body suitable for insertion of said instrumentality and providing an electrical signal indicative thereof, signal receiving and processing means for receiving and processing said signals from said second electronic sensing means and said signaling means, and indicating means connected with said signal receiving and processing means for indicating to a user of said instrumentality when said instrumentality is suitably positioned for insertion and when said instrumentality is positioned at said desired location.

13. The device of claim 12 wherein said first and second means include cooperative electrical energizing means for energization of said first electronic sensing means, said signaling means, said second electronic sensing means, said signal receiving and processing means and said indicating means.

14. The device of claim 13 wherein said second electronic sensing means includes monitoring means for monitoring said cooperative energizing means, and wherein said location on said body suitable for insertion of said intrumentality is indicated by said indicating means when maximum energization of said first sensing means and said signaling means is sensed by said second sensing means.

15. The devide of claim 13 wherein said electrical signal indicative of said inductance changes is one of a radio signal and a signal indicative of a relative change of said energization corresponding to said positioning of said instrumentality with maximum relative change of said energization corresponding to placement of said instrumentality at said desired location.

16. The device of claim 15 wherein said first electronic sensing means includes induction means and oscillator means, and wherein said inductance changes are caused by positioning of said instrumentality relative to said induction means.

17. The device of claim 12 wherein said second means further includes microprocessor means connected to said receiving and processing means, and said indicating means.

18. A circulatory system accessing device for enabling repeated, precise placement of fluid in a body at a predetermined location through a metallic object capable of fluid delivery therethrough, said device comprising:

an implantable portion positionable in said body at said predetermined location;

an external portion positionable on the surface of said body including transmitting means for transmitting an electrically induced input signal;

chamber means in said implantable portion having a first section for receiving said metallic object therethrough while remaining substantially impervious to passage of matter from said body therethrough, a second section for storing said fluid delivered through said metallic object, and a passageway for delivery of said fluid from said second section to said circulatory system;

sensing means in said implantable portion adjacent said first section of said chamber means for sensing the position of said metallic object relative to said first section of said chamber means and establishment of said metallic object through said first section of said chamber means;

signaling means connected with said sensing means in said implantable portion for providing a signal indicative of said sensed relative position and said establishment of said metallic object through said first section of said chamber means;

input signal receiving means connected with said sensing means and said signaling means in said implantable portion for receiving said electrically induced input signal from said transmitting means of said external portion thereby activating and making operational said sensing means and said signal generating means of said implantable portion;

sensing means in said external portion for locating said implantable portion relative to a position on the surface of said body suitable for insertion of said metallic object and producing a signal indicative thereof;

signal receiving means in said external portion for receiving said signal indicative of said sensed relative position and achievement of placement of said metallic object from said signaling means of said implantable portion;

processing means connected with said sensing means and signal receiving means of said external portion and including indicator means for indicating to a user of said metallic object said position suitable for insertion, said sensed relative position of said metallic object to said first section of said chamber means and establishment of said metallic object through said first section of said chamber means; and

battery means connected with said transmitting means, said sensing means, said signal receiving means and said processing means of said external portion.

19. The device of claim 18 wherein said transmitting means of said external portion includes driver means with coil means connected thereto for generating a magnetic field.

20. The device of claim 19 wherein said input signal receiving means of said implantable portion includes coil means, rectifier means and capacitor means for receiving said operational input signal and producing a voltage for said sensing means, and regulator means to cause said voltage to remain constant.

21. The device of claim 20 wherein said sensing means of said implantable portion includes oscillator means connected to said regulator means and coil means connected to said oscillator means and adjacent said first section of said chamber means and configured for receipt of said metallic object therethrough whereby the frequency of said oscillator means is modulated by the relative position of said metallic object to said coil means.

22. The device of claim 21 wherein said signaling means of said implantable portion includes modulation means connected to said oscillator means and said power input signal receiving means whereby said frequency of said oscillator means modulates said signal received by said coil means of said power input signal receiving means.

23. The device of claim 22 wherein said signal receiving means of said external portion includes detection means for detecting said modulated loading of said coil means of said power input signal receiving means and producing a signal indicative thereof, amplifier means connected to said detection means for amplifying said signal indicative thereof, and comparator means connected with said amplifier means and said transmitting means of said external portion for providing an output to said processing means indicative of said modulated frequency from said sensing means of said implantable portion.

24. The device of claim 23 wherein said sensing means of said external portion includes current monitoring means connected to said battery means, said transmitting means and said signal receiving means of said external portion whereby the overall current of said external portion is monitored and an output indicative of said overall current is provided to said processing means.

25. The device of claim 18 wherein said indicator means of said processing means provides at least one of a visual indication of said sensed relative position of said metallic object to said first section of said chamber means and positioning of said metallic object through said first section of said chamber means and an audible indication of disestablishment of said metallic object through said first section of said chamber means subsequent to said establishment thereof.

26. The device of claim 18 where said first section of said chamber means is a septum and wherein said third section of said chamber means is a catheter.

27. A method of monitoring placement of a medical instrument within a body to insure accurate positioning of an opening in the inserted end portion of said instrument relative to a predetermined desired location in said body comprising:

utilizing an electrical power output to generate a first signal from a first position outside said body;

inserting said end portion of said instrument into said body at a position on the surface of said body adjacent said predetermined desired location in said body;

moving said inserted end portion of said instrument toward said predetermined desired location;

receiving said first signal at a second position separate from connection with said instrument and utilizing said first signal to sense when said inserted end portion arrives at said predetermined desired location;

providing an electrical output indicative at least of positioning of said opening in said inserted end portion of said instrument at said predetermined desired location;

utilizing said electrical output indicative at least of positioning to provide an electrically induced output signal; and

utilizing said electrically induced output signal to indicate to a user establishment of said desired placement of said opening in said inserted end portion of said instrument at said predetermined desired location.

28. The method of claim 27 including the step of sensing the relative proximity of said inserted end portion of said instrument to said predetermined desired location while said inserted end portion is being moved toward said predetermined desired location and indicating said relative proximity to said user.

29. A method for directing insertion of a metallic object having an open end portion into a body for achievment of desired placement of a fluid therethrough at a predetermined location in said body comprising:

positioning a reservoir at said predetermined location in said body;

providing an electrical power output outside of said body;

utilizing said electrical power output to generate a first signal from a position outside said body;

utilizing said first signal to sense the location of said reservoir relative to a position on the surface of said body suitable for insertion of said metallic object and indicating said position suitable for insertion to a user of said metallic object;

inserting said open end portion of said metallic object into said body at said suitable position;

moving said open end portion of said metallic object toward said reservoir;

receiving said first signal at a position inside said body and utilizing said first signal to sense movement of said open end portion of said metallic object into said reservoir;

providing an electrical output indicative at least of movement of said open end portion of said metallic object into said reservoir;

utilizing said electrical output indicative at least of movement to provide an electrically induced output signal;

utilizing said electrically induced output signal to indicate to a user establishment of the desired placement of said open end portion of said metallic object within said reservoir; and

effecting fluid delivery through said metallic object to said reservoir while said desired placement of said open end of said metallic object within said reservoir is maintained.

30. The method of claim 29 including the step of sensing the proximity of said inserted open end portion to said reservoir while said inserted open end portion is being moved toward said reservoir and indicating said proximity to said user.