Monitor for interventional procedures

• US 6,264,611 B1
• Filed: 11/24/1999
• Issued: 07/24/2001
• Est. Priority Date: 11/25/1998
• Status: Expired due to Fees

• Current Assignee: Ball Semiconductor, Inc.
• Original Assignee: Ball Semiconductor, Inc.
• Inventors: Ishikawa, Akira, Ahn, Samuel S., Ahn, Suzanne I., Takeda, Nabuo, Hays, Steven R., Gaffney, F. Andrew
• Primary Examiner(s): Lacyk, John P.
• Assistant Examiner(s): Natnithithadha, Navin
• Application Number:
  US09/448,644
• Time in Patent Office: 608 Days
• Field of Search: 600/486, 600/488, 600/485, 600/483, 600/481, 600/585
• US Class Current: 600/486
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/02055 Simultaneously evaluating both cardiovascular condition and temperature
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61B 5/03 Detecting, measuring or recording fluid pressure within the body other than blood pressure, e.g. cerebral pressure; Measuring pressure in body tissues or organs A61B5/205 takes precedence
• CPC Class Codes: A61B 5/083 Measuring rate of metabolism by using breath test, e.g. measuring rate of oxygen consumption
• CPC Class Codes: A61B 5/145 Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissuemeasuring of blood pressure or blood flow A61B5/02; non-radiation detecting or locating of foreign bodies in blood A61B5/06
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/6848 Needles
• CPC Class Codes: A61B 5/6851 Guide wires

Abstract

A ball-shaped semiconductor monitoring device (150) having one or more transducer functions for use with an instrument that is insertable into a human body. In one disclosed embodiment, a needle (130) and modified stylet (140) are inserted into intraluminal body cavities for measuring fluid pressure. The modified stylet (140) has the monitoring device (150) attached to one end. The stylet (140) has a metal annulus (142) extending throughout its length and a communication wire (144) disposed therein. The wire (144) is surrounded by an insulator (146) to electrically isolate it from the stylet (140). A recessed cavity (148) is provided at the distal end of the stylet (140) to accommodate the ball monitoring device (150). A transducer (152) is integrated on the ball device (150) to measure such quantitative conditions as pressure. The ball (150) has a ground terminal (154) and a data terminal (156). The ground terminal (154) is electrically connected to the metal annulus (142) of the stylet (140) by a solder joint (158). The data terminal (156) is connected to the communication wire (144) by a contact (160). The instrument that carries the semiconductor device to a particular site within the body may be a catheter, guidewire, stylet, needle or any other insertable instrument. The transducer can be fabricated to sense pressure, fluid flow rate, temperature and other physiological parameters and physical conditions.

Claims

1. A monitoring system, comprising:

an instrument for insertion into a body, the instrument having a distal end for accessing a site within the body and a proximal end that remains outside of the body;

one or more miniature semiconductor devices affixed at a point on the distal end of the instrument, the device including a transducer for converting information from one medium to another;

an external monitoring station in communication with the semiconductor device; and

a communication device for effecting the transfer of information between the semiconductor device and the monitoring station;

wherein the transducer is capable of reporting information to a central processing unit in the monitoring station via radio frequency transmitted signals;

wherein the instrument is selected from the group consisting of a guidewire, a needle, and a catheter;

wherein the transducer is placed on the distal end of the instrument to deliver energy within the body;

and wherein the transducer is powered by radio frequency transmitted signals.

2. The monitoring system of claim 1, wherein the semiconductor device includes a spherical substrate on which the transducer resides together with integrated circuitry for processing signals in communication with the monitoring station.

3. The monitoring system of claim 1, wherein the transducer is capable of measuring pressure from within the body and communicating corresponding signals outside the body.

4. The monitoring system of claim 1, wherein the transducer is formed on a spherical surface portion of a substrate.

5. The monitoring system of claim 1, wherein the transducer is attached to and incorporated into a guidewire.

6. The monitoring system of claim 1, wherein the transducer is attached to and incorporated into an open hollow catheter.

7. The monitoring system of claim 1, wherein the transducer is attached to a needle, needle chamber, or intravenous tubing.

8. The monitoring system of claim 1, wherein the transducer is used on a guidewire in the vascular system.

9. The monitoring system of claim 1, wherein the transducer is used on a catheter in the urinary tract.

10. The monitoring system of claim 1, wherein the transducer is introduced into the biliary tract.

11. The monitoring system of claim 1, wherein the transducer is introduced into the gastrointestinal tract.

12. The monitoring system of claim 1, wherein the transducer is introduced into the uterus and cervix.

13. The monitoring system of claim 1, wherein the transducer is introduced into the tracheobronchial airways.

14. The monitoring system of claim 1, wherein the transducer is introduced into a body cavity or space in the abdomen, chest, cranium, or neck.

15. The monitoring system of claim 1, wherein the transducer measures results of various therapeutic maneuvers selected from the group consisting of angioplasty, stent placement, atherectomy, and balloon dilatation.

16. The monitoring system of claim 1, wherein the transducer measures various parameters in the cardiopulmonary circulations.

17. The monitoring system of claim 1, wherein the transducer delivers light energy, such as laser or infrared light.

18. The monitoring system of claim 1, wherein the transducer delivers sound energy, such as ultrasound.

19. The monitoring system of claim 1, wherein the transducer delivers electrical energy.

20. The monitoring system of claim 1, wherein a plurality of the semiconductors devices are interconnected to provide a plurality of functions in support of converting the information from one medium to another.

21. A method of monitoring bodily processes of a body, comprising the steps of:

providing an instrument for insertion into the body, the instrument having a distal end for accessing a site within the body and a proximal end that remains outside of the body;

providing one or more miniature semiconductor devices affixed at a point on the distal end of the instrument, the device including a transducer for converting information from one medium to another;

communicating with the semiconductor device using an external monitoring station; and

transmitting information from the semiconductor device to the monitor station in response to the step of communicating;

wherein the transducer is capable of reporting information to a central processing unit in the monitoring station via radio frequency transmitted signals;

wherein the instrument is selected from the group consisting of a guidewire, a needle, and a catheter;

wherein the transducer is placed on the distal end of the instrument to deliver energy within the body;

and wherein the transducer is powered by radio frequency transmitted signals.

22. The method of claim 21, wherein the semiconductor device includes a spherical substrate on which the transducer resides together with an integrated circuitry for processing signals in communication with the monitoring station.

23. The method of claim 21, wherein the transducer is capable of measuring pressure from within the body and communicating corresponding signals outside of the body.

24. The method of claim 21, wherein the transducer is formed on a spherical surface portion of a substrate.

25. The method of claim 21, wherein the transducer is attached to and incorporated into a guidewire.

26. The method of claim 21, wherein the transducer is attached to and incorporated into an open hollow catheter.

27. The method of claim 21, wherein the transducer is attached to a needle, needle chamber, or intravenous tubing.

28. The method of claim 21, wherein the transducer is used on a guidewire in the vascular system.

29. The method of claim 21, wherein the transducer is used on a catheter in the urinary tract.

30. The method of claim 21, wherein the transducer is introduced into the biliary tract.

31. The method of claim 21, wherein the transducer is introduced into the gastrointestinal tract.

32. The method of claim 21, wherein the transducer is introduced into the uterus and cervix.

33. The method of claim 21, wherein the transducer is introduced into the tracheobronchial airways.

34. The method of claim 21, wherein the transducer is introduced into a body cavity or space in the abdomen, chest, cranium, or neck.

35. The method of claim 21, wherein the transducer measures results of various therapeutic maneuvers selected from the group consisting of angioplasty, stent placement, atherectomy, and balloon dilatation.

36. The method of claim 21, wherein the transducer measures various parameters in the cardiopulmonary circulations.

37. The method of claim 21, wherein the transducer delivers light energy, such as laser or infrared light.

38. The method of claim 21, wherein the transducer delivers sound energy, such as ultrasound.

39. The method of claim 21, wherein the transducer delivers electrical energy.

40. The method of claim 21, wherein a plurality of the semiconductor devices are interconnected to provide a plurality of functions in support of converting the information from one medium to another.