Systems, methods, and devices for facilitating access to target anatomical sites or environments

• US 9,888,881 B2
• Filed: 10/24/2014
• Issued: 02/13/2018
• Est. Priority Date: 08/19/2009
• Status: Active Grant

• Current Assignee: Medline Industries Incorporated (Medline Holdings Incorporated)
• Original Assignee: Mirador Biomedical Inc.
• Inventors: Hulvershorn, Justin, Schmidt, Karl, Swartz, Douglas
• Primary Examiner(s): Stout, Michael C
• Application Number:
  US14/523,046
• Publication Number:
  US 20160113576A1
• Time in Patent Office: 1,208 Days
• 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 2090/064 for measuring force, pressure or mechanical tension
• CPC Class Codes: A61B 5/0006 ECG or EEG signals
• CPC Class Codes: A61B 5/0205 Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61B 5/032 Spinal fluid pressure
• CPC Class Codes: A61B 5/036 by means introduced into body tracts A61B5/032 and A61B5/035 take precedence
• CPC Class Codes: A61B 5/14542 for measuring blood gases A61B5/14551 takes precedence
• CPC Class Codes: A61B 5/25 Bioelectric electrodes therefor
• CPC Class Codes: A61B 5/339 Displays specially adapted therefor
• CPC Class Codes: A61B 5/4821 Determining level or depth of anaesthesia A61B5/1106 takes precedence
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61B 5/4887 Locating particular structures in or on the body
• CPC Class Codes: A61B 5/489 Blood vessels
• CPC Class Codes: A61B 5/4896 Epidural space
• CPC Class Codes: A61B 5/742 using visual displays A61B5/339 takes precedence
• CPC Class Codes: A61B 8/0833 involving detecting or locating foreign bodies or organic structures
• CPC Class Codes: A61B 8/4472 Wireless probes
• CPC Class Codes: A61M 25/06 Body-piercing guide needles or the like
• CPC Class Codes: A61M 25/0693 Flashback chambers
• CPC Class Codes: A61M 5/16854 : by monitoring line pressure
• CPC Class Codes: A61M 5/42 : having means for desensitising skin, for protruding skin to facilitate piercing, or for locating point where body is to be pierced
• 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
• CPC Class Codes: A61M 5/46 : having means for controlling depth of insertion
• CPC Class Codes: A61M 5/484 : Regulating injection pressure
• CPC Class Codes: A61M 5/486 : Indicating injection pressure

Abstract

Methods and structures for detecting a physiologic parameter of a target anatomical environment. The device including a housing with a distal portion first port couplable to a probe and a proximal portion; and a sensing unit, a processing unit, and an output unit carried by the housing, the output unit configured to output a reporting signal based on the determined physiologic parameter value such as pressure; the sensing unit, processing unit, and output unit being disposed substantially between the first port and the proximal portion of the housing.

Claims

1. A medical device, comprising:

a housing having a distal portion with a first port that is detachably couplable to a probe, and a proximal portion with a second port that is detachably couplable to a syringe, the first port fluidly coupled to the second port, the housing graspable by a user to manipulate the housing and the probe;

a pressure sensor carried by the housing, the sensor configured to generate a pressure signal in response to a pressure of a tissue environment in which a distal portion of the probe is positioned, the pressure signal comprising a series of instantaneous pressure values;

a processing unit coupled to the sensor, the processing unit configured to receive and process the series of instantaneous pressure values so as to determine a pressure value using a moving average of the series over a time period, the pressure value indicative of the tissue environment about the distal portion of the probe; and

an output unit coupled to the processing unit and carried by the housing, the output unit configured to wirelessly output the series of instantaneous pressure values.

2. The medical device of claim 1, wherein the pressure sensing unit, the processing unit, and the output unit are disposed substantially between the first port and the second port of the housing and wherein the housing, the distal portion of the probe are manipulatable together in order to place the probe in response to the mean pressure using the moving average of the series.

3. The medical device of claim 2, wherein the housing comprises a visual display and the output unit also outputs the reporting signal to a second, remote visual display for display of medical data.

4. The medical device of claim 1, wherein the processing unit is carried by the housing, and wherein the output unit further outputs a calculated value from the processing unit.

5. The medical device of claim 1, wherein the output unit is triggered by bodily fluid in the housing.

6. The medical device of claim 1, wherein the probe is a central venous catheter.

7. The medical device of claim 1, wherein the processing unit is configured to detect whether the probe is inserted into a patient body within a target anatomical environment.

8. The medical device of claim 1, wherein the processing unit is configured to determine at least one of oxygen saturation, electrocardiography values, blood pressure values or combinations thereof.

9. The medical device of claim 1, wherein the housing includes a guidewire port configured to receive a guidewire that can be advanced from the guidewire port extend out a distal end of the probe.

10. The medical device of claim 1, wherein the output unit is pre-registered with a receiver unit configured to wirelessly receive the reporting signal.

11. The medical device of claim 10, wherein the receiver unit is at least one of a dongle, a monitor, a display, a portable electronic assistant, a storage device or combinations thereof.

12. A medical device, comprising:

a housing having a distal portion with a first port that is detachably couplable to a probe, a proximal portion with a second port, and a chamber to transfer fluid in response to action of a plunger, the first port fluidly coupled to the second port, the housing graspable by a user to manipulate the housing and the probe;

a pressure sensor carried by the housing, the sensor configured to generate a pressure signal in response to a tissue pressure of a tissue environment in which a distal portion of the probe is positioned, the tissue pressure signal comprising a series of instantaneous tissue pressure values;

a processing unit coupled to the sensor, the processing unit configured to receive and process the series of instantaneous tissue pressure values so as to determine a tissue pressure value using a moving average of the series over a time period, the tissue pressure value indicative of the tissue environment about the distal portion of the probe; and

an output unit coupled to the processing unit and carried by the housing, the output unit configured to output a reporting signal.

13. The device of claim 12, wherein the output unit is configured to wirelessly output the reporting signal.

14. The device of claim 13, wherein the housing comprises a visual display and the output unit outputs the reporting signal to a second visual display, positioned remote from the housing, for display of medical data.

15. The device of claim 13, wherein the processing unit is carried by the housing.

16. The device of claim 13, wherein the pressure sensor is within the housing.

17. The device of claim 13, wherein the pressure sensor is configured to sense pressure in the chamber of the housing.

18. The device of claim 12, wherein the output unit is configured to output the reporting signal over a wired connection to a remote device.

19. The device of claim 18, wherein the remote device includes an ultrasound unit.

20. The device of claim 18, wherein the output unit is configured to output a sequence of physiologic values, physiologic parameter values or both to the remote device.

21. The device of claim 12, wherein the distal portion of the probe is configured to penetrate into a body of a patient.

22. The device of claim 12, wherein the housing comprises an intermediate portion disposed substantially between the distal housing portion and the proximal housing portion, the intermediate portion carrying the pressure sensing unit, processing unit, and output unit.

23. The device of claim 12, wherein the visual display is angled proximally as coupled with the housing.

24. The device of claim 12, wherein the probe is a needle or a catheter.

25. The device of claim 12, where the housing is disposable.

26. The device of claim 12, wherein the output unit is pre-registered with a receiver unit configured to wirelessly receive the reporting signal.

27. The medical device of claim 26, wherein the receiver unit is at least one of a dongle, a monitor, a display, a portable electronic assistant, a storage device or combinations thereof.

28. A medical device, comprising:

a housing having a distal portion with a fluid port that is detachably couplable to a probe, and a chamber to receive bodily fluid from the fluid port, the housing graspable by a user to manipulate the housing and the probe;

a processing unit coupled to a fluid pressure sensor associated with the chamber to generate pressure signals, the processing unit configured to receive and process electrical signals from an external sensor, wherein the external sensor is an electrocardiography (EKG) lead that electrically communicates with the processing unit, wherein the processing unit is configured to process an EKG signal from the EKG lead; and

an output unit coupled to the processing unit and carried by the housing, the output unit configured to output a reporting signal.

29. The medical device of claim 28, wherein the processing unit is configured to process an electrical signal from the EKG lead and provide a processed signal to the output unit.

30. The medical device of claim 29, wherein the output unit is adapted to wirelessly output the processed EKG signal to a remote device.

31. The medical device of claim 30, wherein the remote device is a dongle configured to wirelessly receive a signal from the output unit and configured to be received in a communication port of a remote processing device to electrically communicate with the remote processing device.

32. The medical device of claim 31, wherein the dongle is pre-registered with the output unit and packaged with the housing for medical use.

33. The medical device of claim 29, wherein the output unit is adapted to output the processed EKG signal on a display on the housing.

34. The medical device of claim 28, wherein the external sensor further includes an electroencephalography (EEG) lead that electrically communicates with the processing unit.

35. The medical device of claim 34, wherein the processing unit is configured to process an electrical signal from the EEG lead and provide a processed signal to the output unit.

36. The medical device of claim 35, wherein the output unit is adapted to wirelessly output the processed EEG signal to a remote device.

37. The medical device of claim 35, wherein the output unit is adapted to output the processed EEG signal on a display on the housing.

38. The medical device of claim 28, wherein the external sensor further includes a blood oxygen saturation sensor that electrically communicates with the processing unit.

39. The medical device of claim 38, wherein the processing unit is configured to process an electrical signal from the blood oxygen saturation sensor and provide a processed signal to the output unit.

40. The medical device of claim 39, wherein the output unit is adapted to wirelessly output the processed blood oxygen saturation signal to a remote device.

41. The medical device of claim 39, wherein the output unit is adapted to output the processed blood oxygen saturation signal on a display on the housing.

42. The medical device of claim 28, wherein the proximal end of the housing is sealed.

43. The medical device of claim 28, wherein the housing includes the fluid pressure sensor that is configured to generate a pressure signal in response to a pressure of a tissue environment in which a distal portion of the probe is positioned, the pressure signal comprising a series of instantaneous tissue pressure values;

wherein the processing unit is configured to process the series of instantaneous pressure values so as to determine a pressure value and to receive and process electrical signals from an external sensor, the pressure value indicative of the tissue environment about the distal portion of the probe; and

wherein the output unit is configured to send the reporting signal comprising the processed electrical signals.