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

• US 20110060229A1
• Filed: 08/19/2010
• Published: 03/10/2011
• Est. Priority Date: 08/19/2009
• Status: Active Grant

• Current Assignee: Medline Industries Incorporated (Medline Holdings Incorporated)
• Original Assignee: Mirador Biomedical Inc.
• Inventors: Swartz, Douglas, Hulvershorn, Justin, Schmidt, Karl
• Granted Patent: US 8,926,525 B2
• Time in Patent Office: Days
• US Class Current: 600/486
• 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

1-67. -67. (canceled)

68. A device for detecting whether a distal portion of a probe inserted into a body is located within a target anatomical environment, the device comprising:

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

a pressure sensing unit carried by the housing, the sensing unit configured to generate a pressure signal in response to a pressure of an environment in which a coupled probe is positioned;

a processing unit coupled to the sensing unit and carried by the housing, the processing unit configured to receive the pressure signal and determine based on the signal a pressure value of the environment about the distal portion of the coupled probe; and

an output unit coupled to the processing unit and carried by the housing, the output unit configured to output to a visual display a reporting signal based on the determined pressure value,

wherein the pressure sensing unit, processing unit, and output unit are disposed substantially between the first port and the second port of the housing.

69. The device of claim 68, the housing comprising 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.

70. The device of claim 68, wherein the visual display is angled proximally as coupled with the housing.

71. The device of claim 68 where the probe is a needle or a catheter.

72. The device of claim 68 where the device is disposable.

73. The device of claim 68 wherein the visual display contains both a digital and an analog representation of detected pressure.

74. The device of claim 68 wherein both the visual display and at least a portion of the probe are visible during use of the device.

75. The device of claim 68, further comprising a guidewire port carried by the housing and fluidly coupled to the first port.

76. The device of claim 68, further comprising a probe coupled to the first port and a syringe coupled to the second port so as to provide an assembly comprising the probe, the device, and the syringe coupled together and arranged axially and in sequence.

77. The device of claim 68, wherein the device is sized for hand-held use by a medical provider.

78. The device of claim 68, further comprising a pressure relief or buffer system structured to accommodate fluctuations of pressure in the device from factors other than fluctuations of pressure in an anatomical environment of the patient.

79. The device of claim 78, wherein the pressure relief or buffer system comprises a reservoir disposed between a pressure tube and a fluid channel of the device.

89. A method, comprising providing a device as in claim 68, inserting a distal portion of a probe coupled to the first port of the device into the body of a patient, and detecting a pressure of an environment in which the probe is positioned.

90. The method of claim 89, further comprising manipulating or maintaining the position of the device or distal portion of the coupled probe in response to the detected pressure.

91. The method of claim 90, further comprising introducing a guidewire, catheter, or chemical agent in response to the detected pressure.

92. The method of claim 90, further comprising aspirating a fluid from the environment in which the probe is positioned in response to the detected pressure.

93. The method of claim 89, wherein the patient'"'"'s body environment in which the probe is positioned comprises a blood vessel;

a subarachnoid space;

an epidural space;

a pleural space;

a body compartment suspected of compromised blood flow;

tissue proximate to a nerve targeted for injection of an anesthetic drug;

an ankle artery;

a vascular graft;

or an arteriovenous fistula.

94. A kit, comprising a device as in claim 68, and one or more probes for coupling to the first port, one or more syringes, a guidewire, or a catheter, or a combination thereof.

80. A device for detecting whether a distal portion of a probe inserted into a body is located within a target anatomical environment, the device comprising:

a housing having a proximal portion and a distal portion with a first port that is detachably couplable to the probe;

a pressure sensing unit carried by the housing, the sensing unit configured to generate a pressure signal in response to a pressure of an environment in which a coupled probe is positioned;

a processing unit coupled to the sensing unit and carried by the housing, the processing unit configured to receive the pressure signal and determine based on the signal a pressure value of the environment about the proximate portion of the coupled probe; and

an output unit coupled to the processing unit and carried by the housing, the output unit configured to output to a visual display a reporting signal based on the determined pressure value,

a guidewire port carried by the housing and fluidly coupled to the first port.

81. The device of claim 80, the proximal portion of the housing comprising a second port that is detachably couplable to a syringe, and the first port fluidly coupled to the second port about a channel.

82. The device of claim 81, wherein the channel is at least partially translucent exteriorly to the device so as to allow visualization of fluid within the channel.

83. The device of claim 81, wherein the guidewire port is fluidly coupled to the channel.

84. The device of claim 81, wherein the pressure sensing unit is in operable communication with the channel.

85. The device of claim 80, wherein the visual display is angled proximally as carried by the housing.

86. An assembly comprising a device as in claim 81, a probe coupled to the first port, and a syringe coupled to the second port.

87. The assembly of claim 86, further comprising a guidewire advanced through the guidewire port, with a distal portion of the guidewire extending out a distal end of the probe.

88. A device for detecting whether a distal portion of a probe inserted into a body is located within a target anatomical environment, the device comprising:

a housing having a distal portion with a first port that is detachably couplable to the probe, and a closed proximal portion;

a pressure sensing unit carried by the housing, the sensing unit configured to generate a pressure signal in response to a pressure of an environment in which a coupled probe is positioned;

a processing unit coupled to the sensing unit and carried by the housing, the processing unit configured to receive the pressure signal and determine based on the signal a pressure value of the environment about the proximate portion of the coupled probe; and

an output unit coupled to the processing unit and carried by the housing, the output unit configured to output to a visual display a reporting signal based on the determined pressure value, wherein the visual display is angled proximally as carried by the housing,

wherein the pressure sensing unit, processing unit, and output unit are disposed substantially between the first port and the proximal portion of the housing.