U.S. patent application number 12/147413 was filed with the patent office on 2009-05-07 for apparatus and method for vascular access.
Invention is credited to Sorin Grunwald, Bradley Hill, Wilfred J. Samson, Fiona Maria Sander.
Application Number | 20090118612 12/147413 |
Document ID | / |
Family ID | 40588844 |
Filed Date | 2009-05-07 |
United States Patent
Application |
20090118612 |
Kind Code |
A1 |
Grunwald; Sorin ; et
al. |
May 7, 2009 |
Apparatus and Method for Vascular Access
Abstract
In an aspect, embodiments of the invention relate to the
effective and accurate placement of intravascular devices such as
central venous catheters, in particular such as peripherally
inserted central catheters or PICC. One aspect of the present
invention relates to vascular access. It describes devices and
methods for imaging guided vascular access and more effective
sterile packaging and handling of such devices. A second aspect of
the present invention relates to the guidance, positioning and
placement confirmation of intravascular devices without the help of
X-ray imaging. A third aspect of the present invention relates to
devices and methods for the skin securement of intravascular
devices and post-placement verification of location of such
devices. A forth aspect of the present invention relates to
improvement of the workflow required for the placement of
intravascular devices.
Inventors: |
Grunwald; Sorin; (Palo Alto,
CA) ; Sander; Fiona Maria; (Los Altos Hills, CA)
; Samson; Wilfred J.; (Saratoga, CA) ; Hill;
Bradley; (Santa Clara, CA) |
Correspondence
Address: |
SHAY GLENN LLP
2755 CAMPUS DRIVE, SUITE 210
SAN MATEO
CA
94403
US
|
Family ID: |
40588844 |
Appl. No.: |
12/147413 |
Filed: |
June 26, 2008 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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11431140 |
May 8, 2006 |
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12147413 |
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11431118 |
May 8, 2006 |
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11431140 |
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11431093 |
May 8, 2006 |
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11431118 |
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11430511 |
May 8, 2006 |
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11431093 |
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60937280 |
Jun 26, 2007 |
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60678209 |
May 6, 2005 |
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60682002 |
May 18, 2005 |
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60678209 |
May 6, 2005 |
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60682002 |
May 18, 2005 |
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60678209 |
May 6, 2005 |
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60682002 |
May 18, 2005 |
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60678209 |
May 6, 2005 |
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60682002 |
May 18, 2005 |
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Current U.S.
Class: |
600/424 ;
600/453; 600/586; 705/2 |
Current CPC
Class: |
A61B 2090/3929 20160201;
A61B 5/06 20130101; A61B 34/20 20160201; A61B 5/1459 20130101; A61B
2090/3782 20160201; A61B 7/00 20130101; A61B 8/445 20130101; A61B
8/461 20130101; A61B 8/12 20130101; A61B 2017/00106 20130101; A61B
8/06 20130101; G16H 20/40 20180101; A61B 5/318 20210101; A61B
8/0841 20130101; A61B 5/411 20130101; A61B 90/11 20160201; A61B
2090/378 20160201; A61B 2017/003 20130101; A61B 8/42 20130101 |
Class at
Publication: |
600/424 ;
600/586; 705/2; 600/453 |
International
Class: |
A61B 8/00 20060101
A61B008/00; A61B 7/00 20060101 A61B007/00; G06Q 50/00 20060101
G06Q050/00 |
Claims
1. A transcutaneous ultrasound vascular access guiding system
comprising: an elongate body having a handle; a guide on the
elongate body configured to receive a vascular access device; a
single element ultrasound device on the elongate body configured to
provide A-Mode imaging, Doppler and correlation-based blood
velocity estimation; a processor to process and correlate
ultrasound information from the single element ultrasound device;
and a system for information output based on the output of the
processor.
2. The device of claim 1 further comprising: a lens positioned to
control the single element ultrasound beam shape.
3. The device of claim 1 further comprising a lens positioned on
the ultrasound device configured to provide a matching layer
between the ultrasound transducer and the skin.
4. The device of claim 1 constructed as a single-use device.
5. The device of claim 1 wherein the information output is a
scrolling chart.
6. The device of claim 1 wherein the Doppler information can be
bidirectional.
7. The device of claim 1 wherein the Doppler acquisition can be
pulsed wave or continuous wave.
8. The device of claim 1 wherein the guide attached to the imaging
device is configured to guide one of the endovascular device
selected from the group consisting of: a needle; a stylet; a
catheter; and an introducer.
9. The device of claim 8 further comprising: an adaptor to match
the outer diameter of the endovascular guided device to the inner
diameter of the guide.
10. The device of claim 8 wherein the endovascular device is
configured to slide or move with respect to the imaging device as
to provide single hand deployment capability of the endovascular
guided device.
11. A method of accessing a blood vessel comprising the steps of:
preparing sterile vascular access site on patient's skin; sliding a
vascular access device in the device guide, flush aligning with the
tip of the imaging element, and locking in position; positioning
the assembly on the patient's skin on the sterile site without the
use of ultrasound gel; orienting the assembly like a flashlight
until the desired vessel can be seen on the scrolling chart
display; advancing the endovascular element into the vasculature by
sliding the guide element over the imaging device; and monitoring
the advancement of the endovascular device towards the desired
target by using at least one element from a list including A-mode
imaging, Doppler flow information, and correlation-based blood flow
information.
12. An endovascular device comprising: an elongate body; an element
on or in the elongate body configured to generate, emit or produce
sound waves; and a device to control the generation, emission or
production of sound waves from the element.
13. The device of claim 12 wherein the element is placed on or in
the elongate body.
14. The device of claim 12 wherein the device to control operates
by pushing and pulling wires manually.
15. The device of claim 12 wherein the device to control is
actuated by motorized movement of moving connective parts.
16. The device of claim 12 wherein the device to control generation
of the element is actuated by delivering a gas through a lumen on
or in the elongate body.
17. The device of claim 12 wherein the sound generating elements
may be actuated by delivering fluid through a lumen of the
endovascular device.
18. The device of claim 12 wherein the sound generating elements
may be actuated through interaction with the blood or an anatomical
site.
19. The device of claim 12 wherein sound waves are generated by
rubbing notched or serrated components.
20. The device of claim 12 wherein sound waves may be generated by
hitting a stylet against a solid member in order to generate a
repetitive ping.
21. The device of claim 12 wherein sound waves may be generated by
a moving membrane.
22. The device of claim 12 wherein sound waves may be generated by
a moving membrane configured to amplify sound.
23. The device of claim 12 wherein a device lumen is configured to
amplify sound.
24. An auscultation system comprising: one or more sound sensitive
elements; a sound processor in communication with the one or more
sound sensitive elements; and an information output device in
communication with the sound processor.
25. The system of claim 24 wherein the sound processor is
configured such that a plurality of auscultation devices can be
synchronized to provide acoustic triangulation for accurate
detection of an endovascular sound source.
26. A guiding method for endovascular devices comprising the steps
of: positioning one or more sound sensitive elements on a patient's
chest; inserting a sound emitting endovascular device into the
patient's vasculature; emitting sounds from the endovascular
device; and detecting the sounds from the emitting step with the
sound sensitive elements.
27. The method of claim 26 wherein the emitting step is performed
continuously, intermittently or on demand.
28. The method of claim 26 wherein the sound intensity measured in
the detecting step is used to estimate the distance between the
sound emitting endovascular device and the one or more sound
sensitive elements.
29. The method of claim 26 further comprising: triangulating the
sounds from the detecting step to locate the sound emitting
endovascular device with respect to the one or more sound sensitive
elements.
30. A method to locate an endovascular device comprising an
ultrasound sensor using one or more transcutaneous ultrasound
systems, comprising the steps of: introducing an endovascular
member containing an ultrasound sensor into the vasculature of a
body; sending and receiving ultrasound waves in the vasculature
using the ultrasound sensor; placing one or more transcutaneous
ultrasound systems on the patient's body; detecting the
interference between the endovascular ultrasound device and the
transcutaneous ultrasound systems using either the endovascular
sensor or with any of the transcutaneous systems; and notifying the
user when interference has been detected such the user becomes
aware of the presence of the endovascular device in the field of
view of the transcutaneous systems.
31. The method of claim 30 wherein the endovascular device is
configured to emit ultrasound signals.
32. The method of claim 30 wherein the endovascular device is
configured to receive ultrasound signals.
33. The method of claim 30 wherein the transcutaneous ultrasound
system is configured to emit ultrasound signals.
34. The method of claim 30 wherein the transcutaneous ultrasound
system is configured to receive ultrasound signals.
35. The method of claim 30 wherein the transcutaneous ultrasound
system is configured as an ultrasound imaging scan head connecting
to an ultrasound imaging system.
36. The method of claim 30 wherein the information in the detecting
step from several transcutaneous ultrasound systems is used for
triangulating and/or locating the endovascular ultrasound
sensor.
37. The method of claim 30 wherein the endovascular ultrasound
device is connected to the one or more transcutaneous system such
as to allow synchronization of transmitting and receiving
ultrasound waves in the same region of the body.
38. An endovascular device, comprising: an elongate body sized for
insertion into the vasculature; a sensor on the distal end of the
elongate body; and a structure on or in the elongate body to move
its tip from an inner blood vessel wall while maintaining the blood
stream flow when the endovascular device is in a blood vessel.
39. The device of claim 38, the elongate body further comprising: a
distal segment that is flexible and made of metal or polymer, and
the polymer may be reinforced to increase tensile strength.
40. The device of claim 38 wherein the structure is a star shaped
balloon on or about the elongate body.
41. The device of claim 38 wherein the structure is a 2 piece
displaced asymmetrical shaped balloon.
42. The device of claim 38 wherein the structure is a deployable
circular braid.
43. The device of claim 38 wherein the structure is a deployable
balloon.
44. The device of claim 38 wherein the structure comprises: strips
cut in the elongate body material; and deployed to move the
endovascular device from a wall using a deployment member.
45. The device of claim 38 wherein the structure comprises a
deployable basket.
46. An endovascular device, comprising: an elongate body sized for
insertion into the vasculature; a sensor on the distal end of the
elongate body; and a structure configured to align the elongate
body tip or the sensor with the blood stream while maintaining the
blood stream flow.
47. The endovascular device of claim 46 wherein the structure
comprises axial alignment facilitated by a tether component
attached to the elongate body.
48. The device of claim 46 wherein the alignment with the blood
stream is provided by a star shaped balloon.
49. The device of claim 46 wherein the structure for alignment with
the blood stream is provided by a 2 piece displaced asymmetrical
shaped balloon.
50. The device of claim 46 wherein the structure for the alignment
with the blood stream is provided by a deployable circular
braid.
51. The device of claim 46 wherein the structure for the alignment
with the blood stream is provided by a deployable balloon.
52. The device of claim 46 wherein the structure for the alignment
with the blood stream is provided by strips cut in the elongate
body material and deployed using a deployment member.
53. The device of claim 46 wherein the structure for the alignment
with the blood stream is provided by a deployable basket.
54. A securement device for an endovascular member which provides
electrical and optical sensor connectors and actuation elements to
connect and control sensors and devices attached at the distal end
of the endovascular members.
55. A system for tracking clinical procedures and workflow,
comprising: a workflow processor; an input interface; an output
interface; a code reader; a communication component; and a database
interface.
56. The system of claim 55 wherein the workflow processor stores
information about procedure times, device information, patient and
operator information, calculates parameters of the procedure like
time duration and elapsed time between activities, and provides
statistical data analysis of such parameters.
57. The system of claim 55 wherein information about the
endovascular procedure is input into the system through a dedicated
user interface guiding data acquisition.
58. The system of claim 55 wherein the output interface presents
results of procedure workflow analysis.
59. The system of claim 55 wherein the code reader can be an RFID
reader, a bar code reader or a reader of any computer readable
label.
60. The system of claim 55 wherein the communication component can
communicate over a wired network or a wireless network with a
hospital information system.
61. The system of claim 55 wherein the communication component can
communicate with other systems for tracking clinical procedures and
establish a network of such systems.
62. The system of claim 55 wherein the database interface allows
the procedure and workflow information to be archived.
63. A method for tracking clinical procedures and workflow,
comprising: entering a time when a consult request is received;
entering a time when a work step is started; and entering a time
when a work step is finished.
64. The method of claim 63 where the work step comprises the
following activities: gathering patient data; transporting to a
case; obtaining patient consent; gaining vascular access; placing
an endovascular device or any other type of device; providing
therapy through the endovascular device; removing or securing an
endovascular device; ordering or waiting for x-ray or other
confirmatory imaging modality; repositioning a device based on
input from an imaging modality; and documenting that an
endovascular device is ready for use.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims the benefit of U.S. Provisional
Patent Application No. 60/937,280 filed on Jun. 26, 2007 by Sorin
Grunwald et al., entitled "Apparatus and Method for Vascular
Access" which is incorporated herein by reference in its
entirety.
[0002] This application is also a continuation-in-part of U.S.
Non-Provisional patent application Ser. No. 11/431,140 filed on May
8, 2006 by Sorin Grunwald et al., entitled "Endovenous Access and
Guidance System Utilizing Non-Image Based Ultrasound", now
publication no. 2007-0016072-A1; U.S. Non-Provisional patent
application Ser. No. 11/431,118 filed on May 8, 2006 by Sorin
Grunwald et al., entitled "Endovascular Access and Guidance System
Utilizing Divergent Beam Ultrasound", now publication no.
2007-0016070-A1; U.S. Non-Provisional patent application Ser. No.
11/431,093 filed on May 8, 2006 by Sorin Grunwald et al., entitled
"Ultrasound Sensor", now publication no. 2007-0016069-A1; and U.S.
Non-Provisional patent application Ser. No. 11/430,511 filed on May
8, 2006 by Sorin Grunwald et al., entitled "Ultrasound Methods of
Positioning Guided Vascular Access Devices in the Venous System",
now publication no. 2007-0016068-A1, all of which claim the benefit
of U.S. Provisional Patent Application No. 60/678,209 filed on May
6, 2005 by Sorin Grunwald et al., entitled "Method and Apparatus
for Intravascular Catheter Guiding and Positioning" and U.S.
Provisional Patent Application No. 60/682,002 filed on May 18, 2005
by Sorin Grunwald et al., entitled "Method and Apparatus for
Intravascular Catheter Guiding and Positioning", each of which is
incorporated herein by reference in their entirety.
[0003] All the above-mentioned publications and patent applications
are commonly assigned patent applications (hereinafter referred to
as "the VasoNova patent applications"):
INCORPORATION BY REFERENCE
[0004] All publications and patent applications mentioned in this
specification are herein incorporated by reference to the same
extent as if each individual publication or patent application was
specifically and individually indicated to be incorporated by
reference.
FIELD OF THE INVENTION
[0005] The field of the invention relates to guided cannulation of
veins and arteries. The field of the invention also relates to the
guidance, positioning and placement confirmation of intravascular
devices without the help of X-ray imaging. The field of the
invention further relates to the workflow of vascular access
procedures, in particular at the bedside.
BACKGROUND
[0006] Currently, preparing the patient for and performing vein and
artery cannulation is time consuming, challenging in terms of
locating the blood vessels and, under circumstances, ensuring the
desired vessel is accessed (e.g., vein vs. artery). Current guided
cannulation devices are either too expensive or difficult to use.
General purpose imaging systems are gaining acceptance but they are
expensive and represent an increase in workflow complexity because
they are not sterile. In addition, general imaging systems are
limited in terms of their ability to image in near field, i.e.,
closed to the surface of the skin. There is a need for improved
placant devices.
[0007] Additional challenges remain unaddressed in many areas
related to endovascular devices. One challenge that remains is for
devices and methods endovascular positioning within or towards the
center of a vessel. Another challenge that remains are devices and
methods that rely on acoustic triangulation or positioning to
localize and place endovascular devices. Another challenge related
to work flow efficiency and monitoring of the placement and
confirmation of endovascular device locations. There remains a need
in the endovascular field for devices, systems and methods that
address these challenges.
[0008] In addition RFID (radio frequency identification) tags are
currently being used for a number of applications including
medical, in particular for inventory management. The idea of using
RFID to optimize processes has been applied for tracking documents
in a workflow.
SUMMARY OF THE INVENTION
[0009] In an aspect, embodiments of the invention relate to the
effective and accurate placement of intravascular devices such as
central venous catheters, in particular such as peripherally
inserted central catheters or PICC. One aspect of the present
invention relates to vascular access. It describes devices and
methods for imaging guided vascular access and more effective
sterile packaging and handling of such devices. A second aspect of
the present invention relates to the guidance, positioning and
placement confirmation of intravascular devices without the help of
X-ray imaging. A third aspect of the present invention relates to
devices and methods for the skin securement of intravascular
devices and post-placement verification of location of such
devices. A forth aspect of the present invention relates to
improvement of the workflow required for the placement of
intravascular devices.
[0010] Some embodiments of the invention provide devices and
methods to substantially reduce the amount of time required to
place an intravascular device using conventional devices and
methods. Some embodiments of the invention provide devices and
methods to substantially reduce the need for X-ray imaging related
to placing such device. Some embodiments of the invention provide
devices and methods to increase placement reliability and accuracy
and to verify device location post-placement.
[0011] Other aspects of the various embodiments are outlined in the
detailed description that follows.
[0012] An aspect of the invention includes a transcutaneous
ultrasound vascular access guiding system comprising: a single
element ultrasound device providing A-Mode imaging, Doppler and
correlation-based blood velocity estimation; a processor to process
and correlate ultrasound information; and a system for information
output. The transcutaneous ultrasound vascular access guiding
system may also comprise a lens which controls the single element
ultrasound beam shape. The transcutaneous ultrasound vascular
access guiding system may also comprise a lens which provides a
matching layer between the ultrasound transducer and the skin.
transcutaneous ultrasound vascular access guiding system comprising
can be constructed as a single-use device. Also, the information
can be output as a scrolling chart. The Doppler information can be
bidirectional. The Doppler acquisition can be pulsed or continuous
wave (PW or CW).
[0013] Another aspect of the invention includes an endovascular
device guide attached to the imaging device capable of guiding
several types of endovascular devices comprising a needle, a
stylet, a catheter, and an introducer. The device may include
adaptors to match the outer diameter of the endovascular guided
device to the inner diameter of the guide. The device having the
ability to slide or otherwise move with respect to the imaging
device as to provide single hand deployment capability of the
endovascular guided device.
[0014] Another aspect of the invention comprises a method of
accessing a blood vessel comprising the steps of: preparing sterile
vascular access site on patient's skin; sliding an access needle or
any other type of access device in the device guide, flush align
with the tip of the imaging element, and lock in position;
positioning the assembly on the patient's skin on the sterile site
without the use of ultrasound gel; orienting the assembly like a
flashlight until the desired vessel can be seen on the scrolling
chart display; advancing the endovascular element into the
vasculature by sliding the guide element over the imaging device;
and monitoring the advancement of the endovascular device towards
the desired target by using at least one element from a list
including A-mode imaging, Doppler flow information, and/or
correlation-based blood flow information.
[0015] Another aspect of the invention comprises an endovascular
device capable of emitting audible sounds. The sound emitting
element or elements may be placed anywhere along the endovascular
member. The sound generating elements may be actuated by pushing
and pulling wires manually. The sound generating elements may be
actuated by motorized movement of moving connective parts. The
sound generating elements may be actuated by delivering a gas
through a lumen of the endovascular device. The sound generating
elements may be actuated by delivering fluid through a lumen of the
endovascular device. The sound generating elements may be actuated
through interaction with the blood or anatomical sites. The sound
waves may be generated by rubbing together of notched or serrated
components. The sound waves may be generated by hitting a stylet
against a solid member in order to generate a repetitive ping. The
sound waves may be generated by a moving membrane. The sound waves
may be generated by a moving membrane configured to amplify sound.
A device lumen is configured to amplify sound.
[0016] Another aspect of the invention comprises an auscultation
system comprising one or more sound sensitive elements. The system
includes a sound processor and an information output device. The
several auscultation devices can be synchronized to provide
acoustic triangulation for accurate detection of the endovascular
sound source.
[0017] Another aspect of the invention includes a guiding method
for endovascular devices comprising the steps of: 1) one or more
sound sensitive elements are placed on the patient's chest; 2) the
sound emitting endovascular device is inserted in the patient's
vasculature; 3) The endovascular device emits sound continuously,
intermittently or on demand; and 4) Sound sensitive elements detect
the sound generated by the endovascular device. The sound intensity
can be used to estimate the distance between the sound emitting
element and the sound sensitive element. The sound detected by
several sound sensitive elements can be triangulate as to find the
location of the sound source with respect to the sound detecting
elements.
[0018] Another aspect of the invention includes a method to locate
an endovascular device comprising an ultrasound sensor using one or
several transcutaneous ultrasound systems comprising the steps of:
1) introducing an endovascular member containing an ultrasound
sensor into the vasculature of a body; 2) sending and receiving
ultrasound waves in the vasculature using the ultrasound sensor; 3)
placing one or more transcutaneous ultrasound systems on the
patient's body; detecting the interference between the endovascular
ultrasound device and the transcutaneous ultrasound systems with
either the endovascular sensor or with either of transcutaneous
systems; notifying the user when interference has been detected
such the user becomes aware of the presence of the endovascular
device in the field of view of the transcutaneous systems. The
endovascular device is able to emit ultrasound signals. The
endovascular device is able to receive ultrasound signals. The
transcutaneous ultrasound system is able to emit ultrasound
signals. The transcutaneous ultrasound system is able to receive
ultrasound signals transcutaneous ultrasound system. The
transcutaneous ultrasound system can be an ultrasound imaging scan
head connecting to an ultrasound imaging system. Several
transcutaneous ultrasound systems can be used to triangulate the
location of the endovascular ultrasound sensor. The endovascular
ultrasound device is connected to the one or more transcutaneous
system such as to allow synchronization of transmitting and
receiving ultrasound waves in the same region of the body.
[0019] Another aspect of the invention includes an endovascular
device comprising means to separate its tip from the inner blood
vessel wall while maintaining the blood stream flow. A distal
segment of the endovascular device is flexible and made of metal or
polymer, and the polymer may be reinforced to increase tensile
strength. The separation from the wall is provided by a star shaped
balloon. The separation from the wall is provided by a 2 piece
displaced asymmetrical shaped balloon. The separation from the wall
is provided by a deployable circular braid. The separation from the
wall is provided by a deployable balloon. The separation from the
wall is provided by strips cut in the device material and deployed
using a deployment member. The separation from the wall is provided
by a deployable basket.
[0020] Another aspect of the invention includes an endovascular
device comprising means to align its tip with the blood stream
while maintaining the blood stream flow. The means comprises axial
alignment that is facilitated by a tether component. The alignment
with the blood stream is provided by a star shaped balloon. The
alignment with the blood stream is provided by a 2 piece displaced
asymmetrical shaped balloon. The alignment with the blood stream is
provided by a deployable circular braid. The alignment with the
blood stream is provided by a deployable balloon. The alignment
with the blood stream is provided by strips cut in the device
material and deployed using a deployment member. The alignment with
the blood stream is provided by a deployable basket.
[0021] Another aspect of the invention includes a securement device
for an endovascular member which provides electrical and optical
sensor connectors and actuation elements to connect and control
sensors and devices attached at the distal end of the endovascular
members.
[0022] Another aspect of the invention includes a system for
tracking clinical procedures and improve workflow efficiency
comprising: a workflow processor; an input interface; an output
interface; a code reader; a communication component; and a database
interface. The workflow processor stores information about
procedure times, device information, patient and operator
information, calculates parameters of the procedure like time
duration and elapsed time between activities, and provides
statistical data analysis of such parameters. The information about
the endovascular procedure can be input into the system through a
dedicated user interface guiding data acquisition. The output
interface presents results of procedure workflow analysis. The code
reader can be an RFID reader, a bar code reader or a reader of any
computer readable label. The communication component can
communicate over the network (wired or wireless) with the hospital
information system. The communication component can communicate
with other systems for tracking clinical procedures and establish a
network of such systems. The database interface allows the
procedure and workflow information to be archived.
[0023] Another aspect of the invention includes a method for
tracking clinical procedures and improve workflow efficiency
comprising the steps of: 1) Input to the time when a consult
request has been received; 2) Input the time when a work step is
started; and 3) Input the time when a work step is finished. The a
work step comprises the following activities:
[0024] a. Gather patient data (check history, allergies, lab
results, etc)
[0025] b. Transportation to case (cart/supplies)
[0026] c. Obtain patient consent
[0027] d. Gain vascular access, e.g., venipuncture
[0028] e. Place endovascular device or any other type of device
[0029] f. Provide therapy through the endovascular device
[0030] g. Remove or secure the endovascular device
[0031] h. Order/wait for x-ray or other confirmatory imaging
modality
[0032] i. Reposition device in case x-ray does not confirm
location; and
[0033] j. Document that endovascular device is ready for use\
[0034] In one aspect of the invention, there is a transcutaneous
ultrasound vascular access guiding system having one or more of: an
elongate body having a handle; a guide on the elongate body
configured to receive a vascular access device; a single element
ultrasound device on the elongate body configured to provide A-Mode
imaging, Doppler and correlation-based blood velocity estimation; a
processor to process and correlate ultrasound information from the
single element ultrasound device; and a system for information
output based on the output of the processor.
[0035] The guiding system may also include a lens positioned to
control the single element ultrasound beam shape or a lens
positioned on the ultrasound device configured to provide a
matching layer between the ultrasound transducer and the skin.
[0036] Numerous alternatives are possible such as being constructed
as a single-use device or where the information output is a
scrolling chart. Additionally, the Doppler information can be
bidirectional and/or the Doppler acquisition can be pulsed wave or
continuous wave. Additionally, the guide attached to the imaging
device is configured to guide one of the endovascular device
selected from the group consisting of: a needle; a stylet; a
catheter; and an introducer. There may also be an adaptor to match
the outer diameter of the endovascular guided device to the inner
diameter of the guide. The endovascular device may also be
configured to slide or move with respect to the imaging device as
to provide single hand deployment capability of the endovascular
guided devices described herein.
[0037] In another aspect, there is a method of accessing a blood
vessel comprising one or more of the steps of: preparing sterile
vascular access site on patient's skin; sliding a vascular access
device in the device guide, flush aligning with the tip of the
imaging element, and locking in position; positioning the assembly
on the patient's skin on the sterile site without the use of
ultrasound gel; orienting the assembly like a flashlight until the
desired vessel can be seen on the scrolling chart display;
advancing the endovascular element into the vasculature by sliding
the guide element over the imaging device; and monitoring the
advancement of the endovascular device towards the desired target
by using at least one element from a list including: A-mode
imaging, Doppler flow information, and correlation-based blood flow
information.
[0038] In another aspect, there is an endovascular device having an
elongate body; an element on or in the elongate body configured to
generate, emit or produce sound waves; and a device to control the
generation, emission or production of sound waves from the element.
The element may be placed on or in the elongate body. In one
aspect, the device to control may operate by pushing and pulling
wires manually. In another aspect, the device to control may be
actuated by motorized movement of moving connective parts. The
device to control generation of the element may be actuated by
delivering a gas through a lumen on or in the elongate body. The
sound generating elements may be actuated by delivering fluid
through a lumen of the endovascular device. The sound generating
elements may be actuated through interaction with the blood or an
anatomical site. The sound waves may be generated by rubbing
notched or serrated components. The sound waves may be generated by
hitting a stylet against a solid member in order to generate a
repetitive ping. The sound waves may be generated by a moving
membrane. The sound waves may be generated by a moving membrane
configured to amplify sound. There may also be a device lumen is
configured to amplify sound.
[0039] In another aspect, there is an auscultation system having
one or more of: one or more sound sensitive elements; a sound
processor in communication with the one or more sound sensitive
elements; and an information output device in communication with
the sound processor. In one aspect, the sound processor is
configured such that a plurality of auscultation devices can be
synchronized to provide acoustic triangulation for accurate
detection of an endovascular sound source.
[0040] In another aspect, there is a guiding method for
endovascular devices performed by one or more of the steps of:
positioning one or more sound sensitive elements on a patient's
chest; inserting a sound emitting endovascular device into the
patient's vasculature; emitting, producing or generating sound or
pressure waves from the endovascular device; and detecting the
sound or pressure waves from the emitting step with the sound
sensitive elements. In one aspect, the emitting step is performed
continuously, intermittently or on demand. In another aspect, the
sound intensity measured in the detecting step is used to estimate
the distance between the sound emitting endovascular device and the
one or more sound sensitive elements. The method may also include
the step of triangulating the sounds from the detecting step to
locate the sound emitting endovascular device with respect to the
one or more sound sensitive elements.
[0041] In still another aspect, there is a method to locate an
endovascular device comprising an ultrasound sensor using one or
more transcutaneous ultrasound systems by performing the steps of:
introducing an endovascular member containing an ultrasound sensor
into the vasculature of a body; sending and receiving ultrasound
waves in the vasculature using the ultrasound sensor; placing one
or more transcutaneous ultrasound systems on the patient's body;
detecting the interference between the endovascular ultrasound
device and the transcutaneous ultrasound systems using either the
endovascular sensor or with any of the transcutaneous systems; and
notifying the user when interference has been detected such the
user becomes aware of the presence of the endovascular device in
the field of view of the transcutaneous systems. In one
alternative, the endovascular device is configured to emit or
receive ultrasound signals. In one alternative, the transcutaneous
ultrasound system is configured to emit or receive ultrasound
signals. In another aspect, the transcutaneous ultrasound system is
configured as an ultrasound imaging scan head connecting to an
ultrasound imaging system. The information in the detecting step
from several transcutaneous ultrasound systems is used for
triangulating and/or locating the endovascular ultrasound sensor.
In another alternative, the endovascular ultrasound device is
connected to the one or more transcutaneous system such as to allow
synchronization of transmitting and receiving ultrasound waves in
the same region of the body.
[0042] In another alternative embodiment, there is an endovascular
device with an elongate body sized for insertion into the
vasculature; a sensor on the distal end of the elongate body; and a
structure on or in the elongate body to move its tip from an inner
blood vessel wall while maintaining the blood stream flow when the
endovascular device is in a blood vessel. The elongate body may
also include a distal segment that is flexible and made of metal or
polymer, and the polymer may be reinforced to increase tensile
strength. The structure is a star shaped balloon on or about the
elongate body; or a 2 piece displaced asymmetrical shaped balloon;
or a deployable circular braid; or deployable balloon; or a
deployable basket. In one aspect, the structure also includes
strips cut in the elongate body material; and the strips are
adapted to be deployed to move the endovascular device from a wall
using a deployment member.
[0043] In still another aspect, there is an endovascular device
having an elongate body sized for insertion into the vasculature; a
sensor on the distal end of the elongate body; and a structure
configured to align the elongate body tip or the sensor with the
blood stream while maintaining the blood stream flow. The structure
may include axial alignment or alignment within the bloodstream
facilitated by a tether component attached to the elongate body; or
provided by a star shaped balloon; or provided by a 2 piece
displaced asymmetrical shaped balloon; or provided by a deployable
circular braid; or provided by a deployable balloon; or provided by
strips cut in the elongate body material and deployed using a
deployment member; or provided by a deployable basket.
[0044] In another alternative embodiment, there is a securement
device for an endovascular member that provides electrical and
optical sensor connectors and actuation elements to connect and
control sensors and devices attached at the distal end of the
endovascular members.
[0045] In another aspect, there is a system for tracking clinical
procedures and workflow having one or more of: a workflow
processor; an input interface; an output interface; a code reader;
a communication component; and a database interface. The workflow
processor may store information about procedure times, device
information, patient and operator information, calculate parameters
of the procedure like time duration and elapsed time between
activities, and provide statistical data analysis of such
parameters. The information about the endovascular procedure may be
input into the system through a dedicated user interface guiding
data acquisition. The output interface may present results of
procedure workflow analysis. The code reader can be an RFID reader,
a bar code reader or a reader of any computer readable label. The
communication component can communicate over a wired network or a
wireless network with a hospital information system. The
communication component can communicate with other systems for
tracking clinical procedures and establish a network of such
systems. The database interface allows the procedure and workflow
information to be archived.
[0046] In another aspect, there is a method for tracking clinical
procedures and workflow, having one or more of the steps of:
entering a time when a consult request is received; entering a time
when a work step is started; and entering a time when a work step
is finished. The work step may include one or more of the following
activities: gathering patient data; transporting to a case;
obtaining patient consent; gaining vascular access; placing an
endovascular device or any other type of device; providing therapy
through the endovascular device; removing or securing an
endovascular device; ordering or waiting for x-ray or other
confirmatory imaging modality; repositioning a device based on
input from an imaging modality; and documenting that an
endovascular device is ready for use.
BRIEF DESCRIPTION OF THE DRAWINGS
[0047] FIG. 1 illustrates a disposable or reusable imaging and
guiding device for vascular access.
[0048] FIG. 2 illustrates interaction of solid components rubbing
together of notched components at the catheter tip with similar
notched or serrated components at the distal end of a stylet that
passes through one of the catheter lumens.
[0049] FIG. 3 shows an embodiment in which the motion required is
perpendicular to the stylet axis.
[0050] FIG. 4 shows an embodiment in which the motion required is
parallel to the stylet axis.
[0051] FIG. 5 illustrated motion of the valve flap or flaps is
induced by the rapid injection of a liquid or gas such as CO.sub.2
through the catheter lumen within which valve resides.
[0052] FIG. 6 illustrated motion of the valve flap or flaps is
induced by the rapid injection of a liquid or gas such as CO.sub.2
through the catheter lumen within which valve resides.
[0053] FIG. 7 illustrates an embodiment, in which a convoluted
lumen acts as an amplifier, thus enabling a smaller sized membrane
that can be positioned in the more proximal lumen or located at the
tip of an insertable catheter that can then be removed after
performing the sound triangulation procedure for verification of
catheter tip position.
[0054] FIG. 8 illustrates a simplified embodiment in which the
membrane is situated at the terminal side port of a lumen.
[0055] FIG. 9 illustrates the basic configuration of auscultation
devices and user interface.
[0056] In FIG. 10 an ultrasound system (20) and transducer (23) are
used as an external (transcutaneous or transesophageal) energy
source.
[0057] FIG. 11 illustrates possible ultrasound beam geometry as
generated by the transducer 23, called field of view.
[0058] FIG. 12 illustrated the concept of orienting the transducer
a minimum distance from the vessel wall as seen in.
[0059] FIGS. 13A and 13B illustrate the concept of aligning the
transducer at an angle from the flow axis as shown in.
[0060] FIG. 14 shows a transition section made of a relatively much
more flexible material than what the proximal or distal sections
are made of.
[0061] FIG. 15 shows a concept similar to the transition tube,
except that the transition tube essentially becomes the entire
distal section of the catheter shaft.
[0062] FIG. 16 depicts another concept of axial alignment in that
instead of the distal section being tubing, it is made mostly out
of a solid flexible material, such as a polymer.
[0063] FIG. 17 shows another concept of axial alignment facilitated
by a tether component.
[0064] FIGS. 18A and 18B shows a preferred embodiment of two
power-injectable lumens each with one side port for fluid delivery
adjacent to the closed distal tip.
[0065] FIG. 19 is a side view of a shaft surface-mounted balloon
embodiment.
[0066] FIG. 20 illustrates a profiled balloon is mounted to the
catheter shaft surface.
[0067] FIG. 21 shows an alternate embodiment of a catheter shaft
surface-mounted balloon embodiment with 2 radially asymmetric
balloons placed on the catheter shaft.
[0068] FIGS. 22A, 22B and 22C depict embodiments in which a balloon
is mounted onto a catheter shaft such that less than 180 deg,
measured circumferentially with respect to the catheter shaft, is
covered by the balloon material.
[0069] FIG. 23 shows an embodiment of the catheter-based
flow-directed vascular access device in which a flow-directable
component.
[0070] FIG. 24 shows proximally-actuated and shaft surface-mounted
embodiment in which the catheter shaft itself is split such that
movement of the distal tip in a proximal direction will cause the
shaft to splay outward thereby creating a flow-directable
component.
[0071] FIG. 25 shows yet another proximally-actuated and shaft
surface-mounted embodiment in which an umbrella-like component acts
as the flow-directable member.
[0072] FIG. 26 illustrates that the flow-directable member can be
made up of self-expanding struts covered by a sail material.
[0073] FIG. 27 shows another perspective view of another embodiment
of a distally-housed flow-directed device that uses an
axially-compressed braid as a flow-directable member.
[0074] FIG. 28 shows a perspective view of another embodiment of a
distally-housed flow-directed device that uses a balloon as a
flow-directable member.
[0075] FIG. 29 illustrates a transducer tether embodiment.
[0076] FIG. 30A illustrated a sensor may still be positioned
against the wall even when the balloon is inflated and when the
balloon is mounted too far proximal on the catheter shaft with
respect to the sensor location.
[0077] FIG. 30B illustrates one of the ways in which a balloon
embodiment can address this issue is by being mounted as far
distal, with respect to the sensor, as possible.
[0078] FIG. 31 shows a shaft surface-mounted balloon embodiment,
building on the idea described in FIGS. 30A and 30B.
[0079] FIG. 32 illustrates a profiled balloon when a flow
restriction becomes an issue and prevent the sensor from acquiring
a signal.
[0080] FIG. 33 illustrated another balloon embodiment may include a
balloon mounted entirely on the distal catheter tip, completely
covering the sensor.
[0081] FIGS. 34A and 34B show a catheter-based vascular access
device in which the proximal section is made of a relatively
stiffer material when compared to the distal section to facilitate
the columnar strength required during distal steering
actuation.
[0082] FIGS. 35A and 35B show an embodiment of a sensor-directed
vascular access device in which a mostly circular pre-formed stylet
is advanced through a catheter lumen to create a passive mechanism
by which transducer position is maintained so that data can be
acquired.
[0083] FIGS. 36A and 36B show another embodiment utilizing a
pre-formed stylet to shape the catheter shaft itself without
exiting a side port.
[0084] FIG. 37 shows an embodiment of an over-the-wire
guidewire-based device in which the sensor(s) is also mounted on
the guidewire.
[0085] FIG. 38A shows an embodiment of an over-the-wire
guidewire-based device in which the sensor(s) is mounted on the
catheter.
[0086] FIG. 38B shows an example of a possible cross-sectional
configuration of the distal catheter shaft (right-side of Figure)
vs. the very distal catheter tip (left side of Figure).
[0087] FIG. 39 shows an embodiment of a rapid exchange
guidewire-based device in which the sensor(s) is again mounted on
the guidewire.
[0088] FIG. 40 shows an embodiment of a rapid exchange
guidewire-based device, as previously described, in which the
sensor(s) is again mounted on the catheter.
[0089] FIG. 41 shows another embodiment of FIG. 40 in which one of
the distal fluid lumen ports could have a section that is split in
a longitudinal fashion as opposed to being completely open.
[0090] FIG. 42 shows an embodiment of a sensor-directed guide-wire
based device advanced to the target site via active manipulation of
the guidewire during advancement by the user.
[0091] FIG. 43 shows an embodiment of a securement device that
attaches to the proximal catheter shaft thereby minimizing catheter
tip migration from the target site.
[0092] FIGS. 44A and 44B show top and end views, respectively, of
an alternative embodiment of a securement device.
[0093] FIG. 45 shows an example of workflow tracking on a Vasonova
handheld GUI.
[0094] FIG. 46 illustrates a VasoNova handheld GUI has a menu
feature that indicates which workflow interval is being tracked and
the operator can modify or change the present task by using the
`up` and `down` buttons on the data entry device.
[0095] FIG. 47 illustrates a GUI that will display the tasks and
with the present task highlighted as illustrated in.
[0096] FIG. 48 shows the players in a medical workflow.
DETAILED DESCRIPTION
[0097] An aspect of the invention includes a transcutaneous
ultrasound vascular access guiding system comprising: a single
element ultrasound device providing A-Mode imaging, Doppler and
correlation-based blood velocity estimation; a processor to process
and correlate ultrasound information; and a system for information
output. The transcutaneous ultrasound vascular access guiding
system may also comprise a lens which controls the single element
ultrasound beam shape. The transcutaneous ultrasound vascular
access guiding system may also comprise a lens which provides a
matching layer between the ultrasound transducer and the skin.
transcutaneous ultrasound vascular access guiding system comprising
can be constructed as a single-use device. Also, the information
can be output as a scrolling chart. The Doppler information can be
bidirectional. The Doppler acquisition can be pulsed or continuous
wave (PW or CW).
[0098] Another aspect of the invention includes an endovascular
device guide attached to the imaging device capable of guiding
several types of endovascular devices comprising a needle, a
stylet, a catheter, and an introducer. The device may include
adaptors to match the outer diameter of the endovascular guided
device to the inner diameter of the guide. The device having the
ability to slide or otherwise move with respect to the imaging
device as to provide single hand deployment capability of the
endovascular guided device.
[0099] Another aspect of the invention comprises a method of
accessing a blood vessel comprising the steps of: preparing sterile
vascular access site on patient's skin; sliding an access needle or
any other type of access device in the device guide, flush align
with the tip of the imaging element, and lock in position;
positioning the assembly on the patient's skin on the sterile site
without the use of ultrasound gel; orienting the assembly like a
flashlight until the desired vessel can be seen on the scrolling
chart display; advancing the endovascular element into the
vasculature by sliding the guide element over the imaging device;
and monitoring the advancement of the endovascular device towards
the desired target by using at least one element from a list
including A-mode imaging, Doppler flow information, and/or
correlation-based blood flow information.
[0100] Another aspect of the invention comprises an endovascular
device capable of emitting audible sounds. The sound emitting
element or elements may be placed anywhere along the endovascular
member. The sound generating elements may be actuated by pushing
and pulling wires manually. The sound generating elements may be
actuated by motorized movement of moving connective parts. The
sound generating elements may be actuated by delivering a gas
through a lumen of the endovascular device. The sound generating
elements may be actuated by delivering fluid through a lumen of the
endovascular device. The sound generating elements may be actuated
through interaction with the blood or anatomical sites. The sound
waves may be generated by rubbing together of notched or serrated
components. The sound waves may be generated by hitting a stylet
against a solid member in order to generate a repetitive ping. The
sound waves may be generated by a moving membrane. The sound waves
may be generated by a moving membrane configured to amplify sound.
A device lumen is configured to amplify sound.
[0101] Another aspect of the invention comprises an auscultation
system comprising one or more sound sensitive elements. The system
includes a sound processor and an information output device. The
several auscultation devices can be synchronized to provide
acoustic triangulation for accurate detection of the endovascular
sound source.
[0102] Another aspect of the invention includes a guiding method
for endovascular devices comprising the steps of: 1) one or more
sound sensitive elements are placed on the patient's chest; 2) the
sound emitting endovascular device is inserted in the patient's
vasculature; 3) The endovascular device emits sound continuously,
intermittently or on demand; and 4) Sound sensitive elements detect
the sound generated by the endovascular device. The sound intensity
can be used to estimate the distance between the sound emitting
element and the sound sensitive element. The sound detected by
several sound sensitive elements can be triangulate as to find the
location of the sound source with respect to the sound detecting
elements.
[0103] Another aspect of the invention includes a method to locate
an endovascular device comprising an ultrasound sensor using one or
several transcutaneous ultrasound systems comprising the steps of:
1) introducing an endovascular member containing an ultrasound
sensor into the vasculature of a body; 2) sending and receiving
ultrasound waves in the vasculature using the ultrasound sensor; 3)
placing one or more transcutaneous ultrasound systems on the
patient's body; detecting the interference between the endovascular
ultrasound device and the transcutaneous ultrasound systems with
either the endovascular sensor or with either of transcutaneous
systems; notifying the user when interference has been detected
such the user becomes aware of the presence of the endovascular
device in the field of view of the transcutaneous systems. The
endovascular device is able to emit ultrasound signals. The
endovascular device is able to receive ultrasound signals. The
transcutaneous ultrasound system is able to emit ultrasound
signals. The transcutaneous ultrasound system is able to receive
ultrasound signals transcutaneous ultrasound system. The
transcutaneous ultrasound system can be an ultrasound imaging scan
head connecting to an ultrasound imaging system. Several
transcutaneous ultrasound systems can be used to triangulate the
location of the endovascular ultrasound sensor. The endovascular
ultrasound device is connected to the one or more transcutaneous
system such as to allow synchronization of transmitting and
receiving ultrasound waves in the same region of the body.
[0104] Another aspect of the invention includes an endovascular
device comprising means to separate its tip from the inner blood
vessel wall while maintaining the blood stream flow. A distal
segment of the endovascular device is flexible and made of metal or
polymer, and the polymer may be reinforced to increase tensile
strength. The separation from the wall is provided by a star shaped
balloon. The separation from the wall is provided by a 2 piece
displaced asymmetrical shaped balloon. The separation from the wall
is provided by a deployable circular braid. The separation from the
wall is provided by a deployable balloon. The separation from the
wall is provided by strips cut in the device material and deployed
using a deployment member. The separation from the wall is provided
by a deployable basket.
[0105] Another aspect of the invention includes an endovascular
device comprising means to align its tip with the blood stream
while maintaining the blood stream flow. The means comprises axial
alignment that is facilitated by a tether component. The alignment
with the blood stream is provided by a star shaped balloon. The
alignment with the blood stream is provided by a 2 piece displaced
asymmetrical shaped balloon. The alignment with the blood stream is
provided by a deployable circular braid. The alignment with the
blood stream is provided by a deployable balloon. The alignment
with the blood stream is provided by strips cut in the device
material and deployed using a deployment member. The alignment with
the blood stream is provided by a deployable basket.
[0106] Another aspect of the invention includes a securement device
for an endovascular member which provides electrical and optical
sensor connectors and actuation elements to connect and control
sensors and devices attached at the distal end of the endovascular
members.
[0107] Another aspect of the invention includes a system for
tracking clinical procedures and improve workflow efficiency
comprising: a workflow processor; an input interface; an output
interface; a code reader; a communication component; and a database
interface. The workflow processor stores information about
procedure times, device information, patient and operator
information, calculates parameters of the procedure like time
duration and elapsed time between activities, and provides
statistical data analysis of such parameters. The information about
the endovascular procedure can be input into the system through a
dedicated user interface guiding data acquisition. The output
interface presents results of procedure workflow analysis. The code
reader can be an RFID reader, a bar code reader or a reader of any
computer readable label. The communication component can
communicate over the network (wired or wireless) with the hospital
information system. The communication component can communicate
with other systems for tracking clinical procedures and establish a
network of such systems. The database interface allows the
procedure and workflow information to be archived.
[0108] Another aspect of the invention includes a method for
tracking clinical procedures and improve workflow efficiency
comprising the steps of: 1) Input to the time when a consult
request has been received; 2) Input the time when a work step is
started; and 3) Input the time when a work step is finished. The a
work step comprises the following activities:
[0109] a. Gather patient data (check history, allergies, lab
results, etc)
[0110] b. Transportation to case (cart/supplies)
[0111] c. Obtain patient consent
[0112] d. Gain vascular access, e.g., venipuncture
[0113] e. Place endovascular device or any other type of device
[0114] f. Provide therapy through the endovascular device
[0115] g. Remove or secure the endovascular device
[0116] h. Order/wait for x-ray or other confirmatory imaging
modality
[0117] i. Reposition device in case x-ray does not confirm
location; and
[0118] j. Document that endovascular device is ready for use
1.0 System for Guided and Sterile Vascular Access
[0119] Aspects of the following embodiments may share some or all
of the following characteristics such as disposable imaging device,
an imaging device with a needle guide and the ability to cannulate
a vessel in a single disposable sterile bag or container.
Free-Hand A-Mode Imaging
[0120] The free-hand A-mode imaging preferably includes a
disposable, inexpensive, accurate vascular placement device that
reduces access time as compared to conventional vascular placement
devices and methods. The free-hand A-mode imaging preferably
enables a procedure for bedside central line placement.
[0121] The patient's arm and axilla/shoulder are prepped in the
usual sterile fashion. A ribbon of latex or other type tourniquet
is used on the upper arm to help distend the veins.
[0122] FIG. 1 illustrates a disposable or reusable imaging and
guiding device for vascular access. The device in FIG. 1 includes
an elongate body 13, guide 11, a needle 1, an introducer 2, a
dilator 3, an access wire 4, a catheter 5, a handle 7 and an
ultrasound transducer 502. In particular, FIG. 1 illustrates an
A-mode device that has a pencil or other shaped handheld device
with the ultrasound device (i.e., disposable ultrasound transducer
502) at a distal tip, which may be perpendicular or at a 30, 45, 60
or other degree angle relative to an axis of the handheld device. A
needle 1/guide 11 or catheter 5/needle 1 combination may also be
configured as part of the device such that a beam 12 of the
ultrasound transducer 502 crosses a set needle path as it pierces
skin 9 and traverses subcutaneous tissues. This arrangement allows
an operator to visualize the needle 1 as it punctures a blood
vessel 6 of interest. The device presented in FIG. 1 may be
delivered in a sterile package and is disposable.
[0123] Once a most superficial wall of a vein has been punctured a
flash of blood is visualized at a hub end of the catheter 5/needle
1. The access wire 4 is then advanced through the needle 1 and the
catheter 5 (if present) is then advanced over the access wire 4
into the blood vessel 6. The guiding device, needle 1/access wire 4
(as in an Angiocath combination) is then removed, leaving in place
only the catheter 5. The catheter 5 is of sufficient size to allow
passage of a larger access wire 4, 0.035'' or larger for example,
to enable placement of a peel-away sheath and dilator 3. The
dilator 3 and access wire 4 are then removed and the PICC is
inserted through the peel-away sheath. Alternatively, access wire 4
is advanced into the blood vessel 6 through the needle 1 and no
Angiocath is utilized. The guiding device and needle 1 are then
removed and the peel-away sheath and dilator 3 are advanced over
the access wire 4. Once the sheath is all the way in the dilator 3
and access wire 4 are removed and the PICC is inserted through the
peel-away sheath.
[0124] The guiding device connects to a VasoNova handheld with GUI
by a cord or with wireless connectivity. The guiding device may be
disposable or sterilizable/reusable. The catheter 5/needle 1/access
wire 4 component is disposable and may be integrated with the
ultrasound device if the catheter 5/needle 1/access wire 4 is
disposable. The catheter 5/needle 1/access wire 4 may be inserted
or attached to a reusable ultrasound device. The primary ultrasound
modality is A-mode for visualizing the tissues on gray-scale with
real time analysis; however the modality can also be switched
manually or automatically to Doppler mode within the blood vessel
lumen to confirm venous flow versus arterial flow based on velocity
of blood flow and pulsatility pattern.
[0125] A handheld component of ultrasound-guided blood vessel
access system may be ergonomically designed in order to optimize
user positioning and angle of contact with the patient's skin. This
may involve placing the ultrasound device in an enclosure that
resembles a computer mouse, a pencil-shaped device, short stubby
cylindrical device or other shaped handheld that can also
incorporate the needle 1/access wire 4 introduction system as
described above. The device may provide for the ability to swivel
the ultrasound and needle guiding components to optimize position
relative to the portion that is held in place by the operator and
the blood vessel to be punctured.
[0126] The ultrasound-guided blood vessel access system is not
exclusively intended for use in placing PICCs. The
ultrasound-guided blood vessel access system may also be used for
blood vessel puncture in general when the blood vessel of interest
is not visible or easily palpable to the operator's satisfaction
and ultrasound confirmation and guidance is desired for puncturing
the blood vessel. As such the ultrasound-guided blood vessel access
system may be used for accessing veins, such as peripheral veins
such as the cephalic, basilica, median cubital, brachial,
antecubital, or other veins of the arm, the long and short
saphenous or other superficial veins in the legs, or for accessing
more centrally located veins such as axillary, subclavian, internal
or external jugular veins, or common femoral veins for example. The
ultrasound-guided blood vessel access system may be used to
identify arteries such as the radial, ulnar, brachial, axillary,
femoral, or other for puncture or simple detection of blood flow,
such as with a "Doppler check" as when a nurse assesses a patient's
arterial blood flow in an extremity after a vascular operation
during the postoperative phase.
1.1 Ultrasound-Guided Apparatus and Method for Blood Vessel
Access
The Apparatus
[0127] As noted above, the apparatus in FIG. 1 includes an elongate
body 13, guide 11, a needle 1, an introducer 2, a dilator 3, an
access wire 4, a catheter 5, a handle 7 and an ultrasound
transducer 502. The apparatus illustrated in FIG. 1 includes a
single element imaging element comprising a body 13, shaped like a
pen or a flashlight. The single element imaging element consist of
a handle 7 and an ultrasound transducer 502. The ultrasound
transducer 502 emits a single beam 12 and can consist of a single
or multiple elements, e.g., piezoelectric crystals. The beam 12 can
be focused, unprocessed, or divergent. Frequency of operation
should be such as to allow near field imaging and penetration to
the vessels of interest for cannulation, for example 7 to 10
MHz.
[0128] The apparatus contains further a detachable or fixed guide
11 which allows for sliding a needle 1, a dilator 3, an access wire
4 or a catheter 5 through the guide 11 into the blood vessel 6 and
into the field of view of the ultrasound beam.
[0129] The apparatus is further capable of providing blood flow
velocity and direction information using non-directional or
bi-directional CW or PW Doppler or cross-correlation methods
similarly to the system described in the VasoNova patent
applications.
[0130] The ultrasound device (i.e. ultrasound transducer 502) is
connected to an instrument for processing (i.e., processor) and
displaying single beam ultrasound images in an amplitude (A-Mode)
display. The type of vascular access imaging may be free hand
A-Mode obtained with the device. The imaging may be color A-mode
imaging, whereby the colors indicate bidirectional blood flow
velocities obtained using Doppler or cross-correlation
calculations, or duplex A-Mode imaging mode, where the
bidirectional Doppler spectral distribution (velocity distribution)
is in a sample window.
[0131] The handle 7 further comprises one or more buttons that
allow for single finger operation of any component controlled by
the handle 7, e.g., turning the Doppler mode on and off or
adjusting the depth of the sample window.
[0132] The guide comprises a lumen adaptor to accommodate different
size devices, such as for example, a dilator, an access wire, a
catheter and the like.
Guided Cannulation Method
[0133] In one embodiment, a guided cannulation method includes the
following steps: [0134] 1. Prepare the sterile field for
cannulation; [0135] 2. Connect the sterile apparatus to the
ultrasound device; [0136] 3. Use the apparatus like a flashlight to
look for a target vessel using A-Mode imaging; [0137] 4. Optionally
use Doppler to double check if the target vessel is a vein or an
artery based on flow characteristics; [0138] 5. Attach the needle 1
to the guide 11 and insert needle 1 until needle 1 can be seen on
the A-Mode image as reaching the vessel of interest. Insert the
access wire 4, dilator 3/introducer 2 and any other desired
endovascular member under ultrasound visualization; and/or [0139]
6. Detach the apparatus from the inserted endovascular member,
disconnect from the ultrasound device and dispose of the single use
component.
2.0 Guided Endovascular Access Device
[0140] 2.1 Energy Element (Sensor and Source)
[0141] 2.1.1 Acoustic Triangulation
[0142] Sound waves are generated at the catheter tip and detected
by strategically placed electronically amplified auscultation
devices that are in contact with the patient's skin.
[0143] The sound waves may be generated by the mechanical
interaction of solid components, by transduction of vibrational
energy along a stylet, by vibration of valve flaps near the
catheter tip, or by pneumatic activation of a membrane that is at
the interface of a gas or liquid filled catheter lumen/cavity and
the patient's blood.
[0144] Interaction of solid components may involve rubbing together
of notched components at the catheter 500 tip with similar notched
element 14 or serrated components at the distal end of a stylet 12
that passes through one of the catheter lumens 10 (FIG. 2). FIG. 2
includes a catheter 500, a catheter lumen 10, a stylet 12, a
notched element 14 within catheter lumen 10, a notched member 14,
sound waves 16, motion of stylet 12 to create sound waves 16 and
notched element 14 on stylet 12 to interact with notched element 14
in catheter lumen 10. This type of sound wave 16 generation is
similar to stridulation in certain insect species that use rubbing
together of exoskeletal prominences to create sound that is
necessary for identifying the location of potential mates. To
generate the sound, the stylet 12 must be advanced forward and
backward in rapid succession. In order to accomplish the necessary
motion, the end of the stylet 12 at the hub end of the catheter 500
may be attached to a motorized device that can move the stylet 12
the correct distance, which may be from less than one centimeter of
displacement up to 2 centimeters and at the correct speed in order
to optimize the sound that is created.
[0145] Another method of sound generation may involve the stylet 12
hitting against a solid member at the catheter 500 tip to generate
a repetitive ping. This vibratory sound generation would require
that the stylet 12 be actuated or maneuvered by a motorized process
that is controlled at the proximal end of the stylet 12, which is
outside the patient. The stylet 12 is attached to a motorized
device that will cause the stylet to move in the appropriate
direction and the appropriate distance in order to optimize the
sound. FIG. 3 shows an embodiment in which the motion required is
perpendicular to the stylet 12 axis and FIG. 4 shows an embodiment
in which the motion required is parallel to the stylet 12 axis.
FIG. 3 includes catheter 500, catheter lumen 10, stylet 12, sound
waves 16, stylet tip 22, solid members 20, striker 24 and motion of
striker 24 to create sound waves 16. FIG. 4 includes catheter 500,
catheter lumen 10, stylet 12, sound waves 16, stylet tip 22, solid
member 20, striker 24 and motion of striker 24 to create sound
waves 16.
[0146] If a vibrating valve is used to produce sound, motion of a
valve flap 30 or valve flaps 40 is induced by the rapid injection
of a liquid or gas such as CO.sub.2 through the catheter lumen 10
within which valve resides (FIGS. 5 and 6). FIG. 5 includes
catheter 500, catheter lumen 10, sound waves 16, single flap valve
30 and gas/fluid flow path 32. FIG. 6 includes catheter 500,
catheter lumen 10, sound waves 16, valve flaps 40 and gas/fluid
flow path 32. The sound generated by the flap motion may be
amplified by the shape of the more distal catheter lumen 10 and
exit port distal to the flap as illustrated in FIG. 7. FIG. 7
includes catheter 500, catheter tip 46, amplified channel or
chamber 48, gas filled lumen 42, membrane 44 and amplified sound
waves 46 from membrane 44.
[0147] If a pneumatic system is employed, the catheter lumen 10
that is in contact with the membrane 44 at the catheter 500 tip is
attached at the catheter 500 hub to a gas compressor device that
causes rapid pneumatic pressure fluctuation, thereby distending the
membrane 44 at an optimal frequency, thereby generating a sound
wave that propagates through the patient's blood and adjacent soft
tissues such that it can be detected by the auscultation devices
that are placed on the patient's skin. FIG. 8 illustrates a
simplified embodiment in which the membrane 44 is situated at the
terminal side port of a lumen 10. FIG. 8 includes catheter 500,
catheter tip 46, gas filled lumen 42, membrane 50, sound waves 16
and side port 52. FIG. 7 illustrates an embodiment, in which a
convoluted lumen 10 acts as an amplifier, thus enabling a smaller
sized membrane 44 that can be positioned in the more proximal lumen
or located at the tip of an insertable catheter 500 that can then
be removed after performing the sound triangulation procedure for
verification of catheter tip position.
[0148] The sound waves that are generated by all methods described
above are optimized for best detection by the amplified
auscultation devices that are placed on the patient's skin by means
of an adhesive attachment. The placement of the auscultation
devices may be such as to optimize sound detection and
triangulation to determine the sound source. For example,
auscultation detectors should be placed in areas that will permit
propagation of the sound waves in a direct path through solid
tissue from the source to the detector instead of areas of the skin
where a direct path from the catheter tip to the detector would
pass through lung tissue for example. Potential ideal locations for
detecting sound generated within the caval-atrial junction or lower
1/3 of the IVC along a direct path include but may not be limited
to: [0149] 1) skin overlying the right internal jugular vein at the
base of the neck, [0150] 2) skin overlying the right 4th
intercostals space adjacent to the sternum, [0151] 3) skin
overlying over the ipsilateral and/or contralateral subclavicular
space (relative to the side of catheter insertion) at the junction
of the medial 2/3 and lateral 1/3 of the clavicle, two
fingerbreadths below the clavicle.
[0152] Detected sound frequencies and amplitudes are analyzed and
processed by the handheld system according to specific algorithms
and a the sound source is displayed on the handheld GUI, with the
source shown relative to the auscultation devices that are depicted
as reference points on a graphical human torso. FIG. 9 illustrates
the basic configuration of auscultation devices and user interface.
FIG. 9 includes a patient 64, auscultation devices 66, position 1,
position 2, position 3, leads 68, location of sound source 62,
display 60, processor 70 and image 71 on GUI as a result of
processing.
2.1.2 Interaction with Transcutaneous Energy Source
[0153] An aspect of the invention relates to using two or more
focused energy transmitters and receivers in order to detect each
others presence in each others field of view. The overlap region
between the fields of view of the two or more energy elements is
indicative of the relative location of the energy elements with
respect to each other. Techniques triangulation (Brisken), marking
with active/passive elements (Breyer), synchronized imaging
(Frazin).
[0154] Aspects of the following embodiments share some or all of
the following characteristics:
[0155] 1. Use of the effect of interference between two ultrasound
energy elements on the Doppler frequency shift. The Doppler capable
detecting elements detects the presence of the other element or of
the energy emitted by the other element in its field of view by
detecting artifacts in the Doppler frequency shift.
[0156] 2. Visualization of small targets without requiring
synchronization between energy elements.
[0157] 3. Use of an endovascular element to detect the presence of
the field of view of the imaging device.
[0158] 4. The ability of an endovascular Doppler sensor to detect
Doppler frequency shifts as a result of interference with another
ultrasound energy source working at a different frequency and
unsynchronized.
[0159] 5. Methods to determine position of an energy element in the
anatomy without X-ray imaging, without expensive automatic
triangulation and with the accuracy of the region of overlap
between the fields of view of the two energy elements.
[0160] These and other aspects of the various embodiments of the
invention will be appreciated in the description that follows.
[0161] FIG. 10 includes an external ultrasound system 20,
transducer 23, wire 21, endovascular ultrasound system 25,
endovascular probe 24, external connection 26 and patient 22. In
FIG. 10 an ultrasound system (74) and transducer (23) are used as
an external (transcutaneous or transesophageal) energy source. The
system (20) may be Doppler capable. An endovascular probe (24,
catheter, wire, stylet) has an ultrasound sensor attached to it and
is connected to a Doppler capable ultrasound system (25). The
external and the endovascular Doppler systems may be synchronized
via an external connection (26).
[0162] The system (20) may be one like the Bard SiteRite
(www.bardaccess.com) or the SonoSite iLook (www.sonosite.com)
system working at frequencies between 4 and 8 MHz. The Doppler
endovascular probe (24) may work at 10 MHz and be similar to those
described in the VasoNova patent applications.
[0163] FIG. 11 illustrates possible ultrasound beam geometry as
generated by the transducer 23, called field of view. FIG. 11
includes transducer 23, sensor 27 and axis 28. FIG. 11 also
illustrates the ultrasound beam geometry (field of view) generated
by the ultrasound sensor of the endovascular probe. When the field
of view of the endovascular ultrasound sensors overlaps with the
field of view of the transducer (23) energy interference patterns
can be detected by both systems.
[0164] The interference patterns may be created either a) by direct
transfer of energy from one ultrasound sensor to another in the
field of view or b) through perturbations in the medium created by
one sensor which are detected by the other sensor. For example, the
transducer (23) can generate waves in the blood within the vessel
where the endovascular probe resides and the endovascular Doppler
sensor detects the effect of such waves on blood. The interference,
i.e. the transfer of acoustic energy may occur at the central or
harmonic frequencies as well as at any other resulting interference
frequency which is within the bandwidth of the individual
ultrasound sensors.
[0165] Interference patterns are detected by the system (20)
through the sensor (23). Additionally or alternatively the
interference patterns may be detected by the endovascular
ultrasound Doppler system.
[0166] In one embodiment an ultrasound imaging system like SiteRite
or SonoSite is used to image the heart towards the caval-atrial
junction. An intravascular device (catheter, wire, and stylet) with
a Doppler-capable sensor is inserted through the vasculature and
guided towards the heart. The endovascular sensor is connected to a
Doppler system which produces signals in accordance with the
Doppler frequency shift detected by the sensor. When the
endovascular sensor navigates through a vessel, e.g., the SVC and
the caval-atrial junction, which is in the field of view of the
imaging transducer, the energy emitted by the imaging transducer
interferes with the energy emitted by the endovascular probe and
the Doppler system connected to the endovascular probe generates
signal patterns representative of the interference. Based on these
patterns, a user observing the Doppler signals generated by the
endovascular probe can infer that the endovascular sensor is
situated in the field of view of the imaging probe looking towards
the caval-atrial junction. Thus the position of the sensor in the
caval-atrial junction is confirmed without having to visualize the
catheter in the ultrasound image and without the need of a chest
X-ray.
[0167] In a further embodiment a Duplex ultrasound imaging system
like the Aspen model from Acuson Siemans, Inc. (Mountain View,
Calif.) is operated in a Duplex mode: simultaneous imaging and
pulsed wave (PW) Doppler or continuous wave (CW) Doppler. The 2D
imaging window can show the blood vessel where the endovascular
probe is located and the Doppler window shows the Doppler velocity
information. In PW mode the sample window is shown over the 2D
image. When the endovascular sensor is in the field of view of the
CW or in the sample window of the PW mode, a Doppler artifact
showing velocity patterns representative of the interference
between the two energy elements is shown in the Doppler window.
Thus the position of the endovascular sensor is detected.
[0168] In a further embodiment a transcutaneous CW or PW pencil
probe is used to monitor blood flow in a peripheral blood vessel,
e.g., the internal jugular vein. A Doppler-capable endovascular
probe is advanced through the internal jugular vein. When the
endovascular and the transcutaneous probes are within the field of
view of the other, each detects Doppler velocity artifacts
representative of the interference patterns. A similar technique
applies in the case of multiple endovascular probes.
[0169] In a further embodiment the two or more energy elements can
be synchronized, such that one emits at a certain delay with
respect to the other, e.g., in the receive window of the other.
This allows for calculating the distance between probes by knowing
the transmit delay and assuming a certain velocity in the anatomy.
Thus depth and distance separation/resolution can be achieved. The
two energy elements can communicate with each further using coded
excitation. If one of the elements generates a certain code
pattern, the other one receiving it can identify the presence and
location of the transmitting element.
[0170] In a further embodiment several locating energy elements can
be used to calculate the location of a target energy element by
using triangulation. In such a situation the multiple locating
elements serve also as reference or as a coordinate system.
Alternatively only one locating energy element can be used to
locate a target energy element by triangulation if the locating
element is moved from place to place in a controlled manner; such
that each time the target is located the position is calculated and
stored. After a number of such computations taken with the same
locating element at different times and from different locations,
the position of the target can be reconstructed. In such a case the
reference/coordinate system is determined by anatomical landmarks
relative to which both the single locating element and the target
can be positioned.
2.2 Transducer Placement Concepts
[0171] There exist at least two important concepts with respect to
optimizing data acquisition from the transducer: radial distance
from the inside vessel wall, and axial alignment with respect to
blood flow. Each factor influences the quantity and quality of data
acquired by the ultrasound transducer.
2.2.1 Radial Distance
[0172] Fluid flowing through the inner diameter of a lumen has
different characteristics with respect to flow velocities nearer to
the vessel wall than farther towards the center of the lumen: the
flow may be more turbulent and slower at the periphery. To take
advantage of this known difference thereby avoiding undesirable
data acquisition, is the concept of orienting the transducer a
minimum distance from the vessel wall as seen in FIG. 12. FIG. 12
includes catheter shaft 500, ultrasound transducer 502, transducer
beam 504 and vessel wall 510.
[0173] The minimum distance, x, may be determined empirically, or
it may be determined by traditional fluid dynamics calculations.
This distance may be expressed as a percentage of the lumen
diameter, or it may be an absolute number irrespective of lumen
dimension.
[0174] This application describes several concepts of achieving
this radial distance in the following device embodiments.
2.2.2 Axial Alignment
[0175] Fluid flowing through the inner diameter of a lumen has a
`preferred` axis of flow that mostly follows the shape of the
vessel axis it is flowing within. This preferred axis may be
described as that which facilitates the largest magnitude velocity
flow vector. Therefore, different characteristics with respect to
flow velocities may be found as alignment shifts in an angular
sense from the central vector. To take advantage of this known
difference thereby avoiding undesirable data acquisition, is the
concept of aligning the transducer at an angle from the flow axis
as shown in FIGS. 13A and 13B. FIGS. 13A and 13B include vessel
wall 510, transducer 502, transducer beam 504, catheter shaft 500,
transducer axis 506 and fluid flow axis 508.
[0176] The axial offset angle may be expressed as an angular value,
.alpha., and this may again be empirically determined or be
expressed by traditional fluid dynamics calculations. The angle may
be expressed as a percentage of vessel curvature, or it may be an
absolute irrespective of vessel configuration.
[0177] Several general concepts of achieving this axial alignment
can be applied to the embodiments described in this application.
These embodiments allow for a more flexible portion of the device
just proximal to the transducer, and relative to the remaining
portion of the catheter, that can be manipulated by the flow in the
vessel. Because these sections are able to be biased by fluid flow,
the transducer is more likely to find a position in the position of
maximum flow.
[0178] FIG. 14 shows a transition section 522 made of a relatively
much more flexible material 528 than what the proximal 520 or
distal 524 sections are made of. FIG. 14 includes catheter shaft
500 comprising a proximal section 520, transition section 522,
distal section 524, flexible material 528 and ultrasonic transducer
502. However to prevent likely kinking of a softer material is the
concept of sandwiching a stiffening member to provide maximum
kink-resistance yet impact flexibility as little as possible. This
may be accomplished with a coil or braid or other axially-involved
members. The stiffening material may be metallic or polymeric in
nature.
[0179] FIG. 15 shows a concept similar to the transition tube,
except that the transition section essentially becomes the entire
distal section 524 of the catheter shaft 500. FIG. 15 includes
catheter shaft 500 comprising a proximal section 520, distal
section 524, flexible material 528 and ultrasonic transducer 502.
Again, this could be reinforced with a coil or braid of a metal or
a polymer.
[0180] FIG. 16 depicts another concept of axial alignment in that
instead of the distal section 524 being tubing, it is made mostly
out of a solid flexible material, such as a polymer. FIG. 16
includes catheter shaft 500 comprising a proximal section 520,
distal section 524, flexible material 528 and ultrasonic transducer
502.
[0181] FIG. 17 shows another concept of axial alignment facilitated
by a tether component. The tether is again very flexible in nature
and affixed tightly to the distal end of the proximal shaft. FIG.
17 includes catheter shaft 500 comprising a proximal section 520,
tether 526 and ultrasonic transducer 502. The tether can be made of
metal or polymer, and the polymer may be reinforced to increase
tensile strength.
2.3 Catheter Type
[0182] Embodiments of the inventive device include three basic
forms: catheter-based, stylet-based & guidewire-based. Some
embodiments of the vascular access device may be considered
catheter-based, utilizing no removable components. Other
embodiments are stylet-based, utilizing a removable component
designed to work within the catheter. Other embodiments are
guidewire-based, utilizing a removable component designed to work
without the catheter. Combinations of the three basic forms are
also possible.
[0183] Fluid delivery can be achieved through the catheter shaft in
any of the configurations described here within in a number of
ways. In a preferred embodiment, the catheter has a closed distal
end, is power-injectable and has distal side ports for fluid
delivery. These side port(s) can be located along the catheter
shaft to comply with pressure and flow rate requirements as well as
to provide for optimal access location. Each lumen can have one or
more ports and each catheter can have one or more lumens. FIGS. 18A
and 18B show preferred embodiments of two power-injectable lumens
each with one side port for fluid delivery adjacent to the closed
distal tip. In another preferred embodiment, the power-injectable
catheter has fluid ports that exit straight out the distal catheter
tip. FIG. 18A includes catheter shaft 500, ultrasonic transducer
502, braid 538, fluid 530, ECG 534 and actuation tube 532. FIG. 18B
includes a distal section 524, ultrasonic transducer 502, braid
538, fluid 530, ECG 534 and actuation tube 532.
2.3.1 Catheter-Based
[0184] Catheter-based devices are "all-in-one" type devices in
which no component is completely removable. These remain entirely
intact during catheter advancement, drug delivery and subsequent
implant dwell time.
[0185] Embodiments of the catheter-based inventive device include
three basic forms: flow-directed, sensor-directed (passive) and
sensor-directed (active). Some embodiments of the catheter-based
vascular access device have catheter tips directed mostly by fluid
flow within the vasculature. Other embodiments are passively
directed by the sensor(s) during catheter advancement through the
vasculature. Other embodiments require active manipulation of the
catheter tip to acquire and or optimize the data collected by the
sensor(s).
2.3.1.1.1 Flow-Directed
[0186] In the flow-directed embodiments of the catheter-based
vascular access device, placement of the device is `automatic` in
that minimal user interaction is required to position the catheter
at the target site. The catheter is positioned `automatically` by
utilizing the blood flowing adjacent to and around it. The
sensor(s) are therefore used to verify catheter tip placement at
the desired target site as opposed to providing information during
advancement to facilitate the advancement itself.
2.3.1.1.1 Shaft Surface-Mounted, Balloon Embodiments
[0187] In these embodiments, blood flow is utilized by way of a
flow-directable member mounted onto the catheter shaft surface that
takes the form of a balloon. The balloon is inflated from a
proximally-located port by techniques well-known to those skilled
in the art of balloon catheters.
[0188] FIG. 19 is a side view of a shaft surface-mounted balloon
embodiment. FIG. 19 includes vessel wall 510, catheter shaft 500,
transducer 502 and balloon 540. The balloon 540 material, either
compliant or non-compliant, is mounted onto the catheter shaft 500,
and the transducer 502 is left at the distal tip. In one
embodiment, the balloon 540 is considered symmetrical in both the
axial and radial directions. Balloon embodiments may impede blood
flow around the transducer causing a signal substandard to that
which could otherwise be obtained were more blood allowed to flow
around and adjacent to the transducer. In another embodiment, a
profiled balloon 540 is mounted to the catheter shaft 500 surface,
as shown in the side and end views of FIG. 20. FIG. 20 includes
vessel wall 510, catheter shaft 500, transducer 502 and balloon
540. It is believed that the profiled shape facilitates blood flow
near the transducer 502.
[0189] FIG. 21 shows an alternate embodiment of a catheter shaft
500 surface-mounted balloon embodiment with 2 radially asymmetric
balloons placed on the catheter shaft 500. FIG. 21 includes
catheter shaft 500, transducer 502 and proximal balloon 540 and
distal balloon 542. From a radial perspective, the flow is
circumferentially captured to maximize the use of a balloon 542 or
544 as a sail. The balloons 542 and 544 are staggered from an axial
point of view to facilitate more blood flow around and adjacent to
the transducer. While two balloons are shown, more or less may be
used.
[0190] FIGS. 22A, 22B, and 22C depict embodiments in which a
balloon 586 is mounted onto a catheter shaft 500 such that less
than 180 degree, measured circumferentially with respect to the
catheter shaft 500, is covered by the balloon material. FIGS. 22A,
22B and 22C include vessel wall 510, catheter shaft 500, transducer
502, balloon 586, strap 584 and beam profile 590. A non-distensible
member, i.e. a `strap` 584, is placed over the balloon 586 in an
axial direction to facilitate mostly catheter 500 shaft bending and
minimally balloon 586 inflation. The assembly is straight when the
balloon 586 is uninflated. Once inflation is complete, the distal
catheter 500 shaft is deflected and becomes a flow-directable
member, thereby moving the catheter tip into the blood flow
facilitating movement through the blood vessel.
2.3.1.1.1.2 Shaft Surface-Mounted, Non-Balloon Embodiments
[0191] In these embodiments, blood flow is utilized not by
balloons, but by flow-directable members mounted onto the catheter
shaft surface and actuated from the proximal handle via several
methods well-known to those skilled in the art of catheter
actuation, i.e.: push/pull tube or wire, outer diameter sheath,
etc.
[0192] FIG. 23 shows an embodiment of the catheter-based
flow-directed vascular access device in which a flow-directable
component, shown in the figure as an axially-compressed braid 544,
is mounted directly on the exterior surface of the catheter 500
shaft. FIG. 23 includes catheter shaft 500, ultrasonic transducer
502, braid 544, fluid 530, ECG 534. In one embodiment, the braid
544 component is manufactured in such a way such that the radial
expansion of the fibers is maximized. The braid 544 material can be
metallic or polymer-based. The amount of flow captured by the braid
544 can be varied depending upon the number of filaments used or
the diameter of same.
[0193] FIG. 24 shows another proximally-actuated and shaft
surface-mounted embodiment in which the catheter 500 shaft itself
is split such that movement of the distal tip in a proximal
direction will cause the shaft 500 to splay outward thereby
creating a flow-directable component. FIG. 24 includes catheter
shaft 500, transducer 502, strip 552.
[0194] The flow-directability of any of the configurations
described in the previous figures can be augmented by placing a
covering of some sort to capture more of the flow. The amount
captured may be fine-tuned by varying such features as the density
(i.e.: placing perforations in the material), or flexibility as
well.
[0195] FIG. 25 shows yet another proximally-actuated and shaft
surface-mounted embodiment in which an umbrella-like component acts
as the flow-directable member. FIG. 25 includes catheter shaft 500,
transducer 502, umbrella 554.
2.3.1.1.2 Tip-Mounted Embodiments
[0196] In these embodiments, blood flow is utilized by way of a
flow-directable member mounted directly onto the catheter tip
instead of the shaft surface.
[0197] Any of the configurations shown in FIGS. 15, 16 and 17 as
alignment examples are also candidates for embodiments relating to
tip-mounting, with no retraction. The concept is that the lighter
the transducer assembly is, the more likely it will be to float in
the vasculature.
2.3.1.1.2.1 Distally-Housed Embodiments
[0198] In these embodiments, blood flow is again utilized by
flow-directable members, but instead of being mounted onto the
catheter shaft surface, they are mounted to an internally-based
actuation tube that is actuated from the proximal handle via
methods well-known to those skilled in the art of catheter
actuation. Once the flow-directable member is no longer needed, it
may be retracted into the distal catheter shaft.
[0199] FIG. 18A shows a perspective view of an embodiment of the
flow-directed catheter-based vascular access device in which a
flow-directable component is `housed` inside the distal end of a
catheter shaft. In this particular embodiment, the flow-directable
component is an open-ended braid shaped similar to the `Lacrosse`
basket. It is predisposed to an expanded or open configuration, and
collapses when pulled inside the distal catheter housing. The
transducer is mounted within the braid, and both are mounted onto
an actuation tube. The actuation tube houses the transducer wire
and the ECG wire as well. The braid and actuation tube may be made
entirely out of a polymer, entirely out of a metal or a combination
of both. If the tube was made of a conductive material or
encapsulated a conductor of some sort, it could double as the ECG
lead as well. The actuation tube is actuated from the proximal
catheter handle.
[0200] In this particular embodiment, the braid is designed such
that it captures the majority of blood flowing through the lumen,
in order to facilitate movement of the device through the
vasculature, yet still allows enough blood to flow through it to
provide data for the transducer to utilize. This concept may
facilitate device movement in the correct direction (with flow),
averting the need to influence or steer the tip. Then as the need
for influencing or steering the tip diminishes, the importance of
catheter shaft torque-ability is also reduced. This in turn
facilitates the use of a softer, more flexible catheter shaft
compliant to the vessel and more comfortable to the patient.
[0201] FIG. 18B shows a close-up cross-sectional view of the distal
catheter shaft of FIG. 18A. The catheter shaft is made of a
proximal and distal section. The proximal section is made up of at
least 3 lumens: two for separate fluid delivery ports and one for
the actuation tube. The distal section may be a single lumen tubing
that `houses` the collapsed braid.
[0202] By relocating the fluid ports just proximal of the distal
`house` (as shown in FIG. 18B), precious catheter `real estate` is
optimized: the distal section is reserved for a bulky
flow-directable member, while the slimmer actuation member follows
the fluid lumens back to the proximal handle.
[0203] The `Lacrosse` braid design may be made by turning a simple
braided tube back onto itself. In this configuration, the very
distal or most expanded end may be difficult to retract into the
housing in terms of the pull force required. To minimize this
force, the very distal end may be asymmetrical in nature so that
the entire circumference isn't pulled into the distal house
concurrently.
[0204] Alternatively, the flow-directable member can be made up of
self-expanding struts covered by a sail material, such as a
biocompatible flexible material, e.g., ePTFE or other suitable
biocompatible sheet, as shown in FIG. 26. FIG. 26 includes distal
catheter shaft 500, transducer 502, struts 562, sail basket 560 and
actuation tube 564.
[0205] FIG. 27 shows another perspective view of another embodiment
of a distally-housed flow-directed device that uses an
axially-compressed braid as a flow-directable member. FIG. 27
includes distal catheter shaft 500, transducer 502, braid 544 and
actuation tube 564.
[0206] FIG. 28 shows a perspective view of another embodiment of a
distally-housed flow-directed device that uses a balloon as a
flow-directable member. FIG. 28 includes distal catheter shaft 500,
balloon 570, transducer 502 and actuation tube 572. In this
concept, the distal catheter section may not facilitate collapse of
the flow-directable member, as in the case of the other described
embodiments, it may simply house the flow-directable member.
[0207] In any of the described configurations, the transducer may
be mounted on the flow-directed component in such a way to optimize
the signal acquired, in other words, distal to the component or so
that the transducer signal is not attenuated by the component's
presence.
[0208] Alternatively, the transducer could be mounted on a tether
(as previously described in FIG. 20). FIG. 29 illustrates a
transducer tether embodiment. FIG. 29 includes distal catheter
shaft 500, transducer 502, tether 573 and actuation tube 564.
2.3.1.2 Sensor-Directed (Passive)
[0209] In the passive sensor-directed embodiments of the
catheter-based vascular access devices, placement of the device is
facilitated by data received passively from the sensor(s) located
on the catheter shaft during catheter advancement. User interaction
is required to advance the catheter according to the data received
and displayed by the sensor(s), and the sensor(s) are again used to
verify catheter tip placement at the desired target site. However,
no user interaction is required to optimize the sensor(s)
information received in these embodiments: this function is
passively accomplished by virtue of the catheter design.
[0210] To accomplish passive acquisition of sensor data or data
acquisition that does not require user interaction to facilitate
either its basic acquisition or optimization of, the distal
catheter design needs to accomplish two things. First, the distal
catheter design needs to facilitate placement of the sensor a
minimum distance, when measured radially, from the vessel wall to
insure that enough flow, as well as steady flow is experienced in
the area directly adjacent to the sensor (as described in section
2.3.1). Second, the distal catheter design needs to facilitate
axial alignment of the ultrasound sensor with respect to the flow
of blood adjacent to it (as described in section 2.3.2).
Shaft Surface-Mounted Balloon Embodiments
[0211] In these embodiments, radial distance from the vessel wall
and/or axial alignment is achieved by a balloon member mounted onto
the catheter shaft. The balloon is inflated from a
proximally-located port by techniques well-known to those skilled
in the art of balloon catheters.
[0212] FIGS. 19, 20 and 21, as previously described, are examples
of shaft-mounted balloon embodiments that could facilitate radial
distance from the vessel wall.
[0213] One of the challenges in achieving the desired radial
distance with the embodiments shown in FIGS. 19 and 20 is when the
tip is adjacent to the vessel wall 510 while in a curve. As
illustrated in FIG. 30A, when the balloon 576 is mounted too far
proximal on the catheter shaft 500 with respect to the sensor
location, the sensor may still be positioned against the wall 510
even when the balloon is inflated. One of the ways in which a
balloon embodiment can address this issue is by being mounted as
far distal, with respect to the sensor, as possible, as shown in
FIG. 30B. Both FIGS. 30A and 30 B include catheter shaft 500,
transducer 502, balloon 576, vessel wall 510.
[0214] FIG. 31 shows a shaft surface-mounted balloon embodiment,
building on the idea described in FIGS. 30A and 30B, in which the
balloon 540 is mounted on the catheter shaft 500 so that it extends
distally beyond the location of the sensor.
[0215] Should flow restriction again become an issue and prevent
the sensor from acquiring a signal, as previously described, a
profiled balloon could be used as shown in FIG. 32.
[0216] Another balloon embodiment may include a balloon mounted
entirely on the distal catheter tip, completely covering the
sensor, as shown in FIG. 33. In this embodiment, the balloon 582
would need to be filled with a medium transparent to the ultrasound
frequencies of the sensor used, i.e.: saline or water.
[0217] Further, any of the balloon embodiments could offer
adjustable radial distances depending upon the amount of fluid
injected into the proximal port and the resulting amount of balloon
inflation.
Shaft Surface-Mounted, Non-Balloon Embodiments
[0218] In these embodiments, radial distance from the vessel wall
and/or axial alignment is achieved by radially expanding members
mounted onto the catheter shaft surface and actuated from the
proximal handle via several methods well-known to those skilled in
the art of catheter actuation, i.e.: push/pull tube or wire, outer
diameter sheath, etc.
[0219] FIGS. 23, 24 and 25, previously described, show embodiments
of catheter-based and sensor-directed vascular access devices in
which shaft surface-mounted components facilitating passive data
acquisition by the sensor provide a circumferential radial offset
of the catheter tip with respect to the vessel wall.
Distally-Housed Embodiments
[0220] In these embodiments, radial distance from the vessel wall
and/or axial alignment is achieved by radially expanding members
mounted to an internally-based actuation tube that is actuated from
the proximal handle via methods well-known to those skilled in the
art of catheter actuation. Once the radially expanding member is no
longer needed, it may be retracted into the distal catheter
shaft.
[0221] The embodiments shown in FIGS. 18A, 26, 27 and 28,
previously described, show embodiments of the catheter-based and
flow-directed vascular access devices, however these same
embodiments can be used for the passive sensor-directed embodiments
as well. The same expanding members may facilitate radial expansion
and axial alignment for passive data acquisition.
[0222] As previously described, relocating the fluid ports just
proximal of the distal `house` conserves precious catheter `real
estate`: the distal section is reserved for a bulky flow-directable
member, while the slimmer actuation member follows the fluid lumens
back to the proximal handle.
2.3.1.3 Sensor-Directed, Active
[0223] In the active sensor-directed embodiments of the
catheter-based vascular access devices, placement of the device is
facilitated by data received from the sensor(s) located on the
catheter shaft during catheter advancement by actively manipulating
the catheter shaft and subsequently the catheter tip. User
interaction is required to advance the catheter according to the
data received and displayed by the sensor(s), and the sensor(s) are
again used to verify catheter tip placement at the desired target
site. User interaction is also required to optimize the sensor(s)
information received in these embodiments as this function cannot
be accomplished by virtue of the catheter design alone.
[0224] The distal catheter design may be modified to accomplish
active acquisition of sensor data, or data acquisition that
utilizes user interaction to facilitate either its basic
acquisition or optimization. The distal catheter design may
facilitate placement of the sensor a minimum distance, when
measured radially, from the vessel wall to insure that enough flow,
as well as steady flow is experienced in the area directly adjacent
to the sensor (as described in section 2.3.1). The distal catheter
design may facilitate axial alignment of the ultrasound sensor with
respect to the flow of blood adjacent to it (as described in
section 2.3.2). Further, the distal catheter design may facilitate
radial distance and axial alignment on demand, by the user.
2.3.1.3.1 Shaft Surface-Mounted, Balloon Embodiments
[0225] In these embodiments, radial distance from the vessel wall
and/or axial alignment is achieved by a balloon member mounted onto
the catheter shaft. The balloon is inflated from a
proximally-located port by techniques well-known to those skilled
in the art of balloon catheters.
[0226] FIGS. 22A, 22B and 22C, previously described, depict
embodiments in which the distal catheter shaft is deflected and the
sensor is moved away from the vessel wall. This movement may not
only optimize the data the ultrasound sensor is to acquire, but
facilitate the very acquisition of that data in the first place.
Furthermore, to facilitate sensor axis alignment to the blood flow
once tip actuation has taken place, the sensor can be mounted in an
off-axis or skewed manner. The angular difference depends on the
amount of catheter bend created by balloon inflation, and this can
be pre-determined. FIG. 22A shows the un-inflated non-skewed
transducer mounted embodiment, and likely the resulting beam
profile. FIG. 22B shows the inflated state of the device and the
resultant improved transducer position away from the vessel wall;
however an unimproved beam profile may still remain. FIG. 22C shows
the inflated state of the device couple with an off-axis mounted
transducer that provides for a more optimum beam profile.
[0227] FIG. 21, previously described, shows at least 2 `staggered`
balloons that facilitate flow around the catheter shaft, however
were just one balloon placed and further inflated, it could provide
a means by which the user could actively reposition the catheter
with respect to the vessel wall as needed during catheter
advancement and subsequent placement at the target site.
2.3.1.3.2 Shaft Surface-Mounted, Non-Balloon Embodiments
[0228] In these embodiments, radial distance from the vessel wall
and/or axial alignment is achieved by radially expanding members
mounted onto the catheter shaft surface and actuated from the
proximal handle via several methods well-known to those skilled in
the art of catheter actuation, i.e.: push/pull tube or wire, outer
diameter sheath, etc.
[0229] FIGS. 23, 24 and 25, previously described, show embodiments
of catheter-based and sensor-directed vascular access devices in
which shaft surface-mounted components facilitate passive data
acquisition by the sensor by providing a circumferential radial
offset of the catheter tip with respect to the vessel wall.
However, were these members asymmetrical with respect to the radial
direction, they may also facilitate the ability to manually offset
the distal tip from a proximal actuation thereby creating active
direction to the sensor.
2.3.1.3.3 Distally-Housed Embodiments
[0230] In these embodiments, radial distance from the vessel wall
and/or axial alignment is achieved by radially expanding members
mounted to an internally-based actuation tube that is actuated from
the proximal handle via methods well-known to those skilled in the
art of catheter actuation. Once the radially expanding member is no
longer needed, it may be retracted into the distal catheter
shaft.
[0231] FIGS. 18A, 26, 27 and 28, previously described, show
embodiments of catheter-based and flow-directed vascular access
devices in which distally-housed components facilitate passive data
acquisition by the sensor by providing a circumferential radial
offset of the catheter tip with respect to the vessel wall.
However, were these members asymmetrical with respect to the radial
direction, they may also facilitate the ability to manually offset
the distal tip from a proximal actuation, thereby creating active
direction to the sensor.
[0232] As previously described, relocating the fluid ports just
proximal of the distal `house` conserves precious catheter `real
estate`: the distal section is reserved for a bulky flow-directable
member, while the slimmer actuation member follows the fluid lumens
back to the proximal handle.
2.3.1.3.4 Steerable Embodiments
[0233] In these embodiments, radial distance from the vessel wall
is achieved by a steerable distal catheter section actuatable from
the proximal handle by techniques well-known to those skilled in
the art of steerable catheters, i.e.: a distally-mounted pull-wire.
Once tip deflection is no longer needed, it may be relaxed into a
straight position. It is to be appreciated that steering techniques
may be used to provide desired transducer orientation within the
vessel.
[0234] FIGS. 34A and 34B show a catheter-based vascular access
device in which the proximal section is made of a relatively
stiffer material when compared to the distal section to facilitate
the columnar strength required during distal steering actuation.
FIGS. 34A and 34B include catheter shaft 500, proximal section 594,
pull wire 596, distal section 592 and beam profile 590. The
pull-wire 596 would be affixed to the distal section 592, either
proximal or distal to the sensor. The sensor could be mounted
off-center with respect to the catheter shaft 500, any where from
about 0 degrees to about 180 degrees, depending upon the angle
created by the pull-wire 596, as shown in FIG. 34A, or the sensor
could remain axially-oriented while the pull-wire 596 is affixed to
the distal catheter shaft 500 in a axially-aligned position, as
shown in FIG. 34B. Alternatively, the sensor could be positioned
such that it faces a backward direction as well.
2.3.2 Stylet-Based
[0235] Stylet-based devices allow the catheter to have
characteristics it normally wouldn't have without the stylet, i.e.:
stiffness or shape. Moreover, the stylet affords that catheter the
additional benefit of having these characteristics at certain
times, only when needed.
[0236] An additional benefit of the stylet-based device is that a
fluid lumen may be utilized for passage of the stylet since the
stylet will be removed once the catheter has been appropriately
placed. Since a lumen would not need to be dedicated to sensor(s)
or other functionality, precious `real estate` of an approximately
5 F or smaller catheter is optimized. The stylet embodiments in the
following sections can be used both with fluid lumens that exit out
the distal tip or out through side slots.
[0237] Embodiments of the inventive device include two basic forms.
Some embodiments of the stylet-based vascular access device are
passively directed by the sensor(s) during stylet/catheter
advancement through the vasculature. Other embodiments require
active manipulation of the stylet/catheter tip to acquire and or
optimize the data collected by the sensor(s).
2.3.2.1 Sensor-Directed, Passive
[0238] In the passive sensor-directed embodiments of the
stylet-based vascular access devices, placement of the device is
facilitated by data received passively from the sensor(s) located
on either the catheter or stylet shaft during catheter advancement.
User interaction is required to advance the catheter according to
the data received and displayed by the sensor(s), and the sensor(s)
are again used to verify catheter tip placement at the desired
target site. However, no user interaction is required to optimize
the sensor(s) information received in these embodiments: this
function is passively accomplished by virtue of the stylet/catheter
design.
[0239] The stylet design may be modified to accomplish passive
acquisition of sensor data, or data acquisition that does not
require user interaction to facilitate either its basic acquisition
or optimization. The stylet may facilitate placement of the sensor
a minimum distance, when measured radially, from the vessel wall to
insure that enough flow, as well as steady flow is experienced in
the area directly adjacent to the sensor (as described in section
2.3.1). The stylet may also facilitate axial alignment of the
ultrasound sensor with respect to the flow of blood adjacent to it
(as described in section 2.3.2).
[0240] FIGS. 35A and 35B show an embodiment of a sensor-directed
vascular access device in which a mostly circular pre-formed stylet
is advanced through a catheter lumen to create a passive mechanism
by which transducer position is maintained so that data can be
acquired. This is achieved via the stylet's 600 exit out a
distally-placed port, either out the side of the catheter shaft 500
or directly out the tip. FIGS. 35A and 35B include catheter shaft
500, transducer 502 and stylet 600. FIG. 35A shows a single loop,
similar to a `halo` in shape exiting a side port and FIG. 35B shows
multiple loops, similar to a `pig-tail`, also exiting out a side
port. Like a pig-tail, the loops diameters can get smaller, remain
the same, or get larger as one moves distally on the stylet
body.
[0241] FIGS. 36A and 36B show another embodiment utilizing a
pre-formed stylet to shape the catheter shaft itself without
exiting a side port. In this embodiment, the catheter would have to
accommodate a separate lumen for stylet delivery. FIG. 36A
illustrates the pre-formed stylet prior to entering the distal
section. FIG. 36B shows the shaped distal section with the stylet
in place. FIGS. 36A and 36B include catheter shaft 500, proximal
section 604, distal section 606, preformed stylet 602, transducer
502, beam profile 612 and vessel wall 510.
2.3.2.2 Sensor-Directed, Active
[0242] In the active sensor-directed embodiments of the
stylet-based vascular access devices, placement of the device is
facilitated by data received from the sensor(s) located on the
catheter shaft or stylet tip during catheter advancement by
actively manipulating the catheter shaft and subsequently the
catheter tip. User interaction is required to advance the catheter
according to the data received and displayed by the sensor(s), and
the sensor(s) are again used to verify catheter tip placement at
the desired target site. User interaction is also required to
optimize the sensor(s) information received in these embodiments as
this function cannot be accomplished by virtue of the catheter
design alone.
[0243] Coupled with a torque-able main/proximal catheter shaft 500,
any of the FIG. 40 designs may be utilized for actively placing the
sensor-directed catheter into the vessel, centrally with respect to
blood flow.
2.3.3 Guidewire-Based Devices
[0244] Guidewire-based devices may be used independently of the
catheter it is designed to work with; it may be used with other
catheters, assuming the sizing needs, i.e.: the inner diameter of
the catheter lumen accommodates the largest outer diameter of the
guidewire, are met.
[0245] Embodiments of the guidewire-based inventive device include
three basic forms. Some embodiments have tips directed mostly by
fluid flow within the vasculature. Other embodiments are passively
directed by the sensor(s) during guidewire/catheter advancement
through the vasculature. Other embodiments require active
manipulation of the guidewire/catheter tip to acquire and or
optimize the data collected by the sensor(s).
2.3.3.1 Flow-Directed
[0246] As previously described in both the catheter and
stylet-based devices, in the flow-directed embodiments of
guidewire-based vascular access devices, placement of the device is
`automatic` in that minimal user interaction is required to
position the catheter at the target site. The guidewire, and
subsequently the catheter itself, is positioned `automatically` by
utilizing the blood flowing adjacent to and around it. The sensor
is therefore used to verify guidewire/catheter tip placement at the
desired target site as opposed to providing information during
advancement to facilitate the advancement itself.
[0247] In these embodiments, blood flow is again utilized by
flow-directable members mounted directly onto the guidewire. The
guidewire is advanced into the vasculature, the flow-directable
component is actuated, and the guidewire is allowed to `float` to
the desired target site. Once the target site is believed to have
been reached, the user can verify position with the sensor(s). Then
when the guidewire is no longer required, it can be removed leaving
only the catheter shaft (with fluid delivery capability).
2.3.3.1.1 Guidewire-Mounted Sensor, Over the Wire
[0248] As described previously in Section 2.2, the catheter, once
placed, may be able to deliver at least 2 different fluids through
at least 2 dedicated lumens simultaneously. Further, the guidewire
should be able to enter the vasculature alone and first, and then
be completely removed. In an "over-the-wire" configuration, the
guidewire may further be able to be removed entirely within the
catheter shaft.
[0249] FIG. 37 shows an embodiment of an over-the-wire
guidewire-based device in which the sensor(s) is also mounted on
the guidewire 622. FIG. 37 includes distal catheter shaft 614,
fluid 616, guidewire 622, balloon 620 and transducer 502. In this
embodiment, the guidewire 622 would be advanced into the
vasculature, the balloon 620 would be inflated, the guidewire 622
would `float` to the target site, the position would be verified
with the attached sensor(s), the catheter (with fluid lumens) would
be advanced to the target site, the balloon would be deflated, and
the guidewire would be pulled out of the catheter.
[0250] Although this embodiment specifically illustrates a
balloon-based flow-directed member, other such members as
previously described that can collapse small enough to run through
an internal catheter lumen could also be utilized.
2.3.3.1.2 Catheter-Mounted Sensor, Over the Wire
[0251] FIG. 38A shows an embodiment of an over-the-wire
guidewire-based device in which the sensor(s) is mounted on the
catheter. FIG. 38A includes distal catheter shaft 614, fluid 616,
distal catheter tip 618, guidewire 622, balloon 620 and transducer
502. FIG. 38B shows an example of a possible cross-sectional
configuration of the distal catheter shaft (right-side of Figure)
vs. the very distal catheter tip (left side of Figure). FIG. 38B
includes distal catheter tip 630, distal catheter shaft 632, fluid
lumens 636, guidewire lumens 634 and transducer niche 638. In this
embodiment, the wire would be advanced into the vasculature, the
balloon would be inflated, the guidewire would `float` to the
apparent target site, the catheter (with fluid lumens and
sensor(s)) would be advanced to the apparent target site, the
position would be verified with the attached sensor(s), the balloon
would be deflated, and the guidewire would be pulled out of the
catheter.
[0252] Although this embodiment specifically illustrates a
balloon-based flow-directed member, other such members as
previously described that can collapse small enough to run through
an internal catheter lumen could also be utilized.
2.3.3.1.3 Guidewire-Mounted Sensor, Rapid Exchange
[0253] FIG. 39 shows an embodiment of a rapid exchange
guidewire-based device in which the sensor(s) is again mounted on
the guidewire 646, however the guidewire would not reside
completely within the entire catheter shaft 632 as in the
over-the-wire devices; instead, the guidewire 646 could reside only
within a small lumen located at the distal catheter tip. FIG. 39
includes distal catheter shaft 632, fluid 644, guidewire 646,
collapsed balloon 640, rapid exchange section 642 and transducer
502. This may allow larger fluid delivery lumens since a lumen
dedicated for the guidewire need not travel the entire catheter
length. In this embodiment, the wire 646 would be advanced into the
vasculature, the balloon would be inflated, the guidewire 646 would
`float` to the target site, the position would be verified with the
attached sensor(s), the catheter (with fluid lumens) would be
advanced to the target site, the balloon would be deflated, and the
guidewire 646 would be pulled out of the catheter.
[0254] Although this embodiment specifically illustrates a
balloon-based flow-directed member, other such members as
previously described that can collapse small enough to run through
a rapid exchange lumen could also be utilized.
2.3.3.1.4 Catheter-Mounted Sensor, Rapid Exchange
[0255] FIG. 40 shows an embodiment of a rapid exchange
guidewire-based device, as previously described, in which the
sensor(s) is again mounted on the catheter. FIG. 40 includes distal
catheter shaft 632, fluid 644, guidewire 646, collapsed balloon
640, rapid exchange section 642 and transducer 502. This may allow
larger fluid delivery lumens since a lumen dedicated for the
guidewire 646 need not travel the entire catheter length. In this
embodiment, the wire 646 would be advanced into the vasculature,
the balloon would be inflated, the guidewire would `float` to the
apparent target site, the catheter (with fluid lumens and sensor)
would be advanced to the apparent target site, the position would
be verified with the attached sensor(s), the balloon would be
deflated, and the guidewire would be pulled out of the
catheter.
[0256] Alternatively, the distal catheter shaft where the rapid
exchange lumen is located in FIG. 40 could be split in a
longitudinal fashion so as to facilitate removal of the guidewire
without needing the entire balloon assembly to retract through the
rapid exchange lumen.
[0257] FIG. 41 shows another embodiment of FIG. 40 in which one of
the distal fluid lumen ports could have a section that is split in
a longitudinal fashion as opposed to being completely open. FIG. 41
includes distal catheter shaft 632, fluid 644, guidewire 646,
collapsed balloon 640, separation 650 and transducer 502. The
distal guidewire 646 is retracted through the distal section of the
split port until the separator 650 feature reaches the split
section. The separator 650 then spreads and separates the entire
port length such that the entire guidewire 646 is freed from the
lumen and can be removed separately from the catheter shaft
632.
[0258] Although these embodiments specifically illustrate
balloon-based flow-directed members, other such members as
previously described that can collapse small enough to run through
a rapid exchange lumen could also be utilized.
2.3.3.2 Sensor-Directed (Passive)
[0259] In the passive sensor-directed embodiments of the
guidewire-based vascular access devices, placement of the device is
facilitated by data received passively from the sensor(s) located
on the guidewire or catheter shaft during catheter advancement.
User interaction is required to advance the catheter according to
the data received and displayed by the sensor(s), and the sensor(s)
are again used to verify catheter tip placement at the desired
target site. However, no user interaction is required to optimize
the sensor(s) information received in these embodiments: this
function is passively accomplished by virtue of the
guidewire/catheter design.
[0260] Any of the embodiments described in FIGS. 37, 38A, 38B, 39,
40 and 41 may be utilized to facilitate a passive sensor-directed
catheter positioning technique.
2.3.3.3 Sensor-Directed (Active)
[0261] In the active sensor-directed embodiments of the
catheter-based vascular access devices, placement of the device is
facilitated by data received from the sensor(s) located on the
catheter shaft during catheter advancement by actively manipulating
the catheter shaft and subsequently the catheter tip. User
interaction may be needed to advance the catheter according to the
data received and displayed by the sensor(s), and the sensor(s) are
again used to verify catheter tip placement at the desired target
site. User interaction may be utilized to optimize the sensor(s)
information received in these embodiments.
[0262] FIG. 42 shows an embodiment of a sensor-directed guide-wire
based device advanced to the target site via active manipulation of
the guidewire 646 during advancement by the user. FIG. 42 includes
guidewire 646, vessel wall 510, inflated balloon 652 and transducer
502. Assuming a torquable guidewire shaft is available, a
radially-asymmetric balloon could be mounted on the distal
guidewire end. Once inflated, the guidewire 646 could be actively
`steered` through the vasculature by using the off-set created by
the balloon 652. The left side of the figure shows an uninflated
balloon; the right side shows an inflated balloon 652.
[0263] Many of the previously described embodiments may also be
utilized to facilitate an active sensor-directed catheter
positioning technique.
3.0 Device for Securement of Proximal End of Access Device
[0264] Once the vascular access device has been placed and its
distal tip position confirmed, a means by which to secure the
proximal catheter shaft is needed. This proximal securement device
may hold the catheter hub in place and prevent migration with
respect to the skin incision, and may manage the connections,
whether electrical, fluid or actuation/inflation in nature.
[0265] A securement device is affixed to the patient's skin at a
suitable location near the puncture site using a suitable
biocompatible pressure sensitive adhesive. The securement device
has a mounting surface adapted to engage with the device hub
described herein. The device hub may be affixed to the mounting
surface using any suitable mechanical attachment, e.g. snaps,
friction lock or keyed surfaces. The device hub and/or the
securement device may include suitable RFID tags as described in
section 7.0.
[0266] Various details of the design for a securement device may be
appreciated through reference to U.S. Pat. Nos. 7,153,291 and
7,223,256, incorporated herein by reference in their entirety.
[0267] FIG. 43 shows an embodiment of a securement device that
attaches to the proximal catheter shaft 500 thereby minimizing
catheter tip migration from the target site. FIG. 43 includes pad
660, receiver 662, catheter shaft 500, hub 666 and skin incision
664 as well as connections such as fluid 670, electrical 674 and
actuator 672. To facilitate ease of use, connections may remain on
the catheter hub 666 itself, i.e., as `pigtails`, such as:
electrical 674 (to make the transducer and ECG connections), fluid
670 (to a luer fitting to facilitate inflation/deflation and fluid
delivery), or mechanical 672 (to facilitate some sort of distal
component actuation or manipulation).
[0268] FIGS. 44A and 44B show top and end views, respectively, of
an alternative embodiment of a securement device. FIG. 44A includes
pad 660, receiver 662, catheter shaft 500, catheter hub 666,
fasteners 676, docketing station 678 and skin incision 664 as well
as connections such as fluid 670, electrical 674 and actuation 672.
FIG. 44B includes adhesive epad 680, docket station 678, pad 660
and connections such as fluid 670, electrical 674 and actuation
672. In this embodiment, a smart catheter hub 666 is positioned on
the proximal end of the vascular access device. The smart hub 666
is designed such that the placement of the hub 666 into the
receiver would facilitate the necessary connections, i.e.:
transducer, electrical activity, fluid delivery . . . etc. This
could be accomplished by any number of methods, for example, the
hub could be snapped in place, held with Velcro or engaged with a
keyed mechanism. The smart catheter hub 666 includes all of the
connections for the added functionalities used in the vascular
access device. Once connected, the smart catheter hub 666
establishes the appropriate conductivity between the vascular
access device and the guiding system. In the illustrated
embodiment, the smart hub makes 666 connections for two electrical
674, two fluid 670 and one actuation 672 interfaces.
4.0 Device and Method for Improving Workflow Efficiency of Bedside
Patient Care
[0269] An aspect of the invention describes RFID and or barcode
based labeling and identification of devices and players in the
bedside care workflow. The invention also describes a method for
making use of such devices for workflow optimization. In particular
the invention relates to using two or more focused energy
transmitters and receivers in order to detect each others presence
in each others field of view.
[0270] Other aspects of the following embodiments share some or all
of the following characteristics:
[0271] The use of RFID concepts and RFID based devices (tags,
readers, synchronization and optimization) in medical care
workflow.
[0272] Tagging devices using RFID, barcodes or other suitable
machine readable indicators as well as using such tags for players
in the medical care workflow. Players include any of a variety of
heath care providers that interact with the patient and/or the
device, are responsible for dispensing the device or ensuring the
device is or remains properly placed during use.
[0273] Optimize medical workflow by maintaining and integrating
records of devices and activities, by programming activities on a
"just-in-time" basis as needed and as resources are available.
[0274] These and other aspects of the various embodiments of the
invention will be appreciated in the description that follows.
[0275] The VasoNova PICC system may provide for workflow tracking,
which is important for optimizing operational efficiency. More
PICCs can be placed in a given time period by identifying and
avoiding significant down time. To help in analyzing workflow and
time management during the PICC placement and confirmation process,
the VasoNova PICC system enables tracking by recording the time at
various key steps during the process.
[0276] A simple but comprehensive tracking system is setup with
three key time entries and various work types that are identified
and entered into the system by the operator.
[0277] In one embodiment, the three key time entries are: [0278]
Receive consult request [0279] Start `work` on case [0280] Stop
`work` on case
[0281] Non-limiting examples of primary work types are: [0282]
Gather patient data (check history, allergies, labs, etc.) [0283]
Transportation to case (cart/supplies) and patient consent [0284]
Sterile setup [0285] Venipuncture [0286] Catheter
insertion/placement [0287] Verification of tip position [0288]
Secure catheter [0289] Order/wait for x-ray [0290] Confirm catheter
ready for use
[0291] Other work types can be added as desired and work types can
be combined. For example sterile setup, venipuncture, catheter
insertion, verification, and securing catheter may be grouped
together as a single work type called `procedure`.
[0292] Data entry for tracking can be done by means of pressing
buttons located on a small mobile device that is to be worn as one
carries a pedometer or digital pager. The device interfaces with
the VasoNova handheld unit and it may be connected to the handheld
by a cord or it may have a wireless connection. Alternatively,
scanning bar codes or electromagnetic strips for example could
accomplish the data entry.
[0293] In the case of a data entry device with buttons, specific
tasks are tracked by pushing a `start` button followed by `task`
button that is highlighted by using `up` and `down` buttons that
are easily located on the device by their position and confirmed on
the GUI of the handheld. Once the task is completed, the `stop`
button is pushed, which then records the stop time for that task,
which is simultaneously recorded as the start time for the next
task in the process as illustrated in FIG. 45.
[0294] The VasoNova handheld GUI has a menu feature that indicates
which workflow interval is being tracked and the operator can
modify or change the present task by using the `up` and `down`
buttons on the data entry device as shown in FIG. 46. FIG. 46
includes handheld GUI 690, start button 692, stop button 694, up
button 696, enter button 698 and down button 700.
[0295] The buttons have different shapes and sizes that are easily
memorized by the operator so that they can be located and pressed
through a sterile gown if the device is clipped to the operator's
belt for example
[0296] The GUI will display the tasks and with the present task
highlighted as illustrated in FIG. 47. The task can be changed at
any time by pressing the up/down buttons on the data entry
device.
[0297] FIG. 48 shows the players in a medical workflow. According
to an embodiment of the invention, users e.g., hospital medical
personnel or players wear RFID tags or other machine detectable
labels. FIG. 48 includes users 106a and 106b, devices 108a, 108b,
108c and 108d, database 122, RFID reader 132a and 132b, workflow
processor 136 and sensor processor 138. Players may have their ID
integrated provided as a separate article of may be integrated into
an existing article used by the player, e.g., on their pager,
phone, PDA, nametag, and the like. Devices (S) have RFID tags or
barcodes on packaging labels. Patients have RFID tags associated
with them and on their documents. A Sensor Processor is integrated
with the VasoNova Guiding System (e.g., RFID tag reader). An
individual Workflow Processor 136 is integrated with the VasoNova
Guiding System. A centralized Optimization Processor is residing on
the server and makes use of the hospital database. RFID tags can be
placed on other pieces of equipment or with other players of the
bedside care system: radiologists, X-ray systems, etc. The VasoNova
RFID reader 132a/132b, the Sensor Processor 138 and the Workflow
Processor 136 integrated in the VasoNova Guiding System allow for
coordination of all players and for workflow optimization.
[0298] While RFID tags are used in the above description, the
invention is not limited only to the use of RFID tags but may
include the use of any suitable machine readable or detectable
device that may be configured for use in tracking the progress of a
medical procedure.
[0299] The U.S. Pat. No. 5,311,871 entitled "Smart Needle" by Paul
Yock is also incorporated by reference.
[0300] U.S. Pat. No. 6,860,422 "Method and Apparatus for Tracking
Documents in a Workflow" by -Hull et al. is also incorporated
herein by reference in its entirety.
[0301] Further, the following patents and published application are
incorporated herein by reference in their entirety:
[0302] U.S. Pat. No. 5,546,949
[0303] U.S. Pat. No. 4,706,681
[0304] U.S. Pat. No. 5,515,853
[0305] U.S. Pat. No. 5,830,145
[0306] U.S. Pat. No. 6,259,941
[0307] U.S. Pat. No. 6,298,261
[0308] U.S. Pat. No. 6,958,677
[0309] U.S. Pat. No. 7,054,228
[0310] U.S. Published Patent Application 20030036696.
[0311] While preferred embodiments of the present invention have
been shown and described herein, it will be obvious to those
skilled in the art that such embodiments are provided by way of
example only. Numerous variations, changes, and substitutions will
now occur to those skilled in the art without departing from the
invention. It should be understood that various alternatives to the
embodiments of the invention described herein may be employed in
practicing the invention. It is intended that the following claims
define the scope of the invention and that methods and structures
within the scope of these claims and their equivalents be covered
thereby.
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