U.S. patent application number 10/618223 was filed with the patent office on 2005-01-13 for lumen-measuring devices and method.
Invention is credited to Alexander, Tony D., Borg, Ulf R., Mangiardi, Eric K., Reynolds, Jason M..
Application Number | 20050010138 10/618223 |
Document ID | / |
Family ID | 33565093 |
Filed Date | 2005-01-13 |
United States Patent
Application |
20050010138 |
Kind Code |
A1 |
Mangiardi, Eric K. ; et
al. |
January 13, 2005 |
Lumen-measuring devices and method
Abstract
The present invention provides a lumen measuring device and
method that allows the user to calculate the exact length and
diameter of a suitable interventional prosthesis as well as the
height and length of stenosis during the same exploratory
procedure.
Inventors: |
Mangiardi, Eric K.;
(Charlotte, NC) ; Reynolds, Jason M.; (Charlotte,
NC) ; Borg, Ulf R.; (Cornelius, NC) ;
Alexander, Tony D.; (Charlotte, NC) |
Correspondence
Address: |
Tony D. Alexander
ALVEOLUS INC
c/o PortfolioIP
P.O. Box 52050
Minneapolis
MN
55402
US
|
Family ID: |
33565093 |
Appl. No.: |
10/618223 |
Filed: |
July 11, 2003 |
Current U.S.
Class: |
600/587 |
Current CPC
Class: |
A61B 5/103 20130101;
A61B 5/1076 20130101; A61B 5/6858 20130101; A61B 5/6853
20130101 |
Class at
Publication: |
600/587 |
International
Class: |
A61B 005/103 |
Claims
What is claimed is:
1. A device that allows a user to calculate the length and diameter
of a suitable interventional prosthesis as well as the height and
length of stenosis during the same exploratory procedure, the
device comprising: an exterior conduit longitudinally extending
between proximal and distal ends, the exterior conduit having
measurement markers formed on a portion thereof; an interior
conduit longitudinally extending between proximal and distal ends,
disposed within the exterior conduit, and displaceable with respect
to the exterior conduit, the interior conduit having a depth
marking mechanism visible through a portion of the exterior
conduit; a measurement assembly comprising at least two legs having
distal and proximal ends and inward facing and lumen facing
surfaces, the legs coupled with each other proximal the distal ends
thereof, the measurement assembly also coupled about the distal end
of the interior conduit; a handle operatively connected with the
measurement assembly, the handle comprising a means for opening and
closing the measurement assembly by actuating the handle along a
continuum between a first closed configuration and a second open
configuration.
2. The device of claim 1, wherein the inward facing surfaces of the
legs are substantially flush with one another when the measurement
assembly is closed.
3. The device of claim 2, wherein when the measurement assembly is
moved distally in relation to the first conduit, the legs form an
acute angle with respect to one another.
4. The device of claim 3, wherein the measurement assembly further
comprises a third leg.
5. The device of claim 1, wherein the distal ends of the legs are
coupled together, wherein measurement of the target site takes
place between the distal and proximal ends thereof.
6. The device of claim 1, wherein the handle further comprises a
measurement indicator, wherein target lumen dimensions are
calculated based on the relative distance the handle travels along
the continuum between the first and second handle locations.
7. A method of measuring a target segment of a lumen of a patient
so as to select a suitable interventional prosthesis, the method
comprising: providing a measuring device having an exterior conduit
longitudinally extending between proximal and distal ends, the
exterior conduit having measurement markers formed on a portion
thereof; an interior conduit longitudinally extending between
proximal and distal ends, disposed within the exterior conduit, and
displaceable with respect to the exterior conduit, the interior
conduit having a depth marking mechanism visible through a portion
of the exterior conduit; a measurement assembly comprising at least
two legs having distal and proximal ends and inward facing and
lumen facing surfaces, the legs coupled with each other proximal
the distal ends thereof, the measurement assembly also coupled
about the distal end of the interior conduit; a handle operatively
connected with the measurement assembly, the handle comprising a
means for opening and closing the measurement assembly by actuating
the handle along a continuum between a first closed configuration
and a second open configuration; introducing the device into an
appropriate anatomical orifice of a patient; delivering the device
adjacent a target segment of a lumen within the patient; and
measuring the length of the target segment of the lumen within the
patient.
8. The method of claim 7, wherein the device further comprises an
optical scope operatively coupled therewith, such that the
measuring step is accomplished using the optical scope.
9. The method of claim 7, wherein the inward facing surfaces of the
legs are substantially flush with one another when the measurement
assembly is closed.
10. The method of claim 9, wherein when the measurement assembly is
moved distally in relation to the first conduit, the legs form an
acute angle with respect to one another.
11. The method of claim 10, wherein the measurement assembly
further comprises a third leg.
12. The method of claim 7, wherein the distal ends of the legs are
coupled together, wherein measurement of the target site takes
place between the distal and proximal ends thereof.
13. The method of claim 7, wherein the handle further comprises a
measurement indicator, wherein target lumen dimensions are
calculated based on the relative distance the handle travels along
the continuum between the first and second handle locations.
14. The method of claim 7, further comprising the step of measuring
the diameter of the target segment of the lumen within the
patient.
15. The method of claim 14, wherein the diameter measuring step
comprises the step of actuating the handle along the continuum from
the first closed configuration toward the second open configuration
until the legs of the measurement mechanism come in contact with
the target segment of the lumen and calculating the length as a
function of the number of leg measurement markings distal the
exterior conduit.
16. The method of claim 14, wherein the target segment of the lumen
is stenotic.
17. The method of claim 7, wherein the device further comprises an
optical scope operatively coupled therewith, such that the
measuring step is accomplished using the optical scope.
18. The method of claim 16, further comprising the step of
measuring the length of the stenosis.
19. The method of claim 18, wherein the delivering step further
comprises the step of positioning the distal end of the first
conduit distal the stenosis.
20. The method of claim 19, wherein the measurement mechanism is
opened and placed distal the stenosis such that the exterior
conduit is retracted and the stenosis length measurement is a
function of the distance the exterior conduit is retracted
proximally.
21. The method of claim 18, wherein the stenosis length measuring
step comprises the step of actuating the handle along the continuum
from the first closed configuration toward the second open
configuration until the legs of the measurement mechanism come in
contact with the target segment of the lumen and calculating the
length as a function of the distance between the first handle
position and the current point of the handle along the
continuum.
22. The method of claim 16, further comprising the step of
measuring the height of the stenosis.
23. The method of claim 22, further comprising the step of
measuring the length of the stenosis.
24. A method of measuring a target segment of a lumen of a patient
so as to select a suitable interventional prosthesis, the method
comprising: providing a measuring device having an exterior conduit
longitudinally extending between proximal and distal ends, the
exterior conduit having measurement markers formed on a portion
thereof; an interior conduit longitudinally extending between
proximal and distal ends, disposed within the exterior conduit, and
displaceable with respect to the exterior conduit, the interior
conduit having a depth marking mechanism visible through a portion
of the exterior conduit; a measurement assembly comprising four
legs having distal and proximal ends and inward facing and lumen
facing surfaces, the legs coupled with each other proximal the
distal ends thereof, the measurement assembly also coupled about
the distal end of the interior conduit; a handle operatively
connected with the measurement assembly, the handle comprising a
means for opening and closing the measurement assembly by actuating
the handle along a continuum between a first closed configuration
and a second open configuration; introducing the device into an
appropriate anatomical orifice of a patient; delivering the device
adjacent a target segment of a lumen within the patient; and
measuring the diameter of the target segment of the lumen within
the patient.
25. A device that allows a user to calculate the length and
diameter of a suitable interventional prosthesis as well as the
height and length of stenosis during the same exploratory
procedure, the device comprising: a diameter measurement balloon
comprising substantially flat distal and proximal surfaces, with a
substantially circular edge there between, the diameter measuring
balloon having diameter measurement markers on the proximal and/or
distal surface thereof; a dilation balloon that has a substantially
cylindrical shape with proximal and distal ends; a plurality of
conduits, a diameter measurement conduit for inflating the diameter
measurement balloon, a dilation conduit for inflating the dilation
balloon and an outermost conduit, the outermost conduit having
proximal and distal ends and measurement markings there between,
the diameter measurement conduit and the dilation conduit disposed
within the outermost conduit such that the dilation balloon and the
diameter measurement balloon are coupled along the outermost
conduit yet operatively coupled with the dilation and measurement
conduits, respectively through the outermost conduit.
26. The device of claim 25, wherein the plurality of conduits are
co-extruded.
27. A method of measuring a target segment of a lumen of a patient
so as to select a suitable interventional prosthesis, the method
comprising: providing a measuring device having a diameter
measurement balloon comprising a substantially flat distal and
proximal surfaces, with a substantially circular edge there
between, the diameter measuring balloon having diameter measurement
markers on the proximal and/or distal surface thereof; a dilation
balloon that has a substantially cylindrical shape with proximal
and distal ends; a plurality of conduits, a diameter measurement
conduit for inflating the diameter measurement balloon, a dilation
conduit for inflating the dilation balloon and an outermost
conduit, the outermost conduit having proximal and distal ends and
measurement markings there between, the diameter measurement
conduit and the dilation conduit disposed within the outermost
conduit such that the dilation balloon and the diameter measurement
balloon are coupled along the outermost conduit yet operatively
coupled with the dilation and measurement conduits, respectively
through the outermost conduit; introducing the device into an
appropriate anatomical orifice of a patient; delivering the device
adjacent a target segment of a lumen within the patient; and
measuring the specific dimensions of the target segment of the
lumen within the patient.
28. The method of claim 27, wherein the device further comprises an
optical scope operatively coupled therewith, such that the
measuring step is accomplished using the optical scope.
29. The method of claim 27, wherein the target segment of the lumen
is stenotic.
30. The method of claim 29, wherein the specific dimensions of the
target segment is selected from the group consisting of length,
height, circumference, radius, diameter and combinations
thereof.
31. A device that allows a user to calculate the length and
diameter of a suitable interventional prosthesis as well as the
height and length of stenosis during the same exploratory
procedure, the device comprising: a diameter measurement balloon
comprising substantially flat distal and proximal surfaces, with a
substantially circular edge there between, the diameter measuring
balloon having diameter measurement markers on the proximal and/or
distal surface thereof; a dilation balloon that has a substantially
cylindrical shape with proximal and distal ends; a tube having and
interior and an exterior, the interior defining three apertures
passing at least partially there through, the first aperture
comprising a diameter measurement conduit for inflating the
diameter measurement balloon, the second aperture comprising a
dilation conduit for inflating the dilation balloon and an third
aperture that extends the length thereof, the third aperture
comprising a working channel, the diameter measurement conduit and
the dilation conduit disposed within the tube conduit such that the
dilation balloon and the diameter measurement balloon are coupled
along the exterior of the tube yet operatively coupled with the
dilation and measurement conduits, respectively through the
outermost conduit.
32. A method of measuring a target segment of a lumen of a patient
so as to select a suitable interventional prosthesis, the method
comprising: providing a measuring device having a diameter
measurement balloon comprising a substantially flat distal and
proximal surfaces, with a substantially circular edge there
between, the diameter measuring balloon having diameter measurement
markers on the proximal and/or distal surface thereof; a dilation
balloon that has a substantially cylindrical shape with proximal
and distal ends; a tube having and interior and an exterior, the
interior defining three apertures passing at least partially there
through, the first aperture comprising a diameter measurement
conduit for inflating the diameter measurement balloon, the second
aperture comprising a dilation conduit for inflating the dilation
balloon and an third aperture that extends the length thereof, the
third aperture comprising a working channel, the diameter
measurement conduit and the dilation conduit disposed within the
tube conduit such that the dilation balloon and the diameter
measurement balloon are coupled along the exterior of the tube yet
operatively coupled with the dilation and measurement conduits,
respectively through the outermost conduit; introducing the device
into an appropriate anatomical orifice of a patient; delivering the
device adjacent a target segment of a lumen within the patient; and
measuring the specific dimensions of the target segment of the
lumen within the patient.
33. The method of claim 32, wherein the device further comprises an
optical scope operatively coupled therewith, such that the
measuring step is accomplished using the optical scope.
34. The method of claim 32, wherein the target segment of the lumen
is stenotic.
35. The method of claim 34, wherein the specific dimensions of the
target segment is selected from the group consisting of length,
height, circumference, radius, diameter and combinations
thereof.
36. The device of claim 35, wherein the tube further comprises
proximal and distal ends and measurement markings there
between.
37. A device that allows a user to calculate the length and
diameter of a suitable interventional prosthesis as well as the
height and length of stenosis during the same exploratory
procedure, the device comprising: an exterior conduit
longitudinally extending between proximal and distal ends, the
exterior conduit having measurement markers formed on a portion
thereof; an interior conduit longitudinally extending between
proximal and distal ends, disposed within the exterior conduit, and
displaceable with respect to the exterior conduit; a measurement
assembly comprising a plurality of legs having distal and proximal
ends and inward facing and lumen facing surfaces, the legs coupled
with each other proximal the distal ends thereof, the measurement
assembly also coupled about the distal end of the interior conduit;
a handle operatively connected with the measurement assembly, the
handle comprising a means for opening and closing the measurement
assembly by actuating the handle along a continuum between a first
closed configuration and a second open configuration.
38. The device of claim 37, wherein the inward facing surfaces of
the legs are substantially flush with one another when the
measurement assembly is closed.
39. The device of claim 38, wherein when the measurement assembly
is moved distally in relation to the first conduit, the legs form
an acute angle with respect to one another.
40. The device of claim 39, wherein the measurement assembly
comprises four legs.
41. The device of claim 37, wherein the distal ends of the legs are
coupled together, wherein measurement of the target site takes
place between the distal and proximal ends thereof.
42. The device of claim 37, wherein the handle further comprises a
measurement indicator, wherein target lumen dimensions are
calculated based on the relative distance the handle travels along
the continuum between the first and second handle locations.
Description
FIELD OF THE INVENTION
[0001] The present invention relates to measurement devices and
methods and more particularly, to devices and methods of measuring
the internal diameter of a lumen of a patient and the dimensions of
luminal imperfection.
BACKGROUND OF THE INVENTION
[0002] Physicians involved in therapy in general and interventional
cardiology and interventional radiology in particular have been
attempting to find a way to deal with occluded (so called
"stenotic") coronary arteries (among other blood vessels, various
tubular conduits and similar structures). Additionally, the vessel
diameter, as often measured using electronic calipers (`imaging`
mode), and the frequency shift (`Doppler` mode) are of prime
importance in determining the mean flow rate through a vessel and
both must be accurately known. Unfortunately, methods of obtaining
essential luminal dimensions have diverged based on inquiry; the
physicians interested in interventional treatment of stenosis have
approached the problem differently than those interested in
determining mean flow rate through a vessel.
[0003] Interventional radiologists interested in treatment of
stenosis have focused attention principally on the topology of the
stenosis almost to the exclusion of other important factors. Of
principal importance is the identification of stent length as a
risk factor for restenosis. The usual method of choosing stent size
relies on visual estimation from the angiogram. Like many
practitioners interested in this area the goal has been to assess
the value of an objective means of determining stent length. In one
instance, a calibrated guide wire (ATW Marker wire; Cordis) is used
as a measurement tool. J. P. Reilly et al. Use of ATW Marker Wire
to Guide Choice of Stent Length, Am J Cardiol 2001; 88 (suppl
5A).
[0004] The theory behind this and other studies is that choice of
appropriate endoluminal revascularization device (e.g., balloon
angioplasty, atherectomy, laser recanalization, stents, etc) is a
function of stenosis topology. Though excessive length of
endoluminal revascularization devices can lead to migration and
restenosis, a principal limitation of this analysis is that there
are equally important risk factors associated with vessel diameter.
Many practitioners pay more care in determining appropriate stent
length than expanded stent diameter. As a rule of thumb, physicians
generally employ a stent that is one to two sizes larger than the
estimated lumen diameter. This practice in and of itself can lead
to tissue granulation and further vessel damage.
[0005] Practitioners interested in hemodynamics or patency of
vessels, defined as continued flow through the treated segment, not
necessarily the absence of recurrent stenosis, use alternative
tools to measure lumen diameter for purposes of determining the
extent of flow there through. Most frequently, imaging tests such
as CT Scans are used to assist with dimensional calculations. As a
result, no apparatus has been developed that allows for accurate in
situ measurement of treated or target tissue for purposes of
evaluating patency and/or providing interventional prosthesis.
[0006] Therefore, there is an existing need for an accurate method
of measuring both stenosis topography as well as luminal dimensions
so that the precise interventional prosthesis may be employed. In
particular, there is a need for a single device that can measure
the width and height of a stenosis while also measuring the
diameter of lumen at both healthy and stenotic regions.
SUMMARY OF EXEMPLARY EMBODIMENTS
[0007] It is a principal object in accordance with the present
invention to provide a device capable of measuring the topology of
a stenosis. In the furtherance of this and other objectives, a
preferred embodiment of the present invention provides a measuring
means that is disposable about, distal and proximal a stenosis for
measuring the dimensions of the tissue in those locations.
[0008] Yet another objective in accordance with a preferred
embodiment of the present invention is to provide a device that is
suitable for measuring the working diameter of both healthy and
diseased lumen for purposes of accurately determining the
dimensions of an appropriate interventional prosthesis.
[0009] Still another objective of a preferred embodiment in
accordance with the present invention is to provide a lumen
measuring device and method that allows the user to calculate the
exact length and diameter of a suitable interventional prosthesis
as well as the height and length of stenosis during the same
exploratory procedure.
[0010] It is another objective in accordance with the present
invention to provide a lumen-measuring device configured to be
introduced into the working channel of a suitable anatomically
correct optical scope. In the furtherance of this and other
objectives, and provided by way of non limiting example only, a
device in accordance with the present invention that is used for
nonvascular indications in general and pulmonary indications in
particular may be suitably configured for use in the working
channel of a bronchoscope. It is envisioned that the optical
instrument chosen will be a function of the general
vascular/nonvascular decision, anatomical location, and physician
preference.
[0011] Further objectives, features and advantages of the invention
will be apparent from the following detailed description taken in
conjunction with the accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0012] FIG. 1 is an aerial perspective view of an exemplary
lumen-measuring delivery device in accordance with the present
invention;
[0013] FIG. 2 is a side cross sectional view of an exemplary lumen
delivery device of FIG. 1, along lines 2-2;
[0014] FIG. 3 is a side perspective view of the lumen-measuring
device of FIG. 1, showing a measurement indicator through the
exterior lumen;
[0015] FIG. 4 is a bottom cross sectional view of the
lumen-measuring device of FIG. 3, along lines 4-4;
[0016] FIG. 5 is an aerial perspective view of an exemplary
lumen-measuring delivery device in accordance with the present
invention, showing the measurement assembly distally extended;
[0017] FIG. 6 is a side cross sectional view of an exemplary lumen
delivery device of FIG. 5, along lines 6-6;
[0018] FIG. 7 is a side perspective view of the lumen-measuring
device of FIG. 5, showing a measurement indicator through the
exterior lumen;
[0019] FIG. 8 is a bottom cross sectional view of the
lumen-measuring device of FIG. 7, along lines 8-8;
[0020] FIG. 9 is a cross sectional view of the legs of the
measurement assembly in a closed configuration inside the exterior
conduit;
[0021] FIG. 10 is a perspective view of the measurement assembly
showing the legs in an open configuration, as shown along lines
10-10 of FIG. 6:
[0022] FIG. 11 is a cross sectional view of the distal region of
the exterior conduit showing how the detent or lip of the exterior
conduit interacts with the corresponding measurement markers on the
measurement assembly legs, along lines 11-11;
[0023] FIG. 12 shows a perspective view of the lumen-measuring
device of FIG. 1, showing the measurement assembly in the closed
configuration as viewed from the distal tip thereof;
[0024] FIG. 13 is a perspective view of the lumen-measuring device
of FIG. 1, showing the measurement assembly in the open
configuration as viewed from the distal tip thereof;
[0025] FIG. 14 is a side perspective view of the closed measurement
configuration of the alternative lumen-measuring device embodiment
of FIG. 14 showing a measurement indicator through the exterior
lumen;
[0026] FIG. 15 is a bottom perspective view of the alternative
lumen-measuring device of FIG. 14, showing the legs in the closed
measuring configuration;
[0027] FIG. 16 is a side perspective view of an open measurement
configuration of an alternative lumen-measuring device embodiment
showing a measurement indicator through the exterior lumen;
[0028] FIG. 17 is a bottom perspective view of the alternative
lumen-measuring device of FIG. 14, showing the legs in the open
measuring configuration;
[0029] FIG. 18 is a side perspective view of the measurement
assembly of the alternative lumen-measuring device of FIG. 14,
showing the legs in the open measuring configuration;
[0030] FIG. 19 is a side perspective view of an exemplary
lumen-measuring device, wherein the measurement assembly comprises
a dilation balloon, a diameter measurement balloon and measurement
markers.
[0031] FIG. 20 is a cross sectional view of the lumen-measuring
device of FIG. 19, showing the internal conduits, that feed the
respective balloons, along lines 20-20;
[0032] FIG. 21 is a perspective view of the measuring portion of
the lumen-measuring device of FIG. 19, showing the measurement
markers on the dilation balloon in the uninflated
configuration;
[0033] FIG. 22 is a side view of the measuring portion of the
lumen-measuring device of FIG. 19, showing the measurement markers
on the dilation balloon in the uninflated;
[0034] FIG. 23 is a perspective view of the measuring portion of
the lumen-measuring device of FIG. 19, showing the measurement
markers on the diameter measurement balloon in the inflated
configuration;
[0035] FIG. 24 is a side view of the measuring portion of the
lumen-measuring device of FIG. 19, showing the measurement markers
on the diameter measurement balloon in the inflated;
[0036] FIG. 25 is a perspective view of the measuring portion of
the lumen-measuring device of FIG. 19, showing the measurement
markers on the dilation and diameter measurement balloons in the
inflated configuration;
[0037] FIG. 26 is a side view of the measuring portion of the
lumen-measuring device of FIG. 19, showing the measurement markers
on the dilation and diameter measurement balloons in the
inflated;
[0038] FIG. 27 is a perspective view of an exemplary
lumen-measuring device of FIG. 19, indicated for nonvascular lumen,
showing the lumen-measuring device disposed within the working
channel of a bronchoscope, wherein the measurement assembly
comprises a dilation balloon about a stenosis, a diameter
measurement balloon which is in the inflated configuration and
measurement markers;
[0039] FIG. 28 is a side view of an exemplary lumen-measuring
device of FIG. 19, indicated for nonvascular lumen, showing the
lumen-measuring device disposed within the working channel of a
bronchoscope, wherein the measurement assembly comprises a dilation
balloon about a stenosis, a diameter measurement balloon which is
in the inflated configuration and measurement markers;
[0040] FIG. 29 is a cross sectional view of the co-extruded
conduits, of FIG. 20, showing an inflation channel along lines
29-29; and
[0041] FIG. 30 is a side cross sectional view of the co-extruded
conduits, of FIG. 20, showing an inflation channel along lines
30-30.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0042] A preferred embodiment in accordance with the present
invention provides a lumen measuring device and method that allows
the user to calculate the exact length and diameter of a suitable
interventional prosthesis as well as the height and length of
stenosis during the same exploratory procedure. In the furtherance
of this and other objectives, an exemplary device is capable of
measuring the topology of a stenosis by providing a measuring means
that is disposable about, distal and proximal a stenosis for
measuring the dimensions of the tissue in those locations.
Moreover, the device is suitable for measuring the working diameter
of both healthy and diseased lumen for purposes of accurately
determining the dimensions of an appropriate interventional
prosthesis.
[0043] The device is capable of being introduced into the working
channel of a suitable anatomically correct optical scope. For
example, a device in accordance with the present invention that is
used for nonvascular indications in general and pulmonary
indications in particular may be suitably configured for use in the
working channel of a bronchoscope. As discussed above, the optical
instrument chosen will be a function of the general
vascular/nonvascular decision, anatomical location, and physician
preference.
[0044] Now making specific reference to the Figures where like
numerals refers to like components, a lumen-measuring device is
provided to give more accurate lumen dimensional information for
purposes of interventional treatment. In particular, a
lumen-measuring device 100 is provided generally in FIGS. 1-13.
[0045] In a preferred embodiment, the lumen-measuring device 100
comprises a plurality of conduits longitudinally extending between
proximal and distal ends, namely exterior 130 and interior 180
conduits, the exterior conduit 130 is coupled with a handle 220 at
the proximal end and a measurement assembly 240 at the distal end.
The handle 220 and the measurement assembly 240 being operatively
connected with one another via the interior conduit 180 at the
interior conduit's proximal 190 and distal ends 200, respectively.
The interior conduit 180 also has a depth marking mechanism 210
visible through the proximal region of the exterior conduit 140.
The handle 220 provides a trigger mechanism 230 that allows the
user to place the measurement assembly 240 in an open or closed
configuration by pushing or pulling the trigger mechanism 230. The
trigger 230 is preferably a slide-gauged mechanism but may be any
number of alternative guiding systems known in the art. In the
slide gauge embodiment, when the trigger mechanism 230 is pushed in
a distal direction with respect to the handle 220, the interior
conduit 180 urges the measurement assembly 240 distal the exterior
conduit 130 causing the measurement assembly 240 to open.
Retracting the trigger mechanism 230 in a proximal direction with
respect to the handle 220 closes the measurement assembly 230.
[0046] The measurement assembly 230 comprises at least two legs
250, 300 having distal 260, 310 and proximal ends 270, 320 and
inward facing 280, 330 and lumen facing 290, 340 surfaces, the legs
are preferably coupled with each other at their respective proximal
ends 270, 320. Distal the point at which the legs 250, 300 are
coupled, the legs 250, 300 are designed to diverge from one another
when unconstrained. In the furtherance of this objective, the legs
250, 300 are preferably formed of a shape memory alloy such as
nitinol so that when the legs are constrained by the exterior
conduit 130 they lay substantially flush with respect to one
another but diverge when the exterior conduit 130 is evacuated.
[0047] Additional legs may be employed so that the topology of the
lumen 570 may be assessed from varying perspectives. In a preferred
embodiment, four legs are provided. Each leg is provided with
measurement markers 350 that are disposed at predetermined
intervals between the distal and proximal ends of each leg.
Accuracy and corresponding leg dimensional measurements can be
confirmed and calibrated by providing the lumen-measuring device
100 into a vessel with known interior dimensions. The legs are then
urged distally until the distal ends of the legs touch the interior
surface of the vessel. Since the interior dimensions of the vessel
are known, it is easy to calibrate the measuring device so that the
measurement markers correspond to the known dimensions.
[0048] As an added feature to ensure accuracy, preferred
embodiments of the present device provide legs that have
measurement markers 350 that are carved into the legs so as to form
detent or lip catches 360. Depending on the embodiment described,
markers 350 and lip catches 360 may be used interchangeably as one
or both may be present in the same location. The exterior conduit
130 has corresponding detents 170 or a lip 170 about the distal end
150 thereof to ensure that the legs do not overshoot the maximum
lumen measurement and damage the lumen tissue. Moreover, only
moderate distal force is necessary to urge the legs beyond the lip
170, however, once the proper extension has been achieved, this
feature allows the measuring assembly to remain stable until the
calculation has been made.
[0049] Referring now to FIGS. 14-18, in an alternative embodiment,
instead of the distal ends of the legs making independent contact
with the lumen surface, the distal ends are coupled together so
that measurement takes place proximal the distal ends of the legs.
In this embodiment, the measurement assembly takes on the
configuration of a whisk, wherein the exterior diameter at the
distal and proximal ends, when if fully extended, is significantly
smaller relative to the measurement portion there between. However,
when the measurement assembly is retracted, the legs are relaxed
and reside adjacent one another so that the legs may be retracted
within the exterior conduit.
[0050] In this and other related embodiments, the exterior conduit
has measurement markers 160 formed thereon. Additionally, the lumen
facing surfaces 280, 330 of the measurement assembly 240 legs have
measurement markers 350 and/or 360 formed thereon. As the trigger
mechanism 230 is pushed distally, the measurement assembly 240
moves distal the distal end 150 of the exterior conduit 130 and
begins to separate the legs of the measurement assembly 240 with
respect to one another. The further the trigger mechanisms 230 is
pushed in the distal directions, the further the legs open and the
greater the number of measurement markings 350 and/or 360 on the
measurement assembly 240 extended beyond the distal end 150 of the
exterior conduit 130. In a preferred embodiment, the distal end 150
of the exterior conduit 130 have inward facing detents or lip 170
that are complementary to the measurement markers 350 and/or 360 on
the measurement assembly 240. At each measurement marking 350, the
detent or lip 170 may be engaged by they detent catches 360 of the
measurement marker 350 to prevent overshooting the target. Once the
legs have been opened until the distal ends of the legs of the
measurement assembly 240 are in contact with the tissue to be
measured, the user need only count the measurement markings 350 to
determine the desired dimensions of the target tissue.
[0051] In order to determine the length of the target tissue, the
user need only open the measurement assembly 240 just proximal and
just distal the target tissue, in no particular order and note the
distances between the two locations on the depth marking mechanism
210 of the interior conduit 180, which is preferably just distal
the handle 220.
[0052] An alternative embodiment of the present invention, as shown
specifically in FIGS. 19-30 comprises a flexible device 420 with
preferably two balloons and three conduits--one conduit for each
balloon and one that goes all the way through. The bottom balloon
is substantially flat and round and is referred to generally as the
diameter measurement balloon 480; the upper balloon is longer and
narrow and is referred to generally as the dilation balloon 430.
The first conduit 520 preferably inflates the diameter measurement
diameter measurement balloon 470 and the second conduit 550
inflates the dilation balloon 430. The third conduit 560, which
preferably terminates at the distal end tip 540, principally serves
a delivery and measurement function. In a preferred embodiment, the
outermost conduit 520 has measurement markings 530 that are visible
from the interior and/or the exterior thereof.
[0053] The diameter measurement balloon 470 has substantially flat
distal 480 and proximal 490 surfaces, with a substantially circular
edge 500 there between, resulting in a hollow pancake shaped
configuration. In a preferred embodiment, the diameter measurement
balloon 470 has diameter measurement marker 510 of varying colors
on the proximal and/or distal surface thereof to form a target like
representation. Alternatively, the dilation balloon 430 has a
substantially cylindrical shape with proximal 450 and distal ends
440 coupled along the outermost conduit 520.
[0054] When the pre-sterilized device is initially installed the
diameter measurement balloon 470 is compressed proximal the distal
tip 540 of the outermost conduit 520 and the dilation balloon 430
is compressed about the outermost conduit 520, proximal the
diameter measurement balloon 470. In this configuration, as
specifically shown in FIGS. 27-28, the device is easily delivered
to the target site. When used to evaluate stenotic tissue, the tip
540 is preferably positioned distal the stenosis 580 such that the
diameter measurement balloon is placed just distal the stenosis.
The diameter measurement balloon 470 is then inflated sufficiently
to allow it to sit flush with the inner diameter of the subject
lumen 570 or stenosis 580.
[0055] Through the use of visualization means, such as optical
instruments like a bronchoscope 110, the topology of the stenosis
580 can be directly viewed. The diameter measurement balloon 470 is
preferably designed with diameter measurement markers 510 formed on
the proximal face thereof to allow the user to visually measure the
extent of luminal occlusion based on the number of diameter
measurement markers covered by the stenosis 580 when viewing the
diameter measurement balloon 470 from a position proximal the
stenosis 580. Furthermore, this allows the physician to see if the
stenosis 580, or other observed occlusion, is symmetrical, etc.
[0056] Simultaneously, the physician may observe the measurement
markers 460, 510 visible through the outermost conduit 520 to see
the dimensions of the occlusion from end-to-end or from specific
points. Additionally, the dilation balloon 430 may also be inflated
to serve as an additional measurement of the working diameter of
the diseased lumen 570. To this end, the dilation balloon 430 is
inflated until it substantially closes the diseased portion of the
lumen 570.
[0057] Based on the measurements collected from this simple and
inexpensive procedure, an interventional prosthesis may be
selected, if necessary, that is appropriate in length and diameter
so as to prevent further damage to the target lumen while providing
sufficient outward radial support.
[0058] In this and other embodiments that employ balloons, a
predetermined air pressure is provided to each balloon and each
balloon conduit may be configured with a pressure manometer.
[0059] The present invention may be embodied in other specific
forms without departing from its spirit or essential
characteristics. The described embodiments are to be considered in
all respects only as illustrative, and not restrictive. The scope
of the invention is, therefore, indicated by the appended claims,
rather than by the foregoing description. All changes, which come
within the meaning and range of equivalency of the claims, are to
be embraced within their scope.
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