U.S. patent application number 10/853079 was filed with the patent office on 2005-03-03 for stent delivery catheter positioning device.
Invention is credited to Hart, Colin P., LeClair, Ryan M., Martin, Kevin C., Van Diver, Mark H., Wadleigh, Glenn H., Wetherbee, Bill A..
Application Number | 20050049607 10/853079 |
Document ID | / |
Family ID | 25133452 |
Filed Date | 2005-03-03 |
United States Patent
Application |
20050049607 |
Kind Code |
A1 |
Hart, Colin P. ; et
al. |
March 3, 2005 |
Stent delivery catheter positioning device
Abstract
The present invention generally relates to a medical device and
procedure for accurately positioning a catheter across a desired
region within a patient's vasculature. In particular, the present
invention provides a hub assembly unit that allows a physician to
precisely position a stent within a vessel utilizing a stent
delivery catheter. The hub assembly unit includes a fine adjustment
mechanism. The fine adjustment mechanism extends or contracts the
length of the hub assembly unit in controlled incremental units.
These controlled fine displacements are then translated directly to
the stent delivery or balloon dilation catheter.
Inventors: |
Hart, Colin P.; (Queensbury,
NY) ; Martin, Kevin C.; (Stillwater, NY) ;
LeClair, Ryan M.; (Delmar, NY) ; Van Diver, Mark
H.; (Argyle, NY) ; Wadleigh, Glenn H.;
(Queenbury, NY) ; Wetherbee, Bill A.; (Queensbury,
NY) |
Correspondence
Address: |
CROMPTON, SEAGER & TUFTE, LLC
1221 NICOLLET AVENUE
SUITE 800
MINNEAPOLIS
MN
55403-2420
US
|
Family ID: |
25133452 |
Appl. No.: |
10/853079 |
Filed: |
May 25, 2004 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10853079 |
May 25, 2004 |
|
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09784762 |
Feb 15, 2001 |
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6743210 |
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Current U.S.
Class: |
606/108 |
Current CPC
Class: |
A61F 2/95 20130101; A61F
2/9517 20200501 |
Class at
Publication: |
606/108 |
International
Class: |
A61F 011/00 |
Claims
What is claimed is:
1. A method for placing and positioning a delivery catheter at a
desired location in a vascular system, the method comprising the
steps of: advancing a guide catheter having a proximal end, a
distal end and a lumen extending the length therethrough within the
vascular system; providing a hub assembly, the hub assembly being
hemostatically affixed to and in fluid communication with the
proximal end of the guide catheter, the hub assembly further
including a fine adjustment mechanism capable of extending or
contracting the hub assembly unit from a first length to a second
length; advancing a delivery catheter having a proximal end, a
distal end and a lumen extending the length therethrough within the
hub assembly and through the guide catheter until reaching a
desired region; and positioning the distal end of the delivery
catheter precisely across a desired point within the desired region
using the fine adjustment mechanism.
2. The method of claim 1, wherein rotation of the delivery catheter
is prohibited while positioning the distal end of the delivery
catheter using the fine adjustment mechanism.
3. The method of claim 1, wherein longitudinal movement of the
guide catheter is prohibited while positioning the distal end of
the delivery catheter using the fine adjustment mechanism.
4. The method of claim 1, wherein the guide catheter includes a
means for securing the guide catheter in a fixed position relative
to a patient.
5. The method of claim 1, wherein the fine adjustment mechanism
comprises a turnbuckle mechanism.
6. The method of claim 1, wherein the fine adjustment mechanism
comprises a rack and pinion mechanism.
7. A method for placing and positioning a medical device at a
desired location in a vascular system, the method comprising the
steps of: advancing a first medical device having a proximal
portion, a proximal end, a distal end and a lumen extending the
length therethrough within the vascular system until the distal end
of the first medical device reaches a first desired region;
advancing a second medical device having a proximal portion, a
proximal end and a distal end within the lumen of the first medical
device until the distal end of the second medical device reaches a
second desired region distal of the first desired region; providing
a fine adjustment mechanism, the fine adjustment mechanism attached
to the proximal portion of the first medical device and the
proximal portion of the second medical device; actuating the fine
adjustment mechanism wherein the distal end of the second medical
device is translated proximally or distally relative to the distal
end of the first medical device.
8. The method in claim 7, wherein the second medical device is
translated proximally or distally relative to the distal end of the
first medical device by rotating the fine adjustment mechanism.
9. The method in claim 7, wherein the fine adjustment mechanism
includes a lumen extending therethrough, wherein the second medical
device extends through the lumen.
10. The method in claim 7, wherein the fine adjustment mechanism
comprises a turnbuckle mechanism.
11. The method in claim 7, wherein the fine adjustment mechanism
comprises a rack and pinion mechanism.
12. A method for placing and positioning a delivery catheter at a
desired location in a vascular system, the method comprising the
steps of: advancing a guide catheter having a proximal end, a
distal end and a lumen extending the length thererthrough within
the vascular system; providing a hub assembly, the hub assembly
having a proximal end, a distal end and a lumen extending
therethrough and in fluid communication with the lumen of the guide
catheter, wherein the distal end of the hub assembly is connected
to the proximal end of the guide catheter; advancing a delivery
catheter having a proximal end and a distal end within the hub
assembly lumen and the guide catheter lumen until the distal end of
the delivery catheter reaches a desired region distal of the guide
catheter; providing a fine adjustment mechanism, the fine
adjustment mechanism connected to the proximal end of the hub
assembly and the proximal end of the delivery catheter; actuating
the fine adjustment mechanism whereby the delivery catheter is
longitudinally extended or contracted relative to the guide
catheter.
13. The method of claim 12, wherein the proximal end of the
delivery catheter includes a hemostatsis valve.
14. The method of claim 12, wherein the fine adjustment mechanism
is actuated by rotating the fine adjustment mechanism.
15. The method of claim 12, wherein the fine adjustment mechanism
comprises a turnbuckle mechanism.
16. The method of claim 12, wherein the fine adjustment mechanism
includes a lumen extending therethrough, wherein the delivery
catheter extends through the lumen.
Description
CROSS-REFERENCE TO CO-PENDING APPLICATIONS
[0001] This application is a continuation of U.S. application Ser.
No. 09/784,762, filed Feb. 15, 2001.
FIELD OF THE INVENTION
[0002] The present invention generally relates to a medical device
for positioning a stent delivery or dilatation balloon catheter
within the vascular system of a patient. More specifically, the
present invention discloses a hub assembly unit providing an
operator the ability to finely adjust the positioning of a stent
delivery or a balloon dilation catheter within a patient's vascular
system.
BACKGROUND OF THE INVENTION
[0003] Percutaneous Transluminal Coronary Angioplasty (PTCA) is a
well-established procedure for dilating stenosed vessel regions
within a patient's vasculature. In this procedure, a balloon
angioplasty catheter is introduced into the vasculature, typically
through an incision in the femoral artery in the groin. The balloon
catheter is then advanced through the femoral artery, through the
aortic arch, and into the artery to be treated. The balloon portion
of the dilation catheter is specifically advanced across the
stenosis or constricted vessel, wherein the balloon is inflated.
Inflation of the balloon dilates the surrounding vessel and/or
displaces the plaque the forms the stenosis. The resulting treated
vessel is then characterized by a greater cross-sectional area
permitting additional blood flow through the previously occluded or
constricted region.
[0004] Over a period, a previously dilated vessel may narrow. Often
this narrowing is a result of a vessel "rebounding" from an
angioplasty procedure. In order to prevent vessel rebounding,
stents are often deployed concurrently with a vessel dilation
procedure. A stent is positioned across the treated dilated region
of vasculature where it is radially expanded utilizing a stent
delivery catheter. Once properly seated within the vessel wall, the
frame of the stent opposes any inward radial forces associated with
vessel rebounding.
[0005] During a PTCA procedure, it is often necessary to finely
adjust the positioning of the stent delivery or balloon dilatation
catheter. Improper placement of a stent within a desired region can
cause a portion of the treated vessel to narrow, substantially
decreasing the benefits of the initial medical procedure.
[0006] Currently, a physician positions the distal end of a balloon
dilatation or stent delivery catheter by manually pushing or
pulling on the proximal end of the catheter. These pushing and
pulling motions must be transmitted through the entire length of
the catheter shaft to affect the catheter's distal tip. The
catheter shaft in a medical procedure, however, is usually quite
intricately routed within a patient's vascular system. The vascular
pathlength from the femoral artery to the desired treatable artery
is usually long and quite tortuous. Manipulations made by the
physician at the catheter's proximal end, therefore, do not
necessarily directly translate to the same movements at the
catheter's distal end.
[0007] Catheters have a natural tendency to compress or elongate
irregularly when manipulated proximally. More specifically, when
advancing a catheter from the catheter's proximal end, the catheter
tends to advance into and through the curves of vessel walls where
they contact a greater surface area. An advancing catheter,
therefore, requires greater force and displacement at the
catheter's proximal end to move the catheter a desired length at
the catheter's distal end. In contrast, a retracting catheter
straightens through the curvature of vessel walls causing the
catheter to elongate when withdrawn.
[0008] A physician is often required to make a series of
advancements and retractions of the catheter to effectively
navigate through the tortuous vascular system of a patient. Each
advancement and retraction compresses or elongates various sections
of the catheter. These compressions and elongations store potential
energy throughout the length of the catheter shaft. Coarse
manipulations by a physician at the catheter's proximal end may
affect the arrangement of these compressions and elongations.
Specifically, pulling and pushing of the proximal end of a catheter
may cause an unaccounted for release of stored potential energy in
the catheter shaft. This unaccounted for release of energy is
called the "backlash" phenomenon. Backlash causes a physician to
experience either a sudden burst or a lag in relative movement of
the distal end of the catheter. This unaccounted for release
functionally decreases accuracy in positioning a catheter within a
patient's vascular system. Further, even without the issues related
to stored energy and backlash, making the necessary fine
adjustments requires more time and is less accurate than
desirable.
[0009] Further complications arise when a physician attempts to
inflate the stent delivery or balloon dilation catheter. Before
inflation, a physician must tighten the hemostasis valve around the
catheter. Tightening the hemostasis valve, however, may cause the
stent delivery catheter to move out of position. Consequently, the
physician is forced to reposition the catheter once again across
the desired vascular region. As a result, the time spent
repositioning the distal end of a catheter causes unnecessary
medical expense and further trauma to the patient.
SUMMARY OF THE INVENTION
[0010] The present invention provides a medical device permitting
fine adjustments of the distal end of a stent deployment or balloon
dilatation catheter. In particular, the present invention discloses
a hub assembly unit providing a fine adjustment mechanism. The fine
adjustment mechanism extends or contracts the length of the hub
assembly unit in controlled incremental units. These controlled
fine displacements are then translated directly to the stent
delivery or balloon dilation catheter.
[0011] Contrary to coarse adjustments, fine displacements have been
found to conserve stored potential energy within a catheter system.
A physician may therefore incrementally adjust the displacement of
the hub assembly unit of the present invention to accurately and
predictably advance or withdraw a stent delivery or balloon
dilation catheter. In the present invention, fine adjustments made
at the proximal end of the hub assembly unit directly translate to
similar adjustments at the distal end of the catheter. Thus, the
hub assembly unit of the present invention allows a physician to
precisely position a stent delivery or balloon dilation catheter at
a desired point within a desired region of a patient's
vasculature.
BRIEF DESCRIPTION OF THE DRAWINGS
[0012] FIG. 1 shows a side elevation view of a hub assembly unit of
the present invention, the hub assembly unit being attached to the
proximal end of a guide catheter and further receiving a stent
delivery catheter at the hub assembly unit's proximal end;
[0013] FIG. 2 shows an enlarged cross-sectional elevation view of a
turnbuckle style fine adjustment mechanism embodiment of the hub
assembly unit;
[0014] FIG. 3 shows a transverse cross-sectional view of a tubular
section of the hub assembly unit of the present invention, the
tubular section having a lumen of oval shape;
[0015] FIG. 4 shows a transverse cross-sectional view of a tubular
section of the hub assembly unit of the present invention, the
tubular section having a lumen of rectangular shape;
[0016] FIG. 5 shows a transverse cross-sectional view of a tubular
section of the hub assembly unit of the present invention, the
tubular section having a lumen of triangular shape;
[0017] FIG. 6 shows a cross-sectional elevation view of an
additional embodiment of the hub assembly unit of the present
invention comprising a lever style fine adjustment mechanism;
[0018] FIG. 7 shows a side elevation view of an alternative
embodiment of the hub assembly unit of the present invention
comprising a rack and pinion style fine adjustment mechanism;
[0019] FIG. 8 shows a cross-sectional elevation view of a slot and
key style fine adjustment mechanism embodiment of the hub assembly
unit of the present invention;
[0020] FIG. 9 shows a partial key element of the slot and key style
fine adjustment mechanism of the present invention comprising a
partially threaded key;
[0021] FIG. 10 shows a slotted track element of the slot and key
style fine adjustment mechanism comprising a slotted track in which
the partial key element travels within;
[0022] FIG. 11 shows a threading nut element for the slot and key
style fine adjustment mechanism, the threading nut element
comprising two reversibly attaching cylindrical halves that mate
when assembled with the partially threaded key of the partial key
element; and
[0023] FIG. 12 shows a transverse cross-sectional view of the slot
and key style fine adjustment mechanism illustrating the seating
relationships between the partial key element, the slotted track
element and the threading nut element.
DETAILED DESCRIPTION OF THE INVENTION
[0024] The following detailed description should be read with
reference to the drawings, in which like elements in different
drawings are numbered identically. The drawings, which are not
necessarily to scale, depict selected embodiments and are not
intended to limit the scope of the invention. Examples of
constructions, materials, dimensions and manufacturing processes
are provided for selected elements. Those skilled in the art will
recognize that many of the examples provided have suitable
alternatives that may be utilized.
[0025] Referring now to the drawings, FIG. 1 shows one embodiment
of a hub assembly unit 10 of the present invention. Hub assembly
unit 10 comprises a proximal end 12 and a distal end 14. Distal end
14 includes a linking mechanism 16 connecting hub assembly unit 10
to a first medical device 18. In preferred embodiments, first
medical device 18 is a catheter, and more specifically, a guide
catheter. A proximal fitting is positioned at the proximal end of
guide catheter 18 for attaching and fluidly connecting ancillary
apparatus to the lumen of guide catheter 18. The proximal fitting
generally includes at least one male or female threaded region on
the proximal fitting. Referring specifically to FIG. 1, the
proximal fitting of guide catheter 18 comprises a female luer type
fitting (not shown). As a result, distal end 14 of hub assembly
unit 10 comprises a male luer type fitting (not shown) to properly
mate and seat within the guide catheter's proximal fitting. In
certain embodiments, the union between hub assembly unit 10 and
guide catheter 18 is completed using alternative connectors.
Additional attaching mechanisms between hub assembly unit 10 and
guide catheter 18, being known in the art, are also incorporated as
within the scope of the present invention. In an alternative
embodiment, hub assembly unit 10 is permanently affixed to the body
of guide catheter 18.
[0026] Proximally from the proximal end of the guide catheter 18 is
a first tubular section 20 of hub assembly unit 10. First tubular
section 20 comprises a proximal end, a distal end and further
comprising a lumen extending the length therethrough. The distal
end of first tubular section 20 includes either a male or a female
connector that mates with the proximal fitting of guide catheter
18. In certain additional embodiments, first tubular section 20
further comprises a Y-adapter 22. Y-adapter 22 includes a molded
section that permits additional medical apparatus access to the
internal lumen of hub assembly unit 10, and furthermore, access to
the lumen of guide catheter 18 when so attached.
[0027] First tubular section 20 may additionally comprise a means
for securing hub assembly unit 10 during a medical procedure.
Proper operation of hub assembly unit 10 requires maintaining hub
assembly unit 10 in a single or fixed position, relative to the
patient, during adjustment of the hub assembly during a medical
procedure. Medical personnel often hold and maintain the position
of hub assembly unit 10 in this proper relationship during the
medical procedure. A suture ring 24, however, may mechanically
maintain the positioning of hub assembly unit 10, thereby freeing
up medical personnel during the medical procedure. Other mechanical
means such as tape and clamps may likewise be used to secure hub
assembly unit 10 during the medical procedure.
[0028] Proximal end 12 of hub assembly unit 10 comprises a second
tubular section 26 having a proximal end, a distal end and a lumen
extending the length therethrough. The proximal end of second
tubular section 26 preferably includes a hemostasis valve 28, or
other fitting capable of maintaining the position and orientation
of second medical device 30 inserted therein. As shown in FIG. 2,
second tubular section 26 preferably includes a tubular extension
or section 27 slidably disposed within the lumen of the first
tubular section 20. Second medical device 30 is advanced to a
desired region within a patient's vasculature by initially
inserting second medical device 30 into the proximal end of second
tubular section 26. Second medical device 30 is advanced through
the lumen of second tubular section 26, through the lumen of first
tubular section 20, and finally through the lumen of guide catheter
18, until finally reaching a desired region within the patient's
vasculature. In one embodiments of the present invention, second
medical device 30 is a stent delivery catheter. In an alternative
embodiment of the present invention, second medical device 30 is a
balloon dilation catheter.
[0029] Hemostasis valve 28, or the like, mechanically constricts
about the outer diameter of second medical device 30, hermetically
sealing the atmospherically exposed portion of second medical
device 30 from the internally advanced portions of second medical
device 30. This hemostatic measure concurrently affixes second
medical device 30 into a single longitudinal and rotational
orientation. The mechanical pressure applied by hemostatsis valve
28 maintains this single orientation while hemostasis valve 28 is
actively engaged with second medical device 30.
[0030] Fine adjustment mechanism 32 connects and maintains the
position of the proximal end of first tubular section 20 with or
relative to the distal end of second tubular section 26. Fine
adjustment mechanism 32 additionally engages either first tubular
section 20, second tubular section 26, or both tubular sections.
Fine adjustment mechanism 32 additionally provides a mechanical
means for displacing the two tubular sections with respect to one
another. In particular, fine adjustment mechanism 32 extends or
contracts the length of hub assembly unit 10 by displacing the
spatial relationship between first tubular section 20 and second
tubular section 26. As shown, internal threads on the fine
adjustment mechanism mate with threads on the two tubular sections
and functions as a turnbuckle when rotated to draw the member
together or apart.
[0031] In preferred embodiments, fine adjustment mechanism 32 may
expand or contract the length of hub assembly unit 10 by a total of
1 to 3 centimeters. Most preferably, hub assembly unit 10 may be
displaced a total of 1 to 2 centimeters. Units of measurement 33
are placed upon hub assembly unit 10 to aid physicians in gauging
spatial displacement of hub assembly unit 10 during a medical
procedure.
[0032] In a preferred embodiment, a guide catheter is first
advanced to a desired region within a patient's vasculature. Hub
assembly unit 10 is then attached to the proximal end of the
advanced guide catheter, if not already attached. A second medical
device 30 is then advanced to a desired region within the patient's
vasculature by initially inserting the second medical device 30
into the proximal end of second tubular section 26 of hub assembly
unit 10. The second medical device 30 is then advanced through the
lumen of second tubular section 26, through the lumen of first
tubular section 20, and finally through the lumen of guide catheter
18. Second medical device 30 is then coarsely positioned at
approximately the desired region within a patient's
vasculature.
[0033] A physician may make coarse adjustments to second medical
device 30 by manually pushing and pulling on the proximal end of
second medical device 30. Coarse manual adjustments allow a
physician to position the distal end of second medical device 30
approximately at a desired point within a desired region within the
patient's vasculature. As described earlier, however, the length of
second medical device makes precise placement difficult.
Manipulations made by the physician at the proximal end of second
medical device 30 do not necessarily translate to the same motions
at the distal end of second medical device 30. Compression or
elongation of second medical device 30, caused by second medical
device 30 following the tortuous vasculature of the patient,
results in second medical device 30 retaining an unaccountable
amount of stored potential energy. Small coarse adjustments,
therefore, may release this stored energy causing a physician to
overshoot a desired target. The present invention overcomes the
problem associated with the release of stored potential energy
within an advanced catheter.
[0034] After second medical device 30 is coarsely positioned within
the patient's vasculature, hemostasis valve 28 is mechanically
engaged. Hemostatsis valve 28 hemostatically preferably affixes
second medical device 30 into a single longitudinal and rotational
orientation. As a result, movements made by hub assembly unit 10
and/or guide catheter 18 are directly translated to the second
medical device 30. Fine adjustment mechanism 32 provides for minor
spatial advancements or retreats of the catheter system. In
particular, fine adjustment mechanism 32 extends or contracts the
length of hub assembly unit 10 by displacing the spatial
relationship between first tubular section 20 and second tubular
section 26. These fine displacements are then translated to second
medical device 30.
[0035] Contrary to coarse adjustments, fine displacements have been
found to conserve stored potential energy within a catheter system.
The present invention allows a physician to incrementally adjust
the positioning of second medical device 30 within a patient's
vasculature. Specifically, a physician may accurately advance or
withdraw second medical device 30 by fractions of a millimeter
through proper operation of fine adjustment mechanism 32. A
physician may incrementally adjust the spatial relationships within
hub assembly unit 10 to accurately and predictably advance or
withdraw a second medical device up to a total distance of
approximately 3 centimeters. Fine adjustments made at the proximal
end of a catheter system, therefore, directly translate to similar
adjustments at the distal end of the catheter system in the present
invention. Thus, hub assembly unit 10 allows a physician to
precisely position a second medical device 30 at a desired point
within the desired region of a patient's vasculature.
[0036] Refer now to FIG. 2, wherein an enlarged cross-sectional
elevation view of the turnbuckle style fine adjustment mechanism 40
embodiment is shown. With respect to FIG. 2, a distal portion of
second tubular section 26 includes a tubular extension or section
27 that is slidably disposed within the lumen of first tubular
section 20. At the distal-most end 36 of second tubular section 26
is an O-ring 34. O-ring 34 engages both second tubular section 26
and the lumen wall of first tubular section 20. When second tubular
section 26 is slidably displaced along the length of the lumen of
first tubular section 20, O-ring 34 hemostatically prevents or
reduces blood or other bodily fluids from being displaced between
the outer wall of second tubular section 26 and the inner wall of
first tubular section 20. This relationship between first tubular
section 20 and second tubular section 26 may likewise be reversed
wherein first tubular section 20 may be slidably disposed within
the lumen of second tubular section 26. In yet another embodiment,
both the proximal-most end of first tubular section 20 and the
distal-most end of second tubular section 26 terminate within fine
adjustment mechanism 32. In this embodiment, fine adjustment
mechanism 32 maintains fluid communication between the two tubular
sections, as well as provides a location for the two sections to be
slidably disposed.
[0037] In the illustrated turnbuckle style fine adjustment
mechanism 40, a portion of proximal end 42 of first tubular section
20 and a portion of distal portion 44 of second tubular section 26
are threaded. The direction of threading on tubular section 20 is
the reverse of the direction of threading on tubular section 26.
One tubular section is right hand threaded and the other tubular
section is left hand threaded. Thus, in this particular embodiment,
the threading of each tubular section is never the same.
[0038] Threading nut 46 overlays the threaded portions 42, 44 of
first and second tubular sections 20 and 26. Complementary threads
48, to both left and right handed threaded portions 44 and 42, are
manufactured into threading nut 46. In a preferred embodiment,
complementary threads 48 are molded into threading nut 46.
Complimentary threads 48 extend inwardly from the ends of threading
nut 46 to a location approximating the center 50 of threading nut
46. At the center 50, complimentary threads 48 terminate, defining
the ends of two threaded tracks.
[0039] The threaded tracks provide a pathlength for which threaded
tubular sections 42 and 44 may travel. Threaded tubular section 42
and 44 travel along the threaded tracks through the appropriate
rotation of threaded nut 46. Rotation of threading nut 46 in a
clockwise direction causes both first tubular section 20 and second
tubular section 26 to both move either inwardly or outwardly,
depending upon the direction of the threads. Inward or outward
directional movement occurs in unison because threading nut 46
controls the rate of both threaded tubular sections 42 and 44 at
the same time. Likewise, rotation of threading nut 46 in the
counter-clockwise direction causes the tubular sections to move in
unison in the opposite direction as the first.
[0040] When threading nut 46 is rotated, complementary threads 48
guide both threaded tubular sections 42 and 44 along their
respective threaded tracks. Since threaded tubular sections 42 and
44 are merely portions of first tubular section 20 and second
tubular section 26, respectively, movement of threaded tubular
sections 42 and 44 are translated as an extension or contraction of
hub assembly unit 10 as a whole. The length of hub assembly unit
10, therefore, may be extended or contracted by the proper rotation
of threading nut 46, thereby allowing a physician to precisely
position a second medical device 30 at a desired point within a
desired region of a patient's vasculature.
[0041] Extension of the hub assembly unit 10 is proportional to the
length of the threading nut 46. As such, hub assembly unit 10 may
be lengthened a distance until the threaded portions 44 and 42
disengage from the threading nut 46. Similarly, the length of hub
assembly unit 10 may be contracted until the complementary
threading 48 ceases within the center 50 of threading nut 46. In
preferred embodiments, turnbuckle style fine adjustment mechanism
40 may expand or contract the length of hub assembly unit 10 by a
total of 0.5 to 3 centimeters. Most preferably, hub assembly unit
10 may be displaced a total of 1 to 2 centimeters. Each rotation of
threaded nut 46 correlates to an incremental displacement of hub
assembly unit 10. In preferred embodiments, each rotation of
threaded nut 46 spatially displaces hub assembly unit 10 by 1 to 6
millimeters.
[0042] Turnbuckle style fine adjustment mechanism 40 may be
modified in order to adjust the rate and distance threaded tubular
sections 42 and 44 travel within threaded nut 46. One modification
includes manufacturing threads of threaded tubular section 42, and
its complementary threads 48 in threaded nut 46, more fine (having
more threads per linear centimeter) than the other threaded tubular
section 44. As a result of this modification, the rotation of
threaded nut 46 causes one threaded tubular section 44 to extend or
contract farther and faster than its finely threaded counterpart
42. Likewise, only threaded tubular section 44 and its
complementary threads 48 may be manufactured with fine
threading.
[0043] Operation of turnbuckle style fine adjustment mechanism 40
causes exerted rotational energy performed by threading nut 46 to
transfer to surrounding apparatus. In this case, transferred
rotational energy tends to affect either first tubular section 20
or second tubular section 26. The present invention channels this
rotational energy from threading nut 46 into a longitudinal force
that causes the spatial displacement of the two tubular section 20
and 26 within hub assembly unit 10.
[0044] Rotational energy has a propensity to remain as rotational
energy. Thus, by leaving the above-described system alone, exerted
rotational energy from threading nut 46 would cause first tubular
section 20 and second tubular section 26 to additionally rotate. In
order to transform this rotational energy into other forms of work,
the rotational energy must be redirected. The present invention
transforms exerted rotational energy into a longitudinal motive
force.
[0045] Securing suture ring 24, or the like, generally restrains
first tubular section 20 to a single orientation. Transferred
rotational energy from threading nut 46 is therefore refrained from
affecting the rotational orientation of first tubular section 20.
Second tubular section 26, however, generally remains free to be
affected by such transferred rotational energy. Modifications to
the shape of tubular sections 20 and 26 can redirect this
transferred rotational energy into a functional, longitudinal
motive force.
[0046] Refer now to FIG. 3, wherein a transverse cross-sectional
view at 3-3 of hub assembly unit 10 is shown. The cross-section
taken at 3-3 includes portions of both first tubular section 20 and
second tubular section 26. Specifically, the cross-section shows a
distal extension 27 of second tubular section 26 seated within
first tubular section 20. The inner lumen of first tubular section
20 is non-circular in shape. More specifically, the inner lumen of
first tubular section 20 is oval. The outer diameter of second
tubular section 26 is complementary oval shaped to properly seat
within the inner lumen of first tubular section 20. This
non-circular lumen design provides torsional resistance.
Specifically, the oval shaped lumen configuration prevents second
tubular section 26 from spinning within first tubular section 20
when threading nut 46 is rotated. In effect, the oval-shaped design
channels transferred rotational energy from threading nut 46 into a
longitudinal motive force. This longitudinal motive force displaces
second tubular section 26 and first tubular section 20 in a single
longitudinal and rotational plane. Transferred energy is then
transformed into work that displaces the two tubular sections 20
and 26 along the manufactured oval shaped lumen pathlength.
[0047] FIG. 4 is an additional embodiment showing a transverse
cross-sectional view at 3-3 of hub assembly unit 10. The
cross-section of this particular embodiment similarly includes
portions of both first tubular section 20 and second tubular
section 26. Specifically, the cross-section includes the distal
extension 27 of second tubular section 26 seated within the lumen
of first tubular section 20. In FIG. 4, however, the inner lumen of
first tubular section 20 is non-circular rectangular shaped. The
outer diameter of second tubular section 26 is complementary
rectangular shaped to properly seat within the inner lumen of first
tubular section 20. This rectangular shaped lumen design
additionally provides torsional resistance within hub assembly unit
10. Specifically, the four elongated regions of the rectangular
shaped lumen configuration prevent second tubular section 26 from
spinning within first tubular section 20 when threading nut 46 is
rotated. The rectangular shaped design further channels transferred
rotational energy from threading nut 46 into a longitudinal motive
force. This longitudinal motive force displaces second tubular
section 26 and first tubular section 20 in a single longitudinal
and rotational plane. Transferred energy is then transformed into
work that displaces the two tubular sections 20 and 26 along the
manufactured rectangular shaped lumen pathlength.
[0048] FIG. 5 is yet another embodiment showing a transverse
cross-sectional view at 3-3 of hub assembly unit 10. The
cross-section of this particular embodiment again includes portions
of both first tubular section 20 and second tubular section 26.
Specifically, the cross-section includes the distal extension 27 of
second tubular section 26 seated within first tubular section 20.
In FIG. 5, however, the inner lumen of first tubular section 20 is
triangular shape. To properly seat within the inner lumen of first
tubular section 20, the outer diameter of second tubular section 26
is complementary triangular shaped. This triangular shaped lumen
design additionally provides torsional resistance within hub
assembly unit 10. Specifically, the three elongated regions of the
triangular shaped lumen configuration prevent second tubular
section 26 from spinning within first tubular section 20 when
threading nut 46 is rotated. The triangular shaped design further
channels transferred rotational energy from threading nut 46 into a
longitudinal motive force. This longitudinal motive force displaces
second tubular section 26 and first tubular section 20 in a single
longitudinal and rotational plane. Transferred energy is then
transformed into work that displaces the two tubular sections 20
and 26 along the manufactured triangular shaped lumen
pathlength.
[0049] The inner lumen of second tubular section 26 need not
necessarily be oval shaped, rectangular shaped or triangular shaped
(as depicted in FIGS. 3, 4 and 5, respectively). Torsional
resistance is an outgrowth of the friction fit between the inner
lumen diameter of first tubular section 20 and the outer diameter
of second tubular section 26. As a result, the inner lumen
configuration of second tubular section 26 may be circular without
affecting the torsional resistance characteristics of the present
invention provided there is sufficient friction between the
members.
[0050] Refer now to FIG. 6, wherein a cross-sectional elevation
view of an additional embodiment of hub assembly unit 10 is shown
comprising a lever style fine adjustment mechanism 50. Lever style
fine adjustment mechanism 50 similarly comprises a portion of the
proximal-most end of first tubular section 20 and a distal portion
of second tubular section 26. The distal portion of second tubular
section 26 includes two distinct regions, a first distal portion 35
and a second distal portion 37, both having lumens running the
length therein. First distal portion 35 attaches at a proximal end
to a hemostasis valve (not shown) or other fitting capable of
maintaining the position and orientation of a second medical device
inserted the length therethrough. Second distal portion 37, on the
other hand, is slidably disposed within the lumen of first tubular
section 20. Because second distal portion 37 is slidably disposed
within first tubular section 20, the lever style fine adjustment
mechanism 50 maintains a fluid connection between the proximal end
12 to the distal end 14 of hub assembly unit 10.
[0051] At the distal-most end of second distal portion 37 is a
seal, such as an O-ring 34. O-ring 34 engages both the distal-most
end of second distal portion 37 and the lumen wall of first tubular
section 20. When the distal-most end of second distal portion 37 is
slidably displaced along the length of the lumen of first tubular
section 20, O-ring 34 hemostatically prevents blood or other bodily
fluids from being displaced between the outer wall of the
distal-most end of second distal portion 37 and the inner wall of
first tubular section 20.
[0052] With particularity to FIG. 6, lever style fine adjustment
mechanism 50 is a three-lever arm mechanism. Affixed to first
distal portion 35 and first tubular section 20 are two anchoring
devices 52 and 53. Anchoring device 52 is affixed to first distal
portion 35, whereas anchoring device 53 is affixed to first tubular
section 20. Anchoring devices 52 and 53 are preferably molded to
hub assembly unit 10. However, other suitable attachment procedures
known in the art may also be utilized. Anchoring devices 52 and 53
additionally provide an attachment point for first lever arm 54 and
second lever arm 56, respectively. First lever arm 54 and second
lever arm 56 are both comprised of a generally rigid material and
have a proximal end and a distal end. The proximal ends of both
lever arms 54 and 56 are pivotally attached to their corresponding
anchoring device. The distal end of first lever arm 54 is hinged 58
to a portion of second lever arm 56. Second lever arm 56,
therefore, is preferably longer than first lever arm 54. The third
lever arm within lever style fine adjustment mechanism 50 includes
the portion of hub assembly unit 10 wherein second distal portion
37 is slidably disposed within the lumen of first tubular section
20. Because the third lever arm is comprised of two slidably
disposed portions, the third lever arm is variable in length.
[0053] A physician operates lever style fine adjustment mechanism
50 by raising and lowering distal end 57 of second lever arm 56.
Raising distal end 57 of second lever arm 56 slidably displaces
second distal portion 37 within first tubular section 20. As a
result, the length of hub assembly unit 10 decreases. Lowering
distal end 57 of second lever arm 56, on the other hand, slidably
displaces second distal portion 37 apart from first tubular section
20. With this lever arm movement, the length of hub assembly unit
10 increases. Lever style fine adjustment mechanism 50, therefore,
provides a physician with a medical device for finely adjusting the
positioning of a second medical device 30. More specifically, lever
style fine adjustment mechanism 50 allows a physician to precisely
position a stent delivery catheter without the concern of a
potential energy release associated with coarse adjustments.
[0054] Movement within the lever style fine adjustment mechanism 50
occurs in a single plane. All lever arms are hinged or fixed to
operate within this single plane. As a result, little to no
rotation occurs while extending and contracting the variable length
third arm of hub assembly unit 10. Second distal portion 37 may be
slidably disposed within the lumen of the first tubular section 20
in a oval shaped, a rectangular shaped or a triangular shaped lumen
design to further prevent rotation within lever style fine
adjustment mechanism 50, as described in detail with reference to
FIGS. 3, 4 and 5.
[0055] Refer now to FIG. 7, wherein a side elevation view of an
alternative embodiment of hub assembly unit 10 is shown comprising
a rack and pinion style fine adjustment mechanism 60. Rack and
pinion style fine adjustment mechanism 60 similarly comprises a
portion of the proximal-most end of first tubular section 20 and a
distal portion of second tubular section 26. The distal portion of
second tubular section 26 additionally includes two distinct
regions, a first distal portion 35 and a second distal portion 37,
both having lumens running the length therein. First distal portion
35 attaches at a proximal end to hemostasis valve 28, or other
fitting capable of maintaining the position and orientation of a
second medical device 30 inserted the length therethrough. Second
distal portion 37, on the other hand, is hemostatically, slidably
disposed within the lumen of first tubular section 20. The two
sections maintain a fluid connection between proximal end 12 to
distal end 14 of hub assembly unit 10 because second distal portion
37 is hemostatically, slidably disposed within first tubular
section 20.
[0056] With particularity to rack and pinion style fine adjustment
mechanism 60, a rack 64 spans between first tubular section 20 and
second tubular section 26. Rack 64 is characterized by a row of
teeth 65 that extent outwardly away from the body of hub assembly
unit 10. A first end of rack 64 is affixed to first tubular section
20 by first anchoring element 63. The second end of rack 64 is
slidably affixed to first distal portion 35 by second anchoring
element 62 and pinion 66. Second anchoring element 62 is affixed to
first distal portion 35. Attached to second anchoring element 62 is
pinion 66. Pinion 66 comprises a cogwheel having a series of teeth
67 on the rim of pinion 66. Through engagement with complementary
teeth 65 of rack 64, pinion 66 transmits a horizontal motive force
to rack 64. To aid in slidably disposing rack 64 through pinion 66
rotation, a recessed track incorporating a friction-reducing
surface may be added to first distal portion 35.
[0057] A physician operates rack and pinion style fine adjustment
mechanism 60 by rotating pinion 66 on rack 64. With respect to FIG.
7, rotation of pinion 66 in a clockwise fashion slidably displaces
second distal portion 37 within first tubular section 20. As a
result, the length of hub assembly unit 10 decreases. Rotation of
pinion 66 in a counter-clockwise fashion, on the other hand,
slidably displaces second distal portion 37 apart from first
tubular section 20, thereby lengthening hub assembly unit 10. Rack
and pinion style fine adjustment mechanism 60, therefore, provides
a physician with a medical device for finely adjusting a second
medical device 30 within a patient's vasculature. More
specifically, rack and pinion style fine adjustment mechanism 60
allows a physician to precisely position a second medical device 30
without backlash, which is commonly associated with coarse manual
adjustments.
[0058] Refer now to FIG. 8, wherein a cross-sectional elevation
view of another embodiment of hub assembly unit 10 is shown having
a slot and key style fine adjustment mechanism 70. Slot and key
style fine adjustment mechanism 70 is comprised of a partial key
element 71 (see FIG. 9), a slotted track element 80 (see FIG. 10)
and a threading nut element 90 (see FIG. 11).
[0059] FIG. 9 illustrates, in detail, partial key element 71.
Partial key element 71 comprises a first tubular section 72 having
a proximal end, a distal end and a lumen 102 running the length
therethrough. Affixed along a portion of first tubular section 72
is a partially threaded key 74. Partially threaded key 74 is
preferably molded onto, or is a part of first tubular section 72.
Partially threaded key 74 comprises raised threaded sections 76 and
further comprises two first planar surfaces 78. First planar
surfaces 78 are manufactured on partially threaded key 74 in a
parallel relationship. The distance between first planar surfaces
78 further define a width for partially threaded key 74.
[0060] At the distal end of first tubular section 72 is a seal,
such as an O-ring 34. O-ring 34 engages both the distal end of
first tubular section 72 and the lumen wall of second tubular
section 82 of slotted track element 80. When the distal end of
first tubular section 72 is slidably displaced along the length of
the lumen of second tubular section 82, O-ring 34 hemostatically
prevents blood or other bodily fluids from being displaced between
the outer wall of first tubular section 72 and the inner wall of
second tubular section 82.
[0061] FIG. 10 illustrates a detailed perspective view of slotted
track element 80. Slotted track element 80 comprises a second
tubular section 82 having a proximal end 83, a distal end and a
lumen extending the length therethrough. Proximal end 83 terminates
into a first washer-like disc 84 that extends radially from second
tubular section 82. At a location distal from proximal end 83 is a
second washer-like disc 85 that additionally extends radially from
second tubular section 82. Between first washer-like disc 84 and
second washer-like disc 85 is slotted track 86.
[0062] Slotted track 86 comprises a portion of second tubular
section 82 preferably having a first and a second opening. It is,
however, recognized that a single opening could also be utilized.
First and second openings possess identical widths and lengths and
are additionally positioned on opposing sides of second tubular
section 82. The widths of first and second openings are
substantially the same as the distance between first planar
surfaces 78 defining the width of partially threaded key 74. As
such, partially threaded key 74 may be slidably disposed with
slotted track 86 when positioned therein.
[0063] In order to position partially threaded key 74 within
slotted track 86, slotted track element 80 includes a line of
separation 88. Line of separation 88 extends along a portion of the
length of slotted track element 80, dividing slotted track 86 into
two sections. Once the two sections of slotted track element 80 are
separated, first tubular section 72 is disposed within second
tubular section 82. Partially threaded key 74 is then advanced to
and aligned within the separated sections of slotted track 86. Once
properly aligned within the separated section of slotted track 86,
the two separated sections are again re-adhered.
[0064] Threading nut element 90 is positioned between first and
second washer-like discs 84 and 85. Additionally, threading nut
element is displaced over partially threaded key 74. In this
configuration, threading nut element 90 provides a horizontal
motive force upon partial key element 71 when rotated. FIG. 11
illustrates a detailed perspective view of threading nut element
90. In a preferred embodiment, the length of threading nut element
90 is equivalent to the length between first and second washer-like
discs 84 and 85.
[0065] Threading nut element 90 includes two half sections 92 and
94. The inner lumen wall of half sections 92 and 94 include a
machine threading 96. Machine threading 96 complementarily matches
threading 76 on partially threaded key 74. Threading nut element 90
further comprises at least one press-fit pin 98 and its
complementarily recessed hole 100. Press-fit pin 98 is positioned
on half section 92 to properly align threading 96 between the two
half sections 92 and 94. Proper alignment is important to provide a
smooth continuous threading when the two half sections 92 and 94
are adhered. Press-fit pin 98 interference fits within recessed
hole 100 in half section 94 to additionally prevent separation of
half section 92 and 94 during operation.
[0066] Referring back to FIG. 8, luer connection 17 connects hub
assembly unit 10 to a first medical device (not shown). In
preferred embodiments, the first medical device is a catheter, and
more specifically, a guide catheter. Additional attaching
mechanisms between hub assembly unit 10 and the guide catheter,
being known in the art, are also incorporated as within the scope
of the present invention. In an alternative embodiment, hub
assembly unit 10 is permanently affixed to the structure of the
guide catheter.
[0067] Proximally from luer connector 17 is second tubular section
82 of hub assembly unit 10. Second tubular section 82 comprises a
proximal end, a distal end and a lumen extending the length
therethrough. As illustrated in FIG. 8, second tubular section 82
further includes channel 104 for partial key element 71 to be
slidably displaced therein.
[0068] Although not shown, second tubular section 82 may comprise a
means for securing hub assembly unit 10 during a medical procedure.
Proper operation of hub assembly unit 10 requires maintaining hub
assembly unit 10 in a single position, relative to the patient,
during a medical procedure. A suture ring (not shown), may
mechanically maintain the hub assembly unit's positioning during
the medical procedure. Other mechanical means such as tape and
clamps may likewise be used to secure hub assembly unit 10 during
the medical procedure.
[0069] Extending from the proximal end 83 of second tubular section
82 is a portion of partial key element 71, specifically first
tubular section 72. The proximal end of first tubular section 72
includes a hemostasis valve (not shown) or other fitting capable of
maintaining the position and orientation of a second medical device
inserted therein. The second medical device is advanced to a
desired region within a patient's vasculature by initially
inserting the second medical device into the proximal end of first
tubular section 72. The second medical device is then advanced
through the lumen of first tubular section 72, through the lumen of
second tubular section 82, and finally through the lumen of the
guide catheter until finally reaching a desired region within the
patient's vasculature. In one embodiment of the present invention,
the second medical device is a stent delivery catheter. In an
alternative embodiment of the present invention, the second medical
device is a balloon dilation catheter.
[0070] The distal end of partial key element 71 additionally
extends into slot and key style fine adjustment mechanism 70. FIG.
8 illustrates the positioning of partially threaded key 74 within
slotted track 86 of slot and key style fine adjustment mechanism
70. FIG. 8 further illustrates the positioning of threading nut
element 90 between first and second washer-like discs 84 and 85,
and further over partially threaded key 74.
[0071] A physician operates slot and key style fine adjustment
mechanism 70 by rotating threading nut element 90, when assembled
as shown in FIG. 8. When threading nut element 90 is rotated,
complementary threads 96 guide partially threaded key 74 either up
or down slotted track 86. Since partially threaded key 74 is merely
a portion of first tubular section 72, movement of partially
threaded key 74 translates as an extension or a contraction of hub
assembly unit 10 as a whole. The length of hub assembly unit 10,
therefore, may be extended or contracted by the proper rotation of
threading nut element 90, thereby allowing a physician to precisely
position a second medical device 30 at a desired point within a
desired region of a patient's vasculature.
[0072] Extension and contraction of hub assembly unit 10 is
proportional to the pathlength with which partially threaded key 74
may travel within slotted track 86. In preferred embodiments, slot
and key style fine adjustment mechanism 70 may expand or contract
the length of hub assembly unit 10 by a total of 0.5 to 3
centimeters. Most preferably, hub assembly unit 10 may be displaced
a total of 1 to 2 centimeters. Each rotation of threaded nut
element 90 correlates to an incremental displacement of hub
assembly unit 10. The length of incremental displacement associated
with each rotation is a product of the size of the threading on
partially threaded key 74 and complementary threads 96 on threaded
nut element 90. Finer threading provides for small incremental
displacements for each rotation. In preferred embodiments, each
rotation of threaded nut element 90 spatially displaces hub
assembly unit by 1 to 6 millimeters.
[0073] Refer now to FIG. 12, wherein a transverse cross-sectional
view of slot and key style fine adjustment mechanism 70 is shown.
FIG. 12 further illustrates the spatial relationships between
partial key element 71, slotted track element 80 and threading nut
element 90. In particular, FIG. 12 illustrates partially threaded
nut 74 within slotted track element 80.
[0074] Numerous characteristics and advantages of the invention
covered by this document have been set forth in the foregoing
description. It will be understood, however, that this disclosure
is, in many respects, only illustrative. Changes may be made in
details, particularly in matters of shape, size and ordering of
steps without exceeding the scope of the invention. The invention's
scope is of course defined in the language in which the appended
claims are expressed.
* * * * *