U.S. patent application number 13/900584 was filed with the patent office on 2013-11-14 for catheter with direction orientation.
The applicant listed for this patent is Smiths Medical ASD, Inc.. Invention is credited to David Jason Tucker.
Application Number | 20130304022 13/900584 |
Document ID | / |
Family ID | 37735304 |
Filed Date | 2013-11-14 |
United States Patent
Application |
20130304022 |
Kind Code |
A1 |
Tucker; David Jason |
November 14, 2013 |
CATHETER WITH DIRECTION ORIENTATION
Abstract
A regional anesthesia catheter used with a guide, for example a
cannula, has a distal portion integrally connected to its main
portion by a junction portion that has a cross-sectional profile
different from the distal and main portions, so as to predispose
the distal portion of the catheter to move in a given direction
when it is not constrained by the guide. The cross-sectional
profile of the junction portion may be configured in a particular
shape, or be constructed to have a flexibility that predisposes the
distal portion to bend, curve or move toward a given direction. A
number of portions of a catheter may be configured to bend at a
predefined direction. Further, a catheter may be configured to have
a cross sectional profile or a predefined flexibility along its
entire length to cause the catheter to move in a predefined
direction.
Inventors: |
Tucker; David Jason;
(Walpole, NH) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Smiths Medical ASD, Inc. |
Rockland |
MA |
US |
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|
Family ID: |
37735304 |
Appl. No.: |
13/900584 |
Filed: |
May 23, 2013 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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11012824 |
Dec 16, 2004 |
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13900584 |
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Current U.S.
Class: |
604/506 ;
264/340 |
Current CPC
Class: |
A61M 25/0054 20130101;
A61M 25/06 20130101; A61M 25/0023 20130101; A61M 2025/0007
20130101; A61B 17/3401 20130101 |
Class at
Publication: |
604/506 ;
264/340 |
International
Class: |
A61M 25/06 20060101
A61M025/06 |
Claims
1-20. (canceled)
21. A method of introducing a catheter into a patient, comprising
the steps of: a) providing a hollow cannula having a proximal end
and a distal end; b) providing a catheter insertable into and
movable along said cannula, said catheter having at least one
portion between its distal and proximal ends configured to cause
the distal end of said catheter to be predisposedly moved toward a
direction not in alignment with said cannula when said one portion
is not confined within said cannula; c) inserting said cannula into
the patient proximate to a desired location where said catheter is
to be located in the patient; d) inserting said catheter into said
cannula by first inserting the distal end of said catheter into
said cannula; and e) continuing to move said catheter into said
cannula until at least said one portion of said catheter extends
beyond the distal end of said cannula to move the distal end of
said catheter to the desired location within the patient.
22. Method of claim 21, further comprising the step of: orientating
said one portion of said catheter relative to the cannula so that
the distal end of said catheter is effected to move toward said
direction when said one portion of said catheter is not confined by
said cannula.
23-41. (canceled)
42. Method of claim 21, wherein the step (b) further comprises the
step of: forming said catheter from a tubing having a circular
cross sectional profile except at said one portion.
43. Method of claim 21, wherein the step (b) further comprises the
step of: configuring the cross sectional profile of said one
portion of said catheter to be oval shaped.
44. Method of claim 21, wherein the step (b) further comprises the
step of: providing said one portion of said catheter to be
approximately 3 mm to 15 cm in length proximate to a distal end of
said catheter.
45. Method of claim 21, wherein said cannula comprises an epidural
needle, the method further comprising the step of: inserting the
epidural needle into the spine of the patient.
46. Method of claim 21, wherein the step (b) further comprises the
step of: configuring at least one section of said one portion of
said catheter to have a wall thickness less than that of the rest
of said tubing.
47. Method of claim 21, wherein the step (b) further comprises the
step of: configuring said one portion of said catheter to have a
flexibility that is different from that of the rest of said
catheter.
45. Method of claim 21, wherein said catheter comprises a regional
anesthesia catheter, the method further comprising the step of:
applying an anesthetic or other treatment agent to the desired
location within the patient.
46. A method of manufacturing a catheter to be used with and
passable through a guide for insertion into a patient, comprising
the steps of: forming a plastic tubing; configuring said tubing to
have a cross sectional profile that causes the tubing to have a
naturally biased orientation in a given direction when said one
portion of said tubing extends out of said guide, said tubing being
routed in said given direction.
47. Method of claim 46, wherein the configuring step comprises
configuring the cross sectional profile of said tubing to be oval
shaped.
48. Method of claim 46, wherein the configuring step comprises
configuring the cross sectional profile of said tubing to be C
shaped.
49. Method of claim 46, wherein the configuring step comprises
configuring the cross sectional profile of said tubing to be
partially concaved inwards toward the center axis of said
tubing.
50. Method of claim 46, wherein the configuring step comprises
configuring the cross sectional profile of said tubing to be
non-circular.
51. A method of directing a distal end of a tubing to move in a
given direction, comprising the steps of: (a) providing a tubing
having a distal portion connected to a main portion by a junction
that has a cross section different from the respective cross
sections of said main and distal portions; (b) configuring said
junction to have a cross sectional profile that causes said distal
portion to point to and movable along a first direction and said
main portion to point to and move along a second direction not in
alignment with said first direction if said tubing is unguided; (c)
positioning a hollow guide relative to said given direction; and
(d) inserting said tubing into and moving said tubing along said
guide; wherein when said distal portion and said junction are no
longer confined within said guide, the distal end of said distal
portion is caused to move in said given direction.
52. Method of claim 51, wherein said guide comprises a cannula and
said tubing comprises a regional anesthesia catheter, the method
further comprising the steps of: positioning said cannula relative
to a desired location within the patient; and inserting said
catheter into and moving said catheter along said cannula to
position the distal end of the catheter proximate to said desired
location so that an anesthetic may be applied directly to said
desired location of the patient.
53. Method of claim 51, wherein said tubing is a catheter and said
guide is a cannula, wherein the step (b) comprises the steps of:
configuring said catheter to have a substantially circular cross
section along its entire length except at said junction; and
configuring said junction to have a non-circular cross section
configured to cause the distal portion of said catheter to move in
a direction when the distal portion when not confined.
Description
FIELD OF THE INVENTION
[0001] The present invention relates generally to catheters such as
for example regional anesthesia catheters including epidural
catheters that provide local anesthesia to a patient and more
particularly to a catheter that has a built-in direction
orientation that enhances the movement of the catheter to a
particular location inside the patient.
BACKGROUND OF THE INVENTION
[0002] For regional anesthesia, a cathether such as an epidural
catheter is used to introduce anesthetic agents to the nerves for
example at the spine of a patient. To place a catheter close to the
nerve spinal column, an epidural needle such as a Tuohy needle is
used by the anaesthesiologist. The Tuohy needle is inserted into
the nerve sheath, alongside a nerve plexus of the patient. The
Tuohy needle has a sharp distal end that has a beveled aperture,
the sharp distal end adapted to readily pierce the nerve sheath at
the spinal column of the patient. Once the anaesthesiologist
believes that she has placed the epidural needle at the appropriate
location in the patient, she would insert the catheter into the
needle and move the catheter until its distal end extends out from
the beveled end of the needle cannula. The catheter is usually
marked along its length so that the anaesthesiologist knows
approximately how much the distal end of the catheter extends
beyond the distal tip of the needle cannula. The direction in which
the catheter is moved inside the patient depends, to a large
extent, on the insertion and placement of the needle cannula inside
the patient by the anaesthesiologist and the skill of
anaesthesiologist in maneuvering the catheter. Oftentimes, an
anaesthesiologist, experienced or not, may have a difficult time
maneuvering the distal end of the catheter to the desired location.
As a result, a larger than necessary dose of anesthetic agent may
be required to be delivered to the patient to locally anaesthetize
the patient.
[0003] There is therefore a need to provide a catheter that can
readily be maneuvered by the physician to a desired location inside
a patient.
SUMMARY OF THE PRESENT INVENTION
[0004] To assist a physician or an anaesthesiologist with the
placement of a catheter for supplying local anesthetic to a
patient, the catheter of the instant invention has at a portion
proximate to its distal end, whereby anesthetic agent is output to
a patient, a cross-sectional profile that predefines or predisposes
the distal end of the catheter to be bent or headed to a given
direction, once the catheter is no longer constrained by the guide
or needle cannula wherethrough it passes. Conventionally, a
catheter usually has a uniform circular cross sectional
configuration throughout. For the instant invention, at least one
portion of the catheter, preferably at a distance proximate to the
distal end of the catheter, is configured to have a cross-section,
which may or may not be circular, that predefines or predisposes
the distal end of the catheter to move in a given direction. One of
the cross-sectional profiles that may be used is an oval shaped
configuration that causes, or predisposes, the catheter to be bent
in the direction of the width of the greater cross-section width.
Another sectional profile that may be used at the one portion of
the catheter is C-shaped so that the distal end of the catheter is
predisposed to bend toward the direction represented by the open
mouth of the C.
[0005] In addition to having different cross-sectional profiles,
the one portion that is configured to cause the distal end of the
catheter to bend at a distal direction could have a different
thickness at a section thereof so that, even though from the
outside diameter the catheter may appear to be no different from
the rest of the catheter, the inside diameter at the one portion is
dimensioned to have thicker and thinner sections so that, once the
one portion is outside of the needle cannula or guide, subject to
additional movement, the catheter would tend to bend at a
predefined orientation to a given direction, thereby enhancing the
movement of the distal end of the catheter inside the patient.
[0006] The instant invention therefore relates to a catheter to be
used with and passable through a guide for insertion to a patient.
The catheter includes a tubing that has at least one portion having
a cross-sectional profile that is configured to bend or orient the
tubing in a given direction so that when the one portion of the
tubing extends out of the guide, the tubing is predisposed to be
routed or headed in a given direction.
[0007] The instant invention also relates to a combination of a
hollow guide and a catheter passably fitted to and moveable along
the guide. The catheter has a substantially circular
cross-sectional profile along its entire length except for at least
one portion between its distal and proximal ends. This one portion
has a cross-sectional profile configured to predispose the distal
end of the catheter toward a given direction so as to cause the
catheter to move toward the given direction once the one portion of
the catheter is no longer constrained by the guide.
[0008] The instant invention further relates to a catheter that has
a distal portion connected to a main portion by a junction that has
a cross-section that is different from the respective
cross-sections of the main and distal portions. The distal portion,
if unguided, points to and is movable along a first direction; and
the main portion, if unguided, would point to and is movable along
a second direction not in alignment with the first direction. The
catheter is insertable into and movable along a hollow guide
extending along a given axis. The junction that connects the distal
portion with the main portion is configured to have a
cross-sectional profile that causes the distal portion to bend or
head toward the first direction once the distal portion and the
junction are no longer confined within the guide after the catheter
has been inserted to the guide and moved therealong.
[0009] The instant invention yet further relates to an apparatus
that comprises a needle cannula and a regional anesthesia catheter
such as an epidural catheter having a distal end and a proximal
end. The catheter is movably fitted to the cannula with its distal
end being inserted first into the first end of the cannula so that
the catheter is movable along the cannula. The catheter has a
substantially circular cross-section along its entire length except
for at least one portion proximate to its distal end. This one
portion has a non-circular cross-section configured to cause the
distal end of the catheter to move in a direction predefined by the
configuration of the one portion when the distal end and then the
one portion of the catheter exit outside the cannula through its
distal end.
[0010] The instant invention moreover relates to a method for
introducing a catheter into a patient in which a hollow cannula is
provided. The catheter has at least one portion between its distal
and proximal ends that is configured to cause the distal end of the
catheter to be predisposably moved toward a direction not in
alignment with the cannula when the one portion is not confined
within or constrained by the cannula. The cannula is inserted into
the patient proximate to a location where anesthesia is desired. A
catheter is inserted into and moved along the cannula. The distal
end of the catheter is first inserted into the cannula. Thereafter,
the catheter is continuously moved into the cannula until at least
the one portion of the catheter is extended beyond the distal end
of the cannula to predisposedly move the distal end of the catheter
to the desired placement within the patient.
[0011] Another embodiment of the instant invention features a
catheter such as for example a regional anesthesia catheter that
has a cross sectional profile that extends longitudinally along the
entire length of the catheter. The cross sectional profile is
configured to cause the catheter to move in a predefined direction.
In particular, the catheter of this embodiment comprises a tubing
passable through a guide for insertion into a patient, the tubing
having a given length and the cross sectional profile of the tubing
along its entire length is configured to cause the catheter to
bend, curve or move in a given direction.
[0012] The cross sectional profile of the catheter of the instant
invention at the one portion as noted above or along the entire
length of the catheter may be configured to be oval shaped or C
shaped, or other non-circular shapes for example. The cross
sectional profile may also be configured to be partially concaved
inwards toward the center axis of the catheter or tubing, or may
have a section of the wall where its thickness is different from
that of the rest of the catheter.
[0013] It is therefore an objective of the instant invention to
provide a catheter that is configured to be moved in a predisposed
direction inside the patient.
BRIEF DESCRIPTION OF THE FIGURES
[0014] The present invention will become apparent and the invention
itself will be best understood with reference to the following
description of the present invention taken in conjunction with the
accompanying drawings, wherein:
[0015] FIG. 1 is a plan view of the catheter system of the instant
invention showing a guide in the form of a needle cannula such as
an epidural needle, and the regional anesthesia catheter of the
instant invention that is to be fitted into and passes through the
needle cannula;
[0016] FIG. 2 is the cross-sectional view at A-A of the catheter of
the instant invention;
[0017] FIG. 3 is the cross-sectional view B-B of the catheter of
the instant invention;
[0018] FIG. 4 is another cross-sectional view at B-B of the
catheter of the instant invention;
[0019] FIG. 5 is yet another cross-sectional view at B-B of the
catheter of the instant invention;
[0020] FIG. 6 is a plan view showing the distal end of the catheter
of the instant invention having been extended outside the distal
tip of the needle cannula through which the catheter of the instant
invention is fitted and guidedly moved; and
[0021] FIG. 7 is a plan view of another embodiment of the instant
invention catheter where the catheter is configured to have a cross
sectional profile along its entire length that predisposes the
entire catheter to be move in a predefined direction.
DETAILED DESCRIPTION OF THE INVENTION
[0022] With reference to FIG. 1, a hollow guide in the form of a
regional anesthetic needle such as for example an epidural needle 2
is shown to include a cannula 4 that has a beveled distal tip 6
having an aperture, not shown. Cannula 4 extends from distal tip 6
to, and through, a needle hub 8, which for discussion purposes may
be considered to be the proximal end of needle cannula 4. Needle 2
may be a Tuohy needle, but not necessarily so for the operation and
understanding of the instant invention. Needle hub 8 is made of a
rigid plastic that enables the anesthesiologist to manipulate the
needle cannula for insertion into a patient, for example into the
nerve sheath, alongside a nerve plexus of the patient.
[0023] Although FIG. 1 illustrates an apparatus that comprises an
epidural catheter and a needle guide in the form of an epidural
needle cannula, it should be appreciated that the instant invention
is not limited to epidural catheters. Rather, the instant invention
is directed to regional anesthetic catheters which may include, but
not limited to, Peripheral Nerve Block catheters, Vascular Access
catheters, CV catheters, PICC (Peripherally Inserted Central
Catheters) lines, Ureteral catheters, IVF catheters, Oocyte
Recovery Suction catheters and Cardiac catheters.
[0024] Conventionally, a regional anesthesia catheter, such as for
example the epidural catheter shown in the embodiment of FIG. 1,
has a circular cross-section such as that shown in FIG. 2. Prior to
the instant invention, to move a catheter to a desired location
within a patient, after a needle cannula has been properly inserted
into the patient, the physician has to manipulate the proximal
portion of the catheter so as to gently guide the distal end of the
catheter to the desired location in the patient. This manipulation
of the catheter oftentimes requires a number of trials, even for
experienced practitioners. Even when the physician is able to view
the catheter, for example via an ultrasound viewing monitor, the
placement of the distal end of the catheter nonetheless entails
some degree of difficultly. This is possibly due to the fact that
the distal end of the catheter, when inside the patient, would
usually follow or go in the direction of the least resistance, as
the physician moves the catheter.
[0025] Cannula 4 is adapted to receive a catheter 10. Catheter 10,
which has a distal end 12 and a proximal end 14, is inserted into
cannula 4 via its distal end 12 to the opening (not shown) formed
by cannula 4 at hub 8. Catheter 10 is moved so that its distal end
12 passes through cannula 4, exiting at the latter's distal tip 6.
Catheter 10 may be manufactured from materials such as but not
limited to: nylon including polyamides, Teflon, PVC, urethane,
silicone and polyolefins such as polypropylene, polyethylene and
polybutylene.
[0026] In FIG. 1, catheter 10 is shown to include a distal portion
13 and a main portion 15 that are integrally connected by a
junction portion 16. Portion 16 is located proximate to distal end
12 and has a cross-section that is different from the rest of the
catheter, i.e., from both distal portion 13 and main portion 15.
Distal portion 13 may be considered to extend from distal end 12 of
catheter 10 to portion 16 while main portion 15 of catheter 10 may
be considered to extend from portion 16 to proximal end 14 of the
catheter. Albeit only one portion 16 is shown in the catheter of
FIG. 1 embodiment, in practice, a number of portions 16 may be
effected along the length of catheter 10 so that different
predefined bends or curves may be configured in a single
catheter.
[0027] When confined within a hollow guide, such as for example
needle cannula 4, both the distal portion 13 and the main portion
15 of the catheter, being constrained by the cannula, are in
alignment along the longitudinal axis defined by the needle
cannula. However, when not confined or constrained, distal portion
13 of catheter 10 of the instant invention is not in alignment with
its main portion 15, as portion 16 is configured to predisposedly
position distal portion 13 out of alignment with main portion 15 of
the catheter 10. Portion 16 of catheter 10 may also be configured
to have a given flexibility that allows distal portion 13 and main
portion 15 of catheter 10 to align along substantially the same
longitudinal axis, so long as distal end 12 of catheter 10 does not
come into contact with any obstruction. In other words, portion 16
may be configured to flexibly bend in a predisposed direction
relative to main portion 15 of catheter 10 when distal portion 13
encounters an obstruction. Although shown as being only a part of
catheter 10, portion 16 may in some iterations include the entire
catheter.
[0028] As noted above, portion 16 of catheter 10 is configured to
have a cross-sectional profile that is different from the rest of
the catheter. For the FIG. 1 embodiment, the cross-section profile,
per view B-B, may be in the shape of an oval, as shown in FIG. 3.
With the oval shaped cross-section at portion 16, distal end 12 of
catheter 10 is predisposed to move in either direction 18a or 18b,
rather than 20a or 20b. Thus, in practice, when distal end 12, and
then portion 16, of the catheter are moved beyond distal tip 6 of
cannula 4, depending on the orientation of catheter 10, as it is
being manipulated by the anesthesiologist, distal end 12 of the
catheter may either go to the direction as indicated by 18a or the
direction as indicated by 18b. This movement of distal end 12 in a
given direction may be governed by the distal tip 6 of needle
cannula 4 to a certain extent, as well as the orientation of
catheter 10 as it was initially inserted into cannula 4.
[0029] In the event that obstruction is encountered, distal end 12
would bend in either direction 18a or direction 18b, depending on
the orientation of the catheter, and the flexibility of the
catheter at portion 16. Portion 16 of the catheter, which may be
made from polyamide, may have a different thickness than that of
the rest of the catheter. The difference in thickness may be
effected during the extrusion process by stretching portion 16 more
than the rest of the catheter. To effect an oval shape, portion 26
may be compressed by an appropriate tool after the catheter has
been extruded or during extrusion. In any event, to effect the
predisposed bending of the distal end 12 of the catheter relative
to the remaining portion of the catheter, portion 16 may have a
length from approximately 3 mm to 15 cm, depending on the length of
the catheter.
[0030] FIG. 4 shows another cross-sectional profile for portion 16
of catheter 10 of the instant invention. As shown, portion 16 has a
cross-section in a shape of a C in which a section 22 of the
catheter is constructed to have a concave shape toward the center
of the catheter. As a consequence, distal end 12 tends to bend in
the direction as shown by directional arrow 24. Depending on the
flexibility built into portion 16, the bend may be a built-in curve
where distal end 12 would not lie in alignment with the remainder
portion of the catheter even when the catheter is not confined
within a hollow guide such as for example needle cannula 4.
Alternatively, the bend may be such that it only bends toward
direction 24 when obstruction is encountered.
[0031] FIG. 5 shows yet another cross-sectional profile of portion
16 of the catheter of the instant invention. In this embodiment,
the cross-section is configured to be thicker at section 26 and
thinner at section 28. As a consequence, section 28 is more
flexible, or pliable, than section 26 at portion 16. Thus, for the
embodiment of FIG. 5, distal end 12 of the catheter is predisposed
to move in the direction as indicated by directional arrow 30.
[0032] FIG. 6 shows the apparatus of the instant invention in which
catheter 10 has been inserted into epidural needle 2 and moved such
that its distal end 12 and portion 16 extend out of distal tip 6 of
cannula 4. No longer being constrained by cannula 4, for the
embodiment shown in FIG. 6, distal end 12 of catheter 10 curves
toward the direction indicated by directional arrow 32, due to
portion 16 having been configured to have a cross-sectional profile
that predisposes distal end 12 to point toward direction 32, once
distal end 12 and portion 16 are no longer confined within cannula
4.
[0033] In operation, a physician is provided with a hollow guide,
such as needle cannula 4. The cannula is inserted into the patient
proximate to a desired location where the catheter is to be placed.
The catheter, and more particularly the distal end of the catheter,
is inserted into the needle cannula and moved therealong, so that
distal portion 13, portion 16, and main portion 15 of catheter 10
are confined within the cannula and are therefore in alignment
along the longitudinal axis of the cannula. The catheter is moved
further until distal end 12, and then portion 16, exit distal tip 6
of cannula 4. The orientation of distal end 12 of catheter 10,
relative to cannula 4, is rotatably adjusted or oriented by the
physician prior to her inserting the catheter into the cannula so
that the distal end of the catheter would exit from the distal tip
of the cannula in the direction of the desired location in the
patient.
[0034] FIG. 7 is a plan view illustrating another embodiment of the
catheter of the instant invention. Insofar as the needle cannula to
be used with the catheter of the FIG. 7 embodiment is the same as
the needle cannula shown in FIG. 1, no further discussion thereof
is needed.
[0035] For the catheter 34 of the FIG. 7 embodiment, note that the
entire length of the catheter is configured, per cross-section view
C-C, with a cross-sectional profile that may be represented, for
example, by any one of the profiles shown in FIGS. 3, 4 and 5. In
addition to, or as an alternative of, the catheter of FIG. 7 may
have along its entire length a section configured to have a
flexibility characteristic that is different from the other
sections of the catheter. With any one of the non-circular
cross-sectional profiles as shown in FIGS. 3-5 and/or the flexible
cross-section, catheter 34, as shown in FIG. 7, may have a
naturally curved or biased orientation, even when the catheter is
at rest and not being constrained or confined within the needle
cannula 4. Putting it differently, catheter 34 of the FIG. 7
embodiment is configured to bend or move in the predefined
direction as indicated by directional arrow 36. Thus, when catheter
34 is inserted into needle cannula 4, assuming that it remains
oriented in the position as shown in FIG. 7, when it is moved by
the physician and its distal end exits distal tip 6 of needle
cannula 4, catheter 34 would move in the direction designated by
directional arrow 40, as the distal portion of catheter 34, shown
by dotted line, is naturally biased to and therefore is movable in
the predefined direction. Catheter 34 thereby enabling the
physician to readily place the distal end 38 of the catheter at the
desired location within the patient for the supplying the
anesthetic agent to the patient.
[0036] Although the catheter of the instant invention has been
described thus far as used for supplying an anesthetic agent to a
patient, it should be noted that other treatment agents may also be
supplied via the inventive catheter. Such other treatment agents
may include for example electrical energy, radio frequency (RF),
microwave and ultrasound waves that may be transmitted by the
catheter. In the case of electrical energy, it is envisioned that
the catheter may be imbedded with an electrical conductive material
such as carbon or includes a wire extending along its length.
[0037] It should be appreciated that the present invention is
subject to many variations, modifications and changes in detail.
Thus, it is the intention of the inventor that all matters
described throughout this specification and shown in the
accompanying drawings be interpreted as illustrative only and not
in a limiting sense. Accordingly, it is intended that the invention
be limited only by the spirit and scope of the hereto appended
claims.
* * * * *