Note: Descriptions are shown in the official language in which they were submitted.
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Surgical Chair for Percutaneous Suinal Catheter Insertion
Priority Claim
[0001] The present application claims priority frorn~ US 601391,085, filed
June
25, 2002, the contents of which are incorporated herein by reference.
Field of the Invention
[0002] The present invention relates generally to catheters and more
particularly relates to a surgical chair and a spinal catheter kit for
percutaneous spinal
catheter insertion via lumbar puncture.
Background of the Invention
[0003] Spinal catheter insertion may be used fox cerebrospinal fluid (CSF)
pressure monitoring and controlled CSF drainage for the diagnosis of adult
hydrocephalus (See, for example, discussions in Williams MA, Razumovsky AY,
PIanley DF. Comparison of Pcsf monitoring and controlled CSF drainage to
diagnose
normal pressure hydrocephalus. Acta Neurochir 1998;71:328-330. and, Flaan J,
Thomeer RT. Predictive value of temporary external lumbar drainage in normal
pressure hydrocephalus. Neurosurgery 1988;22:388-391. The contents of which
are
incorporated herein by reference.)
[0004] Existing spinal catheter insertion techniques are based. on traditional
lumbax puncture (LP) and spinal anesthetic techniques, with patients either in
the
lateral decubitus or seated positions. (See, for example, Patten J.
Neurological
Differential Diagnosis. 2 ed. London:Spxinger-Verlag, 1995:273; Lee JA,
Atkinson
RS, Watt MJ. Sir Robert Macintosh's Lumbar Puncture and Spinal Analgesia:
Intradural and Extradural. Edinburgh:Churchill Livin.gstone, 1985:159; Barnett
R.Nathan. Cerebrospinal Fluid and Intracranial Pressure., In: Goetz CG,
Pappert EJ,
eds. Textbook of Clinical Neurology [online]. Phi adelphia: ~Rr.B. Saunders,
1999:480-481. Available at:
CA 02433269 2003-06-25
http://home.mdconsult.com/das/book/13710379/view/889. Accessed October 10,
2001; and, Lund PC. Principles and Practice of Spinal Anesthesia. Springfield,
IL:Charles C. Thomas, 1971:304 The contents of all of these references are
incorporated herein by reference.) >3ecause adult hydrocephalus predominantly
affects persons between the ages of 60 and 90, the LP in the lateral decubitus
position
may be difficult because it is hard for patients to maintain the proper
position due to
discomfort or arthritic changes of the spine that impede their ability to
flex, or
because it is difficult to keep their pelvis and shoulders perpendicular to
the surface of
the bed or examination table, resulting in rotation the spine. {See Patten J.
Neurological Differential Diagnosis. 2 ed. London:Springer-Verlag, 1995:273,
the
contents of which is incorporated herein by reference.)
[0005] Attempts to perform LFs with patients in the seated position are often
difficult in the hospital setting because of the lack of a stable, safe
platform for the
patient. A commonly used technique, though apparently undocumented in peer-
reviewed literature, is to have the patient sit on the edge of the bed while
flexing and
leaning on an over-bed table with a pillow on it. dVhile this approach may
improve
flexion of the lumbosacral spine, it carries the risk that the over-bed table
(which is on
wheels) can move forward, potentially causing the patient to fall, or
sideways,
potentially misaligning the spine. This technique further requires the
assistance of an
additional person or persons to help maintain the patient's position, to
prevent the
over-bed table from moving, or to assure that the patient's breathing is. not
obstructed
because the face is in the pillow. The presence of an assistant to stabilize
the seated
patient for lumbar puncture is illustrated in two spinal anesthesia texts.
(See Lee JA,
Atkinson RS, Watt MJ. Sir Robert Macintosh's Lumbar Puncture and Spinal
Analgesia: Intradural and Extradural. Edinburgh:Churchill Livingstone,
1985:159.
See also Lund PC. Principles and Practice of Spinal Anesthesia. Springfield,
IL:Charles C. Thomas, 1971:304, the contents of both of which are incorporated
herein by reference. See also Williams MA: Seated LP using a massage chair
Page 2)
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Summary of the Invention
[0006) It is an object of the invention to provide a novel surgical chair and
method for its use that obviates or mitigates at Ieast one of the above-
identified
disadvantages of the prior art.
[0007] An aspect of the invention provides a surgical chair comprising, a
frame and a seat attached to the frame. The chair also comprises a face-rest
attached
to the frame, and a chest-pad attached to the frame at a position between the
seat and
the face-rest. The seat, face-rest and chest-pad are mounted on the frame such
that
when a patient sits in the seat and the patient's face rests in the face-rest
then a desired
portion of the patient's spine is presented in an ergonomic manner to a
medical
professional so that the professional can perform a procedure on the spine.
The seat
and face-rest can be adjustable to accommodate patient's of different sizes.
The chair
can further comprise at least one knee-pad attached to the frame for
supporting the
patient's knees when the patient is seated. The knee-pads can be removable
andlor
adjustable.
[0008] The frame can support the seat, face-rest, chest-pad and knee-pads in a
particular configuration such that the patient can slide sideways into a
seated position
within the chair without raising his or her leg over the frame.
[0009] The chair can further comprise an arm rest. The arm rest can be
adjustable to allow the patient's arms to be positioned at substantially the
same height
as the patient's chest.
[0010] The face rest of the chair can be donut shaped to support the periphery
of the patient's face while providing a pathway for breathing through a centre
of the
donut shape.
[0011 ] The desired portion of the patient's spinal is typically the patient's
lumbosacral spine.
[0012] Another aspect of the invention provides a prepackaged sterile tray of
parts for use in performing a spinal catheter insertion comprising a lumbar
puncture
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CA 02433269 2003-06-25
tray, a separate spinal catheter tray, and a separate collection of gauze
sponges, iodine
solution, sutures, needle holders, and scissors.
[0013) Another aspect of the invention provides a spinal catheter that can be
packaged as part of the tray of parts or separately therefrom. The catheter
has a
narrow end for insertion into a lumbar puncture and a waist at a predetermined
distance from the narrow end, the waist being wider than the narrow end such
that the
waist provides a seal between an exterior ofthe catheter and the puncture.
Brief Description of the Drawings
[0014] Preferred embodiments of the present invention will now be explained,
by way of example only, with reference to the attached Figures in which:
Figure 1 shows an isometric view of a surgical chair in accordance
with an embodiment of the invention;
Figure 2 shows a side view of the surgical chair shown in Figure 1;
Figure 3 shows the chair of Figure 2 with a patient seated thereon;
Figure 4 shows a rear view of the chair and patient shown in Figure 3;
Figure 5 shows an isometric view of a surgical chair in accordance
with another embodiment of the invention;
Figure 6 shows a side view of the chair and patient shov~rn in Figure 5;
Figure 7 shows a tray of parts for use in performing a spinal catheter
insertion in accordance with another embodiment of the invention;
Figure 8 is an isometric view of the tray of Figure 7;
Figure 9 shows the guidewire of Figure 7 in when removed from the
tray of Figure 7; and
Figure 10 shows a tapered spinal catheter in accordance with another
embodiment of the invention.
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Detailed Descrit~tion of the Invention
[0015] Referring now to Figures 1-4, a surgical chair for use in performing a
seated lumbar puncture in accordance with an embodiment of the invention is
indicated generally at 20. A presently preferred surgical chair is a suitably
configured
Ergo Pro Massage chair sold by Stronglite, Inc. 255 Davi.dson Street Cottage
Grove
Oregon 97424 U.S.A., and shown as chair 20 in Figure 1. In a presently
preferred
embodiment, chair 20 has an aluminum tubular construction capable of
supporting
about 1200 pounds {545 Kg) static weight. Chair 20 comprises an aluminum
tubular
frame 24 that supports a substantially donut-shaped face rest 28 which is
intended to
support a patient's head when facing downwards, such that the periphery of the
patient's face is supported by face rest 28, while the hollow centre provides
an
unobstructed airway to allow the patient to comfortably breathe, see and speak
during
the procedure. Chair 20 further includes a chest-pad onto which a patient can
lean his
or her chest while placing their head face-down on face rest 28.
[0016] Chair 20 also includes an arm rest 36 that is supported by frame 24,
which the patient can use to place his or her arms while the procedure is
being
performed. Frame 24 of chair 20 also supports a seat 40 and knee pads 44. In
sum,
the various components of chair 20 allow a patient to rest comfortably while
facing
forward, and thereby present the lumbar region of the patient to a surgeon (or
other
medical professional) who will perform a spinal catheter procedure, the
details of
which will be discussed in greater detail below.
[0017j Preferably, face rest 28, chest pad 32, arm rest 36, seat 40 and knee
pads 44 are all adjustable to comfortably accommodate patients of various
sizes,
heights and weights, and conditions of the patient. For e:~ample, the height
and angle
of face rest 28 are adjustable to accommodate differences in patient height or
ability
to flex the neck. Arm rest 36 allows the arms to rest comfortably at
apvproximately the
level of the heart. Further, it is presently preferred that knee pads 44 can
be
removable. When present, knee pads 44 can be used to permit the patient to
rest with
both hips and knees in flexion. When knee pads 44 are removed chair 20 can
then
accommodate patients with limited knee mobility.
s
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[0018] t~s best seen in Figures 3 and 4, when seated in chair 20, the patient
faces forward and the chair is adjusted for comfortable flexion of the hips
and
lumbosacral spine, thereby ergonomically presenting the lumbosacral spine,
identified
in Figure 3 generally at 50 to the medical professional. It will riow be
understood that
face rest 28, chest pad 32, arm rest 36, seat 40 and knee pads 44 of°
chair 20 are
adjusted so as to achieve a desired level of comfort for the patient, while
also
presenting lumbosacral spine 50 in an ergonomically desirable manner 1:o the
medical
professional.
[0019] Refernng now to Figures S and 6, a surgical chair in accordance with
another embodiment of the invention is indicated generally at 20a. Chair 20a
includes
a similar structure to chair 20 shown in Figures 1-4, and thus bears Iike
reference
numerals to its various components, except that components in chair 20a are
followed
with the letter "a". Thus, chair 20a is substantially the same as chair 20,
except that
frame 24a and knee rests 44a do not form a cross spar (as found in chair 20)
that
impedes sideways movement of the patient's legs across the center line ~~ of
the
chair 20 as seen in Figure 4, when the patient slides into chair 20a from the
side. ~~s
best seen in Figures 5 and 6, this embodiment of the chair, will allow
patients to slide
onto the chair from the side, as if sliding across a bench, allowing them to
attain the
proper position for the spinal catheter procedure without having to straddle
the seat or
cross spar, or otherwise flex or bend their legs over the cross spar so as to
attain the
proper position for the procedure. Put in other words, the patient can slide
sideways
into chair 20a without having to raise his or her leg over flame 24a. Chair
20a is thus
suitable for epidural anesthesia with or without epidural catheter insertion
for
pregnant women for the purpose of labor and delivery, or for other patients in
need of
spinal anesthesia.
[0020] In another embodiment of the invention, chair 20, chair 20a or a
combination or variation of components thereof are made from materials such
tlFat
frame 24, seat 40, knee pads 44, chest pad 32, arm rest 36, and face rest 28
are
constructed of radioluscent materials (e.g. wood, graphite composite, or
structurally
sound polymers) so that the chair is invisible under an imaging beam, but
lumbar
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puncture and associated catheter procedures are visible and can thus be
performed
under fluoroscopic guidance (or the like) as necessary.
[0021 ] In another embodiment of the invention, there is provided a sterile
tray
of parts for use in performing a spinal catheter insertion technique using the
surgical
chair shown in Figures 1-6. The tray of parts preferably contains the items
listed in
Table 1. An exemplary configuration of the tray is shown in Figures 7 and 8,
and
indicated generally at 90.
Table 1
ReferencePart 101ame Quantity Description or Source
Number
of
Item or (if applicalble)
fray
Location
100 Lumbar punctureI Allegiance Healthcare
Corp.,
tray McGaw Park, IL 60085;
#4301 C
104 Spinal Catheter1 Medtronic PS Medical,
~'ay Goleta, California;
#27364
110 Gauze sponges 10 Kendall Curity, 3x3"
;
#1903
112 2% tincture 50 ml Cumberland Swann; Smyrna,
Iodine
Solution TN 37167
108 Sutures 1 1JJSS/DG; Sofsilk;
#SS-685;
45 cm, C-15 cutting
needle
108 Needle Holder 1 Acme Healthcare; Medical
Action Industries Co.;
Arden,
NC
108 Scissors 1 Acme Healthcare; Medical
Action Industries Co.;
Arden,
NC
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Reference Part leTame quantity Description or Source
l~Tumber
of
Item or (if applicable)
Tray
location
108 Paper Drape 1 Shaped to expose lumbar
spine 50 and cover the
surrounding area. Includes
an adhesive strip.
108 Local AnestheticSOmI Abbott Laboratories;
North
with 1 or 2% Chicago, IL 60064
Lidocaine Solution
116 Closed tip lumbar Medtronic PS Medical,
catheter Goleta, CalivPorni~
120 16 Gauge Needle 1 Becton Dickinson & Co.;
Franklin Lakes, NJ 0741'
124 14 Gauge Tuohy 1 Medtronic P'S Medical,
Needle Goleta, California
128 Luer Hub with i
Cap
108 Transparent ~p Site; Srnith ~ Nephew
Adhesive Dressing Medical Ltd; Hull HIJ3
2BN
England
i
I
132 lOcc Syringe 1
136 3cc Syringe 3
140 Guidewire 1
[0022] Having appropriately seated the patient on chair 20, the anatomical
landmarks (iliac crests and spinous processes) are indicated with a surgical
marking
pen on lumbosacral spine 50. Personnel present to perform or assist wear
sterile cap
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and masks, and the person inserting the lumbar catheter wears cap, mask, and
sterile
gown and gloves. Intravenous prophylactic antibiotics (1 gram oxacillin or 600
mg
clindamycin) are administered during the procedure. The lumbosacral spine 50
area of
the patient's back is prepared with 2% tincture of iodine solution. A sterile
paper
drape with an adhesive strip is attached at the lower margin. of the sterile
field.
[0023] Local anesthetic with lidocaine is administered along the planned
puncture track of lumbosacral spine 50, as well as adjacent to the spinous
processes
for a field block of the recurrent spinal nerves (For further discussion on
this step, see
Wilkinson HA. "Field block anesthesia for lumbar puncture." JAMA
1983;249:2177,
the contents of which are incorporated herein by reference.)
[0024] A closed tip lumbar catheter is prepared with a guidewire advanced to
within 3-4 cm of the tip of the catheter, leaving the tip flexible. A suitable
closed tip
lumbar catheter is available from Medtronic PS Medical, Goleta, California.
The skin
may be punctured to a depth of 2-4 mm with a 16-Ga needle to provide easier
insertion of the 14-Ga Tuohy needle. The Tuohy needle is advanced with the
bevel
directed either to the right or to the left so that it is parallel to the
longitudinal fibers of
the lumbar spinal dura. ~nce CSF is encountered, the needle is rotated so the
bevel is
directed cephalad.
[0025] Next, the stylet of the Tuohy needle is withdrawn and the catheter with
guidewire is rapidly inserted so that 10-15 cm of catheter are inserted beyond
the
needle tip. The needle is withdrawn. The guidewire is withdrawn by grasping
the
catheter where it exits the skin to prevent its withdrawal while the guidewire
is
carefully removed in its entirety. The spinal catheter is then trimmed to an
appropriate
length so that a Luer hub with cap can be attached. A small area of skin on
the flank is
anesthetized with lidocaine, and the Luer hub is secured to the skin with a
silk suture,
thereby providing strain relief for the spinal catheter if tension is placed
on the Luer
hub. Finally, the catheter site is covered with a transparent adhesive
dressing, and the
spinal catheter is connected at the Luer hub to tubing that attaches to a
pressure
transducer, controlled CSF drainage apparatus (or system), or a combination of
the
two.
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[0026] Referring now to Figure 10, a spinal catheter in accordance with
another embodiment of the invention is shown at 116a. Spinal catheter 116a is
essentially the same as catheter 116, particularly in its length, except that
spinal
catheter 116a is tapered. The narrow end 180 of spinal catheter 116a is
smaller in
diameter than the touhy needle. Spinal catheter 116a gradually widens to a wai
st 184
that is slighter greater in diameter than the touhy needle. Waist 184 can be
about two
to eight inches in length from narrow end 180, or it can be about three to
seven inches
from narrow end 180, or, more preferably it can be about six inches from
narrow end
180. Narrow end 180 of catheter 116a is inserted into the puncture, until
waist 184
reaches the opening of the puncture. By so doing, a seal is formed around the
exterior
of catheter 116a and the puncture, thereby reducing leakage from the puncture.
Such
a seal provides a number of advantages, including the ability to attach a
device for
measuring CSF pressure. With the seal, a more accurate measurement of CSF
pressure can be made than that with certain prior art catheters. While not
necessary,
catheter 116a is preferably coated with an infection resistant layer and/or an
adhesion
resistant layer.
[0027] While only specific combinations of the various features and
components of the present invention have been discussed herein, it will be
apparent to
those of skill in the art that desired subsets of the disclosed features and
components
andlor alternative combinations of these features and corn. ponents can be
utilized, as
desired. For example, the above-described embodiments of surgical chairs and
kit of
parts and technique can be used for standard diagnostic lumbar puncture,
therapeutic
lumbar puncture, spinal catheter insertion, or epidural catheter insertion for
spinal
anesthesia or other purposes that will occur to those of skill in the art.
[0028] The present invention provides a novel spinal catheter and method for
its insertion via seated lumbar puncture using a surgical chair. It is the
inventors°
experience that a successful spinal catheter insertion can be achieved in
certain
patients that do not have physical impairments that might restrict their
ability to
physically position themselves on the surgical chair in a presently preferred
embodiment. The suxgical chair provides a stable, substantially safe platform
for
patients, and reduces the need for additional personnel to maintain the
patient's
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position. The seated position provides for goad alignment of the spinous
processes,
improving the chances for successful lumbar puncture and spinal cathf;ter
insertion.
The surgical chair can provide a stable platform that permits patients to
maintain
proper position with reduced effort, and without the need for additional.
personnel to
keep the patient's legs tucked toward the chest in the decubitus position, or
to prevent
an over-bed table from rolling if seated on the edge of the bed. The face rest
can
reduce and even prevent breathing obstruction that occurs when patients lean
on an
over-bed table with a pillow on it. The seated position also makes it much
more likely
that the spinous processes will be aligned without the rotation of the <,>pine
that can
occur in the lateral decubitus position. The present invention can reduce the
procedure
time by up to about 50-75% over prior art procedures for insertion of a spinal
catheter,
as typically about 30 minutes or less is required for most patients .for the
entire
procedure.
1i
