U.S. patent application number 10/778698 was filed with the patent office on 2004-08-26 for surgical kit for repairing leaks in fluid carrying vessels and organs and method thereof.
Invention is credited to Boehm, Frank H. JR., Melnick, Benedetta Delorenzo.
Application Number | 20040167571 10/778698 |
Document ID | / |
Family ID | 22006885 |
Filed Date | 2004-08-26 |
United States Patent
Application |
20040167571 |
Kind Code |
A1 |
Boehm, Frank H. JR. ; et
al. |
August 26, 2004 |
Surgical kit for repairing leaks in fluid carrying vessels and
organs and method thereof
Abstract
A surgical kit for percutaneously repairing post-operative leaks
in internal fluid carrying vessels and organs. The kit includes at
least one syringe and at least one marker for placement on the body
of the patient to mark the location of the leak. The syringe and
marker are enclosed in a sterile package which includes a top cover
and a bottom cover. A method for repairing a leak in a fluid
carrying vessel or organ, such as the dura mater of the spinal
cord, is also disclosed.
Inventors: |
Boehm, Frank H. JR.; (Utica,
NY) ; Melnick, Benedetta Delorenzo; (Rome,
NY) |
Correspondence
Address: |
DILWORTH & BARRESE, LLP
333 EARLE OVINGTON BLVD.
UNIONDALE
NY
11553
US
|
Family ID: |
22006885 |
Appl. No.: |
10/778698 |
Filed: |
February 13, 2004 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10778698 |
Feb 13, 2004 |
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10056841 |
Nov 7, 2001 |
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6692515 |
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Current U.S.
Class: |
606/214 |
Current CPC
Class: |
A61B 17/00491 20130101;
A61B 2017/0065 20130101; A61B 50/30 20160201; A61B 17/0057
20130101; A61B 2017/00495 20130101 |
Class at
Publication: |
606/214 |
International
Class: |
A61B 017/08 |
Claims
What is claimed is:
1. A surgical kit for repairing a fluid leak in internal fluid
carrying vessels and organs, comprising: at least one syringe
having a needle; at least one container for carrying a
bio-compatible fluid, said fluid serving to fill a breach in an
internal fluid carrying vessel or organ; at least one marker for
placement on a patient's body to mark the breach in the vessel or
organ, the marker serving as a needle guide for the needle of the
syringe to assist in placement of the needle adjacent the breach;
and a package including a top cover and a bottom cover, said top
and bottom cover forming a package containing the at least one
syringe, the at least one container, and the at least one
marker.
2. A surgical kit according to claim 1, further comprising at least
one sterile surgical drape.
3. A surgical kit according to claim 1, wherein the bio-compatible
fluid is a fibrin glue material.
4. A surgical kit according to claim 1, wherein the marker is
radiopaque and includes a hole which passes through the marker to
accommodate the needle of the syringe, to guide insertion of the
needle into the patient.
5. A surgical kit according to claim 1, wherein the syringe
contains a fluid which reacts with the bio-compatible material to
form a fibrin glue material to fill the breach in the fluid
carrying vessel or organ.
6. A surgical kit according to claim 1, further comprising a
container for carrying a myelographic contrast agent, and a syringe
having a needle for delivering the agent to the vessel or organ
having the breach.
7. A surgical kit according to claim 1, wherein the at least one
syringe, the at least one container and the at least one marker are
sterile.
8. A surgical kit for repairing a fluid leak in internal fluid
carrying vessels and organs, comprising: a syringe having a needle
and containing a fluid for filling a breach in an internal fluid
carrying vessel or organ; at lest one marker for placement on a
patient's body to mark the breach in the vessel or organ, the
marker serving as a needle guide for the syringe to assist in
placement of the needle adjacent the breach; and a package
including a top cover and bottom cover, said top and bottom cover
forming a package containing the at least one syringe and the at
least one marker.
9. A surgical kit according to claim 8, further comprising at least
one sterile surgical drape.
10. A surgical kit according to claim 8, wherein the syringe is a
dual chamber syringe.
11. A surgical kit according to claim 10, wherein said fluid in
said syringe is a fibrin glue, and a first chamber and a second
chamber of the syringe contain the components of the fibrin
glue.
12. A surgical kit according to claim 11, wherein a needle of the
syringe has two lumens.
13. A surgical kit according to claim 8, wherein the marker
includes a hole which passes through the marker to accommodate the
needle of the syringe, to guide insertion of the needle into the
patient.
14. A surgical kit according to claim 8, further comprising an
additional syringe having a needle and containing a myelographic
contrast agent for delivery to the vessel or organ having the
breach.
15. A surgical kit according to claim 14, wherein the syringe
containing the fluid, the at least one marker, and the syringe
containing the contrast agent are sterile.
16. A surgical kit for repairing a fluid leak in internal fluid
carrying vessels and organs, comprising: a syringe having a needle
for applying a fibrin glue material to a location adjacent a leak
in an internal fluid carrying vessel or organ; at least one marker
for placement on a patient's body to mark the location of the leak;
and a package including a top cover and a bottom cover, said top
and bottom cover forming a package containing the at least one
syringe and the at least one marker.
17. A surgical kit according to claim 16, further comprising at
least one sterile surgical drape.
18. A surgical kit according to claim 16, wherein the syringe is a
dual chamber syringe, a first chamber containing platelets and a
second chamber containing fibrin.
19. A surgical kit according to claim 18, wherein a needle of the
syringe has two lumens.
20. A surgical kit according to claim 16, wherein the marker
includes a hole which passes through the marker to accommodate the
needle of the syringe, to guide insertion of the needle into the
patient.
21. A surgical kit according to claim 16, further comprising a
syringe having a needle and containing a myelographic contrast
agent for delivery to the vessel or organ having the leak.
22. A surgical kit according to claim 21, wherein the syringe
having the fibrin glue, that at least one marker, and the syringe
having the contrast agent are sterile.
23. A method for repairing a fluid leak in internal fluid carrying
vessels and organs, comprising the steps of: determining that a
leak has occurred in a fluid carrying vessel or organ; injecting a
radiographic contrast agent into the fluid carrying vessel or
organ; observing flow of the contrast agent using radiographic
imaging to determine the location of the leak; placing a marker on
the patient's body to mark the location of the leak; confirming the
location of the leak with respect to the marker using radiographic
imaging; providing a syringe having a needle and containing a
fibrin glue material; inserting the needle into the patient's body
through the marker; confirming the location of the distal tip of
the needle of the syringe using radiographic imaging; and
delivering the fibrin glue material to the location of the leak to
seal the leak on the fluid carrying vessel or organ.
24. A method for repairing a CSF leak in the dura mater of the
spinal cord, comprising the steps of: (a) determining that a leak
has occurred; (b) determining the location of the leak; (c) placing
a marker on the patient's body to mark the location of the leak;
(d) providing a syringe having a needle and containing fibrin glue;
(e) inserting the needle into the patient's body through the marker
to the location of the leak; and (f) delivering the fibrin glue to
the location of the leak to seal the leak in the dura mater.
25. The method of claim 24, further comprising the step of
delivering a contrast agent to the dura mater and observing at
least steps (b), (c), (e) and (f) through scanning techniques.
Description
BACKGROUND OF THE INVENTION
[0001] 1. Field of the Invention
[0002] The present invention relates to a surgical kit for
repairing leaks in fluid carrying vessels and organs, and in
particular, to a surgical kit for percutaneously repairing
post-operative cerebrospinal fluid leaks associated with
intraoperative rents of the dura mater of the spinal cord.
[0003] 2. Description of the Related Art
[0004] Surgical procedures involving fluid carrying vessels and
organs have risks associated with them that can extend beyond the
actual surgery itself. Once the actual surgery is complete, the
patient must be closely monitored to ensure that leaks at the
surgical site do not develop. With the advent of many popular
minimally invasive surgical procedures, such as laparoscopy, the
vast benefits associated with the minimally invasive procedure may
be lost if the patient must return to the operating room to close
leaks that develop in fluid carrying vessels, particularly if the
leak must be closed using traditional open surgical techniques.
[0005] Post-operative leaks are of particular concern following
neurosurgical procedures. The human spine is comprised of the
spinal column, having many vertebra which support the body and
protect the delicate spinal cord. The vertebra are generally of
pentagon shape, with the spinal processes (or "points") extending
posteriorly to the patient's back. The vertebra are separated and
cushioned from each other by the discs, which act as pads between
the vertebra to permit movement and shock absorption for the spine.
The center of the vertebra are hollow, to permit the spinal cord to
extend from the base of the spine to join with the medulla
oblongata of the brain. Nerves extend outwardly from the spinal
cord between the vertebra. The brain and the spinal cord itself are
covered with three main layers: the pia mater, the arachnoid
membrane, and the dura mater. The pia mater is a generally thin
vascular membrane which is covered by the arachnoid membrane. The
arachnoid membrane is in turn covered by the dura mater, which is a
tough fibrous membrane that contains and provides a passageway for
the cerebrospinal fluid (CSF) to flow. Following neurosurgery, the
patient is closely monitored to determine if a rent in the dura
mater has developed, which can have deleterious effects on the
patient.
[0006] In the prior art, once a dural rent is identified, it is
common to place a spinal drain at the site and the patient is
placed in the Trendelenburg position, with his head positioned
below the feet at about a 30-40 degree angle, with the knees bent.
Typically, this will solve the problem; however, if the leak is not
sealed, oftentimes surgery is necessary to close the rent and
prevent further leakage of the CSF. This of course is traumatic to
the recovering patient.
[0007] A need, therefore, exists for a kit having the instruments
required for performing percutaneous procedures to repair leaks in
fluid carrying vessels and organs without requiring the patient to
undergo a traditional surgical procedure to repair the vessel or
organ. A minimally invasive surgical technique is also needed to
repair fluid leaks, such CSF leaks in the spinal cord, that may be
accomplished quickly and efficiently, to reduce the recovery time
of the patient and to minimize the trauma associated with such
repair procedures.
SUMMARY OF THE INVENTION
[0008] It is, therefore, an object of the present invention to
provide a surgical kit to facilitate the percutaneous repair of
leaks in internal fluid carrying vessels and organs.
[0009] It is also an object of the present invention to provide a
surgical kit for repairing post-operative CSF leaks in the dura
mater following neurosurgery in a minimally invasive manner.
[0010] It is yet another object of the present invention to provide
a minimally invasive method for repairing leaks in internal fluid
carrying vessels and organs, particularly CSF leaks in the dura
mater of the spinal cord.
[0011] The above and other objects are achieved by providing a
surgical kit for repairing leaks in fluid carrying vessels and
organs which includes a syringe and at least one marker in a
sterile package, the syringe for containing fibrin glue for sealing
the leak and the at least one marker for placement on the body of
the patient to mark the location of the leak.
[0012] In a preferred embodiment, the kit includes the syringe and
at least one marker, and a package for containing the syringe and
marker, where the package includes a top cover and a bottom cover
for enclosing the syringe and marker. In another embodiment, the
kit includes a syringe, a container carrying a bio-compatible fluid
such as a fibrin glue, at least one marker, and a package having a
top cover and a bottom cover for containing the syringe, container
and marker. In another embodiment, the kit includes a syringe
filled with a fluid such as a fibrin glue for sealing the leak, at
least one marker, and a package including a top cover and a bottom
cover for containing the syringe and marker. Preferably, the marker
is adhesive-backed for maintaining its placement location on the
body of the patient, and includes a hole in its center through
which the needle of the syringe may pass, to guide the needle to
the location of the leak. In addition, it is preferred that the
syringe have calibrations or graduations on outer surface to enable
the physician to gauge the depth of penetration of the needle to
ensure accurate placement of the needle with respect to the leak
site. The kit may also be provided with other items that will
assist in the repair procedure, such as a container, or even a
second syringe, containing a contrast agent to facilitate locating
the leak under radiographic or magnetic imaging, such as
fluoroscopy, CT scan and magnetic resonance imaging (MRI). A dual
chamber syringe, a dual lumen needle attached to the syringe, and
even two syringes each carrying the separate components of the
fibrin glue are also contemplated. Sterile surgical drapes may also
be included.
[0013] A method for repairing leaks in internal fluid carrying
vessels and organs is also provided, which is minimally invasive
and includes the steps of determining the location of the leak,
placing a marker on the patient's body to mark the location of the
leak, providing a syringe and a fibrin glue material, inserting the
needle through a guide hole in the marker into the patient's body
to a location adjacent the leak, and delivering the fibrin glue to
seal the leak. It is contemplated that the method be performed
under radiographic or magnetic imaging to confirm the accuracy of
the location of the leak, the accuracy of the placement of the
marker and the needle with respect to the leak site, and the
accuracy of the delivery of the fibrin glue.
BRIEF DESCRIPTION OF THE DRAWINGS
[0014] The above and other objects, features and advantages of the
present invention will become more readily apparent from the
following detailed description of the preferred embodiments, taken
in conjunction with the accompanying drawings, in which:
[0015] FIG. 1 illustrates a surgical kit for repairing leaks in
fluid carrying vessels and organs according to a first embodiment
of the present invention;
[0016] FIG. 2 illustrates a second embodiment of the surgical kit
of the present invention;
[0017] FIG. 3 illustrates a third embodiment of the surgical kit of
the present invention;
[0018] FIG. 4 illustrates a fourth embodiment of the surgical kit
of the present invention;
[0019] FIG. 5 illustrates a fifth embodiment of the surgical kit of
the present invention;
[0020] FIG. 6 illustrates a sixth embodiment of the surgical kit of
the present invention;
[0021] FIG. 7 illustrates a marker of the present invention, for
placement on the patient's body to mark the location of the leak in
a fluid carrying vessel or organ;
[0022] FIG. 8 illustrates an exploded perspective view of the
surgical kit of FIG. 1; and
[0023] FIG. 9 is a flow chart of the method of repairing a leak in
fluid carrying vessels and organs of the present invention.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0024] Referring now to the drawings, in which like reference
numerals identify similar or identical elements throughout the
several views, and in particular to FIG. 1, there is shown a
surgical kit 100 for repairing leaks in fluid carrying vessels and
organs according to the present invention. Surgical kit 100
includes a syringe 106 and a plurality of markers 108 for use in
repairing leaks in internal vessels and organs, as will be
described below. Syringe 106 preferably includes markings or
graduations on its needle, to assist the physician in locating the
distal tip of the needle with respect to the leak site inside the
patient's body. The syringe 106 may be pre-filled with a
bio-compatible fibrin glue material for delivery to the breach or
rent in the wall of the vessel or organ, or may be provided empty
for filling by the physician during the repair procedure. Referring
also to FIG. 8, the kit 100 includes package 101, which consists of
top cover 102 and bottom cover 104, which enclose and house the
syringe 106 and the plurality of markers 108. Preferably, top cover
102 is a molded plastic cover, with spaces for the syringe and
markers to hold them in place and to facilitate assembly. Bottom
cover 104 preferably overlays top cover 102 and is secured thereto
by heat sealing or other known methods. The entire package is
preferably sterilized.
[0025] FIG. 2 illustrates another embodiment of the surgical kit of
the present invention. Kit 200 is similar to kit 100 except for the
addition of container 202 to the package. Container 202 contains a
glue material for delivery to the leak site to seal the leak. In
use, the physician removes the syringe 106 and container 202 from
the package, and fills the syringe with the glue by drawing the
glue into the syringe in a known manner for delivery to the leak
site. Alternatively, the container may contain one of the
components of a fibrin glue, while the syringe is filled with an
equal amount of the other component. Fibrin glue is typically equal
parts fibrin and platelets.
[0026] FIG. 3 illustrates a preferred embodiment of the kit of the
present invention. Kit 300 is similar to kit 100 except that dual
chamber syringe 302 replaces single chamber syringe 106 of kit 100.
Syringe 302 includes chambers 304 and 306, and contains the fluid
components of a fibrin glue, which gel and harden upon contact with
each other when mixed together. Chamber 304 may contain fibrin,
while chamber 306 may contain an equal amount of platelets. The
dual chambers prevent the glue material from gelling until the
fluids are delivered to the leak site. The dual chamber syringe 302
is preferably constructed with a dual lumen needle 308 attached
thereto, which maintains the contents of chamber 304 separate from
the contents of chamber 306 until the fluids are adjacent the tip
310 of needle 308, so that the components of the fibrin glue do not
mix until they are very close to the leak site.
[0027] FIG. 4 illustrates yet another embodiment of the kit of the
present invention. Kit 400 is similar to kit 100 except for the
addition of a second syringe 402, which is provided
[0028] FIG. 9 is a flowchart setting forth the method of the
present invention, which utilizes the kit of the present invention.
In step 900, it is determined that a patient is suffering from a
post-operative rent or leak in a fluid carrying vessel organ. The
present invention is particularly suited for the repair of
post-operative CSF leaks, following neurosurgical procedures, where
the rent has occurred in the dura mater of the spinal cord.
Pinhole-sized leaks in the dura mater usually will seal themselves,
while the patient is maintained in the Trendelenburg position until
the rent is sealed. However, in the event the rent does not seal
itself, after the leak is discovered in step 900, the patient is
injected with a radiographic contrast agent intrathecally at step
902, and the flow of the contrast agent is observed at step 904
under CT, MRI, fluoroscopy, or the like. If the location of the
leak is determined at step 906, a marker, such as marker 108 of kit
100 described above, is affixed to the patient's body in step 908.
If the leak site is not located to the satisfaction of the
physician, the process returns to step 904.
[0029] Once the marker is placed, its location is confirmed with
respect to the leak site through continued scanning at step 910. A
syringe, such as syringe 106 of kit 100 or syringe 302 of kit 300,
is then provided containing a fibrin glue material at step 912. The
needle of the syringe is inserted into the patient's body through
the guide hole 710 of marker 108 at step 914. The tip of the needle
is positioned adjacent the rent, and its position is observed and
confirmed by observation of the graduations on the needle of the
syringe and through continued scanning at step 916. Once it is
determined at step 918 that the tip of the needle is located at the
site of the leak, the fibrin glue is delivered to seal the leak at
step 920. If it is determined that the needle is not properly
positioned, the process preferably for the delivery of a contrast
agent for intrathecal injection into the spinal cord in the
patient's body when the kit 400 is used in procedures to repair
leaks in the dura mater of the spinal cord following a
neurosurgical procedure, to assist in determining the location of
the leak. The contrast agent is preferably a radiographic agent,
such as a myelographic contrast agent, but of course can be any
contrast agent that is sensitive to scanning techniques such as
fluoroscopy, CT scanning, MRI, and the like. The contrast agent can
be provided in a pre-filled syringe 402, or may be provided
separately during the repair procedure. Alternatively, the contrast
agent may be provided in a kit having a container 502 filled with
the contrast agent, along with syringe 402, syringe 106 and
container 202 filled with the fibrin glue material, all provided in
a package 500 as shown in FIG. 5.
[0030] FIG. 6 illustrates a further embodiment of the kit of the
present intention. Kit 600 is similar to kit 100 except for the
addition of surgical drape 602, which can be used during the
surgical repair procedure.
[0031] FIG. 7 illustrates a preferred embodiment of the fiducial
marker 108 that is packaged with the kit of the present invention,
and used in accordance with the method of repairing a leak in a
fluid carrying vessel or organ of the present invention.
Preferably, the marker 108 is constructed of a radiopaque plastic
material and includes a centrally located hole 710, which is of a
size that can accommodate the needle of syringe 106. The marker 108
is adhesive backed for securement to the skin of the patient.
returns to step 916.
[0032] While the invention has been shown and described with
reference to certain preferred embodiments, it will be understood
by those skilled in the art that various changes in form and detail
may be made therein without departing from the spirit and scope of
the invention, as defined by the appended claims.
* * * * *