U.S. patent application number 11/981078 was filed with the patent office on 2009-04-30 for apparatus and methods for closing a gastrotomy.
Invention is credited to Rudolph H. Nobis.
Application Number | 20090112059 11/981078 |
Document ID | / |
Family ID | 40583727 |
Filed Date | 2009-04-30 |
United States Patent
Application |
20090112059 |
Kind Code |
A1 |
Nobis; Rudolph H. |
April 30, 2009 |
Apparatus and methods for closing a gastrotomy
Abstract
A surgical instrument for forming a gastrotomy. In various
embodiments, the surgical instrument may comprise a hollow tip for
attachment to a distal end of a tubular member such as an
endoscope. In other embodiments, the hollow tip is integrally
formed on the distal end of the endoscope. The hollow tip is
configured such that when it is brought into contact with the inner
layer of tissue in the stomach, the tissue is caused to stretch. A
hole-forming device may be passed through the hollow tip to pierce
through the stretched inner layer and adjacent outer layers of
tissue to form a passageway therethrough for permitting surgical
procedures to be performed therethrough. After the surgical
procedures are performed through the passageway, the hollow tip is
removed from contact with the inner layer of tissue to permit the
inner layer of tissue to relax and to cause the holes formed
through the inner layer and outer layers of tissue to be offset
from each other.
Inventors: |
Nobis; Rudolph H.; (Mason,
OH) |
Correspondence
Address: |
K&L GATES LLP
535 SMITHFIELD STREET
PITTSBURGH
PA
15222
US
|
Family ID: |
40583727 |
Appl. No.: |
11/981078 |
Filed: |
October 31, 2007 |
Current U.S.
Class: |
600/104 ;
128/898 |
Current CPC
Class: |
A61B 1/2736 20130101;
A61B 1/12 20130101 |
Class at
Publication: |
600/104 ;
128/898 |
International
Class: |
A61B 1/012 20060101
A61B001/012 |
Claims
1. A surgical instrument for forming a gastrotomy, said surgical
instrument comprising: a tubular member sized to receive a surgical
instrument, said tubular member having a proximal end and a distal
end; and a non-piercing hollow tip on said distal end of said
tubular member, said hollow tip defining a tip axis and having a
distal end extending at an acute angle relative to said tip
axis.
2. The surgical instrument of claim 1 wherein said acute angle is
approximately forty-five degrees.
3. The surgical instrument of claim 1 wherein said hollow tip is
attached to said distal end of said tubular member by a frictional
fit.
4. The surgical instrument of claim 1 wherein said hollow tip is
attached to said tubular member by adhesive.
5. The surgical instrument of claim 1 wherein said hollow tip is
integrally formed on said distal end of said tubular member.
6. The surgical instrument of claim 1 wherein said tubular member
comprises an endoscope.
7. The surgical instrument of claim 5 wherein said endoscope has at
least one working channel therethrough to receive a hole-forming
device therethrough.
8. The surgical instrument of claim 7 wherein said endoscope has a
working channel therethrough for receiving a vacuum forming
instrument therethrough.
9. A method for processing an instrument for surgery, the method
comprising: obtaining the surgical instrument of claim 1;
sterilizing the instrument; and storing the instrument in a sterile
container.
10. A surgical instrument for forming a gastrotomy, said surgical
instrument comprising a non-piercing hollow tip configured for
attachment to a distal end of an endoscope, said hollow tip
defining a tip axis and having a distal end extending at an acute
angle relative to said tip axis.
11. The surgical instrument of claim 10 wherein said acute angle is
approximately 45 degrees.
12. A method for processing an instrument for surgery, the method
comprising: obtaining the hollow tip of claim 10; sterilizing the
hollow tip; and storing the hollow tip in a sterile container.
13. A surgical kit comprising: an endoscope; and a hollow tip of
claim 11.
14. A surgical method for forming a gastrotomy through an organ
wall having an inner layer of tissue and at least one outer layer
of tissue adjacent to said inner layer of tissue, wherein the inner
layer of tissue is stretchable from a first relaxed condition to a
stretched condition, said method comprising: stretching the inner
layer of tissue to a stretched condition relative to the at least
one outer layer of tissue; forming a first hole through the
stretched inner layer of tissue and a second hole through the at
least one outer layer of adjacent tissue such that said first and
second holes are aligned with each other to permit passage of a
surgical instrument therethrough; performing a surgical procedure
through the aligned first and second holes; and permitting the
inner layer to return to the first relaxed condition such that the
first and second holes are no longer aligned with each other.
15. The surgical method of claim 14 wherein said stretching
comprises: providing a surgical instrument having a hollow tip
thereon, the hollow tip having a tip axis and a distal end that
extends at an acute angle relative to the tip axis; and pushing the
angled distal end of the hollow tip into contact with the inner
layer of tissue to cause a portion of the inner layer of tissue to
move to the stretched condition.
16. The surgical method of claim 15 wherein said forming comprises:
inserting a hole-forming instrument through the surgical instrument
and the hollow tip; and piercing a portion of the hole forming
instrument through the portion of stretched inner layer of tissue
and the at least one outer layer of tissue adjacent to the portion
of stretched inner layer of tissue.
17. The surgical method of claim 15 further comprising applying
suction within the hollow tip.
18. The surgical method of claim 15 wherein the surgical instrument
comprises an endoscope.
19. The surgical method of claim 18 wherein said pushing comprises:
inserting a portion of the endoscope having the hollow tip thereon
through a natural orifice in a patient to bring the hollow tip into
engagement with the inner layer of tissue; an applying a pushing
force to another portion of the endoscope protruding out of the
natural orifice.
20. The surgical method of claim 15 wherein said permitting
comprises removing the angled distal end of the hollow tip from
contact with the inner layer of tissue.
21. The surgical method of claim 14 wherein said performing a
surgical procedure comprises performing transgastric access.
22. The surgical method of claim 14 wherein said performing a
surgical procedure comprises inserting one of a guide wire and a
dilating balloon through the aligned first and second holes.
Description
FIELD OF THE INVENTION
[0001] The present invention relates, in general, to surgical
devices and methods of use and, more particularly, to devices and
methods relating to closing an opening made through the abdominal
wall utilizing laparoscopic surgical instruments and
procedures.
BACKGROUND OF THE INVENTION
[0002] Access to the abdominal cavity may, from time to time, be
required for diagnostic and therapeutic endeavors for a variety of
medical and surgical diseases. Historically, abdominal access has
required a formal laparotomy to provide adequate exposure. Such
procedures which require incisions to be made in the abdomen are
not particularly well-suited for patients that may have extensive
abdominal scarring from previous procedures, those persons who are
morbidly obese, those individuals with abdominal wall infection,
and those patients with diminished abdominal wall integrity, such
as patients with burns and skin grafting. Other patients simply do
not want to have a scar if it can be avoided.
[0003] Minimally invasive procedures are desirable because such
procedures can reduce pain and provide relatively quick recovery
times as compared with conventional open medical procedures. Many
minimally invasive procedures are performed with an endoscope
(including without limitation laparoscopes). Such procedures permit
a physician to position, manipulate, and view medical instruments
and accessories inside the patient through a small access opening
in the patient's body. Laparoscopy is a term used to describe such
an "endosurgical" approach using an endoscope (often a rigid
laparoscope). In this type of procedure, accessory devices are
often inserted into a patient through trocars placed through the
body wall. The trocar must pass through several layers of
overlapping tissue/muscle before reaching the abdominal cavity. One
of the most significant problems associated with such surgical
procedures is the need to provide a secure closure of the
gastrotomy site that is required for endoscope passage and, for
example, specimen removal. Prior methods required the surgeon to
close each of the muscle layers after the procedure is
completed.
[0004] Still less invasive treatments include those that are
performed through insertion of an endoscope through a natural body
orifice to a treatment region. Examples of this approach include,
but are not limited to, cystoscopy, hysteroscopy,
esophagogastroduodenoscopy, and colonoscopy. Many of these
procedures employ the use of a flexible endoscope during the
procedure. Flexible endoscopes often have a flexible, steerable
articulating section near the distal end that can be controlled by
the user by utilizing controls at the proximal end. Minimally
invasive therapeutic procedures to treat diseased tissue by
introducing medical instruments to a tissue treatment region
through a natural opening of the patient are known as Natural
Orifice Translumenal Endoscopic Surgery (NOTES).TM.. In the past,
however, those instruments suited for insertion through a natural
orifice lacked means for performing a gastrotomy that avoids the
need for the surgeon to separately close each tissue and muscle
layer after the operation is completed.
[0005] Consequently a need exists for devices and methods that can
be employed through a patient's natural orifice for closing a
gastrotomy while avoiding the need to separately close the hole in
each muscle and tissue layer in the abdominal wall.
[0006] The foregoing discussion is intended only to illustrate some
of the shortcomings present in the field of the invention at the
time, and should not be taken as a disavowal of claim scope.
SUMMARY
[0007] In one aspect of the invention, there is provided a surgical
instrument for forming a gastrotomy. In various embodiments, the
instrument comprises a tubular member that has a proximal end and a
distal end. A hollow tip is provided on the distal end of the
tubular member. The hollow tip has a tip axis and a distal end that
extends at an acute angle relative to the tip axis.
[0008] In another general aspect of various embodiments of the
present invention, there is provided a surgical instrument for
forming a gastrotomy. In various embodiments, the surgical
instrument comprises a hollow tip that is configured for attachment
to a distal end of an endoscope. The hollow tip has a tip axis
extending therethrough and a distal end that extends at an acute
angle relative to the tip axis.
[0009] In still another general aspect of various embodiments of
the present invention, there is provided a surgical method for
forming a gastrotomy through an organ wall that has an inner layer
of tissue and at least one outer layer of tissue that is adjacent
to the inner layer of tissue, wherein the inner layer of tissue is
stretchable from a first relaxed condition to a stretched
condition. The method may comprise stretching the inner layer of
tissue to a stretched condition relative to the at least one outer
layer of tissue and forming a first hole through the stretched
inner layer of tissue and a second hole through the at least one
outer layer of adjacent tissue such that the first and second holes
are aligned with each other to permit passage of a surgical
instrument therethrough. The method may further comprise performing
a surgical procedure through the aligned first and second holes and
thereafter permitting the inner layer to return to the first
relaxed condition such that said first and second holes are no
longer aligned with each other.
BRIEF DESCRIPTION OF THE FIGURES
[0010] The accompanying drawings, which are incorporated in and
constitute a part of this specification, illustrate embodiments of
the invention, and, together with the general description of the
invention given above, and the detailed description of the
embodiments given below, serve to explain various principles of the
present invention.
[0011] FIG. 1 is a diagrammatical view illustrating the use of one
embodiment of a surgical instrument of the present invention
inserted through a patient's mouth and esophagus to perform a
gastrotomy through the stomach wall;
[0012] FIG. 2 is partial perspective view of a portion of an
endoscope having a hollow tip of one embodiment of the present
invention thereon with the hollow tip shown in cross-section for
clarity;
[0013] FIG. 3 is another view of the endoscope and hollow tip of
FIG. 2 in confronting spaced relationship with a portion of the
stomach wall;
[0014] FIG. 4 is another view of the endoscope and hollow tip of
FIGS. 2 and 3 in contact with a portion of the inner layer of
tissue of the stomach wall;
[0015] FIG. 5 is another view of the endoscope and hollow tip of
FIG. 4 with a hole-forming instrument inserted through a working
channel in the endoscope and piercing through the inner and outer
layers of tissue;
[0016] FIG. 6 is another view of the endoscope and hollow tip of
FIG. 5 with the hole-forming instrument withdrawn from the inner
and outer layers of tissue; and
[0017] FIG. 7 is a cross-sectional view of a portion of the stomach
wall after the endoscope and hollow tip have been removed from
contact therewith.
DETAILED DESCRIPTION
[0018] Certain exemplary embodiments will now be described to
provide an overall understanding of the principles of the
structure, function, manufacture, and use of the devices and
methods disclosed herein. One or more examples of these embodiments
are illustrated in the accompanying drawings. Those of ordinary
skill in the art will understand that the devices and methods
specifically described herein and illustrated in the accompanying
drawings are non-limiting exemplary embodiments and that the scope
of the various embodiments of the present invention is defined
solely by the claims. The features illustrated or described in
connection with one exemplary embodiment may be combined with the
features of other embodiments. Such modifications and variations
are intended to be included within the scope of the present
invention.
[0019] It will be appreciated that the terms "proximal" and
"distal" are used herein with reference to a clinician manipulating
an end of the instrument 20 that protrudes out of the natural
orifice. The term "proximal" referring to the portion closest to
the clinician and the term "distal" referring to the portion
located away from the clinician. It will be further appreciated
that, for convenience and clarity, spatial terms such as
"vertical", "horizontal", "up" and "down" may be used herein with
respect to the drawings. However, surgical instruments are used in
many orientations and positions, and these terms are not intended
to be limiting and/or absolute.
[0020] The present invention generally relates to devices and
methods that may be used in connection with endoscopes to perform a
gastrotomy through the stomach wall and thereafter have the
gastrotomy site be closed without the need for the surgeon to
separately close the opening formed in each layer of muscle and
tissue. While the various Figures illustrate one form of endoscope
with which the various embodiments of the present invention may be
advantageously employed, those of ordinary skill in the art will
readily appreciate that the unique and novel features of the
present invention may be employed with a variety of other forms of
endoscopes without departing from the spirit and scope of the
present invention.
[0021] FIG. 1 illustrates, in general form, a surgical instrument
20 of the present invention that can be inserted through a natural
orifice to form an opening through the stomach wall 16. In the
example depicted in FIG. 1, the instrument 20 is inserted through
the mouth 10 and esophagus 12 into the stomach 14 to form an
opening through the stomach wall 16. In various embodiments, the
instrument 20 may comprise a tubular member sized to receive a
surgical instrument. In various embodiments, for example, the
tubular member may comprise an endoscope 30 that may be inserted
through a substantially hollow overtube 40 that is inserted into
the stomach 14 through the patient's mouth 10. A variety of
different types of endoscopes are known and, therefore, their
specific construction and operation will not be discussed in great
detail herein. In various embodiments, the endoscope 30 has a
distal end 32 and a proximal end 34 and may operably support a
video camera 36 that communicates with a video display unit 40 that
can be viewed by the surgeon during the operation. The endoscope 30
may further have one or more working channels 38 extending
therethrough for receiving various types of surgical instruments.
See FIG. 2.
[0022] Also in various embodiments of the present invention, a
hollow tip 50 may be attached to, or integrally formed on, the
distal end 32 of the endoscope 30. In various embodiments, the
hollow tip 50 may be attached to the endoscope 30 by, for example,
an appropriate adhesive or be pressed onto the distal end 32 and be
retained thereon by a "frictional fit". The hollow tip 50 may be
fabricated from, for example, a thermoplastic material and have a
tip axis "A-A" that may be substantially coaxially aligned with the
central axis of the endoscope 30 when installed thereon. In
addition, the hollow tip 50 may be formed with an angled distal end
52 that is angled at an acute angle ".alpha." relative to the tip
axis A-A. In various embodiments, the angle .alpha. may be, for
example, approximately forty-five degrees or from ten degrees to
eighty degrees. As will become apparent as the present Detailed
Description proceeds, the distal end 52 of the hollow tip is to be
formed in such away so that, when pressed against the inner tissue
layer 17 of the stomach wall 16, that tissue layer 17 is stretched
within the hollow tip 50. In various embodiments, the distal end 52
of the hollow tip 50 may be substantially non-piercing.
"Non-piercing" as used herein means that when used as described
herein, the tip 50 will not pierce through the organ by itself;
however, after the organ is pierced by other means, the hollow tip
could be inserted through the opening, if so desired.
[0023] FIGS. 3-6 illustrate use of the instrument 20. FIG. 3
depicts a portion of the stomach wall 16 through which the
gastrotomy will be performed. As can be seen in that Figure, the
stomach wall 16 may consist of, for example, a first inner layer of
tissue 17 known as mucosa or Rugae that lines the stomach wall 16
and at least a second layer of tissue or muscle 18. The inner layer
of tissue 17 is stretchable from a relaxed condition (FIGS. 3 and
7) to a stretched condition (FIGS. 4-6). The second layer 18 of
tissue may actually comprise more than one layer or amount of
muscle and other tissue. It will be appreciated, however, that all
of that tissue/muscle 18 and the inner layer 17 make up the stomach
wall 16.
[0024] As shown in FIG. 3, the surgeon initially manipulates the
endoscope 30 to bring the hollow tip 50 into spaced confronting
relationship with the portion of the stomach wall 16 through which
the gastrotomy is to be performed. Thereafter, the endoscope 30 is
manipulated in such a manner to cause the distal end 52 of the
hollow tip 50 to be pressed against the inner layer 17 of the
stomach wall 16. Because of the differences between the inside
layers 17 and outside layers of tissue 18, the tissue layers 17, 18
stretch at different rates. See FIG. 4. In some embodiments, a
vacuum instrument 60 may be passed through a working channel 38 in
the endoscope 30 to apply a suction or vacuum within the hollow tip
50 from a source of vacuum 62 (FIG. 1) to draw the inner layer 17
of the stomach wall 16 into stretched sealing engagement with the
distal end 52 of the hollow tip 50. See FIG. 5.
[0025] Once the hollow tip 50 is pressed against the inner layer 17
of the stomach wall 16 in the above-described manner, a
conventional hole-forming device 70 such as, for example, a
conventional Sphinctorotome, a needle knife or other incisor-type
instrument is inserted through a working channel 38 to form a
continuous hole or passageway 19 through the layers 17 and 18 of
the stomach wall 16. See FIG. 5. As can be seen in FIGS. 6 and 7,
the continuous hole 19 actually consists of hole segment 19A and
hole segment 19B that are aligned with each other. After the hole
19 has been formed through the stomach wall 16, the hole-forming
instrument 17 may be withdrawn back through the working channel 38
in the endoscope 30 and other surgical instruments such as, for
example, guide wires, dilating balloons, etc. (not shown) may be
inserted through the working channels 38 and through the hole
19.
[0026] After the desired surgical procedures such as, for example,
Diagnostic Peritonoscopy or Transgastric Cholecystectomy have been
performed through the hole 19, the entire instrument 20 may be
removed from the site. After the instrument 20 is removed, the
inner tissue layer 17 is once again permitted to move to a relaxed
state which causes an offset between the hole segments 19A and 19B
as represented by the distance "OS" in FIG. 7. The hole segments
19A and 19B are then permitted to naturally seal through the body's
normal healing process.
[0027] As can be readily appreciated from the foregoing, the
various embodiments of the present invention described above
represent a vast improvement over prior devices and methods used to
form and thereafter close a gastrotomy. The unique and novel
features of the present invention enable the operation to be
performed through a natural orifice in the patient and thereby
avoid several disadvantages associated with other conventional
surgical methods and procedures that require incisions to be made
into the abdomen. The present invention may encompass tips that are
configured for attachment to a distal end of a surgical instrument
and, if desired, supplied and/or sold separately from that
instrument. Such tips may be pressed onto or otherwise temporarily
attached to the distal end of the instrument to complete the
above-described procedure and thereafter removed from the
instrument and discarded or reprocessed for future use. Other
embodiments of the present invention contemplate permanent
attachment of the tip to the distal end of the instrument and still
other embodiments envision that the angled distal end of the tip be
integrally formed on the distal end of the instrument.
[0028] While several embodiments of the invention have been
described, it should be apparent, however, that various
modifications, alterations and adaptations to those embodiments may
occur to persons skilled in the art with the attainment of some or
all of the advantages of the invention. For example, according to
various embodiments, a single component may be replaced by multiple
components, and multiple components may be replaced by a single
component, to perform a given function or functions. This
application is therefore intended to cover all such modifications,
alterations and adaptations without departing from the scope and
spirit of the disclosed invention as defined by the appended
claims.
[0029] The devices disclosed herein can be designed to be disposed
of after a single use, or they can be designed to be used multiple
times. In either case, however, the device can be reconditioned for
reuse after at least one use. Reconditioning can include an
combination of the steps of disassembly of the device, followed by
cleaning or replacement of particular pieces, and subsequent
reassembly. In particular, the device can be disassembled, and any
number of particular pieces or parts of the device can be
selectively replaced or removed in any combination. Upon cleaning
and/or replacement of particular parts, the device can be
reassembled for subsequent use either at a reconditioning facility,
or by a surgical team immediately prior to a surgical procedure.
Those of ordinary skill in the art will appreciate that the
reconditioning of a device can utilize a variety of different
techniques for disassembly, cleaning/replacement, and reassembly.
Use of such techniques, and the resulting reconditioned device, are
all within the scope of the present application.
[0030] Preferably, the invention described herein will be processed
before surgery. First a new or used instrument is obtained and, if
necessary, cleaned. The instrument can then be sterilized. In one
sterilization technique, the instrument is placed in a closed and
sealed container, such as a plastic or TYVEK.RTM. bag. The
container and instrument are then placed in a field of radiation
that can penetrate the container, such as gamma radiation, x-rays,
or higher energy electrons. The radiation kills bacteria on the
instrument and in the container. The sterilized instrument can then
be stored in the sterile container. The sealed container keeps the
instrument sterile until it is opened in the medical facility.
[0031] Any patent, publication, or other disclosure material, in
whole or in part, that is said to be incorporated by reference
herein is incorporated herein only to the extent that the
incorporated materials does not conflict with existing definitions,
statements, or other disclosure material set forth in this
disclosure. As such, and to the extent necessary, the disclosure as
explicitly set forth herein supersedes any conflicting material
incorporated herein by reference. Any material, or portion thereof,
that is said to be incorporated by reference herein, but which
conflicts with existing definitions, statements, or other
disclosure material set forth herein will only be incorporated to
the extent that no conflict arises between that incorporated
material and the existing disclosure material.
[0032] The invention which is intended to be protected is not to be
construed as limited to the particular embodiments disclosed. The
embodiments are therefore to be regarded as illustrative rather
than restrictive. Variations and changes may be made by others
without departing from the spirit of the present invention.
Accordingly, it is expressly intended that all such equivalents,
variations and changes which fall within the spirit and scope of
the present invention as defined in the claims be embraced
thereby.
* * * * *