U.S. patent application number 12/745458 was filed with the patent office on 2010-12-09 for sheath for gastrostoma, sheathed dilator, sheath for gastrostoma with insertion aid, gastrostomy catheter kit, and method of splitting sheath for gastrostoma.
This patent application is currently assigned to Sumitomo Bakelite Co., Ltd.. Invention is credited to Masao Ikeda, Keiji Kamata, Hideaki Matsunami, Tomokazu Nakayama, Yukihiko Sakaguchi, Yutaka Suzuki, Ryo Tanaka.
Application Number | 20100312261 12/745458 |
Document ID | / |
Family ID | 40678696 |
Filed Date | 2010-12-09 |
United States Patent
Application |
20100312261 |
Kind Code |
A1 |
Suzuki; Yutaka ; et
al. |
December 9, 2010 |
SHEATH FOR GASTROSTOMA, SHEATHED DILATOR, SHEATH FOR GASTROSTOMA
WITH INSERTION AID, GASTROSTOMY CATHETER KIT, AND METHOD OF
SPLITTING SHEATH FOR GASTROSTOMA
Abstract
The present invention provides a sheath for gastrostoma (1), a
sheathed dilator, a gastrostomy catheter kit and a method of
splitting a sheath for gastrostoma. The sheath for gastrostoma (1)
includes a sheath body (11) in which a gastrostomy catheter (2) is
inserted and a handle (12). The sheath for gastrostoma (1) lowers
the insertion resistance of a gastrostomy catheter when inserted in
a fistula before insertion of the gastrostomy catheter in the
fistula for replacement in the patient's body. According to the
invention, a sheath for gastrostoma, a sheathed dilator, a sheath
for gastrostoma with insertion aid, a gastrostomy catheter kit and
a method of splitting a sheath for gastrostoma which can lower the
insertion resistance during placement of a catheter in the
patient's body, facilitate air supply control of an endoscope and
stabilize endoscopic visual field during surgery are provided.
Inventors: |
Suzuki; Yutaka;
(Nasushiobara-shi, JP) ; Matsunami; Hideaki;
(Akita-shi, JP) ; Sakaguchi; Yukihiko; (Akita-shi,
JP) ; Ikeda; Masao; (Akita-shi, JP) ;
Nakayama; Tomokazu; (Akita-shi, JP) ; Kamata;
Keiji; (Akita-shi, JP) ; Tanaka; Ryo;
(Akita-shi, JP) |
Correspondence
Address: |
OBLON, SPIVAK, MCCLELLAND MAIER & NEUSTADT, L.L.P.
1940 DUKE STREET
ALEXANDRIA
VA
22314
US
|
Assignee: |
Sumitomo Bakelite Co., Ltd.
Shinagawa-ku, Tokyo
JP
SUZUKI, Yutaka
Nasushiobara-shi, Tochigi
JP
|
Family ID: |
40678696 |
Appl. No.: |
12/745458 |
Filed: |
December 1, 2008 |
PCT Filed: |
December 1, 2008 |
PCT NO: |
PCT/JP08/71832 |
371 Date: |
May 28, 2010 |
Current U.S.
Class: |
606/153 |
Current CPC
Class: |
A61J 15/0007 20130101;
A61J 15/0038 20130101; A61J 15/0023 20130101; A61J 15/0026
20130101; A61J 15/003 20130101; A61B 17/3415 20130101; A61B 5/42
20130101; A61M 25/0662 20130101; A61M 29/00 20130101; A61J 15/0065
20130101; A61M 25/0668 20130101; A61M 2025/0008 20130101; A61B
5/1076 20130101; A61M 2025/0681 20130101 |
Class at
Publication: |
606/153 |
International
Class: |
A61B 17/11 20060101
A61B017/11 |
Foreign Application Data
Date |
Code |
Application Number |
Nov 30, 2007 |
JP |
2007-310789 |
Nov 28, 2008 |
JP |
2008-305328 |
Claims
1. A sheath for gastrostoma comprising: the sheath for gastrostoma
used for gastrostomy and replacement of the gastrostomy catheter in
which a gastrostomy catheter is inserted in a fistula for
placement, the gastrostomy catheter including a tubular section
which includes an inner path for introducing a nutrient or a
chemical into the stomach from outside of the body, and an
indwelling section attached to a distal section of the tubular
section and formed as a dome protruding radially outward of the
tubular section, the indwelling section being able to reduce its
diameter by an extending force applied by an obturator, which is
used to extend the indwelling section: a cylindrical sheath body in
which the gastrostomy catheter is inserted; and a handle provided
to protrude at one longitudinal end of the sheath body.
2. The sheath for gastrostoma according to claim 1, further
comprising: a lid which is provided pivotably via a hinge section
at a base end of the sheath body which is an end at the side of the
handle and is disposed in an inner path which is a through-hole
defined inside the sheath body, the lid opening and closing the
inner path of the sheath body through pivotation about the hinge
section, wherein: the sheath body is provided with a lid abutting
section against which the lid is made to abut at a distal end which
is an end opposite to the base end of the sheath body through
pivotation about the hinge section; and the lid is made to abut
against the lid abutting section in its closed position where the
lid closes the inner path and is pivoted from the closed position
toward the distal section of the sheath body to release the inner
path.
3. The sheath for gastrostoma according to claim 2, wherein the lid
abutting section is provided in the sheath body at a side opposite
to the hinge section across the inner path and an end of the lid
opposite to the side of the hinge section abuts against the lid
abutting section.
4. The sheath for gastrostoma according to claim 2, wherein the
handle is pivotably provided at the base end of the sheath body via
the hinge section, and the lid is provided to protrude in the inner
path from the handle to open and close the inner path of the sheath
body through integrated pivotation with the handle.
5. The sheath for gastrostoma according to claim 2, wherein the
hinge section is an elastic support member which elastically
supports the lid at the closed position while allowing pivotation
of the lid from the closed position in an open direction.
6. The sheath for gastrostoma according to claim 2, further
comprising: an elastic member which functions as an elastic support
member that applies an urging force to the handle so as to
elastically support the lid at the closed position while allowing
pivotation of the lid from the closed position in an open
direction.
7. The sheath for gastrostoma according to claim 1, further
comprising: a lid which is provided in the handle via the lid hinge
section and disposed in the inner path which is a through-hole
defined in the sheath body, wherein: the handle is provided
pivotably at the base end which is an end at the side of the handle
of the sheath body via a hinge section other than the lid hinge
section; and the lid is disposed in its closed position at which
the lid closes the inner path and is able to open and close the
inner path of the sheath body through pivotation about the lid
hinge section.
8. The sheath for gastrostoma according to claim 7, wherein: the
sheath body is provided with a lid abutting section against which
the lid is made to abut at a distal end which is an end opposite to
the base end of the sheath body through pivotation about the hinge
section; and the lid is made to abut against the lid abutting
section in its closed position where the lid closes the inner path
and is pivoted from the closed position toward the distal section
of the sheath body to release the inner path.
9. The sheath for gastrostoma according to claim 8, wherein the
hinge section and the lid hinge section are provided in the sheath
body at a side opposite to the lid abutting section across the
inner path and an end of the lid at the side opposite to the lid
hinge section is made to abut against the lid abutting section.
10. The sheath for gastrostoma according to claim 7, wherein: the
lid hinge section is disposed at an end of a stopper projection
piece which is provided to protrude from the handle, inserted in
the sheath body and is disposed along an inner surface of the
sheath body at a side opposite to the lid abutting section across
the inner path; and when the lid receives a force to cause the same
to pivot from the closed position in an open direction, the stopper
projection piece is pressed against the inner surface of the sheath
body to restrict pivotation of the stopper projection piece with
respect to the sheath body.
11. The sheath for gastrostoma according to claim 10, wherein the
stopper projection piece is made of a material with rubber
elasticity.
12. The sheath for gastrostoma according to claim 7, wherein the
lid hinge section is made of a material with rubber elasticity and
constitutes a lid elastic support member for elastically supporting
the lid at the closed position.
13. The sheath for gastrostoma according to claim 7, wherein the
lid hinge section and the lid are formed from a material with
rubber elasticity.
14. The sheath for gastrostoma according to any one of claims 7 to
13, wherein a mounting section which constitutes a part of the
handle, the lid hinge section and the lid is formed from synthetic
resin.
15. The sheath for gastrostoma according to claim 2, wherein a
recess for housing the lid is formed on an inner surface of the
inner path of the sheath body.
16. The sheath for gastrostoma according to claim 15, wherein an
expanded section is provided at the base end of the sheath body,
the expanded section being formed so that the sheath body is
expanded radially outward, wherein the recess for housing the lid
is a space provided so as to extend the inner path toward the
inside of the expanded section.
17. The sheath for gastrostoma according to claim 1, wherein a
handle main piece which constitutes a part or all of the handle,
the sheath body and the hinge section is formed integrally as one
component from synthetic resin.
18. The sheath for gastrostoma according to claim 1, wherein a
grasping ring is provided at a side opposite to the hinge section
of the handle to allow a user to insert finger (s) for
grasping.
19. The sheath for gastrostoma according to claim 1, wherein one or
more notch sections are formed which facilitate vertical splitting
of the sheath body in a longitudinal direction.
20. The sheath for gastrostoma according to claim 19, wherein the
notch section is a notched groove formed in the sheath body so as
not to penetrate the sheath body in the thickness direction, and an
uncut portion is provided by locally reducing the thickness of the
sheath body at a bottom side of the notched groove.
21. The sheath for gastrostoma according to claim 20, wherein the
sheath body includes a V-shaped distal notch section configured to
recess from an end surface at the base end of the sheath body and
the notched groove is formed to extend toward a distal end of the
seal body from a depth section of the distal notch section.
22. The sheath for gastrostoma according to claim 19, wherein: the
notch section is a slit formed to extend along the longitudinal
direction of the sheath body, the slit being formed at a part along
the longitudinal direction of the sheath body and being shorter
than the entire longitudinal direction length of the sheath body;
and the sheath body has an uncut portion at which no slit is formed
along a virtual extended line of the slit.
23. The sheath for gastrostoma according to claim 20, wherein a
load applied to the inner surface of the sheath body is not smaller
than 0.5N to not greater than 5N in order to fracture at least one
of the uncut portions.
24. The sheath for gastrostoma according to claim 19, wherein the
notch section is formed in a wedge-shaped cross-section with its
opening width increasing from an inner surface toward an outer
surface of the sheath body.
25. The sheath for gastrostoma according to claim 19, wherein the
notch section is formed through a laser processing of the sheath
body.
26. The sheath for gastrostoma according to claim 25, wherein the
sheath body is made of a FEP-containing material and a portion of
the sheath body where the notch section has been formed is whitened
by the laser processing.
27. The sheath for gastrostoma according to claim 19, wherein the
handle is provided at a position where the handle does not
interfere with the notch section in a circumferential direction of
the sheath body.
28. The sheath for gastrostoma according to claim 27, wherein the
notch section is formed only at one position along the
circumferential direction of the sheath body and only one handle is
provided.
29. The sheath for gastrostoma according to claim 1, wherein the
sheath body is oriented in the longitudinal direction thereof.
30. The sheath for gastrostoma according to claim 1, wherein an end
surface of the sheath body at the side of the base end is inclined
with respect to an axial center of the sheath body.
31. The sheath for gastrostoma according to claim 1, wherein an
inner diameter of the sheath body is larger than an outer diameter
of the tubular section of the gastrostomy catheter.
32. The sheath for gastrostoma according to claim 1, wherein the
material of the sheath body contains fluororesin.
33. The sheath for gastrostoma according to claim 32, wherein the
fluororesin comprises any one of PTFE, ETFE and FEP.
34. The sheath for gastrostoma according to claim 1, wherein the
sheath body can be removably disposed outside of a dilator used for
forming a fistula.
35. The sheath for gastrostoma according to claim 34, wherein the
dilator includes a guidewire path which penetrates the dilator in
the longitudinal direction.
36. The sheath for gastrostoma according to claim 34, wherein the
dilator has a scale on a peripheral surface thereof for measurement
of a distance between an inner stomach wall and an outer body
surface.
37. The sheath for gastrostoma according to claim 36, wherein the
sheath body has transparency that enables the scale of the dilator
to be viewed from outside.
38. The sheath for gastrostoma according to claim 34, wherein the
dilator has a narrow-diameter dilator and a large-diameter dilator
which are integrated together, the narrow-diameter dilator
including the guidewire path inside thereof and the large-diameter
dilator being disposed outside of the narrow-diameter dilator and
assembled to the narrow-diameter dilator.
39. The sheath for gastrostoma according to claim 1, wherein an
inner diameter of the sheath body is smaller than the maximum outer
diameter of the indwelling section of the gastrostomy catheter
which adopts a reduced-diameter state due to the extending force
applied by the obturator.
40. The sheath for gastrostoma according to claim 39, wherein the
sheath body is vertically splittable when the gastrostomy catheter
is inserted with the indwelling section being in its
reduced-diameter state by the obturator.
41. The sheath for gastrostoma according to claim 1, wherein the
sheath body is formed of a stretch-deformable material and is thus
radially expandable.
42. The sheath for gastrostoma according to claim 1, wherein an
inner diameter of the sheath body is larger than the maximum outer
diameter of the indwelling section of the gastrostomy catheter
which adopts a reduced-diameter state due to the extending force
applied by the obturator.
43. The sheath for gastrostoma according to claim 1, wherein the
sheath body is configured such that a sheath insertion aid having a
rod-shaped appearance can be inserted in the sheath body and the
sheath insertion aid includes a rod-shaped body and a tapered
distal section having a tapering configuration provided to protrude
at one longitudinal end of the rod-shaped body.
44. The sheath for gastrostoma according to claim 43, wherein the
sheath insertion aid includes a guidewire insertion hole which
penetrates the sheath insertion aid along the longitudinal
direction.
45. The sheath for gastrostoma according to claim 43 or 44, wherein
the sheath insertion aid can function as a dilator used for forming
a fistula.
46. A sheathed dilator in which the sheath for gastrostoma
according to claim 1 is disposed outside the dilator used for
forming a fistula.
47. A sheath for gastrostoma with insertion aid in which a sheath
insertion aid is inserted in the sheath body of the sheath for
gastrostoma according to claim 1, the sheath insertion aid being
provided to protrude at a tapered distal section having a tapering
configuration at one longitudinal end of a rod-shaped body.
48. A gastrostomy catheter kit, comprising: a gastrostomy catheter
for percutaneously feeding a nutrient or a chemical into the
patient's stomach from outside of the body; an obturator; and one
of the sheath for gastrostoma according to claim 1 and the sheathed
dilator according to claim 46, wherein: the gastrostomy catheter
includes a tubular section which includes an inner path for
introducing a nutrient or a chemical into the stomach from outside
of the body, and an indwelling section which is attached to a
distal section of the tubular section and is formed as a dome
protruding radially outward of the tubular section, in which the
indwelling section can reduce its diameter due to the extending
force applied by an obturator for extending the indwelling section;
the gastrostomy catheter in which an indwelling section in its
reduced-diameter state by the obturator is inserted in a sheath for
gastrostoma of the sheath for gastrostoma according to claim 1 and
a sheath for gastrostoma of the sheathed dilator according to claim
46 while the sheath for gastrostoma is inserted in a fistula.
49. The gastrostomy catheter kit according to claim 48, wherein:
the obturator includes an outer case, a pushing rod for extension
which includes a rod body inserted in the outer case to be movable
in a longitudinal direction of the outer case and a stopper for
anchoring the gastrostomy catheter to the outer case; and in a
state in which the gastrostomy catheter is anchored to the outer
case with the stopper, an operator inserts a distal end of the
pushing rod for extension protruding from the outer case of the rod
body in the indwelling section of the gastrostomy catheter and
presses the most distal section of the indwelling section so as to
extend the indwelling section.
50. The gastrostomy catheter kit according to claim 48, wherein the
gastrostomy catheter and the obturator include a guidewire path and
the obturator is configured to reduce the diameter of the
indwelling section of the gastrostomy catheter in a state in which
the obturator is disposed outside of the guidewire which is
inserted in the gastrostomy catheter.
51. The gastrostomy catheter kit according to claim 48, further
comprising: the sheath for gastrostoma according to any one of
claims 1 to 45 as a sheath for gastrostoma used for replacement,
wherein the gastrostomy catheter in which the indwelling section is
in its reduced-diameter state by the obturator is inserted in the
sheath for gastrostoma.
52. The gastrostomy catheter kit according to claim 51, further
comprising: the sheath for gastrostoma with insertion aid according
to claim 47 configured by using the sheath for gastrostoma used for
replacement.
53. A method of splitting a sheath for gastrostoma, comprising
splitting one or more parts of a sheath body in a circumferential
direction along the entire longitudinal direction length of the
sheath body by inserting, in a sheath body of the sheath for
gastrostoma according to any one of claims 1 to 45, a medical
device having an outer diameter larger than an inner diameter of
the sheath body.
54. The method of splitting a sheath for gastrostoma according to
claim 53, wherein the medical device is a gastrostomy catheter of
which the indwelling section is in its reduced-diameter state due
to the extending force from the obturator, and the maximum outer
diameter of the indwelling section which adopts a reduced-diameter
state due to the extending force applied by the obturator is larger
than an inner diameter of the sheath body.
Description
TECHNICAL FIELD
[0001] The present invention relates to a sheath for gastrostoma, a
sheathed dilator, a sheath for gastrostoma with insertion aid, a
gastrostomy catheter kit and a method of splitting a sheath for
gastrostoma, which are applied to gastrostomy in which a
gastrostomy catheter is inserted in a fistula and left in a
patient's body and to catheter replacement.
[0002] Priority is claimed on Japanese Patent Application Nos.
2007-310789, filed Nov. 30, 2007, and 2008-305328, filed Nov. 28,
2008, the content of which is incorporated herein by reference.
[0003] Patients who cannot take in nutrition through their mouths
are usually given nutrients in the following three ways:
intravenous nutrition administration; nasogastric nutrition
administration in which a tube is inserted in the stomach or other
organs through the nose; and enteral nutrition administration
through a gastric fistula.
[0004] With recent developments in enteral nutrients and method of
administration thereof, enteral nutrition administration through
percutaneous endoscope gastrostomy (PEG) has been often
employed.
[0005] Widely known methods to provide the PEG are a Pull method in
which a gastric fistula tube is inserted orally, a Push method, and
an Introducer method in which a tube is inserted from the patient's
body surface via a sheath.
[0006] However, as to the Pull method and the Push method have the
following deficiencies. Since the gastric fistula tube passes
through the pharyngeal region, there is a risk of surgical site
infection at a site where the gastric fistula tube is placed. In
addition, it is necessary to insert the endoscope twice. On the
other hand, as to in the Introducer method, since the gastric
fistula tube does not pass through the pharyngeal region, the risk
of surgical site infection is low and the endoscope need be
inserted only once. However, the Introducer method has the
following deficiency. Since it is necessary to insert a large-bore
puncture needle without use of a guidewire and only a
narrow-diameter balloon catheter can be placed in the patient's
body via a sheath, a balloon can become deflated in a prolonged
period of time, whereby management becomes complicated.
[0007] Recently, a new approach has been used widely in which a
large-diameter button gastrostomy catheter is inserted from outside
of the patient's body in an abdominal wall and placed directly in
the stomach. In this method, an operator fixes the abdominal wall
and the stomach wall together using a suture with a device for
fixing the stomach wall and the abdominal wall, forms a fistula in
the abdominal wall and the stomach wall using a dilator in the
presence of a guidewire, inserts a large-diameter button
gastrostomy catheter of which an indwelling section has been
extended with the obturator in the formed fistula in the presence
of the guidewire and leaves the catheter in the patient's body.
[0008] The button gastrostomy catheter used in this method is
constituted of a tubular section, an indwelling section and an
externally fixed section. The tubular section is provided in a
state inserted in the fistula as an introduction passage for
percutanelously introducing nutrients or chemicals into the stomach
from outside of the patient's body. The indwelling section is
attached to a distal section of the tubular section. The indwelling
section is formed in a dome shape (in particular, a basket shape)
from a plurality of elastically deformable arcuate strip-shaped
members so as to expand radially outward of the tubular section.
The externally fixed section is attached to an end (base end) of
the tubular section at the side opposite to the distal section. The
externally fixed section is provided to protrude radially outward
of the tubular section and is made to abut the patient's body
surface from outside of the body. Then, the indwelling section is
deformed to adopt a reduced-diameter state (i.e., extended in a
virtual extending direction of the distal end of the tubular
section) using an extending device called a burator, thereby
lowering insertion resistance with respect to the fistula (see, for
example, Patent Document 1). The indwelling section takes a shape
protruding radially outward of the tubular section in the stomach
to be left there.
[Patent document 1] Japanese Unexamined Patent Application, First
Publication No. 2006-296794
DESCRIPTION OF THE INVENTION
Problems to be Solved by the Invention
[0009] However, usually, a diameter of the fistula is substantially
equivalent to an outer diameter of the tubular section. In
addition, at the time of forming a new fistula using a dilator, the
abdominal wall tries to bury the fistula after the dilator is
removed from the patient's body. It is therefore expected that the
diameter of the fistula becomes smaller before the gastrostomy
catheter is inserted therein. To address this problem, the
indwelling section of the button gastrostomy catheter may adopt a
reduced-diameter state using the obturator. It is currently
difficult, however, to reduce the outer diameter to become smaller
than that of the tubular section. Accordingly, at the time of
insertion of the button gastrostomy catheter, the indwelling
section extends the fistula and thus insertion resistance becomes
large.
[0010] Also, usually, the stomach is distended with sufficient air
supplied from an endoscope at the time of forming a new fistula.
However, in order to insert a large-diameter button gastrostomy
catheter, a large fistula must be formed using the dilator. As a
result, after the dilator is removed, air supplied from an
endoscope escapes through the fistula, which may narrow the
endoscopic visual field. In this case, air supply control is often
necessary.
[0011] The invention has been made in view of the aforementioned
circumstances and an object thereof is to provide a sheath for
gastrostoma, a sheathed dilator, a sheath for gastrostoma with
insertion aid, a gastrostomy catheter kit and a method of splitting
a sheath for gastrostoma which can lower insertion resistance
during placement of a catheter in the patient's body, facilitate
air supply control of an endoscope and stabilize endoscopic visual
field during surgery.
Means for Solving the Problems
[0012] In order to solve the aforementioned problems, the invention
provides the following configurations.
[0013] A first invention provides a sheath for gastrostoma used for
gastrostomy and replacement of the gastrostomy catheter in which a
gastrostomy catheter is inserted in a fistula for placement, the
gastrostomy catheter including a tubular section which includes an
inner path for introducing a nutrient or a chemical into the
stomach from outside of the body, and an indwelling section
attached to a distal section of the tubular section and is formed
as a dome protruding radially outward of the tubular section, the
indwelling section being able to reduce its diameter by an
extending force applied by an obturator, which is used to extend
the indwelling section, the sheath for gastrostoma including: a
cylindrical sheath body in which the gastrostomy catheter is
inserted; and a handle provided to protrude at one longitudinal end
of the sheath body.
[0014] A second invention provides the sheath for gastrostoma
according to the first invention, further including a lid which is
provided pivotably via a hinge section at a base end of the sheath
body which is an end at the side of the handle and is disposed in
an inner path which is a through-hole defined inside the sheath
body, the lid opening and closing the inner path of the sheath body
through pivotation about the hinge section, wherein: the sheath
body is provided with a lid abutting section against which the lid
is made to abut at a distal end which is an end opposite to the
base end of the sheath body through pivotation about the hinge
section; and the lid is made to abut against the lid abutting
section in its closed position where the lid closes the inner path
and is pivoted from the closed position toward the distal section
of the sheath body to release the inner path.
[0015] A third invention provides the sheath for gastrostoma
according to the second invention, wherein the lid abutting section
is provided in the sheath body at a side opposite to the hinge
section across the inner path and an end of the lid opposite to the
side of the hinge section abuts against the lid abutting
section.
[0016] A fourth invention provides the sheath for gastrostoma
according to the second or third invention, wherein the handle is
pivotably provided at the base end of the sheath body via the hinge
section, and the lid is provided to protrude in the inner path from
the handle to open and close the inner path of the sheath body
through integrated pivotation with the handle.
[0017] A fifth invention provides the sheath for gastrostoma
according to any one of the second to fourth inventions, wherein
the hinge section is an elastic support member which elastically
supports the lid at the closed position while allowing pivotation
of the lid from the closed position in an open direction.
[0018] A sixth invention provides the sheath for gastrostoma
according to any one of the second to fifth inventions, further
including an elastic member which functions as an elastic support
member that applies an urging force to the handle so as to
elastically support the lid at the closed position while allowing
pivotation of the lid from the closed position in an open
direction.
[0019] A seventh invention provides the sheath for gastrostoma
according to the first invention, further including a lid which
provided in the handle via the lid hinge section and disposed in
the inner path which is a through-hole defined in the sheath body,
wherein: the handle is provided pivotably at the base end which is
an end at the side of the handle of the sheath body via a hinge
section other than the lid hinge section; and the lid is disposed
in its closed position at which the lid closes the inner path and
is able to open and close the inner path of the sheath body through
pivotation about the lid hinge section.
[0020] An eighth invention provides the sheath for gastrostoma
according to the seventh invention, wherein: the sheath body is
provided with a lid abutting section against which the lid is made
to abut at a distal end which is an end opposite to the base end of
the sheath body through pivotation about the hinge section; and the
lid is made to abut against the lid abutting section in its closed
position where the lid closes the inner path and is pivoted from
the closed position toward the distal section of the sheath body to
release the inner path.
[0021] A ninth invention provides the sheath for gastrostoma
according to the eighth invention, wherein the hinge section and
the lid hinge section are provided in the sheath body at a side
opposite to the lid abutting section across the inner path and an
end of the lid at the side opposite to the lid hinge section is
made to abut against the lid abutting section.
[0022] A tenth invention provides the sheath for gastrostoma
according to any one of the seventh to ninth inventions, wherein
the lid hinge section is disposed at an end of a stopper projection
piece which is provided to protrude from the handle, inserted in
the sheath body and is disposed along an inner surface of the
sheath body at a side opposite to the lid abutting section across
the inner path; and when the lid receives force to cause the same
to pivot from the closed position in an open direction, the stopper
projection piece is pressed against the inner surface of the sheath
body to restrict pivotation of the stopper projection piece with
respect to the sheath body.
[0023] An 11th invention provides the sheath for gastrostoma
according to the tenth invention, wherein the stopper projection
piece is made of a material with rubber elasticity.
[0024] A 12th invention provides the sheath for gastrostoma
according to any one of the seventh to 11th inventions, wherein the
lid hinge section is made of a material with rubber elasticity and
constitutes a lid elastic support member for elastically supporting
the lid at the closed position.
[0025] A 13th invention provides the sheath for gastrostoma
according to any one of the seventh to 12th inventions, wherein the
lid hinge section and the lid are formed integrally together from a
material with rubber elasticity.
[0026] A 14th invention provides the sheath for gastrostoma
according to any one of the seventh to 13th inventions, wherein a
mounting section which constitutes a part of the handle, the lid
hinge section and the lid is formed integrally as one component
from synthetic resin.
[0027] A 15th invention provides the sheath for gastrostoma
according to any one of the second to 14th inventions, wherein a
recess for housing the lid is formed on an inner surface of the
inner path of the sheath body.
[0028] A 16th invention provides the sheath for gastrostoma
according to the 15th invention, wherein an expanded section is
provided at the base end of the sheath body, the expanded section
being formed so that the sheath body is expanded radially outward,
wherein the recess for housing the lid is a space provided so as to
extend the inner path toward the inside of the expanded
section.
[0029] A 17th invention provides the sheath for gastrostoma
according to any one of the first to 16th inventions, wherein a
handle main piece which constitutes a part or all of the handle,
the sheath body and the hinge section are formed integrally
together as one component from synthetic resin.
[0030] An 18th invention provides the sheath for gastrostoma
according to any one of the first to 17th inventions, wherein a
grasping ring is provided at a side opposite to the hinge section
of the handle to allow a user to insert fingers for grasping.
[0031] A 19th invention provides the sheath for gastrostoma
according to any one of the first to 18th inventions, wherein one
or more notch section(s) are formed which facilitate vertical
splitting of the sheath body in a longitudinal direction.
[0032] A 20th invention provides the sheath for gastrostoma
according to the 19th invention, wherein the notch section is a
notched groove formed in the sheath body so as not to penetrate the
sheath body in the thickness direction and an uncut portion is
provided by locally reducing the thickness of the sheath body at a
groove bottom side of the notched groove.
[0033] A 21st invention provides the sheath for gastrostoma
according to the 20th invention, wherein the sheath body includes a
V-shaped distal notch section configured to recess from an end
surface at the base end of the sheath body and the notched groove
is formed to extend toward a distal end of the seal body from a
depth section of the distal notch section.
[0034] A 22nd invention provides the sheath for gastrostoma
according to the 19th invention, wherein: the notch section is a
slit formed to extend along the longitudinal direction of the
sheath body, the slit being formed at a part along the longitudinal
direction of the sheath body and being shorter than the entire
longitudinal direction length of the sheath body; and the sheath
body has a uncut portion at which no slit is formed along a virtual
extended line of the slit.
[0035] A 23rd invention provides the sheath for gastrostoma
according to any one of the 20th to 22nd inventions, wherein the
load applied to the inner surface of the sheath body is not smaller
than 0.5N to not greater than 5N in order to fracture at least one
of the uncut portions.
[0036] A 24th invention provides the sheath for gastrostoma
according to any one of the 19th to 23rd inventions, wherein the
notch section is formed in a wedge-shaped cross-section with its
opening width increasing from an inner surface toward an outer
surface of the sheath body.
[0037] A 25th invention provides the sheath for gastrostoma
according to any one of the 19th to 24th inventions, wherein the
notch section is formed through laser processing of the sheath
body.
[0038] A 26th invention provides the sheath for gastrostoma
according to the 25th invention, wherein the sheath body is made of
a FEP-containing material and a portion of the sheath body where
the notch section has been formed is whitened by the laser
processing.
[0039] A 27th invention provides the sheath for gastrostoma
according to any one of the 19th to 26th inventions, wherein the
handle is provided at a position where the handle does not
interfere with the notch section in a circumferential direction of
the sheath body.
[0040] A 28th invention provides the sheath for gastrostoma
according to the 27th invention, wherein the notch section is
formed only at one position along the circumferential direction of
the sheath body and only one handle is provided.
[0041] A 29th invention provides the sheath for gastrostoma
according to any one of the first to 28th inventions, wherein the
sheath body is oriented in the longitudinal direction thereof.
[0042] A 30th invention provides the sheath for gastrostoma
according to any one of the first to 29th inventions, wherein an
end surface of the sheath body at the side of the base end is
inclined with respect to an axial center of the sheath body.
[0043] A 31st invention provides the sheath for gastrostoma
according to any one of the first to 30th inventions, wherein an
inner diameter of the sheath body is larger than an outer diameter
of the tubular section of the gastrostomy catheter.
[0044] A 32nd invention provides the sheath for gastrostoma
according to any one of the first to 31st inventions, wherein the
material of the sheath body contains fluororesin.
[0045] A 33rd invention provides the sheath for gastrostoma
according to the 32nd invention, wherein the fluororesin comprises
any one of PTFE, ETFE and FEP.
[0046] A 34th invention provides the sheath for gastrostoma
according to any one of the first to 33th inventions, wherein the
sheath body can be removably disposed outside of a dilator used for
forming a fistula.
[0047] A 35th invention provides the sheath for gastrostoma
according to the 34th invention, wherein the dilator includes a
guidewire path which penetrates the dilator in the longitudinal
direction.
[0048] A 36th invention provides the sheath for gastrostoma
according to the 34th or 35th invention, wherein the dilator has a
scale on a peripheral surface thereof for measurement of a distance
between an inner stomach wall and a body surface.
[0049] A 37th invention provides the sheath for gastrostoma
according to the 36th invention, wherein the sheath body has
transparency that enables the scale of the dilator to be viewed
from outside.
[0050] A 38th invention provides the sheath for gastrostoma
according to any one of the 34th to 37th inventions, wherein the
dilator has a narrow-diameter dilator and a large-diameter dilator
which are integrated together, the narrow-diameter dilator
including the guidewire path inside thereof and the large-diameter
dilator being disposed outside of the narrow-diameter dilator and
assembled to the narrow-diameter dilator.
[0051] A 39th invention provides the sheath for gastrostoma
according to any one of the first to 38th inventions, wherein an
inner diameter of the sheath body is smaller than the maximum outer
diameter of the indwelling section of the gastrostomy catheter
which adopts a reduced-diameter state due to the extending force
applied by the obturator.
[0052] A 40th invention provides the sheath for gastrostoma
according to the 39th invention, wherein the sheath body is
vertically splittable when the gastrostomy catheter is inserted
with the indwelling section being in its reduced-diameter state by
the obturator.
[0053] A 41st invention provides the sheath for gastrostoma
according to any one of the first to 40th inventions, wherein the
sheath body is formed of a stretch-deformable material and is thus
radially expandable.
[0054] A 42nd invention provides the sheath for gastrostoma
according to any one of the first to 38th inventions, wherein an
inner diameter of the sheath body is larger than the maximum outer
diameter of the indwelling section of the gastrostomy catheter
which adopts a reduced-diameter state due to the extending force
applied by the obturator.
[0055] A 43rd invention provides the sheath for gastrostoma
according to any one of the first to 42nd inventions, wherein the
sheath body is configured such that a sheath insertion aid having a
rod-shaped appearance can be inserted in the sheath body and the
sheath insertion aid includes a rod-shaped body and a tapered
distal section having a tapering configuration provided to protrude
at one longitudinal end of the rod-shaped body.
[0056] A 44th invention provides the sheath for gastrostoma
according to the 43rd invention, wherein the sheath insertion aid
includes a guidewire insertion hole which penetrates the sheath
insertion aid along the longitudinal direction.
[0057] A 45th invention provides the sheath for gastrostoma
according to the 43rd or 44th invention, wherein the sheath
insertion aid can function as a dilator used for forming a
fistula.
[0058] A 46th invention provides a sheathed dilator in which the
sheath for gastrostoma according to any one of the first to 45th
inventions is disposed outside the dilator used for forming a
fistula.
[0059] A 47th invention provides a sheath for gastrostoma with
insertion aid in which a sheath insertion aid is inserted in the
sheath body of the sheath for gastrostoma according to any one of
the first to 45th inventions, the sheath insertion aid being
provided to protrude at a tapered distal section having a tapering
configuration at one longitudinal end of a rod-shaped body.
[0060] A 48th invention provides a gastrostomy catheter kit,
including: a gastrostomy catheter for percutaneously feeding a
nutrient or a chemical into the patient's stomach from outside of
the body; an obturator; and one of the sheath for gastrostoma
according to any one of the first to 45th inventions and the
sheathed dilator according to the 46th invention. The gastrostomy
catheter includes a tubular section which includes an inner path
for introducing a nutrient or a chemical into the stomach from
outside of the body, and an indwelling section which is attached to
a distal section of the tubular section and is formed as a dome
protruding radially outward of the tubular section, in which the
indwelling section can reduce its diameter due to the extending
force applied by an obturator for extending the indwelling section;
the gastrostomy catheter in which indwelling section being its
reduced-diameter state by the obturator is inserted in a sheath for
gastrostoma of the sheath for gastrostoma according to claim 1 and
a sheath for gastrostoma of the sheathed dilator according to claim
46 while the sheath for gastrostoma is inserted in a fistula.
[0061] A 49th invention provides the gastrostomy catheter kit
according to the 48th invention, wherein: the obturator includes an
outer case, a pushing rod for extension which includes a rod body
inserted in the outer case to be movable in a longitudinal
direction of the outer case and a stopper for anchoring the
gastrostomy catheter to the outer case; and in a state in which the
gastrostomy catheter is anchored to the outer case with the
stopper, an operator inserts a distal end of the pushing rod for
extension protruding from the outer case of the rod body in the
indwelling section of the gastrostomy catheter and presses the most
distal section of the indwelling section so as to extend the
indwelling section.
[0062] A 50th invention provides the gastrostomy catheter kit
according to the 48th or 49th invention, wherein the gastrostomy
catheter and the obturator include a guidewire path and the
obturator is configured to reduce the diameter of the indwelling
section of the gastrostomy catheter in a state in which the
obturator is disposed outside of the guidewire which is inserted in
the gastrostomy catheter.
[0063] A 51st invention provides the gastrostomy catheter kit
according to any one of the 48th to 50th inventions, further
including the sheath for gastrostoma according to any of the first
to 45th inventions as a sheath for gastrostoma used for
replacement, wherein the gastrostomy catheter in which the
indwelling section is in its reduced-diameter state by the
obturator is inserted in the sheath for gastrostoma.
[0064] A 52nd invention provides the gastrostomy catheter kit
according to the 51st invention, including a sheath for gastrostoma
with insertion aid according to claim 47 configured by using the
sheath for gastrostoma used for replacement.
[0065] A 53rd invention provides a method of splitting a sheath for
gastrostoma, including splitting one or more parts of a sheath body
in a circumferential direction along the entire longitudinal
direction length of the sheath body by inserting, in a sheath body
of the sheath for gastrostoma according to any one of the first to
45th inventions, a medical device having an outer diameter larger
than an inner diameter of the sheath body.
[0066] A 54th invention provides the method of splitting a sheath
for gastrostoma according to the 53rd invention, wherein the
medical device is a gastrostomy catheter of which the indwelling
section is in its reduced-diameter state due to the extending force
from the obturator, and the maximum outer diameter of the
indwelling section which adopts a reduced-diameter state due to the
extending force applied by the obturator is larger than an inner
diameter of the sheath body.
EFFECT OF THE INVENTION
[0067] According to the invention, it is possible to lower
insertion resistance during placement of a button gastrostomy
catheter.
[0068] It is also possible to open and close an inner path easily
with a configuration in which the inner path of a sheath body is
opened and closed with a plug member which is removably fit into a
base end of the sheath body and a configuration (a second
invention) in which a sheath for gastrostoma itself includes a lid
which functions as a plug member to open and close the inner path
of the sheath body. With such configurations, air supply from an
endoscope can be controlled easily and an endoscopic visual field
can be stabilized during surgery.
BRIEF DESCRIPTION OF THE DRAWINGS
[0069] FIG. 1A is a perspective view of a sheath for gastrostoma
according to the invention with a lid closed.
[0070] FIG. 1B is a left cross-sectional view of the sheath for
gastrostoma according to the invention with the lid closed.
[0071] FIG. 2A is a top view of the sheath for gastrostoma
according to the invention with the lid closed.
[0072] FIG. 2B is a front view of the sheath for gastrostoma
according to the invention with the lid closed.
[0073] FIG. 2C is a right side view of the sheath for gastrostoma
according to the invention with the lid closed.
[0074] FIG. 2D is a rear view of the sheath for gastrostoma
according to the invention with the lid closed.
[0075] FIG. 2E is a bottom view of the sheath for gastrostoma
according to the invention with the lid closed.
[0076] FIG. 3A is a perspective view of the sheath for gastrostoma
according to the invention with the lid opened.
[0077] FIG. 3B is a left cross-sectional view of the sheath for
gastrostoma according to the invention with the lid opened.
[0078] FIG. 4A is a top view of the sheath for gastrostoma
according to the invention with the lid opened.
[0079] FIG. 4B is a front view of the sheath for gastrostoma
according to the invention with the lid opened.
[0080] FIG. 4C is a right side view of the sheath for gastrostoma
according to the invention with the lid opened.
[0081] FIG. 4D is a rear view of the sheath for gastrostoma
according to the invention with the lid opened.
[0082] FIG. 4E is a bottom view of the sheath for gastrostoma
according to the invention with the lid opened.
[0083] FIG. 5A is a cross-sectional view of a configuration in
which the sheath for gastrostoma according to the invention
includes an elastic member disposed outside of a base end of a
sheath body as an elastic support member for elastically supporting
the lid at a closed position, illustrated with the lid being at its
closed position.
[0084] FIG. 5B is a cross-sectional view of a configuration in
which the sheath for gastrostoma according to the invention
includes an elastic member disposed outside of a base end of a
sheath body as an elastic support member for elastically supporting
the lid at a closed position, illustrated in a state in which the
lid is moved from its closed position to release an inner path of
the sheath body.
[0085] FIG. 6A is a perspective view of a button for gastrostoma
used in the invention.
[0086] FIG. 6B is a top view of the button for gastrostoma used in
the invention.
[0087] FIG. 6C is a bottom view of the button for gastrostoma used
in the invention.
[0088] FIG. 7 is a cross-sectional view of a structure of the
button for gastrostoma used in the invention.
[0089] FIG. 8A is a left cross-sectional view of an obturator and a
side view of a stopper used in the invention.
[0090] FIG. 8B is a front view of the obturator used in the
invention.
[0091] FIG. 8C is a right side view of the obturator used in the
invention.
[0092] FIG. 9A illustrates a relationship between the obturator
used in the invention and the stopper attached to obturator,
illustrated in a state in which the stopper can engage with an
externally fixed section of a button for gastrostoma.
[0093] FIG. 9B illustrates a relationship between the obturator
used in the invention and the stopper attached to the obturator,
with the stopper being in its disengaged state.
[0094] FIG. 10A is a front view illustrating a state in which the
button for gastrostoma and the obturator used in the invention are
assembled together.
[0095] FIG. 10B is a front view illustrating a state in which the
button for gastrostoma and the obturator used in the invention are
assembled together and the button for gastrostoma is extended.
[0096] FIG. 11 is a front view illustrating a state in which the
button for gastrostoma and the obturator used in the invention are
assembled together and the button for gastrostoma is extended using
a guidewire.
[0097] FIG. 12A is a front view of a dilator used in the
invention.
[0098] FIG. 12B is a front view of a narrow-diameter dilator used
in the invention.
[0099] FIG. 12C is a front view of a sheathed dilator in which the
sheath for gastrostoma according to the invention is combined with
a dilator.
[0100] FIG. 12D is a cross-sectional view of a sheathed dilator in
which the sheath for gastrostoma according to the invention is
combined with a dilator.
[0101] FIG. 13 is a front view illustrating a state immediately
before the button for gastrostoma extended with the obturator is
disposed in the sheath for gastrostoma according to the
invention.
[0102] FIG. 14 is a front view illustrating a state in which the
button for gastrostoma extended with the obturator is being
disposed in the sheath for gastrostoma according to the
invention.
[0103] FIG. 15A is a perspective view of a configuration in which a
slit is formed as a notch section in the sheath body of the sheath
for gastrostoma according to the invention, with the lid being in
its closed position.
[0104] FIG. 15B is a perspective view of a configuration in which a
slit is formed as a notch section in the sheath body of the sheath
for gastrostoma according to the invention, with the lid moved away
from the closed position to release the inner path of the sheath
body.
[0105] FIG. 16A schematically illustrates a cross-sectional
structure and a position of a handle of the sheath body of the
sheath for gastrostoma according to the invention, with a notched
groove formed in the sheath body as a notch section.
[0106] FIG. 16B schematically illustrates a cross-sectional
structure and a position of a handle of the sheath body of the
sheath for gastrostoma according to the invention, with a slit
formed in the sheath body as a notch section.
[0107] FIG. 17 is a cross-sectional view of a sheath for
gastrostoma configured with the slits formed at two circumferential
positions of the sheath body.
[0108] FIG. 18 illustrates a state in which an abdominal wall and a
stomach wall have yet to be in contact with each other.
[0109] FIG. 19 illustrates a state in which the abdominal wall and
the stomach wall are in contact with each other with a suture.
[0110] FIG. 20 illustrates a state in which a guidewire is
placed.
[0111] FIG. 21 illustrates a state in which a dilator covered with
the sheath for gastrostoma (i.e., a sheathed dilator) is being
inserted in the abdominal wall and the stomach wall using a
guidewire.
[0112] FIG. 22 illustrates a state in which the sheath for
gastrostoma is placed.
[0113] FIG. 23 is a state in which the button for gastrostoma is
being inserted in the sheath for gastrostoma.
[0114] FIG. 24 is a state in which the button for gastrostoma has
been inserted from an inner path of the sheath for gastrostoma.
[0115] FIG. 25 illustrates a state in which only the button for
gastrostoma is placed after the sheath for gastrostoma is
removed.
[0116] FIG. 26 illustrates a state in which extension of the
obturator is released.
[0117] FIG. 27 illustrates a state in which the obturator is
removed.
[0118] FIG. 28 illustrates a state in which placement of the button
for gastrostoma is completed.
[0119] FIG. 29 illustrates a state before the button for
gastrostoma extended with the obturator is inserted in the radially
expandable sheath body.
[0120] FIG. 30 illustrates a state in which the button for
gastrostoma extended with the obturator is being inserted in the
radially expandable sheath body.
[0121] FIG. 31A illustrates another embodiment of the sheath for
gastrostoma according to the invention, which is a perspective view
with the lid closed.
[0122] FIG. 31B is a left cross-sectional view of the sheath for
gastrostoma of FIG. 31A with the lid closed.
[0123] FIG. 32A is a top view of the sheath for gastrostoma of FIG.
31A with the lid closed.
[0124] FIG. 32B is a left side view of the sheath for gastrostoma
of FIG. 31A with the lid closed.
[0125] FIG. 32C is a front view of the sheath for gastrostoma of
FIG. 31A with the lid closed.
[0126] FIG. 32D is a right side view of the sheath for gastrostoma
of FIG. 31A with the lid closed.
[0127] FIG. 32E is a rear view of the sheath for gastrostoma of
FIG. 31A with the lid closed.
[0128] FIG. 32F is a bottom view of the sheath for gastrostoma of
FIG. 31A with the lid closed.
[0129] FIG. 33 illustrates a button placed in the fistula.
[0130] FIG. 34 illustrates a state in which a cap of the button for
gastrostoma has been removed.
[0131] FIG. 35 illustrates a state in which the obturator is
inserted in an inner cavity of the button for gastrostoma and an
externally fixed section of the button is held by a stopper.
[0132] FIG. 36 illustrates a state in which the guidewire is
inserted from a guidewire insertion hole of the obturator and is
made to protrude from a distal end of the button for
gastrostoma.
[0133] FIG. 37 illustrates a state in which an operating section of
the obturator assembled to the button for gastrostoma is pressed so
that the indwelling section of the button for gastrostoma adopts an
extended state.
[0134] FIG. 38 illustrates a state in which the obturator, the
button for gastrostoma and the guidewire are removed, leaving the
guidewire alone in the fistula.
[0135] FIG. 39 illustrates a state in which a sheath with insertion
aid obtained by disposing the sheath for gastrostoma outside of the
sheath insertion aid is inserted in the fistula by using the
guidewire as a guidance member.
[0136] FIG. 40 illustrates a state in which the sheath insertion
aid and the guidewire are removed, leaving the sheath for
gastrostoma alone.
[0137] FIG. 41 illustrates a state in which the button for
gastrostoma has been inserted in the fistula via the sheath for
gastrostoma.
[0138] FIG. 42 illustrates a state in which the button for
gastrostoma is placed in the stomach via the sheath for
gastrostoma.
[0139] FIG. 43 is a cross-sectional view of another exemplary
sheath for gastrostoma with a configuration in which the handle is
covered with a lid via a lid hinge section other than the hinge
section.
[0140] FIG. 44A is a perspective view of an exemplary sheath for
gastrostoma in which a V-shaped distal notch section that can be
used as a beginning point (starting point) of vertical splitting of
the sheath body is formed in the sheath body.
[0141] FIG. 44B is an enlarged front view (an enlarged front view
of an area X in FIG. 44A) illustrating a configuration near the
distal notch section of the sheath body of FIG. 44A.
[0142] FIG. 45A is a perspective view of an exemplary sheath for
gastrostoma having a configuration in which a grasping ring is
provided in the handle.
[0143] FIG. 45B is a left cross-sectional view of a structure of
the sheath for gastrostoma of FIG. 45A.
[0144] FIG. 46A is a top view of the sheath for gastrostoma of FIG.
45A with the lid closed.
[0145] FIG. 46B is a left side view of the sheath for gastrostoma
of FIG. 45A with the lid closed.
[0146] FIG. 46C is a front view of the sheath for gastrostoma of
FIG. 45A with the lid closed.
[0147] FIG. 46D is a right side view of the sheath for gastrostoma
of FIG. 45A with the lid closed.
[0148] FIG. 46E is a rear view of the sheath for gastrostoma of
FIG. 45A with the lid closed.
[0149] FIG. 46F is a bottom view of the sheath for gastrostoma of
FIG. 45A with the lid closed.
[0150] FIG. 47 illustrates an exemplary method of grasping the
grasping ring of the sheath for gastrostoma of FIG. 45A with
fingers.
REFERENCE NUMERALS
[0151] 1: sheath for gastrostoma [0152] 11: sheath body [0153] 11a:
tapered distal end [0154] 11b: sheath body [0155] 111a: notch
section (notched groove) [0156] 111a: uncut portion [0157] 111b:
notch section (slit) [0158] 112: tapered portion [0159] 113: inner
path [0160] 114: handle main piece (tubular piece) [0161] 115:
expanded section (forming section) [0162] 115a: inner space [0163]
115b: back wall section [0164] 116: hinge section [0165] 117: lid
abutting section [0166] 117a: lid abutting section [0167] 117b: lid
abutting section [0168] 118: uncut portion [0169] 119: split piece
[0170] 12: handle [0171] 121: handle member (first handle member)
[0172] 122: handle member (second handle member) [0173] 123:
inclined piece [0174] 13: lid [0175] 14: elastic member [0176] 15:
sheath body [0177] 151: end notch section [0178] 152: depth section
[0179] 16: grasping ring [0180] 2: gastrostomy catheter (button for
gastrostoma) [0181] 21: tubular section [0182] 21c: central axis
[0183] 22: indwelling section [0184] 221: strip-shaped piece [0185]
222: base end gathering section [0186] 223: distal end gathering
section [0187] 23: externally fixed section [0188] 231: flexible
section [0189] 232: patient contact surface [0190] 24: path [0191]
25: valve [0192] 251: slit [0193] 26: communication path [0194] 27:
rod abutting section [0195] 271: rod fitting projection [0196] 272:
reinforcing member [0197] 28: cap [0198] 3: obturator [0199] 31:
pushing rod for extension [0200] 311: operating section [0201] 312:
spring [0202] 313: rod body [0203] 314: reinforcing member [0204]
315: wire insertion groove [0205] 316: lock piece [0206] 317:
distal section [0207] 32: outer case [0208] 321: cylindrical
portion [0209] 322: finger plate [0210] 323: fitting portion [0211]
323a: fit-in groove [0212] 324: groove [0213] 325: groove hole
[0214] 326: lock hole [0215] 33: stopper [0216] 331: arm [0217]
332: holding section [0218] 333: back plate [0219] 334: pushed-in
portion [0220] 4: guidewire [0221] 5: dilator (extender) [0222] 5a:
sheathed dilator [0223] 51: large-diameter dilator [0224] 511:
large-diameter dilator body section [0225] 512: large-diameter
dilator distal section [0226] 513: large-diameter dilator side
connector [0227] 514: scale [0228] 5141: reference point (zero
point) [0229] 52: narrow-diameter dilator [0230] 521:
narrow-diameter dilator body section [0231] 522: narrow-diameter
dilator distal section [0232] 523: narrow-diameter dilator side
connector [0233] 524: guidewire path [0234] 6: sheath for
gastrostoma [0235] 6a: sheath for gastrostoma [0236] 6b: sheath for
gastrostoma [0237] 61: handle [0238] 611: handle member (lid side
handle member) [0239] 612: handle member (main piece side handle
member) [0240] 62: lid hinge section [0241] 63: lid [0242] 64:
elongated plate lid member [0243] 64a: elongated plate lid member
[0244] 64b: elongated plate lid member with ring [0245] 641:
mounting section [0246] 642: stopper projection piece [0247] 7:
sheath insertion aid [0248] 70: sheath for gastrostoma with
insertion aid [0249] 71: rod-shaped body [0250] 72: tapered distal
section [0251] 73: guidewire insertion hole [0252] 900: abdominal
wall [0253] 901: stomach wall [0254] 902: suture
BEST MODE FOR CARRYING OUT THE INVENTION
[0255] Below, referring now to the drawings, preferred embodiments
of the invention will be described. Examples of a sheath for
gastrostoma, a sheathed dilator, a gastrostomy catheter kit and a
method for splitting a sheath for gastrostoma to which the
invention is applied will be described.
[0256] Although upper and lower directions are defined in the
following description, these are for descriptive purposes to simply
define relative positions of components of the invention. Thus,
these directions do not limit directions in production and usage
for implementation of the invention.
[0257] Also, in all the drawings, the same components will be
denoted by the same reference numerals and duplicated description
will be omitted. In the drawings, upper ends of components are
illustrated at an upper side and lower ends of components are
illustrated at a lower side.
[0258] FIGS. 1A, 1B and 2A to 2E illustrate an embodiment of the
invention with a lid 13 of a sheath for gastrostoma 1 closed. FIG.
1A is a perspective view, FIG. 1B is a cross-sectional view, FIG.
2A is a top view, FIG. 2B is a front view, FIG. 2C is a right side
view, FIG. 2D is a bottom view and FIG. 2E is a rear view.
[0259] The sheath for gastrostoma 1 is inserted in a fistula formed
using a dilator in gastrostomy (see FIG. 21). A gastrostomy
catheter is inserted in the sheath which has been inserted in the
fistula.
[0260] As illustrated in FIGS. 1A, 1B and 2A to 2E, the sheath for
gastrostoma 1 is constituted of a cylindrical sheath body 11 (i.e.,
a sheath tube), a handle 12, and a lid 13.
[0261] The sheath body 11 includes an inner path 113 through which
a gastrostomy catheter (i.e., a button for gastrostoma, see FIG. 6A
and other drawings) is inserted. In addition, the inner path 113 is
also used when the sheath for gastrostoma 1 (in particular, the
sheath body 11) is disposed to cover a dilator illustrated in FIG.
12A in order to form a hole (hereinafter referred to as a fistula)
for placing the button for gastrostoma.
[0262] The handle 12 is provided at an upper end of the sheath for
gastrostoma 1. The handle 12 may be used when the sheath for
gastrostoma 1 is grasped during insertion of the button for
gastrostoma.
[0263] The handle 12 is constituted of a first handle member 121
and a second handle member 122 fixed to a tongue-shaped handle main
piece 114 extending from one longitudinal end (i.e., an end of the
sheath body 11 at the side of the handle 12: an upper end in FIGS.
1A to 1E, which is hereinafter referred to as a base end) of the
sheath body 11. The first handle member 121 and the second handle
member 122 are planar members and are integrally fixed to the
handle main piece 114 so as to sandwich the same. The handle 12
extends from the base end of the sheath body 11 as a tongue-shaped
piece.
[0264] The handle main piece 114 is cut out of a resin tube
together with the sheath body 11 during production of the sheath
body 11. The handle main piece 114 is formed so as to be continuous
to and integral with the sheath body 11. In addition, the fixing
strength of the handle can be increased by an adhesive applied
between the handle main piece 114 and the first handle member 121
and between the handle main piece 114 and the second handle member
122.
[0265] Note that the first handle member 121 and the second handle
member 122 may be provided as separate members or may be formed
integrally with each other.
[0266] Alternatively, the entire handle 12 may be constituted only
of the handle main piece 114.
[0267] The handle 12 can be pivoted with respect to the sheath body
11 about a boundary section between the sheath body 11 and the
handle main piece 114, which is a tongue-shaped extending portion
formed continuously from the sheath body 11. That is, the boundary
section functions as a hinge section 116 which enables pivotation
of the handle 12 with respect to the sheath body 11. The handle 12
is provided to be pivotable with respect to the sheath body 11 via
the hinge section 116.
[0268] The handle 12 pivots about the hinge section 116, i.e.,
about a pivot axis extending perpendicular to the axis of the
sheath body 11 (i.e., a central axis of the inner path 113 denoted
by reference numeral C1 in FIG. 1B). The handle 12 pivots about the
hinge section 116 as illustrated by an arrow A in FIG. 1B.
[0269] In addition, the hinge section 116 may be machined to easily
bend by, for example, making a cut in the boundary section,
chipping to reduce thickness, and pressing a hot plate or heat ray
against the hinge section to reduce thickness.
[0270] Furthermore, a resin molding product integrally constituted
of the sheath body 11, the hinge section 116 and the handle main
piece 114 may also be obtained through metal molding.
[0271] The handle 12 may be pivoted integrally with the lid 13,
which opens and closes the inner path 113, which is a through-hole
penetrating an inner side of the sheath body 11, which will be
described later.
[0272] The lid 13 will now be described.
[0273] In the exemplary sheath for gastrostoma 1 illustrated in
FIGS. 1A, 1B, 2A to 2E and other drawings, in particular, the lid
13 is a tongue-shaped portion configured by the first handle member
121 which is fixed to the handle main piece 114, and the lid 13
extending from the handle 12 toward the inner path 113 of the
sheath body 11. The lid 13 is disposed in the inner path 113 of the
sheath body 11.
[0274] The first handle member 121 is disposed on an upper surface
of the handle main piece 114 (i.e., an upper surface of the handle
main piece 114 at a state with the lid closed as illustrated by
solid lines in FIGS. 1A and 1B). That is, the first handle member
121 is provided on a surface which continues from an inner surface
of the sheath body 11 via the hinge surface 116. The lid 13 extends
into the inner path 113 of the sheath body 11 from the hinge
section 116 while being inclined toward a distal section of the
sheath body 11 (i.e., an end opposite to the base end at the side
of the handle 12 in the longitudinal direction of the sheath body
11 and the lower end in FIGS. 1A and 1B) with respect to a virtual
vertical plane extending perpendicular to an axial center of the
sheath body 11.
[0275] The lid 13 pivots about the hinge section 116 within the
inner path 113. The pivot axis of the lid 13 about the hinge
section 116 is located at a rim section of the base end of the
sheath body 11.
[0276] A pivotation radius of the lid 13 about the hinge section
116 is larger than an inner diameter D (i.e., an inner diameter of
a portion where no expanded section 115, which will be described
later, is formed) of the inner path 113 of the sheath body 11.
[0277] In addition, in the sheath for gastrostoma 1 of the
illustrated example, the expanded section 115 (allocated type
section) which carried out the allocated type in detail so that a
part of circumferential direction of the base end of the sheath
body 11 is expanded radially outward of the sheath body 11 is
formed. The hinge section 116 is provided in the expanded section
115 and disposed at the rim section of the base end of the sheath
body 11 so that a distance from the axial center of the sheath body
11 (i.e., a central axis C1 of the inner path 113) is larger than
the radius of the inner path 113 by the dimension of space (i.e.,
an inner space 115a) provided inside the expanded section 115 which
extends the inner path 113.
[0278] The expanded section 115 extends laterally from the sheath
body 11 and has a U-shaped cross section (i.e., a U-shaped cross
section along a plane perpendicular to the axial center of the
sheath body 11). The hinge section 116 is provided at a back wall
section 115b located behind the inner space 115a of the expanded
section 115 from the axial center (i.e., the central axis C1 of the
inner path 113) of the sheath body 11. However, a pivotation radius
of the lid 13 about the hinge section 116, i.e., a distance between
a pivotal center and a distal end of a portion extending from the
hinge section 116 of the lid 13 and placed in the inner path 113 of
the sheath body 11 is larger than the sum of the radius of the
inner path 113 of the sheath body 11 and a distance L1 from the
axial center of the sheath body 11 (i.e., the central axis C1) to
the back wall section 115b of the expanded section 115.
[0279] In FIG. 1, the reference numeral 117 denotes a lid abutting
section which a distal end of the lid 13 abuts.
[0280] The lid abutting section 117 is located at the base end of
the sheath body 11 at an opposite side to the hinge section 116
across the inner path 113. The lid 13 pivots about the hinge
section 116 and the distal end thereof abuts the lid abutting
section 117 from the side of the distal section of the sheath body
11. The lid 13 is in its closed position to close the inner path
113 at which the distal end of the lid 13 abuts against the lid
abutting section 117. When the lid 13 abuts against the lid
abutting section 117, the lid abutting section 117 functions as a
stopper which restricts pivotation of the lid 13 from a closed
position toward a direction opposite to the distal section of the
sheath body 11. With this configuration, the lid 13 does not
protrude from an opening of the inner path 13 at the base end of
the sheath body 11 and stays only within the sheath for gastrostoma
1.
[0281] Note that the lid abutting section 117 is not necessarily
located at the side opposite to the hinge section 116 across the
inner path 113 in the base end of the sheath body 11.
Alternatively, for example, the entire base section of the sheath
body may function as a lid abutting section in accordance with
configurations of the lid 13.
[0282] The lid 13 is supported at the closed position by the
bending property imparted to the hinge section 116. In addition,
preferably, the lid 13 is urged to abut the lid abutting section
117 by the bending property imparted to the hinge section 116
(i.e., urged with elasticity of the hinge section 116).
[0283] That is, the lid 13 is in its closed position as illustrated
in FIG. 1 in a natural state in which no force is applied to the
sheath for gastrostoma 1. The hinge section 116 functions as an
elastic support member which elastically supports the lid 13 at the
closed position. When the lid 13 pivots about the hinge section 116
to move apart from the lid abutting section 117, elasticity of the
hinge section 116 applies an urging force to the lid 13 so that the
lid 13 returns to the closed position. With this configuration, the
inner path 113 can be closed with the lid 13 unless an operator
grasps the handle 12 of the sheath for gastrostoma 1 with a
hand.
[0284] With such a configuration in which the inner path 113 is
closed with the lid 13, outflow of air supplied to the stomach from
an endoscope can be prevented during surgery which will be
described later. Also, of course, ingression of foreign objects,
such as dust, into the sheath 1 can be avoided.
[0285] The hinge section 116 as an elastic support member which
elastically supports the lid 13 at the closed position may, for
example, have an arched configuration which functions as a plate
spring in order to improve elasticity of the hinge section 116.
[0286] Alternatively, for example, an elastic member 14 may be
provided separately from the hinge section 116 as an elastic
support member which elastically supports the lid 13 to the closed
position. The elastic member 14 is disposed outside of the base end
of the sheath body 11 as illustrated in FIGS. 5A and 5B and applies
an urging force to the handle 12 in a direction in which the handle
12 is moved toward the peripheral surface of the base end of the
sheath body 11. In this case, the hinge section 116 does not have
necessarily function as an elastic support member and it is
sufficient that the hinge section 116 has a function to provide the
handle 12 and the lid 13 pivotable with respect to the sheath body
11.
[0287] Note that the elastic member 14 may be configured in various
manners. For example, an elastic member (e.g., a silicone rubber
elastic member and a coil spring) may be used as a draw spring.
Such an elastic member extends from the base end of the sheath body
11 radially outward of the sheath body 11 and is connected to the
handle 12. Alternatively, the elastic member 14 may be a flat
spring which is fixed to an outer surface of the base end and the
handle 12 of the sheath body 11: to apply an urging force in a
direction in which the handle 12 is moved toward the peripheral
surface of the base end of the sheath body 11.
[0288] In a configuration illustrated in FIGS. 5A and 5B, the
elastic member 14 is an elastic member made of silicone rubber. The
elastic member 14 connects the base end of the sheath body 11 and
an inclined piece 123 provided at an end of the handle 12 near the
hinge section 116 (i.e., near a base end of the handle 12) to
protrude toward the base end of the sheath body 11 in an inclined
manner with respect to the plate-like handle 12. When the lid 13 is
in its closed position, the inclined piece 123, as a part of the
handle 12, is disposed close to the base end of the sheath body 11.
When the lid 13 is moved to pivot from the closed position to an
open direction, the inclined piece 123 is moved away from the base
end of the sheath body 11 as the handle 12 pivots about the hinge
section 116.
[0289] In this configuration, as the inclined piece 123 is moved to
pivot about the hinge section 116 from its position (hereinafter,
referred to as a re-approaching position) when the lid 13 is in its
closed position and is separated from the re-approaching position,
the elastic member 14 is subject to extension (i.e., stretching
deformation or elastic deformation in an elongation direction). The
extended elastic member 14 functions as a draw spring which applies
an urging force to the handle 12 (in particular, to the inclined
piece 123) to move back to the re-approaching position. This urging
force functions as an elastic force for elastically supporting the
lid 13 at the closed position.
[0290] In addition, in the invention, as described above, the hinge
section 116 with a function to elastically support the lid 13 to
the closed position is preferably employed to provide a
configuration in which the lid 13 is closed by the elastic support
member in a natural state in which no force is applied to the
sheath for gastrostoma 1. Alternatively, however, a configuration
may be employed in which a hinge section 116 with no function to
elastically support the lid 13 at the closed position is provided
and a state in which the inner path 113 is closed with the lid 13
can be implemented by an operation of the handle 12. In this case,
while implementing the state in which the lid 13 closes the inner
path 113 by the operation of the handle 12, pressure of air
supplied to the stomach from the endoscope during surgery may keep
the lid 13 from closing the inner path 113.
[0291] Since the lid 13 closes the inner path 113 of the sheath for
gastrostoma 1, it prevents air supplied from an endoscope which is
introduced orally into the stomach from leaking out of the stomach
when a dilator is removed from a fistula expanded by the dilator 5
before a button for gastrostoma 2 is inserted.
[0292] In the state in which the lid 13 is closed, it is not
necessary to provide airtightness for completely preventing outflow
of air toward the base end from the distal section. It suffices to
prevent leakage of air supplied to the stomach from an endoscope
(hereinafter, referred to as air leakage) so as to avoid a narrowed
endoscopic visual field. More preferably, the lid 13 is formed to
completely prevent air leakage.
[0293] FIG. 3A is a perspective view and FIG. 3B is a
cross-sectional view of the sheath for gastrostoma 1 illustrated
with the lid 13 opened. Also, FIG. 4A is a top view, FIG. 4B is a
front view, FIG. 4C is a right side view, FIG. 4D is a rear view
and FIG. 4E is a bottom view of the sheath for gastrostoma
according to the invention illustrated with the lid opened.
[0294] In the state in which the lid 13 is opened, it is necessary
to prevent the inner path 113 from blocking a route along which the
button for gastrostoma 2 and the dilator 5 are inserted. In order
to receive the lid 13 pivoted from the closed position, it is
preferable to provide a recess for receiving the lid inside the
inner path 113. Such a recess may be implemented by, for example,
an expanded section 115 provided in the sheath body 11. In the
illustrated example, an inner space 115a of the expanded section
115 functions as a recess for receiving the lid 13 pivoted from the
closed position. With this configuration, insertion resistance at
the time of inserting the button for gastrostoma 2 and the dilator
5 in the sheath body 11 can be lowered.
[0295] FIGS. 6A to 6C and 7 illustrate an embodiment of the
gastrostomy catheter 2 (hereinafter, also referred to as a button
for gastrostoma) used together with the sheath for gastrostoma 1
according to the invention.
[0296] FIG. 6A is a perspective view, FIG. 6B is a top view, FIG.
6C is a bottom view and FIG. 7 is a front cross-sectional view of
the button for gastrostoma.
[0297] As illustrated in these drawings, the button for gastrostoma
2 includes a tubular section 21, an indwelling section 22 and an
externally fixed section 23.
[0298] The indwelling section 22 is provided at one longitudinal
end (hereinafter, referred to as a distal end) of the tubular
section 21. The externally fixed section 23 is provided at the
other longitudinal end (hereinafter, referred to as a base end) of
the tubular section 21.
[0299] In more detail, a through-hole which penetrates inside the
tubular section 21 functions as a path 24 for introducing a
nutrient (i.e., a nutrient), chemical or other fluids. The
externally fixed section 23 includes a cap 28 which closes the path
24 to shield the patient's body from outside when no nutrient or
other fluid is introduced in the path 24. The cap 28 is provided at
a distal end of a strip-shaped flexible piece 231 to extend from
the externally fixed section 23 and is removably fit to an opening
of the path 24 of the tubular section 21.
[0300] A valve 25 is provided at a distal section of the tubular
section 21 to prevent back flow from the stomach.
[0301] The indwelling section 22 includes a plurality of (four in
the illustrated example) elastically deformable strip-shaped pieces
221 disposed about a central axis 21C of the tubular section 21 (in
particular, a portion on an extended line of the central axis 21C
toward the distal end).
[0302] One longitudinal end of each of the strip-shaped pieces 221
extends from a base end gathering section 222 provided integrally
with a distal end of the tubular section 21. The other longitudinal
end of each of the strip-shaped pieces 221 is integrated at a
distal end gathering section 223 (i.e., the most distal section of
the indwelling section 222). The distal end gathering section 223
is spaced away from the base end gathering section 222 and along
the central axis 21C of the tubular section 21 (in particular, a
portion on an extended line of the central axis 21C toward the
distal end). The entire indwelling section 22 is formed as a dome
(i.e., as a round basket) constituted by the plurality of arcuate
strip-shaped pieces 221 disposed between the base end gathering
section 222 and the distal end gathering section 223.
[0303] The one longitudinal ends of the plurality of these
strip-shaped pieces 221 extends radially from the base end
gathering section 222 and the other longitudinal ends of the
plurality of these strip-shaped pieces 221 extend radially from the
distal end gathering section 223.
[0304] Also, the indwelling section 22 has the largest outer
diameter in a middle portion between the base end gathering section
222 and the distal end gathering section 223.
[0305] Preferably, the button for gastrostoma 2 is integrally
molded from synthetic resin.
[0306] The longitudinal direction ends of the plurality of these
strip-shaped pieces 221 are gathered together at the base end
gathering section 222 and the distal end gathering section 223 of
the indwelling section 22.
[0307] FIGS. 8A to 8C illustrate an obturator 3 which is used to
extend the protruding indwelling section 22 which has a diameter
enlarged radially outward of the button for gastrostoma 2 so that
the indwelling section 22 adopts a reduced-diameter state. FIG. 8A
is a side cross-sectional view (left cross-sectional view of FIG.
8B), FIG. 8B is a front view and FIG. 8C is a side view (right side
view of FIG. 3B) of the obturator 3.
[0308] Note that the obturator 3 will be described with an upper
end being a base end and a lower end being a distal end in FIGS. 8A
to 8C.
[0309] As illustrated in FIGS. 8A to 8C, the obturator 3 includes a
pushing rod for extension 31, an outer case 32, a spring 312 and a
stopper 33.
[0310] The pushing rod for extension 31 consists of an operating
section 311, a rod body 313 and a lock piece 316. A reference
numeral 317 denotes a distal section of the rod body 313 and a
reference numeral 314 denotes a reinforcing member attached to the
distal section 317 of the rod body 313. Also, a reference numeral
315 denotes a wire insertion groove (i.e., a guidewire path) formed
along the longitudinal direction of the rod body 313.
[0311] The operating section 311 is fixedly attached to the rod
body 313.
[0312] The outer case 32 includes a cylindrical portion 321, a
finger plate 322, a fitting portion 323, a groove 324, a groove
hole 325 and a lock hole 326. The finger plate 322, the fitting
portion 323, the groove 324, the groove hole 325 and the lock hole
326 are provided in the cylindrical portion 321.
[0313] The spring 312 urges the pushing rod for extension 31 in a
direction in which an amount of protrusion of the distal end distal
end (in particular, the distal end of the rod body 313) of the
pushing rod for extension 31 from a distal end of the outer case 32
is decreased. In particular, the spring 312 is a coil spring which
is placed over the rod body 313.
[0314] The rod body 313 of the pushing rod for extension 31 is
disposed inside the cylindrical portion 321 of the outer case 32 so
as to be slidable in the longitudinal direction of the outer case
32. The pushing rod for extension 31 can be moved in the
longitudinal direction thereof with respect to the outer case
32.
[0315] In this obturator 3, when an operator pushes the operating
section 311 of the rod body 313 in a direction in which the
operating section 311 is pushed into the outer case 32, the pushing
rod for extension 31 is moved along the longitudinal direction of
the outer case 32 to increase an amount of protrusion of the distal
end of the rod body 313 from the distal end of the outer case 32.
The operating section 311 the pushing rod for extension 31 fixed to
a portion (a base end: also functions as a base end of the pushing
rod for extension 31) protruding from one longitudinal end (base
end) of the outer case 32 of the rod body 313 is moved along the
longitudinal direction of the outer case 32. Thus, an amount of
protrusion of the distal end of the rod body 313 from the distal
end of the outer case 32 increases. Note that in the illustrated
example, the distal section 317 of the rod body 313 protrudes from
the distal end of the outer case 32 before the operating section
311 is pushed in (i.e., an initial state). The distal end 317,
however, does not necessarily protrude from the distal end of the
outer case 32.
[0316] In accordance with moving of the pushing rod for extension
31 with respect to the outer case 32 by pushing the operating
section 311, the lock piece 316 of the pushing rod for extension 31
moves from the groove 324 of the outer case 32, passes through the
inside of the outer case 32 and engages with the lock hole 326 of
the outer case 32. In this manner, movement of the pushing rod for
extension 31 with respect to the outer case 32 can be prevented
(this locked state will be referred to as a protruded state
hereinafter). The lock piece 316 is urged by the urging force of
the spring incorporated in the rod body 313. The lock piece 316 is
provided to protrude from a side surface of the rod body 313 and is
able to be pushed into the rod body 313.
[0317] In the protruded state, the amount of protrusion of the
distal end of the pushing rod for extension 31 (i.e., the distal
end of the rod body 313) from the distal end of outer case 32 is
maintained. When the lock piece 316 is pushed and disengaged from
the lock hole 326 of the outer case 32 in this protruded state, the
pushing rod for extension 31 moves with respect to the outer case
32 due to the urging force of the spring 312 and the lock piece 316
moves to the groove 324 from the lock hole 326 of the outer case 32
to return to the initial state. The initial state is a state in
which the amount of protrusion of the distal end of the rod body
313 from the distal end of the outer case 32 is smaller (including
a state in which the distal end of the rod body 313 does not
protrude at all) as compared with the protruded state.
[0318] The spring 312 is provided in the pushing rod for extension
31 to enable a switchover from the protruded state to the initial
state only through pushing in of the lock piece 316.
[0319] In the illustrated example, although the spring 312 is a
coil spring which is disposed over the rod body 313 at the base end
thereof and located between the operating section 311 and the base
end of the outer case 32, arrangements and configurations of the
spring 312 for enabling a switchover from the protruded state to
the initial state only through pushing in of the lock piece 316 are
not limited to those in the illustrated example.
[0320] As illustrated in FIGS. 10A and 10B, the obturator 3 is
first made to engage with the button for gastrostoma 2 in the
initial state and then adopt the protruded state. In this protruded
state, the distal section 317 of the rod body 313 presses the rod
abutting section 27 (see FIG. 7) provided in the button for
gastrostoma 2 at an inner side of the indwelling section 22 of the
distal end gathering section 223 so as to move the rod abutting
section 27 away from the base end gathering section 222. As
illustrated in FIG. 7, the rod abutting section 27 is a wall (i.e.,
a rod abutting wall) formed integrally with the distal end
gathering section 223 at a position opposite to the base end
gathering section 222 at the inside of the indwelling section 22 of
the distal end gathering section 223. In particular, in FIG. 7, the
rod abutting section 27 is formed by thickening a portion opposite
to the base end gathering section 222 at the inside of the
indwelling section 22 of the distal end gathering section 223 and
is continuous to and integral with the distal end gathering section
223.
[0321] Accordingly, when the obturator 3 engaging with the button
for gastrostoma 2 (i.e., the obturator 3 at its initial state)
adopts the protruded state, the distal end gathering section 223
and the rod abutting section 27 are moved away from the base end
gathering section 222. As a result, the indwelling section 22 of
the button for gastrostoma 2 is extended to adopt a
reduced-diameter state.
[0322] The pushing rod for extension 31 functions as a member which
is inserted in the indwelling section 22 of the gastrostomy
catheter 2 so as to press rod abutting section 27 of the indwelling
section 22, thereby extending the indwelling section 22.
[0323] The rod abutting wall 27 functions also as a reinforcing
wall which reinforces the distal end gathering section 223.
[0324] As illustrated in FIG. 7, the rod abutting section 27 is
reinforced by the reinforcing member 272. It is preferable that,
when the obturator 3 applies the extending force to the
extracorporeal section 22, the indwelling section 22 can be
introduced in the patient's body easily and reliably in its
reduced-diameter state without a risk of the distal section 317 of
the rod body 313 of the obturator 3 breaking through the distal end
gathering section 223. Reinforcement by the reinforcing member 272
is preferred also in respect of keeping a configuration of a
communication path 26 (described later) which is a small bore
formed through the rod abutting section 27 and the distal end
gathering section 223.
[0325] The reinforcing member 272 may be formed of, for example,
metal, reinforced fiber and reinforced plastic and may preferably
have a mesh structure. The reinforcing member 272 is provided
integrally with the rod abutting section 27 by, for example,
embedding into the rod abutting section 27 as illustrated to FIG.
7, or fixing (e.g., adhesion fixing) to a surface of the rod
abutting section 27 (i.e., a surface facing the distal end of the
tubular section 21 of the button for gastrostoma 2).
[0326] A meshed reinforcing member 272 is easily extendable. An
easily extendable configuration of the reinforcing member 272 is
preferable also in respect of reducing the diameter of the
indwelling section 22.
[0327] Note that the communication path 26 is formed at the distal
section of the indwelling section 22 of the button for gastrostoma
2. The communication path 26 is a bore which penetrates the rod
abutting section 27 and the distal end gathering section 223 for
drawing a guidewire 4 into the button for gastrostoma 2 from the
distal section of the indwelling section 22. The communication path
26 is formed to penetrate the rod abutting section 27 and the
distal end gathering section 223 on the central axis 21C of the
tubular section 21 (in particular, a portion on an extended line of
the central axis 21C toward the distal end).
[0328] In addition, a reference numeral 271 in FIG. 7 denotes a rod
fitting projection provided to protrude annularly around an outer
periphery of the rod abutting section 27. This rod fitting
projection 271 is formed as a ring which surrounds an opening of
the communication path 26 in the rod abutting section 27 coaxially
with the central axis 21C (in particular, a portion on an extended
line of the central axis 21C toward the distal end) of the tubular
section 21 of the button for gastrostoma 2. As illustrated in FIG.
10A, when the obturator 3 is made to fit onto the button for
gastrostoma 2, obturator 3, the distal section 317 of the rod body
313 of the obturator 3 is inserted in and fit into the inside of
the rod fitting projection 271. Thus, the rod body 313 of the
obturator 3 is aligned with the rod abutting section 27, that is,
aligned coaxially with the communication path 26.
[0329] When the obturator 3 is made to fit to the button for
gastrostoma 2, in particular, the obturator 3 is inserted in the
path 24 of the tubular section 21 of the button for gastrostoma 2
from the side of the externally fixed section 23 and then fit to
the button for gastrostoma 2.
[0330] The obturator 3 is inserted in the tubular section 21 from
the distal end thereof. When the obturator 3 is fit to the button
for gastrostoma 2, the peripheral surface of the outer case 32 is
made to contact the inner surface of the path 24 of the tubular
section 21 so that the obturator 3 is aligned with the button for
gastrostoma 2 without any backlash. The distal section of the rod
body 313 protruding from the distal end of the outer case 32 is
inserted into the indwelling section 22 via the valve 25 (see FIG.
7) provided at an indwelling section 22 side end of the tubular
section 21 and is made to abut or be disposed near the rod abutting
section 27 of the indwelling section 22.
[0331] The valve 25 is made of synthetic resin and is formed in an
elastically deformable umbrella shape which closes an end opening
of the tubular section 21 at the side of the indwelling section 22.
The valve 25 includes a slit 251 formed at the top thereof. The
distal end of the rod body 313 is pushed into the indwelling
section 22 from the path 24 of the tubular section 21 so as to
penetrate the slit 251 and is disposed coaxially with the central
axis 21C (see FIG. 7) of the tubular section 21 of the button for
gastrostoma 2. Thus, in the protruded state, the distal end of the
rod body 313 can press the rod abutting section 27 to extend the
indwelling section 22.
[0332] As illustrated in FIG. 8B, a reinforcing member 314 is
attached to the distal section 317 of the rod body 313 of the
obturator 3 which is subject to a large load at the time of
extension of the button for gastrostoma. In the illustrated
example, the reinforcing member 314 is a thin reinforcement
sleeve.
[0333] As illustrated in FIG. 11, a wire insertion groove 315 (see
FIGS. 8A, 9A and 9B) of the rod body 313 is formed along the
longitudinal direction of the rod body 313 toward the base end of
the rod body 313 from the distal end of the rod body 313. The
guidewire 4 can be inserted in this wire insertion groove 315 from
the opening at the distal end of the rod body 313.
[0334] Moreover, the wire insertion groove 315 is always visible
from the outside of the outer case 32 via a groove hole 325
provided in the outer case 32 either when the obturator 3 is
extended or when the obturator 3 is retracted. The groove hole 325
of the outer case 32 is an outlet of the guidewire 4 inserted in
the wire insertion groove 315 from the button for gastrostoma
2.
[0335] A finger plate 322 is provided to protrude from the outer
case 32. An operator can hold the obturator 3 easily with his or
her fingers with the finger plate 322.
[0336] Moreover, a fitting portion 323 for fixedly fitting the
stopper 33 which will be described later is provided on an outer
periphery of the outer case 32.
[0337] The stopper 33 can function as an anchoring member for
anchoring the button for gastrostoma 2 with respect to the
obturator 3.
[0338] The fitting portion 323 of the obturator 3 is a plurality of
(three or more) projections provided at constant intervals provided
along the longitudinal direction of the outer case 32 at both sides
of the outer case 32 of the obturator 3. A pair of arms 331 are
provided at the stopper 33 which removably engages with a fit-in
groove 323a provided between the adjacent fitting portions 323.
[0339] As illustrated in FIGS. 9A and 9B or other drawings, the
stopper 33 is formed as a square frame which includes a back plate
333, a plate-like pushed-in portion 334 and a pair of rod-shaped
arms 331. The stopper 33 is placed over the outer case 32 of the
obturator 3. The arms 331 have a function to connect the back plate
333 and the pushed-in portion 334 disposed opposite to each other
across the obturator 3 inserted in an inner space of the square
frame-shaped stopper 33.
[0340] A mounting position of the stopper 33 with respect to the
obturator 3 is determined by the arms 331 fit to any of the fit-in
groove 323a selected among the plurality of the fit-in grooves
323a. Also, the mounting position of the stopper 33 with respect to
the obturator 3 can be changed by changing the fit-in groove 323a
to which the arms 331 are made to fit.
[0341] The arms 331 which have been fitted to the fit-in groove
323a can be removed from the fit-in groove 323a by rotating the
stopper 3 with respect to the obturator 3 in the direction of the
axis of the outer case 32. As illustrated in FIGS. 9A, 9B and other
drawings, there are provided areas where no fitting portion 323 is
provided (i.e., non-fitting areas) at 90 degrees apart from areas
where the fitting portions 323 are provided (i.e., fitting areas)
about the axial direction of the outer case 32 on the outer
periphery of the outer case 32 of the obturator 3. The stopper 3
can be switched between a state in which it engages with the
obturator 3 and a state in which it disengages from the obturator 3
due to axial rotation of the outer case 32. The distance between
the back plate 333 and the pushed-in portion 334 of the stopper 33
is larger than that between a pair of arms 331. Accordingly, when
the arms 331 are in the non-fitting areas, the stopper 3 can be
slidingly moved along the longitudinal direction of the outer case
32 without interference of the back plate 333 and the pushed-in
portion 334 with the fitting portion 323. In this manner, the
fit-in groove 323a to which the arms 331 are to be fit can be
selected or changed.
[0342] In addition, the arms 331 engaging with the fit-in groove
323a of the obturator 3 can be slidingly moved along the
longitudinal direction of the arms 331 with respect to the
obturator 3 while being disposed inside the fit-in groove 323a.
That is, the obturator 3 can be slidingly moved along the
longitudinal direction of the arms 331 with respect to the stopper
33 attached to the obturator 3 with the arms 331 engaging with the
fit-in groove 323a functioning as a guide.
[0343] The back plate 333 and the pushed-in portion 334 can be used
as an operating piece which provides easy operation to cause the
stopper 33 attached to the obturator 3 to slidingly move with
respect to the obturator 3 (i.e., slidingly move in a direction
perpendicular to the longitudinal direction of the obturator
3).
[0344] With this sliding movement, the stopper 33 can make a
holding section 332 provided to protrude from the back plate 333
engage and disengage with respect to the externally fixed section
23 of the button for gastrostoma 2 engaging with the obturator
3.
[0345] The holding section 332 is a hook-shaped piece protruding
from a surface on which the arms 331 of the back plate 333 are
provided to protrude at a position separated from the arms 331 on
the back plate 333. As illustrated in FIGS. 10A, 10B and 11, when
the stopper 33 attached to the obturator 3 is slidingly moved with
respect to the obturator 3 (i.e., slidingly moved in a direction
perpendicular to the longitudinal direction of the obturator 3),
the holding section 332 is inserted in and removed from the patient
contact surface 232 side of the externally fixed section 23 of the
button for gastrostoma 2 with which the obturator 3 is engaged and
is thus engaged or disengaged with respect to the externally fixed
section 23.
[0346] In a state in which the pushed-in portion 334 of the stopper
33 abuts the outer case 32 of the obturator 3, the holding section
332 is separated from the externally fixed section 23 of the button
for gastrostoma 2 with which the obturator 3 is engaged and thus
does not anchor the button for gastrostoma 2 (i.e., a disengaged
state as illustrated in FIG. 9B). In this disengaged state, the
button for gastrostoma 2 can be slidingly moved freely along the
longitudinal direction of the outer case 32 of the obturator 3.
[0347] From this disengaged state, when the stopper is slidingly
moved with respect to the obturator 3 so that the back plate 333 is
moved close to the obturator 3, the holding section 332 is inserted
in the patient contact surface 232 side of the externally fixed
section 23 and engages with the externally fixed section 23 (a
state illustrated in FIG. 9A). The holding section 332 contacts the
patient contact surface 232 and engages with the externally fixed
section 23. Thus, the holding section 332 anchors the button for
gastrostoma 2 so as not to move toward the distal end of the
obturator 3. In this manner, when the obturator 3 engaging with the
button for gastrostoma 2 adopts the protruded state from the
initial state, the extending force from the pushing rod for
extension 31 (in detail rod body 313) can be reliably transmitted
to the indwelling section 22 while reliably keeping the indwelling
section 22 in its extended state, i.e., the reduced-diameter
state.
[0348] The obturator 3 can be assembled to the button for
gastrostoma 2 in the following manner. As illustrated in FIG. 10A,
the outer case 32 of the obturator 3 (in its initial state) is
inserted in the path 24 of the button for gastrostoma 2 for
engagement and the back plate 333 of the stopper 33 is pushed in
the direction of the pushed-in portion 334. Thus, a body surface
fixing portion 23 of the button for gastrostoma 2 is held
(anchored) by the holding section 332 of the stopper 33. When the
outer case 32 of the obturator 3 is inserted in the path 24 of the
button for gastrostoma 2, the back plate 333 of the stopper 33 is
moved away from the outer case 32 and is made to adopt the
disengaged state so that the back plate 333 does not interfere with
the externally fixed section 22 of the button for gastrostoma
2.
[0349] In this assembled state, as illustrated in FIG. 10B, the
operating section 311 of the pushing rod for extension 31 is
operated to cause the obturator 3 to adopt its protruded state and
the indwelling section 22 of the button for gastrostoma 2 is
extended.
[0350] Also, after the obturator 3 adopts the state of FIG. 10A, a
guidewire 4 is inserted through the pushing rod for extension 31 of
the obturator 3 before the obturator 3 adopts the protruded state
as illustrated in FIG. 11. The guidewire 4 is inserted through the
pushing rod for extension 31 of the obturator 3 (i.e., through a
wire insertion groove 315 of the rod body 313) via the rod abutting
section 27 of the indwelling section 22 of the gastrostomy catheter
2 and the communication path 26 (see FIG. 7) penetrating the distal
end gathering section 223. The guidewire 4 is pulled out from a
groove hole 325 of the outer case 32 in advance.
[0351] When the obturator 3 is made to engage with the button for
gastrostoma 2, an opening of the wire insertion groove 315 provided
at a distal end of the pushing rod for extension 31 of the
obturator 3, the rod abutting section 27 of the indwelling section
22 of the gastrostomy catheter 2 and the communication path 26
penetrating the distal end gathering section 223 are positioned to
communicate with one another. Thus, in the set-up state, the
guidewire 4 can be inserted easily in the pushing rod for extension
31.
[0352] FIGS. 12A to 12D illustrate an exemplary dilator (extender)
5 for forming a fistula, FIG. 12A is a front view and FIG. 12B is a
front view of a narrow-diameter dilator 52 which constitutes the
dilator. FIG. 12C is a front view illustrating a state in which a
dilator 5 is covered with the sheath for gastrostoma 1 (i.e., a
sheathed dilator 5A) with the sheath for gastrostoma 1 being
illustrated as a cross-sectional view. FIG. 12D is a
cross-sectional view of a dilator 5 covered with the sheath for
gastrostoma 1 (i.e., a sheathed dilator 5A).
[0353] Note, in FIGS. 12A to 12D, that a left side of the paper is
defined as a distal end side and a right side of the paper is
defined as a rear end side.
[0354] As illustrated in FIGS. 12A to 12D, the dilator 5 has a
narrow-diameter dilator 52 (see FIG. 10) and a large-diameter
dilator 51 which are integrated with each other (i.e., an
integrated dilator). The large-diameter dilator 51 is a cylindrical
body disposed over the narrow-diameter dilator 52 and is assembled
to the narrow-diameter dilator 52.
[0355] The narrow-diameter dilator 52 is a rod-shaped member which
includes a tapered distal section 522 (i.e., a narrow-diameter
dilator distal section 522) at the distal end thereof. The
narrow-diameter dilator 52 also includes a guidewire path 524
penetrating the same in the longitudinal direction.
[0356] The large-diameter dilator 51 includes a cylindrical
large-diameter dilator body section 511 and a tapered
large-diameter dilator distal section 512 provided to protrude from
a distal end of the large-diameter dilator body section 511. The
narrow-diameter dilator distal section 522 of the narrow-diameter
dilator 52 protrudes from the large-diameter dilator distal section
512.
[0357] Also, connectors 513 and 523 are provided in each of the
rear ends of the dilators 51 and 52. The connectors 513 and 523 fit
each other with luer taper fitting. The narrow-diameter dilator 52
is integrally assembled to the large-diameter dilator 51 through
fitting of the connectors 513 and 523.
[0358] As illustrated in FIG. 12A, a scale 514 is provided on a
peripheral surface of the large-diameter dilator body section 511.
A reference point (zero point) 5141 is provided at the
large-diameter dilator distal section 512 side. The scale is used
to measure the distance from the patient's body surface to an inner
stomach wall. After the dilator 5 is inserted, an operator
positions the reference point 5141 at the inner stomach wall and
reads the scale at the side of the patient's body surface under the
endoscope. With this measurement, the length of the tubular section
21 of the button for gastrostoma 2 can be selected.
[0359] FIG. 12C illustrates a state in which the dilator 5 is
covered with the sheath for gastrostoma 1 to provide a sheathed
dilator 5A.
[0360] The sheath for gastrostoma 1 is disposed with the distal
section thereof positioned at a distal end of the large-diameter
dilator body section 511. Although the sheath for gastrostoma 1
includes no means for positioning itself with respect to the
dilator 5, the dilator 5 may include a movement restriction means
(e.g., a projection which the base end of the sheath body 11 of the
sheath for gastrostoma 1 abuts) which restricts sliding movement of
the sheath for gastrostoma 1 toward the rear end thereof.
[0361] In addition, a tapered portion 112 (see FIG. 3B) is
preferably provided at the distal section of the sheath for
gastrostoma 1 so as to eliminate level difference between the
sheath for gastrostoma 1 and the large-diameter dilator body
section 511. With the tapered portion 112, it becomes possible to
lower insertion resistance at the time of inserting the dilator 5
with the sheath for gastrostoma 1 disposed thereon (sheathed
dilator 5A) in an abdominal wall and a stomach wall. The tapered
portion 112 can be provided by, for example, tube extension or heat
molding. Misalignment of the sheath for gastrostoma 1 with respect
to the body section 511 of the dilator 5 can be restricted by
adjusting the inner diameter of the sheath body 11 so that the
inner diameter is pressed against an outer diameter of the
large-diameter dilator body section 511.
[0362] FIG. 13 illustrates a state before the button for
gastrostoma 2 is inserted in the inner path 113 of the sheath for
gastrostoma 1. At this time, the indwelling section 22 of the
button for gastrostoma 2 has been extended to have a reduced
diameter by the obturator 3.
[0363] The inner diameter of the sheath body 11 of the sheath for
gastrostoma 1 preferably corresponds to the outer diameter of the
tubular section 21 of the button for gastrostoma 2.
[0364] However, the indwelling section 22 of the button for
gastrostoma 2 which will be left in the patient's body has the
maximum outer diameter larger than the outer diameter of the
tubular section 21 in the initial state before its diameter is
reduced and thus protrudes significantly from the tubular section
21 in a radially outward direction. Accordingly, it is often a
significant technical challenge to reduce the diameter of the
greatly protruding indwelling section 22 to the outer diameter of
the tubular section.
[0365] On the other hand, it is preferred that the inner path 113
of a diameter of the sheath for gastrostoma 1 be substantially
equivalent to the maximum outer diameter of the dilator 5. The
maximum outer diameter of the dilator 5, i.e., the outer diameter
of the large-diameter dilator body section 511, determines the size
of the fistula to be formed. It is preferred that the size of the
fistula be almost equivalent to the outer diameter of the tubular
section 21 of the button for gastrostoma 2 or larger by not less
than 1 to 2 mm.
[0366] A configuration has been considered for efficiently placing
the indwelling section 22 by lowering resistance when the
indwelling section 22 is inserted in and made to pass through the
fistula of the indwelling section 22 using the sheath 1 even if the
maximum outer diameter of the extended indwelling section 22 is
larger than the diameter of the inner path 113 of the sheath for
gastrostoma 1. In this case, since the diameter of the sheath body
11 of the sheath 1 can be made smaller than the maximum outer
diameter of the extended indwelling section 22, the size of the
fistula may also be decreased.
[0367] In this configuration, since the inner diameter of the inner
path 113 of the sheath for gastrostoma 1 is made smaller than the
maximum outer diameter of the extended indwelling section 22, the
sheath body 11 splits when a portion of the indwelling section 22
of the button for gastrostoma 2 at which outer diameter is larger
than the diameter of the inner path 113 tries to pass through the
inner path 113. It is preferred that the diameter of the inner path
113 of the sheath for gastrostoma 1 be larger than the outer
diameter of the most distal section of the indwelling section
22.
[0368] FIGS. 13 and 14 illustrate the sheath for gastrostoma 1
configured to have dimensions described above. These drawings
illustrate a state in which the button for gastrostoma 2 is
inserted in the sheath for gastrostoma 1. The sheath for
gastrostoma 1 is configured such that the sheath body 2 can
vertically split when a portion of the indwelling section 22 of the
button for gastrostoma 2 which is made to adopt an extended state
(reduced-diameter state) by the obturator 3 where the outer
diameter is larger than the diameter of the inner path 113 tries to
pass through the inner path 113. The button for gastrostoma 2
inserted in the sheath body 11 of the sheath for gastrostoma 1 has
the maximum outer diameter in the reduced-diameter state of the
indwelling section 22 which is larger than the diameter of the
inner path 113 of the sheath for gastrostoma 1.
[0369] Since the outer diameter of the most distal section (i.e.,
the distal end gathering section 223) of the indwelling section 22
is smaller than the diameter of the inner path 113 of the sheath
for gastrostoma 1, the most distal section can be easily inserted
and made to pass through the inner path 113. However, the sheath
body 11 splits when the portion of the indwelling section 22 of the
button for gastrostoma 2 having the outer diameter larger than the
diameter of the inner path 113 tries to pass through the inner path
113.
[0370] Also in the case illustrated in FIG. 14, insertion
resistance can be lowered because an inner cavity through which the
most distal section of the indwelling section 22 passes is formed
of the inner path 113 of the sheath for gastrostoma 1.
[0371] Materials for constituting the sheath body 11 are not
particularly limited, but preferably include polyethylene resin,
polypropylene resin, polytetrafluoroethylene resin (PTFE),
tetrafluoroethylene hexafluoropropylene copolymer (FEP) and
tetrafluoroethylene ethylene copolymer (ETFE). Among these,
fluoro-resin having low frictional resistance is preferably used as
the material to constitute the sheath body 11. It is therefore
possible to lower frictional resistance of the button for
gastrostoma 2 and the inner path 113 when the button for
gastrostoma 2 is inserted and made to pass through the inner path
113, thereby lowering insertion resistance of the button for
gastrostoma 2.
[0372] Examples of configurations for making the sheath body 11
split when the portion of the indwelling section 22 having the
outer diameter larger than the diameter of the inner path 113 of
the sheath for gastrostoma 1 is inserted include, but are not
limited to: a configuration in which a PTFE tube is used as the
sheath body 11 which has an orientation in the longitudinal
direction that can split vertically; a configuration which has a
sheath body 11 which is locally thinned by a cut-out groove (i.e.,
a notch section) extending along the longitudinal direction of the
sheath body 11; and a configuration in which a cut portion is
formed in advance in the sheath body 11 by a slit (i.e., notch
section) extending along the longitudinal direction of the sheath
body 11. When notch sections, such as a cut-out groove and a slit,
are formed in the sheath body 11, the sheath body 11 splits along
the entire length along the portion where the notch section is
formed when the indwelling section 22 is inserted.
[0373] In particular, FIGS. 1A, 1B, 4A to 4E, 13 and 14 illustrate
a configuration in which a notched groove 111A is formed in the
sheath body 11 as a notch section.
[0374] As illustrated in FIG. 16A, the notched groove 111A is
formed in the sheath body 11 so as not to penetrate the sheath body
11 in the thickness direction. The sheath body 11 includes an uncut
portion 111a formed by locally reducing the thickness of the sheath
body 11 at a groove bottom side of the notched groove 111A.
[0375] The uncut portion 111a fractures when the portion of the
indwelling section 22 in its reduced-diameter state having the
outer diameter larger than the diameter of the inner path 113 of
the sheath for gastrostoma 1 is inserted in the sheath body 11.
[0376] As a result of the fracture of the uncut portion 111a, the
sheath body 11 splits vertically.
[0377] In contrast, FIGS. 15A and 15B illustrate a configuration in
which a slit 111B is formed in the sheath body 11 as a notch
section.
[0378] In the configuration in which the slit 111B is formed, the
slit 111B is formed at a portion along the longitudinal direction
of the sheath body 11. An uncut portion 118 is provided on a
virtual extended line of the slit 111B where no slit 111B is
formed. The uncut portion 118 keeps the form of the sheath body 11
until the button for gastrostoma 2 is inserted in the sheath body
11 (in particular, until the portion of the indwelling section 22
having the outer diameter larger than the diameter of the inner
path 113 of the sheath for gastrostoma 1 is inserted in the sheath
body 11). In FIGS. 15A and 15B, the slit 111B is not formed at both
the longitudinal ends of the sheath body 11 and the uncut portions
118 are provided at both the longitudinal ends of the sheath body
11.
[0379] The uncut portion 118 fractures when the portion of the
indwelling section 22 in its reduced-diameter state having the
outer diameter larger than the diameter of the inner path 113 of
the sheath for gastrostoma 1 is inserted in the sheath body 11, or
alternatively, when the portion presses and deforms the portion of
the sheath body 11 where the slit 111B is formed from the side of
the inner path 113 so that the uncut portion 118 fractures from the
slit 111B. Fracture of the uncut portion 118 results in vertical
splitting of the sheath body 11.
[0380] The uncut portion 118 is not necessarily formed at both
longitudinal ends of the sheath body 11, but may be formed at one
of the longitudinal ends of the sheath body 11 along the virtual
extended line of the slit 111B. A plurality of slits 111B (i.e., a
slit array) may alternatively be formed at intervals along the
longitudinal direction of the sheath body 11. In this case, uncut
portions 118 are defined between the slits 111B which constitute
the slit array.
[0381] The length (i.e., a dimension along the longitudinal
direction of the sheath body 11) of the uncut portion 118 is 0.5 to
10 mm and preferably 1 to 5 mm.
[0382] The uncut section 118 may fracture more easily with a
cut-out groove (i.e., a notch section) provided to extend in the
longitudinal direction of the sheath body 11.
[0383] In the sheath body 11, the load applied to the inner surface
(i.e., the inner surface of the inner path 113) of the sheath body
11 is preferably not smaller than 0.5N to not greater than 5N in
order to fracture at least one of the uncut portions 111a and 118.
The load is more preferably not smaller than 0.5N to not greater
than 3N. In this case, the sheath body 11 can be split smoothly
with, for example, insertion of the indwelling section 22 in its
reduced-diameter state.
[0384] Note that the notched groove 111A is advantageous to the
slit 111B as the notch section in increased morphological stability
of the sheath body 11 and maintenance of the configuration of the
inner path 113 of the sheath body 11 when the sheath body 11 is
inserted in the fistula.
[0385] In addition, in FIG. 16B, portions of the sheath body 11
located opposite to each other over the slit 111B are disposed
close to each other and thus the slit 111B is substantially closed.
However, it is not easy to completely close the slit 111B and to
stably keep the closed state. On the contrary, the notched groove
111A is formed in the sheath body 11 so as not to penetrate the
sheath body 11 in the thickness direction while providing the uncut
portion 111a at the groove bottom side. Such a configuration has an
advantage in that, as compared with the configuration with the slit
111B, air supplied from the endoscope does not leak in the radially
outward direction of the sheath body 11 from the middle of the
inner path 113 inside the sheath body 11.
[0386] In the sheath 1 of the illustrated example, the notch
section is formed in the sheath body 11 only at one position along
a circumferential direction of the sheath body 11. However, the
invention includes a configuration in which notch sections are
formed at a plurality of positions along the circumferential
direction of the sheath body 11.
[0387] FIGS. 16A and 16B schematically illustrate an example in
which the notch section is formed only at one position along the
circumferential direction of the sheath body 11. FIG. 16A
illustrates the notched groove 111A and FIG. 16B illustrates the
slit 111B. In FIGS. 16A and 16B, the handle 12 is provided at a
position where the handle 12 does not interfere with the notch
section (i.e., the notched groove 111A or the slit 111B) in the
circumferential direction of the sheath body 11.
[0388] Accordingly, when the sheath body 11 is vertically split at
the notch section as a cutout line, the sheath body 11 is not
divided into two or more parts but remains as a single part. Thus,
there is an advantage that the entire sheath body 11 can be easily
removed from the fistula when the handle 12 is drawn.
[0389] FIG. 17 schematically illustrates an example in which the
notch sections (in illustrated example, the slits 111B) are formed
at two positions in the circumferential direction of the sheath
body 11.
[0390] The handle 12 is provided at a position where the handle 12
does not interfere with the notch sections. Here, the handle 12 is
provided at each split part of the sheath body 11 (hereinafter,
referred to as split pieces 119; in FIG. 17, the sheath body 11 is
split into two split pieces 119) when the sheath body 11 is
vertically split due to insertion of the button for gastrostoma 2.
Thus, the handle 12 is provided at each of the split pieces
119.
[0391] The sheath body 11 is denoted by a reference numeral 11B in
FIG. 17.
[0392] Note, of course, that the notched groove 111A may be
employed in place of the slit 111B.
[0393] In the case of FIG. 16, as compared with the configuration
of FIG. 17, the sheath body 11 can be drawn out of the fistula
after vertical splitting in an easier manner.
[0394] It is preferable that the notch section (the notched groove
111A and the slit 111B) be formed in a wedge-shaped cross-section
with its opening width increasing from an inner surface toward an
outer surface of the sheath body 11.
[0395] In the notch section with such a cross-section shape, as the
sheath body 11 is extended and deformed in a radially outward
direction by the indwelling section 22 inserted in the inner path
113, the cross section of the notch section is also extended. Thus,
the uncut portions 111a and 118 easily fracture from the notch
section.
[0396] The notch section can be formed through, for example, laser
processing or machining of the sheath body 11.
[0397] Laser processing is preferable because the opening width of
the notch section can be easily adjusted and a notch section with a
wedge-shaped cross-section can be easily formed through controlling
the focal position of laser.
[0398] Also, when the notch section is formed in a FEP-based sheath
body 11 (herein the sheath body 11 includes FEP as a major
component) through laser processing (especially, laser processing
with YAG laser), a portion of the sheath body 11 where the notch
section has been formed can be whitened by the laser
processing.
[0399] Thus, an easily visible mark is formed by this whitening so
that a user can easily recognize the position of the notch section.
As a result, the user can vertically split the sheath body 11
inserted in the fistula and draw out of the patient's body in an
efficient manner.
[0400] Moreover, an end surface of the sheath for gastrostoma 1 at
the side of the base end of the sheath body 11 is inclined with
respect to the axial center (i.e., the central axis C1) of the
sheath body 11.
[0401] In the sheath for gastrostoma 1 of the illustrated example,
the end surface at the side of the base end of the sheath body 11
is inclined so that the side of the lid abutting section 117 is
closer to the distal section of the sheath body 11 than the side of
the hinge section 116.
[0402] With this configuration in which the end surface of the
sheath body 11 at the side of the base end thereof is inclined with
respect to the axial center (central axis C1) of the sheath body
11, the section of the opening of the inner path 113 at the base
end of the sheath body 11 is increased substantially, which
facilitates smooth insertion of the indwelling section 22 of the
button for gastrostoma 2 in the sheath body 11 from the base end of
the sheath body 11. Especially when an indwelling section 22 with
the maximum outer diameter larger than the inner diameter of the
sheath body 11 is pushed into the sheath body 11, such an opening
section facilitates a smooth pushing operation in an efficient
manner.
[0403] Next, an exemplary usage of the sheath for gastrostoma, the
sheathed dilator and the gastrostomy catheter kit according to the
invention will be described with reference to FIGS. 18 to 28.
[0404] The gastrostomy catheter kit includes the sheath for
gastrostoma 1, the button for gastrostoma 2, the obturator 3 and
the dilator 5. The gastrostomy catheter kit will be described
later.
[0405] Before the sheath for gastrostoma 1 according to the
invention is used, an endoscope is inserted in the stomach of a
patient, i.e., a living body, and sufficient air is supplied to
make an abdominal wall 900 and a stomach wall 901 closely contact
each other (as illustrated in FIG. 18, the abdominal wall 900 and
the stomach wall 901 are not in close contact with each other
before they are made to closely contact each other). Then, the
operator confirms the stomach position with light transmitted from
the endoscope, palpates the abdomen from the body surface,
determines a position where the stomach wall is to be fixed,
disinfects the abdomen skin and applies local anesthesia.
[0406] Subsequently, the operator fixes the abdominal wall 900 and
the stomach wall 901 together with a suture using a device for
fixing the stomach wall and the abdominal wall (see FIG. 19).
[0407] The abdominal wall 900 and the stomach wall 901 should be
fixed together with a suture usually at two points so as to provide
a site for catheter gastrostomy as a plane in the later step.
[0408] After the stomach wall and the abdominal wall are fixed
together, a cannula needle is inserted in the abdominal wall and
the stomach wall from the body surface to leave the guidewire
4.
[0409] The dilator 5 is inserted through the guidewire 4 which is
left in the patient's body (i.e., the guidewire 4 is made to pass
through the guidewire path 524 of the dilator 5). The dilator 5
with the sheath for gastrostoma 1 disposed thereon (sheathed
dilator 5A) is inserted in the abdominal wall and the stomach wall
from the body surface to form a one-stage fistula (see FIG. 21). At
this time, the dilator is inserted while being twisted to provide
safe extension.
[0410] In addition, when the dilator 5 is inserted in the abdominal
wall and the stomach wall to form the fistula, the operator
positions the reference point 5141 of the scale 514 (see FIG. 12A)
on the peripheral surface of the large-diameter dilator body
section 511 at the stomach wall surface (inner surface) and reads
the scale provided on the body surface side so as to measure the
distance from the body surface to the stomach wall inner surface
under the endoscope. With this measurement, the length of the
tubular section 21 of the button for gastrostoma 2 can be selected.
A position of the stopper 33 of the obturator 3 (i.e., a position
at which the stopper 33 is mounted along the longitudinal direction
of the outer case 32) is determined in accordance with the
selection of the tube 21.
[0411] The length of a portion of the obturator 3 inserted into the
tubular section 21 is determined in accordance with the length of
the tubular section 21 of the button for gastrostoma 2. Adjustment
of the mounting position of the stopper 33 in the longitudinal
direction of the outer case 32 enables the extension force to be
reliably applied by the obturator 3 to the indwelling section 22 of
the button for gastrostoma 2 anchored by the stopper 33. The
mounting position of the stopper 33 in the longitudinal direction
of the outer case 32 is selected by selectively engaging the arm
331 of the stopper 33 with the plurality of fitting portions 323
and the plurality of fit-in grooves 323a provided along the
longitudinal direction of the outer case 32.
[0412] In order to provide easy reading of the scale 514 of the
dilator 5, the sheath body 11 may preferably have transparency that
enables the scale 514 of the dilator 5 to be viewed from
outside.
[0413] When extension is completed, the dilator 5 and the guidewire
4 are removed from the body while leaving the sheath for
gastrostoma 1 (see FIG. 22).
[0414] When the dilator 5 is removed from the sheath for
gastrostoma 1, the lid 13 of the sheath for gastrostoma 1 closes to
block the inner path 113. The lid 13 comes to the closed position
due to elasticity of the hinge section 116 as described above. The
inner path 113 may also be closed with air itself supplied into the
stomach from the endoscope.
[0415] Thus, leakage of the air supplied from the endoscope outside
of the body can be reduced.
[0416] Then, the operator grasps the handle 12 to open the lid 13
of the sheath for gastrostoma and inserts the button for
gastrostoma 2 of which indwelling section 22 has been extended with
the obturator 3 in the inner path 113 of the sheath for gastrostoma
(see FIG. 23).
[0417] Since the sheath for gastrostoma 1 is provided with a means
which splits along the longitudinal direction, the sheath body 11
is split in the longitudinal direction and is developed when a
portion of the extended indwelling section 22 of the button for
gastrostoma 2 having the outer diameter larger than the inner
diameter of the sheath for gastrostoma 1 is inserted in the sheath
body 11. The button for gastrostoma 2 makes its indwelling section
22 pass through the sheath 1 to reach the stomach, where the
indwelling section 22 is left (see FIG. 24).
[0418] In addition, when the button for gastrostoma 2 extended with
the obturator 3 is inserted, the most distal section of the
indwelling section 22 can be inserted smoothly with lowered
insertion resistance since an insertion route is established in the
inner path 113 of the sheath for gastrostoma 1.
[0419] After the button for gastrostoma 2 is placed in the stomach,
the sheath for gastrostoma 1 is removed from the body in a state in
which the button for gastrostoma 2 is still extended with the
obturator 3 (FIG. 25).
[0420] The operator pushes the pushed-in portion 334 of the stopper
33 attached to the obturator 3 toward the back plate 333 so that
the arms 331 are slid to cancel the extension of the indwelling
section of the button for gastrostoma 2 (see FIG. 26).
[0421] Then, the operator withdraws the obturator 3 disposed on the
button for gastrostoma 2 (see FIG. 27) and places the cap 28
attached to the externally fixed section 23 of the button for
gastrostoma 2 so as to block the path 24. In this manner, leaving
the button for gastrostoma 2 in the patient's body is completed
(see FIG. 28).
[0422] As described above, usage of the sheath for gastrostoma 1
according to the invention lowers insertion resistance during
insertion of the button for gastrostoma 2 and enables easy control
of the endoscope regarding air supply during gastrostomy.
[0423] Also, the sheath body 11 of the sheath for gastrostoma may
be formed of a deformable material and thus expandable radially
(see FIG. 29). At the time of insertion of the button for
gastrostoma, if the outer diameter of the indwelling section of the
button for gastrostoma 2 of which the indwelling section 22 has
been extended with the obturator 3 is larger than the inner
diameter of the sheath body 11, the sheath body 11 is expanded
radially in accordance with the configuration of the indwelling
section 22 (see FIG. 30).
[0424] Examples of the material of the sheath body 11 in this case
include plastic materials or elastomeric materials, such as
polyurethane resin, tetrafluoroethylene and fluorinated ethylene
propylene.
[0425] In addition, the sheath body 11 may be formed as a braided
product in which inelastic filaments, such as polyamide fiber and
stainless steel, are braided to provide a mesh structure. In this
case, the braided product which constitutes the sheath body 11 may,
for example, also be constituted so that the radial extension of
the sheath body 11 may shorten the sheath body 11 in the axial
direction thereof.
[0426] As described above, with the sheath body 11 made of a
radially expandable material, insertion resistance of the button
for gastrostoma 2 can be lowered when the button for gastrostoma 2
is inserted in the inner path 113 of the sheath body 11.
[0427] In addition, the sheath body 11 made of a radially
expandable material may preferably be provided with a configuration
with which the sheath body 11 can be split vertically. For example,
a fine wire (i.e., a wire for vertical splitting including a high
tension fiber, such as polyamide fiber) is embedded along the
entire axial direction length of the sheath body 11 which is made
of the plastic material or the elastomeric material described
above. When the operator pulls strongly an end of the wire for
vertical splitting which has been made to extend toward the base
end of the sheath body 11, the wire for vertical splitting is
removed from the sheath body 11. Then, a thin-walled section for
vertical splitting is formed in the sheath body 11. With this
configuration, the sheath body 11 can be easily split vertically.
In this case, for example, when the operator pulls the wire for
vertical splitting from the sheath body 11 to make the sheath body
11 vertically split after the indwelling section 22 of the button
for gastrostoma 2 is made to pass, from outside of the body,
through the sheath body 11 which has been inserted in the fistula,
the sheath body 11 can be removed from the fistula while leaving
the button for gastrostoma 2 in the body.
(Another Embodiment of Sheath for Gastrostoma)
[0428] As illustrated in FIGS. 31A, 31B and 32A to 32E, the sheath
for gastrostoma according to the invention may employ a
configuration in which a lid 63 is pivotably provided in a handle
61 via a hinge section 62 (hereinafter, also referred to as a lid
hinge section) which is provided separately from a hinge 116.
[0429] A sheath for gastrostoma 6 illustrated in FIGS. 31A and 31B
has a schematic structure which includes a sheath body 11 (sheath
tube), the handle 61, the lid hinge section 62 and the lid 63.
[0430] The handle 61 extends from the base end of the sheath body
11 of the sheath for gastrostoma 6 as a tongue-shaped piece. The
handle 61 may be used by an operator who grasps the sheath for
gastrostoma 6 when inserting the button for gastrostoma in the
sheath for gastrostoma 6.
[0431] This handle 61 is configured by fixing a pair of plate-like
handle members 611 and 612 to a tongue-shaped handle main piece 114
which extends from the base end of the sheath body 11. The pair of
handle members 611 and 612 is attached integrally with the handle
main piece 114 so as to sandwich the handle main piece 114
therebetween.
[0432] In addition, the sheath for gastrostoma 6 of the illustrated
example includes a synthetic resin-made elongated plate lid member
64 in which the lid hinge section 62 and the lid 63 are formed.
This elongated plate lid member 64 is integrally molded from
synthetic resin as one component. This elongated plate lid member
64 is formed of a material with rubber elasticity, such as silicone
rubber and elastomer.
[0433] This elongated plate lid member 64 has a mounting section
641 via the lid hinge section 62 at a side opposite to the lid 63
and is integral with the handle 61 with the mounting section 641
fixed to the handle 61. A portion of the elongated plate lid member
64 further toward the lid 63 from the mounting section 641 is
formed as a tongue-shaped piece extending from the handle 61 and
inserted in the sheath body 11.
[0434] The lid 63 is disposed in the inner path 113 of the sheath
body 11 and is elastically supported at a closed position (i.e., a
position illustrated in FIG. 31B) at which the lid 63 closes the
inner path 113 due to elasticity of the elongated plate lid member
64 itself.
[0435] In particular, the handle 61 has a configuration in which
the plate-like mounting section 641 and the handle main piece 114
of the elongated plate lid member 64 are sandwiched between and
integrally fixed to the pair of handle members 611 and 612.
[0436] Examples of a method (configuration) for sandwiching and
integrally fixing the mounting section 641 and the handle main
piece 114 of the elongated plate lid member 64 between the pair of
handle members 611 and 612 (i.e., the lid side handle member 611
and the main piece side handle member 612) include the following
configurations: a configuration in which the other handle member is
engaged by one handle member by an engaging pawl provided to
protrude from one or both of the pair of handle members 611 and 612
and the mounting section 641 and the handle main piece 114 of the
elongated plate lid member 64 are sandwiched between and fixed to
the pair of handle members; and a configuration in which the pair
of handle members 611 and 612, the mounting section 641 of the
elongated plate lid member 64 and the handle main piece 114 are
made to integrally adhere together using an adhesive.
[0437] Also, the pair of handle members 611 and 612, the mounting
section 641 of the elongated plate lid member 64 and the handle
main piece 114 may be integrally bundled together using a bundling
member for bundling the mounting section 641 of the elongated plate
lid member 64 and the handle main piece 114. The bundling member is
not particularly limited as long as it can bundle the mounting
section 641 of the elongated plate lid member 64 and the handle
main piece 114 together (i.e., it can integrate the mounting
section 641 of the elongated plate lid member 64 and the handle
main piece 114 together so that no relative misalignment may
occur). For example, a configuration in which a heat-shrinkable
tube is used and the mounting section 641 of the elongated plate
lid member 64 and the handle main piece 114 are integrally bundled
together through heat shrinking of this heat-shrinkable tube.
[0438] Note that the pair of handle members 611 and 612 may be
provided separately from each other or may be provided integrally
with each other.
[0439] In addition, it suffices that the mounting section 641 be
integrally fixed to the handle 61 to form a tongue-shaped portion
of which the portion of the elongated plate lid member 64 further
toward the lid 63 from the mounting section 641 is extended from
the handle 61 and inserted in the sheath body 11. The position at
which the mounting section 641 is fixed to the handle 61 is not
necessarily between the pair of handle members 611 and 612.
[0440] Moreover, the handle does not necessarily include a
plate-like handle member. A configuration may be employed in which,
for example, the handle includes no handle member but is
constituted by the handle main piece 114 and the mounting section
641 of the elongated plate lid member 64.
[0441] As illustrated in FIG. 31B, the distal end of the lid 63 is
made to abut or be disposed close to the inner wall surface of the
sheath body 11 at the side opposite to the handle 61 across the
inner path 113.
[0442] The lid hinge section 62 is provided at the base end side of
the lid 63 and is formed as a tongue-shaped portion extending from
the handle 61 of the elongated plate lid member 64.
[0443] The lid 63 extends in a manner inclined from the lid hinge
section 62 toward the distal end of the sheath body 11 at an angle
of smaller than 90 degrees with respect to the axial center
(central axis C1) of the sheath body 11. The lid 63 is elastically
supported with elasticity of the lid hinge section 62 and the
distal end of the lid 63 is made to abut or be disposed close to
the inner wall surface of the sheath body 11 at the side opposite
to the handle 61 across the inner path 113.
[0444] The lid 63 is supported to be pivotable about the lid hinge
section 62 along an axis extending perpendicular to the axial
center of the sheath body 11 (i.e., an axis parallel to the pivot
axis of the hinge section 116). When the lid 63 is pivoted
clockwise from the closed position illustrated in FIG. 31B (i.e.,
pivoted toward an opening direction) to open the inner path 113 of
the sheath body 11. The lid 63 pivoted from the closed position in
the open direction by external force applied by, for example,
insertion of a device, such as the dilator 5, into the sheath body
11 returns to the closed position with the elasticity of the lid
hinge section 62 when the external force acting as displacement
force in the open direction is eliminated by, for example,
withdrawal of the dilator 5, which had been inserted in the sheath
body 11, from the sheath body 11.
[0445] Also, pivotation of the lid 63 in a direction opposite to
the direction from the closed position in the open direction, i.e.,
counterclockwise pivotation from the closed position in FIG. 31B,
is restricted by the distal end abutting the sheath body 11. Thus,
the lid 63 can be kept in a state which closes the inner path 113
of the sheath body 11. When, for example, the handle 61 is pivoted
counterclockwise about the hinge section 116 in FIG. 31B and
pivoting force in a direction opposite to the open direction is
applied to the lid 63 located at its closed position, pivotation of
the lid 63 abutting the sheath body 11 is restricted and the lid
hinge section 62 is elastically deformed. Thus, in this sheath for
gastrostoma 6, a state can be kept in which the lid 63 closes the
inner path 113 of the sheath body 11 when the pivoting force in a
direction opposite to the open direction is applied to the lid 63.
Accordingly, there is an advantage that outflow of air supplied
from endoscope in the stomach can be avoided.
[0446] The distal end of the lid 63 is pressed against the sheath
body 11 when the lid is pivoted from the closed direction toward
the direction opposite to the open direction.
[0447] Hereinafter, a portion of the sheath body 11 where the
distal end of the lid 63 is made to abut will be referred to as a
lid abutting section (denoted by a reference numeral 117a).
[0448] The hinge section 116 and the lid hinge section 62 are
provided in the sheath body 11 at a side opposite to the lid
abutting section 117a across the inner path 113. The distal end of
the lid 63 is made to abut the lid abutting section 117a from the
direction of the distal end of the sheath body 11 when the lid 63
is pivoted from the closed direction in the open direction.
[0449] The lid hinge section 62 and a stopper projection piece 642
are formed between the mounting section 641 of the elongated plate
lid member 64 and the lid 63.
[0450] The stopper projection piece 642 is formed as a projecting
piece extending from the handle 61 and inserted in the sheath body
11 and is disposed along an inner surface of the sheath body 11 at
a side opposite to the lid abutting section 117a across the inner
path 113. In particular, the stopper projection piece 642 is made
to abut or be disposed close to the inner surface of the expanded
section 115 formed in the sheath body 11.
[0451] The lid hinge section 62 is provided at a distal end of the
stopper projection piece 642 in a direction in which the stopper
projection piece 642 protrudes from the handle 61. The lid 63
extends from the distal end of the stopper projection piece 642 in
a direction in which the stopper projection piece 642 protrudes
from the handle 61 in a manner inclined toward the distal end of
the sheath body 11 at an angle of smaller than 90 degrees with
respect to the axial center (central axis C1) of the sheath body
11. The lid hinge section 62 is located in a connecting section at
which the stopper projection piece 642 and the lid 63 continue to
each other. The lid hinge section 62 corresponds to a bending
section at which the elongated plate member 64 is formed to be
bent.
[0452] When force is applied to the lid 63 to pivot the same from
the closed position in the open direction, pivotation of the lid 63
with respect to the sheath body 11 is restricted by the stopper
projection piece 642 being pressed against the inner surface of the
sheath body 11. Pivotation of the lid 63 from the closed position
in the open direction is allowed due to elastic deformation of the
lid hinge section 62.
[0453] At this time, pivotation of the handle 61 following the lid
63 can be restricted by the stopper projection piece 642 which is
not pivoted even when the lid 63 is pivoted from the closed
position in the open direction due to elastic deformation of the
lid hinge section 62. Thus, since the position of the handle 61
with respect to the sheath body 11 is stabilized, failure of a user
of this sheath for gastrostoma 6 to grasp the handle 61 with the
fingers occurs less often, thereby securing good workability. That
is, the configuration of this sheath for gastrostoma 6 is that,
when the handle 61 is pivoted clockwise in FIG. 31B about the hinge
section 116, the stopper projection piece 642 is pressed against
the inner wall surface of the sheath body 11 and pivotation is
restricted. Thus, pivotation of the lid 63 from the closed position
in the open direction is restricted to keep the state in which the
inner path 113 of the sheath body 11 is closed.
[0454] That is, the sheath for gastrostoma 6 is less often affected
by the pivotation of the handle 61 about the hinge section 116 in
the state in which the lid 63 is disposed at the closed position
and the lid 63 is elastically supported at the closed position with
the elasticity of the lid hinge section 62 in the state in which no
external force is applied to the handle 61 or the elongated plate
lid member 64. Thus, in the event that the user of the sheath for
gastrostoma 6 inadvertently touches the handle 61, the lid 63 is
not easily pivoted in the open direction and, even when being
pivoted in the open direction, the lid 63 returns to its closed
position immediately. Accordingly, the state in which the lid 63
closes the inner path 113 of the sheath body 11 can be stably
continued.
[0455] In addition, the stopper projection piece 642 formed of a
material with rubber elasticity, such as silicone rubber and
elastomer, is disposed between the handle 61 and the lid hinge
section 62. When the handle 61 is pivoted, the stopper projection
piece 642 elastically deforms so that following displacement of the
lid hinge section 62 or the lid 63 with respect to the handle 61
occurs less often. This configuration also contributes to
effectively maintaining the state in which the lid 63 closes the
inner path 113 of the sheath body 11.
[0456] Note that any materials can be used for the elongated plate
lid member 64 as long as they provide the lid hinge section 62 with
elasticity that allows the lid 63 to pivot from the closed position
(the position illustrated in FIGS. 31A and 31B) to a position at
which the lid 63 touches the inner surface of the sheath body 11 at
a side opposite to the lid abutting section 117a, and allows the
lid 63 to return to the closed position from position at which the
lid 63 touches the inner surface of the sheath body 11 at a side
opposite to the lid abutting section 117a. Such materials are not
limited to materials with rubber elasticity, such as silicone
rubber and elastomer described above, but various synthetic resin
materials can be employed. For example, materials that can be used
for forming the sheath body 11 may also be employed as the
materials of the elongated plate lid member 64.
[0457] In the sheath for gastrostoma according to the invention,
for example, in the elongated plate lid member, the lid hinge
section and the lid may be formed integrally with each other from a
material with rubber elasticity, such as silicone rubber and
elastomer. Alternatively, only the lid hinge section may be formed
of a material with rubber elasticity, such as silicone rubber and
elastomer, and other portions may be formed of a hard material with
no rubber elasticity, such as rigid resin or metal.
[0458] The sheath for gastrostoma 6 described here may also be used
in an operation to form a fistula (gastrostomy) and place the
button for gastrostoma 2 in the patient's body as in the sheath for
gastrostoma described above with reference to FIGS. 1A and 1B.
[0459] As in the sheath for gastrostoma described above, the
dilator 5 may be inserted in the sheath body 11 to provide a
sheathed dilator (see FIG. 39).
[0460] In addition, as described above, in the sheath for
gastrostoma 6, the lid 63 is pivoted from the closed position in
the open direction when the dilator 5 is inserted in the sheath
body 11, and the lid 63 pivoted from the closed position in the
open direction returns to the closed position with the elasticity
of the lid hinge section 62 when the dilator 5 inserted in sheath
body 11 is removed from the sheath body 11 to close the inner path
113 of the sheath body 11. Since it is possible to prevent outflow
of air supplied into the stomach from an endoscope in the state in
which the sheath for gastrostoma 6 is inserted in the fistula, the
sheath for gastrostoma 6 can be suitably used in an operation for
forming a fistula and placing the button for gastrostoma 2 in the
patient's body and in an operation for replacing the button for
gastrostoma 2 placed in the patient's body.
[0461] Here, a procedure of replacing the button for gastrostoma 2
placed in the patient's body using the sheath for gastrostoma 6
will be described.
[0462] FIG. 33 illustrates the button for gastrostoma 2 placed in
the patient's body.
[0463] In order to replace the button for gastrostoma 2, as
illustrated in FIG. 34, the cap 28 fitted into the opening of the
path 24 of the button for gastrostoma 2 at the side of the
externally fixed section 23 is removed from the opening of the path
24 to release the opening of the path 24. Then, as illustrated in
FIG. 35, the obturator 3 is inserted in the path 24 from outside of
the body and placed in the button for gastrostoma 2 (i.e., the
distal section 317 of the pushing rod for extension 31, i.e., the
distal end of the outer case 32 is inserted in the path 24 of the
button for gastrostoma 2 and the stopper 33 (in particular, the
holding section 332) is engaged by the externally fixed section 23
of the button for gastrostoma 2). A guidewire 4 is inserted through
the path 24 in the tubular section 21 of the button for gastrostoma
2 to reach the stomach from outside of the body using the wire
insertion groove 315 of the obturator 3 as illustrated in FIG. 36.
Subsequently, as illustrated in FIG. 37, the obturator 3 is
operated so that the indwelling section 22 of the button for
gastrostoma 2 is extended (i.e., reduced in diameter) and the
obturator 3 and the button for gastrostoma 2 are removed from the
fistula to the outside of the body together (see FIG. 38). As
illustrated in FIG. 38, the guidewire 4 is left in the patient's
body.
[0464] Then, as illustrated in FIG. 40, the sheath for gastrostoma
6 is inserted in the fistula and placed in the patient's body.
[0465] At this time, as illustrated in FIG. 39, it is preferable
to, for example, insert a sheath insertion aid 7 having a
rod-shaped appearance in the sheath body 11 to assemble a sheath
for gastrostoma with an insertion aid 70 (hereinafter, also
referred to as a sheath with insertion aid). The sheath with
insertion aid 70 is inserted in the fistula and then the sheath for
gastrostoma 6 is inserted in the fistula for placement of the
button for gastrostoma 2.
[0466] The sheath insertion aid 7 includes a rod-shaped body 71 and
a tapered distal section 72 having a tapering configuration
provided to protrude from one longitudinal end (distal end) of the
rod-shaped body. In the sheath insertion aid 7, an outer diameter
of the rod-shaped body 71 is equivalent to or slightly smaller than
the inner diameter of the sheath body 11 and thus the sheath
insertion aid 7 can be removably inserted in the sheath body 11.
This sheath insertion aid 7 includes a guidewire insertion hole 73
to penetrate the same in the longitudinal direction. The guidewire
4 is inserted in the guidewire insertion hole 73 so that the sheath
insertion aid 7 is disposed outside of the guidewire 4. One of both
ends of the guidewire insertion hole 73 opens at a distal end of
the tapered distal section 72 of the sheath insertion aid 7 and the
other opens at an end (rear end) of the rod-shaped body 71 at the
side opposite to the tapered distal section 72.
[0467] As illustrated in FIG. 39, the procedure of inserting the
sheath for gastrostoma 6 in the fistula using the sheath with
insertion aid 70 and leaving in the patient's body is as follows.
First, a portion of the guidewire 4 placed in the patient's body
extending from the fistula toward outside of the body is inserted
in the guidewire insertion hole 73 of the sheath insertion aid 7
and the sheath insertion aid 7 and the entire sheath with insertion
aid 70 are disposed outside of the guidewire 4. After the sheath
with insertion aid 70 is inserted in the fistula with the guidewire
4 as a guidance member, the sheath insertion aid 7 is removed
outside of the body while leaving the sheath for gastrostoma 6 in
the fistula, as illustrated in FIG. 40.
[0468] The sheath with insertion aid 70 is assembled by inserting
the sheath insertion aid 7 in the opening at the side of the base
end of the sheath body 11 of the sheath for gastrostoma 6 from the
distal end and then making the tapered distal section 72 of the
sheath insertion aid 7 protrude from the distal end of the sheath
body 11. By making the tapered distal section 72 protrude from the
distal end of the sheath body 11, insertion resistance at the time
of inserting the sheath with insertion aid 70 in the fistula
(inserting from the tapered distal section 72 side) can be lowered
and insertion can be performed smoothly. The tapered distal section
72 also has a function to extend the fistula when the sheath with
insertion aid 70 is inserted in the fistula.
[0469] It suffices that the sheath insertion aid 7 have a function
to facilitate the procedure of inserting the sheath for gastrostoma
6 and the entire sheath with the insertion aid 70 in the fistula
and extend the fistula, and thus the sheath insertion aid 7 does
not necessarily have a function to form a new fistula. However, the
sheath insertion aid 7 may also be used for fistulization. In this
case, the dilator described above may be used as a sheath insertion
aid 7.
[0470] In the sheath with insertion aid 70 in which the sheath
insertion aid 7 is inserted in the sheath for gastrostoma 6, as
illustrated in FIG. 39, the lid 63 of the sheath for gastrostoma 6
is moved from the closed position in the open direction by the
sheath insertion aid 7 inserted in the sheath body 11 and is housed
in the expanded section 115 (inside the inner space 115a) at the
base end of the sheath body 11. As illustrated in FIG. 40,
immediately after the sheath insertion aid 7 is removed from the
sheath for gastrostoma 6, the lid 63 returns to the closed position
with the elasticity of the lid hinge section 62. That is, when the
sheath insertion aid 7 is removed from the sheath for gastrostoma 6
of the sheath with insertion aid 70 inserted in the fistula, the
lid 63 closes the inner path 113 of the sheath body 11
automatically with no operation of the handle 61, thereby
preventing ingression of foreign object into the inner path 113.
When an endoscope is used, there is an advantage that outflow of
air supplied from the endoscope to the stomach can be avoided.
[0471] The following configurations can be commonly applied to the
sheath for gastrostoma of each embodiment according to the
invention: a configuration with a sheath body 11 in which the
sheath insertion aid 7 can be inserted; and a configuration in
which the sheath with insertion aid 70 can be assembled by
inserting the sheath insertion aid 7 in the sheath body.
[0472] As illustrated in FIG. 31B, it is noted that the distal
section (a bottom section in FIG. 31B) of the sheath body 11 of the
sheath for gastrostoma 6 is formed as a tapered distal end 11a
which is tapered from the sheath body 11 to reduce its diameter.
The inner diameter of the distal end of the tapered distal end 11a,
i.e., the minimum inner diameter of the tapered distal end 11a, is
substantially equivalent to the outer diameter of the sheath
insertion aid 7.
[0473] This tapered distal end 11a has a function to avoid the
formation of a level difference resulting from a difference between
the outer diameter of the sheath insertion aid 7 and the inner
diameter of the sheath body 11 inserted in the sheath body 11 and
to smoothly insert the sheath body 11 of the sheath for gastrostoma
6 in the fistula. The configuration providing a tapered distal end
11a at the distal section of the sheath body 11 can be commonly
applied to each embodiment according to the invention.
[0474] Next, the obturator 3 is assembled to and disposed in the
button for gastrostoma 2 for a fistula to be newly formed as
illustrated in FIG. 41. The operating section 311 of the obturator
3 is operated (i.e., pushed) to extend (i.e., reduce in diameter)
the in-body fixing portion 23 of the button for gastrostoma 2. The
button for gastrostoma 2, while keeping a state in which the
in-body fixing portion 23 is extended, is inserted in the inner
path 113 of the sheath body 11 of the sheath for gastrostoma 6
placed in the fistula from the in-body fixing portion 23. Then, the
in-body fixing portion 23 is made to protrude inside the patient's
body from the sheath for gastrostoma 6 (see FIG. 42).
[0475] Then, in the same manner as described above with reference
to FIGS. 25 to 28, the sheath for gastrostoma 6 is removed from the
patient's body, the in-body fixing portion 23 is stopped to advance
(i.e., extend) and the obturator 3 is removed outside of the
patient's body. In this manner, placement of the button for
gastrostoma 2 for newly provided fistula in the patient's body is
completed.
[0476] In the replacement of the button for gastrostoma 2 using the
sheath for gastrostoma 6, as described above, when the sheath
insertion aid 7 is removed from the sheath for gastrostoma 6 of the
sheath with insertion aid 70 inserted in the fistula, a state can
be obtained in which the lid 63 closes the inner path 113 of the
sheath body 11 automatically without requiring operation of the
handle 61. Thus, time and effort to close the inner path 113 can be
omitted.
[0477] When the sheath insertion aid 7 is withdrawn from the sheath
for gastrostoma 6 of the sheath with insertion aid 70 inserted in
the fistula, a state can be obtained in which the lid 63 closes the
inner path 113 of the sheath body 11 automatically without
requiring operation of the handle 61. Thus, outflow of air supplied
to the stomach from the endoscope can be prevented. Such an
advantage is not limited to replacement of the button for
gastrostoma 2 but may be provided in new gastrostomy. Gastrostomy
using the sheath for gastrostoma 6 is achieved by using the sheath
for gastrostoma 6 in place of the sheath for gastrostoma 1 in
gastrostomy described with reference to FIGS. 18 to 28.
[0478] In addition, replacement of the button for gastrostoma 2
described with reference to FIGS. 34 to 42 can also be carried out
using the sheath for gastrostoma 1 described with reference to
FIGS. 1A and 1B.
[0479] Using the sheath for gastrostoma (sheath for gastrostoma
according to the invention) in replacement of the button for
gastrostoma 2 has an advantage that insertion resistance at the
time of insertion of the button for gastrostoma 2 (sheath for
gastrostoma for replacement) can be lowered.
[0480] As illustrated in FIG. 43, the sheath for gastrostoma
according to the invention may have a configuration in which an
elongated plate lid member 64A configured by omitting the stopper
projection piece 642 from the elongated plate lid member 64 as
described above (sheath for gastrostoma 6A).
[0481] The handle 61 can be configured the same as that of the
sheath for gastrostoma 6 as described above. The sheath for
gastrostoma 6A has a configuration in which the lid 63 is
elastically supported with elasticity of the hinge section 116 and
elasticity of the lid hinge section 62 at a closed position at
which the lid 63 closes the inner path 113 of the sheath body
11.
[0482] The lid 63 is formed as a tongue-shaped piece extending from
the lid hinge section 62 and inserted in the sheath body 11. The
lid 63 extends in a manner inclined toward the distal end of the
sheath body 11 at an angle of smaller than 90 degrees with respect
to the central axis C1 of the sheath body 11.
[0483] The distal end of the lid 63 is made to abut against a
portion of the sheath body 11 at the side opposite to the hinge
section 116 and the lid hinge section 62 across the inner path 113
when the lid 63 is pivoted from the closed position to the
direction opposite to the open direction. Hereinafter, a portion of
the sheath body 11 where the distal end of the lid 63 is made to
abut will be referred to as a lid abutting section which is denoted
by a reference numeral 117b. The hinge section 116 and the lid
hinge section 62 are located at the side opposite to the lid
abutting section 117b across the inner path 113.
[0484] The lid 63 can be pivoted toward the open direction against
elasticity of the hinge section 116 and the lid hinge section 62
(i.e., pivoted in the direction in which the lid 63 is moved away
from the lid abutting section 117b, i.e., clockwise in FIG. 43) and
can return the closed position with elasticity of the hinge section
116 and the lid hinge section 62 from its pivoted position.
[0485] With this sheath for gastrostoma 6A, in a state in which,
for example, a user of the sheath for gastrostoma 6A does not grasp
the handle 61 with fingers and thus no external force is applied to
the handle 61 and the lid 63, the lid 63 is elastically supported
at the closed position (i.e., a position illustrated in FIG. 43)
with the elasticity of the hinge section 116 and the lid hinge
section 62.
[0486] Also, the lid hinge section 62 is configured to undergo
elastic deformation (bending deformation) with smaller force than
the hinge section 116 requires. Thus, with the sheath for
gastrostoma 6A, elastic deformation of the lid hinge section 62
enables pivoting operation of the handle 61 freely regardless of
the position of the lid 63. If, in the configuration of FIG. 43, no
lid hinge section 62 is provided and the lid 63 is pivoted
integrally with the handle 61, pivotation of the handle 61 in the
counterclockwise direction in FIG. 43 is restricted when the lid 63
is abutting the lid abutting section 117b. Thus, the orientation of
the handle 61 with respect to the sheath body 11 is restrained. On
the contrary, in a configuration in which the lid hinge section 62
is provided as described above, the handle 61 can be pivoted
counterclockwise in FIG. 43 (a position denoted by a reference
numeral 61 of imaginary line in FIG. 43: hereinafter, also referred
to as a "retracted position") even if the lid 63 is abutting the
lid abutting section 117b. Accordingly, a greater degree of freedom
of an angle (orientation) of the handle 61 with respect to the
sheath body 11 is provided. Thus, the handle 61 can, for example,
be kept at a desired orientation during insertion of the button for
gastrostoma 2, thereby improving insertion operability of the
button for gastrostoma 2. When, for example, the handle 61 is
disposed at the retracted position, interference of the fingers
which are grasping the handle 61 with the button for gastrostoma 2
to be inserted in the sheath body 11 can be avoided and thus
interference of the inserting operation can be avoided.
[0487] The lid hinge section provides an increased degree of
freedom of angle (orientation) of the handle 61 with respect to the
sheath body 11 also in the sheath for gastrostoma 6 described with
reference to FIG. 31.
[0488] Also, although the position of the lid hinge section 62 is
near the hinge section 116, the lid hinge section 62 is provided
separately from the hinge section 116. Thus, the lid 63 can be
pivoted due to elastic deformation of the lid hinge section 62 when
the handle 61 does not pivot about the hinge section 116.
Accordingly, when the lid 63 is pivoted in the open direction by
the sheath insertion aid 7 inserted in the inner path 113 of the
sheath body 11 of the sheath for gastrostoma 6A, for example,
following pivotation of the handle 61 to the lid 63 can be
prevented. Thus, since change in the position of the handle 61
accompanying pivotation of the lid 63 can be prevented, failure of
a user of the sheath for gastrostoma 6A to grasp the handle 61 with
the fingers occurs less often, thereby securing good
workability.
[0489] As illustrated in FIGS. 44A and 44B, the sheath for
gastrostoma according to the invention employs a sheath body 15
which includes a V-shaped distal notch section 151 configured to
recess from an end surface at the base end of the sheath body 11
and a notched groove 111A formed to extend in the longitudinal
direction (axial center direction) of the sheath body 11 from a
depth section 152 of the distal notch section 151 toward the distal
end of the seal body 11.
[0490] The sheath for gastrostoma which employs the sheath body 15
provides an advantage that, when the sheath body 15 is to be
vertically split, vertical splitting can be performed easily and
smoothly from the depth section 152 of the distal notch section
151.
[0491] FIGS. 44A and 44B illustrate a sheath for gastrostoma 6B
configured by employing, in the sheath body 11 of the sheath for
gastrostoma 6 described with reference to FIGS. 31A, 31B and other
drawings, the sheath body 15 which includes the distal notch
section 151 and the notched groove 111A which extends toward the
distal end of the seal body 11 from the depth section 152 of the
distal notch section 151. However, such a sheath body configured to
include the distal notch section 151 and the notched groove 111A
which extends toward the distal end of the seal body 11 from the
depth section 152 of the distal notch section 151 is applicable to
each embodiment according to the invention.
[0492] As illustrated in FIGS. 45A to 47, the sheath for
gastrostoma according to the invention may also employ a
configuration in which a grasping ring 16 is provided at the side
opposite to the hinge section 116 of the handle 61. The user can
insert the fingers to grasp the sheath for gastrostoma.
[0493] A sheath for gastrostoma 6C illustrated in FIGS. 45A to 47
has a schematic structure in which the grasping ring 16 is provided
at the side opposite to the hinge section 116 of the handle 61 of
the sheath for gastrostoma 6 described with reference to FIGS. 31A,
31B and other drawings. The sheath for gastrostoma 6C employs an
elongated plate lid member with a ring 64B in place of the
elongated plate lid member 64. The elongated plate lid member with
the ring 64B is provided integrally with the grasping ring 16, the
mounting section 641, the stopper projection piece 642, the lid
hinge section 62 and the lid 63. The mounting section 641 of the
elongated plate lid member with ring 64B is integrated with the
handle 61.
[0494] The elongated plate lid member with ring 64B is configured
to include the grasping ring 16 at the opposite side of the lid
hinge section 62 across the mounting section 641 of the elongated
plate lid member 64.
[0495] Here, the elongated plate lid member with ring 64B is
integrally formed from a material with rubber elasticity, such as
silicone rubber and elastomer.
[0496] The method (configuration) of integrally forming the
mounting section 641 of the elongated plate lid member with ring
64B with the handle 61 may be the same as the method
(configuration) of integrally forming the mounting section 641 of
the elongated plate lid member 64 with the handle 61.
[0497] As illustrated in FIG. 47, the sheath for gastrostoma 6C has
an advantage that, since the user of the sheath for gastrostoma 6C
can firmly hold the sheath body 11 by grasping the grasping ring 16
with fingers, the user can, for example, reliably insert the button
for gastrostoma 2 in the sheath body 11 without dropping. In a
procedure in which the sheath insertion aid 7 is inserted in the
sheath body 11 to assemble the sheath with insertion aid 70,
insertion and assembly can be reliably performed similarly.
[0498] The user may preferably grasp the grasping ring 16 with the
fingers in the following manner from the viewpoint of reliability.
As illustrated in FIG. 47, one or more fingers (e.g., one or more
of the middle finger, the third finger and the little finger) of
one hand are placed inside the grasping ring 16 to be caught in the
grasping ring 16.
[0499] However, the method of grasping the grasping ring 16 is not
limited to the same. Another method of grasping the grasping ring
16 may be employed in which, for example, one or more fingers
(e.g., one or more of the middle finger, the third finger and the
little finger) of one hand are placed inside the grasping ring 16
to be caught in the grasping ring 16 and the handle 61 is grasped
with the rest of the fingers of the same hand.
[0500] Note that the grasping ring 16 is not necessarily made of a
material with rubber elasticity and is thus flexible. Instead, the
grasping ring 16 may be formed of rigid resin. It is advantageous,
however, to employ a grasping ring 16 made of a material with
rubber elasticity and thus configured to be excellent in
bendability and flexibility from the view point of good workability
since a grasping ring 16 made of a hard material may interfere with
the operation.
[0501] In addition, it suffices that the grasping ring 16 be
securely fixed to the handle 61 at the side opposite to the hinge
section 116 of the handle 61. Thus, the elongated plate lid member
with the ring 64B is not necessarily employed and the grasping ring
16 may be fixed to the handle as a separate member from members
that constitute the mounting section 641, the lid hinge section 62
and the lid 63.
[0502] Moreover, although a configuration in which the grasping
ring 16 is employed in the sheath for gastrostoma 6 described with
reference to FIGS. 31A, 31B and other drawings has been illustrated
in FIGS. 45A to 47, the configuration in which the grasping ring 16
is provided at the side opposite to the hinge section 116 of the
handle as described above is applicable to each embodiment
according to the invention.
[0503] Furthermore, the invention provides a gastrostomy catheter
kit which includes the sheath for gastrostoma 1, the button for
gastrostoma 2, the obturator 3 and the dilator 5. Preferably, the
gastrostomy catheter kit is configured to, for example,
collectively carry the sheath for gastrostoma 1, the button for
gastrostoma 2, the obturator 3 and the dilator 5 in a casing. The
sheath for gastrostoma 1 and the dilator 5 may be a sheathed
dilator 5A in which the sheath for gastrostoma 1 is disposed over
the dilator 5. The gastrostomy catheter kit may include a sheath
for gastrostoma for replacement or a sheath with insertion aid 70
in which the insert sheath insertion aid 7 is inserted in the
sheath for gastrostoma for replacement. A gastrostomy catheter kit
with a sheath for gastrostoma for replacement which does not
constitute the sheath with insertion aid 70 may include the sheath
insertion aid 7 which can be inserted in the sheath body of the
sheath for gastrostoma for replacement. The sheath for gastrostoma
for replacement, the sheath with insertion aid 70 and the sheath
insertion aid 7 to be employed are housed in the casing.
[0504] Of course, the gastrostomy catheter kit may further include
a guidewire.
[0505] Note that the invention is not limited to a configuration in
which the lid and the handle pivot integrally with each other.
[0506] For example, a configuration may be employed in which a lid
is pivotably provided on the sheath body via the hinge section
separately from the handle.
[0507] Also, the invention includes a configuration with no lid
provided. In this case, for example, a plug member which is
removably fit into the base end of the sheath body may be provided
to open and close the inner path of the sheath body. With the plug
member closing the inner path, air supply from the endoscope can be
easily controlled.
[0508] Also, the invention includes a configuration in which a
diameter (inner diameter) of the inner path of the sheath for
gastrostoma is the same or larger than the maximum outer diameter
of the extended indwelling section.
INDUSTRIAL APPLICABILITY
[0509] As described above, according to the invention, it is
possible to lower insertion resistance at the time of placing a
button gastrostomy catheter in the patient's body during
gastrostomy and catheter replacement in which a gastrostomy
catheter is inserted in a fistula and left. A stable endoscopic
visual field during surgery can be provided.
* * * * *