U.S. patent application number 14/626184 was filed with the patent office on 2015-06-11 for surgical tissue protection sheath.
The applicant listed for this patent is SPIWay LLC. Invention is credited to Randall A. Bly, Eugene Chen, Blake Hannaford, Aylin Kim, Cang Lam.
Application Number | 20150157193 14/626184 |
Document ID | / |
Family ID | 48797762 |
Filed Date | 2015-06-11 |
United States Patent
Application |
20150157193 |
Kind Code |
A1 |
Chen; Eugene ; et
al. |
June 11, 2015 |
SURGICAL TISSUE PROTECTION SHEATH
Abstract
A surgical sheath for use in endoscopic trans-nasal or
intra-ocular surgery has an angle section joined to a conical
section, with the conical section having a central axis not
parallel to a central axis of the angle section. A body section is
joined to the angle section, with the body section having a length
at least twice the length of the angle section. The conical
section, the angle section and the body section may be a flexible
or compliant material. The sheath reduces collateral trauma to the
tissues in the surgical pathway.
Inventors: |
Chen; Eugene; (Carlsbad,
CA) ; Kim; Aylin; (Seattle, WA) ; Lam;
Cang; (Irvine, CA) ; Hannaford; Blake;
(Seattle, WA) ; Bly; Randall A.; (Seattle,
WA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
SPIWay LLC |
Carlsbad |
CA |
US |
|
|
Family ID: |
48797762 |
Appl. No.: |
14/626184 |
Filed: |
February 19, 2015 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
13798990 |
Mar 13, 2013 |
8986201 |
|
|
14626184 |
|
|
|
|
12943779 |
Nov 10, 2010 |
|
|
|
13798990 |
|
|
|
|
13760971 |
Feb 6, 2013 |
9011326 |
|
|
12943779 |
|
|
|
|
61730588 |
Nov 28, 2012 |
|
|
|
61261310 |
Nov 14, 2009 |
|
|
|
61293932 |
Jan 11, 2010 |
|
|
|
61346476 |
May 20, 2010 |
|
|
|
61596996 |
Feb 9, 2012 |
|
|
|
Current U.S.
Class: |
600/114 |
Current CPC
Class: |
A61B 17/3423 20130101;
A61B 2017/2926 20130101; A61B 1/32 20130101; A61B 17/29 20130101;
A61B 90/00 20160201; A61B 90/39 20160201; A61B 17/3431 20130101;
A61B 2217/007 20130101; A61B 2017/00849 20130101; A61B 2017/00278
20130101; A61B 2017/00876 20130101; A61B 2217/005 20130101; A61B
1/00154 20130101; A61M 1/0084 20130101; A61B 17/24 20130101; A61B
2090/306 20160201; A61B 2090/08021 20160201; A61B 2017/345
20130101; A61B 17/00234 20130101 |
International
Class: |
A61B 1/00 20060101
A61B001/00 |
Claims
1. A surgical sheath comprising: a conical section having a larger
conical section first end tapering to a smaller conical section
second end, with the larger conical section first end forming a
proximal opening of the surgical sheath; an angle section having a
quadrilateral cross-sectional shape, and the smaller conical
section second end joined to a first side of the angle section; a
body section having a larger body section first end tapering to a
smaller body section second end, with a second side of the angle
section joined to the body section second end; and with the body
section having a first length and the conical section having a
second length, and with the first length greater than the second
length, and with the conical section, the angle section and the
body section comprising a flexible material to allow the sheath to
conform to inner walls of a patient's nostril.
2. The sheath of claim 1 further comprising one or more pleats on
the body section to allow the body section to stretch outwardly
more easily than the conical section.
3. The sheath of claim 1 with the body section having a wall
thickness less than a wall thickness of the conical section.
4. The sheath of claim 1 further comprising two or more ridges on
an outside surface of the body section.
5. The sheath of claim 1 with conical section having an opening in
a plane at an acute angle of 50-70 degrees to a central axis of the
body section.
6. The sheath of claim 1 with the body section having a central
axis and a distal opening in a plane oriented substantially
perpendicular to the central axis.
7. The sheath of claim 1 with the angle section having four sides
and with none of the sides parallel to each other.
8. The sheath of claim 1 with the first and second sides of the
angle section opposite from each other, and with the angle section
having third and fourth sides opposite from each other, and with
the third side perpendicular to the first side.
9. The sheath of claim 1 with the body section having a central
axis perpendicular to the second side of the angle section.
10. The sheath of claim 12 wherein the body section has a central
axis that bisects the second side of the angle section.
11. A surgical sheath comprising: a conical section having a free
first end tapering to a smaller second end, with the free first end
forming a proximal opening of the surgical sheath; an angle section
having at least first, second and third sides, with first side at
an acute angle to the second side, and the smaller second end of
the conical section adjoining the first side of the angle section;
a body section having a free first end tapering to a smaller second
end, with the second side of the angle section joined to the
smaller second end of the body section; and with the body section
having a first length and the conical section having a second
length, and with the first length greater than the second length,
and with the conical section, the angle section and the body
section comprising a flexible material to allow the sheath to
conform to inner walls of a patient's nostril.
12. The sheath of claim 11 with the third side of the angle section
forming a first acute angle with the first side of the angle
section and forming a second acute angle with the second side of
the angle section.
Description
[0001] This application is a Continuation of U.S. patent
application Ser. No. 13/798,990, filed Mar. 13, 2013, and now
pending, which claims priority to U.S. Provisional Patent
Application No. 61/730,588 filed Nov. 28, 2012. U.S. patent
application Ser. No. 13/798,990 is also a Continuation-in-Part of
U.S. patent application Ser. No. 12/943,779, filed on Nov. 10,
2010, now abandoned, which claims priority to U.S. Provisional
Patent Application Nos. 61/261,310, filed Nov. 14, 2009;
61/293,932, filed Jan. 11, 2010; and 61/346,476, filed May 20,
2010. This application is also a Continuation-in-Part of U.S.
Patent Application No. 13/760,971 filed Feb. 6, 2013 and now
pending, which claims priority to U.S. Provisional Patent
Application No. 61/596,996 filed Feb. 9, 2012. Each of the
applications listed above is incorporated herein by reference
BACKGROUND OF THE INVENTION
[0002] Endoscopic surgery within the head is a common procedure in
neurological surgery and otolaryngology. It avoids large cranial
incisions and can reduce the need brain retraction and prolonged
wound healing. Endoscopic surgery within the head also provides
improved illumination and visualization of the target tissues
because the camera of the endoscope is brought directly to the
surgical site.
[0003] During this type of surgery, there may be local trauma to
the tissues in the surgical pathway, resulting from pressure or
abrasion caused by the surgical instruments. Generally these
tissues are the nasal mucosa, turbinates, nasal septum, and
sphenoid/frontal/maxillary sinus. When transorbital approaches are
used, orbital and periorbital tissue are subject to local trauma.
Surgical pathway trauma can add to the trauma of the procedure and
prolong the patient's recovery time. Liquids in the surgical
pathway, such as mucous, blood, and soiled irrigation fluid, tend
to obscure the view of the endoscope. This leads to the constant
need for irrigation and suction of the obstructing liquids. In some
cases the endoscope may also have to be removed, cleaned and
replaced multiple times during a single procedure. This
disadvantage tends to increase the complexity and time requirements
of the operation. In addition, with each movement of a surgical
tool into or out of the surgical pathway, the surrounding tissues
are put at risk of additional trauma. Improved devices and methods
are therefore needed.
BRIEF DESCRIPTION OF THE DRAWINGS
[0004] In the drawings, the same reference number indicates the
same element in each of the views.
[0005] FIG. 1 is a side view of a tissue protection sheath.
[0006] FIG. 2 is a bottom view of the sheath shown in FIG. 1.
[0007] FIG. 3 is a section view of the sheath shown in FIG. 1.
[0008] FIG. 4 is left end view of the sheath of FIG. 1.
[0009] FIG. 5 is a right end view of the sheath of FIG. 1.
[0010] FIG. 6 is an enlarged detail view of detail A shown in FIG.
3.
[0011] FIG. 7 is front, top and right side perspective view of the
sheath shown in FIG. 1.
[0012] FIG. 8 is rear, bottom and right side perspective view of
the sheath shown in FIG. 1.
[0013] FIG. 9 is a side view of a second embodiment of a tissue
protection sheath.
[0014] FIG. 10 is a bottom view of the sheath of FIG. 9.
[0015] FIG. 11 is a centerline section view of the sheath of FIG.
9.
[0016] FIG. 12 is left end view of the sheath of FIG. 9.
[0017] FIG. 13 is a right end view of the sheath of FIG. 9.
[0018] FIG. 14 is front, top and right side perspective view of the
sheath shown in FIG. 9.
[0019] FIG. 15 is rear, bottom and right side perspective view of
the sheath shown in FIG. 9.
[0020] FIG. 16 is a side view of a third embodiment of a tissue
protection sheath.
[0021] FIG. 17 is a bottom view of the sheath shown in FIG. 9.
[0022] FIG. 18 is a section view of the sheath of FIG. 16 taken
along a centerline.
[0023] FIG. 19 is left end view of the sheath of FIG. 15.
[0024] FIG. 20 is a right end view of the sheath of FIG. 15.
[0025] FIG. 21 is front, top and right side perspective view of the
sheath shown in FIG. 15.
[0026] FIG. 22 rear, bottom and right side perspective view of the
sheath shown in FIG. 15.
[0027] FIG. 23 is rear, top and right side perspective view of
another sheath design.
[0028] FIG. 24 rear, top and right side perspective view of a
sheath similar to the sheath of FIG. 1 and further including side
pockets.
[0029] FIG. 25 is a side view of a sheath delivery tool.
[0030] FIG. 26 is a rear, top and right side perspective view of
the sheath of FIG. 1 with surgical instruments schematically
illustrated in use.
[0031] FIG. 27 is a front, top and right side perspective view of
the sheath and surgical instruments as shown in FIG. 26.
DETAILED DESCRIPTION OF THE DRAWINGS
[0032] FIGS. 1-8 show a first design for a sheath 50 having a body
section 52, and angle section 54 and a flare or conical section 56.
The sheath 50 may be molded of rubber or plastic as a one piece
unit with the body section 52, the angle section 54 and the flare
section integrally joined together. As shown in FIG. 6, the sheath
50 may have a thin flexible wall 58 having a thickness TT which
allows the sheath to conform to the surgical space, or the inner
wall of the patient's nostrils. The flare section 56 may be
provided as a conical ring forming an angle DD of 120-160 or
130-150 degrees with the top wall of the angle section. The sheath
50 may have a single through passageway 60 extending from a distal
opening 62 to a proximal opening 65. As shown in FIGS. 4, 5 and 8,
the openings 62 and 65, and the cross section of the body 52, may
be generally in the shape of an oval or an ellipse.
[0033] Referring to FIGS. 1 and 3, the distal opening 62 may lie in
a plane forming an angle forming an angle BB with the bottom of the
sheath, with BB ranging from 95 to 125 or 100 to 115 degrees. As
best shown in FIG. 3, the angled section 54 may be described as
joined to the body section 52 at a vertical line 51. The upper and
lower walls of the sheath extend distally away from the vertical
line 51 towards the distal opening 62 at acute angles to the line
51, which may the same or different angles. As shown in FIG. 1, the
included angle CC between the top surface of the angled section 54
and the lower wall of the body section may range from 25 to 40 or
30 to 35 degrees. The angle PP in FIG. 1 relating to the diverging
angle of the top and bottom surfaces of the body section is
typically 10-20 or 12-16 degrees. Dimension KK may be 8-16 or 10-14
mm, with dimensions MM and SS both generally about 65-85 or 70-80
mm.
[0034] For some procedures the sheath 50 may be provided as a
cut-to-length unit. For example, the sheath may be provided in a
sterile package, and have a length up to about 100 mm, with the
surgeon cutting off a section of the front or distal end 62, to
obtain a desired length. Scale markings (inches or millimeters) may
optionally be printed or molded on an outside surface of the sheath
for this purpose.
[0035] Turning to FIGS. 1-2 and 7-8, one or more ridges 64 may be
provided on an outer surface of the body section 52. The ridges 64
may project up by 0.5 to 3 mm above the nominal outer surface of
the sheath 50. A cluster of 2-5 ridges 64 may be provided near the
distal opening 52, as shown in FIGS. 1 and 2. These ridges 64 may
be parallel to each other, and optionally also parallel to the
plane of the distal opening 52. Additional ridges 64, oriented at
an angle of e.g., 10-20 or 13-17 degrees, may be provided more
centrally on the body section 52 of the sheath 50. The ridges may
optionally be provided as rings extending continuously around the
outside surface of the body section.
[0036] Optionally, one or more spring or elastic elements 66, such
as a spring wire 66, may be attached to or embedded in the sheath
50, to help expand the sheath from a folded or collapsed position
into and expanded deployed position, after the sheath is positioned
in the surgical pathway. The elastic element 66 may be a Nitinol
wire. The dimensions and angles shown in the drawings of all
embodiments may typically be varied by 10, 20 or 30% depending on
various design parameters.
[0037] The angle section 54 may allow the proximal end of the
sheath 50 to be more easily stretched and/or deflected. This allows
for more versatile movement of surgical instruments extending
through the sheath during surgery. As shown in FIGS. 1 and 3, the
angle section 54 forms an irregular quadrilateral shape in cross
section. In FIG. 3, the angle section 54 may be defined by line F4
along with segments or lines F1, F2 and F3, with F4 and F2 forming
a first acute angle and with F1 and F3 forming a second acute
angle. Each of the sides or segments F4, F1, F2 and F3 forming the
angle section 54 may also have different lengths. F3 may be
substantially perpendicular to F2. The angle section 54 may
alternatively be described via a centerline AN perpendicular to and
bisecting segment or line F4 and intersecting a centerline AF of
the conical section 54 at an angle AB of 5-30 or 10-20 degrees.
[0038] The wall thickness of the sheath 50 may be thinner at the
proximal end adjacent to the flare 56, to allow the proximal end to
more easily stretch. For example, the sheath 50 shown in FIGS. 1-8
may be 6 to 10 cm long with the proximal 10 to 30% of the length
having a reduced wall thickness in comparison to the rest of the
sheath. The wall thickness of this section may be 20 to 80 or 30 to
70% of the regular wall thickness of the rest of the sheath. The
wall thickness may optionally be largely uniform with all sections
of the sheath having a similar thickness TT.
[0039] FIGS. 9-15 show a second design 70 similar to the sheath 50
but without the angle section 54. As with the sheath 50, the sheath
70 may have distal and proximal openings oriented in non-parallel
planes. The sheath 70 may have a flare end 74 that is flatter than
the flare end 56 on the sheath 50, with the flare end 74 at an
angle EE to the centerline of 50 to 70 or 55 to 65 degrees, and
with angle FF typically ranging from 8 to 15 degrees. The outer
diameter GG of the flare end 74 may be 22-30 or 24-28 mm, with the
outer diameter of the front end generally about 16-22 mm. The
sheath 70 may also have a longer and narrower through passageway,
as shown in FIG. 12. Comparing FIG. 13 to FIG. 3 shows that the
body section of the sheath 70 may be symmetrical about the
centerline 71 while the body section of the sheath 50 is not
similarly symmetrical.
[0040] As shown in FIGS. 9 and 13, the body section of the sheath
70 and/or the distal opening 62 may have upper and lower creases 73
and 75 having a radius of 2 mm or less, with curved sidewalls 77
leading from the creases to a substantially flat center sidewall
79. As shown in FIGS. 12 and 15, the proximal opening 65 may be an
oval.
[0041] FIGS. 16-22 show a third design 80 that is similar to the
sheath 70 but having a distal opening 62 in a plane forming an
acute angle with a longitudinal centerline of the body section,
similar to FIG. 1, as opposed to the perpendicular distal opening
orientation in FIG. 9. As shown in FIG. 19 the proximal opening 62
may have non-parallel sidewalls upwardly converging sidewalls W1
and W2 joined by a smaller radius of curvature at the top and and a
larger radius of curvature at the bottom, in the form of a teardrop
or an uneven oval. In each of the sheaths described, the body
section may be at least 2, 4, 6, 8 or 10 times longer than the
conical section, or the combined length of the conical section and
the angle section, if used.
[0042] FIG. 23 shows a similar design further including pleats or
folds 92 at the proximal end. The flare end may also be split into
an upper section 94 and a lower section 96, with no flare section
overlying the pleats 92. This allows the proximal end of the sheath
90 to more easily stretch open to better accommodate manipulation
of surgical tools. The pleats 92 may be molded into the proximal
end of the sheath 90, with the pleats reducing and blending into
the body section of the sheath towards the distal end of the sheath
90. The wall thickness at the pleats may be reduced to e.g.,
0.2-0.7 mm, to allow the pleats to stretch with nominal force.
[0043] FIG. 24 shows a sheath which may be similar or the same as
the sheaths 50, 70 or 80, and further including pockets 110 on
opposite sides configured to accept the jaws of a bayonet forceps.
The pockets may help the forceps to grasp and hold the sheath, and
also allow the sheath to be pushed forward using the forceps, but
without excessively clamping or squeezing the sheath.
[0044] FIG. 25 shows a sheath deployment tool 130 that may be used
to deploy a sheath. The tool 130 has a plunger 134 slidable into a
handle 132. A hook 136 or other grasping feature on the plunger 134
engages a hook slot 138 on the sheath, with the hook slot 138 shown
in FIG. 1. Funnel guides 140 may be provided on the handle 132 to
collapse down and guide the sheath into the handle. The tool 130
may then be used to place the sheath into a surgical pathway.
[0045] FIGS. 26 and 27 show two surgical tools in use with the
sheath. As the sheath tapers outwardly from the proximal opening 65
to the distal opening 62, clashing of the instruments may be
reduced as the sheath provides more room for the instruments to
move at a distance from the leverage point of the nostril.
[0046] The sheaths described above are useful in transnasal and
transorbital surgery of the head. The sheaths may also be used in
other surgical procedures for protection of tissue around a
surgical pathway. The sheaths above are discussed in terms of
having different sections only for purposes of description. The
sheaths may be manufactured from rubber or plastic as an integral
one-piece unit, without specific or visible separation lines or
features between the sections described.
[0047] Thus, a novel surgical sheath has been shown and described.
Various changes and substitutions may of course be made without
departing from the spirit and scope of the invention. The
invention, therefore, should not be limited except by the following
claims and their equivalents.
* * * * *