U.S. patent application number 15/195825 was filed with the patent office on 2016-12-29 for atraumatic arthroscopic instrument sheath.
This patent application is currently assigned to Cannuflow, Inc.. The applicant listed for this patent is Cannuflow, Inc.. Invention is credited to Theodore R. Kucklick, Martin Trieb.
Application Number | 20160374539 15/195825 |
Document ID | / |
Family ID | 46303529 |
Filed Date | 2016-12-29 |
United States Patent
Application |
20160374539 |
Kind Code |
A1 |
Kucklick; Theodore R. ; et
al. |
December 29, 2016 |
Atraumatic Arthroscopic Instrument Sheath
Abstract
A removable, resilient atraumatic sheath for arthroscopic
instruments. The sheath covers sharp edges on the arthroscopic
instrument, particularly the distal tip of the rigid cannula, and
thereby protects tissue and objects near a surgical site from
accidental trauma. The sheath may be provided in the form of an
inflow/outflow sheath that allows a surgeon to irrigate and drain a
surgical field without the use of a separate irrigation instrument.
The distal tip of the sheath may comprise a dissimilar material of
a higher modulus of elasticity than the material comprising the
remainder of the tube. The sheath is provided with a cylindrical
grip on the proximal end to resiliently squeeze the proximal end of
the arthroscopic instrument. A level is provided to move the grip
radially outwardly to release the grip from the arthroscopic
instrument.
Inventors: |
Kucklick; Theodore R.;
(Campbell, CA) ; Trieb; Martin; (Cloverdale,
CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Cannuflow, Inc. |
Campbell |
CA |
US |
|
|
Assignee: |
Cannuflow, Inc.
Campbell
CA
|
Family ID: |
46303529 |
Appl. No.: |
15/195825 |
Filed: |
June 28, 2016 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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14475378 |
Sep 2, 2014 |
9375207 |
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15195825 |
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13225908 |
Sep 6, 2011 |
8821387 |
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14475378 |
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12251351 |
Oct 14, 2008 |
8012083 |
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13225908 |
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11016274 |
Dec 17, 2004 |
7435214 |
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12251351 |
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10769629 |
Jan 29, 2004 |
7413542 |
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11016274 |
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Current U.S.
Class: |
600/204 |
Current CPC
Class: |
A61B 1/00121 20130101;
A61B 1/00135 20130101; A61B 17/1675 20130101; A61B 2017/3445
20130101; A61B 1/015 20130101; A61B 1/0014 20130101; A61B 2217/005
20130101; A61B 1/317 20130101; A61M 1/0084 20130101; A61B 17/00234
20130101; A61B 1/00154 20130101; A61B 2217/007 20130101; A61B
2017/349 20130101; A61B 17/3421 20130101; A61B 2017/00336 20130101;
A61B 17/3423 20130101; A61B 1/00066 20130101; A61M 25/0662
20130101; A61B 17/0218 20130101; A61B 2017/3456 20130101 |
International
Class: |
A61B 1/00 20060101
A61B001/00; A61B 17/34 20060101 A61B017/34; A61B 17/16 20060101
A61B017/16; A61B 17/02 20060101 A61B017/02; A61B 1/317 20060101
A61B001/317; A61B 1/015 20060101 A61B001/015 |
Claims
1. A surgical device comprising: arthroscopic means for performing
an arthroscopic surgical procedure, said arthroscopic means having
an outer diameter and a proximal end; a tubular means for removably
enclosing the arthroscopic means, the tubular means having a
proximal portion, a proximal end, an outer surface and an inner
diameter sized and dimensioned to closely conform to the outer
diameter of the arthroscopic means; a means for gripping the
tubular means disposed coaxially over the outer surface of the
tubular means on the proximal portion of the tubular means, said
means for gripping having a proximal portion that extends
proximally beyond the proximal end of the tubular means; wherein
the proximal portion of the means for gripping frictionally engages
the proximal end of the arthroscopic means; and a first lever means
operably attached to the means for gripping to move a first segment
of the proximal portion of the means for gripping in a radially
outwardly direction.
Description
[0001] This application is a continuation of U.S. patent
application Ser. No. 14/475,378, filed Sep. 2, 2014, now U.S. Pat.
No. 9,375,207, which is a continuation of U.S. patent application
Ser. No. 13/225,908, filed Sep. 6, 2011, now U.S. Pat. No.
8,821,387, which is a continuation of Ser. No. 12/251,351, filed
Oct. 14, 2008, now U.S. Pat. No. 8,012,083, which is a continuation
of U.S. patent application Ser. No. 11/016,274, filed Dec. 17,
2004, now U.S. Pat. No. 7,435,214, which in turn is a
continuation-in-part of U.S. patent application Ser. No.
10/769,629, filed Jan. 29, 2004, now U.S. Pat. No. 7,413,542.
FIELD OF THE INVENTIONS
[0002] The inventions described below relate to the field of
arthroscopic surgical instruments.
BACKGROUND OF THE INVENTIONS
[0003] Arthroscopic surgery involves using optical instruments,
such as an arthroscope, to visualize an operating field inside or
near a joint of a patient. The same instrument or other instruments
may be used to perform a surgical procedure in the operating field.
Common instruments used in addition to the arthroscope include a
trimming instrument for cutting tissue and an irrigation instrument
for irrigating the surgical field. Each of the instruments requires
its own incision to be introduced into the surgical field; thus,
many surgeons prefer to use only a trimming instrument and an
arthroscope during arthroscopic surgical procedures.
[0004] Arthroscopes are fragile in relation to the forces applied
during arthroscopic surgery, so a rigid cannula is placed over the
arthroscope to reinforce it. The distal end of the rigid cannula is
pointed, usually sharp, and so the rigid cannula can scratch or
gouge soft tissue within the operating field. The rigid cannula can
also become stuck between bones or cartilage during a procedure. A
rigid cannula can also damage metal prosthetics used to replace
joints, resulting in a shortening of the useful life of the
prosthetic and forcing the patient to undergo additional, painful
surgeries to correct the problem.
[0005] An additional problem associated with arthroscopic surgery
is maintaining a clear surgical field during surgery. Blood and
debris can cloud the field, impairing a surgeon's ability to
visualize tissue. One method of solving this problem is to use the
irrigation instrument to clear the surgical field with saline;
however, many surgeons strongly prefer to avoid the additional
trauma caused by inserting a third instrument. These surgeons will
perform arthroscopic surgeries despite problems with visualizing
the surgical field. Thus, devices and methods are needed both to
maintain a clear surgical field and reduce accidental injury to the
patient while only using two instruments.
SUMMARY
[0006] The devices and methods shown below provide for a soft
plastic, disposable atraumatic sheath that slides over the rigid
cannula of an arthroscope. The distal end of the atraumatic sheath
extends slightly past the distal end of the rigid cannula, thereby
providing a soft, blunt cushion over the distal end of the rigid
cannula. The atraumatic sheath thereby protects any surrounding
tissue or objects from accidental injury or damage while the
arthroscope is manipulated inside the operating field.
[0007] The atraumatic sheath may also be provided as an
inflow/outflow sheath that allows a surgeon to drain fluids from or
introduce fluids into the surgical field, thereby keeping the
surgical field clear. The inflow/outflow sheath is a multi-lumen
tube into which the arthroscope is inserted. The proximal portion
of the sheath is provided with fluid ports, a manifold and other
means of controlling the flow of fluid inside the sheath. The
distal portion of the inflow/outflow sheath is provided with a
plurality of holes. Each hole communicates with one or more of the
lumens inside the tube, thereby allowing fluid to flow between the
surgical field and sources or sinks located outside the patient.
The inflow/outflow sheath thereby allows the surgeon to maintain a
clear surgical field and protect the patient from accidental injury
while eliminating the need for a third irrigation instrument.
BRIEF DESCRIPTION OF THE DRAWINGS
[0008] FIG. 1 shows a method of performing arthroscopic surgery on
a patient.
[0009] FIG. 2 shows an atraumatic sheath for use with arthroscopic
instruments.
[0010] FIG. 2a shows an atraumatic sheath having two tabs.
[0011] FIG. 3 shows an atraumatic sheath for use with arthroscopic
instruments and an arthroscope disposed inside the atraumatic
sheath.
[0012] FIG. 4 shows an atraumatic sheath for use with arthroscopic
instruments, an arthroscope disposed inside the atraumatic sheath
and an irrigation tube disposed on the sheath.
[0013] FIG. 5 shows a cross section of the atraumatic sheath shown
in FIG. 2 and an arthroscopic instrument disposed inside the
atraumatic sheath.
[0014] FIG. 6 shows an inflow/outflow atraumatic sheath for use
with arthroscopic instruments.
[0015] FIG. 7 shows an inflow/outflow atraumatic sheath for use
with arthroscopic instruments and an arthroscope disposed inside
the atraumatic sheath.
[0016] FIG. 8 shows a cross section of the distal portion of the
inflow/outflow atraumatic sheath of FIG. 7.
[0017] FIG. 9 shows a cross section of the distal portion of an
inflow/outflow atraumatic sheath.
[0018] FIG. 10 shows a cross section of the distal portion of an
inflow/outflow atraumatic sheath.
[0019] FIG. 11 shows a cross section of the distal portion of an
inflow/outflow atraumatic sheath.
[0020] FIG. 12 shows a cross section of the distal portion of an
inflow/outflow atraumatic sheath.
[0021] FIG. 13 shows a cross section of the distal portion of an
inflow/outflow atraumatic sheath.
[0022] FIG. 14 shows a cross section of the distal portion of an
inflow/outflow atraumatic sheath.
[0023] FIG. 15 shows a cross section of the distal portion of an
inflow/outflow atraumatic sheath.
[0024] FIG. 16 shows a cross section of the distal portion of an
inflow/outflow atraumatic sheath.
[0025] FIG. 17 shows an inflow/outflow atraumatic sheath for use
with arthroscopic instruments.
[0026] FIG. 18 shows a cross section of the distal portion of the
inflow/outflow sheath shown in FIG. 17.
[0027] FIG. 19 shows an inflow/outflow sheath having a distal
portion that has an inner diameter that closely conforms to the
outer diameter of the distal portion of an arthroscope.
[0028] FIG. 20 shows an atraumatic sheath and an elastic grip
disposed on the proximal portion of the sheath.
[0029] FIG. 21 shows a cross section of an atraumatic sheath
disposed over an arthroscope and an elastic grip disposed on the
proximal portion of the sheath.
[0030] FIG. 22 shows a cross section of an atraumatic sheath
disposed over an arthroscope, an elastic grip and levers disposed
inside the grip.
[0031] FIG. 23 shows the distal end of the grip.
[0032] FIG. 24 shows the distal end of the grip and levers
extending distally from the openings in the grip.
[0033] FIG. 25 shows the distal portion of an atraumatic sheath and
an arthroscope extending distally of the distal end of the
sheath.
[0034] FIG. 26 shows the distal portion of an atraumatic sheath and
an arthroscope extending distally of the distal end of the
sheath.
DETAILED DESCRIPTION OF THE INVENTIONS
[0035] FIG. 1 shows a method of performing arthroscopic surgery on
a patient by using an arthroscopic instrument 2 sheathed in an
atraumatic introducer sheath 3. An arthroscopic instrument may be
an arthroscope, endoscope, awl, pick, shaver, etc. In FIG. 1, the
arthroscopic instrument 2 shown is an arthroscope. (The various
parts of the arthroscope are shown in phantom to indicate their
positions inside the sheath.) Various anatomical landmarks in the
patient's knee 4 are shown for reference, including the femur 5,
patella 6, posterior cruciate ligament 7, anterior cruciate
ligament 8, meniscus 9, tibia 10 and fibula 11. During surgery, the
surgeon introduces the arthroscope 2 into the knee via a first
incision 12 in order to visualize the surgical field. A trimming
instrument 13 is introduced through a second incision 14 to remove
or trim tissue that the surgeon determines should be removed or
trimmed. Optionally, an irrigating instrument 15 may be introduced
through a third incision 16 in order to irrigate the surgical field
and thereby maintain a clear view. As provided below, the
irrigating instrument may be replaced by a combined arthroscope and
inflow/outflow atraumatic sheath, thus reducing the number on
incisions required to perform the surgery.
[0036] The arthroscope 2 is an optical instrument 17 surrounded by
a rigid cannula 18 having a distal edge that typically is cut at an
angle. To protect the patient from unintended injury or trauma
during the procedure, the arthroscope has been inserted into a
resilient, outer introducer sheath or atraumatic sheath 3 that
extends over the rigid cannula. The distal tip 19 of the atraumatic
sheath extends distally just past the distal end of the arthroscope
and rigid cannula to further protect the patient.
[0037] FIGS. 2 through 4 illustrate the atraumatic sheath 3. The
atraumatic sheath is a tube of a resilient material, such as a soft
plastic or rubber. The inner diameter of the atraumatic sheath is
sized and dimensioned to closely fit over the outer diameter of an
arthroscopic instrument. The distal tip 19 of the atraumatic sheath
is provided with a shape that closely approximates the shape of the
distal tip of the arthroscope and/or the rigid cannula. A flange 30
disposed around the distal end of the sheath prevents the distal
tip of the rigid cannula from gouging the patient. The flange is
integral with the walls of the sheath and extends inwardly towards
the axis of the sheath. The flange is sized and dimensioned to
prevent the distal tip of the rigid cannula from accidentally
slipping distally during a surgical procedure. An opening 36 is
provided in some atraumatic sheaths so that the surgeon may insert
the endoscope or other instruments through the opening and into the
surgical space. The distal lens 31 of an optical instrument is
shown for reference in FIGS. 3 and 4.
[0038] The proximal end 32 of the atraumatic sheath is provided
with a tab 33 to allow medical personnel to easily pull the
atraumatic sheath over the rigid cannula, arthroscope and/or
arthroscopic instrument. The proximal end of the atraumatic sheath
may also be provided with fittings 38, such as a locking hub or
snap latches, that attach to fittings 39 or openings disposed on
the arthroscope or other instrument, thereby securing the
atraumatic sheath as illustrated in FIG. 7.
[0039] The tab 33 is sized and dimensioned to divert liquids away
from any device proximal the atraumatic sheath, such as cameras,
optics, motors and other equipment that may be sensitive to liquids
or moisture. Liquids that escapes the surgical site and that travel
along the outer surface of the sheath will be deflected by the tab,
which has a radial dimension greater than that of the lumen of the
sheath.
[0040] FIG. 2a shows an atraumatic sheath 3 having two tabs 33
disposed along the longitudinal length of the sheath. If the flow
of liquids is expected to be heavy for a surgical procedure, then
the additional tab ensure that liquids do not reach sensitive
devices located proximally of the sheath.
[0041] Additional tabs may be provided along the longitudinal
length of the sheath.
[0042] The outer surface of the atraumatic sheath may be provided
with a smooth coating 40 as shown in FIG. 5 to allow the
arthroscope and rigid cannula to more easily move within an
operating site. For example, the sheath may be provided with a
Teflon.RTM. (PTFE or expanded polytetrafluoroethylene) coating or
covered with a water-activated lubricant. In contrast, the inner
surface of the atraumatic sheath (the walls that define the lumen
of the tube) may be provided with a non-slip coating 41 or other
high coefficient of friction coating. For example, the inner
surface of the atraumatic sheath may be coated with a co-extruded
tacky thermoplastic elastomer (TPE). The non-slip coating prevents
the sheath from easily slipping over the outer surface of the rigid
cannula or arthroscope, thereby helping to prevent the atraumatic
sheath from twisting or slipping around the arthroscope.
[0043] FIGS. 3 and 4 show an atraumatic sheath 3 for use with
arthroscopic instruments and an endoscope or arthroscope 2 disposed
inside the atraumatic sheath. The atraumatic sheath shown in FIG. 3
is provided with a balloon 34 on the distal portion of the sheath.
(The balloon may be integrally formed with the sheath.) The balloon
allows a surgeon to open a space within tissue, thereby dissecting
the surgical field. The arthroscope may then be extended distally
out of the opening 36 and the surgical space visualized. In
addition, the distal end of the sheath may be provided with a
distally projecting spoon or other distally projecting object to
prop open a space in front of the arthroscope. The balloon and the
distally projecting spoon thus provide a means for dissecting or
retracting tissue to form a small surgical space.
[0044] FIG. 4 shows an atraumatic sheath 3 having a second, working
tube 35. The working tube allows irrigation, fiber optics, sutures,
needles, probes or surgical tools through the lumen. The atraumatic
sheath shown in FIG. 4 may be combined with the atraumatic sheath
shown in FIG. 3 to provide an atraumatic sheath with both a balloon
and a working tube.
[0045] FIG. 5 shows a cross section of the atraumatic sheath 3
shown in FIG. 2 and an arthroscopic instrument 2 disposed inside
the sheath. The atraumatic sheath is provided with a tab 33 on the
proximal end of the sheath in order to increase the ease of pulling
the sheath over the arthroscope. The distal end of the sheath is
provided with an opening 36 to allow light to pass between the
arthroscope and the operating space and, optionally, to allow
additional instruments to pass through or alongside the arthroscope
and into the surgical field. The walls 37 of the sheath at the
distal end 19 of the sheath are thicker than the rest of the sheath
walls to form a flange 30 at the distal end of the sheath. (The
flange may be a separate ring of material attached to the inside of
the sheath.) The flange covers the sharp distal tip of the
arthroscopic instrument and prevents the instrument from slipping
distally through opening 36. The rest of the walls of the
atraumatic sheath are thin in order to minimize the overall
thickness of the combined sheath and arthroscopic instrument.
[0046] In use, the atraumatic sheath is provided and pulled over an
arthroscopic instrument. (The instrument may also be thought of as
being inserted into the sheath.) The sheathed arthroscopic
instrument is then inserted into the surgical site and the surgeon
performs a medical procedure therein. If a balloon is provided, the
balloon is used to dissect tissue so that the arthroscope may be
extended distally out of the opening 36 and the surgical space
visualized.
[0047] FIGS. 6 and 7 show an inflow/outflow atraumatic sheath 50
and an arthroscope 2 disposed inside the sheath. Like the sheath
shown in FIG. 2, the inflow/outflow atraumatic sheath 50 is formed
of a resilient material that protects the patient from accidental
injury should the arthroscope poke at or scrape along tissue. The
sheath material may also be radiopaque. A preferred durometer
hardness of the sheath material is in the range of about 40 Shore D
to about 90 Shore D. In this hardness range the sheath is
sufficiently resilient that the sheath protects the patient from
accidental injury but is sufficiently hard to prevent the lumens
within sheath from collapsing.
[0048] The inflow/outflow sheath 50 is a multi-lumen tube into
which an arthroscope is inserted. Each lumen extends from the
distal portion 51 of the sheath to the proximal portion 52 of the
sheath. The proximal portion of the sheath is provided with one or
more fluid ports, such as first port 53 or second port 54; one or
more stopcocks 55 or fluid switches; one or more valves, such as a
check valve; a manifold 56; or other means of controlling the flow
of fluid inside the sheath. The distal portion 51 of the
inflow/outflow sheath is provided with a plurality of holes 57.
Each hole communicates with one or more of the lumens inside the
tube, thereby allowing fluid to flow between the surgical field and
the lumens inside the sheath.
[0049] Prior to surgery, medical personnel or the device
manufacturer inserts the arthroscope into the inflow/outflow
atraumatic sheath and secures the sheath to the arthroscope via a
set-screw, snap-on attachment, other releasable attachments or
other means 58 for securing the sheath to the arthroscope. During
use, a surgeon may cause a fluid, preferably saline, to flow from a
fluid source 59, through the arthroscope and into the surgical
field, as shown by inflow arrows 60. (The arthroscope is provided
with one or more lumens, ports or working tubes that allow fluid to
flow through the arthroscope and into the surgical field.) In turn,
blood, other fluids and debris are drained from the surgical field
through the holes 57, as shown by outflow arrows 61, and flow
through one or more lumens in the sheath. The inflow of clear
saline and the outflow of cloudy fluid and debris allow the surgeon
to maintain a clear surgical field using a single instrument. In
turn, this capability eliminates the need to use an irrigating
instrument.
[0050] Thus, the surgeon may have a clear field of view while using
only a two-incision arthroscopic procedure.
[0051] FIG. 7 also shows that fluids are drained through the
inflow/outflow atraumatic sheath by using a vacuum source 70 or
gravity drain operatively attached to a fluid port, such as port
53, connected to the sheath manifold 56. Fluids are provided
through the arthroscope 2 from a fluid source 59 (by using a pump
or gravity feed) operatively attached to a fluid port, such as
third port 72 or fourth port 73 connected to the arthroscope.
Depending on the capabilities of the arthroscope and the surgeon's
needs, the vacuum source and fluid source may be connected to
different combinations of ports provided with the inflow/outflow
sheath or the arthroscope. For example, the vacuum source may be
attached to port 73 and the fluid source may be attached to port 72
on the inflow/outflow sheath. In this case, the surgeon may both
introduce fluids into and drain fluids from the surgical site using
only the inflow/outflow sheath. Thus, even if the arthroscope is
incapable of introducing fluids to or draining fluids from the
surgical site, the inflow/outflow sheath allows the surgeon to
eliminate the need for the irrigation instrument. In any case, a
pressure sensor, and flow rate control system and feedback control
system may be provided to automatically monitor and control the
rate of fluid flow into and out of the surgical site.
[0052] FIG. 8 shows a cross section of the distal portion of the
inflow/outflow sheath 3 shown in FIG. 6. The inflow/outflow sheath
50 has a central lumen 80, bounded by inner wall 81, through which
the arthroscope is inserted. The sheath has four outer lumens,
including a first outer lumen 82, a second outer lumen 83, a third
outer lumen 84 and a fourth outer lumen 85 bounded by the inner
wall 81, the outer wall 86 and four relatively stiff ribs 87 that
extend between the inner and outer walls and that run along the
length of the sheath. The outer lumens are annular. The distal end
of the sheath in the area of the outer lumens 82, 83, 84 and 85 is
sealed closed and provided with a rounded shape to help prevent
injury to the patient (the central lumen remains open to
accommodate the arthroscopic instrument). Holes 57 or apertures
disposed in the outer wall allow fluids to flow into or out of the
outer lumens. For example, lumens 82 and 84 could serve as passages
through which fluids are introduced into the surgical site and
lumens 83 and 85 could serve as passages through which fluids are
drained from the surgical site. During another surgical procedure,
all four lumens could be used to either drain or introduce fluids.
Thus, the surgeon has the option of using the inflow/outflow
atraumatic sheath in many different modes. (In addition, the sheath
may be formed with more than or fewer than the four ribs shown, so
long as at least one outer lumen remains open to fluid flow after
the sheath and scope have been inserted into the surgical
site.)
[0053] FIGS. 9 through 16 show cross sections of the distal portion
of various inflow/outflow atraumatic sheaths. FIG. 9 shows an
inflow/outflow sheath having a second set of inner lumens,
including a first inner lumen 100, a second inner lumen 101, a
third inner lumen 102 and a fourth inner lumen 103. With this
design, the surgeon can increase the rate of fluid exchange by
using all of the inner lumens to introduce fluids into the surgical
site and by using all of the outer lumens 82, 83, 84 and 85 to
drain fluid from the surgical site (or visa versa).
[0054] FIG. 10 shows an inflow/outflow sheath 50 without an inner
wall. Instead, the outer surface of the arthroscope 2 serves as the
inner wall of the sheath once the arthroscope has been inserted
into the sheath. The four, relatively stiff ribs 87 form a seal
with the outer surface of the arthroscope, thereby creating the
four outer lumens 82, 83, 84 and 85. The ends of the ribs may be
provided with elastic flanges 104 to enhance the seal made between
the ribs and the arthroscope. This configuration reduces the
overall size of the combined inflow/outflow sheath and arthroscope.
(If the outer wall 86 is made of an elastomeric material, then the
tube can stretch radially to accommodate a variety of sizes of
arthroscopes.)
[0055] FIG. 11 shows an inflow/outflow atraumatic sheath 50 similar
to that shown in FIG. 10. The relatively hard ribs 87 are pleated,
but still form a seal with the outer wall of the arthroscope 2,
thereby forming the outer lumens 82, 83, 84 and 85 once the
arthroscope is inserted into the sheath. The sheath of FIG. 11
accommodates a variety of sizes of arthroscopes since the pleated
ribs will bend to a degree necessary to accommodate larger sizes of
arthroscopes, as shown in FIG. 12.
[0056] FIG. 13 shows an inflow/outflow atraumatic sheath 50 similar
to that shown in FIG. 11. The ribs 87 of this sheath are elastic
tubes that form a seal with the outer wall of the arthroscope 2,
thereby forming the outer lumens 82, 83, 84 and 85 once the
arthroscope is inserted into the sheath. The sheath of FIG. 13
accommodates a variety of sizes of arthroscopes since the tubes
will compress to a degree necessary to accommodate larger sizes of
arthroscopes, as shown in FIG. 14.
[0057] FIG. 15 shows a "C"-shaped or slit inflow/outflow sheath 50.
Like the sheath of FIG. 8, four outer lumens 82, 83, 84 and 85 are
provided, with the outer lumens bounded by three ribs 87, the inner
wall 81 and the outer wall 86. When the arthroscope 2 is inserted
into the sheath, a small gap 105 may form between the respective
tips of the first arcuate segment 106 and the second arcuate
segment 107. (As the arthroscope is inserted into the surgical
space, tissue 108 will seal the gap and prevent fluids from leaking
from the surgical space to outside the body.) The sheath of FIG. 15
accommodates a variety of sizes of arthroscopes since the arcuate
segments will move radially outwardly as a larger arthroscope is
inserted into the sheath, as shown in FIG. 16.
[0058] Optionally, a protrusion or a guide rail 109 may extend from
either the arthroscope or the sheath. The guide rail helps the user
align the sheath on the arthroscope while inserting the arthroscope
into the sheath. The guide rail also prevents unwanted rotation or
twisting of the sheath over the arthroscope during a surgical
procedure.
[0059] FIGS. 17 and 18 show an inflow/outflow atraumatic sheath 50
and an arthroscope 2 inserted into the sheath. In contrast to the
inflow/outflow sheaths shown in FIGS. 6 through 16, the outer wall
86 of the distal portion 51 of the sheath is made from a continuous
tube (the distal portion of the sheath is not provided with holes).
Nevertheless, like the sheath of FIG. 8 the sheath of FIG. 17 has
an inner lumen to accommodate the arthroscope and four outer lumens
to accommodate fluid inflow and outflow, including a first outer
lumen 82, a second outer lumen 83, a third outer lumen 84, and a
fourth outer lumen 85. The outer lumens are bounded by the inner
wall 81, outer wall 86 and supporting ribs 87. The instrument shown
in FIG. 17 provides fluid inflow and outflow out of the distal end
110 of the sheath.
[0060] FIG. 19 shows an inflow/outflow atraumatic sheath 50 having
a closely-conforming distal portion 111 that has an inner diameter
that closely conforms to the outer diameter of the distal portion
of an arthroscope 2. The fluid-conducting portion 112 of the sheath
is set proximally from the closely conforming distal portion 111 of
the sheath. The outer diameter of the fluid conducting portion 112
and the outer diameter of the closely conforming distal portion 111
may be formed integrally with each other such that both portions
are part of the same sheath. Holes 57 disposed in the
fluid-conducting portion 112 just proximally of the distal portion
111 of the sheath communicate with one or more lumens inside the
sheath, thereby allowing a surgeon to either introduce or drain
fluids from a surgical site. The sheath shown in FIG. 19 has a
distal portion 111 with a relatively small radius, since the sheath
closely conforms to the arthroscope at the distal portion of the
arthroscope. This provides the surgeon with the capability of
inserting the arthroscope into narrow surgical sites. In addition,
the fluid-conduction portion still allows a surgeon to irrigate the
surgical field with the combined sheath/arthroscope instrument.
[0061] FIGS. 20 and 21 show an atraumatic sheath 3 disposed over an
arthroscope 2 and an elastic grip 120 disposed on the proximal
portion 121 of the sheath. The grip 120 is preferably a hollow,
ergonomic cylinder of elastic material (such as a thermoplastic
elastomer) that is sized and dimensioned to allow a surgeon to
manipulate the arthroscope and sheath easily, even if the surgeon's
hands become wet. The grip extends proximally of the proximal end
32 of the sheath so that the proximal portion 122 of the grip will
extend over an arthroscope 2 disposed within the sheath 3. (The
proximal portion 121 of the sheath in FIG. 20 is shown in phantom
to indicate its position inside the grip.) The grip is designed
such that the grip is biased to assume a shape having an inner
diameter less than the outer diameter of the arthroscopic
instrument and preferably less than the inner diameter of the
sheath's inner lumen. Thus, the grip will exert an inwardly
directed radial force, as indicated by arrows 123 in FIG. 21,
against an instrument disposed within the sheath.
[0062] In use, the proximal portion 122 of the grip 120 will
squeeze down on and grasp an arthroscope 2 disposed within the
sheath 3. If the proximal portion of the grip is peeled back and
released, the grip is biased to spring back to its original shape.
Thus, the arthroscope will remain secure within the sheath as the
arthroscope or sheath is manipulated during surgery.
[0063] FIG. 22 shows a cross section of an atraumatic sheath 3
disposed over an arthroscope 2, an elastic grip 120 and levers 124
and 125 disposed inside the grip for widening the proximal opening
of the grip. The grip shown in FIG. 22 is provided with a first
channel 126 and a second channel 127 into which a corresponding
first lever 124 and second lever 125 have been inserted. The levers
are provided with barbs, tangs or other means for securing the
levers within their respective channels. The distal portions of the
levers are provided with an arcuate shape such that the levers bend
away from the sheath.
[0064] In use, a user presses on the distal portions of the levers.
As the distal portions of the levers move radially inwardly, the
proximal portions of the levers will exert a force directed
radially outwardly against a corresponding segment of the proximal
portion of the grip, thereby bending the proximal portion of the
grip radially outwardly. This action widens the proximal opening of
the grip. With the proximal opening of the grip widened, the user
may easily insert or remove the arthroscope from the sheath.
Fulcrums 128 disposed on the distal portions of the levers prevent
the levers from moving radially inwardly by more than a
pre-determined amount. The fulcrums also allow a user to apply more
outward force to corresponding segments in the proximal portion of
the grip, thereby making the insertion of instruments easier.
[0065] FIGS. 23 and 24 show the distal end of the grip 120 and
levers 124 and 125 extending from the distal end of the grip. A
portion of the sheath 3 is shown extending distally from the grip
in FIG. 23 for reference. Channels 126 and 127 disposed in the grip
extend longitudinally through (or partially through) the grip to
accommodate the levers. In use, a user presses on the levers to
peel back the proximal portion of the grip. The user then slides
the arthroscope into or out of the sheath as desired.
[0066] FIG. 25 shows the distal portion of an atraumatic sheath 3
and an arthroscope 2 extending distally of the distal end 140 of
the sheath 3. Holes 57 are provided in the distal portion of the
sheath. The holes communicate with one or more lumens in the
sheath. The lumen or lumens communicate with a vacuum source, fluid
source, therapeutic agent source or a combination of sources. Thus,
the holes provide for the inflow and outflow of fluids during a
procedure.
[0067] The distal tip 141 of the sheath is made of an elastic
material having a higher modulus of elasticity than the modulus of
elasticity found in the material of the proximal portion of the
sheath. In another embodiment, the sheath and the distal tip 141
may be manufactured from a single flexible sterilizable polymer.
The distal tip of the sheath also has an inner diameter that is
slightly smaller than the outer diameter of most arthroscopes. In
another embodiment, the sheath and the distal tip 141 may be
manufactured from a single flexible sterilizable polymer.
[0068] In use, a user inserts the arthroscope into the sheath. The
distal tip expands as the distal end of the arthroscope slides past
the distal tip of the sheath. Because the inner diameter of the tip
is less than the outer diameter of the arthroscope, the tip will
form a fluid-proof seal with the arthroscope.
[0069] FIG. 26 shows the distal portion of an atraumatic sheath 3
and an arthroscope 2 extending distally of the distal end 140 of
the sheath. Holes 57 are provided in the sheath to allow the inflow
and outflow of fluids during a surgical procedure. The distal tip
141 of the sheath is made of an elastic material having a hardness
that is less than the hardness of the proximal portion of the
sheath. A slit 142 is provided in the tip and may extend into the
distal portion of the sheath. In use, the slit and tip expand as a
user slides an arthroscope through the tip. Thus, the slit allows
the sheath to accommodate larger arthroscopes or other medical
instruments.
[0070] Since the atraumatic sheath may be designed or sized and
dimensioned to conform to differently shaped instruments, the
sheath is also useful with other medical instruments and other
surgical procedures in which it is desirable to protect surrounding
tissue from accidental trauma. For example, the atraumatic sheath
may be disposed over a trimming instrument for use during
arthroscopic surgery or over an energy-delivering medical
instrument, such as a laser or RF energy instrument. Other
procedures in which the atraumatic sheath is useful include
laparoscopic surgery and other kinds of endoscopic surgery. For
thin arthroscopes or other fragile medical instruments, the walls
of sheath may be provided with braided carbon fibers or a mesh of
steel, plastic or other composite that resists bending. As the
sheath and instrument bend, force is transferred to the mesh within
the sheath, thereby protecting the fragile instrument inside the
sheath. In addition, the various sheath configurations shown herein
may be combined to form additional types of instrument sheaths.
Thus, while the preferred embodiments of the devices and methods
have been described in reference to the environment in which they
were developed, they are merely illustrative of the principles of
the inventions. Other embodiments and configurations may be devised
without departing from the spirit of the inventions and the scope
of the appended claims.
* * * * *