U.S. patent number RE36,702 [Application Number 09/282,473] was granted by the patent office on 2000-05-16 for seal assembly for accommodating introduction of surgical instruments.
This patent grant is currently assigned to United States Surgical Corporation. Invention is credited to Salvatore Castro, David T. Green.
United States Patent |
RE36,702 |
Green , et al. |
May 16, 2000 |
Seal assembly for accommodating introduction of surgical
instruments
Abstract
A seal assembly is provided which includes a gimbal-like
structure permitting rotation of a mounting member relative to the
housing. The rotation of the mounting member allows the seal member
to align with an instrument being inserted therethrough. The seal
assembly is adapted to be detachably mounted to a cannula assembly
for use in endoscopic surgery.
Inventors: |
Green; David T. (Gulf Stream,
FL), Castro; Salvatore (Seymour, CT) |
Assignee: |
United States Surgical
Corporation (Norwalk, CT)
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Family
ID: |
22229687 |
Appl.
No.: |
09/282,473 |
Filed: |
March 30, 1999 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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317416 |
Oct 3, 1994 |
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091794 |
Jul 14, 1993 |
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Reissue of: |
589426 |
Jan 22, 1996 |
05720759 |
Feb 24, 1998 |
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Current U.S.
Class: |
606/167 |
Current CPC
Class: |
A61B
17/3462 (20130101); A61M 39/06 (20130101); A61B
2017/3464 (20130101); A61M 2039/0626 (20130101); A61M
2039/0686 (20130101) |
Current International
Class: |
A61B
17/34 (20060101); A61M 39/06 (20060101); A61M
39/02 (20060101); A61B 017/00 () |
Field of
Search: |
;606/167,185
;604/169,256,164 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
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0344907 |
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Dec 1989 |
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EP |
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0350291 |
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Jan 1990 |
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EP |
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3042229 |
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May 1982 |
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DE |
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699253 |
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Nov 1953 |
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GB |
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2019219 |
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Oct 1979 |
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GB |
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2057269 |
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Apr 1981 |
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GB |
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2065479 |
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Jul 1981 |
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GB |
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Primary Examiner: Buiz; Michael
Assistant Examiner: Trinh; Vikki
Parent Case Text
This is a continuation of application Ser. No. 08/317,416, filed on
Oct. 3, 1994 which is a continuation of application Ser. No.
08/091,794, filed Jul. 14, 1993, both of which are abandoned.
Claims
What is claimed is:
1. A seal assembly which comprises:
(i) a housing having a passage defining a longitudinal axis and
disposed between at least two open ends,
(ii) a mounting member rotatably mounted within said housing,
and
(iii) a seal member at least partially disposed within said passage
and mounted to said mounting member, said seal member having an
aperture formed therein through which a surgical instrument may
pass;
wherein rotation of said mounting member relative to said housing
angularly displaces said aperture of said seal member relative to
said longitudinal axis.
2. The seal assembly of claim 1, further comprising at least one
guide wall at least partially disposed within said housing,
adjacent said seal member, wherein said guide wall aids in guiding
said surgical instrument through said seal member.
3. A seal assembly of claim 1, further comprising a limiting ring
disposed within said housing for limiting the rotation of said
mounting member with respect to said housing.
4. The seal assembly of claim 1, wherein said mounting member
includes a convex, arcuate outer face in sliding contact with an
internal concave ring-like track disposed within said housing.
5. The seal assembly of claim 1, further comprising at least one
seal protect or disposed within said housing and positioned
adjacent said seal member for preventing direct contact of a
leading edge of said surgical instrument with said seal member.
6. The seal assembly of claim 1, wherein said housing defines a
longitudinal axis and said mounting member is adapted to rotate up
to about 25 degrees with respect to said longitudinal axis.
7. The seal assembly of claim 1, wherein said housing further
includes a bellows structure extending from said mounting member,
said bellows structure ensuring a substantially fluid-tight seal
within said housing, regardless of the relative position of said
mounting member with respect to said housing.
8. The seal assembly of claim 1, wherein said housing is adapted to
be detachably mounted at one end to a cannula assembly for
providing a substantially fluid-tight seal when said instrument is
inserted into said seal assembly and through said cannula
assembly.
9. The seal assembly of claim 1, wherein said seal member is
adapted to accommodate instruments ranging in diameter from 4 to 15
mm.
10. The seal assembly of claim 1, wherein said seal member is
conical and is fabricated from a resilient material.
11. In combination:
(a) a cannula assembly which includes a cannula housing mounted at
one end to a cannula, said cannula housing including a valve
assembly disposed at least partially within said housing, said
valve assembly being adapted to provide a fluid-tight seal; and
(b) a seal assembly removably mounted with respect to said cannula
assembly, said seal assembly including a seal assembly housing
including mounting means for mounting to said cannula housing and
having a passage defining a longitudinal axis and disposed between
at least two open ends, a mounting member rotatably mounted within
said seal assembly housing, and a seal member at least partially
disposed within said passage and mounted to said mounting member,
said seal member having an aperture formed therein through which a
surgical instrument may pass;
wherein rotation of said mounting member relative to said seal
assembly housing angularly displaces said aperture of said seal
member with respect to the longitudinal axis.
12. The combination of claim 11, wherein said seal assembly is
detachably mounted to said cannula assembly. .Iadd.
13. A seal assembly which comprises:
(i) a housing having a passage defining a longitudinal axis and
disposed between at least two open ends;
(ii) a mounting member movably mounted within said housing;
(iii) a seal member at least partially disposed within said passage
and mounted to said mounting member, said seal member having an
aperture formed therein through which a surgical instrument may
pass; and
(iv) a bellows structure extending from said mounting member and
secured to said housing, said bellows structure ensuring a
substantially fluid-tight seal between said mounting member and
said housing, regardless of the relative position of said mounting
member with respect to said housing;
wherein movement of said mounting member relative to said housing
displaces said aperture of said seal member relative to said
longitudinal axis..Iaddend..Iadd.
14. A seal assembly according to claim 13, wherein said mounting
member is rotatably mounted within said housing..Iaddend..Iadd.15.
A seal assembly according to claim 13, wherein said bellows
structure defines a first side and a second side which is opposite
to said first side, and wherein movement of said mounting member
relative to said housing causes said first side of said bellows
structure to stretch and said opposite side of said bellows
structure to compress..Iaddend..Iadd.16. A seal assembly according
to claim 13, wherein said bellows structure is fabricated from
a
resilient material..Iaddend..Iadd.17. A seal assembly according to
claim 16, wherein said resilient material is
polyisoprene..Iaddend..Iadd.18. In combination:
(a) a cannula assembly which includes a cannula housing mounted at
one end to a cannula, said cannula housing including a valve
assembly disposed at least partially within said housing, said
valve assembly being adapted to provide a fluid-tight seal;
(b) a seal assembly removably mounted with respect to said cannula
assembly, said seal assembly including a seal assembly housing
including mounting means for mounting to said cannula housing and
having a passage defining a longitudinal axis and disposed between
at least two open ends, a mounting member movably mounted within
said seal assembly housing, and a seal member at least partially
disposed within said passage and mounted to said mounting member,
said seal member having an aperture formed therein through which a
surgical instrument may pass; and
(c) a bellows structure extending from said mounting member and
secured to said seal assembly housing, said bellows structure
ensuring a substantially fluid-tight seal between said mounting
member and said seal assembly housing, regardless of the relative
position of said mounting member with respect to said seal assembly
housing;
wherein movement of said mounting member relative to said seal
assembly housing displaces said aperture of said seal member with
respect to the
longitudinal axis..Iaddend..Iadd.19. A combination according to
claim 18, wherein said mounting member is rotatably mounted within
said housing..Iaddend.
Description
BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates to seal systems which are adapted to allow
the introduction of surgical instrumentation into a patient's body.
In particular, the invention is applicable to a cannula assembly
wherein a cannula housing includes or is adapted to receive a seal
assembly to sealingly accommodate instruments of different
diameters inserted through the seal assembly and cannula.
2. Description of the Related Art
In laparoscopic procedures surgery is performed in the interior of
the abdomen through a small incision; in endoscopic procedures
surgery is performed in any hollow viscus of the body through
narrow tubes or cannula inserted through a small entrance incision
in the skin. Laparoscopic and endoscopic procedures generally
require that any instrumentation inserted into the body be sealed,
i.e. provisions must be made to ensure that gases do not enter or
exit the body through the incision as, for example, in surgical
procedures in which the surgical region is insufflated. Moreover,
laparoscopic and endoscopic procedures often require the surgeon to
act on organs, tissues, and vessels far removed from the incision,
thereby requiring that any instruments used in such procedures be
relatively long and narrow.
For such procedures, the introduction of a tube into certain
anatomical cavities such as the abdominal cavity is usually
accomplished by use of a trocar assembly comprised of a cannula
assembly and an obturator assembly. Since the cannula assembly
provides a direct passage for surgical instrumentation from outside
the patient's body to access internal organs and tissue, it is
important that the cannula assembly maintain a relatively gas-tight
interface between the abdominal cavity and the outside atmosphere.
The cannula assembly thus generally includes a cannula attached to
a cannula housing containing a seal assembly adapted to maintain a
seal across the opening of the cannula housing.
Since surgical procedures in the abdominal cavity of the body
require insufflating gases to raise the cavity wall away from vital
organs, the procedure is usually initiated by use of a Verres
needle through which a gas such as CO2 is introduced into the body
cavity, thereby creating a pneumoperitoneum. Thereafter, the
pointed obturator of the obturator assembly is inserted into the
cannula assembly and used to puncture the abdominal wall. The gas
provides a positive pressure which raises the inner body wall away
from internal organs, thereby providing the surgeon with a region
within which to operate and avoiding unnecessary contact with the
organs by the instruments inserted through the cannula assembly.
Following removal of the obturator assembly from the cannula
assembly, laparoscopic or endoscopic surgical instruments may be
inserted through the cannula assembly to perform surgery within the
abdominal cavity.
Without the obturator assembly to block the flow of insufflation
gas out from the cavity, other structure must be provided to
maintain a relatively fluid-tight interface between the abdominal
cavity and the outside atmosphere. Generally in the context of
insufflatory surgical procedures, there are two sealing
requirements for cannula assemblies. The first requirement is to
provide a substantially fluid-tight seal when an instrument is not
being introduced into or is not already present in the cannula. The
second requirement is to provide a substantially fluid-tight seal
when an instrument is being introduced into or is already present
in the cannula. Additionally, as endoscopic and laparoscopic
surgical procedures and techniques have advanced, it has become
desirable to accommodate surgical instrumentation of varying
outside diameters through a single cannula assembly in a given
surgical procedure, thereby minimizing the number of cannulae
required and facilitating efficiency in the surgical procedure.
To meet the first sealing requirement, various seals have been
provided for maintaining the pneumoperitoneum in the cavity when no
trocar or other surgical instrument is present in the cannula. For
example, a pivotally mounted flapper valve may be provided which
pivots open upon insertion of an instrument and pivots closed,
under a spring bias, once the instrument is removed. Conventional
flapper valves may also be manually opened by pivoting a lever
provided on the exterior of the housing. An example of such a
flapper valve is disclosed in U.S. Pat. No. 4,943,280 to Lander.
Trumpet valves are also well known for use in sealing a cannula
assembly in the absence of a surgical instrument.
U.S. Pat. No. 4,655,752 to Honkanen et al. discloses a cannula
including a housing and first and second seal members. The first
seal member is conically tapered towards the bottom of the housing
and has a circular opening in its center, while the second seal
member is cup-shaped. The second seal member includes at least one
slit to allow for passage of instruments.
U.S. Pat. No. 4,929,235 to Merry et al. discloses a self-sealing
catheter introducer having a sealing mechanism to prevent blood or
fluid leakage that includes a planar sealing element having a slit,
and a conical sealing element distal of said planar sealing element
so that if the distal conical sealing element is moved distally it
rests upon the planar sealing element, each sealing element being
adapted to surround a tube.
U.S. Pat. Nos. 4,874,377 and 5,064,416 to Newgard et al. relate to
a self-occluding intravascular cannula assembly in which an
elastomeric valving member is positioned transversely to a housing
and is peripherally compressed to cause displacement, distortion
and/or rheological flow of the elastomeric material. A
frustoconical dilator projection is provided which cooperates with
the elastomeric valving member in moving the valving member to a
non-occluding position.
U.S. Pat. No. 5,104,3838 to Shichman relates to a trocar adapter
seal which is adapted to be associated with a cannula assembly and
which advantageously reduces the diameter of the cannula assembly
to accommodate instruments of smaller diameter. The trocar adapter
seal may be removed from the cannula assembly so that the cannula
assembly may once again accommodate instruments of larger diameter.
WO 93/04717 to Mueller et al. describes a similar trocar adapter
seal system in which a pair of seal adapter plates are slidably
mounted to the cannula housing and may be selectively positioned
transverse the cannula housing aperture for accommodating surgical
instrumentation therethrough.
Cannula assemblies have also been developed which are provided with
a series of resilient sealing elements having a central aperture,
e.g., commonly assigned, co-pending applications Ser. No.
07/874,291 filed Apr. 24, 1992 and Ser. No. 07/873,416 filed Apr.
24, 1992. Upon insertion of an instrument, the sealing elements
resiliently receive the instrument, while maintaining a seal around
the instrument across a range of instrument diameters, e.g., 5 to
12 mm. Upon withdrawal of the instrument, a fluid-tight seal is
provided by the internal sealing elements.
Although attempts have been made to provide a seal assembly as part
of or for use in conjunction with a cannula assembly which
maintains the integrity of the seal between the body cavity and the
atmosphere outside the patient's body, seal systems provided to
date have failed to address the full range of surgeons' needs,
especially when it is desired to utilize different instruments
having different diameters therethrough.
SUMMARY OF THE INVENTION
The present invention provides a seal assembly which will allow a
surgeon to efficaciously utilize instruments of varying diameter in
a surgical procedure. The seal assembly of the invention obviates
the need for multiple adapters to accommodate instruments of
varying diameter by providing an apertured resilient seal member
which is mounted in a gimbal-like assembly, thereby facilitating
alignment of the instrument with the aperture of the seal
member.
In accordance with the present invention, a seal assembly is
provided which includes a housing that defines a concave ring-like
track on its inner face. The seal assembly further includes a
mounting member to which a resilient seal member is mounted. The
mounting member has a convexly oriented arcuate outer wall that is
configured and dimensioned to ride within the ring-like track. An
axial cylindrical guide wall is preferably associated with the
mounting member to guide surgical instruments into alignment with
the aperture of the seal member. A limiter ring is also preferably
associated with the housing to limit the range of motion of the
mounting member relative to the housing. In a preferred embodiment,
the limiter ring limits the angular motion of the mounting member
to between 20 to 25 degrees relative to the axis of the housing.
Internal structure may also be provided within the housing to
ensure a fluid tight seal distal to the resilient seal member,
e.g., a flexible bellows member.
The resilient seal member of the invention is configured and
dimensioned to provide a fluid-tight seal with instruments of
varying diameter. In one embodiment, the resilient seal member is
cone shaped and includes an aperture of approximately 4 mm
diameter. The resilience of the material from which the seal member
is fabricated, e.g., polyisoprene, allows the aperture to expand or
stretch to accommodate instruments of greater diameter, e.g., up to
12 mm in diameter. Structure may also be provided adjacent the
proximal side of the conical seal member, e.g., multi-lobed seal
protector elements, to protect the resilient seal member from
puncture or laceration as a surgical instrument aligns itself with
the central aperture.
Preferably, the seal assembly of the invention is adapted to be
associated with a cannula assembly. The cannula assembly typically
includes a tubular cannula and a cannula housing within which is
positioned a cannula seal assembly. The seal cannula assembly
typically provides structure which is adapted to provide a
fluid-tight seal in the absence of a surgical instrument. Suitable
cannula seal assemblies include a spring loaded flapper valve, a
trumpet valve, a duck bill valve, or the like. The seal assembly of
the invention may be associated with the cannula housing by any
suitable means, e.g., a bayonnet lock.
In use, the seal assembly of the invention may be associated with a
cannula assembly at any point the surgeon desires flexibility in
the instrument sizes he may utilize therethrough. Thus, for
example, if the surgeon is utilizing a 12 mm cannula assembly in an
endoscopic surgical procedure and determines that it would be
advantageous to have the flexibility to use instruments ranging in
size from 4 to 12 mm through that cannula assembly, the seal
assembly of the invention may be secured to the cannula assembly.
Thereafter, instruments ranging in diameter from 4 to 12 mm may be
efficaciously introduced therethrough. The cylindrical guide wall
guides the instrument toward the aperture of the resilient seal
member. The mounting member rides within the ring-like track,
angularly repositioning itself with respect to the housing in
response to force exerted thereon by the instrument contacting a
wall thereof.
The movement of the mounting member relative to the housing which
is accommodated by the gimbal-like structure of the present
invention also facilitates seal maintenance once an instrument is
being used within the body cavity. In particular, as an instrument
is manipulated, the resilient seal member transversely repositions
itself through movement of the mounting member relative to the
housing, thereby ensuring that the resilient seal member maintains
a fluid-tight seal around the instrument shaft.
BRIEF DESCRIPTION OF THE DRAWINGS
The foregoing features of the present invention will become more
readily apparent and will be better understood by referring to the
following detailed description of preferred embodiments of the
invention, which are described hereinbelow with reference to the
drawings wherein:
FIG. 1 is a side view, partially in section, of a seal assembly of
the present invention mounted to a cannula assembly;
FIG. 2 is a side view of the assembly of FIG. 1 with the mounting
member and associated structure in a second position; and
FIG. 3 is a sectional side view of a portion of the seal assembly
of the invention.
DETAILED DESCRIPTION OF THE INVENTION
The present invention contemplates the use of all types of
endoscopic and laparoscopic surgical instruments therethrough
including, but not limited to, clip appliers, surgical staplers,
lasers, endoscopes, laparoscopes, forceps, photographic devices,
graspers, dissectors, suturing devices, scissors, and the like. All
of such devices are referred to herein as "instruments".
The seal assembly of the present invention, either alone or in
combination with a seal system internal to a cannula assembly,
provides a substantial seal between a body cavity of a patient and
the outside atmosphere before, during and after insertion of an
instrument through the cannula assembly. Moreover, the seal
assembly of the present invention is capable of accommodating
instruments of varying diameters, e.g., from 5 mm to 15 mm, by
providing a gas tight seal with each instrument when inserted. The
flexibility of the present seal assembly greatly facilitates
endoscopic surgery where a variety of instruments having differing
diameters are often needed during a single surgical procedure.
Referring to the drawings, in which like reference numerals
identify identical or similar parts, FIGS. 1 and 2 illustrate seal
assembly 10 mounted to cannula assembly 12. Cannula assembly 12
includes a cannula 14 and a cannula housing 16. Within cannula
housing 16 is a distally directed duck bill valve 18 which tapers
inward to a sealed configuration, as shown. The diameter of cannula
14 may vary, but typically ranges from 10 to 15 mm for use with the
seal assembly 10 of the present invention.
Seal assembly 10 includes a housing 20 which defines an internal
passage 22. Housing 20 typically has a substantially cylindrical
configuration. A cylindrical guide wall 24 is positioned within
passage and is mounted to mounting member 25. Guide wall 24 is
fabricated from a rigid plastic material, e.g., ABS, and functions
to guide an instrument inserted into passage 22 into alignment with
an aperture 26 formed in conical seal member 28 (see FIG. 3). Seal
member 28 is fabricated from a resilient
material, e.g., polyisoprene or natural rubber, and aperture 26 is
adapted to stretch to sealingly engage instruments of varying
diameter, e.g., from 4 to 12 mm.
Mounting member 25 is fabricated from a rigid plastic, e.g., lexan,
and has a convexly oriented arcuate outer wall 30 that is adapted
to cooperate with a concave ring-like track 32 formed on an inner
face of housing 20. The arcuate outer wall 30 of mounting member 25
is adapted to rotate within the corresponding ring-like track 32 of
housing 20. Although the mounting member 25 is free to rotate
around the longitudinal axis A of cannula assembly 12, the rotation
of mounting member 25 relative to housing 20 which is of importance
to the present invention is the rotation of mounting member 25
relative to the axis transverse to the longitudinal axis A. This
rotation may be measured as an angle relative to the longitudinal
axis of cannula assembly, as designated by angle "D" in FIG. 2. A
lubricant may be provided between outer wall 30 and track 32 to
facilitate such rotation. A limiter ring 34 is formed on housing 20
to limit the freedom of movement of mounting member 25 with respect
to housing 20. Preferably, limiter ring 34 limits the rotation of
mounting member 25 relative to housing 20 to an angular
orientation, designated by "D" in FIG. 2, of up to about 25
degrees.
A bellows structure 36 is mounted to and extends distally from
mounting member 25. Bellows 36 is fabricated from a resilient
material, e.g., polyisoprene, and ensures a substantial fluid-tight
seal within housing 20, regardless of the relative position of
mounting member with respect to housing 20. A cylindrical
protective wall 38 is provided interior of bellows structure 36 to
protect bellows 36 from puncture or laceration as an instrument is
inserted through housing 20, and to guide such instrument toward
duckbill valve 18. As mounting member 25 rotates relative to
housing 20, bellows 36 stretches at one side and compresses on the
opposite side to accommodate such motion.
Seal assembly 10 may be joined to cannula assembly 12 in a variety
of ways. In a preferred embodiment, housing 20 of seal assembly 10
and cannula housing 16 of cannula assembly 12 are adapted to
detachably engage each other, e.g., through a bayonnet lock or like
mechanical means. Other means of joining seal assembly 10 to
cannula assembly 12 will be readily apparent to one of ordinary
skill in the art.
Referring to FIG. 3, a seal protector 40 may be provided adjacent
the proximal side of seal member 28. Seal protector 40 functions to
prevent direct contact between the potentially sharp leading edge
of a surgical instrument while facilitating the passage of the
instrument through aperture 26. A preferred design for seal
protector 40 includes a pair of members 40a, 40b having
triangularly shaped sections 42 which define slits 44, the
respective members 40a, 40b being positioned such that the slits 44
of the first member bisect the triangular sections 42 of the second
member, and vice versa. The triangularly shaped sections 42 deflect
and contact the seal member 28 as an instrument is passed
therethrough, thereby protecting the seal member 28 from
puncture/laceration. The seal protectors 40a, 40b described herein
are described in more detail in copending, commonly assigned Ser.
No. 07/950,205, the contents of which are hereby incorporated by
reference.
In use, seal assembly 10 is mounted to cannula assembly 12. An
instrument is inserted into seal assembly 10 through passage 22 and
into cylindrical guide wall 24 in housing 20. If the axis of the
instrument is not perfectly aligned with the axis A of the cannula
assembly 12/seal assembly 10, then the surgical instrument will
contact the interior of guide wall 24 and/or the wall of seal
member 28. This contact causes mounting member 25 to rotate within
housing 10, up to the angular limit of limiting ring 34, thereby
bringing aperture 26 into alignment with the surgical instrument.
The seal protector(s) 40 deflect as the instrument passes through
seal member 28. Aperture 26 stretches to accommodate the instrument
diameter, as necessary. The instrument passes further distally into
the cannula housing 16, passing through duckbill valve 18 and
cannula 14, into the body cavity. As the instrument passes
distally, mounting member 25 is free to rotate further with respect
to housing 20. In particular, if angle D is initially relatively
large as the instrument passes through aperture 26, the angle D
typically is typically reduced as the instrument passes further
into the cannula 14 and/or body cavity. In addition, as the surgeon
manipulates the instrument within the body cavity, mounting member
25 is free to rotate relative to housing 20, thereby allowing seal
member 28 to maintain sealing engagement with the instrument passed
therethrough.
While the invention has been particularly shown, and described with
reference to the preferred embodiments, it will be understood by
those skilled in the art that various modifications and changes in
form and detail may be made therein without departing from the
scope and spirit of the invention. Accordingly, modifications such
as those suggested above, but not limited thereto, are to be
considered within the scope of the invention.
* * * * *