U.S. patent application number 11/378639 was filed with the patent office on 2006-10-12 for surgical instrument seal assembly.
Invention is credited to William G. Dennis, Michael E. Prosek.
Application Number | 20060229565 11/378639 |
Document ID | / |
Family ID | 26824564 |
Filed Date | 2006-10-12 |
United States Patent
Application |
20060229565 |
Kind Code |
A1 |
Dennis; William G. ; et
al. |
October 12, 2006 |
Surgical instrument seal assembly
Abstract
A surgical instrument valve assembly is provided with a valve
seal where the upper portion of the valve seal is rigidly mounted
to the body of the valve assembly. The lower portion of the valve
seal is configured to allow some radial movement while the upper
portion of the valve seal remains rigidly mounted within the valve
assembly. The valve seal may be provided with stay that prevents
the valve seal from inverting when an instrument is withdrawn from
the valve assembly.
Inventors: |
Dennis; William G.;
(Jacksonville, FL) ; Prosek; Michael E.;
(Jacksonville, FL) |
Correspondence
Address: |
MCGUIREWOODS, LLP
1750 TYSONS BLVD
SUITE 1800
MCLEAN
VA
22102
US
|
Family ID: |
26824564 |
Appl. No.: |
11/378639 |
Filed: |
March 20, 2006 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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09885856 |
Jun 20, 2001 |
7056303 |
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11378639 |
Mar 20, 2006 |
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09434608 |
Nov 5, 1999 |
6258065 |
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09885856 |
Jun 20, 2001 |
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60126356 |
Mar 26, 1999 |
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Current U.S.
Class: |
604/167.03 |
Current CPC
Class: |
A61B 17/3462 20130101;
A61B 2017/3464 20130101 |
Class at
Publication: |
604/167.03 |
International
Class: |
A61M 5/178 20060101
A61M005/178 |
Claims
1-32. (canceled)
33. A surgical instrument seal assembly which is connected during
use to a cannula and forms a seal about a surgical instrument that
is passing through the cannula, the seal assembly comprising: a
housing comprising a plurality of walls including at least a top
wall and a bottom wall, wherein the walls are configured to enclose
an interior space, wherein the top wall has a hole therethrough
configured to receive the surgical instrument into the interior
space, wherein the bottom wall has a cannula receiving opening
therethrough aligned with respect to the hole so that the hole and
the cannula receiving opening define a throughbore through the
housing which is axially aligned with the cannula and configured to
accept the surgical instrument; a generally cylindrical wall
protector integrally formed with the top wall of the housing at the
throughbore and positioned so as to project distally with respect
to the top wall into the interior space of the housing; and a first
valve seal mounted with respect to the housing so that the first
valve seal surrounds the cylindrical wall protector and extends
distally past a distal end of the cylindrical wall protector,
wherein a distal portion of the first valve seal is arranged to
form a seal around the surgical instrument when the surgical
instrument is passed through the throughbore.
34. The surgical instrument seal assembly of claim 33, further
comprising a second valve seal, wherein the second valve seal is
mounted with respect to the housing so that the second valve seal
is positioned distally with respect to the first valve seal and
aligned with the throughbore.
35. The surgical instrument seal assembly of claim 34 wherein the
second valve seal comprises a duckbill valve seal.
36. The surgical instrument seal assembly of claim 33 wherein the
housing further comprises side walls that connect to the top wall
to form a cap that further encloses the interior space.
37. The surgical instrument seal assembly of claim 36 wherein the
cap is integrally formed with the cylindrical wall protector.
38. The surgical instrument seal assembly of claim 33 wherein the
first valve seal has a first larger diameter at a first end
adjacent the top wall and the first valve seal has a second smaller
diameter at a second end.
39. The surgical instrument seal assembly of claim 33 wherein the
first valve seal is spaced from the cylindrical wall protector and
surrounds the cylindrical wall protector.
40. The surgical instrument seal assembly of claim 33 further
comprising an inner support member, wherein the first valve seal is
mounted with respect to the housing so that a proximal portion of
the first valve seal is sandwiched between the top wall and the
inner support member.
41. A surgical instrument seal assembly connected to a cannula for
the insertion of a surgical instrument, the seal assembly
comprising: an upper body portion having an upper surface with an
aperture that defines a throughbore extending through the seal
assembly; a cylindrical wall protector integrally formed with the
upper surface at the throughbore that projects inwardly into an
interior portion of the upper body portion at the throughbore; a
lower body portion projecting below the upper body portion wherein
the lower body portion defines a cannula receiving opening through
which the surgical instrument enters the cannula during use; and a
unitary valve seal comprising: an upper seal portion having a
mounting portion mounted in the upper body portion, the upper seal
portion being mounted about the throughbore, the cylindrical wall
protector located between the throughbore and the upper seal
portion; and a lower seal portion extending below the upper seal
portion, the lower seal portion structured and arranged to seal
around a surgical instrument.
42. The surgical instrument seal assembly of claim 41, further
comprising a second valve seal, wherein the second valve seal is
mounted with respect to the upper body portion so that the second
valve seal is positioned distally with respect to the unitary valve
seal and aligned with the throughbore.
43. The surgical instrument seal assembly of claim 42 wherein the
second valve seal comprises a duckbill valve seal.
44. The surgical instrument seal assembly of claim 41 wherein the
upper body portion further comprises side walls that connect to the
upper surface to form a cap that further encloses the interior
space.
45. The surgical instrument seal assembly of claim 42 wherein the
cap is integrally formed with the cylindrical wall protector.
46. The surgical instrument seal assembly of claim 41 wherein the
upper seal portion has a first larger diameter and the lower seal
portion has a second smaller diameter.
47. The surgical instrument seal assembly of claim 41 wherein the
unitary valve seal is spaced from the cylindrical wall protector
and surrounds the cylindrical wall protector.
48. The surgical instrument seal assembly of claim 41 further
comprising an inner support member, wherein the mounting portion is
sandwiched between the upper body portion and the inner support
member.
49. A surgical instrument seal assembly which is connectable to a
cannula to form a seal about a surgical instrument that is passing
through the cannula, the seal assembly comprising: a housing
comprising a plurality of walls including at least a top wall and a
bottom wall, wherein the walls are configured to enclose an
interior space, wherein the top wall has a hole therethrough
configured to receive the surgical instrument into the interior
space, wherein the bottom wall has a cannula receiving opening
therethrough aligned with respect to the hole so that the hole and
the cannula receiving opening define a throughbore through the
housing which is axially aligned with the cannula and configured to
accept the surgical instrument; a generally cylindrical wall
protector integrally formed with the top wall of the housing at the
throughbore and positioned so as to project distally with respect
to the top wall into the interior space of the housing; and a first
valve seal mounted with respect to the housing so that the first
valve seal surrounds the cylindrical wall protector and extends
distally past a distal end of the cylindrical wall protector,
wherein a distal portion of the first valve seal is arranged to
form a seal around the surgical instrument when the surgical
instrument is passed through the throughbore.
50. The surgical instrument seal assembly of claim 49, further
comprising a second valve seal, wherein the second valve seal is
mounted with respect to the housing so that the second valve seal
is positioned distally with respect to the first valve seal and
aligned with the throughbore.
51. The surgical instrument seal assembly of claim 50 wherein the
second valve seal comprises a duckbill valve seal.
52. The surgical instrument seal assembly of claim 50 wherein the
housing further comprises side walls that connect to the top wall
to form a cap that further encloses the interior space.
53. The surgical instrument seal assembly of claim 52 wherein the
cap is integrally formed with the cylindrical wall protector.
54. The surgical instrument seal assembly of claim 49 wherein the
first valve seal has a first larger diameter at a first end
adjacent the top wall and the first valve seal has a second smaller
diameter at a second end.
55. The surgical instrument seal assembly of claim 49 wherein the
first valve seal is spaced from the cylindrical wall protector and
surrounds the cylindrical wall protector.
56. The surgical instrument seal assembly of claim 49 further
comprising an inner support member, wherein the first valve seal is
mounted with respect to the housing so that a proximal portion of
the first valve seal is sandwiched between the top wall and the
inner support member.
57. A surgical instrument seal assembly connectable to a cannula
for the insertion of a surgical instrument, the seal assembly
comprising: an upper body portion having an upper surface with an
aperture that defines a throughbore extending through the seal
assembly; a cylindrical wall protector integrally formed with the
upper surface at the throughbore that projects inwardly into an
interior portion of the upper body portion at the throughbore; a
lower body portion projecting below the upper body portion wherein
the lower body portion defines a cannula receiving opening through
which the surgical instrument enters the cannula during use; and a
unitary valve seal comprising: an upper seal portion having a
mounting portion mounted in the upper body portion, the upper seal
portion being mounted about the throughbore, the cylindrical wall
protector located between the throughbore and the upper seal
portion; and a lower seal portion extending below the upper seal
portion, the lower seal portion structured and arranged to seal
around a surgical instrument.
58. The surgical instrument seal assembly of claim 57, further
comprising a second valve seal, wherein the second valve seal is
mounted with respect to the upper body portion so that the second
valve seal is positioned distally with respect to the unitary valve
seal and aligned with the throughbore.
59. The surgical instrument seal assembly of claim 58 wherein the
second valve seal comprises a duckbill valve seal.
60. The surgical instrument seal assembly of claim 57 wherein the
upper body portion further comprises side walls that connect to the
upper surface to form a cap that further encloses the interior
space.
61. The surgical instrument seal assembly of claim 60 wherein the
cap is integrally formed with the cylindrical wall protector.
62. The surgical instrument seal assembly of claim 57 wherein the
upper seal portion has a first larger diameter and the lower seal
portion has a second smaller diameter.
63. The surgical instrument seal assembly of claim 57 wherein the
unitary valve seal is spaced from the cylindrical wall protector
and surrounds the cylindrical wall protector.
64. The surgical instrument seal assembly of claim 57 further
comprising an inner support member, wherein the mounting portion is
sandwiched between the upper body portion and the inner support
member.
Description
[0001] This application is a continuation of and claims the benefit
of co-pending application Ser. No. 09/885,856, filed Jun. 20, 2001,
which stands allowed and which is a continuation of and claims
benefit of application Ser. No. 09/434,608, filed Nov. 5, 1999, now
U.S. Pat. No. 6,258,065; which claims benefit of Provisional
Application No. 60/126,356 filed on Mar. 26, 1999, which are
incorporated herein by reference in their entireties.
FIELD OF THE INVENTION
[0002] The present invention relates broadly to medical devices
used during surgical procedures and, more particularly to a
surgical instrument seal assembly for selective mounting to a
cannula for the insertion of a surgical instrument therethrough
while maintaining a fluid seal around the instrument.
BACKGROUND OF THE INVENTION
[0003] In certain types of surgery, a cannula is used to provide a
passageway into a body cavity through which surgical instruments
may be passed. Cannulas are typically elongate rod-like members
having a bore therethrough the surgical instrument may be passed
through the bore. At times, the body cavity will be insufflated by
a gas and at all times, the cannula will be subjected to internal
body fluids. Therefore, some form of seal assembly is necessary to
allow the surgical instrument to pass while maintaining sealed
integrity around the instrument such that the insufflation gas, the
internal body fluids, or both, cannot escape.
[0004] Typically, in conventional devices, such a seal mechanism
will include a housing for mounting on the cannula, with the
housing having a bore therethrough for passage of the surgical
instrument. Two seals are typically located within the housing. The
lower housing contains a seal, typically called a duckbill valve
that assists maintaining gases and fluids in place when an
instrument is not inserted within the duckbill valve. The duckbill
valve is typically formed from flexible material and includes a
slit opening that gives way to the instrument upon insertion. The
upper housing typically includes a valve seal that includes a
relative wide access opening and a relatively narrow valve opening.
The valve opening can expand to accommodate the surgical instrument
and is sufficiently resilient to form a seal around the instrument
upon insertion.
SUMMARY OF THE INVENTION
[0005] However, certain problems have been identified in
conjunction with use and operation of conventional devices.
Initially, the elastomeric material of the valve seal can be
damaged by contact with the surgical instrument upon insertion. As
a result seal protectors have been used. The seal protectors are
units separate from the valve seal and disposed intermediate the
seal and a surgical instrument. Some seal protectors include
complex lever arrangements that may engage and open the valve
opening while acting as a barrier between the instrument and the
valve seal. Other approaches include the application of rigid
plastic leaf-like members in an overlapping, circular array in
abutment with the valve seal. The overlapping arrangement allows
the leaves to open upon insertion of an instrument. These
approaches have been generally costly and complex.
[0006] Another problem with conventional devices has been the
inability of the valve opening to align with the instrument if the
instrument is inserted "off axis," i.e., out of alignment with the
throughbore in the valve seal. Attempts to resolve this problem
have resulted in special mounting arrangements for the valve seal
wherein the valve seal is laterally displaceable within a housing
holding the valve seal. These solutions have required additional
material and can be expensive and complex.
[0007] Therefore, there is a need for a surgical instrument sealing
assembly that provides protection for the valve seal during contact
with the instrument, especially during off axis insertion of the
instrument, that is inexpensive and simple to produce.
[0008] It is accordingly an object of the present invention to
provide a surgical instrument seal assembly having a valve seal
that can withstand impact from a surgical instrument.
[0009] As another object of the present invention a seal assembly
is provided that protects the valve seal upon off axis insertion of
a surgical instrument.
[0010] It is another object of the present invention to provide a
seal assembly that is simple and easy to produce.
[0011] Accordingly, a surgical instrument seal assembly is provided
as described in the description of the exemplary embodiments. The
present invention provides a unitary valve seal that includes an
armor reinforcement that is unitarily formed with the elastomeric
seal material and protects the integrity of the elastomeric seal
material during insertion of the surgical instrument. Further, the
valve seal is configured to allow some off-axis movement of a valve
opening in the valve seal while a mounting portion of the valve
seal itself remains rigidly mounted within its housing. Thus, while
the upper portion of the valve seal may be incapable of lateral
movement, the valve opening itself can shift a small amount to
accommodate an off-axis instrument insertion.
[0012] The surgical instrument seal assembly for mounting to a
cannula for the insertion of a surgical instrument therethrough
while maintaining a fluid seal around the instrument is provided
with an upper body portion having an upper surface that defines a
throughbore extending completely through the seal assembly. A lower
body portion projects below the upper body portion and the lower
body portion defines a cannula receiving opening adapted to mount
the valve seal assembly on the cannula. The valve assembly is
provided with a unitary valve seal that has an upper seal portion
having a mounting portion rigidly mounted in the upper body portion
adjacent the interior portion of the upper surface wherein the
upper seal portion is mounted about the throughbore and a lower
seal portion extending from the upper seal portion adapted to seal
around the instrument.
[0013] Further, in accordance with an aspect of the invention, the
surgical instrument seal assembly is provided with a stay wherein
at least a portion of the stay is encapsulated in the valve seal.
The stay may be unitarily formed with the lower seal portion.
[0014] The surgical instrument seal assembly, in accordance with an
aspect of the invention, is further provided with an upper seal
portion and a lower seal portion integrally formed from the same
material and wherein the valve seal further comprises a stay
partially encapsulated in the lower seal portion.
[0015] Still further, in accordance with an aspect of the
invention, the surgical instrument seal assembly is provided with a
valve seal formed from an elastomeric material.
[0016] The surgical instrument seal assembly, in accordance with an
aspect of the invention, may be provided with a duckbill valve in
the lower body portion.
[0017] In one embodiment, the surgical instrument seal assembly is
provided with a stay that is adapted to resist inversion of the
valve seal when an instrument is withdrawn from the valve seal.
[0018] The surgical instrument seal assembly, in accordance with an
aspect of the invention, may be provided with a stay made from a
material selected from the group consisting of polyethylene,
polypropylene, nylon, and plastic elastomers. The stay of the
surgical instrument valve assembly may be shaped to substantially
match the lower seal portion.
[0019] In accordance with an aspect of the invention, the surgical
instrument seal assembly is provided with a stay wherein at least a
portion of the stay is encapsulated in at least a portion of the
lower seal portion.
[0020] Still further, in accordance with an aspect of the
invention, the surgical instrument seal assembly may be provided
with a stay having a circumferential flange above at least a
portion of the stay encapsulated in the lower seal portion.
[0021] The surgical instrument seal assembly, in accordance with an
aspect of the invention, is provided with a stay wherein at least a
portion of the stay is approximately frusto-conical in shape.
[0022] The surgical instrument seal assembly, in accordance with an
aspect of the invention, may be provided with a stay where the stay
has a plurality of flexible members.
[0023] Still further, in accordance with the aspect of the
invention, the surgical instrument seal assembly may be provided
with a stay wherein the stay has a lower portion encapsulated by
the valve seal material and forms a unitary structure.
[0024] In accordance with an aspect of the present invention, a
valve seal for use in a surgical instrument seal assembly is
provided with an upper seal portion, a lower seal portion extending
from the upper seal portion, and a stay wherein at least a portion
of the stay is encapsulated in the lower portion of the valve
seal.
[0025] In accordance with an aspect of the present invention, the
valve seal may be provided with a stay that is unitarily formed
with the lower seal portion. Further, the upper seal portion and
the lower seal portion may be integrally formed from the same
material. Further, the valve, seal may be formed from elastomeric
material. The elastomeric material may be selected from the group
consisting of silicone, plastic elastomers, polyisoprene, butyl
rubber, neoprene, and natural rubber.
[0026] Still further in accordance with an aspect of the present
invention, the stay may be adapted to resist inversion of the valve
seal when an instrument is withdrawn from the valve seal. Further,
the stay may be made from materials select from the group
consisting of polyethylene, polypropylene, nylon, and plastic
elastomers. Still further, the stay, may be shaped to substantially
match the shape of the lower seal portion.
[0027] In accordance with another aspect of the present invention,
the stay may further comprise circumferential flange above the at
least a portion of the stay encapsulated in the lower seal portion.
Further, the stay may include a circumferential upper wall disposed
above the circumferential flange. Still further, at least a portion
of the stay may be approximately frusto-conical in shape. The stay
may be provided with a plurality of flexible members. In accordance
with another aspect of the present invention, the stay may have a
lower portion that is encapsulated by the valve seal material and
forms a unitary structure.
BRIEF DESCRIPTION OF THE DRAWINGS
[0028] These and other aspects of the invention will become
apparent from the following descriptions which illustrate exemplary
embodiments of the invention when read in conjunction with the
accompanying drawings, in which:
[0029] FIG. 1 is a perspective view of a surgical instrument with a
seal assembly according to an exemplary embodiment of the present
invention;
[0030] FIG. 2 is a top plan view of the seal assembly illustrated
in FIG. 1 in accordance with an exemplary embodiment of the present
invention.
[0031] FIG. 3 is a cross-sectional view of the seal assembly
illustrated in FIG. 1 taken along lines I-I in accordance with an
exemplary embodiment of the present invention;
[0032] FIG. 4 is a bottom view of the seal assembly shown in FIG. 3
in accordance with an exemplary embodiment of the present
invention.
[0033] FIG. 5 is a cross-sectional view of another embodiment of
the seal assembly illustrated in FIG. 1 taken along lines I-I in
accordance with an exemplary embodiment of the present
invention;
[0034] FIG. 6 is a cross-sectional view of the valve seal shown in
FIG. 5 in accordance with an exemplary embodiment of the present
invention;
[0035] FIG. 7 is a side view of the stay used in the valve seal in
accordance with an exemplary embodiment of the present invention;
and
[0036] FIG. 8 is a top plan view of the stay shown in FIG. 7 in
accordance with an exemplary embodiment of the present
invention.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0037] With reference to the drawings, wherein like numerals have
been used to represent like features, and, more particularly to
FIG. 1, a surgical instrument valve seal assembly 10 is illustrated
and includes an upper body portion 12 and a lower body portion 18.
The upper body portion 12 is generally cylindrical and includes a
washer-shaped upper surface 16 integrally formed with a generally
cylindrical sidewall 14. A throughbore 20 is provided at the center
of the upper surface 16 with the throughbore 20 extending
completely through the seal assembly 10. A generally cylindrical
protector wall member 24 is integrally formed with upper surface 16
at the throughbore 20 to project inwardly into the interior of the
upper body portion 12 to both strengthen the structure and to guide
the surgical instrument into the throughbore 20.
[0038] The lower body portion 18 includes a generally cylindrical
wall 19 projecting below the upper body portion 12. A tapered
transition wall 21 is disposed intermediate the cylindrical lower
wall 19 and the upper body portion 12, and acts to taper the
diameter of the seal assembly 10 from the larger upper body portion
12 to the smaller lower body portion 18. A cannula receiving
opening 22 is formed in the lower body portion 18 for mounting the
device on a cannula (not shown). It should be recognized that the
upper body portion 12, the transition wall 21, and the lower body
portion 18 may be formed from molded polymeric material for ease of
manufacture.
[0039] With reference to FIG. 2, it can be seen that the
throughbore 20 provides access to the valve seal 30 and a duckbill
valve 42, both of which will be explained in greater detail
hereinafter.
[0040] Turning now to FIG. 3, a cross-sectional view of the seal
assembly 10 illustrated in FIG. 1 reveals the structure of the seal
assembly 10, in accordance with an exemplary embodiment of the
present invention. It can be seen that the upper body portion 12 is
mounted to the lower body portion 18 with a shoulder 25 formed on
the transition wall 21. The shoulder 25 engages a similar shoulder
formed on the cylindrical wall 14 of the upper body portion 12. The
two piece construction provides for ease of assembly during
manufacture.
[0041] Inner support member 28 projects downwardly from an interior
portion 37 of the upper body portion 12, opposite to the upper
surface 16, into engagement with a shoulder 29 formed on the lower
body portion 18. The inner support member 28 provides stability for
the seal assembly and a mounting location for a valve seal 30.
Preferably, an o-ring 27 is located between the inner support
member 28 and shoulder 29 to form a substantially leak-tight seal
between the upper body portion 12 and the lower body portion
18.
[0042] As shown in FIG. 4 with continuing reference to FIG. 3, the
lower body portion 18 is configured for mating engagement with a
cannula and, accordingly, includes mating members 26 formed
adjacent the cannula opening 22 in the lower body portion 18. For
example, the mating members 26 may be a plurality of ribs.
[0043] A duckbill valve 42 is formed as an elastomeric member
disposed in the lower body portion 18 using a mounting assembly 44.
The duckbill valve 42 includes a slit-like opening that forms a
seal, and allows for an instrument to be inserted through the
cannula. Further, the duckbill valve 42 acts as an initial barrier
to gases and fluids.
[0044] Turning now the valve seal 30, a mounting portion 41 of
valve seal 30 is rigidly mounted in the upper body portion 12 at a
mounting member 36 on the inner support member 28. That is, the
valve seal 30 is mounted adjacent the interior portion 37 opposite
to the upper surface 16. The valve seal 30, including the mounting
member 36 and the inner support member 28, is rigidly mounted
within the upper body portion 12 and incapable of lateral shifting,
within the upper body portion 12, with respect to either the
mounting member 36 or the inner support member 28.
[0045] The valve seal 30 is formed as a generally frusto-conical
member having two distinct portions defined by respective
differently tapered walls. Specifically, the valve seal 30 is
formed as an elastomeric member having a reinforcing layer 53
formed therewith. This structure provides the flexibility necessary
to expand the valve opening 32 yet protects the valve seal 30 from
damage from a surgical instrument. An upper seal portion 33
includes an upper inner wall 34 and an upper outer seal wall 35,
both formed as a generally unitary portion having a first taper. A
lower seal portion 38 is integrally formed with the upper seal
portion 33 and includes a lower inner seal wall 39 formed unitarily
with a lower outer seal wall 40. The lower seal portion 38 includes
a taper that is more sloped and curved than the upper seal portion
33. The reinforcing layer 53 may be the inner seal wall 39 or the
outer seal wall 40. Alternatively, the reinforcing layer 53, may be
sandwiched between the inner seal wall 39 and the outer seal wall
40.
[0046] Accordingly, the upper seal portion 33 of the valve seal 30
tapers from a relatively wide access opening 31 to the lower seal
portion 38 where the taper is increased to extend the lower seal
portion 38 to the instrument seal opening 32. Further, in one
embodiment, the lower seal portion 38 may be curved slightly
inwardly rather than being a straight conical taper. This
construction allows the seal opening 32 to move radially, at least
a small distance to accommodate an off axis instrument insertion.
Further, the reinforcing layer 53 of the unitary valve seal body
provides protection against punctures by an instrument and resists
inversion of the valve seal 30 when an instrument is withdrawn from
the valve seal. It should be noted that the valve seat 30 may be
formed as a single layer without having the reinforcing layer 53
formed within. Such a single layer would be formed from a material
that provides advantages similar to the unitary valve seal body
described above with respect to puncture resistance, flexibility
and sealing capability.
[0047] With reference now to FIG. 5, an alternate exemplary
embodiment of the valve seal shown generally as 130 is shown
therein. The mounting portion 141 of valve seal 130 is rigidly
mounted in the upper body portion 12 at a mounting member 36 on the
inner support member 28 adjacent the interior portion 37, which
opposes the upper surface 16. The mounting portion 141 of valve
seal 130, including the mounting member 36 and the inner support
member 28, is rigidly mounted within the upper body portion 12 and
incapable of shifting laterally with respect to the upper body
portion 12. The valve seal 130 is substantially similar in shape to
the valve seal 30 described above except that the lower seal
portion 138 is formed with a reinforcing stay 50 described in
detail below.
[0048] With reference now to FIG. 6, the position of the
reinforcing stay 50 in the valve seal 130 is shown. In an exemplary
embodiment, the stay 50 is shaped and sized to approximately match
the shape of lower seal portion 138 of the valve seal 130 and at
least a portion of the upper seal portion 133 of the valve seal
130. At least a portion of the reinforcing stay 50 is encapsulated
in the lower seal portion 138 of the valve seal 130 to form a
unitary structure.
[0049] As shown in FIGS. 7 and 8, the portion of the reinforcing
stay 50 that is shaped to match the lower portion 138 of the valve
seal 130 preferably contains a plurality of flexible to reinforcing
members 52. The plurality of flexible members 52 allows the stay 50
to flex proportionally with the elastomeric material of the valve
seal when an instrument is inserted through the valve opening 132.
The stay 50 also substantially resists inversion of the valve seal
130 when an instrument is withdrawn from the valve seal 130.
Additionally, in an exemplary embodiment, the stay 50 has a
circumferential flange 54 around the outside of the stay located
above the flexible members 52. As best shown in FIG. 5, the
circumferential flange 54 prevents the upper seal portion 133 from
being pushed into the lower half of inner support member 28. That
is, the circumferential flange 54 will come into contact with the
lower half of the inner support member 28 upon bending of the upper
seal portion 133. Additionally, the stay 50 includes a
circumferential upper wall 56 as shown in FIGS. 6 and 7. The upper
wall 56 is disposed above the circumferential flange 54 and
adjacent to the upper seal portion 133.
[0050] The valve seals 30 and 130 are preferably made from
elastomeric materials that are able to expand to accommodate a
surgical instrument and form a seal around the instrument. In an
exemplary embodiment the elastomeric material is able to resist
puncturing from the instrument. Representative elastomeric
materials include, but are not limited to, silicone, plastic
elastomers, polyisoprene, butyl rubber, neoprene or natural rubber
and the like.
[0051] Representative reinforcing layer materials are those
materials sufficient to expand to accommodate a surgical
instrument, resist puncturing from the instrument, form a seal
around the instrument and capable of forming a unitary structure
with the elastomeric material.
[0052] The stay 50, as shown in FIG. 5, for example, is made from a
material that is able to resist inversion when an instrument is
withdrawn from the valve seal. Further, the stay may be made from a
material that is able to bond with the material of the valve seal
130 thereby forming a unitary structure. The bonding may occur by
an adhesive or by any other suitable process, by chemical means
known to one skilled in the art, or by any other suitable process.
Suitable materials for the stay may include, but are not limited to
polyethylene, polypropylene, nylons, plastic elastomers and the
like.
[0053] In operation, the seal assembly 10 of the present invention
is mounted to a cannula (not shown) using the mating members 26. A
surgical instrument (not shown) is inserted into the throughbore 20
for passage through the instrument seal opening 32 and the duckbill
valve 42. If the instrument is inserted off axis, the valve seal 30
resists puncture and the lower seal portion 38 allows some movement
of the instrument seal opening 32 to accommodate the insertion of
the instrument. Further, the curved taper of the lower seal portion
38 helps to guide the instrument toward the instrument seal opening
32. In an exemplary embodiment, the lower seal portion 38 has a
curved taper from the bottom of the upper seal portion 33 to the
seal opening of 32.
[0054] When the instrument passes through the instrument seal
opening 32, the elastomeric nature of the valve seal 30 allows the
opening 32 to expand to accommodate the instrument. Typical
openings may be 5 mm across in a relaxed state and may expand up to
12 mm to accommodate the instrument. It will be appreciated that
the seal assembly may be constructed to accommodate various sizes
of instruments. The lower seal walls 39 and 40 allow the instrument
seal opening to fit snugly around the instrument to provide a fluid
and gas seal. The instrument is then inserted through the duckbill
valve 42. The instrument may then be inserted downwardly into the
cannula and, eventually, into the body cavity.
[0055] When the valve seal 130 is used, the operation is similar to
that described above. A surgical instrument (not shown) is inserted
into the throughbore 20 for passage through the instrument seal
opening 132 and the duckbill valve 42. If the instrument is
inserted off axis, the protector wall 24 helps align the instrument
and the valve seal 130 resists puncture. The lower body portion 138
allows some movement of the instrument seal opening 132 to
accommodate the insertion of the instrument. Further, the curved
taper of the lower seal to portion 138 helps to guide the
instrument toward the instrument seal opening 132. In an exemplary
embodiment, the lower seal portion 138 has a curved taper from the
bottom of the upper seal portion 133 to the seal opening of
132.
[0056] When the instrument passes through the instrument seal
opening 132, the elastomeric nature of the valve seal 130 and the
flexible members 52 of the stay 50 allows the opening 132 to expand
to accommodate the instrument. As the instrument is inserted
through the valve seal 130, the circumferential flange 54 on the
stay 50 engages the inner support member 28 to help prevent the
valve seal 130 from dislodging from the mounting member 36 and acts
to prevent the upper seal portion 133 from being pushed into the
lower half of inner support member 28. Typical openings may be 5 mm
across in a relaxed state and may expand up to 12 mm to accommodate
the instrument. It will be appreciated that the seal assembly may
be constructed to accommodate various sizes of instruments. The
lower seal portion 138 allows the instrument seal opening 132 to
fit snugly around the instrument to provide a fluid and gas seal.
The instrument is then inserted through the slit 43 in the duckbill
valve 42. The instrument may then be inserted downwardly into the
cannula and, eventually, into the body cavity. When the instrument
is withdrawn from the valve seal assembly, the flexible members 52
of the stay 50 act to resist inversion of the valve seal.
[0057] By the above description, the present invention provides a
simple, effective surgical instrument seal assembly. The surgical
instrument seal assembly in accordance with the invention protects
the valve seal from damage from off axis instrument insertions, is
cost effective to produce and is durable.
[0058] It will therefore be readily understood by those persons
skilled in the art that the present invention is susceptible to
broad utility and application. Many embodiments and adaptations of
the present invention other than those herein described, as well as
many variations, modifications and equivalent arrangement, will be
apparent from or reasonably suggested by the present invention and
the foregoing description thereof, without departing from the
substance or scope of the present invention.
[0059] Accordingly, while the present invention has been described
herein in detail in relation to its preferred embodiment, it is to
be understood that this disclosure is only illustrative and
exemplary of the present invention and is made merely for purposes
of providing a full and enabling disclosure of the invention. The
foregoing disclosure is not intended or to be construed to limit
the present invention or otherwise to exclude any such other
embodiments, adaptations, variations, modifications and equivalent
arrangements, the present invention being limited only by the
claims and the equivalents thereof.
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