U.S. patent application number 11/097550 was filed with the patent office on 2006-01-26 for valve assembly including diameter reduction structure for trocar.
Invention is credited to Robert C. Smith.
Application Number | 20060020281 11/097550 |
Document ID | / |
Family ID | 36649752 |
Filed Date | 2006-01-26 |
United States Patent
Application |
20060020281 |
Kind Code |
A1 |
Smith; Robert C. |
January 26, 2006 |
Valve assembly including diameter reduction structure for
trocar
Abstract
A surgical seal assembly includes a sleeve housing adapted to be
operatively connected to a surgical sleeve, a seal housing adapted
for releasable mounting to the sleeve housing and having a seal
member with inner portions adapted to permit passage of a surgical
object in substantial sealed relation therewith, and a manual lock
member associated with the sleeve housing. The manual lock member
is adapted for movement relative to the seal housing between a
first position corresponding to a release position of the seal
housing to permit removal of the seal housing from mounting to the
sleeve housing and a second position corresponding to a lock
position of the seal housing to secure the seal housing to the
sleeve housing. The manual lock member is preferably adapted for
rotational movement relative to a longitudinal axis of the seal
housing to move between the first and second positions thereof.
Inventors: |
Smith; Robert C.; (Cheshire,
CT) |
Correspondence
Address: |
UNITED STATES SURGICAL,;A DIVISION OF TYCO HEALTHCARE GROUP LP
150 GLOVER AVENUE
NORWALK
CT
06856
US
|
Family ID: |
36649752 |
Appl. No.: |
11/097550 |
Filed: |
April 1, 2005 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10380942 |
Mar 19, 2003 |
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PCT/US01/31911 |
Oct 12, 2001 |
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11097550 |
Apr 1, 2005 |
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60240506 |
Oct 13, 2000 |
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Current U.S.
Class: |
606/167 ;
604/167.01 |
Current CPC
Class: |
A61B 2017/00477
20130101; A61B 17/3462 20130101; A61B 2017/3464 20130101 |
Class at
Publication: |
606/167 ;
604/167.01 |
International
Class: |
A61B 17/32 20060101
A61B017/32 |
Claims
1. A surgical seal assembly, which comprises: a sleeve housing
connected to a surgical sleeve; a seal housing including a seal
member, the seal member having inner portions adapted to permit
passage of a surgical instrument in substantial sealed relation
therewith; and a manual lock member movably mounted relative to the
sleeve housing, the manual lock member being movable between a
first position corresponding to a release position to permit
detachment of the seal housing from the sleeve housing, and a
second position corresponding to a lock position of the seal
housing, to secure the seal housing to the sleeve housing.
2. The surgical seal assembly according to claim 1 wherein the
manual lock member is adapted for rotational movement relative to a
longitudinal axis of the seal housing.
3. The surgical seal assembly according to claim 2 wherein the
manual lock member includes an annular member associated therewith,
the annular member including at least one locking surface adapted
to engage a corresponding at least one locking tab of the seal
housing upon movement of the manual lock member to the second
position.
4. The surgical seal assembly according to claim 3 wherein the
annular member defines a central aperture for passage of the
surgical object.
5. The surgical seal assembly according to claim 4 wherein the
annular member defines a plurality of mounting recesses adjacent
the central aperture, and the seal housing has a plurality of
locking tabs corresponding to the mounting recesses, the mounting
recesses in general alignment with the locking tabs of the seal
housing when in the first position of the manual lock member to
receive the locking tabs, the mounting recesses being displaced
from the locking tabs upon movement of the manual lock member to
the second position thereof.
6. The surgical seal assembly according to claim 5 wherein the
manual lock member includes a manual grip member depending radially
outwardly relative to the longitudinal axis of the seal housing,
the manual grip member dimensioned and configured for engagement by
the surgeon.
7. The surgical seal assembly according to claim 1 including at
least two stand-off elements mounted within the seal housing distal
of the seal member, the stand-off elements adapted for pivotal
movement between an initial position and a pivoted position to
permit passage of the surgical object, the stand-off elements being
normally biased to the initial position to urge the surgical object
into general alignment with respect to a longitudinal axis of the
seal housing.
8. The surgical seal assembly according to claim 7 wherein the at
least two stand-off elements are operatively coupled such that
movement of at least one of the stand-off elements between the
initial and pivoted positions causes corresponding movement of the
other entering element.
9. The surgical seal assembly according to claim 1 wherein the
sleeve housing is connected to a cannula assembly.
10. The surgical seal assembly according to claim 1 wherein one of
the seal housing and the sleeve housing includes a locking tab and
the other of the seal housing and the sleeve housing includes a
locking access, the locking tab and the locking recess cooperating
to secure the seal housing to the sleeve housing upon movement of
the manual lock member to the second position.
11. A surgical system, which comprises: a cannula assembly
including a cannula housing and a cannula sleeve extending from the
cannula housing, the cannula sleeve defining a longitudinal axis
and having a longitudinal passageway to permit passage of a
surgical instrument; and a surgical seal assembly including: a
first seal subassembly including a first housing having a seal
member defining inner portions adapted to permit passage of a
surgical object in substantial sealed relation therewith; a second
seal subassembly including a second housing adapted for mounting to
the cannula housing; and a manual lock member adapted for movement
between a first position corresponding to a release position of the
first seal subassembly to permit release of the first seal
subassembly from mounting to the second seal subassembly and a
second position corresponding to a lock position of the first seal
subassembly, to secure the first seal subassembly to the second
seal subassembly.
12. The surgical system according to claim 11 wherein the second
seal subassembly includes the manual lock member.
13. The surgical system according to claim 11 wherein the manual
lock member is adapted for rotational movement relative to the
longitudinal axis to move between the first and second positions
thereof.
14. The surgical system according to claim 11 wherein the second
subassembly includes a zero closure valve adapted to open to permit
passage of the surgical instrument and to substantially close in
the absence of the surgical instrument.
15. The surgical system according to claim 14 wherein one of the
first and second seal assemblies includes a locking latch and the
other of the first and second seal subassemblies includes a
corresponding locking surface, the locking latch and the locking
surface cooperating to secure the first seal subassembly to the
second seal subassembly upon movement of the manual lock member to
the second position thereof.
16. The surgical system according to claim 15 wherein the other of
the first and second seal subassemblies includes a locking recess
dimensioned for receiving the locking latch when the manual lock
member is in the first position whereby upon rotation of the manual
lock member to the second position the locking latch cooperatively
engages the locking surface.
17. The surgical system according to claim 16 wherein the first
seal subassembly includes the locking latch and the second seal
subassembly includes the locking recess and the locking
surface.
18. The surgical system according to claim 17 wherein the first
seal subassembly includes a plurality of locking latches and the
second seal subassembly includes a plurality corresponding locking
recesses for receiving the locking latches.
19. A method for performing a surgical procedure, comprising the
steps of: providing an access assembly including an access housing
and an access sleeve operatively connected to the access housing
the access housing having a manual lock member; mounting a seal
assembly to the access housing, the seal assembly including a seal
housing and a seal member mounted relative to the seal housing, the
seal member including inner portions adapted to form a substantial
seal about a surgical object introduced therethrough; and securing
the seal housing relative to the access housing by moving the
manual lock member to cause corresponding structure of the access
housing and the seal housing to cooperatively engage in secured
relation therewith.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation-in-part of U.S. patent
application Ser. No. 10/380,942, which is a national phase
application of International Application No. PCT/US01/31911, filed
Oct. 12, 2001, which claims priority to U.S. Application Ser. No.
60/240,506, filed Oct. 13, 2000, the entire contents of each
application being hereby incorporated by their entireties by
reference herein.
BACKGROUND
[0002] 1. Technical Field
[0003] The present disclosure relates to a mechanism for
controlling the operable inside diameter of a passageway through a
valve assembly of a trocar housing. More particularly, the present
disclosure relates to a diameter reduction structure that restricts
the movement of small surgical instruments and. accommodates large
diameter surgical instruments in the passageway of a trocar housing
to facilitate the maintenance of a gas tight seal formed by the
valve assembly.
[0004] 2. Background of Related Art
[0005] Trocar valve assemblies preferably provide a fluid tight
seal about a surgical instrument introduced through the trocar
during a minimally invasive surgical procedure. A typical valve
assembly includes an outer seal, which can be fixed or floating, in
combination with additional inner seals. Fixed outer seals are
limited by their ability to sustain a seal when a smaller surgical
instrument is moved off-axis relative to a central axis of the
trocar. Fixed seals are also limited by their ability to sustain
their integrity when the surgical instrument is angulated. Such
extreme ranges of motion of smaller diameter surgical instruments
within the cannula can create a "cat eye" or crescent shaped gap in
the fixed seal that can result in a loss of seal integrity.
Additional problems include the flexibility of the seal in
maintaining its integrity when both small diameter and large
diameter surgical instruments are used.
[0006] Devices to restrict the diameter of a passageway in a trocar
housing generally require an additional mechanism to be positioned
on the proximal end of the trocar housing that restricts the range
of motion of small surgical instruments. These diameter reducing
devices, however, typically employ additional seals and/or
structures that require adjustments by the user to accommodate
different sized surgical instruments, thereby complicating the
surgical process.
[0007] A continuing need exists for a diameter reducing structure
that can limit parallel off-axis as well as angular movements of
small diameter surgical instruments and accommodate larger diameter
surgical instruments without external adjustments.
SUMMARY
[0008] In accordance with a preferred embodiment, a surgical seal
assembly includes a sleeve housing connected to a surgical sleeve,
a seal housing including a seal member having inner portions
adapted to permit passage of a surgical instrument in substantial
sealed relation therewith, and a manual lock member movably mounted
to the sleeve housing. The manual lock member is adapted for
movement relative to the seal housing between a first position
corresponding to a release position of the seal housing to permit
detachment of the seal housing from the sleeve housing and a second
position corresponding to a lock position of the seal housing to
secure the seal housing to the sleeve housing. The manual lock
member is preferably adapted for rotational movement relative to a
longitudinal axis of the seal housing to move between the first and
second positions thereof.
[0009] The manual lock member may include an annular member having
at least one locking surface adapted to engage at least one
corresponding locking tab of the seal housing upon movement of the
manual lock member to the second position. The annular member
defines a central aperture for permitting passage of the object.
Preferably, the annular member defines a plurality of mounting
recesses adjacent the central aperture and the seal housing has a
plurality of locking tabs corresponding to the mounting recesses.
The mounting recesses are in general alignment with the locking
tabs of the seal housing when in the first position of the manual
lock member to receive the locking tabs. The mounting recesses are
thereafter displaced from the locking tabs upon movement of the
manual lock member to the second position thereof. The manual lock
member may include a manual grip member depending radially
outwardly relative to the longitudinal axis of the seal housing.
The manual grip member is dimensioned and configured for engagement
by the surgeon.
[0010] The surgical seal assembly may include at least two
stand-off elements mounted within the seal housing distal of the
seal member. The stand-off elements are adapted for pivotal
movement between an initial position and a pivoted position to
permit passage of the surgical object. The stand-off elements may
be normally biased to the initial position to restrict off-axis
movement of the surgical object with respect to a longitudinal axis
of the seal housing. The at least two stand-off elements are
preferably operatively coupled such that movement of at least one
of the stand-off elements between the initial and pivoted positions
causes corresponding movement of the other stand-off: elements.
[0011] The sleeve housing may be adapted for connection to a
cannula housing of a cannula assembly.
[0012] In another preferred embodiment, a surgical system includes
a cannula assembly including a cannula housing and a cannula sleeve
extending from the cannula housing. The cannula sleeve defines a
longitudinal axis and has a longitudinal passageway to permit
passage of a surgical instrument. The surgical system further
includes a surgical seal assembly incorporating first and second
seal subassemblies. The first seal subassembly includes a first
housing having a seal member defining inner portions adapted to
permit passage of a surgical object in substantial sealed relation
therewith. The second seal subassembly includes a second housing
adapted for mounting to the cannula housing. A manual lock member
is adapted for movement between a first position corresponding to a
release position of the first subassembly to permit removal of the
first subassembly from mounting to the second subassembly, and a
second position corresponding to a lock position of the first
subassembly to secure the first subassembly to the second
subassembly. Preferably, the second subassembly includes the manual
lock member.
[0013] The manual lock member may be adapted for rotational
movement relative to the longitudinal axis to move between the
first and second positions thereof. One of the first and second
seal assemblies includes a locking latch and the other of the first
and second seal subassemblies includes a corresponding locking
surfaces. The locking latch and the locking surface cooperate to
secure the first seal subassembly to the second seal subassembly
upon movement of the manual lock member to the second position
thereof. The other of the first and second seal subassemblies
includes a locking recess dimensioned for receiving the locking
latch when the manual lock member is in the first position whereby
upon rotation of the manual lock member to the second position the
locking latch cooperatively engages the locking surface.
Preferably, the first seal subassembly includes the locking latch
and the second seal subassembly includes the locking recess and the
locking surface. The first seal subassembly preferably includes a
plurality of locking latches and the second seal subassembly
includes a plurality corresponding locking recesses for receiving
the locking latches.
[0014] The second subassembly may include a zero closure valve
adapted to open to permit passage of the surgical instrument and to
substantially close in the absence of the surgical instrument.
[0015] A method for performing a surgical procedure is also
disclosed. The method includes the steps of: [0016] providing an
access assembly including an access housing and an access sleeve
operatively connected to the access housing; [0017] mounting a seal
assembly to the access housing with the seal assembly including a
seal housing and a seal member mounted relative to the seal
housing, the seal member including inner portions adapted to form a
substantial seal about a surgical object introduced therethrough;
and [0018] securing the seal housing relative to the access housing
by moving a manual lock member associated with the access housing
to cause corresponding structure of the access housing and the seal
housing to cooperatively engage in secured relation therewith.
BRIEF DESCRIPTION OF THE DRAWINGS
[0019] Preferred embodiments of the presently disclosed trocar
diameter reduction structures for trocar are described herein with
reference to the drawings, wherein:
[0020] FIG. 1 is a perspective view of one preferred embodiment of
a valve assembly and diameter reduction structure for trocars
constructed in accordance with the present disclosure;
[0021] FIG. 2 is an exploded perspective view of the valve assembly
and diameter reduction structure of FIG. 1;
[0022] FIG. 3 is a close-up perspective view of a proximal end
portion of the valve assembly and diameter reduction structure of
FIG. 1;
[0023] FIG. 4 is a close-up perspective view of the valve assembly
and diameter reduction structure of FIG. 3 partially disassembled
showing a diameter reduction structure positioned in a diameter
reduction structure foundation element;
[0024] FIG. 5 is a close-up perspective view of the valve assembly
and diameter reduction structure of FIG. 1 partially disassembled
showing, a second seal;
[0025] FIG. 6 is a close-up perspective view of a linking member in
accordance with the disclosure of FIG. 1;
[0026] FIG. 7 is a close-up perspective view of a distal end
portion of the diameter reduction structure foundation element in
accordance with the disclosure of FIG. 1;
[0027] FIG. 8 is a close-up perspective view of a stand off in
accordance with the disclosure of FIG. 1;
[0028] FIG. 9 is a cross-sectional view of the valve assembly and
diameter reduction structure of FIG. 1 along lines 9-9;
[0029] FIG. 10 is a close-up of the cross-sectional view of the
valve assembly and diameter reduction structure of FIG. 9;
[0030] FIG. 11 is an exploded view of the diameter reduction
structure and the diameter reduction structure foundation element
of FIG. 4;
[0031] FIG. 12 is a perspective view of the valve assembly and
diameter reduction structure of FIG. 1 being operationally employed
with a large diameter surgical instrument passing through the valve
assembly and diameter reduction structure and into a tissue portion
of a patient;
[0032] FIG. 13 is a close-up of the cross-sectional view of FIG. 12
along lines 13-13 showing the repositioning of the diameter
reduction structure for the large diameter surgical instrument;
[0033] FIG. 14 is a close-up cross sectional view of the valve
assembly and diameter reduction structure of FIG. 10 showing a
small diameter surgical instrument being positioned at least
partially therein;
[0034] FIG. 15 is the cross-sectional view of FIG. 14 showing the
diameter reduction structure controlling the angular movement of a
small diameter surgical instrument positioned therein;
[0035] FIG. 16A is a top view of a second embodiment of a valve and
diameter reduction structure constructed in accordance with the
present disclosure;
[0036] FIG. 16B is a cross-sectional view of FIG. 16A along lines
16B-16B showing a representative movement of one stand off member
of the diameter reduction structure;
[0037] FIG. 16C is. a cross-sectional view of FIG. 16A along lines
16C-16C showing the diameter reduction structure in a first
position;
[0038] FIG. 17 is a perspective view of a proximal end of a third
embodiment of a diameter reduction structure for trocar constructed
in accordance with the present disclosure;
[0039] FIG. 18A is across-sectional view of the trocar illustrating
the diameter reduction structure of FIG. 17 along line 18A-18A;
[0040] FIG. 18B is a cross-sectional view of the valve assembly and
diameter reduction structure of FIG. 18A along line 18B-18B;
[0041] FIG. 18C is a cross-sectional view of the valve assembly and
diameter reduction structure of FIG. 18A along line 18C-18C;
[0042] FIG. 19 is a cross-sectional side view of a fourth
embodiment of the valve assembly and diameter reduction structure
constructed in accordance with the present disclosure;
[0043] FIG. 20A is an enlarged cross-sectional view of the second
embodiment of the stand off configuration of the diameter reduction
structure for trocar of FIGS. 18A, 18B, and 18C;
[0044] FIG. 20B is an enlarged cross-sectional view of the stand
off configuration of the diameter reduction structure for trocar of
FIG. 19;
[0045] FIG. 20C is partial cross-sectional perspective view of a
fifth embodiment of a diameter reduction structure constructed in
accordance with the present disclosure;
[0046] FIG. 21 is a top view of a sixth embodiment of a valve
assembly and diameter reduction structure for trocar having a
movable diameter reduction. assembly constructed in accordance with
the present disclosure;
[0047] FIG. 22A is a cross-sectional view of the valve assembly and
diameter reduction structure for trocar stand for trocar of FIG. 21
along line 21A-21A;
[0048] FIG. 22B is the cross-sectional view of the valve assembly
and diameter reduction structure for trocar of FIG. 22A with the
stand off assembly in the second position;
[0049] FIG. 22C is the cross-sectional view of the stand off
configuration of FIG. 22A with the stand off assembly in a third
position; and
[0050] FIG. 23 is a cross-sectional view of an alternate embodiment
of the valve assembly and diameter reduction structure of FIG.
22A;
[0051] FIG. 24 is a perspective view of another alternate
embodiment of the seal assembly shown mounted to a cannula assembly
in accordance with the principles of the present disclosure;
[0052] FIG. 25 is a perspective view with parts separated of the
seal assembly and cannula assembly in accordance with the
embodiment of FIG. 24 illustrating the components of the first and
second seal subassemblies;
[0053] FIG. 26 is a side cross-sectional view taken along the lines
26-26 of FIG. 24 illustrating the seal assembly mounted to the
cannula housing of the cannula assembly in accordance with the
embodiment of FIGS. 24-25;
[0054] FIG. 27 is a perspective view illustrating mounting of the
first seal subassembly to the second seal subassembly in accordance
with the embodiment of FIGS. 24-26;
[0055] FIG. 28 is a view illustrating the mounting tabs of the
first seal subassembly in accordance with the embodiment of FIGS.
24-27;
[0056] FIG. 29 is a view illustrating the mounting recesses of the
second seal subassembly for receiving the mounting tabs of the
first seal subassembly in accordance with the embodiment of FIGS.
24-28;
[0057] FIG. 30 is a view of the seal assembly illustrating the
manual lock member in a first position corresponding to a release
position in accordance with the embodiment of FIGS. 24-29; and
[0058] FIG. 31 is a view of the seal assembly illustrating the
manual lock member in a second position corresponding to a locked
position in accordance with the embodiment of FIGS. 24-30.
DETAILED DESCRIPTION OF THE TREFERRED EMBODIMENTS
[0059] The present disclosure contemplates the introduction into a
body of a patient a trocar adapted for receiving all types of
surgical instruments including clip appliers, graspers, dissectors,
retractors, staplers, laser fibers, endoscopes, as well as
electrosurgical cutting, coagulating, and ablation devices, and the
like. All such objects are referred to herein as "instruments".
[0060] Referring now in specific detail to the drawings in which
like referenced numerals identify similar or identical elements
throughout the several views, and initially to FIG. 1, a novel
valve assembly and diameter reduction structure for trocar 100 is
shown constructed in accordance with a preferred embodiment of the
present disclosure and intended to be used in combination with a
conventional trocar assembly and cannula 50 defining a passageway
25 aligned with a central longitudinal axis-X. Passageway 25
defines a first operational area.
[0061] Valve assembly and diameter reduction structure 100 includes
diameter reduction assembly 200 located adjacent a proximal end
portion and valve assembly 300 located adjacent a distal end
portion. The diameter reduction assembly 200 of the present
disclosure, either alone or in combination with valve assembly 300
provides a seal between a cavity formed in the patient and the
outside atmosphere during and subsequent to insertion of an
instrument through cannula 50. Moreover, valve assembly and
diameter reduction structure 100 is capable of accommodating
instruments of varying diameter, e.g. from ranges such as 5 mm to
12 mm, by providing a gas tight seal with each instrument during
surgical procedures. The flexibility of the present valve assembly
and diameter reduction structure 100 to retain a fluid tight seal
greatly facilitates endoscopic surgery where a variety of
instruments having differing diameters are often needed during a
single surgical procedure and off axis movements as well as small
tool surgical angulation is employed.
[0062] Valve assembly and diameter reduction structure 100 is
preferably detachably mountable to a proximal end 54 of cannula 50.
During surgery, the surgeon can remove the diameter reduction
assembly 200 from valve assembly 300 at any time during the
surgical procedure and, similarly, mount diameter reduction
assembly 200 to valve assembly 300 to reconfigure diameter
reduction structure and valve assembly 100. In addition, diameter
and valve assembly 100 may be readily adapted to be mounted to
conventional cannulas of differing structures, material, and
lengths. The ability of diameter reduction assembly 200 to detach
from valve assembly 300 facilitates specimen removal through
cannula 50 and reduces the profile of cannula 50 when diameter
reduction assembly 200 is not needed at a particular point of the
surgical procedure. It is envisioned that assembly 200 can also be
configured to adapt to a variety of valve assemblies.
[0063] Referring now to FIGS. 2-3, one preferred embodiment of the
novel valve assembly and diameter reduction structure 100 of the
present disclosure will be discussed in detail. Diameter reduction
assembly 200 includes an end cap 110, a first seal 125, diameter
reduction structure housing or first housing 210, a first O-ring
225, a diameter reduction structure 240, and a diameter reduction
structure foundation element 280. Diameter reduction structure
foundation 280 is connected with valve assembly 300. Seal housing
30 is configured to be removably connected to cannula 50.
[0064] End cap 110 is generally tubular in shape and includes a
distal end portion 112 and a proximal end portion 114. An annular
shaped disc 116 defines a hole 115 aligned with the central
longitudinal axis. End cap 110 is removably connected with diameter
reduction structure housing 210.
[0065] First seal 125 is sealingly positioned between a distal side
of the annular shaped disc 116 of end cap 110 and a proximal end
portion of diameter reduction structure housing 210. First seal 125
forms a first exterior seal of assembly 100 and may be any
conventional type of seal such as, but not limited to, a fixed or
floating seal.
[0066] Diameter reduction structure housing 210 has a generally
hemispherical shell shape decreasing in circumference from a distal
end portion 212 to a proximal end portion 214. Correspondingly,
distal end portion 212 defines a hole 215 having a diameter larger
than the diameter defined by annular portion 213 of proximal end
portion 214. Hole 215 is concentrically aligned with the central
longitudinal axis-X. Proximal end portion 214 is configured to be
connectively received by distal end portion 112. Distal end 212
includes an outside cylindrical portion 216 having a scalloped
surface to facilitate handling thereof. A first O-ring 225 is
seated on the inside surface of diameter reduction structure
housing 210 in the vicinity of annular portion 213.
[0067] Referring now to FIGS. 2 and 4, diameter reduction structure
foundation element 280 is configured to seat diameter reduction
structure 240 on its proximal end portion 284 and support the
movement of the diameter reduction structure 240 through a
predefined range of motion and, in cooperation with housing 210,
provides a suitable support structure for stand offs 250 when
limiting the operational diameter of the passageway 25 through
valve assembly and diameter reduction structure 100. Foundation
element 280 has an outside cylindrical surface 286 and further
defines a distally positioned generally tubular shaped portion 285
centered on the longitudinal axis.
[0068] Diameter reduction structure 240 includes a stand off
assembly 245 having three stand off members 250 interconnected by a
linking mechanism 270 having three linking members 271 in this one
preferred embodiment. Stand offs 250 provide a predetermined degree
of control over the movements of an instrument positioned within
assembly 100. Linking mechanism 270 integrates and synchronizes the
movement of stand offs 250.
[0069] Each linking member 271 is connected with and positioned
between two adjoining stand offs 250 such that diameter reduction
structure 240 forms an approximately hexagonal configuration of
alternating stand offs 250 and linking members 271 centered around
longitudinal axis X.
[0070] Each stand off member 250 includes a cylindrical cogwheel
portion 252 defining a longitudinal axis-Y (see FIG. 8) and having
opposing cylindrical end portions 254 with gears having cogs or
teeth 255 extending parallel to longitudinal axis-Y. Linking
members 271 also have a cylindrical shape defining a longitudinal
axis-Z (see FIG. 6) and opposing ends 274 with gears having cogs or
teeth 275. Teeth 275 extend parallel with the longitudinal axis-Z.
Linking members 271 and stand off members 250 are positioned in
diameter reduction structure foundation element 280 such that each
respective cog 275 or 255 is configured, dimensioned, and
positioned with suitable angular orientation to fit into a
corresponding beveled slot 257 or 277, respectively, of the
adjoining interrelated portion of diameter reduction structure 240
to integrate and coordinate the simultaneous movement of each stand
off 250.
[0071] Linking members 271 provide a synchronizing function for the
pivotal movement of stand offs 250 throughout their range of
movement, wherein the diameter reduction structure 240 is at least
partially repositioned to accommodate a larger diameter surgical
instrument. The limitations of movement of the diameter reduction
structure 240 in the second position include factors such as the
diameter of the cannula, shape of the stand off, and internal
portions of the trocar that limit the pivotal or rotational type
travel of stand offs 250 away from the longitudinal axis. The
second position is defined as when stand offs 250 are pivoted,
flexed, or rotated in their seated position in diameter reduction
structure 280 in a generally arcuate path distally and away from
the longitudinal axis to increase the passageway 25 diameter
defined by the interrupted annular barrier of diameter reduction
structure 240.
[0072] Diameter reduction structure housing 210 and diameter
reduction structure foundation element 280 are configured to
support the positioning, diameter control function, and movement of
diameter reduction structure 240. Housing 210 and foundation
element 280 may be adapted to interface with a variety of different
end caps, first seals, and seal housings, for example, as well as
varying cannula sizes.
[0073] Referring now to FIGS. 2 and 5, valve assembly 300 includes
a second O-ring 335, a first seal support member 350, a second seal
365, a second seal support member 380, a third O-ring 395, and a
seal housing or second housing 310 configured for connecting to
cannula 50. Diameter reduction structure foundation 280 provides
seating for second O-ring 335 providing a seal between distal end
282 and a proximal end portion 354 of first seal support element
350.
[0074] A second seal 365 includes a flange 367 for being sealingly
positioned between a distal end portion 352 of first seal support
element 350 and a proximal end portion 384 of second seal support
element 380. First seal support element 350 is generally annular in
shape with an outside cylindrical surface 356 and has three
distally extending tabs 358. A second seal support element 380 also
has a generally annular shape with an outside cylindrical surface
386 and is configured with radially extending tabs 388. A third
O-ring 395 provides a seal between second seal support element 380
and seal housing 310.
[0075] Seal housing 310 has a proximal end portion 314 including
radially aligned slots 318 configured to correspondingly mate with
tabs 388 and a distal end portion 312 configured to mate with
cannula 50 utilizing a suitable attachment mechanism such as a
bayonet or threaded connection.
[0076] Seal housing 310 further includes two diametrically opposed
cantilevered portions 325. Each cantilevered portion includes two
opposed notches 326 having suture attachment fixtures 327 generally
perpendicular to portions 325. Attachment fixtures 327 include a
cylindrical portion 328 and a hemispherical portion 329 configured
for an easy tie off of sutures for the positive retention of the
trocar assembly in position within the patient against the
sufflation pressure typically employed in minimally invasive
surgery.
[0077] Second seal 365 is shown as a duck bill type seal, but it
may be any seal system such as a frusto-conical seal, for example,
that may be adapted to perform the function of a second seal.
Second seal support element 380 is positioned in seal housing
310.
[0078] End cap 110, diameter reduction structure housing 210,
diameter reduction structure foundation element 280, first seal
support element 350, second seal support element 380, and seal
housing 310 are preferably made of a medical grade plastic, metal,
or composite materials having suitable strength and resilience for
its application. In one preferred embodiment, the above assemblies
are injection molded using a medical grade plastic. The O-rings are
made of a medical grade plastic or rubber suitable for providing a
fluid tight seal between generally rigid structural members.
[0079] Referring now to FIGS. 6-8, in one preferred embodiment,
linking member 271 is shown aligned with longitudinal axis-Z. A
band 272 having an increased circumference and predetermined width
is positioned on the cylindrical surface 274 of each linking
mechanism 270. Cogs 275 have a first arcuate width congruent at the
outside surface of cylindrical portion 274 that tapers or bevels to
a narrower second arcuate width at the opposing side of each cog
275. Thus, cogs 275 extend inwardly from surface 274 to a
predetermined point between surface 274 and longitudinal axis-Z.
Cogs 275 extend beyond and at least partially surround a recessed
flat portion 278 that may include at least one pin 279. Pin 279 is
concentric with longitudinal axis-Z and extends axially. Slots 277
are defined by cogs or teeth 275 and beveled portions of
cylindrical portion 274.
[0080] Diameter reduction structure foundation element 280 is shown
with distal end portion 282 connecting with tubular shaped portion
285 and proximal end 284. Tubular shaped portion 285 is positioned
to guide instruments being inserted into the second seal and has an
inside diameter at least approximately equal to the diameter of
passageway 25. Radially extending tabs 287 and 289 positioned on
tubular shaped portion 285 and cylindrical portion 286,
respectively, are configured and dimensioned to sealingly engage
first seal support element 350 with foundation element 280 in
combination with O-ring 335. Cylindrical portion 286 has an annular
shape including a radially extending lip 281. Proximally extending
tabs 288 and at least partially concave cavities 290 are configured
to support the rotation or flexing of diameter reduction structure
240 within proximal end portion 284.
[0081] Stand off members 250 have a head 260 connected by an arm
256 to a base portion 251 with opposing cylindrical end portions
254 aligned with a longitudinal axis-Y. A tubular band 252 has a
circumference greater than the circumference of end portion 254. A
longitudinally aligned notch 252a is formed in band 252 near the
base of arm 256. Cogs 255 have a first arcuate width congruent with
the surface of cylindrical portion 254 that tapers to a narrower
second arcuate width at the opposing side of each cog 255. Thus,
cogs 255 extend inwardly from surface 254 to a predetermined point
between surface 254 and longitudinal axis-Y. Slots 257 are defined
by cogs or teeth 255 and beveled portion of cylindrical end portion
254. Cogs 255 extend along axis-Y beyond and at least partially
surround a recessed flat portion 258 that may include a pin 259.
Pin 259 is concentric with longitudinal axis-Y and extends axially
from portion 258. Head 260 has a generally hemispherical or bulbous
shape having an exterior surface and a concave interior surface
266.
[0082] Head 260 includes a first side 262 having a generally planar
face and an opposing tapered second side 268. First side 262
includes a cantilevered extension 261. A third side 264 includes a
generally convex portion and beveled side portions 265. A fourth
side 266, opposing, the third side 264, has a generally planar face
that is connected with arm 256. Head 260 also includes a centrally
positioned segmented concave notch 263 approximately perpendicular
to longitudinal axis-Y. The generally concave shape of notch 263 is
configured and dimensioned to accommodate a limited degree off axis
movement by small surgical tools when diameter reduction structure
240 is in a first or initial position. Arm 256 connects head 260
with base portion 251.
[0083] Diameter reduction structure 240 components, including stand
off assembly 245 and linking mechanism 270,. are preferably
fabricated from at. least one medical grade plastic, laminates of
medical grade plastics, or composite materials of suitable
flexibility, bias, rigidity, and compressive strength for
application as diameter reduction structure. Different materials
may also be bonded together in this structure depending on the
application, for example, head 260 may be fabricated from one
medical grade plastic that is of greater resiliency than a second
medical grade plastic that forms arms 256. Similarly, linking
members 271 may be formed of similarly suitable one or more medical
grade plastic or composite materials.
[0084] Further, the system of cogs synchronizing the movement of
stand offs 250 and linking members 271 are but one type of linking
mechanism 270 known by those skilled in the art suitable for
synchronizing the movements of stand offs 250 and other suitable
alternative mechanisms such as, but not limited to a pulley system,
a flexible synchronizing shaft, or an articulated joint performing
the same function are envisioned.
[0085] Referring now to FIGS. 9, and 10, valve assembly and
diameter reduction structure 100 and cannula 50 are shown in
cross-section. First seal 125 includes concave or arcuate membrane
portion 127 that extends radially inwardly and distally forming a
distal end portion 128 defining a hole 129. Portions 127 are in
close proximity to or abut stand off members 250. Stand off members
250 are shown in a first position having an orientation generally
perpendicular to central longitudinal axis-X. The depth and width
of segmented notches 263 are shown relative to hole 129 and second
side 264 and provide a limited and increased degree of off axis
movement or angular movement of small surgical instruments.
[0086] Stand offs 250 include a base portion 251 positioned in
proximity to or abutting cantilevered portion 218. Cantilevered
portion 220 includes wall 222 configured to act as a stop to limit
the radially outward movement of heads 260 of stand off members
250. The material of construction of stand off members, and
especially head 260, may be selectively controlled to provide a
range of flexibly compressive bias against parallel off axis and
angular movements or surgical instruments.
[0087] Diameter reduction structure housing 210 at least partially
encloses diameter reduction structure foundation element 280 and
first seal support element 350. Flange 367 of second seal 365 is
secured between first seal support element 350 and second seal
support element 380. Seal housing 310 at least partially encloses
second seal support element 380. Cannula 50 connects with distal
end portion 312 of seal housing 310.
[0088] In FIG. 11, diameter reduction structure 240, shown as an
integrated assembly in the first position, for placement within
diameter reduction structure foundation element 280. Foundation
element 280 is configured to provide suitable positioning for
diameter reduction structure 240 to control the operable diameter
and thus improving the ability of the sealing system of assembly
100 to retain its integrity during procedures utilizing small
instruments. This includes a suitable supporting structure for
stand offs 250 to act as a barrier providing a controlled
limitation to the movement of surgical instruments and supporting
the movement of diameter reduction structure 240 between the first
and second positions.
[0089] The first position of structure 240 being defined by. heads
260 forming an interrupted annular barrier structure suitable for
controlling forces in a plane generally orthogonal to the
longitudinal axis-X resulting from parallel off axis and angular
movements or movements generally orthogonal to the longitudinal
axis of small surgical instruments positioned in passageway 25. The
third sides 264 of heads 260 defining the second operable area in
the first position.
[0090] In the first position, beveled portions 265 of heads 260
define gaps or interruptions in the annular barrier structure
formed by diameter reduction structure 240. The size of the gap is
controlled by the shape and position of heads 260 and is configured
to ensure smaller diameter surgical instruments are precluded from
passing between heads 260. Diameter reduction structure 240 further
includes a controlled bias configured to resist the movement of
reduction structure 240 radially in an outward direction as well as
from the first position to the second position. The bias in
structure 240 also serves to return structure 240 to the first
position after the removal of the larger diameter surgical
instrument.
[0091] The second position being defined by diameter reduction
structure 240 moving at least partially distally to accommodate the
unrestricted passage or of individual larger sized diameter
surgical instruments through diameter reduction structure 240 and
cannula 50.
[0092] Foundation element 280 includes at least partially concave
seating positions 296 for linking members 271 and 290 for stand off
members 250. Seating positions 290 define an interrupted channel
having two distinct seats or supports 292 configured and
dimensioned to receive cylindrical end portions 254. Band 252 is
positioned between supports 292. Seating positions 290 further
include an arcuate support member 294 with a proximally extending
straight portion 299.
[0093] Seating positions 296 define an at least partially concave
channel portions 298 separated by a slot or recess 297 configured
and dimensioned to receive surface 274 and band 272 of linking
member 271. Seating positions 296 include a proximally extending
straight portion 299.
[0094] Seating positions 290 and 296 are structurally supported by
a proximally extending member 295. Member 295 is connected by arms
to portions 292 and 298 and is configured to structurally support
portions 292 and 298 from excessive deflection or movement.
[0095] Seating positions 290 and 296 provide the alignment;
spacing, and angular orientation critical for the interrelation of
cogs 255 and 275 with their respective slots 277 and 257 for the
synchronizing of the movements of stand offs 250 and linking
members 271. In addition, diameter reduction structure 240 includes
a bias to the first position as individual components or as an
assembly either as a result of its positioning within diameter
reduction structure foundation element 280, a separate bias member
such as an elastic band, or by combinations thereof. When fully
assembled with diameter reduction structure housing 210 (see FIG.
2) and diameter reduction structure foundation 280, diameter
reduction structure 240 is capable of performing its functions at
any angle or in any direction of use without any operator
action.
[0096] Referring now to FIGS. 12 and 13, diameter reduction
structure 100 is shown in an operational position. A large diameter
medical instrument 80 defining a second longitudinal axis is
positioned through valve assembly and diameter reduction structure
100 and cannula 50. A large diameter surgical instrument is an
instrument having a diameter or an cross-sectional area orthogonal
to the second longitudinal axis less than a first diameter or first
operable area of passageway 25, but greater than the second
diameter or second operable orthogonal to the central longitudinal
axis defined by the stand off assembly in the first position.
Similarly, a small diameter surgical instrument 60 defining a first
longitudinal axis has a diameter or cross-sectional area orthogonal
to the first longitudinal axis less than the second diameter or
second operable defined by the stand off assembly in the first
position. Thus, the large instruments by definition being larger
than the second operable area must at least partially deflect stand
off assembly 240 distally in order to enter the passageway. In
contrast, the small instruments can be positioned axially within
the second operable area without deflecting stand off assembly 240.
In this one preferred embodiment, large instruments are those
defined as having diameters greater than 5.5 mm and small
instruments those defining diameters equal to or less than 5.5 mm.
The 5.5 mm distinction between large and small instruments is
relative to the diameter of the passageway defined in the trocar
and can vary depending upon the diameter of the trocar apparatus
the valve assembly and diameter reduction structure 100. When large
diameter instrument 80 is moved distally along central longitudinal
axis-X through first seal 125 and into contact with diameter
reduction structure 240, the axially aligned force component moving
large diameter instrument 80 has to overcome the bias configured to
retain diameter reduction structure 240 in the first position, as
shown in FIG. 10.
[0097] As the force behind instrument 80 exceeds the bias
configured to maintain diameter reduction structure 240 in the
first position, diameter reduction structure 240, pivots or rotates
in a generally arcuate movement in a generally distal direction
initially and then continues its pivotal or rotational arcuate
movement, as shown by arrows "A" and "B", away from the central
longitudinal. axis to define the third operable area and
accommodate the passage of large diameter instrument 80. The amount
of bias employed to retain diameter reduction structure 240 in the
first position is controlled by factors such as the materials of
construction of diameter reduction structure. 240 as well as the
methods employed of securing diameter reduction structure 240 in
position in diameter reduction structure foundation element
280.
[0098] When forced towards. the inside diameter of wall 356 by the
shaft of large diameter of instrument 80, stand offs 250 move to a
second position wherein face 262 of head 260 is placed
approximately parallel with and in apposition to wall 356. The
spatial relationship between wall 356 and diameter reduction
structure 240 in the second position is a function of individual
trocar interior configurations, the inside circumference of
passageway 25, and the intended application of the valve assembly
and diameter reduction structure 100. Valve assembly and diameter
reduction structure 100 is configured to provide suitable space for
the pivoting or flexing of diameter reduction structure 240 and
still accommodate larger diameter instruments 80 that conform with
the maximum inside diameter for a given. cannula 50. Upon
withdrawal of larger diameter instrument 80, diameter reduction
structure 240 is biased to reposition to a first position wherein a
portion of each stand off 250 is adjacent wall 220.
[0099] Referring now to FIGS. 14 and 15, stand off members 250 are
shown in a first or diameter reduction position, wherein head 260
extends in a generally radial direction relative to longitudinal
axis-X. Cantilevered portion 222 provides a generally rigid barrier
configured to structurally support and limit the radial
displacement of head 260. Diameter reduction structure 240 in the
first position is configured to accommodate the penetration of
smaller diameter instruments 60 through valve assembly and diameter
reduction structure 100 and into cannula 50 without any
movement.
[0100] When in this first position, stand off member 250 is placed
at least partially in axial compression by a force with a component
perpendicular to central longitudinal axis-X as a result of the
orthogonal or angular movements of a small diameter surgical
instrument 60. Each stand off member 250 is mounted in diameter
reduction assembly 200 to provide a limit to excessive parallel off
axis and angular movements of small diameter surgical instruments
60.
[0101] A small diameter surgical instrument 60 is positioned
through seal 125 and into cannula 50 typically with little or no
substantial contact with diameter reduction structure 240. When
small diameter surgical instruments 60 are manipulated to make off
axis or angular movements, however, small diameter surgical
instruments 60 come in contact with at least one head portion 260
and the inside circumference of cannula 50 which act in combination
as two separate and approximately parallel structural barriers to
control outwardly directed off axis and angular movements away from
central longitudinal axis-X. The combination of head 260 and
cantilevered portion 222 may be configured as a rigid or flexible
biased structure. This controlling mechanism functions to bound the
operational movements by small diameter surgical instruments 60,
sufficiently to retain the integrity of the sealing system.
[0102] Referring now to FIGS. 16A, 16B, and 16C, in another
preferred embodiment, valve assembly and diameter reduction
structure 500 includes a proximal end portion or diameter reduction
assembly 600 and a valve assembly 700 similar to the previous
embodiment, however, diameter reduction structure 640 is positioned
proximal to a first seal 525.
[0103] Diameter reduction structure 500 includes an end cap 510, a
diameter reduction structure housing 610, a diameter reduction
structure 640, a diameter reduction structure foundation element
680, and as required a first O-ring.
[0104] End cap 510 has a generally cylindrical shape including a
distal end portion 512 and a proximal end portion 514. Proximal end
portion 514 includes an annular shaped disc or portion 516 defining
a hole 515 aligned with the central longitudinal axis-X. In this
configuration, annular portion 516 may be a rigid plastic or a
flexible membrane not configured to be a seal. Thus, hole 515 could
be configured as a rigid or flexible barrier and having a diameter
at least equal to the. inside diameter of a cannula 50 in a rigid
configuration.
[0105] Diameter reduction structure housing 610 has a generally
hemispherical shell shape decreasing in circumference from a distal
end portion 612 to a proximal end portion 614. Proximal end portion
614 includes an annular portion 613 defining hole 615. Hole 615
preferably has a larger diameter than hole 515. Proximal end
portion 614 is configured to be connectively received by distal end
portion 512. Distal end portion 612 includes an outside cylindrical
portion 616 having a scalloped surface to facilitate handling
thereof.
[0106] Diameter reduction structure 640 includes a stand off
assembly having three stand off members 650 and a linking mechanism
670 is positioned proximal to a first seal 525. Stand offs 650
provide a predetermined degree of control over and limitation to
the movements of instruments positioned within assembly 600.
Linking mechanism 670, in the form of three linking members 671,
integrate and synchronize the movement of stand offs 650. While the
specific configuration of stand off members 650 or linking
mechanism 670 may vary, stand off assembly 645 is employed
operationally as described in all of the embodiments herein to
limit the off-axis and angular movements of small surgical
instruments.
[0107] Diameter reduction structure foundation element 680 is
configured to seat diameter reduction structure 640 on. its
proximal end portion 682 and includes at least partially
cantilevered seating positions 690 configured to support and
control the movement of reduction structure 640 throughout a
predefined range of motion as at least partially represented by
arrow "A". A distally extending tubular portion 685 is configured
for the positioning of first seal 525. First seal 525 is positioned
approximately orthogonal to longitudinal axis-X and may be a fixed
or- a floating type seal.
[0108] A first seal support element 750 has a generally tubular
shape with a distal end portion 754 abutting a proximal side of
cantilevered seating portion 690 and a distal end 752. First
support element 750 has an inside wall 756 that may be configured
to limit the distal range of motion of stand offs 650. A
cantilevered portion 753 of first seal element 750 is positioned to
secure and seal a flange 767 of a second seal 765 in positioned
between a proximal portion of second seal support element 780.
[0109] A distal end 752 of first support element 750 at least
partially encloses and sealingly positions a flange 767 of second
seal 765 in cooperation with a distal end portion 782 of a second
seal support element 780. Second seal 765 may be any type of seal,
but is preferably a duck bill type seal commonly configured for use
with a fixed or floating first seal. In the preferred embodiment,
second seal 765 is a duck bill type seal extending distally into a
seal housing 710.
[0110] Seal housing 710 includes a proximal portion 714 configured
to secure and at least partially enclose second seal 765 and at
least a portion of second seal support element 780 and first seal
support element 750. Second seal support element 780 also has a
generally annular shape and is configured to lock with and engage
first seal support element 750. Seal housing 710 has a distal end
portion 712 configured to mate with a cannula.
[0111] Valve assembly and diameter reduction structure 500 is
configured as an assembly for controlling the off axis and angular
movements of small surgical instruments externally or proximally to
the sealing system. This configuration reduces the strain placed on
the first seal by further limiting the range of angular motion to
which the first seal is subjected to by small surgical instrument
manipulation and thereby improving the integrity of the trocar
sealing system. In addition, while valve assembly and diameter
reduction structure 500 may be removably connected to a
correspondingly dimensioned cannula 50, it is also envisioned that
end cap 510, housing 610, diameter reduction structure 640, and
foundation element 680 may be readily adapted as an integrated
assembly, for example, with or without an integrated first seal
525, for use with a wide range of trocar assemblies having fixed or
floating seals to advantageously control off-axis and angular
movements of small surgical instruments without interrupting the
integrity of the sealed portions of the trocar.
[0112] Referring now to FIGS. 17 and 18A-18C, one of the preferred
embodiments of a valve assembly and diameter reduction structure
800 includes a proximal end portion or diameter reduction assembly
900 and a distal end portion or valve assembly 1000. Diameter
reduction structure 940 is positioned distal to a first seal 825
and within a diameter reduction structure housing 910.
[0113] Diameter reduction structure 940 is illustrated with a stand
off assembly. 945 having three stand offs 950 and three linking
members 971 positioned in a diameter reduction structure foundation
980.--While the general configuration of diameter reduction
structure foundation 980 and linking members 971 are structurally
and operationally similar to earlier embodiments, stand offs 950
have a different configuration head portion 960, similar to that
depicted in FIG. 16A, with side portion 965 having a generally
planar shape and a width approximately equivalent to arm 956.
[0114] Head portion 960 may also include an attachment mechanism
963 and a cantilevered extension or flange 967. Flange 967 extends
radially from head 960 toward base 961 in the first position. In
the second position of stand off 950, flange 967 can be configured
with a suitable length to at least partially limit the range of
movement of stand off 950 by contacting an inside wall of diameter
reduction structure housing 910. Attachment mechanism 963 is
configured to receive and retain an annularly shaped bias member
969 on stand off 950 throughout its range of motion. Annularly
shaped biased member 969 is configured to bias stand offs 950 to
the first position, provide an additional bias when off axis or
angular movements act to. compress a stand off 950 in a radially
outward direction against the. diameter reduction structure
foundation 980 or housing 910, and act as an uninterrupted barrier
to preclude smaller diameter surgical instruments from intruding
between standoffs 950.
[0115] The combined effect of attachment mechanism 963, flange
portion 967, and bias member 969 is the control by stand off
assembly 940 of the movement of smaller diameter surgical
instruments when forces having a generally orthogonal orientation
to the longitudinal axis are employed as well as the ability of
stand off assembly 940 to automatically accommodate larger diameter
instruments.
[0116] In FIG. 19, an additional preferred embodiment of valve
assembly and diameter reduction structure 1200 is configured with a
diameter reduction structure 1340 including a stand off assembly
1345 having four diametrically opposed stand offs 1350
independently positioned within a diameter reduction structure
foundation. 1380. Each stand off 1350 independently pivots, without
a linking mechanism, to limit off-axis and angular movements of
small instruments.
[0117] Stand off members 1350 include ahead 1360, an arm 1356, and
a base element 1351 configured for mounting with foundation 1380.
Stand off 1350 can be fixedly mounted to foundation 1380j or
example, or in the alternative base element 1351 may be pivotally
positioned on foundation 1380 and retained in place using a
positioning element (not shown). A bias is employed to position
stand off 1380 to a first position adjacent housing 1310. As a
further alternative embodiment, a linking mechanism may be
positioned to be operative with heads 1360 to perform, for example,
one or both functions of the linking mechanism shown previously.
Alternative head 1360 configurations include having telescoping,
tongue and grooved, or beveled gear mechanisms that interrelate
stand offs 1380 into an approximately contiguous annular structure
throughout their range of motion.
[0118] A bias inherent in stand off 1350 or in combination with its
positioning element to the diameter reduction structure foundation
1380 maintains stand offs 1350 in the first position unless
deflected by a large diameter surgical instrument. As shown in
other embodiments, diameter reduction structure 1350 may be
employed proximal to or distal to a first seal. Stand offs 1350, in
this configuration, also include a bulbous shaped head 1360,
similar to that of head 260 for controlling the movements of
smaller diameter surgical instruments.
[0119] In FIGS. 20A and 20B, two embodiments of stand off members
950 and 1350 are shown corresponding to FIGS. 18A-18C and 19,
respectively. These two major configurations of stand offs,
however, are only to be considered to be representative of all the
stand off configurations described herein. Stand off members 950
and 1350 include base portions 951 and 1351 forming- an axis "y" at
angle alpha (a) with an axis "Y". Axis "Y" is perpendicular to
central longitudinal axis "X". Heads 960 and 1360 define an axis
"x" at an angle theta ".theta." with the "X". Depending upon the
configuration of the trocar housing and application, angles
".alpha." or ".theta." may be coincident with their respective "Y"
and "X" axes or extend to the opposing side of their respective
axes in alternative embodiments of stand offs 950 and 1350. Axis
"X" is parallel to central longitudinal axis "X".
[0120] All the stand offs described herein provide a generally
compression resistant biased structure against forces acting in a
plane having a generally orthogonal orientation to the "X" or
central longitudinal axis. It is envisioned that stand offs 950 and
1350, as well as all the other stand off variations herein are
configured and positioned relative to structures such as the
diameter reduction housings to at least provide a generally
compression resistant biased structure against forces in planes at
angles ranging from plus or minus approximately 15 degrees from an
angle orthogonal to the central longitudinal axis.
[0121] Individual stand off members 950 and 1350 can include
varying head portion 960 and 1360 configurations such as wing
extensions or flanges that overlap, interrelate, or interleave
between adjacent stand offs 950 and 1350. A retention mechanism 939
can also be included in head portion 960 and 1360, for example, for
the positioning of a biased member 939.
[0122] Referring now to FIG. 20C, in a further alternate embodiment
of a diameter reduction structure 1440, a single unified stand off
assembly 1445 is formed into a continuous and integrated flanged
stand off or flange structure 1445. Flange structure 1445 may take
any configuration of head 1460, arm 1456, and base 1451, for
example, suitable for performing the function of limiting the
movement of smaller diameter surgical instruments when moved
generally parallel off-axis or angularly. Diameter reduction
structure 1440 may be at least partially segmented with a plurality
of slots 1431 defining segmented head portions 1460 and arms 1456.
A retention mechanism 1439 can also be employed to further bias
diameter reduction structure 1440. This embodiment could also take
the structural form of a cantilevered generally linear flexible
flange structure or an angled stand off structure at least
partially cantilevered and supported by a correspondingly
positioned structure housing.
[0123] Diameter reduction structure 1440, with independent stand
offs 1450 or configured as an integrated unified flange structure
stand off 1450, is suitably configured to resist forces in a plane
transverse to central longitudinal axis "X" and in particular
forces in a plane approximately orthogonal to the central
longitudinal axis "X". Flange structure 1450 is configured to flex
or pivot with forces generally aligned with the longitudinal axis
"X" so as to accommodate large diameter surgical instruments
without any operational adjustments.
[0124] In another alternate embodiment the diameter reduction
structure is a unified structure wherein the arms are joined to
form an annular type structure configuration and are positioned
within the trocar housing as an assembly. The stand off assembly in
this embodiment can also include separate or integral biased
members.
[0125] In still another embodiment, one or more diameter reduction
structures could be employed together in series or in one assembly
to create parallel diameter reduction structures or diameter
reduction structures of different diameters.
[0126] Referring now to FIGS. 21 and 22A, a further alternate
embodiment of a valve assembly and diameter reduction structure
1500 includes a diameter reduction assembly 1600 and valve assembly
1700. Valve assembly and diameter reduction structure 1500 defines
a passageway 1505 concentric with a central longitudinal
axis-X.
[0127] Diameter reduction assembly 1600 includes a first seal 1525,
diameter reduction structure housing or distal housing 1610, a
diameter reduction structure 1640, and a diameter reduction
structure foundation element 1680. Diameter reduction structure
foundation 1680 connects with valve assembly 1700. Seal housing or
proximal housing 1710 of valve assembly 1700 is configured to be
removably connected to cannula 50.
[0128] Diameter reduction structure housing 1610 is generally
tubular in shape and includes a tubular wall 1615 defining a distal
end portion 1612 and a proximal end portion 1614. Proximal end
portion 1614 has a proximally extending rim 1616 defining a
recessed portion or flange 1618. Flange 1618 is approximately
perpendicular to the longitudinal axis-X and includes a rim 1619
defining a hole or passageway 1505 aligned with longitudinal
axis-X. Diameter reduction structure housing 1610 in this
configuration includes a first seal 1515 positioned distal to
flange 1618 that is held in position by a first seal support
element 1620. First seal support element 1620 also defines a rim
1622 aligned with rim 1619. A distal end of rim 1622 forms an edge
1623 with a distal end 1622 of seal support element 1620. Distal
end portion 1612 includes a flanged portion 1613.
[0129] The inside diameter of tubular wall 1615 abuts and is
configured to slidingly move in relation to a first member 1630 and
a second annular member 1635. A distal edge 1631 of annular member
1630 is positioned abutting a proximal edge 1636 of second annular
member 1635. Second annular member 1635 has a radially extending
protuberance or tab 1637.
[0130] Diameter reduction housing 1610 is connected to an annular
member 1611 extending distally from distal end 1612. A stop 1608 is
positioned on a distal end 1609 of member 1611 that abuts a seal
support element 1750 and defines a first position of housing 1610.
Stop 1608 also interfaces with and is limited by tab 1637 to at
least partially limit the proximal travel of housing 1610 and
defines a second position of housing 1610.
[0131] Diameter reduction structure 1640 is positioned on a
diameter reduction foundation element 1680. Diameter reduction
foundation element 1680 has a distal end 1682 and a proximal end
1684. Distal end 1682 abuts with seal support element 1750. Element
1680 also abuts with a portion of the inside of annular members
1630 and 1635. Diameter reduction structure 1640 is configured to
support up to approximately 180.degree. of travel of each stand off
member 1650 from a position extending distally approximately
parallel to the longitudinal axis to a position extending
proximately approximately parallel to the longitudinal axis.
[0132] In a first stand off assembly 240 position, stand off
members 250 are generally positioned in a plane orthogonal the
central longitudinal axis and to reduce the operable area of
passageway 1505 in. combination with the structural support of
housing 1610. In a second stand off assembly 240 position, stand
off members 250 are generally positioned at least partially distal
to the first position. In a third stand. off assembly 240 position,
stand off members 250 are generally positioned at least partially
proximal to the first position.
[0133] Stand off members 1650 have a head 1660 connected by an arm
1656 to a base portion 1651 with opposing cylindrical end portions
1654. Stand off members 250 are connected by a linking mechanism
including three linking members 1671 as described in earlier
embodiments.
[0134] Head 1660 includes a first side 1662 having a generally
planar face and an opposing tapered second side 1668 in apposition
with first seal 1525 when diameter reduction structure 1640 is in
the first position. First side 1662 includes a cantilevered
extension 1661. A third side 1664 includes a generally convex
portion and beveled side portions 1665. A fourth side 1666,
opposing, the third side, has a generally planar face that is
connected with arm 1656 such that the planar face extends to second
side 1662 and to cantilevered portion 1661. Arm 1656 is a neck down
portion connecting base 1651 and head 1660. Head 1660 also includes
a centrally positioned segmented concave notch 1663 approximately
perpendicular to longitudinal axis-Y. The generally concave shape
of notch 1663 is configured and dimensioned to accommodate a
limited degree off axis movement by small surgical tools when
diameter reduction structure 1640 is in a first or initial
position.
[0135] While diameter reduction structure 1640 is illustrated with
stand off assembly 1645 having three stand offs 1650. and linking
mechanism 1670 having three linking members 1671, the general
configuration of diameter reduction structure foundation 1680 and
linking members 1671 are structurally and operationally similar to
earlier embodiments such as those. of FIGS. 6-8.
[0136] Valve assembly 1700 includes a first seal support member
1,750, a second seal 1765, and a seal housing 1710 configured for
connecting to cannula 50. In addition, an elastic tubular seal or
third seal 1601 is sealingly positioned over a sliding joint 1699
between valve assembly 1700 and diameter reduction assembly
1600.
[0137] Second seal support element 1750 is positioned between
diameter reduction foundation element 1680 and seal housing 1710.
Second seal support element 1750 has a generally annular in shape
with a tubular wall 1755 having an outside cylindrical surface
1756. In addition, a distal end 1752 of second seal support element
1750 seals second seal 1765 in position in combination with a
proximal end 1714 of seal housing 1710.
[0138] Seal housing 1710 proximal end portion 1714 includes
positions for the seating of the second seal support element 1750
and second seal 1765. A distal end portion 1712 of seal housing
1710 is configured to mate with cannula 50 utilizing a suitable
attachment mechanism such as a bayonet or threaded connection.
[0139] Third or tubular seal 1601 has a proximal end 1605 and a
distal end 1603. Proximal end 1715 is sealingly engaged with flange
1613 of diameter reduction housing 1610. Proximal end 1714 of seal
housing 1710 and distal end 1752 of second seal support element
1750 are positioned to sealingly engage a distal end portion 1603
of third seal 1601. Third seal 1601 is configured and dimensioned
as a flexible elastic tubular seal positioned over and providing a
seal for sliding joint 1699. Third seal 1601 is suitably flexible
for accommodating the movement of diameter reduction housing 1610
between the first position wherein stop 1608 is abutting second
seal support element 1750 and the second position wherein stop 1608
is repositioned proximally and is abutting tab 1637. In addition,
third seal 1601 provides a bias to the first position of diameter
reduction housing 1610 of seal housing 1610.
[0140] Third seal 1601 is preferably fabricated from a flexible
and/or stretchable material preferably an extrudable or injected
moldable material, most preferably an elastomer or elastomeric or
elastomer material. Third seal 1601 may include a central shape
indentation 1601 a to permit longitudinal extension and retraction
of structure housing 1610. Alternatively, third seal may be
completely tubular devoid of v-shape indentation as depicted in
FIG. 23, and have suitable elastomeric properties to permit the
seal to stretch during extension and retraction of the housing
1610. An elastomer material having a suitable thickness for
external instrument applications that can encounter rugged handling
and is resistant to tearing or penetration, for example, while
providing a flexible bias. It is also envisioned that third seal
1601 can be readily attached and detached, as required, for
autoclaving or sterilization.
[0141] Referring now to FIGS. 22A-22C, diameter reduction structure
1640 is biased to a first position, similar to that of FIGS. 15,
16A, and 20A wherein at least a portion of fourth side 1666 of head
1660 and arm 1656 are in apposition with a portion of diameter
reduction structure housing 1610 and stop 1608 is abutting second
seal support element 1750. In this embodiment, rim 1621 and distal
end 1622 of first seal support element 1620 are in apposition with
at least a portion of fourth side 1666 and arm 1656, respectively
and in particular, corner 1623 is positioned at the junction of
arms 1656 and side fourth side 1666. Thus, first seal support
element 1620 supports stand offs 1650 in the first position by
providing structural support for stand offs 1650 to limit from the
off axis and angular movements of small diameter surgical
instruments.
[0142] When diameter reduction structure 1640 is deflected distally
by a large surgical instrument, such as shown in. FIG. 13, to the
second position wherein face 1662 is pivoted in the direction of
the inside of tubular wall 1755 of second seal support element
1750, stand off members 1650 are accommodating the increased
diameter of the large surgical instrument without any external
adjustments by the surgeon or operator. Stand off members 1640,
however; retain their bias to the first position.
[0143] When the large surgical instrument is withdrawn proximally
through valve assembly and diameter reduction structure 1500, the
combination of the bias and elastic nature of stand off members
1650 may bind with the large instrument. To preclude undesirable
binding, distal end 1612 is slidingly engaged with first annular
member 1630, second annular member 1635, and second seal support
element 1750 such that the diameter reduction housing 1610 slides
proximally until the instrument ceases to bind or stop 1608 abuts
tab 1637. The proximal movement of diameter reduction structure
1610 from the first housing 1610 position defines an increased
volume within diameter housing 1610 that is suitable for stand off
members 1650 to pivot proximally to the third position and at least
partially increase the operable area of passageway 1505 from the
second operable area to a third operable at least wherein the
operable area is increased similar to that of the second position
of the stand off assembly such that the large instrument can be
withdrawn with limited resistance.
[0144] Additional alternative embodiments for precluding binding
include a catch or an engaging receptacle for each stand off in the
second position with an external release mechanism, for example, or
a friction reducing means such as one or more wheels positioned on
second side 1668 and/or third side 1664 that could accommodate the
withdrawal of the large instrument while in a distal or second
position by the rotation of the wheel and still provide adequate
resistance to movements of small surgical instruments when in the
first position.
[0145] Referring now to FIG. 24, there is illustrated another
embodiment of the present disclosure. System 2000 includes seal
assembly 2002 and cannula assembly 2004 to which the seal assembly
2002 is mounted. Seal assembly 2002 defines a seal housing
consisting of a plurality of components forming an outer member of
the seal assembly 2002, and diameter reduction structure for
limiting excessive off-axis and angular movements of small diameter
surgical instruments as discussed hereinabove. Seal assembly 2002
defines seal axis "x". Seal assembly 2002 includes first or
proximal seal subassembly 2006 and second or distal seal
subassembly 2008 which is connected to cannula assembly 2004. First
seal subassembly 2006 is adapted for releasable connection to
second seal subassembly 2008 and incorporates the diameter
reduction structure.
[0146] With reference now to FIG. 25-27, in conjunction with FIG.
24, first and second seal subassemblies 2006, 2008 of seal assembly
2002 will be discussed. First seal subassembly 2006 includes end
cap 2010, septum seal 2012 and diameter reduction housing 2014.
Diameter reduction housing 2014 includes first and second reduction
housing components 2016, 2018 which house stand-off elements 2020.
In general, stand-off elements 2020 are interconnected and pivot to
permit passage of an instrument. Stand-off elements 2020 are biased
to an initial position by elastomeric O-ring 2022. O-ring 2022 is
received within recess 2020r of each stand-off element 2020 as
shown in FIG. 26. When stand-off elements 2020 pivot downwardly
(shown in phantom in FIG. 26) upon insertion of an instrument,
O-ring 2022 stretches to permit this movement of the stand-off
elements 2020. Upon removal of the instrument, the stand-off
elements 2020 return to their initial position in transverse
relation to the axis "x" under the influence of the O-ring 2022.
The remaining components of first seal subassembly 2006 are
substantially similar to their corresponding components disclosed
and discussed in the prior embodiments, and reference is made
hereinabove for a further discussion of the structure and
functionality of these components.
[0147] In one further aspect of the present embodiment, diameter
reduction housing 2014 includes mounting tabs 2024 radially spaced
about interior wall 2026 of second reduction housing component
2018. As seen in FIG. 25 and FIG. 27, mounting tabs 2024 serve to
releasably secure first seal subassembly 2006 to second seal
subassembly 2008 as will be discussed.
[0148] Second seal subassembly 2008 includes stationary ring member
2028, duckbill valve housing 2030, zero closure or duck bill valve
2032 supported within the valve housing 2030, and manual lock
member 2034. Stationary ring member 2028 defines first annular wall
2036 on its proximal side. Annular wall 2036 incorporates small and
large recesses 2038, 2040 arranged in diametrical opposed relation
as shown. First annual wall 2036 of stationary ring member 2028 is
received within annular gap 2042 defined between walls 2044, 2046
of first and second reduction housing components 2016, 2018,
respectively (FIG. 26). Small and large recesses 2038, 2040 receive
corresponding pairs of positioning legs 2048, 2050 of reduction
housing 2014. As best depicted in FIGS. 28 and 29, the respective
distances between the positioning legs 2048, 2050 and corresponding
lengths of recesses 2038, 2040 (identified as distances and lengths
"a" and "b") ensure proper orientation of reduction housing 2014
within, or relative to, stationary ring member 2028 during
assembly.
[0149] Stationary ring member 2028 further includes second annular
wall 2052 disposed on the distal side of the stationary ring member
2028. Second annular wall 2052 includes partial annular slot 2054
therein and a plurality of radially spaced grooves 2056 in its
outer surface. A single locking tab 2058 is disposed within each
groove 2056. The functioning of partial slot 2054, spaced grooves
2056 and locking tabs 2058 will be discussed in greater detail
hereinbelow.
[0150] As best depicted in FIGS. 25 and 29, duck bill valve housing
2030 includes annular wall 2060 which defines central aperture
2062. Annular wall 2060 defines three grooves 2064 proximal
aperture 2062. Grooves 2064 accommodate mounting tabs 2024 of
diameter reduction housing 2014 during assembly of first and second
seal subassemblies 2006, 2008. Duck bill housing 2030 includes a
plurality of axial depending legs 2066. Legs 2066 of duck bill
valve housing 2030 may include rectangular openings 2068.
[0151] In one preferred arrangement, manual lock member 2034 is
secured to duck bill housing 2030 in fixed relation therewith.
Manual lock member 2034 includes a plurality of recesses 2070
defined in its outer surface. Recesses 2070 receive corresponding
depending legs 2066 of duck bill housing 2030. Recesses 2070 each
include mounting tabs 2072 (as seen in FIG. 25) which are received
within rectangular openings 2068 of depending legs 2066 of duck
bill housing 2030 in snap relation therewith to secure the two
components (see also FIG. 26). Manual lock member 2034 and duck
bill housing 2030 capture the peripheral rim 2074 of duck bill
valve 2032 to secure the duck bill valve 2032 between the two
components.
[0152] Manual lock member 2034 and duck bill housing 2030 are at
least partially disposed within stationary ring member 2028 and are
adapted for rotational movement relative to the stationary ring
member 2028. Manual lock member 2034 includes grip 2076 which
extends radially outwardly for engagement by the user. Grip 2076
includes transverse leg 2078 which is accommodated within partial
annular slot 2054 of stationary ring member 2028 and traverses the
slot 2054 during rotation of manual lock member 2034 and duck bill
housing 2030. Manual lock member 2034 is adapted for rotational
movement between a first position corresponding to a release
position which permits mounting and/or release of first subassembly
2006 from second subassembly 2008, and a second position
corresponding to a lock position which secures first subassembly
2006 to the second subassembly 2008. An O-ring seal 2080 may be
positioned about the circumference of duck bill housing 2030 to
form a substantial seal between the duck bill housing 2030 and
diameter reduction housing 2014.
[0153] In other embodiments, the manual lock member 2034 is
slidably received by duck bill housing 2030. The manual lock member
2034 is then slidable with respect to stationary ring member
2028.
[0154] With reference to FIGS. 24-26, cannula assembly 2004
includes cannula housing 2082 and cannula sleeve 2084 extending
from the housing 2082. Cannula housing 2082 includes vertical legs
2086 which are positioned within grooves 2056 of stationary ring
member 2028. Legs 2086 preferably include internal ledges 2088
advantageously dimensioned to accommodate locking tabs 2058
disposed within the grooves 2056 of stationary ring member 2028 to
fixedly secure the two components. Cannula sleeve 2084 defines
longitudinal passage 2090 which permits passage of instrumentation.
Cannula sleeve 2084 may be secured to cannula housing 2082 by
corresponding tongues 2092 and grooves 2094 of the cannula sleeve
2084 and the cannula housing 2082 respectively. An O-ring seal 2096
may be positioned within cannula housing 2082 for forming a seal
within the housing 2082 adjacent these components.
[0155] In use, second seal subassembly 2008 of seal assembly 2002
is mounted to cannula housing 2082. In this regard, vertical legs
2086 of cannula housing 2082 are aligned with grooves 2056 of
stationary ring member 2028 and the ring member 2028 is advanced
whereby the locking tabs 2058 of the ring member 2028 securely
engage the internal ledges 2088 within the vertical legs 2086.
Thereafter, when it is determined that the diameter reduction
structure is needed, for example, in use with a small diameter
instrument, first seal subassembly 2006 is positioned relative to
second seal subassembly 2008 as depicted in FIGS. 27-29. In this
position, positioning legs 2048, 2050 of first seal subassembly
2006 are aligned with the corresponding recesses 2038, 2040 of
second seal subassembly 2008 (FIGS. 25 and 27). In addition, manual
lock member 2034 is placed in the first or release position of FIG.
29. In this position, mounting tabs 2024 of the first seal
subassembly 2006 are in general alignment with mounting recesses
2064 of the annular plate 2060 of duck bill housing 2030 of the
second seal subassembly 2008. First seal subassembly 2006 is then
mounted to second seal subassembly 2008 whereby positioning legs
2048, 2050 are positioned in respective recesses 2038, 2040 and
mounting tabs 2024 are received within mounting grooves 2064 of
duck bill housing 2030. Manual lock member 2034 is then rotated
about axis "a" from the first or release position depicted in FIG.
30 to the second or lock position depicted in FIG. 31. This
movement of manual lock member 2034 causes corresponding rotational
movement of duck bill housing 2030 to displace the mounting grooves
2064 whereby mounting tabs 2024 are captured beneath annular wall
2060 of duck bill housing 2030. In this position, first seal
subassembly 2006 is secured to second seal subassembly 2008. The
procedure is continued by introducing an instrument through the
seal assembly 2002 and cannula assembly 2004, and performing the
desired surgical procedure.
[0156] It is noted that duck bill housing 2030 and manual lock
member 2034 may be a single component monolithically formed during
manufacture. In addition, it is envisioned that the second seal
subassembly 2008 may be a component of the cannula housing or
sleeve housing 2082, and supplied with the cannula assembly 2004.
In the alternative, second seal subassembly 2008 may replace the
cannula housing 2082 in its entirety and serve as the sleeve
housing. It is further envisioned that other modified first seal
subassemblies, for example, with or without diameter reduction
structure, may be adapted for use with the second seal subassembly
2008.
[0157] Although the illustrative embodiments of the present
disclosure have been described herein with reference to the
accompanying drawings, it is to be understood that the disclosure
is not limited to those precise embodiments and that various other
changes and modifications may be affected therein by one skilled in
the art without departing from the scope or spirit from the
disclosure. All such changes and modifications are intended to be
included within the scope of the appended claims.
* * * * *