US20060020281A1

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Publication number: US20060020281A1
Application number: US11/097,550
Authority: US
Inventors: Robert Smith
Original assignee: Tyco Healthcare Group LP
Current assignee: Covidien LP
Priority date: 2000-10-13
Filing date: 2005-04-01
Publication date: 2006-01-26
Also published as: JP2011251138A; US20100331783A1; JP2006280959A; DE602006019513D1; EP2269523A1; US7744569B2; US8282603B2; AU2006201294A1; EP1707135B1; US20080319396A1; EP1707135A1; CA2541307A1; AU2006201294B2

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.

Description

CROSS REFERENCE TO RELATED APPLICATIONS

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

1. Technical Field

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.

2. Background of Related Art

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.

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.

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

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.

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.

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.

The sleeve housing may be adapted for connection to a cannula housing of a cannula assembly.

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.

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.

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.

A method for performing a surgical procedure is also disclosed. The method includes the steps of:

- providing an access assembly including an access housing and an access sleeve operatively connected to the access housing;
- 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
- 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

Preferred embodiments of the presently disclosed trocar diameter reduction structures for trocar are described herein with reference to the drawings, wherein:

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;

FIG. 2 is an exploded perspective view of the valve assembly and diameter reduction structure ofFIG. 1;

FIG. 3 is a close-up perspective view of a proximal end portion of the valve assembly and diameter reduction structure ofFIG. 1;

FIG. 4 is a close-up perspective view of the valve assembly and diameter reduction structure ofFIG. 3 partially disassembled showing a diameter reduction structure positioned in a diameter reduction structure foundation element;

FIG. 5 is a close-up perspective view of the valve assembly and diameter reduction structure ofFIG. 1 partially disassembled showing, a second seal;

FIG. 6 is a close-up perspective view of a linking member in accordance with the disclosure ofFIG. 1;

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 ofFIG. 1;

FIG. 8 is a close-up perspective view of a stand off in accordance with the disclosure ofFIG. 1;

FIG. 9 is a cross-sectional view of the valve assembly and diameter reduction structure ofFIG. 1 along lines9-9;

FIG. 10 is a close-up of the cross-sectional view of the valve assembly and diameter reduction structure ofFIG. 9;

FIG. 11 is an exploded view of the diameter reduction structure and the diameter reduction structure foundation element ofFIG. 4;

FIG. 12 is a perspective view of the valve assembly and diameter reduction structure ofFIG. 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;

FIG. 13 is a close-up of the cross-sectional view ofFIG. 12 along lines13-13 showing the repositioning of the diameter reduction structure for the large diameter surgical instrument;

FIG. 14 is a close-up cross sectional view of the valve assembly and diameter reduction structure ofFIG. 10 showing a small diameter surgical instrument being positioned at least partially therein;

FIG. 15 is the cross-sectional view ofFIG. 14 showing the diameter reduction structure controlling the angular movement of a small diameter surgical instrument positioned therein;

FIG. 16A is a top view of a second embodiment of a valve and diameter reduction structure constructed in accordance with the present disclosure;

FIG. 16B is a cross-sectional view ofFIG. 16A alonglines16B-16B showing a representative movement of one stand off member of the diameter reduction structure;

FIG. 16C is. a cross-sectional view ofFIG. 16A alonglines16C-16C showing the diameter reduction structure in a first position;

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;

FIG. 18A is across-sectional view of the trocar illustrating the diameter reduction structure ofFIG. 17 alongline18A-18A;

FIG. 18B is a cross-sectional view of the valve assembly and diameter reduction structure ofFIG. 18A alongline18B-18B;

FIG. 18C is a cross-sectional view of the valve assembly and diameter reduction structure ofFIG. 18A alongline18C-18C;

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;

FIG. 20A is an enlarged cross-sectional view of the second embodiment of the stand off configuration of the diameter reduction structure for trocar ofFIGS. 18A, 18B, and18C;

FIG. 20B is an enlarged cross-sectional view of the stand off configuration of the diameter reduction structure for trocar ofFIG. 19;

FIG. 20C is partial cross-sectional perspective view of a fifth embodiment of a diameter reduction structure constructed in accordance with the present disclosure;

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;

FIG. 22A is a cross-sectional view of the valve assembly and diameter reduction structure for trocar stand for trocar ofFIG. 21 along line21A-21A;

FIG. 22B is the cross-sectional view of the valve assembly and diameter reduction structure for trocar ofFIG. 22A with the stand off assembly in the second position;

FIG. 22C is the cross-sectional view of the stand off configuration ofFIG. 22A with the stand off assembly in a third position; and

FIG. 23 is a cross-sectional view of an alternate embodiment of the valve assembly and diameter reduction structure ofFIG. 22A;

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;

FIG. 25 is a perspective view with parts separated of the seal assembly and cannula assembly in accordance with the embodiment ofFIG. 24 illustrating the components of the first and second seal subassemblies;

FIG. 26 is a side cross-sectional view taken along the lines26-26 ofFIG. 24 illustrating the seal assembly mounted to the cannula housing of the cannula assembly in accordance with the embodiment ofFIGS. 24-25;

FIG. 27 is a perspective view illustrating mounting of the first seal subassembly to the second seal subassembly in accordance with the embodiment ofFIGS. 24-26;

FIG. 28 is a view illustrating the mounting tabs of the first seal subassembly in accordance with the embodiment ofFIGS. 24-27;

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 ofFIGS. 24-28;

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 ofFIGS. 24-29; and

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 ofFIGS. 24-30.

DETAILED DESCRIPTION OF THE TREFERRED EMBODIMENTS

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”.

Referring now in specific detail to the drawings in which like referenced numerals identify similar or identical elements throughout the several views, and initially toFIG. 1, a novel valve assembly and diameter reduction structure fortrocar100 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 andcannula50 defining apassageway25 aligned with a central longitudinal axis-X.Passageway25 defines a first operational area.

Valve assembly anddiameter reduction structure100 includesdiameter reduction assembly200 located adjacent a proximal end portion andvalve assembly300 located adjacent a distal end portion. Thediameter reduction assembly200 of the present disclosure, either alone or in combination withvalve assembly300 provides a seal between a cavity formed in the patient and the outside atmosphere during and subsequent to insertion of an instrument throughcannula50. Moreover, valve assembly anddiameter reduction structure100 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 anddiameter reduction structure100 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.

Valve assembly anddiameter reduction structure100 is preferably detachably mountable to aproximal end54 ofcannula50. During surgery, the surgeon can remove thediameter reduction assembly200 fromvalve assembly300 at any time during the surgical procedure and, similarly, mountdiameter reduction assembly200 tovalve assembly300 to reconfigure diameter reduction structure andvalve assembly100. In addition, diameter andvalve assembly100 may be readily adapted to be mounted to conventional cannulas of differing structures, material, and lengths. The ability ofdiameter reduction assembly200 to detach fromvalve assembly300 facilitates specimen removal throughcannula50 and reduces the profile ofcannula50 whendiameter reduction assembly200 is not needed at a particular point of the surgical procedure. It is envisioned thatassembly200 can also be configured to adapt to a variety of valve assemblies.

Referring now toFIGS. 2-3, one preferred embodiment of the novel valve assembly anddiameter reduction structure100 of the present disclosure will be discussed in detail.Diameter reduction assembly200 includes anend cap110, afirst seal125, diameter reduction structure housing orfirst housing210, a first O-ring225, adiameter reduction structure240, and a diameter reductionstructure foundation element280. Diameterreduction structure foundation280 is connected withvalve assembly300. Seal housing30 is configured to be removably connected tocannula50.

End cap

110 is generally tubular in shape and includes adistal end portion112 and aproximal end portion114. An annular shapeddisc116 defines ahole115 aligned with the central longitudinal axis.End cap110 is removably connected with diameterreduction structure housing210.

First seal

125 is sealingly positioned between a distal side of the annular shapeddisc116 ofend cap110 and a proximal end portion of diameterreduction structure housing210.First seal125 forms a first exterior seal ofassembly100 and may be any conventional type of seal such as, but not limited to, a fixed or floating seal.

Diameterreduction structure housing210 has a generally hemispherical shell shape decreasing in circumference from adistal end portion212 to aproximal end portion214. Correspondingly,distal end portion212 defines ahole215 having a diameter larger than the diameter defined byannular portion213 ofproximal end portion214.Hole215 is concentrically aligned with the central longitudinal axis-X.Proximal end portion214 is configured to be connectively received bydistal end portion112.Distal end212 includes an outsidecylindrical portion216 having a scalloped surface to facilitate handling thereof. A first O-ring225 is seated on the inside surface of diameterreduction structure housing210 in the vicinity ofannular portion213.

Referring now toFIGS. 2 and 4, diameter reductionstructure foundation element280 is configured to seatdiameter reduction structure240 on itsproximal end portion284 and support the movement of thediameter reduction structure240 through a predefined range of motion and, in cooperation withhousing210, provides a suitable support structure forstand offs250 when limiting the operational diameter of thepassageway25 through valve assembly anddiameter reduction structure100.Foundation element280 has an outsidecylindrical surface286 and further defines a distally positioned generally tubular shapedportion285 centered on the longitudinal axis.

Diameter reduction structure

240 includes a stand off assembly245 having three stand offmembers250 interconnected by alinking mechanism270 having three linkingmembers271 in this one preferred embodiment.Stand offs250 provide a predetermined degree of control over the movements of an instrument positioned withinassembly100. Linkingmechanism270 integrates and synchronizes the movement ofstand offs250.

Each linkingmember271 is connected with and positioned between twoadjoining stand offs250 such thatdiameter reduction structure240 forms an approximately hexagonal configuration of alternatingstand offs250 and linkingmembers271 centered around longitudinal axis X.

Each stand offmember250 includes acylindrical cogwheel portion252 defining a longitudinal axis-Y (seeFIG. 8) and having opposingcylindrical end portions254 with gears having cogs orteeth255 extending parallel to longitudinal axis-Y. Linkingmembers271 also have a cylindrical shape defining a longitudinal axis-Z (seeFIG. 6) and opposing ends274 with gears having cogs orteeth275.Teeth275 extend parallel with the longitudinal axis-Z. Linkingmembers271 and stand offmembers250 are positioned in diameter reductionstructure foundation element280 such that each

respective cog

275 or255 is configured, dimensioned, and positioned with suitable angular orientation to fit into a corresponding

beveled slot

257 or277, respectively, of the adjoining interrelated portion ofdiameter reduction structure240 to integrate and coordinate the simultaneous movement of each stand off250.

Linkingmembers271 provide a synchronizing function for the pivotal movement ofstand offs250 throughout their range of movement, wherein thediameter reduction structure240 is at least partially repositioned to accommodate a larger diameter surgical instrument. The limitations of movement of thediameter reduction structure240 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 ofstand offs250 away from the longitudinal axis. The second position is defined as when standoffs250 are pivoted, flexed, or rotated in their seated position indiameter reduction structure280 in a generally arcuate path distally and away from the longitudinal axis to increase thepassageway25 diameter defined by the interrupted annular barrier ofdiameter reduction structure240.

Diameterreduction structure housing210 and diameter reductionstructure foundation element280 are configured to support the positioning, diameter control function, and movement ofdiameter reduction structure240.Housing210 andfoundation element280 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.

Referring now toFIGS. 2 and 5,valve assembly300 includes a second O-ring335, a firstseal support member350, asecond seal365, a secondseal support member380, a third O-ring395, and a seal housing orsecond housing310 configured for connecting to cannula50. Diameterreduction structure foundation280 provides seating for second O-ring335 providing a seal betweendistal end282 and aproximal end portion354 of firstseal support element350.

Asecond seal365 includes aflange367 for being sealingly positioned between a distal end portion352 of firstseal support element350 and aproximal end portion384 of secondseal support element380. Firstseal support element350 is generally annular in shape with an outsidecylindrical surface356 and has three distally extendingtabs358. A secondseal support element380 also has a generally annular shape with an outside cylindrical surface386 and is configured with radially extendingtabs388. A third O-ring395 provides a seal between secondseal support element380 and sealhousing310.

Seal housing

310 has aproximal end portion314 including radially alignedslots318 configured to correspondingly mate withtabs388 and adistal end portion312 configured to mate withcannula50 utilizing a suitable attachment mechanism such as a bayonet or threaded connection.

Seal housing

310 further includes two diametrically opposedcantilevered portions325. Each cantilevered portion includes twoopposed notches326 havingsuture attachment fixtures327 generally perpendicular toportions325.Attachment fixtures327 include acylindrical portion328 and ahemispherical portion329 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.

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. Secondseal support element380 is positioned inseal housing310.

End cap

110, diameterreduction structure housing210, diameter reductionstructure foundation element280, firstseal support element350, secondseal support element380, and sealhousing310 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.

Referring now toFIGS. 6-8, in one preferred embodiment, linkingmember271 is shown aligned with longitudinal axis-Z. Aband272 having an increased circumference and predetermined width is positioned on thecylindrical surface274 of each linkingmechanism270.Cogs275 have a first arcuate width congruent at the outside surface ofcylindrical portion274 that tapers or bevels to a narrower second arcuate width at the opposing side of eachcog275. Thus, cogs275 extend inwardly fromsurface274 to a predetermined point betweensurface274 and longitudinal axis-Z.Cogs275 extend beyond and at least partially surround a recessedflat portion278 that may include at least onepin279.Pin279 is concentric with longitudinal axis-Z and extends axially.Slots277 are defined by cogs orteeth275 and beveled portions ofcylindrical portion274.

Diameter reductionstructure foundation element280 is shown withdistal end portion282 connecting with tubular shapedportion285 andproximal end284. Tubular shapedportion285 is positioned to guide instruments being inserted into the second seal and has an inside diameter at least approximately equal to the diameter ofpassageway25. Radially extending

tabs

287 and289 positioned on tubular shapedportion285 andcylindrical portion286, respectively, are configured and dimensioned to sealingly engage firstseal support element350 withfoundation element280 in combination with O-ring335.Cylindrical portion286 has an annular shape including aradially extending lip281. Proximally extendingtabs288 and at least partiallyconcave cavities290 are configured to support the rotation or flexing ofdiameter reduction structure240 withinproximal end portion284.

Stand offmembers250 have ahead260 connected by anarm256 to abase portion251 with opposingcylindrical end portions254 aligned with a longitudinal axis-Y. Atubular band252 has a circumference greater than the circumference ofend portion254. A longitudinally alignednotch252ais formed inband252 near the base ofarm256.Cogs255 have a first arcuate width congruent with the surface ofcylindrical portion254 that tapers to a narrower second arcuate width at the opposing side of eachcog255. Thus, cogs255 extend inwardly fromsurface254 to a predetermined point betweensurface254 and longitudinal axis-Y.Slots257 are defined by cogs orteeth255 and beveled portion ofcylindrical end portion254.Cogs255 extend along axis-Y beyond and at least partially surround a recessedflat portion258 that may include apin259.Pin259 is concentric with longitudinal axis-Y and extends axially fromportion258.Head260 has a generally hemispherical or bulbous shape having an exterior surface and a concaveinterior surface266.

Head

260 includes afirst side262 having a generally planar face and an opposing taperedsecond side268.First side262 includes a cantileveredextension261. Athird side264 includes a generally convex portion and beveledside portions265. Afourth side266, opposing, thethird side264, has a generally planar face that is connected witharm256.Head260 also includes a centrally positioned segmentedconcave notch263 approximately perpendicular to longitudinal axis-Y. The generally concave shape ofnotch263 is configured and dimensioned to accommodate a limited degree off axis movement by small surgical tools whendiameter reduction structure240 is in a first or initial position.Arm256 connectshead260 withbase portion251.

Diameter reduction structure

240 components, including stand off assembly245 andlinking mechanism270,. 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,head260 may be fabricated from one medical grade plastic that is of greater resiliency than a second medical grade plastic that formsarms256. Similarly, linkingmembers271 may be formed of similarly suitable one or more medical grade plastic or composite materials.

Further, the system of cogs synchronizing the movement ofstand offs250 and linkingmembers271 are but one type of linkingmechanism270 known by those skilled in the art suitable for synchronizing the movements ofstand offs250 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.

Referring now toFIGS. 9, and10, valve assembly anddiameter reduction structure100 andcannula50 are shown in cross-section.First seal125 includes concave orarcuate membrane portion127 that extends radially inwardly and distally forming adistal end portion128 defining ahole129.Portions127 are in close proximity to or abut stand offmembers250. Stand offmembers250 are shown in a first position having an orientation generally perpendicular to central longitudinal axis-X. The depth and width ofsegmented notches263 are shown relative tohole129 andsecond side264 and provide a limited and increased degree of off axis movement or angular movement of small surgical instruments.

Stand offs

250 include abase portion251 positioned in proximity to or abutting cantileveredportion218.Cantilevered portion220 includeswall222 configured to act as a stop to limit the radially outward movement ofheads260 of stand offmembers250. The material of construction of stand off members, and especiallyhead260, may be selectively controlled to provide a range of flexibly compressive bias against parallel off axis and angular movements or surgical instruments.

Diameterreduction structure housing210 at least partially encloses diameter reductionstructure foundation element280 and firstseal support element350.Flange367 ofsecond seal365 is secured between firstseal support element350 and secondseal support element380.Seal housing310 at least partially encloses secondseal support element380.Cannula50 connects withdistal end portion312 ofseal housing310.

InFIG. 11,diameter reduction structure240, shown as an integrated assembly in the first position, for placement within diameter reductionstructure foundation element280.Foundation element280 is configured to provide suitable positioning fordiameter reduction structure240 to control the operable diameter and thus improving the ability of the sealing system ofassembly100 to retain its integrity during procedures utilizing small instruments. This includes a suitable supporting structure forstand offs250 to act as a barrier providing a controlled limitation to the movement of surgical instruments and supporting the movement ofdiameter reduction structure240 between the first and second positions.

The first position ofstructure240 being defined by.heads260 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 inpassageway25. Thethird sides264 ofheads260 defining the second operable area in the first position.

In the first position, beveledportions265 ofheads260 define gaps or interruptions in the annular barrier structure formed bydiameter reduction structure240. The size of the gap is controlled by the shape and position ofheads260 and is configured to ensure smaller diameter surgical instruments are precluded from passing betweenheads260.Diameter reduction structure240 further includes a controlled bias configured to resist the movement ofreduction structure240 radially in an outward direction as well as from the first position to the second position. The bias instructure240 also serves to returnstructure240 to the first position after the removal of the larger diameter surgical instrument.

The second position being defined bydiameter reduction structure240 moving at least partially distally to accommodate the unrestricted passage or of individual larger sized diameter surgical instruments throughdiameter reduction structure240 andcannula50.

Foundation element

280 includes at least partiallyconcave seating positions296 for linking

members

271 and290 for stand offmembers250. Seatingpositions290 define an interrupted channel having two distinct seats or supports292 configured and dimensioned to receivecylindrical end portions254.Band252 is positioned between supports292. Seatingpositions290 further include anarcuate support member294 with a proximally extendingstraight portion299.

Seatingpositions296 define an at least partiallyconcave channel portions298 separated by a slot orrecess297 configured and dimensioned to receivesurface274 andband272 of linkingmember271. Seatingpositions296 include a proximally extendingstraight portion299.

Seating

positions

290 and296 are structurally supported by aproximally extending member295.Member295 is connected by arms to

portions

292 and298 and is configured to structurally support

portions

292 and298 from excessive deflection or movement.

Seating

positions

290 and296 provide the alignment; spacing, and angular orientation critical for the interrelation of

cogs

255 and275 with their

respective slots

277 and257 for the synchronizing of the movements ofstand offs250 and linkingmembers271. In addition,diameter reduction structure240 includes a bias to the first position as individual components or as an assembly either as a result of its positioning within diameter reductionstructure foundation element280, a separate bias member such as an elastic band, or by combinations thereof. When fully assembled with diameter reduction structure housing210 (seeFIG. 2) and diameterreduction structure foundation280,diameter reduction structure240 is capable of performing its functions at any angle or in any direction of use without any operator action.

Referring now toFIGS. 12 and 13,diameter reduction structure100 is shown in an operational position. A large diametermedical instrument80 defining a second longitudinal axis is positioned through valve assembly anddiameter reduction structure100 andcannula50. 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 ofpassageway25, 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 diametersurgical instrument60 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 offassembly240 distally in order to enter the passageway. In contrast, the small instruments can be positioned axially within the second operable area without deflecting stand offassembly240. 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 anddiameter reduction structure100. Whenlarge diameter instrument80 is moved distally along central longitudinal axis-X throughfirst seal125 and into contact withdiameter reduction structure240, the axially aligned force component movinglarge diameter instrument80 has to overcome the bias configured to retaindiameter reduction structure240 in the first position, as shown inFIG. 10.

As the force behindinstrument80 exceeds the bias configured to maintaindiameter reduction structure240 in the first position,diameter reduction structure240, 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 oflarge diameter instrument80. The amount of bias employed to retaindiameter reduction structure240 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 securingdiameter reduction structure240 in position in diameter reductionstructure foundation element280.

When forced towards. the inside diameter ofwall356 by the shaft of large diameter ofinstrument80, standoffs250 move to a second position whereinface262 ofhead260 is placed approximately parallel with and in apposition towall356. The spatial relationship betweenwall356 anddiameter reduction structure240 in the second position is a function of individual trocar interior configurations, the inside circumference ofpassageway25, and the intended application of the valve assembly anddiameter reduction structure100. Valve assembly anddiameter reduction structure100 is configured to provide suitable space for the pivoting or flexing ofdiameter reduction structure240 and still accommodatelarger diameter instruments80 that conform with the maximum inside diameter for a given.cannula50. Upon withdrawal oflarger diameter instrument80,diameter reduction structure240 is biased to reposition to a first position wherein a portion of each stand off250 isadjacent wall220.

Referring now toFIGS. 14 and 15, stand offmembers250 are shown in a first or diameter reduction position, whereinhead260 extends in a generally radial direction relative to longitudinal axis-X.Cantilevered portion222 provides a generally rigid barrier configured to structurally support and limit the radial displacement ofhead260.Diameter reduction structure240 in the first position is configured to accommodate the penetration ofsmaller diameter instruments60 through valve assembly anddiameter reduction structure100 and intocannula50 without any movement.

When in this first position, stand offmember250 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 diametersurgical instrument60. Each stand offmember250 is mounted indiameter reduction assembly200 to provide a limit to excessive parallel off axis and angular movements of small diametersurgical instruments60.

A small diametersurgical instrument60 is positioned throughseal125 and intocannula50 typically with little or no substantial contact withdiameter reduction structure240. When small diametersurgical instruments60 are manipulated to make off axis or angular movements, however, small diametersurgical instruments60 come in contact with at least onehead portion260 and the inside circumference ofcannula50 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 ofhead260 and cantileveredportion222 may be configured as a rigid or flexible biased structure. This controlling mechanism functions to bound the operational movements by small diametersurgical instruments60, sufficiently to retain the integrity of the sealing system.

Referring now toFIGS. 16A, 16B, and16C, in another preferred embodiment, valve assembly anddiameter reduction structure500 includes a proximal end portion or diameter reduction assembly600 and a valve assembly700 similar to the previous embodiment, however,diameter reduction structure640 is positioned proximal to afirst seal525.

Diameter reduction structure

500 includes anend cap510, a diameterreduction structure housing610, adiameter reduction structure640, a diameter reductionstructure foundation element680, and as required a first O-ring.

End cap

510 has a generally cylindrical shape including adistal end portion512 and aproximal end portion514.Proximal end portion514 includes an annular shaped disc orportion516 defining ahole515 aligned with the central longitudinal axis-X. In this configuration,annular portion516 may be a rigid plastic or a flexible membrane not configured to be a seal. Thus,hole515 could be configured as a rigid or flexible barrier and having a diameter at least equal to the. inside diameter of acannula50 in a rigid configuration.

Diameterreduction structure housing610 has a generally hemispherical shell shape decreasing in circumference from adistal end portion612 to aproximal end portion614.Proximal end portion614 includes anannular portion613 defininghole615.Hole615 preferably has a larger diameter thanhole515.Proximal end portion614 is configured to be connectively received bydistal end portion512.Distal end portion612 includes an outsidecylindrical portion616 having a scalloped surface to facilitate handling thereof.

Diameter reduction structure

640 includes a stand off assembly having three stand offmembers650 and alinking mechanism670 is positioned proximal to afirst seal525.Stand offs650 provide a predetermined degree of control over and limitation to the movements of instruments positioned within assembly600. Linkingmechanism670, in the form of three linking members671, integrate and synchronize the movement ofstand offs650. While the specific configuration of stand offmembers650 or linkingmechanism670 may vary, stand off assembly645 is employed operationally as described in all of the embodiments herein to limit the off-axis and angular movements of small surgical instruments.

Diameter reductionstructure foundation element680 is configured to seatdiameter reduction structure640 on. its proximal end portion682 and includes at least partially cantilevered seatingpositions690 configured to support and control the movement ofreduction structure640 throughout a predefined range of motion as at least partially represented by arrow “A”. A distally extendingtubular portion685 is configured for the positioning offirst seal525.First seal525 is positioned approximately orthogonal to longitudinal axis-X and may be a fixed or- a floating type seal.

A first seal support element750 has a generally tubular shape with adistal end portion754 abutting a proximal side ofcantilevered seating portion690 and adistal end752. First support element750 has aninside wall756 that may be configured to limit the distal range of motion ofstand offs650. A cantileveredportion753 of first seal element750 is positioned to secure and seal aflange767 of asecond seal765 in positioned between a proximal portion of secondseal support element780.

Adistal end752 of first support element750 at least partially encloses and sealingly positions aflange767 ofsecond seal765 in cooperation with adistal end portion782 of a secondseal support element780.Second seal765 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 seal765 is a duck bill type seal extending distally into aseal housing710.

Seal housing

710 includes aproximal portion714 configured to secure and at least partially enclosesecond seal765 and at least a portion of secondseal support element780 and first seal support element750. Secondseal support element780 also has a generally annular shape and is configured to lock with and engage first seal support element750.Seal housing710 has adistal end portion712 configured to mate with a cannula.

Valve assembly anddiameter reduction structure500 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 anddiameter reduction structure500 may be removably connected to a correspondingly dimensionedcannula50, it is also envisioned thatend cap510,housing610,diameter reduction structure640, andfoundation element680 may be readily adapted as an integrated assembly, for example, with or without an integratedfirst seal525, 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.

Referring now toFIGS. 17 and 18A-18C, one of the preferred embodiments of a valve assembly anddiameter reduction structure800 includes a proximal end portion ordiameter reduction assembly900 and a distal end portion orvalve assembly1000.Diameter reduction structure940 is positioned distal to afirst seal825 and within a diameterreduction structure housing910.

Diameter reduction structure

940 is illustrated with a stand off assembly.945 having threestand offs950 and three linkingmembers971 positioned in a diameter reduction structure foundation980.—While the general configuration of diameterreduction structure foundation980 and linkingmembers971 are structurally and operationally similar to earlier embodiments, standoffs950 have a differentconfiguration head portion960, similar to that depicted inFIG. 16A, withside portion965 having a generally planar shape and a width approximately equivalent toarm956.

Head portion

960 may also include anattachment mechanism963 and a cantilevered extension orflange967.Flange967 extends radially fromhead960 toward base961 in the first position. In the second position of stand off950,flange967 can be configured with a suitable length to at least partially limit the range of movement of stand off950 by contacting an inside wall of diameterreduction structure housing910.Attachment mechanism963 is configured to receive and retain an annularly shapedbias member969 on stand off950 throughout its range of motion. Annularly shaped biasedmember969 is configured to biasstand offs950 to the first position, provide an additional bias when off axis or angular movements act to. compress a stand off950 in a radially outward direction against the. diameterreduction structure foundation980 orhousing910, and act as an uninterrupted barrier to preclude smaller diameter surgical instruments from intruding betweenstandoffs950.

The combined effect ofattachment mechanism963,flange portion967, andbias member969 is the control by stand offassembly940 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 offassembly940 to automatically accommodate larger diameter instruments.

InFIG. 19, an additional preferred embodiment of valve assembly anddiameter reduction structure1200 is configured with adiameter reduction structure1340 including a stand offassembly1345 having four diametrically opposedstand offs1350 independently positioned within a diameter reduction structure foundation.1380. Each stand off1350 independently pivots, without a linking mechanism, to limit off-axis and angular movements of small instruments.

Stand offmembers1350 include ahead1360, anarm1356, and abase element1351 configured for mounting withfoundation1380. Stand off1350 can be fixedly mounted to foundation1380jor example, or in thealternative base element1351 may be pivotally positioned onfoundation1380 and retained in place using a positioning element (not shown). A bias is employed to position stand off1380 to a first position adjacent housing1310. As a further alternative embodiment, a linking mechanism may be positioned to be operative withheads1360 to perform, for example, one or both functions of the linking mechanism shown previously.Alternative head1360 configurations include having telescoping, tongue and grooved, or beveled gear mechanisms that interrelatestand offs1380 into an approximately contiguous annular structure throughout their range of motion.

A bias inherent in stand off1350 or in combination with its positioning element to the diameterreduction structure foundation1380 maintainsstand offs1350 in the first position unless deflected by a large diameter surgical instrument. As shown in other embodiments,diameter reduction structure1350 may be employed proximal to or distal to a first seal.Stand offs1350, in this configuration, also include a bulbous shapedhead1360, similar to that ofhead260 for controlling the movements of smaller diameter surgical instruments.

InFIGS. 20A and 20B, two embodiments of stand off

members

950 and1350 are shown corresponding toFIGS. 18A-18C and19, 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 and1350 include

base portions

951 and1351 forming- an axis “y” at angle alpha (a) with an axis “Y”. Axis “Y” is perpendicular to central longitudinal axis “X”.

Heads

960 and1360 define an axis “x” at an angle theta “θ” with the “X”. Depending upon the configuration of the trocar housing and application, angles “α” or “θ” 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 and1350. Axis “X” is parallel to central longitudinal axis “X”.

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 and1350, 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.

Individual stand off

members

950 and1350 can include varying

head portion

960 and1360 configurations such as wing extensions or flanges that overlap, interrelate, or interleave between

adjacent stand offs

950 and1350. Aretention mechanism939 can also be included in

head portion

960 and1360, for example, for the positioning of abiased member939.

Referring now toFIG. 20C, in a further alternate embodiment of adiameter reduction structure1440, a single unified stand off assembly1445 is formed into a continuous and integrated flanged stand off or flange structure1445. Flange structure1445 may take any configuration ofhead1460,arm1456, andbase1451, 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 structure1440 may be at least partially segmented with a plurality ofslots1431 defining segmentedhead portions1460 andarms1456. Aretention mechanism1439 can also be employed to further biasdiameter reduction structure1440. 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.

Diameter reduction structure

1440, withindependent stand offs1450 or configured as an integrated unified flange structure stand off1450, 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 structure1450 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.

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.

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.

Referring now toFIGS. 21 and 22A, a further alternate embodiment of a valve assembly anddiameter reduction structure1500 includes adiameter reduction assembly1600 andvalve assembly1700. Valve assembly anddiameter reduction structure1500 defines apassageway1505 concentric with a central longitudinal axis-X.

Diameter reduction assembly

1600 includes afirst seal1525, diameter reduction structure housing ordistal housing1610, adiameter reduction structure1640, and a diameter reductionstructure foundation element1680. Diameterreduction structure foundation1680 connects withvalve assembly1700. Seal housing orproximal housing1710 ofvalve assembly1700 is configured to be removably connected tocannula50.

Diameterreduction structure housing1610 is generally tubular in shape and includes atubular wall1615 defining adistal end portion1612 and aproximal end portion1614.Proximal end portion1614 has aproximally extending rim1616 defining a recessed portion orflange1618.Flange1618 is approximately perpendicular to the longitudinal axis-X and includes arim1619 defining a hole orpassageway1505 aligned with longitudinal axis-X. Diameterreduction structure housing1610 in this configuration includes a first seal1515 positioned distal toflange1618 that is held in position by a firstseal support element1620. Firstseal support element1620 also defines arim1622 aligned withrim1619. A distal end ofrim1622 forms anedge1623 with adistal end1622 ofseal support element1620.Distal end portion1612 includes aflanged portion1613.

The inside diameter oftubular wall1615 abuts and is configured to slidingly move in relation to afirst member1630 and a secondannular member1635. Adistal edge1631 ofannular member1630 is positioned abutting aproximal edge1636 of secondannular member1635. Secondannular member1635 has a radially extending protuberance ortab1637.

Diameter reduction housing

1610 is connected to anannular member1611 extending distally fromdistal end1612. Astop1608 is positioned on adistal end1609 ofmember1611 that abuts aseal support element1750 and defines a first position ofhousing1610.Stop1608 also interfaces with and is limited bytab1637 to at least partially limit the proximal travel ofhousing1610 and defines a second position ofhousing1610.

Diameter reduction structure

1640 is positioned on a diameterreduction foundation element1680. Diameterreduction foundation element1680 has adistal end1682 and a proximal end1684.Distal end1682 abuts withseal support element1750.Element1680 also abuts with a portion of the inside of

annular members

1630 and1635.Diameter reduction structure1640 is configured to support up to approximately 180° of travel of each stand offmember1650 from a position extending distally approximately parallel to the longitudinal axis to a position extending proximately approximately parallel to the longitudinal axis.

In a first stand offassembly240 position, stand offmembers250 are generally positioned in a plane orthogonal the central longitudinal axis and to reduce the operable area ofpassageway1505 in. combination with the structural support ofhousing1610. In a second stand offassembly240 position, stand offmembers250 are generally positioned at least partially distal to the first position. In a third stand. offassembly240 position, stand offmembers250 are generally positioned at least partially proximal to the first position.

Stand offmembers1650 have ahead1660 connected by anarm1656 to abase portion1651 with opposing cylindrical end portions1654. Stand offmembers250 are connected by a linking mechanism including three linkingmembers1671 as described in earlier embodiments.

Head

1660 includes afirst side1662 having a generally planar face and an opposing taperedsecond side1668 in apposition withfirst seal1525 whendiameter reduction structure1640 is in the first position.First side1662 includes a cantileveredextension1661. Athird side1664 includes a generally convex portion and beveledside portions1665. Afourth side1666, opposing, the third side, has a generally planar face that is connected witharm1656 such that the planar face extends tosecond side1662 and to cantileveredportion1661.Arm1656 is a neck downportion connecting base1651 andhead1660.Head1660 also includes a centrally positioned segmentedconcave notch1663 approximately perpendicular to longitudinal axis-Y. The generally concave shape ofnotch1663 is configured and dimensioned to accommodate a limited degree off axis movement by small surgical tools whendiameter reduction structure1640 is in a first or initial position.

Whilediameter reduction structure1640 is illustrated with stand off assembly1645 having threestand offs1650. and linking mechanism1670 having three linkingmembers1671, the general configuration of diameterreduction structure foundation1680 and linkingmembers1671 are structurally and operationally similar to earlier embodiments such as those. ofFIGS. 6-8.

Valve assembly

1700 includes a firstseal support member1,750, asecond seal1765, and aseal housing1710 configured for connecting to cannula50. In addition, an elastic tubular seal orthird seal1601 is sealingly positioned over a sliding joint1699 betweenvalve assembly1700 anddiameter reduction assembly1600.

Secondseal support element1750 is positioned between diameterreduction foundation element1680 and sealhousing1710. Secondseal support element1750 has a generally annular in shape with a tubular wall1755 having an outside cylindrical surface1756. In addition, a distal end1752 of secondseal support element1750 sealssecond seal1765 in position in combination with a proximal end1714 ofseal housing1710.

Seal housing

1710 proximal end portion1714 includes positions for the seating of the secondseal support element1750 andsecond seal1765. Adistal end portion1712 ofseal housing1710 is configured to mate withcannula50 utilizing a suitable attachment mechanism such as a bayonet or threaded connection.

Third ortubular seal1601 has aproximal end1605 and adistal end1603. Proximal end1715 is sealingly engaged withflange1613 ofdiameter reduction housing1610. Proximal end1714 ofseal housing1710 and distal end1752 of secondseal support element1750 are positioned to sealingly engage adistal end portion1603 ofthird seal1601.Third seal1601 is configured and dimensioned as a flexible elastic tubular seal positioned over and providing a seal for sliding joint1699.Third seal1601 is suitably flexible for accommodating the movement ofdiameter reduction housing1610 between the first position whereinstop1608 is abutting secondseal support element1750 and the second position whereinstop1608 is repositioned proximally and is abuttingtab1637. In addition,third seal1601 provides a bias to the first position ofdiameter reduction housing1610 ofseal housing1610.

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 seal1601 may include acentral shape indentation1601 a to permit longitudinal extension and retraction ofstructure housing1610. Alternatively, third seal may be completely tubular devoid of v-shape indentation as depicted inFIG. 23, and have suitable elastomeric properties to permit the seal to stretch during extension and retraction of thehousing1610. 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 thatthird seal1601 can be readily attached and detached, as required, for autoclaving or sterilization.

Referring now toFIGS. 22A-22C,diameter reduction structure1640 is biased to a first position, similar to that ofFIGS. 15, 16A, and20A wherein at least a portion offourth side1666 ofhead1660 andarm1656 are in apposition with a portion of diameterreduction structure housing1610 and stop1608 is abutting secondseal support element1750. In this embodiment, rim1621 anddistal end1622 of firstseal support element1620 are in apposition with at least a portion offourth side1666 andarm1656, respectively and in particular,corner1623 is positioned at the junction ofarms1656 and sidefourth side1666. Thus, firstseal support element1620 supports standoffs1650 in the first position by providing structural support forstand offs1650 to limit from the off axis and angular movements of small diameter surgical instruments.

Whendiameter reduction structure1640 is deflected distally by a large surgical instrument, such as shown in.FIG. 13, to the second position whereinface1662 is pivoted in the direction of the inside of tubular wall1755 of secondseal support element1750, stand offmembers1650 are accommodating the increased diameter of the large surgical instrument without any external adjustments by the surgeon or operator. Stand offmembers1640, however; retain their bias to the first position.

When the large surgical instrument is withdrawn proximally through valve assembly anddiameter reduction structure1500, the combination of the bias and elastic nature of stand offmembers1650 may bind with the large instrument. To preclude undesirable binding,distal end1612 is slidingly engaged with firstannular member1630, secondannular member1635, and secondseal support element1750 such that thediameter reduction housing1610 slides proximally until the instrument ceases to bind or stop1608

abuts tab

1637. The proximal movement ofdiameter reduction structure1610 from thefirst housing1610 position defines an increased volume withindiameter housing1610 that is suitable for stand offmembers1650 to pivot proximally to the third position and at least partially increase the operable area ofpassageway1505 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.

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 onsecond side1668 and/orthird side1664 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.

Referring now toFIG. 24, there is illustrated another embodiment of the present disclosure.System2000 includesseal assembly2002 andcannula assembly2004 to which theseal assembly2002 is mounted.Seal assembly2002 defines a seal housing consisting of a plurality of components forming an outer member of theseal assembly2002, and diameter reduction structure for limiting excessive off-axis and angular movements of small diameter surgical instruments as discussed hereinabove.Seal assembly2002 defines seal axis “x”.Seal assembly2002 includes first orproximal seal subassembly2006 and second ordistal seal subassembly2008 which is connected tocannula assembly2004.First seal subassembly2006 is adapted for releasable connection tosecond seal subassembly2008 and incorporates the diameter reduction structure.

With reference now toFIG. 25-27, in conjunction withFIG. 24, first and

second seal subassemblies

2006,2008 ofseal assembly2002 will be discussed.First seal subassembly2006 includesend cap2010,septum seal2012 anddiameter reduction housing2014.Diameter reduction housing2014 includes first and second

reduction housing components

2016,2018 which house stand-off elements2020. In general, stand-off elements2020 are interconnected and pivot to permit passage of an instrument. Stand-offelements2020 are biased to an initial position by elastomeric O-ring2022. O-ring2022 is received withinrecess2020rof each stand-off element2020 as shown inFIG. 26. When stand-off elements2020 pivot downwardly (shown in phantom inFIG. 26) upon insertion of an instrument, O-ring2022 stretches to permit this movement of the stand-off elements2020. Upon removal of the instrument, the stand-off elements2020 return to their initial position in transverse relation to the axis “x” under the influence of the O-ring2022. The remaining components offirst seal subassembly2006 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.

In one further aspect of the present embodiment,diameter reduction housing2014 includes mountingtabs2024 radially spaced aboutinterior wall2026 of secondreduction housing component2018. As seen inFIG. 25 andFIG. 27, mountingtabs2024 serve to releasably securefirst seal subassembly2006 tosecond seal subassembly2008 as will be discussed.

Second seal subassembly

2008 includesstationary ring member2028,duckbill valve housing2030, zero closure orduck bill valve2032 supported within thevalve housing2030, andmanual lock member2034.Stationary ring member2028 defines firstannular wall2036 on its proximal side.Annular wall2036 incorporates small and

large recesses

2038,2040 arranged in diametrical opposed relation as shown. Firstannual wall2036 ofstationary ring member2028 is received withinannular gap2042 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 ofreduction housing2014. As best depicted inFIGS. 28 and 29, the respective distances between the positioning

legs

2048,2050 and corresponding lengths ofrecesses2038,2040 (identified as distances and lengths “a” and “b”) ensure proper orientation ofreduction housing2014 within, or relative to,stationary ring member2028 during assembly.

Stationary ring member

2028 further includes secondannular wall2052 disposed on the distal side of thestationary ring member2028. Secondannular wall2052 includes partialannular slot2054 therein and a plurality of radially spacedgrooves2056 in its outer surface. Asingle locking tab2058 is disposed within eachgroove2056. The functioning ofpartial slot2054, spacedgrooves2056 and lockingtabs2058 will be discussed in greater detail hereinbelow.

As best depicted inFIGS. 25 and 29, duckbill valve housing2030 includesannular wall2060 which definescentral aperture2062.Annular wall2060 defines threegrooves2064

proximal aperture

2062.Grooves2064 accommodate mountingtabs2024 ofdiameter reduction housing2014 during assembly of first and

second seal subassemblies

2006,2008.Duck bill housing2030 includes a plurality of axial dependinglegs2066.Legs2066 of duckbill valve housing2030 may includerectangular openings2068.

In one preferred arrangement,manual lock member2034 is secured toduck bill housing2030 in fixed relation therewith.Manual lock member2034 includes a plurality ofrecesses2070 defined in its outer surface.Recesses2070 receive corresponding dependinglegs2066 ofduck bill housing2030.Recesses2070 each include mounting tabs2072 (as seen inFIG. 25) which are received withinrectangular openings2068 of dependinglegs2066 ofduck bill housing2030 in snap relation therewith to secure the two components (see alsoFIG. 26).Manual lock member2034 andduck bill housing2030 capture theperipheral rim2074 ofduck bill valve2032 to secure theduck bill valve2032 between the two components.

Manual lock member

2034 andduck bill housing2030 are at least partially disposed withinstationary ring member2028 and are adapted for rotational movement relative to thestationary ring member2028.Manual lock member2034 includesgrip2076 which extends radially outwardly for engagement by the user.Grip2076 includestransverse leg2078 which is accommodated within partialannular slot2054 ofstationary ring member2028 and traverses theslot2054 during rotation ofmanual lock member2034 andduck bill housing2030.Manual lock member2034 is adapted for rotational movement between a first position corresponding to a release position which permits mounting and/or release offirst subassembly2006 fromsecond subassembly2008, and a second position corresponding to a lock position which securesfirst subassembly2006 to thesecond subassembly2008. An O-ring seal2080 may be positioned about the circumference ofduck bill housing2030 to form a substantial seal between theduck bill housing2030 anddiameter reduction housing2014.

In other embodiments, themanual lock member2034 is slidably received byduck bill housing2030. Themanual lock member2034 is then slidable with respect tostationary ring member2028.

With reference toFIGS. 24-26,cannula assembly2004 includescannula housing2082 andcannula sleeve2084 extending from thehousing2082.Cannula housing2082 includesvertical legs2086 which are positioned withingrooves2056 ofstationary ring member2028.Legs2086 preferably includeinternal ledges2088 advantageously dimensioned to accommodate lockingtabs2058 disposed within thegrooves2056 ofstationary ring member2028 to fixedly secure the two components.Cannula sleeve2084 defineslongitudinal passage2090 which permits passage of instrumentation.Cannula sleeve2084 may be secured tocannula housing2082 by correspondingtongues2092 andgrooves2094 of thecannula sleeve2084 and thecannula housing2082 respectively. An O-ring seal2096 may be positioned withincannula housing2082 for forming a seal within thehousing2082 adjacent these components.

In use,second seal subassembly2008 ofseal assembly2002 is mounted tocannula housing2082. In this regard,vertical legs2086 ofcannula housing2082 are aligned withgrooves2056 ofstationary ring member2028 and thering member2028 is advanced whereby thelocking tabs2058 of thering member2028 securely engage theinternal ledges2088 within thevertical legs2086. Thereafter, when it is determined that the diameter reduction structure is needed, for example, in use with a small diameter instrument,first seal subassembly2006 is positioned relative tosecond seal subassembly2008 as depicted inFIGS. 27-29. In this position, positioning

legs

2048,2050 offirst seal subassembly2006 are aligned with the corresponding

recesses

2038,2040 of second seal subassembly2008 (FIGS. 25 and 27). In addition,manual lock member2034 is placed in the first or release position ofFIG. 29. In this position, mountingtabs2024 of thefirst seal subassembly2006 are in general alignment with mountingrecesses2064 of theannular plate2060 ofduck bill housing2030 of thesecond seal subassembly2008.First seal subassembly2006 is then mounted tosecond seal subassembly2008 whereby positioning

legs

2048,2050 are positioned in

respective recesses

2038,2040 and mountingtabs2024 are received within mountinggrooves2064 ofduck bill housing2030.Manual lock member2034 is then rotated about axis “a” from the first or release position depicted inFIG. 30 to the second or lock position depicted inFIG. 31. This movement ofmanual lock member2034 causes corresponding rotational movement ofduck bill housing2030 to displace the mountinggrooves2064 whereby mountingtabs2024 are captured beneathannular wall2060 ofduck bill housing2030. In this position,first seal subassembly2006 is secured tosecond seal subassembly2008. The procedure is continued by introducing an instrument through theseal assembly2002 andcannula assembly2004, and performing the desired surgical procedure.

It is noted thatduck bill housing2030 andmanual lock member2034 may be a single component monolithically formed during manufacture. In addition, it is envisioned that thesecond seal subassembly2008 may be a component of the cannula housing orsleeve housing2082, and supplied with thecannula assembly2004. In the alternative,second seal subassembly2008 may replace thecannula housing2082 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 thesecond seal subassembly2008.

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.