ES2358437T3 - SEAL ASSEMBLY THAT INCLUDES SUBJECTS FIRST AND SECOND CONNECTIONS REMOVABLE. - Google Patents

Abstract

A surgical system (2000), comprising: a cannula assembly (2004) that includes a cannula housing (2082) and a cannula tube (2084) extending from the cannula housing, the cannula tube defines an axis longitudinal and has a longitudinal duct (2090) to allow the passage of a surgical instrument; and a surgical assembly (2002) of seal or sealing element, which includes: a first subset (2006) of seal or sealing element that includes a first seal housing (2014) or seal that has a sealing member (2012) defining internal parts adapted to allow the passage of a surgical object in substantially sealed relationship with it; a second subset (2008) of seal or sealing element that includes a second seal housing (2030) adapted for mounting in the cannula housing, in which the second seal housing or sealing element of the second seal subset or sealing element includes an annular plate member (2060) defining a central opening (2062) for the passage of the surgical object, and the annular plate member defines a plurality of mounting recesses (2064) in the central opening; wherein the first housing of the first seal subset or seal element has a plurality of locking tabs (2024) corresponding to the mounting recesses; and characterized by: a manual locking member (2034) adapted for movement between a first position corresponding to a release position of the first subset to allow the release of the first seal subset or sealing element of the assembly in the second seal subset or sealing element, and a second position corresponding to a locking position of the first seal subset or sealing element to secure the first seal subset or sealing element to the second seal subset or sealing element; in which the manual locking member is adapted for the rotational movement with respect to the longitudinal axis to move between the first and second positions thereof, and in which the second seal or sealing element subset includes a stationary ring member (2028 ) fixed to the cannula housing, in which the manual locking member and the second housing are at least partially disposed within the stationary ring member and the manual locking member is adapted for the rotational movement in relation to the stationary ring member, and wherein the mounting recesses are in general alignment with the locking tabs of the seal housing or sealing element when the manual locking member is in the first position to receive the locking tabs and the recesses of assembly move from the locking tabs with the movement of the manual locking member to the second position thereof, whereby the locking tabs are captured below the annular plate member, and in which the manual locking member includes a manual grip member (2076), which hangs radially outward with respect to the longitudinal axis of the seal housing or sealing element, the manual grip member is sized and configured for coupling by the surgeon to move the manual locking member between the first and second positions.

Description

BACKGROUND

1. Technical Field

The present description relates to a mechanism for controlling the internal operating diameter of a conduit through a valve assembly of a trocar housing. More particularly, the present description relates to a diameter reduction structure that restricts the movement of small surgical instruments and accommodates large diameter surgical instruments in the conduit of a trocar housing to facilitate the maintenance of a tight seal. gases formed by the valve assembly.

2. Background of the Related Technique

Trocar valve assemblies preferably provide a fluid tight seal around a surgical instrument inserted through the trocar during a minimally invasive surgical procedure. A typical valve assembly includes an external seal or sealing element, which can be fixed or floating, in combination with other internal seals or sealing elements. Seals or fixed external sealing elements are limited by their ability to maintain a seal when a smaller surgical instrument travels off the axis relative to a central axis of the trocar. Seals or fixed sealing elements are also limited by their ability to maintain their integrity when the surgical instrument is angled. Such extreme intervals of movement of the smaller diameter surgical instruments within the cannula can create a "cat's eye" or crescent shaped hole in the seal or fixed sealing element that can result in loss of seal integrity. or shutter element. Other problems include the flexibility of the seal or sealing element for maintaining its integrity when using both small and large diameter surgical instruments.

Devices for limiting the diameter of a duct in a trocar housing generally require that an additional mechanism be placed at the proximal end of the trocar housing that limits the range of motion of small surgical instruments. These diameter reduction devices, however, typically employ additional structures and / or seals or seals that require adjustments by the user to accommodate surgical instruments of different sizes, which complicates the surgical process.

US 2005/0070851 describes a trocar housing constructed of a first housing member and a second housing member, which are selectively coupled by means of a rotating clamping mechanism.

US 2004/0064100 describes a valve assembly for a surgical access system that includes a mobile diameter reduction structure. The preamble of claim 1 is based on this document.

There is a permanent need for a diameter reduction structure that can limit parallel movements outside the axis as well as angular movements of small diameter surgical instruments and accommodate large diameter surgical instruments without external adjustments.

COMPENDIUM

The present invention provides a surgical system as defined in claim 1. A surgical seal or seal assembly assembly includes a tube housing connected to a surgical tube, a seal housing or sealing element that includes a seal or sealing member having internal parts adapted to allow the passage of a surgical instrument with a substantially sealing relationship therewith, and a manual locking member movably mounted in the tube housing. The manual locking member is adapted for the movement relative to the seal housing or sealing element between a first position corresponding to a position of releasing the seal housing or sealing element to allow separation of the seal housing or sealing element from the housing of tube and a second position corresponding to a locked position of the seal housing or sealing element to secure the seal housing or sealing element in the tube housing. The manual locking member is preferably adapted for rotating movement with respect to a longitudinal axis of the seal housing or sealing element to move between the first and second positions thereof.

The manual locking member includes an annular member having at least one locking surface adapted to engage at least one corresponding locking tab of the seal housing or sealing element with the movement of the manual locking member to the second position. The annular member defines a central opening to allow passage of the object. The annular member defines a plurality of mounting recesses next to the central opening and the seal housing or sealing element has a plurality of locking tabs corresponding to the mounting recesses. The mounting recesses are in general alignment with the working tabs of the seal housing or sealing element when it is in the first position of the manual locking member to receive the locking tabs. The mounting recesses thereafter move from the locking tabs with the movement of the manual locking member to the second position thereof. The manual locking member includes a manual grip member, which hangs radially outward with respect to the longitudinal axis of the seal housing or sealing element. The manual grip member is sized and configured for coupling by the surgeon.

The seal assembly or surgical sealing element may include at least two spacer elements mounted in the seal housing or sealing element distal to the seal or sealing member. The separating elements are adapted for the pivoting movement between an initial position and a pivoted position to allow the surgical object to pass through. The separating elements may normally be predisposed towards the initial position to restrict movement outside the axis of the surgical object with respect to a longitudinal axis of the seal housing or sealing element. The at least two separating elements are preferably operatively coupled in such a way that the movement of at least one of the separating elements between the initial and pivoted positions causes the corresponding movement of other separating elements.

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

The surgical system includes a cannula assembly that includes a cannula housing and a cannula tube that extends from the cannula housing. The cannula tube defines a longitudinal axis and has a longitudinal conduit to allow the passage of a surgical instrument. The surgical system also includes a set of seal or surgical sealing element that incorporates first and second sub-assemblies of seal or sealing element. The first subset of seal or sealing element includes a first housing having a seal or sealing member defining internal parts adapted to allow the passage of a surgical object in relation to it substantially sealing. The second subset of seal or sealing element includes a second housing adapted for mounting in the cannula housing. A manual locking member is adapted for movement between a first position that corresponds to a release position of the first subset to allow removal of the first subset of the assembly in the second subset, and a second position corresponding to a locked position of the first subset to secure the first subset to the second subset. Preferably, the second subset includes the manual locking member.

The manual locking member may be adapted for rotational movement with respect to a longitudinal axis to move between the first and second positions thereof.

The first or second seal or sealing element assembly includes a locking fastener and the other first or second seal or sealing element subset includes a corresponding locking surface. The locking fastener and the locking surface will cooperate to secure the first seal subset or sealing element in the second seal subset or sealing element after the movement of the manual locking member to the second position thereof. The other of the first and second sub-assemblies of the seal or sealing element includes a locking recess sized to receive the locking fastener when the manual locking member is in the first position so that with the rotation of the manual locking member to the second position the locking fastener cooperatively engages the locking surface. The first seal subset or seal element includes the locking fastener and the second seal subset or seal element includes the locking recess and the locking surface. The first seal subset

or sealing element includes a plurality of locking fasteners and the second seal subset

The sealing element includes a plurality of corresponding locking recesses for the reception of the locking fasteners.

The second subset may include a zero shut-off valve adapted to open to allow passage of the surgical instrument and close substantially in the absence of the surgical instrument. A method for performing a surgical procedure is also described. The method includes the stages of:

providing an access assembly, which includes an access housing and an access tube operatively connected to the access housing;

mounting a seal assembly or sealing element in the access housing with the seal assembly or sealing element including a seal housing or sealing element and a seal or sealing member mounted in relation to the seal housing or sealing element, the seal or member shutter includes internal parts adapted to form a substantial seal around a surgical object introduced therethrough; and securing the seal housing or sealing element in relation to the access housing by movement of a manual locking member associated with the access housing to cause the corresponding structure of the access housing and the seal housing or sealing element to be cooperatively engage in a strengthening relationship with him.

BRIEF DESCRIPTION OF THE DRAWINGS

Preferred embodiments of the trocar diameter reduction structures currently described for trocar are described herein with reference to the drawings, in which:

Figure 1 is a perspective view of a preferred embodiment of a valve assembly and diameter reduction structure for trocars constructed in accordance with the present description;

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

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

Figure 4 is a perspective perspective view of the valve assembly and the diameter reduction structure of Figure 3 partially disassembled, showing a diameter reduction structure located in a base element of diameter reduction structure;

Figure 5 is a perspective perspective view of the valve assembly and the diameter reduction structure of Figure 1, showing a second seal or sealing element partially disassembled;

Figure 6 is a close-up perspective view of a link member according to the description of Figure 1;

Figure 7 is a perspective close-up view of a distal end portion of the base element of the diameter reduction structure according to the description of Figure 1;

Figure 8 is a perspective perspective view of a separator according to the description of Figure 1;

Figure 9 is a cross-sectional view of the valve assembly and the diameter reduction structure of Figure 1 along line 9-9;

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

Figure 11 is an exploded view of the diameter reduction structure and the base element of the diameter reduction structure of Figure 4;

Figure 12 is a perspective view of the valve assembly and the diameter reduction structure of Figure 1 that are being operatively employed with a large diameter surgical instrument passing through the valve assembly and the diameter reduction structure and in a part of a patient's tissue;

Figure 13 is a close-up of the cross-sectional view of Figure 12 along line 13-13 showing how the diameter reduction structure of the large diameter surgical instrument is repositioned;

Figure 14 is a close-up of the cross-sectional view of the valve assembly and the diameter reduction structure of Figure 10 showing a small diameter surgical instrument that is being placed at least in part thereon;

Figure 15 is the cross-sectional view of Figure 14 showing the diameter reduction structure controlling the angular movement of a small diameter surgical instrument placed therein;

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

Figure 16B is a cross-sectional view of Figure 16A along line 16B-16B showing a representative movement of a spacer member of the diameter reduction structure;

Figure 16C is a cross-sectional view of Figure 16A along line 16C-16C showing the diameter reduction structure in a first position;

Figure 17 is a perspective view of a proximal end of a third embodiment of a diameter reduction structure for a trocar constructed in accordance with the present description;

Figure 18A is a cross-sectional view of the trocar illustrating the diameter reduction structure of Figure 17 along line 18A-18A;

Figure 18B is a cross-sectional view of the valve assembly and the diameter reduction structure of Figure 18A along line 18B-18B;

Figure 18C is a cross-sectional view of the valve assembly and the diameter reduction structure of Figure 18A along line 18C-18C;

Figure 19 is a cross-sectional side view of a fourth embodiment of the valve assembly and the diameter reduction structure, constructed in accordance with the present description;

Figure 20A is an enlarged cross-sectional view of the second embodiment of the separator configuration of the trocar diameter reduction structure of Figures 18A, 18B and 18C;

Figure 20B is an enlarged cross-sectional view of the separator configuration of the trocar diameter reduction structure of Figure 19;

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

Fig. 21 is a top view of a sixth embodiment of a valve assembly and a trocar diameter reduction structure having a movable diameter reduction assembly, constructed in accordance with the present description;

Figure 22A is a cross-sectional view of the valve assembly and the diameter reduction structure for the trocar of Figure 21 along line 21A-21A;

Figure 22B is a cross-sectional view of the valve assembly and the trocar diameter reduction structure of Figure 22A with the separator assembly in the second position;

Figure 22C is the cross-sectional view of the separator configuration of Figure 22A with the separator assembly in a third position; Y

Figure 23 is a cross-sectional view of an alternative embodiment of the valve assembly and the diameter reduction structure of Figure 22A;

Figure 24 is a perspective view of another alternative embodiment of the seal assembly or sealing element shown mounted on a cannula assembly in accordance with the principles of the present description;

Figure 25 is a perspective view with the separate parts of the seal or seal element assembly and the cannula assembly according to the embodiment of Figure 24 illustrating the components of the first and second seal or seal sub-assembly;

Figure 26 is a cross-sectional side view taken along line 26-26 of Figure 24 illustrating the seal assembly or sealing element mounted in the cannula housing of the cannula assembly according to the embodiment of the Figures 24-25;

Figure 27 is a perspective view illustrating the assembly of the first seal subset or sealing element in the second seal subset or sealing element according to the embodiment of Figures 24-26;

Figure 28 is a view illustrating the mounting tabs of the first seal subset or sealing element according to the embodiment of Figures 24-27;

Figure 29 is a view illustrating the mounting recesses of the second seal subset or sealing element for receiving the mounting tabs of the first seal subset or sealing element according to the embodiment of Figures 24-28;

Figure 30 is a view of the seal assembly or sealing element illustrating the manual locking member in a first position corresponding to a release position, in accordance with the embodiment of Figures 24-29, and

Figure 31 is a view of the seal assembly or sealing element illustrating the manual locking member in a second position corresponding to a locking position, in accordance with the embodiment of Figures 24-30.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The present description contemplates the introduction into the body of a patient of a trocar adapted to receive all types of surgical instruments, including clip appliers, tweezers, dissectors, separators, staplers, laser fibers, endoscopes, as well as electrosurgical cutting devices, of coagulation, ablation and the like. All these objects are referred to herein as "instruments."

Referring now in specific detail to the drawings, in which similar reference numbers identify similar or identical elements in the various views, and initially a figure 1, a valve assembly and a diameter reduction structure are shown novel for a trocar 100 constructed in accordance with a preferred embodiment of the present description and intended to be used in combination with a conventional trocar assembly and cannula 50 defining a conduit 25 aligned with a central longitudinal axis X. Conduit 25 defines A first operational area.

The valve assembly and the diameter reduction structure 100 includes the diameter reduction assembly 200 located next to a proximal end part and the valve assembly 300 located next to a distal end part. The diameter reduction assembly 200 of the present description, either alone or in combination with the valve assembly 300 provides a seal between a cavity formed in the patient and the outside atmosphere during and after the insertion of an instrument through the cannula 50. In addition, the valve assembly and the diameter reduction structure 100 is capable of accommodating instruments of varying diameter, for example, ranging from 5 to 12 mm, by providing a gas-tight seal or sealing element with each instrument during surgical procedures. The flexibility of the current valve assembly and the current diameter reduction structure 100 to maintain a fluid-tight seal or sealing element greatly facilitates endoscopic surgery, in which a variety of instruments are often used that have different diameters necessary during a single surgical procedure and off-axis movements are used, as well as a small angled placement of the surgical tool.

The valve assembly and the diameter reduction structure 100 can preferably be removably mounted on a proximal end 54 of the cannula 50. During surgery, the surgeon can remove the diameter reduction assembly 200 from the valve assembly 300 in at any time during the surgical procedure and, likewise, assemble the diameter reduction assembly 200 into the valve assembly 300 to reconfigure the diameter reduction structure and the valve assembly 100. In addition, the valve assembly 100 and diameter can be easily adapted to be mounted on conventional cannulas with different structures, materials and lengths. The ability of the diameter reduction assembly 200 to detach from the valve assembly 300 facilitates the extraction of samples through the cannula 50 and reduces the profile of the cannula 50 when the diameter reduction assembly 200 is not necessary at a time when Particular of the surgical intervention. It is contemplated that assembly 200 may also be configured to accommodate a variety of valve assemblies.

Referring now to Figures 2-3, a preferred embodiment of the novel valve assembly and diameter reduction structure 100 of the present description will be explained in detail. The diameter reduction assembly 200 includes a cover 110, a first seal or sealing element 125, a housing of diameter reduction structure or first housing 210, a first O-ring 225, a diameter reduction structure 240 and a base element 280 diameter reduction structure. The base 280 of the diameter reduction structure is connected to the valve assembly 300. Seal housing 30 or sealing element is configured to be detachably connected to cannula 50.

The end cap 110 is generally tubular in shape and includes a distal end portion 112 and a proximal end portion 114. An annular shaped disk 116 defines a hole 115 aligned with the central longitudinal axis. The end cap 110 is detachably connected to the housing 210 of the diameter reduction structure.

The first seal or sealing member 125 is tightly placed between a distal side of the annular disk 116 of the cover 110 and a proximal end portion of the housing 210 of the diameter reduction structure. The first seal or sealing element 125 forms a first outer seal or sealing element of the assembly 100 and can be of any conventional type of seal or sealing element such as, but not limited to, a floating or fixed seal or sealing element.

The housing 210 of the diameter reduction structure has a generally hemispherical shell shape that decreases in circumference from a distal end portion 212 to a proximal end portion 214. Accordingly, the distal end portion 212 defines a hole 215 having a diameter greater than the diameter defined by the annular portion 213 of the proximal end portion 214. The hole 215 is concentrically aligned with the central longitudinal axis X. The proximal end portion 214 is configured to be received in a connected manner by the distal end portion 112. The distal end 212 includes an outer cylindrical part 216 which has a corrugated surface to facilitate handling thereof. A first O-ring 225 sits on the inner surface of the housing 210 of diameter reduction structure in the vicinity of the annular part 213.

Referring now to FIGS. 2 and 4, the base member 280 of the diameter reduction structure is configured to settle in the diameter reduction structure 240 at its proximal end portion 284 and to support the movement of the reduction structure 240 in diameter in a predefined range of motion and, in cooperation with housing 210, provides a suitable support structure for spacers 250 when the operating diameter of conduit 25 is limited through the valve assembly and the diameter reduction structure 100. The base element 280 has a cylindrical outer surface 286 and further defines a generally tubular shaped part 285 positioned distally centered on the longitudinal axis.

The diameter reduction structure 240 includes a set 245 of separators having spacer members 250 interconnected by a link mechanism 270 having three link members 271 in this preferred embodiment. The separators 250 provide a predetermined degree of control over the movements of an instrument placed within the assembly 100. The link mechanism 270 integrates and synchronizes the movement of the separators 250.

Each link member 271 is connected to two contiguous spacers 250 and is positioned therebetween such that the diameter reduction structure 240 forms an approximately hexagonal configuration of spacers 250 and alternate link members 271 centered around the longitudinal axis. X.

Each spacer member 250 includes a cylindrical sprocket part 252 defining a longitudinal axis Y (see Figure 8) and having opposite cylindrical end portions 254 with gears having teeth 255 extending parallel to the longitudinal axis Y. The members The link 271 also has a cylindrical shape defining a longitudinal axis Z (see Figure 6) and opposite ends 274 with gears having teeth 275. The teeth 275 extend parallel to the longitudinal axis Z. The link members 271 and the spacer members 250 are placed in the base member 280 of diameter reduction structure such that each respective tooth 275

or 255 is configured, sized and positioned with an angular orientation suitable to fit in a corresponding beveled groove 257 or 277, respectively, of the adjacent related part of the diameter reduction structure 240 to integrate and coordinate the simultaneous movement of each spacer 250 .

Link members 271 provide a synchronization function for pivotal movement of spacers 250 throughout their range of motion, in which the diameter reduction structure 240 is repositioned, at least partially, 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, the shape of the separator and the internal parts of the trocar that limit the rotational or pivotal displacement of the separators 250 moving away of the longitudinal axis. The second position is defined as when the spacers 250 pivot, flex or rotate in their position seated in the diameter reduction structure 280 in a generally arcuate path distally and away from the longitudinal axis to increase the diameter of the conduit 25 defined by the interrupted annular barrier of the diameter reduction structure 240.

The housing 210 of the diameter reduction structure and the base element 280 of the diameter reduction structure are configured to support the placement, the diameter control function and the movement of the diameter reduction structure 240. The housing 210 and the base element 280 may be adapted to interact with a variety of different end caps, first seals or sealing elements and seal or sealing element housings, for example, as well as with different cannula sizes.

Referring now to Figures 2 and 5, the valve assembly 300 includes a second O-ring 335, a first seal support member 350 or sealing element, a second seal or sealing element 365, a second seal support member 380 or sealing element, a third O-ring 395 and a seal housing or sealing element or second housing 310 configured to connect to the cannula 50. The base 280 of the diameter reduction structure provides a seat for the second O-ring 335 which provides a seal between the distal end 282 and a proximal end portion 354 of the first seal support member 350 or seal element.

A second seal or sealing element 365 includes a flange 367 to be sealedly positioned between a distal end portion 352 of the first seal support element 350 or seal element and a proximal end portion 384 of the second seal support element 380 or shutter element. The first seal support member 350 or seal element is generally annular in shape with a cylindrical outer surface 356 and has three tabs 358 extending distally. A second seal support element 380 or seal element also has a generally annular shape with a cylindrical outer surface 386 and is configured with radially extending tongues 388. A third O-ring 395 provides a seal between the second seal support element 380 or seal element and the seal housing 310 or seal element.

Seal housing 310 or seal member has a proximal end portion 314 that includes radially aligned grooves 318 configured to match correspondingly with tabs 388 and a distal end portion 312 configured to pair with cannula 50 using a suitable clamping mechanism , such as a threaded or bayonet connection.

Seal housing 310 or seal element further includes two diametrically opposed cantilever portions 325. Each cantilevered portion includes two opposing notches 326 having fixed suture fasteners 327 generally perpendicular to parts 325. Fixed fasteners 327 they include a cylindrical part 328 and a hemispherical part 329 configured to easily tie the sutures for positive retention of the trocar assembly in its position within the patient against the insufflation pressure normally employed in minimally invasive surgery.

The second seal or sealing element 365 is shown as a seal or sealing element of the duckbill type, but it can be any sealing system, such as a seal or truncated conical sealing element, for example, that can be adapted to perform the function of a second seal or sealing element. The second seal support element 380 or seal element is placed in the seal housing 310 or seal element.

The end cap 110, the housing 210 of the diameter reduction structure, the base element 280 of the diameter reduction structure, the first seal support element 350 or seal element, the second seal support element 380 or sealing element and seal housing 310 or sealing element are preferably made of plastic, metal or medical grade compounds with adequate strength and resilience for application. In a preferred embodiment, the above assemblies are injection molded using a medical grade plastic. The O-rings are made of a plastic or rubber of appropriate medical grade to provide a fluid tight seal between the generally rigid structural members.

Referring now to Figures 6-8, in a preferred embodiment, the link member 271 is shown aligned with the longitudinal axis Z. A band 272 having a larger circumference and a predetermined width is located on the cylindrical surface 274 of each link mechanism

270. Teeth 275 have a first arcuate width congruent on the outer surface of the cylindrical part 274 that narrows or bevels toward a second narrower arched width on the opposite side of each tooth 275. Thus, teeth 275 extend inwards from the surface 274 to a predetermined point between the surface 274 and the longitudinal axis Z. The teeth 275 extend beyond and, at least in part, around a flat recessed part 278 which can include at least one spike 279. The pin 279 is concentric with the longitudinal axis Z and extends axially. There are grooves 277 defined by teeth 275 and beveled parts of cylindrical part 274.

The base member 280 of the diameter reduction structure is shown with the distal end part 282 connecting with the tubular shaped part 285 and the proximal end 284. The tubular shaped part 285 is positioned to guide the instruments that are inserted into the second seal or sealing element and has an inside diameter at least approximately equal to the diameter of the conduit 25. Radially extending tabs 287 and 289 located in the tubular shaped part 285 and the cylindrical part 286, respectively, are configured and sized to engage the first seal or sealing element 350 in a sealed manner with the base member 280 in combination with the O-ring 335. The cylindrical part 286 has an annular shape including a radially extending lip 381. Tabs 288 extending proximally and at least partially concave cavities 290 are configured to support the rotation or bending of the diameter reduction structure 240 within the proximal end portion 284.

The separating members 250 have a head 260 connected by an arm 256 to a base part 251 with opposite cylindrical end portions 254 aligned with a longitudinal axis Y. A tubular band 252 has a circumference greater than the circumference of the end part 254. A longitudinally aligned notch 252a is formed in the band 252 near the base of the arm 256. Some teeth 255 have a first arched width congruent with the outer surface of the cylindrical part 254 which narrows toward a second narrower arched width on the side opposite of each tooth 255. Thus, teeth 255 extend inwardly from surface 254 to a predetermined point between surface 254 and longitudinal axis Y. Slots 257 are defined by teeth 255 and a bevelled portion of the cylindrical end portion 274. The teeth 255 extend along the Y axis beyond and at least partially surround a pa Flat recess 258, which may include a pin 259. The pin 259 is concentric with the longitudinal axis Y, and extends axially from the part 258. The head 260 has a generally hemispherical or bulbous shape having an outer surface and a surface concave interior 266.

The head 260 includes a first side 262 that has a generally flat face and a second opposite side 268 that narrows. The first side 262 includes a cantilever extension 261. A third side 264 includes a generally convex part and beveled side parts 265. A fourth side 266, opposite the third side 264, has a generally flat face, which is connected to the arm 256. The head 260 also includes a concave and segmented notch 263 in a central position approximately perpendicular to the longitudinal axis Y. The generally concave shape of the notch 263 is configured and sized to accommodate a limited degree of movement outside the axis of small surgical tools when the diameter reduction structure 240 is in a first or initial position. The arm 256 connects the head 260 with the base part 251.

The components of the diameter reduction structure 240, including the separator assembly 245 and the linkage mechanism 270, are preferably manufactured from at least one medical grade plastic, medical grade plastic laminated products, or composite materials with the flexibility, predisposition, rigidity and compressive strength suitable for the application as a diameter reduction structure. Different materials can also be joined together in this structure depending on the application, for example, the head 260 can be manufactured from a medical grade plastic that is more resilient than a second medical grade plastic that forms the arms 256 Similarly, link members 271 may be formed of one or more similarly suitable plastics or medical grade composites.

Furthermore, the system of teeth that synchronize the movement of the separators 250 and the link members 271 are nothing more than a type of link mechanism 270 known to those skilled in the art suitable for synchronizing the movements of the separators 250 and Other suitable alternative mechanisms are contemplated, such as, but not limited to, a pulley system, a flexible timing shaft or a joint that performs the same function.

Referring now to Figures 9 and 10, the valve assembly and the diameter reduction structure 100 and the cannula 50 are shown in cross section. The first seal or sealing member 125 includes a concave or arcuate membrane portion 127 that extends radially inwardly and distally forming a distal end portion 128 defining a hole 129. Parts 127 are very close or abut with the separating members 250. The separating members 250 are shown in a first position which has a general orientation perpendicular to the central longitudinal axis X. The depth and width of the segmented notches 263 are shown in relation to the hole 129 and the second side 264 and provide a limited and increased degree of off-axis movement or angular movement of small surgical instruments.

The spacers 250 include a base part 251 located in the vicinity or abutting the cantilever part 218. The cantilever part 220 includes a wall 222 configured to act as a stop to limit the radial movement outward of the heads 260 of the separating members 250. The construction material of the separating members, and especially the head 260, can be selectively controlled to provide a flexible compressive predisposition range against angular or off-axis movements of the surgical instruments.

The housing 210 of the diameter reduction structure encloses, at least partially, the base element 280 of the diameter reduction structure and the first seal support member 350 or sealing element. The flange 367 of the second seal or sealing element is secured between the first seal support element 350 or seal element and second seal support element 380 or seal element. The seal housing 310 or sealing element encloses, at least partially, the second seal support element 380 or sealing element. The cannula 50 is connected to the distal end portion 312 of the seal housing 310 or sealing element.

In Figure 11, the diameter reduction structure 240 is shown as an integrated assembly in the first position, for placement within the base element 280 of the diameter reduction structure. The base element 280 is configured to provide a proper placement of the diameter reduction structure 240 to control the operating diameter and thereby improve the ability of the sealing system of the assembly 100 to maintain its integrity during procedures using small instruments. This includes a suitable support structure for the spacers 250 to act as a barrier providing a controlled limitation for the movement of the surgical instruments and to support the movement of the diameter reduction structure 240 between the first and second positions.

The first position of the structure 240 is defined by the heads 260 that form an annular barrier structure suitable for the control of the forces in a plane generally orthogonal to the longitudinal axis X resulting from the parallel movements outside the axis and angular and the movements in general orthogonal to the longitudinal axis of the small surgical instruments placed in the duct 25. The third sides 264 of the heads 260 define the second operative area in the first position.

In the first position, the beveled portions 265 of the heads 260 define gaps or interruptions in the annular barrier structure formed by the diameter reduction structure 240. The size of the gap is controlled by the shape and position of the heads 260 and is configured to ensure that smaller diameter surgical instruments have the passage between the heads 260 impossible. The diameter reduction structure 240 also includes a controlled predisposition configured to resist the movement of the reduction structure 240 radially outwardly, as well as from the first position to the second position. The predisposition in the structure 240 also serves to return the structure 240 to the first position after the removal of the larger diameter surgical instrument.

The second position is defined by the diameter reduction structure 240 in motion at least partly distally to accommodate the passage of individual surgical instruments of larger or unrestricted diameter through the diameter reduction structure 240 and the cannula 50.

The base element 280 includes at least some seating places 296 at least partially concave for the connecting members 271 and 290 for the separating members 250. The seating places 290 define an interrupted channel having two different supports or seats 292 configured and sized to receive the cylindrical end portions 254. The band 252 is placed between the supports 292. The seat parts 290 further include an arcuate support member 294 with a straight part 299 extending proximally.

The seating places 296 define channel portions 298 at least partially concave separated by a groove or recess 297 configured and sized to receive the surface 274 and the band 272 of the link member 271. The seating positions 296 include a straight part 299 extending proximally.

Seat parts 290 and 296 are structurally supported by a member 295 that extends proximally. The member 295 is connected by arms to the parts 292 and 298 and is configured to structurally support the parts 292 and 298 against excessive movement or deflection.

Seat locations 290 and 296 provide critical alignment, separation and angular orientation for the relationship of teeth 255 and 275 with their respective grooves 277 and 257 for synchronization of movements of spacers 250 and link members 271 In addition, the diameter reduction structure 240 includes a predisposition towards the first position as individual components or as an assembly, either as a result of its placement in the base element 280 of the diameter reduction structure, an independent predisposition member such as an elastic band, or by combinations thereof. When fully assembled with the housing 210 of the diameter reduction structure (see Figure 2) and the base of the diameter reduction structure, the diameter reduction structure 240 is capable of performing its functions at any angle or in Any use address without any operator action.

Referring now to Figures 12 and 13, the diameter reduction structure 100 is shown in an operative position. A large diameter medical instrument 80, which defines a second longitudinal axis, is placed through the valve assembly and the diameter reduction structure 100 and the cannula 50. A large diameter surgical instrument is an instrument having a diameter or a cross section orthogonal to the second longitudinal axis smaller than a first diameter or first operating area of the duct 25, but larger than the second diameter or the second operating area orthogonal to the central longitudinal axis defined by the set of spacers 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 smaller than the second diameter or second operating area defined by the set of spacers in the first position. Thus, large instruments, by definition, are larger than the second operational area, at least partially, they must deflect the set 240 of separators distally in order to enter the conduit. On the contrary, small instruments can be placed axially within the second operating area without diverting the set 240 of separators. In this preferred embodiment, large instruments are those defined as having diameters greater than 5.5 mm and small instruments are defined as those having a diameter equal to or less than 5.5 mm. The 5.5 mm distinction between large and small instruments in relation to the diameter of the duct defined in the trocar may vary depending on the diameter of the trocar apparatus and the valve assembly and the diameter reduction structure 100. When an instrument 80 large diameter moves distally along the central longitudinal axis X through the first seal or sealing member 125 and in contact with the diameter reduction structure 240, the axially aligned force component that moves the instrument Large diameter 80 has to overcome the predisposition configured to retain the diameter reduction structure 240 in the first position, as shown in Figure 10.

As the force behind the instrument 80 exceeds the predisposition configured to maintain the diameter reduction structure 240 in the first position, the diameter reduction structure 240 pivots or rotates in a generally arcuate movement in a generally distal direction at first and then continues its pivotal or pivotal arcuate movement, as shown by the arrows "A" and "B", moving away from the central longitudinal axis to define the third operational area and accommodate the passage of the large diameter instrument 80. The amount of predisposition used to maintain the diameter reduction structure 240 in the first position is controlled by factors such as the construction materials of the diameter reduction structure 240, as well as the methods used to secure the structure reduction structure 240 diameter in position in the base element 280 of the diameter reduction structure.

When forced into the inner diameter of the wall 356 by the large diameter shaft of the instrument 80, the spacers 250 move to a second position in which the face 262 of the head 260 is placed approximately parallel and in proximity to the wall 356. The spatial relationship between the wall and the diameter reduction structure 240 in the second position is a function of the individual interior configurations of the trocar, the internal circumference of the conduit 25 and the intended application of the valve assembly and the reduction structure of diameter 100. The valve assembly and the diameter reduction structure 100 are configured to provide adequate space for the pivot or flexion of the diameter reduction structure 240 and still accommodate instruments of larger diameter 80 that fit with the maximum inside diameter for a given cannula 50. After removal of the diameter instrument Large 80, the diameter reduction structure 240 is predisposed to return to a first position where a part of each spacer 250 is adjacent to the wall 220. Referring now to Figures 14 and 15, the spacer members 250 are shown in a diameter or first reduction position, in which the head 260 extends in a generally radial direction relative to the longitudinal axis X. The cantilever portion 222 provides a generally rigid barrier configured to structurally support and limit the radial displacement of head 260. The diameter reduction structure 240 in the first position is configured to accommodate the penetration of smaller diameter instruments 60 through the valve assembly and the diameter reduction structure 100 and into the cannula 50 without no movement

When in this first position, the separating member 250 is placed, at least partially, with axial compression of a force with a component perpendicular to the central longitudinal axis X as a consequence of orthogonal or angular movements of a small diameter surgical instrument 60 . Each spacer member 250 is mounted in a diameter reduction assembly 200 to provide a limit to the angular and parallel movements outside the excessive axis of the small diameter surgical instruments 60.

A small diameter surgical instrument 60 is placed through the seal or sealing member 125 and in the cannula 50 normally with little or no substantial contact with the diameter reduction structure 240. When the small diameter surgical instruments 60 are manipulated to make angular or off-axis movements, however, the small diameter surgical instruments 60 come into contact with at least one head portion 260 and the inner circumference of the cannula 50 which It acts in combination with two separate and approximately parallel structural barriers to control outward and angular movements directed away from the central longitudinal axis X. The combination of head 260 and cantilever part 222 can be configured as a rigid or flexible predisposed structure. . This control mechanism works to limit the operational movements of the small diameter surgical instruments 60, enough to maintain the integrity of the sealing system.

Referring now to Figures 16A, 16B and 16C, in another preferred embodiment, the 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, the diameter reduction structure 640 is proximal to a first seal or sealing element 525.

The diameter reduction structure 500 includes an end cap 510, a housing 610 of the diameter reduction structure, a diameter reduction structure 640, a base element 680 of the diameter reduction structure and as needed a ring toric

The end cap 510 has a generally cylindrical shape including a distal end portion 512 and a proximal end portion 514. The proximal end part 514 includes an annular shaped disk or part 516 defining a hole 515 aligned with the central longitudinal axis X. In this configuration, the annular part 516 can be a flexible or rigid plastic membrane configured to be a seal or shutter element. In this way, the hole 515 can be configured as a rigid or flexible barrier and have a diameter at least equal to the inside diameter of a cannula 50 in a rigid configuration.

The housing 610 of the diameter reduction structure is generally in the form of a hemispherical shell of decreasing circumference from a distal end part 612 to a proximal end part 614. The proximal end part 614 includes an annular part 613 defining the hole

615. The hole 615 preferably has a larger diameter than the hole 515. The proximal end portion 614 is configured to be received in a connected manner by the distal end portion 512. The distal end portion 612 includes an outer cylindrical part 616 having a corrugated surface to facilitate handling thereof.

The diameter reduction structure 640 includes a set of separators having three separating members 650 and a linkage mechanism 670 is located proximal to a first seal or sealing element 525. The separators 650 provide a predetermined degree of control and limitation of movement. of the instruments placed in the assembly 600. The link mechanism 670, in the form of three link members 671, integrates and synchronizes the movement of the separators

650. Although the specific configuration of the separator members 650 or the link mechanism 670 may vary, the set 645 of separators is operatively employed as described in all embodiments of this specification to limit angular and off-axis movements of the instruments. small surgical

The base element 680 of the diameter reduction structure is configured to seat the diameter reduction structure 640 at its proximal end portion 682 and includes at least partially a cantilever seating positions 690 configured to support and control the movement of the reduction structure 640 over a predefined range of motion as represented at least partially by the arrow "A". A tubular part 685 extending distally is configured for the placement of the first seal or sealing element 525. The first seal or sealing element 525 is approximately orthogonal to the longitudinal axis X and can be a seal or sealing element of the floating type or permanent.

A first seal support element 750 or seal element has a generally tubular shape with a distal end portion 754 that abuts on a proximal side of the cantilever seat portion 690 and a distal end 752. The first support element 750 it has an inner wall 756 that can be configured to limit the range of movement of the spacers 650. A cantilever portion 753 of the first seal element or seal element 750 is positioned to secure and seal a flange 767 of a second seal or seal element 765 located between a proximal part of the second seal support element 780 or seal element.

A distal end 752 of the first support element 750, at least partially, encloses and seals a flange 767 of the second seal or sealing element 765 in cooperation with a distal end portion 782 of a second seal support element 780 or shutter element. The second seal or sealing element 765 may be any type of seal or sealing element, but a seal or duckbill sealing element commonly configured for use with a first seal or floating or fixed sealing element is preferable. In the preferred embodiment, the second seal or sealing element 765 is a duck-like seal or sealing element that extends distally in a seal housing 710 or seal.

Seal housing 710 or seal element includes a proximal part 714 configured to secure and at least partially enclose the second seal or sealing element 765 and at least a part of the second seal support element 780 or seal element and the first element 750 seal holder or sealing element. The second seal support element 780 or seal element also has a generally annular shape and is configured to lock and engage with the first seal support element 750 or seal element. Seal housing 710 or seal element has a distal end portion 712 configured to mate with a cannula.

The valve assembly and the diameter reduction structure 500 are configured as a set for controlling angular and off-axis movements of small surgical instruments externally or proximally to the sealing system. This configuration reduces the tension applied to the first seal or sealing element by further limiting the range of angular movement to which the first seal or sealing element is subjected by handling small surgical instruments and thereby improving the integrity of the sealing system. of trocar. Furthermore, while the valve assembly and the diameter reduction structure 500 can be detachably connected to a cannula 50 sized accordingly, it is also intended that the end cap 510, the housing 610, the reduction structure 640 diameter and the base element 680 can be easily adapted as an integrated assembly, for example, with or without a first seal or integrated sealing element 525, for use with a wide range of trocar assemblies having floating or fixed seals or sealing elements to control the angular and off-axis movements of small surgical instruments with advantage without interrupting the integrity of the sealed parts of the trocar.

Referring now to Figures 17 and 18A-18C, one of the preferred embodiments of a valve assembly and reduction structure of diameter 800 includes a proximal end portion or reduction assembly of diameter 900 and a distal end portion or assembly of valve 1000. The diameter reduction structure 940 is placed distal to a first seal or sealing element 825 and within a housing 910 of diameter reduction structure.

The diameter reduction structure 940 is illustrated with a set 945 of separators having three separators 950 and three link members 971 located on a base 980 of the diameter reduction structure. While the general configuration of the base 980 of the diameter reduction structure and the link members 971 are structurally and functionally similar to the previous embodiments, the spacers 950 have a head part 960 of a different configuration, similar to that represented in Figure 16A, with the side part 965 having a generally flat shape and a width approximately equivalent to the arm 956.

The head portion 960 may also include a connection mechanism 963 and a cantilever extension or flange 967. The flange 967 extends radially from the head 960 to the base 961 in the first position. In the second position of the separators 950, the flange 967 can be configured with a suitable length to limit, at least partially, the range of movement of the separators 950 when making contact with an inner wall of the housing 910 of the reduction structure diameter. The connection mechanism 963 is configured to receive and retain a predisposition member 969 annularly in the separator 950 for its entire range of motion. The predisposed member 969 with an annular shape is configured to predispose the spacers 950 towards the first position, provide an additional predisposition when the angular or off-axis movements act to compress a separator 950 radially outwardly against the housing 910 or the base 980 of the diameter reduction structure, and act as an unbroken barrier to prevent smaller diameter surgical instruments from entering between the separators 950.

The combined effect of the connection mechanism 963, the flange part 967 and the predisposition member 969 is the control by means of the set 940 of movement separators of the smaller diameter surgical instruments when forces having an orientation generally orthogonal to the longitudinal axis, as well as the capacity of the 940 set of spacers to automatically accommodate larger diameter instruments.

In Figure 19, a further preferred embodiment of the valve assembly and the diameter reduction structure 1200 is configured with a diameter reduction structure 1340 that includes a set 1345 of separators having four diametrically opposed separators 1350 located independently within of a base 1380 of the diameter reduction structure. Each separator 1350 pivots independently, without a linkage mechanism, to limit angular and off-axis movements of small instruments.

The separating members 1350 include a head 1360, an arm 1356 and a base element 1351 configured for mounting with the base 1380. The separator 1350 can be fixedly mounted on the base 1380, for example, or on the alternative base element 1351 can be placed pivoting at base 1380 and being held in place with a positioning element (not shown). A predisposition is used to place the separator 1380 towards a first position next to the housing 1310. As a further alternative embodiment, a link mechanism can be placed to be operative with the heads 1360 to perform, for example, one or both functions of the mechanism of link shown above. Alternative 1360 head configurations include telescopic, tongue and groove mechanisms

or bevel gears that interrelate with the spacers 1380 in an annular structure approximately contiguous along their range of motion.

A predisposition inherent in the separator 1350 or in combination with its positioning element towards the base 1380 of the diameter reduction structure keeps the separators 1350 in the first position unless it is deflected by a large diameter surgical instrument. As shown in other embodiments, the diameter reduction structure 1350 may be employed proximal or distal to a first seal or sealing element. The spacers 1350, in this configuration, also include a bulb-shaped head 1360, similar to head 260 for controlling the movements of the smaller diameter surgical instruments.

In Figures 20A and 20B, two embodiments of the spacer members 950 and 1350 corresponding to Figures 18A-18C and 19, respectively, are shown. These two main separator configurations, however, are only to be considered as representative of all separator configurations described herein. The separating members 950 and 1350 include base parts 951 and 1351 that form an "y" axis with an alpha (α) angle with an "Y" axis. Axis "Y" is perpendicular to the central longitudinal axis "X". Heads 960 and 1360 define an "x" axis with a theta angle "con" with the "X". Depending on the configuration of the housing and the application of the trocar, the angles "α" or "" may coincide with their respective "Y" and "X" axes or extend to the opposite side of their respective axes in alternative embodiments of the separators 950 and 1350. The "X" axis is parallel to the central longitudinal axis "X".

All the separators described herein provide a predisposed structure generally resistant to compression against the forces acting in a plane that has an orientation generally orthogonal to the central longitudinal axis or "X". It is contemplated that separators 950 and 1350, as well as all other variations of separators in this memory are configured and positioned in relation to structures such as diameter reduction housings to provide at least one predisposed structure generally resistant to compression against the forces in the planes with angles ranging from about 15 degrees from an orthogonal angle to the central longitudinal axis.

The individual spacer members 950 and 1350 may include variable configurations of the head portion 960 and 1360 such as wing extensions or overlapping flanges, interrelated or intercalated between adjacent separators 950 and 1350. A retention mechanism 939 in the head part 960 and 1360, for example, for the placement of a predisposed member 939.

Referring now to Figure 20C, in a further alternative embodiment of a diameter reduction structure 1440, a unified set 1445 of separators is formed in a continuous and integrated flange structure 1445 or dividers. The flange structure 1445 can have any configuration of the head 1460, the arm 1456 and the base 1451, for example, suitable to perform the function of limiting the movement of the smaller diameter surgical instruments when they are generally moved in parallel outside the axis or angularly. The diameter reduction structure 1440 may be, at least partially, segmented with a plurality of grooves 1431 defining segmented parts of head 1460 and arms 1456. A retention mechanism 1439 can also be used to further predispose structure 1440 of diameter reduction. This embodiment could also take the structural form of a generally linear flexible cantilever flange structure or an angle separator structure, at least partially cantilever supported by a correspondingly located structure housing.

The diameter reduction structure 1440, with independent separators 1450 or configured as an integrated unified flange structure separator 1450, is properly configured to resist forces in a plane transverse to the central longitudinal axis "X" and, in particular, the forces in a plane approximately orthogonal to the central longitudinal axis "X". The flange structure 1450 is configured for bending or pivoting with the forces generally aligned with the longitudinal axis "X" in order to accommodate large diameter surgical instruments without any operational adjustment.

In another alternative embodiment the diameter reduction structure is a unified structure in which the arms are joined to form a ring-like structure configuration and placed inside the trocar housing as a set. The set of separators in this embodiment may also include independent or integral predisposed members.

In even another embodiment, one or more diameter reduction structures could be used together in series or in an assembly to create parallel diameter reduction structures or diameter reduction structures of different diameters.

Referring now to Figures 21 and 22A, a further alternative embodiment of a valve assembly and a diameter reduction structure 1500 includes a diameter reduction assembly 1600 and a valve assembly 1700. The valve assembly and the structure of 1500 diameter reduction defines a concentric duct 1505 with a central longitudinal axis X.

The diameter reduction assembly 1600 includes a first seal or sealing element 1525, a housing of diameter reduction structure or first housing 1610, a diameter reduction structure 1640 and a base element 1680 of diameter reduction structure. The base 1680 of the diameter reduction structure is connected to the valve assembly 1700. The seal housing or sealing element or proximal housing 1710 of the valve assembly 1700 is configured to detachably connect to the cannula 50.

The housing 1610 of the diameter reduction structure is generally tubular in shape and includes a tubular wall 1615 defining a distal end part 1613 and a proximal end part 1614. The proximal end portion 1614 has an edge 1616 extending proximally that defines a recessed portion or flange 1618. The flange 1618 is approximately perpendicular to the longitudinal axis X and includes an edge 1619 defining a hole or conduit 1505 aligned with the longitudinal axis X. The housing 1610 of the diameter reduction structure in this configuration includes a first seal or sealing element 1515 positioned distal to the flange 1618 that is held in position by a first seal support element 1620 or sealing element. The first seal support element 1620 or seal element also defines an edge 1622 aligned with the edge 1619. A distal end of the edge 1622 forms an edge 1623, with a distal end 1622 of the seal support element 1620 or seal element. The distal end portion 1612 includes a flanged portion 1613.

The inner diameter of the tubular wall 1615 abuts and is configured to move slidably in relation to a first member 1630 and a second annular member 1635. A distal edge 1631 of the annular member 1630 is abutted with a proximal edge 1636 of the second member ring 1635. The second ring member 1635 has a protrusion or tongue 1637 that extends radially.

The diameter reduction housing 1610 is connected to an annular member 1611 extending distally from the distal end 1612. There is a stopper 1608 placed at a distal end 1609 of the member 1611 that abuts a seal support member 1750 or sealing element and defines a first position of the housing 1610. The stop 1608 also interacts and is limited by the tongue 1637 to, at least in part, limit the proximal travel of the housing 1610 and defines a second position of the housing 1610.

The diameter reduction structure 1640 is located in a base element 1680 of diameter reduction. The base diameter reduction element 1680 has a distal end 1682 and a proximal end 1684. The distal end 1682 abuts the seal support member 1750 or seal element. The element 1680 also abuts a part of the interior of the annular members 1630 and 1635. The diameter reduction structure 1640 is configured to support up to approximately 180 ° of travel of each separator member 1650 from a position that extends distally. approximately parallel to the longitudinal axis to a position that extends proximally approximately parallel to the longitudinal axis.

In a first position of the separator assembly 240, the separator members 250 are generally in a plane orthogonal to the central longitudinal axis and to reduce the operational area of the conduit 1505 in combination with the structural support of the housing 1610. In a second position of the assembly 240 of separators, separator members 250 are generally at least partially distal to the first position. In a third position of the spacer assembly 240, the spacer members 250 are generally at least partially proximal to the first position.

The spacer members 1650 have a head 1660 connected by an arm 1666 to a base portion 1651 with opposite cylindrical end portions 1654. The spacer members 250 are connected by a link mechanism that includes three link members 1671 as described in embodiments. previous.

The head 1660 includes a first side 1662 having a generally flat face and a second opposite side 1668 that narrows in juxtaposition with the first seal or sealing element 1525, when the diameter reduction structure 1640 is in the first position. The first side 1662 includes a cantilever extension 1661. A third side 1664 includes a generally convex part and bevelled side portions 1665. A fourth side 1666, opposite the third side, has a generally flat face, which is connected to the arm 1656 such that the flat face extends to the second side 1662 and to the cantilevered part 1661. The arm 1656 is a downward neck part that connects the base 1651 and the head 1660. The head 1660 also includes a concave notch and segmented 1663 in a central position approximately perpendicular to the longitudinal axis Y. The generally concave shape of the notch 1663 is configured and sized to accommodate a limited degree of movement outside the axis of the small surgical tools when the diameter reduction structure 1640 It is in a first or initial position.

While the diameter reduction structure 1640 is illustrated with the set 1645 of separators with three separators 1650 and the link mechanism 1670 with three link members 1671, the general configuration of the base 1680 of the diameter reduction structure and the 1671 link members are structurally and functionally similar to the previous embodiments, such as those in Figures 6-8.

The valve assembly 1700 includes a first seal support member 1750 or sealing element, a second seal or sealing element 1765 and a seal housing 1710 configured for connection to the cannula 50. In addition, a seal or sealing element Tubular elastic or third seal or sealing element 1601 is sealed on a sliding joint 1699 between the valve assembly 1700 and the diameter reduction assembly 1600.

The second seal support element 1750 or seal element is located between the base element 1680 of diameter reduction and the seal housing 1710 or seal element. The second seal support element 1750 or seal element has a generally annular shape with a tubular wall 1755 having a cylindrical outer surface 1756. In addition, a distal end 1752 of the second seal support element 1750 or seal element seals the second seal. or sealing element 1765 in place in combination with a proximal end 1714 of the seal housing 1710 or sealing element.

The proximal end portion 1714 of the seal housing or sealing element 1710 includes places for the seat of the second seal supporting element or sealing element and the second seal or sealing element 1765. A distal end portion 1712 of the housing 1710 of stamp

or sealing element is configured to pair with cannula 50 using a suitable connection mechanism, such as a bayonet or threaded connection.

The third seal or tubular or seal element 1601 has a proximal end 1605 and a distal end 1603. The proximal end 1715 is tightly coupled with the flange 1613 of the diameter reduction housing 1610. The proximal end 1714 of the seal housing 1710 or seal element and the distal end 1752 of the second seal support element 1750 are located to be sealedly coupled to a distal end portion 1603 of the third seal or sealing element 1601. The third seal or sealing element 1601 is configured and sized as a flexible and elastic tubular seal or element located on the sliding joint 1699 and which provides a seal. The third seal or sealing element 1601 is sufficiently flexible to absorb the movement of the diameter reduction housing 1610 between the first position in which the stop 1608 abuts the second seal support element 1750 or sealing element and the second position in the that the stopper 1608 is placed proximally and abuts the tongue 1637. In addition, the third seal or sealing element 1601 provides a predisposition towards the first position of the housing 1610 for reducing the diameter of the seal housing 1610 or sealing element .

The third seal or sealing element 1601 is preferably manufactured from a flexible and / or extensible material, preferably an injection moldable or extrudable material, more preferably an elastomer or elastomeric material. The third seat 1601 may include a central dent 1601 to allow the longitudinal extension and contraction of the housing 1610 of the structure. Alternatively, the third seal or sealing element may be completely devoid of the V-shaped dent as shown in Figure 23, and have elastomeric properties to allow the seal or sealing element to expand during the extension and retraction of the housing 1610 An elastomer material has a thickness suitable for applications with external instruments that can find a rough handling and is resistant to breakage or penetration, for example, while providing a flexible predisposition. It is also contemplated that the third seal or sealing element 1601 can be easily connected and disconnected, as necessary, for autoclaving or sterilization.

Referring now to Figures 22A-22C, the diameter reduction structure 1640 is predisposed towards a first position, similar to that of Figures 15, 16A and 20A in which at least a part of the fourth side 1666 of the head 1660 and the arm 1656 are in juxtaposition with a part of the housing 1610 of the diameter reduction structure and the stopper 1608 abuts the second seal support member 1750 or sealing element. In this embodiment, the edge 1621 and the distal end 1622 of the first seal support element 1620 or seal element are in juxtaposition with at least a portion of the fourth side 1666 and the arm 1656, respectively and, in particular, the corner 1623 it is located at the junction of the arms 1656 and the fourth side 1666. Thus, the first seal support element 1620 or seal element supports the spacers 1650 in the first position by providing a structural support for the spacers 1650 to limit the angular and off-axis movements of small diameter surgical instruments.

When the diameter reduction structure 1640 is deflected distally by a large surgical instrument, as shown in Figure 13, to the second position in which the face 1662 pivots in the direction of the inner part of the tubular wall 1755 of the second seal support element 1750 or seal element, the spacer members 1650 accommodate the larger diameter of the large surgical instrument without any external adjustment by the surgeon or the operator. The separating members 1640, however, retain their predisposition towards the first position.

When the large surgical instrument is removed proximally through the valve assembly and the diameter reduction structure 1500, the combination of the predisposition and elastic nature of the spacer members 1650 can be grasped with the large instrument. To prevent undesirable seizure, the distal end 1612 is slidably coupled with the first annular member 1630, the second annular member 1635 and the second seal support member 1750 or sealing element such that the diameter reduction housing 1610 slides in the proximal direction until the instrument stops gripping or the stop 1608 abuts the tongue 1637. The movement in the proximal direction of the diameter reduction structure 1610 from the position of the first housing 1610 defines a greater volume within the housing 1610 in diameter which is suitable for the separating members 1650 to pivot proximally towards the third position and at least partially increase the operational area of the duct 1505 from the second operational area to a third operational at least in which the operational area increases in a manner similar to that of the second position of the set of separators in such a way that the instrument Large can be removed with limited resistance.

Additional alternative embodiments for preventing seizure include a fastener or a coupling receptacle for each separator in the second position with an external release mechanism, for example, or friction reduction means such as one or more wheels placed in the second side 1668 and / or the third side 1664 that could accommodate the removal of the large instrument, while in a distal or second position due to the rotation of the wheel and still provide adequate resistance to the movements of the small surgical instruments when they are in the first position.

Referring now to Figure 24, another embodiment of the present description is illustrated. The 2000 system includes a seal or seal element 2002 assembly and a cannula 2004 assembly in which the seal or seal element assembly 2002 is mounted. Seal assembly 2002 or seal element defines a seal housing or seal element consisting of a plurality of components that form an external member of seal assembly 2002 or seal element and the diameter reduction structure for limiting excessive angular movements. and from outside the axis of small diameter surgical instruments as explained above in this report. The seal or seal element assembly 2002 defines the "x" axis of the seal or seal element. The seal or seal element assembly 2002 includes a subset of the first or proximal seal or sealing element 2006 and a subset of the seal or distal or second seal element 2008, which is connected to the cannula assembly 2004. The first subset 2006 of seal or sealing element is adapted for connection, which can be released, to the second subset 2008 of seal or sealing element and incorporates the diameter reduction structure.

With reference now to Figures 25-27, in relation to Figure 24, the first and second 2006, 2008 seal or seal sub-assemblies of the seal or seal element assembly 2002 will be explained. The first 2006 subset of seal or sealing element includes an end cap 2010, a septum seal or seal 2012 and a 2014 diameter reduction housing. The 2014 diameter reduction housing includes first and second 2016, 2018 reduction housing components that house the 2020 separator elements. In general, the 2020 separator elements are interconnected and pivot to allow the passage of an instrument. The separating elements 2020 are predisposed towards an initial position by the elastomeric O-ring 2022. The O-ring 2022 is received in the recess 2020r of each separating element 2020, as shown in Figure 26. When the separating elements 2020 pivot down ( shown in imaginary line in figure 26), with the insertion of an instrument, the O-ring 2022 is extended to allow this movement of the separating elements 2020. With the removal of the instrument, the separating elements 2020 return to their initial position in transverse relation to the "x" axis under the influence of the O-ring 2022. The rest of the components of the first seal or sealing element 2006 subset are substantially similar to their corresponding components described and explained in the previous embodiments, and reference is made to the foregoing. of this report for a more detailed analysis of the structure and functionality of these components tes.

In a further aspect of the present embodiment, the diameter reduction housing 2014 includes mounting tabs 2024 radially spaced on the inner wall 2026 of the second reduction housing component 2018. As seen in Figure 25 and Figure 27, the mounting tabs 2024 serve to detachably secure the first seal sub-assembly 2006 or seal element and the second seal sub-assembly 2008 or seal element as will be explained.

The second subset of seal or sealing element 2008 includes a stationary ring member 2028, a duckbill valve housing 2030, a duckbill or zero-closing valve 2032 supported on the valve housing 2030 and a manual locking 2034. Stationary ring member 2028 defines a first annular wall 2036 on its proximal side. The annular wall 2036 incorporates small and large recesses 2038, 2040 arranged in diametrically opposite relation, as shown. The first annual wall 2036 of the stationary ring member 2028 is received within an annular recess 2042 defined between the walls 2044, 2046 of the first and second 2016, 2018 components of the reduction housing, respectively (Figure 26). Small and large recesses 2038, 2040 receive corresponding pairs of positioning legs 2048, 2050 of the reduction housing 2014. As best shown in Figures 28 and 29, the respective distance between the positioning legs 2048, 2050 and the corresponding lengths of the recesses 2038, 2040 (identified as distances and lengths "a" and "b") guarantee the proper orientation of the reduction housing 2014 inside or in relation to the stationary ring member 2028 during assembly.

The stationary ring member 2028 further includes a second annular wall 2052 disposed on the distal side of the stationary ring member 2028. The second annular wall 2052 includes a partial annular groove 2054 therein and a plurality of radially spaced grooves 2056 on its outer surface. . A single locking tongue 2058 is disposed within each groove 2056. The operation of the partial groove 2054, the spaced grooves 2056 and the locking tongues 2058 will be explained in more detail below.

As best represented in Figures 25 and 29, the housing 2030 of the duckbill valve includes an annular wall 2060 defining the central opening 2062. The annular wall 2060 defines the proximal opening 2062 with three grooves 2064. The grooves 2064 They accommodate the mounting tabs 2024 of the 2014 diameter reduction housing during the assembly of the first and second 2006, 2008 seal or seal sub-assemblies. The duckbill housing 2030 includes a plurality of dependent axial legs 2066. The legs 2066 of the duckbill housing 2030 may include rectangular openings 2068.

In a preferred arrangement, the manual locking member 2034 is secured to the duckbill housing 2030 in fixed relationship with it. Manual locking member 2034 includes a plurality of recesses 2070 defined on its outer surface. The recesses 2070 receive the corresponding dependent legs 2066 of the 2030 duckbill housing. The recesses 2070 include mounting tabs 2072 (as seen in Fig. 25) that are received within the rectangular openings 2068 of the dependent legs 2066 of the duckbill housing 2030 by elastic jump with the same to secure the two components (see also figure 26). Manual lock member 2034 and duckbill housing 2030 capture the peripheral edge 2074 of duckbill valve 2032 to secure duckbill valve 2032 between the two components.

The manual locking member 2034 and the duckbill housing 2030 are arranged, at least partially, within the stationary ring member 2028 and are adapted for rotational movement in relation to the stationary ring member 2028. The manual locking member 2034 includes the gripping element 2076 that extends radially outward for engagement by the user. The gripping element 2076 includes a transverse leg 2078 that is accommodated within the partial annular groove 2054 of the stationary ring member 2028 and passes through the groove 2054 during the rotation of the manual locking member 2034 and the duckbill housing 2030. Manual locking member 2034 is adapted for rotational movement between a first position corresponding to a release position that allows the assembly and / or release of the first subset 2006 of the second subset 2008, and a second position corresponding to a position of locking that secures the first subset 2006 with the second subset 2008. An O-ring seal or seal element 2080 can be placed on the circumference of the duckbill housing 2030 to form a substantial seal between the duckbill 2030 housing and 2014 diameter reduction housing.

In other embodiments, the manual locking member 2034 is slidably received by the duckbill housing 2030. The manual locking member 2034 can then slide with respect to the stationary ring member 2028.

Referring to Figures 24-26, the cannula assembly 2004 includes a cannula housing 2082 and a cannula tube 2084 extending from the housing 2082. The cannula housing 2082 includes vertical legs 2086 that are placed inside the cannulae. grooves 2056 of the stationary ring member 2028. The legs 2086 preferably include internal projections 2088 advantageously sized to accommodate the locking tabs 2058 disposed within the grooves 2056 of the stationary ring member 2028 to securely secure the two components. The cannula tube 2084 defines a longitudinal passage 2090 that allows the passage of the instrumentation. The cannula tube 2084 can be secured to the cannula housing 2082 by corresponding tabs 2092 and grooves 2094 of the cannula tube 2084 and cannula housing 2082, respectively. An O-ring seal or sealing element 2096 can be placed inside the cannula housing 2082 to form a seal or sealing element within the housing 2082 next to these components.

During use, the second subset 2008 of seal or seal element of seal assembly or seal element 2002 is mounted in cannula housing 2082. In this regard, the vertical legs 2086 of the cannula housing 2082 are aligned with the grooves 2056 of the stationary ring member 2028 and the ring member 2028 is advanced so that the locking tabs 2058 of the ring member 2028 are firmly coupled to the internal protrusions 2088 within the vertical legs 2086. Thereafter, when it is determined that the diameter reduction structure is needed, for example, during the use of a small diameter instrument, the first sealing sub-assembly 2006 is locates in relation to the second subset 2008 of sealing as shown in figures 27-29. In this position, the positioning legs 2048, 2050 of the first seal sub-assembly 2006 or seal element are aligned with the corresponding recesses 2038, 2040 of the second seal sub-assembly 2008 or seal element (Figures 25 and 27). In addition, the manual locking member 2034 is placed in the release or first position of Fig. 29. In this position, the mounting tabs 2024 of the first seal or sealing element sub-assembly 2006 are in general alignment with mounting recesses 2064 of the annular plate 2060 of the 2030 duckbill housing of the second 2008 subset of seal or sealing element. The first subset 2006 of seal or seal element is then mounted on the second subset 2008 of seal or seal element whereby the positioning legs 2048, 2050 are placed in the respective recesses 2038, 2040 and the mounting tabs 2024 are received within the 2064 mounting grooves of the 2030 duckbill housing. The manual lock member 2034 is then rotated on the axis "a" from the release or first position shown in Figure 30 to the locked or second position represented in Figure 31. This movement of the manual lock member 2034 causes the corresponding rotating movement of the duckbill housing 2030 to move the mounting grooves 2064 whereby the mounting tabs 2024 are captured below the annular wall 2060 of the duckbill housing 2030. In this position, in the first 2006 subset of the seal or sealing element, the second subset of the 2008 seal or sealing element is secured. The procedure is continued with the introduction of an instrument through the seal assembly or sealing element 2002 and cannula assembly 2004, and performing the desired surgical procedure.

It should be noted that the duckbill housing 2030 and the manual locking member 2034 may be a single monolithic component formed during manufacturing. Furthermore, it is contemplated that the second subset 2008 of seal or sealing element may be a component of the cannula housing or the tube housing 2082, and are supplied with the cannula assembly 2004. In the second alternative subset 2008 of seal or sealing element the cannula housing 2082 can be replaced in its entirety and serve as a tube housing. Furthermore, it is contemplated that other first modified subsets of seal or sealing element, for example, with or without diameter reduction structure, can be adapted for use with the second 2008 subset of seal or sealing element.

Although the illustrative embodiments of the present description have been described herein with reference to the accompanying drawings, it should be understood that various other changes and modifications may hereafter be made by one skilled in the art without departing from the scope of the invention. All these changes and modifications are intended to be included within the scope of the appended claims.

Claims (11)

1. A surgical system (2000), comprising: a cannula assembly (2004) including a cannula housing (2082) and a cannula tube (2084) extending from the cannula housing, the cannula tube defines a longitudinal axis and has a longitudinal conduit (2090) for allow the passage of a surgical instrument; Y a surgical assembly (2002) of seal or sealing element, which includes: a first subset (2006) of seal or sealing element that includes a first housing (2014) of seal or sealing element having a sealing member (2012) defining internal parts adapted to allow the passage of a surgical object in substantially sealed relationship with the; a second subset (2008) of seal or sealing element that includes a second seal housing (2030) adapted for mounting in the cannula housing, in which the second seal housing or sealing element of the second seal subset or sealing element includes an annular plate member (2060) defining a central opening (2062) for the passage of the surgical object, and the annular plate member defines a plurality of mounting recesses (2064) in the central opening; wherein the first housing of the first seal subset or seal element has a plurality of locking tabs (2024) corresponding to the mounting recesses; and characterized by: a manual locking member (2034) adapted for movement between a first position corresponding to a release position of the first subset to allow the release of the first seal subset or seal element from the assembly in the second seal subset or seal element, and a second position corresponding to a locked position of the first seal subset or seal element to secure the first seal subset or seal element to the second seal subset or seal element; wherein the manual locking member is adapted for the rotational movement with respect to the longitudinal axis to move between the first and second positions thereof, and wherein the second seal subset or seal element includes a stationary ring member (2028) fixed fixed to the cannula housing, in which the manual locking member and the second housing are, at least partially, disposed within the member of the stationary ring and the manual locking member is adapted for the rotating movement in relation to the stationary ring member, and wherein the mounting recesses are in general alignment with the locking tabs of the seal housing or sealing element when the manual locking member is in the first position to receive the locking tabs and the mounting recesses move from the tabs locked with the movement of the manual locking member to the second position thereof, whereby the locking tabs are captured below the annular plate member, and wherein the manual lock member includes a manual grip member (2076), which hangs radially outward with respect to the longitudinal axis of the seal housing or sealing element, the manual grip member is sized and configured for coupling by part of the surgeon to move the manual locking member between the first and second positions.

2.

The surgical system according to claim 1, wherein the second seal assembly or sealing element includes the manual locking member.

3.

The surgical system according to claim 1 or 2, wherein the second subset includes a zero shut-off valve (2032) adapted to open to allow passage of the surgical instrument and close substantially in the absence of the surgical instrument.

Four.

The surgical system according to claim 3, wherein the zero shut-off valve is supported within the second housing of the second seal or seal sub-assembly.

5.

The surgical system according to claim 4, wherein the manual locking member and the second housing of the second seal subset or seal element capture a peripheral edge (2074) of the valve to secure it in between.

6.

The surgical system according to any of the preceding claims, which includes at least two spacer elements (2020) mounted on the first seal subset or seal element distal to the seal member, the spacer elements are adapted for pivotal movement between an initial position and A pivoted position to allow the passage of the surgical object, the separating elements are normally predisposed towards the initial position to urge the surgical object to general alignment with respect to a longitudinal axis of the cannula tube.

7.

The surgical system according to claim 6, wherein at least two separating elements are operatively coupled such that the movement of at least one of the separating elements between the initial and pivoted positions causes the corresponding movement of the other separating elements. .

8.

The surgical system of any one of the preceding claims, wherein the second housing of the second seal subset or seal element is secured in the manual locking member in fixed relationship with it.

9.

The surgical system according to any of the preceding claims, wherein the first housing includes a generally tubular part (2026) located distally, centered on the longitudinal axis, the tubular part is located to guide the surgical object as it is inserted into the second subset of seal or sealing element and having an inside diameter at least approximately equal to the diameter of the conduit, in which the locking tabs are mounted on and around the tubular part.

10.

The surgical system according to any of the preceding claims, wherein the stationary ring member defines a first annular wall (2036) on its proximal side, in which the first annular wall incorporates small and large recesses (2038, 2040) arranged in diametrically opposite positions and in which the first housing includes a corresponding pair of positioning legs (2048, 2050) to ensure the correct orientation of the first housing in relation to the stationary ring member when the first seal sub-assembly or sealing element is mounted on the second subset of seal or sealing element.

eleven.

The surgical system according to any one of the preceding claims, wherein the manual locking member and the second housing are adapted for the rotating movement in relation to the stationary ring member so that the movement of the manual locking member causes the rotating movement corresponding of the second accommodation.