Surgical seal assembly

ES 2 389 736 T3

DESCRIPTION

Surgical Seal Set

Background

Technical field

The present invention relates to a surgical device and, more especially, relates to a surgical seal assembly for a cannula assembly and having an adaptable guide for directing a surgical instrument along a path generally coincident with the axis of the tube. a seal.

Description of the prior art

Minimally invasive surgical procedures that include endoscopic and laparoscopic procedures allow surgery to be performed on organs, tissues, and vessels far away from an opening in the tissue. Laparoscopic and endoscopic procedures generally require that any instrumentation inserted into the body be sealed, that is, elements must be provided to ensure that gases do not enter or exit the body through the incision, as for example in surgical procedures in which the surgical region is insufflated. These procedures typically employ surgical instruments that are introduced into the body through a cannula. The cannula has a housing at a proximal end thereof in which a seal assembly is mounted. The seal assembly provides a substantially fluid-tight seal around the instrument to preserve the integrity of the established pneumoperitoneum.

Minimally invasive procedures have several advantages over traditional open surgery, including less trauma to the patient, little recovery time, low potential for infection, etc. However, despite its recent success and general acceptance as a preferred surgical technique, minimally invasive surgery, such as laparoscopy, has several disadvantages. In particular, insertion of the surgical instrument into the cannula has proven difficult in certain procedures, e.g. For example, in procedures that require extensive manipulation of long, narrow endoscopic instruments in a remote location. Furthermore, many conventional seal assemblies are not particularly well adapted to receive a surgical instrument if it is inserted at an angle. This type of insertion often results in the instrument losing the target (eg, septum seal, etc.) and becoming lodged in an undesired position within the seal assembly. There is still a need for an apparatus that can be used to guide a surgical instrument through a seal assembly in a more efficient and effective manner.

WO 06/020267 describes a surgical access apparatus that includes an access member sized for insertion into tissue and having a longitudinal opening to allow introduction of a surgical object through the access member to perform a procedure in the underlying tissue. A seal member mounts through the longitudinal opening of the access member and has an internal portion defining an opening to form a substantial seal around the surgical object inserted through the longitudinal opening of the access member. The seal member includes a first seal portion extending from the inner portion and is mounted in suspended relationship on the access member, and a second seal portion extending from the inner portion and disposed radially outward from the first. seal portion, and which is connected to the access member.

US 4,655,752 discloses a surgical cannula having a first seal member having a substantially conical shape and an opening at the end thereof, and a second seal member having a substantially conical shape and a slit at the end. of the same, so that (a) when an instrument is inserted into the cannula, the instrument can pass through the first and second seal members in the vicinity of a surgical site below the cannula, and fluid entering the cannula from the site will force the first seal member to close around the instrument and form a tight seal therewith to prohibit fluid from passing out of the cannula and (b) when no instrument is inserted into the cannula, fluid entering the cannula from the site will force the second conical seal member to close tightly in its slot and thereby form a tight seal to prohibit fluid from passing out of the cannula.

US 5,779,697 describes an arthroscopic elongated cannula having a proximal and distal elastomeric sealing means through which surgical instruments can be inserted. The distal sealing means is a transverse linear slot supported around its perimeter by a track-shaped reinforcing member to engage instruments inserted therethrough and to seal the proximal side of the linear slot from the distal side when not being used. use no instrument. The proximal sealing means is a floating circular opening capable of being tilted and moved laterally to provide a sealing function around an instrument shaft, whether or not the shaft is aligned with the axis of the cannula.

US 2003/195472 describes a valve assembly to allow introduction of a surgical instrument into the body of a patient while providing a substantial seal around the instrument. The valve assembly includes a gasket assembly that provides a tight seal to

ES 2 389 736 T3 fluids prior to Instrument Insertion. The valve assembly may further include a deformable sealing member having a substantially central opening to accommodate the instrument. The sealing member provides a substantial seal around the instrument when the instrument is passed through which hinders the exit of fluids and gases through the valve assembly.

Document EP 0 696 459 describes a valve assembly for the sealed reception of an elongated object and includes a valve body having at least one opening configured and dimensioned to allow entry of an object and define an elongated central longitudinal axis, an elongated sealing member formed of an elastic material and defining an opening in general alignment with the opening of the valve body, whereby the opening is configured and dimensioned such that inserting the object into the opening causes the elastic material defining the opening to elastically engage the outer surface of the object in a substantially fluid-tight manner, and at least an elongated protective member disposed within the seal member in bearing contact with the interior surface thereof. The protective member is positioned to engage the elongated object with the at least partial insertion of the elongated object into the valve body. The protective member includes at least a first substantially rigid portion adapted to be displaced with respect to the longitudinal axis to facilitate expansion of the opening of the seal member upon entry of the object therein.

EP 1 671 596 discloses a seal for use in conjunction with a trocar assembly including a seal body adapted to selectively open and close the seal, and a shield adjacent the seal body to protect the seal body from instruments that pass through the body of the seal. The protector includes at least one flap mounted for pivotal movement to force the seal into an open configuration.

Summary

Accordingly, the present invention provides a surgical seal assembly as defined in claim 1 for use with a cannula assembly. The surgical seal assembly includes a seal housing that defines a longitudinal axis of the housing and has a longitudinal opening therethrough; a seal having an interior seal portion that defines a passageway and is adapted to form a substantial seal around a surgical instrument disposed within the passageway and a guide mounted on the proximal end of the seal housing. The guide has an inner guide portion proximal to and spaced from the inner seal portion of the seal. The inner guide portion defines a channel adapted to generally direct the surgical instrument toward the inner seal portion of the seal with the entrance of the surgical instrument within the longitudinal opening of the seal housing. The inner guide portion is relatively compliant to absorb initial deflection or angled entry of the surgical instrument. The inner guide portion of the guide may include an elastomeric material.

The guide channel may be of a generally tapered configuration, with a proximal inlet opening and a distal outlet opening, the distal outlet opening defining an internal dimension less than a corresponding internal dimension of the proximal inlet opening. The channel can define a general frusto-conical configuration. The inner guide portion of the guide is adapted to allow passage of the surgical instrument through the channel without forming a seal around the surgical instrument. The guide includes a plurality of compliant members, the compliant members preferably extending at least radially inward relative to the longitudinal axis. Preferably, the compliant members extend in a general direction having radial and longitudinal components of direction with respect to the longitudinal axis. The compliant members can be mounted in a cantilevered relationship with the seal housing and can be rotated slightly upon engagement with the surgical instrument. The compliant members are arranged such that the adjacent compliant members are in a partial overlapping relationship.

The seal housing may include an internal wall that defines an internal dimension less than the internal dimension of the proximal entry opening of the guide channel to generally restrict the internal dimension of the longitudinal opening of the seal housing.

The present invention also provides a surgical assembly including a cannula assembly and a seal assembly in accordance with the present invention. The cannula assembly includes a cannula housing and a cannula sleeve extending from the cannula housing. The cannula provides access to an underlying surgical site. The seal assembly includes a seal housing adapted for releasable connection with the cannula housing and has a longitudinal opening therethrough, a seal having an interior seal portion adapted to form a substantial seal around a surgical instrument and a guide, for example connected to an outer surface of the seal housing. The guide includes a relatively compliant inner guide portion adapted to accommodate the initial deviated entry of the surgical instrument into the seal housing and to be mounted relative to the seal housing to direct the surgical instrument toward the inner seal portion of the seal. during continued advancement of the instrument through the longitudinal opening of the seal housing. The cannula assembly may include a valve adapted to close in the absence of the surgical instrument inserted therethrough and open in the presence of the surgical instrument. The inner guide portion of the guide is insulated from the inner seal portion of the seal so as not to interfere with the operation of the seal. The guide includes a plurality of compliant members arranged coaxially around 3

ES 2 389 736 T3 of the longitudinal axis. The inner guide portion of the guide is adapted to allow passage of the surgical instrument through the channel without forming a seal around the surgical instrument. The guide may be disposed proximal of the seal.

One method of performing a surgical procedure includes the steps of accessing an underlying operative site with a cannula assembly;

mounting a seal assembly to the cannula assembly, the seal assembly includes a seal housing, a seal mounted within the seal housing, and a guide mounted in the proximal seal housing of the seal;

inserting a surgical instrument into the seal assembly whereby the guide generally directs the surgical instrument into an internal passage of the seal without forming a seal there, the guide is spaced from the internal passage so as not to interfere with the operation of the seal; and performing a surgical procedure with the surgical instrument.

Brief description of the drawings

Preferred embodiments of the present invention are hereinafter described with reference to the drawings, in which:

FIG. 1 is a detached perspective view of a seal assembly, in accordance with the principles of the present disclosure, illustrated with a cannula assembly and a trocar assembly;

FIG. 2 is a cross-sectional side view of the surgical seal assembly of FIG. 1;

FIG. 3 is a perspective view of a compliant guide of the seal assembly of FIGS. 1-2;

FIG. 4 is a cross-sectional side view of an alternate embodiment of the surgical seal assembly of the present disclosure; and

FIG. 5 is a perspective view of a compliant guide having a plurality of compliant members in accordance with the surgical seal assembly of the present invention.

The adaptive guide of Figure 3 is not in accordance with the present invention.

Detailed description of the preferred embodiments

The surgical seal assembly of the present invention provides a substantial seal between a body cavity of a patient and the outside atmosphere during insertion of a surgical instrument through the assembly. In addition, the seal assembly guides the instrument through the assembly and places it in a desirable position for passage through the seal. This guide greatly facilitates endoscopic surgery when surgical instruments can be inserted off-center or angled with respect to the axis of the seal and could become lodged within the seal assembly as a result. The surgical seal assembly may be adapted to mount on a conventional cannula assembly as will be described later.

The seal assembly of the present invention contemplates the introduction of various types of surgical instruments adapted for introduction through an elongated trocar assembly. Some possible examples of such instruments may include fixator applicators, forceps, dissectors, retractors, staplers, laser fibers, photographic devices, endoscopes and laparoscopes, etc. Such instruments are collectively referred to herein as instruments.

In the following description, the term proximal refers to the part of the instrument closest to the operator and the term distal refers to the part of the instrument furthest from the operator.

Referring to FIG. 1, the seal assembly 100 is shown with a cannula assembly 200. The cannula assembly 200 can be any conventional cannula assembly suitable for the intended purpose of accessing a body cavity and allowing the introduction of instruments through she. The cannula assembly 200 is especially adapted for use in laparoscopic surgery in which the peritoneal cavity is inflated with a suitable gas, for example CO2, to elevate the cavity wall relative to the internal organs therein. The cannula assembly 200 is typically used with an obturator assembly 300 which is an elongated instrument that can be positioned within the cannula assembly. The plug assembly 300 may have a sharp end or a blunt end and is used to pass through, e.g. g., abdominal tissue, to facilitate introduction of the cannula assembly into the abdominal cavity. Once access to the abdominal cavity has been achieved, the obturator assembly 300 is removed from the cannula assembly 200 leaving the cannula assembly 200 in place for the introduction of the surgical instrumentation used to perform the procedure. Examples of cannula assemblies in which the present seal assembly 100 may be used are described in commonly assigned patent

US 2 389 736 T3 No. 5,603,702 to Smith et al., Published February 18, 1997, and commonly assigned US Patent No. 5,807,338 to Smith et al., published September 15, 1998.

The cannula assembly 200 includes a cannula sleeve 202 and a cannula housing 204 mounted to one end of the sleeve 202. The cannula sleeve 202 defines a longitudinal axis "a" that extends along the sleeve 202. The sleeve 202 further defines an internal longitudinal passage 206 dimensioned to allow passage of surgical instrumentation.

Cannula housing 204 may be a multi-component element secured through snap fit, ultrasonic welding, or any other means envisioned by one of ordinary skill in the art including, e.g. eg, adhesive media. The cannula housing 204 may further include diametrically opposed housing grips 208 dimensioned and arranged for grip engagement by the user's fingers. The cannula housing 204 may further include a duckbill or zero shutoff valve 210. Such a zero closure valve 210 opens to allow passage of surgical instrumentation and closes in the absence of instrumentation. The valve may preferably be adapted to close upon exposure to forces exerted by insufflation gases in the internal cavity. Other zero-closing valves are also contemplated, including single or multiple slot valve arrangements, horn valves, gate valves, etc.

Sleeve 202 and cannula housing 204 can be formed of stainless steel or other rigid materials, such as a polymeric material or the like. Cannula sleeve 202 and / or cannula housing 204 can be transparent or opaque. The diameter of the sleeve 202 can vary, but is typically 10-15mm for use with the seal assembly 100 of the present disclosure.

The plug assembly 300 includes the plug housing 302 and the plug member 304 extending from the housing 302. The plug member 304 includes a penetrating end 306 adjacent its distal end. The penetrating end 306 can be tapered or blunt. A plug sleeve 308 is coaxially mounted around the plug member 304. The plug sleeve 308 can be retracted to expose the piercing end 306. Alternatively, the plug member 304 may advance within the plug sleeve 308 to expose the piercing end 306. Other alternative plug mechanisms are also envisioned to expose the piercing end 306.

Referring now to FIG. 2, together with FIG. 1, the seal assembly 100 will be explained in detail. The seal assembly 100 includes a seal housing, generally identified by reference numeral 102, and a longitudinal opening 104 that extends through the seal housing 102. Seal housing 102 houses the sealing components of the assembly and defines seal housing axis "b" which is preferably parallel to axis "a" of cannula sleeve 202 and, more preferably, is coincident with axis "a" of cannula when seal assembly 100 is mounted on cannula assembly 100. In one embodiment, the seal housing 102 may integrate a number of housing components 106, 108 which, when assembled together, form the seal housing 102. The assembly of the housing components 106, 108 can be accomplished by suitable adhesive means, including adhesives, cements or the like, or by mechanical means including tongue-groove arrangements, bayonet couplings, interference fittings, etc. Alternatively, the seal housing 102 can be monolithically formed as a single unit.

Seal housing 102 defines proximal and distal ends 110, 112, respectively. Adjacent to proximal end 110 is a tapered inner wall 114 that extends radially inward toward axis "b" of the seal housing from proximal to distal, ie, tapered wall 114 has both longitudinal and radial direction components, and terminates on the annular inner wall 116. Annular wall 116 serves to restrict the internal dimension of longitudinal opening 104 to at least partially restrict lateral movement of a surgical instrument inserted through seal housing 102.

The seal housing 102 can be constructed of a plurality of different materials, including, but not limited to, polymeric, metallic, elastomeric. Preferably, the components of the seal housing 102 are formed of a polycarbonate material such as ABS available from General Electric Company. The seal housing 102 may further include a handle that may be of any suitable ergonomic design. In addition, seal housing 102 can be used in conjunction or removably mounted with cannula assembly 200 as described above.

Seal assembly 100 includes seal 118 mounted within seal housing 102 in a suspended relationship. Seal 118 may be mounted within seal housing 102 by conventional means, such as the use of adhesives, cements, or the like. Alternatively or in conjunction with said adhesive means, seal 118 may be disposed or trapped between housing components 106, 108 of seal housing 102 to effect mounting. It is also contemplated that seal 118 may be mounted in a manner that allows radial or lateral movement of seal 118 within seal housing 102.

Seal 118 preferably includes an interior seal portion 120 that defines a passage adapted to form a substantial seal around a surgical instrument. Seal 118 may be a septum seal incorporating a

ES 2 389 736 T3 circular opening 122 formed of suitable elastomeric material. In one embodiment, stamp 118 is the cloth stamp described in commonly assigned US Patent No. 6,702,787 to Racenet et al. The seal disclosed in the * 787 patent may be a flat septum seal having a first layer of elastic material and a second layer of fabric juxtaposed with respect to the first layer. The fabric layer may include a SPANDEX material containing 20% ​​Spandex from Milliken. In yet another alternative, seal 118 is preferably a cloth seal and is desirably arranged to have a constriction. The fabric is desirably constructed of a material that forms a constriction or closure. The seal can also be molded from an elastic material to have a constriction. Other provisions for stamp 110 are also contemplated.

Although seal 118 is described as an impregnated fabric arrangement, it is appreciated that other types of seal can be used and still achieve the objectives of the present disclosure. For example, the seal 118 can be made of an elastomeric material without the embedded fabric. Other gel, foam or other fluid filled bladder seal arrangements are also envisioned.

Referring now to FIGS. 2-3, the seal assembly 100 further includes a generally compliant guide 124 that mounts to an outer surface of the seal housing 102 preferably the adjacent inner tapered wall 114. The compliant guide 124 can be secured to the outer surface, e.g. g., the tapered inner wall 114 of the seal housing 102 or mounted in suspended relationship with the tapered inner wall 114. The compliant guide 124 has a generally tapered configuration, e.g. eg, generally frusto-conical in shape, with a proximal inlet opening 126 and a distal outlet opening 128, and the inner guide portion 130 defining an inner channel 132. Preferably, the distal outlet opening 128 defines a larger inner dimension than a corresponding internal dimension of opening 122 of seal 118. In a preferred embodiment, the inner guide portion 130 is dimensioned to allow passage of the surgical instrument through the inner channel 132 without forming a seal around the surgical instrument.

In use, the compliant guide 124 is adapted to generally direct the instrument toward the inner seal portion 120 of the seal 118 as the instrument advances through the longitudinal opening 104 of the seal housing 102. In a preferred embodiment, compliant guide 124 has a compliant feature that allows compliant guide 124 to deflect upon engagement with a surgical instrument, such as, e.g. eg, when an instrument is initially inserted offset from the axis or angled with respect to the "b" axis of the seal housing, to substantially avoid housing the instrument within the adaptive guide 124. Thereafter, the narrowed orientation of the adaptive guide 124 Guides the instrument along the "b" axis of the seal. The compliant guide 124 can be constructed of a number of different compliant or flexible materials. In a preferred embodiment, compliant guide 124 is formed of an elastomeric material. The compliant guide 124 is preferably longitudinally spaced from the seal 118 so as not to interfere with the operation of the seal 118.

It is envisioned that the seal assembly 100 can be separately connected to the cannula assembly 200. Preferably, the seal housing 102 is dimensioned to be releasably mounted in the cannula housing 204. In this consideration, it is appreciated that seal housing 102 and cannula housing 204 may integrate means to facilitate releasable connection of seal assembly 100 to cannula assembly 200, including, e.g. eg, an interference fit, bayonet coupling, screw arrangement, etc ... into the corresponding structure of seal housing 102 and cannula housing 204. For example, seal housing 102 may include locking fasteners 136 (FIG. 1) that engage a corresponding structure in cannula housing 204 to secure seal assembly 100 in cannula assembly 100. A suitable means for connecting the seal and cannula assemblies 100, 200 is described in the aforementioned US Patent No. 5,603,702 to Smith et al. Thus, the surgeon can remove the seal assembly 100 from the cannula assembly 200 at any time during the surgical procedure and similarly mount the seal assembly 100 on the cannula whenever desired in order to provide a sealing engagement with an instrument. to be inserted through the cannula. In addition, the seal assembly 100 can be easily adapted for mounting in a conventional cannula of different structures. Alternatively, seal housing 102 may be permanently secured to cannula housing 204 if so desired.

Referring now to FIG. 4, another example of the seal assembly of the present invention will be explained. Seal assembly 140 is substantially similar to seal assembly 100 discussed hereinbefore. However, according to this embodiment, the seal assembly 140 includes a compliant guide 142. The compliant guide 142 is cantilevered in the seal housing 106 to provide a greater degree of flexing ability to the compliant guide 142. In this regard, compliant guide 142 is spaced from tapered inner wall 114. Furthermore, the effective internal dimension adjacent to the distal end of compliant guide 142 is less than the dimension or inner diameter of annular wall 116, ie, compliant guide 142 is spaced a distance d from annular wall 116 such that compliant guide 142 does not necessarily restrict the diameter of the opening of housing component 106. Any means for mounting the compliant guide 142 in a pivotal manner can be appreciated by one of ordinary skill in the art. In a preferred embodiment, the compliant guide 142 includes a flange 144 that is secured by conventional means to the proximal outer surface 110 of the housing component 106. In other respects, the seal assembly 140 functions in a manner similar to that described above in this memory.

ES 2 389 736 T3

FIG. 5 illustrates an adaptable guide for Incorporation with the seal assembly of the present Invention. The compliant guide 150 includes a plurality of compliant members 152 disposed coaxially about the seal axis to define an opening 154. The compliant guide 150 may be mounted in the seal housing 106 in pivotal relationship in substantially the same manner as discussed with With respect to the embodiment of FIG. 4 to provide a greater degree of flexibility with docking and initial entry of the surgical instrument. In this regard, compliant guide 150 includes a flange 156 that is secured to proximal surface 110 of housing component 106 (see FIG. 4). The compliant members 152 may be spaced from the tapered inner wall 114 in the suspended pivotal manner to provide a greater degree of deflection with deviated entry of the surgical instrument. The compliant members 152 are arranged to define a frusto-conical shape extending radially inward with respect to the axis s of the seal from proximal to distal, and may further be arranged such that the adjacent compliant members 152 are in overlapping or partially overlapping relationship. each. The compliant members 152 are flexible to deflect, bend, etc. over engagement with the inserted surgical object and are preferably made of an elastomeric material. Any shape is envisioned, including, but not limited to, rectangular, rounded, triangular, etc. for adaptive limbs 152.

It will be understood that various modifications and changes can be made in the form and detail of the embodiments of the present disclosure without departing from the scope of the invention. Therefore, the above description should not be construed as a limitation of the invention, but merely as examples of preferred embodiments thereof. Those skilled in the art will envision other modifications within the scope of the present invention as defined in the appended claims. Having thus described the invention with the details and particularity required by patent laws, what is claimed and what is desired to be protected is set forth in the appended claims.