WO2014116889A1

WO2014116889A1 - Surgical seal assembly including an overlapping guard structure for a seal

Info

Publication number: WO2014116889A1
Application number: PCT/US2014/012846
Authority: WO
Inventors: Gennady Kleyman
Original assignee: Covidien Lp
Priority date: 2013-01-24
Filing date: 2014-01-24
Publication date: 2014-07-31

Abstract

A surgical seal assembly is presented including a seal housing defining a longitudinal housing axis and a seal defining a passage and being adapted to form a substantial seal about a surgical instrument disposed within the passage, the seal including an inner seal portion. The surgical seal assembly also includes a guide mounted to the proximal end of the seal housing. The guard member, upon being positioned adjacent to the seal, assumes the shape of the seal such that the guard member encircles the seal at least two times, in an overlapping manner, and protects the seal.

Description

SURGICAL SEAL ASSEMBLY INCLUDING AN OVERLAPPING GUARD

STRUCTURE FOR A SEAL

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to, and the benefit of, U.S. Provisional

Application Serial No. 61/756,236 filed January 24, 2013, the disclosure of which is hereby incorporated by reference in its entirety.

BACKGROUND

[0002] The present disclosure relates to a surgical device and, more particularly, but not exclusively, relates to a surgical seal assembly for a cannula assembly and having a seal with an overlapping guard structure thereon.

Background of Related Art

[0003] Minimally invasive surgical procedures including both endoscopic and laparoscopic procedures permit surgery to be performed on organs, tissues and vessels far removed from an opening within the tissue. Laparoscopic and endoscopic procedures generally require that any instrumentation inserted into the body be sealed, i.e., provisions must be made 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 which 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 about the instrument to preserve the integrity of the established pneumoperitoneum. [0004] Minimally invasive procedures have several advantages over traditional open surgery, including less patient trauma, reduced recovery time, reduced potential for infection, etc. However, despite its recent success and overall acceptance as a preferred surgical technique, minimally invasive surgery, such as laparoscopy, has disadvantages. In particular, the insertion of the surgical instrument within the cannula has proven to be difficult in certain procedures, e.g., in procedures requiring extensive manipulation of the long narrow endoscopic instruments within a remote site. In addition, many conventional seal assemblies are not particularly well- adapted to receive a surgical instrument if it is inserted at an angle, thus resulting in damage to the seal assemblies. This type of insertion often results in the instrument missing the target (e.g. septum seal, etc.) and becoming lodged in an undesirable location within the seal assembly. In addition, angulation and/or manipulation of instrumentation within the cannula often present difficulties with respect to maintaining seal integrity. Thus, there remains a need for an apparatus that may be used to guide a surgical instrument through a seal assembly in a more efficient and efficacious manner.

SUMMARY

[0005] The following presents a summary of the claimed subject matter in order to provide a basic understanding of some aspects of the claimed subject matter. This summary is not an extensive overview of the claimed subject matter. It is intended to neither identify key or critical elements of the claimed subject matter nor delineate the scope of the claimed subject matter. Its sole purpose is to present some concepts of the claimed subject matter in a simplified form as a prelude to the more detailed description that is presented later.

[0006] According to one aspect of the present disclosure, a surgical seal assembly is provided that comprises a seal defining a passage and being adapted to form a substantial seal about a surgical instrument disposed within the passage. The assembly also includes a guard member cooperating with the seal. The guard member may comprise a monolithic structure including a plurality of segments, each segment comprising two or more protrusions, the guard member having a first, generally flat shape when in an unrolled position and prior to being mounted within the surgical seal assembly. The guard member may have a second, generally non-flat shape when in a rolled position and subsequent to being mounted within the surgical seal assembly.

[0007] In embodiments, the guard member may be adapted and dimensioned to protect the seal during insertion of the surgical instrument. The guard member may be a flexible, slitted, multi-leafed guard member. The guard member, when in the rolled position, may define a generally frusto-conical configuration. The seal may also define a generally frusto-conical configuration. The guard member may assume a general frusto-conical configuration upon being positioned adjacent to the seal. When the guard member is in the rolled position, the segments may overlap each other such that the protrusions of a first segment are positioned at least partially longitudinally relative to the protrusions of a second segment.

[0008] The guard member may include an upper portion and a lower portion, the upper portion configured to be an elongated strip and the lower portion configured to include a plurality of equally spaced apart protrusions separated from each other via a plurality of slits. The upper portion may have a first thickness and the lower portion has a second thickness, the first thickness being greater than the second thickness.

[0009] A first portion of the plurality of protrusions may have a first length, a second portion of the plurality of protrusions may have a second length, and a third portion of the plurality of protrusions may have a third length, the third length being greater than the second length and the second length being greater than the first length. The plurality of protrusions may be constructed at an angle between 90° and 180°. The distal ends of the plurality of protrusions may be one of rectangular, semi-circular, and triangular.

[0010] In accordance with various embodiments, the present invention may also relate to a method for manufacturing a surgical seal assembly. The method may comprise the steps of: providing a monolithic, generally flat guard member, the guard member having a plurality of segments, each segment including two or more protrusions; rolling the guard member such that it adopts a generally non-flat shape, at least one of the protrusions of a first segment overlapping with at least one of the protrusions of a second segment; and mounting the guard member, when in the rolled position, within the surgical seal assembly and adjacent to a seal within the surgical seal assembly.

[0011] The present invention, in accordance with various embodiments, may also relate to a surgical seal assembly in which the surgical seal assembly includes a seal housing defining a longitudinal housing axis and having a longitudinal opening therethrough, the seal housing defining proximal and distal ends and a seal defining a passage and being adapted to form a substantial seal about a surgical instrument disposed within the passage, the seal including an inner seal portion. The surgical seal assembly also includes a guide mounted to the proximal end of the seal housing, the guide having an inner guide portion defining a channel adapted to generally direct the surgical instrument toward the inner seal portion of the seal upon entry of the surgical instrument within the longitudinal opening of the seal housing. The surgical seal assembly further includes a guard member cooperating with the seal, the guard member constructed as a flat element that is subsequently deformed to assume a shape of the seal. The guard member, upon being positioned adjacent to the seal, assumes the shape of the seal such that the guard member encircles the seal at least two times, in an overlapping manner, to establish a leak-free relationship between the seal and the guard member. The guard member is further adapted and dimensioned to protect the seal during insertion of the surgical instrument.

[0012] In one exemplary embodiment, the guard member is a flexible, slitted, multi- leafed guard member.

[0013] In another exemplary embodiment, the channel of the guide defines a general frusto-conical configuration. Additionally, the seal defines a general frusto-conical configuration.

[0014] In yet another exemplary embodiment, the guard member assumes a general frusto-conical configuration upon being positioned adjacent to the seal.

[0015] In another exemplary embodiment, the guard member includes an upper portion and a lower portion, the upper portion configured to be an elongated strip and the lower portion configured to include a plurality of equally spaced apart protrusions separated from each other via a plurality of slits.

[0016] In one exemplary embodiment, the upper portion has a first thickness and the lower portion has a second thickness, the first thickness being greater than the second thickness.

[0017] In another exemplary embodiment, a first portion of the plurality of protrusions has a first length, a second portion of the plurality of protrusions has a second length, and a third portion of the plurality of protrusions has a third length, the third length being greater than the second length and the second length being greater than the first length.

[0018] In yet another exemplary embodiment, the plurality of protrusions are constructed at an angle between 90° and 180°. [0019] In another exemplary embodiment, distal ends of the plurality of protrusions are one of rectangular, semi-circular, and triangular.

[0020] According to another aspect of the present disclosure, a surgical assembly is provided. The surgical assembly includes a cannula assembly including a cannula housing and a cannula sleeve extending from the cannula housing, the cannula providing access to an underlying surgical site and a seal assembly. The seal assembly includes a seal housing defining a longitudinal housing axis and having a longitudinal opening therethrough, the seal housing defining proximal and distal ends and a seal defining a passage and being adapted to form a substantial seal about a surgical instrument disposed within the passage, the seal including an inner seal portion. The surgical seal assembly also includes a guide mounted to the proximal end of the seal housing, the guide having an inner guide portion defining a channel adapted to generally direct the surgical instrument toward the inner seal portion of the seal upon entry of the surgical instrument within the longitudinal opening of the seal housing. The surgical seal assembly further includes a guard member cooperating with the seal, the guard member constructed as a flat element that is subsequently deformed to assume a shape of the seal. The guard member, upon being positioned adjacent to the seal, assumes the shape of the seal such that the guard member encircles the seal at least two times, in an overlapping manner. The guard member is further adapted and dimensioned to protect the seal during insertion of the surgical instrument.

[0021] In another aspect of the present disclosure, a method for performing a surgical procedure is provided. The method includes the steps of accessing an underlying operative site with a cannula assembly, mounting a seal assembly to the cannula assembly, the seal assembly including: a seal housing defining a longitudinal housing axis and having a longitudinal opening therethrough, the seal housing defining proximal and distal ends; a seal defining a passage and being adapted to form a substantial seal about a surgical instrument disposed within the passage, the seal including an inner seal portion; a guide mounted to the proximal end of the seal housing, the guide having an inner guide portion defining a channel adapted to generally direct the surgical instrument toward the inner seal portion of the seal upon entry of the surgical instrument within the longitudinal opening of the seal housing; and a guard member cooperating with the seal, the guard member constructed as a flat element that is subsequently deformed to assume a shape of the seal. The method further includes the steps of positioning the guard member adjacent to the seal such that the guard member assumes the shape of the seal after being deformed from a straight configuration; encircling the guard member around the seal at least two times, in an overlapping manner. The guard member is further adapted and dimensioned to protect the seal during insertion of the surgical instrument and maintain separation of the seal from the surgical instrument. The method also includes the steps of introducing the surgical instrument within the seal assembly whereby the guide generally directs the surgical instrument toward the inner seal portion of the seal and performing a surgical procedure with the surgical instrument.

[0022] Further scope of applicability of the present disclosure will become apparent from the detailed description given hereinafter. However, it should be understood that the detailed description and specific examples, while indicating preferred embodiments of the present disclosure, are given by way of illustration only, since various changes and modifications within the spirit and scope of the present disclosure will become apparent to those skilled in the art from this detailed description.

BRIEF DESCRIPTION OF THE DRAWINGS [0023] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the disclosure and, together with a general description of the disclosure given above, and the detailed description of the embodiment(s) given below, serve to explain the principles of the disclosure, wherein:

[0024] FIG. 1 is a perspective view, with parts separated, of the seal assembly in accordance with the principles of the present disclosure illustrated with a cannula assembly and a trocar assembly;

[0025] FIG. 2 is a side, cross-sectional view of the seal assembly of FIG. 1, illustrating the guard member being positioned adjacent to an inner seal of the seal assembly, in accordance with the present disclosure;

[0026] FIG. 3 is a top, partially cut-away view of the seal assembly of FIG. 2, in accordance with the present disclosure;

[0027] FIG. 4 is a cross-sectional view of a portion of the seal assembly illustrating the guard member being positioned adjacent to the inner seal of the seal assembly, in accordance with an embodiment of the present disclosure;

[0028] FIG. 5 is a perspective view of one embodiment of the guard member in a flat configuration, in accordance with an embodiment of the present disclosure;

[0029] FIG. 6 is a perspective view of the guard member of FIG. 5 in a partially bent configuration, in accordance with an embodiment of the present disclosure;

[0030] FIG. 7 is a perspective view of the guard member of FIG. 5 in a fully bent configuration, where the guard structure overlaps itself three times, in accordance with an embodiment of the present disclosure; [0031] FIG. 8A is a side cross-sectional view of the overlapping guard structure of FIG.

7, in accordance with an embodiment of the present disclosure;

[0032] FIG. 8B is a top view of the overlapping guard structure of FIG. 7, in accordance with an embodiment of the present disclosure;

[0033] FIG. 9A is a side view of the guard member of FIG. 5, where the plurality of protrusions are slightly angled with the body portion of the guard member, in accordance with an embodiment of the present disclosure;

[0034] FIG. 9B is a side view of the guard member of FIG. 5, where the plurality of protrusions are fully angled at 90° with respect to the body portion of the guard member, in accordance with an embodiment of the present disclosure;

[0035] FIG. 1 OA is a perspective view of a guard member, where the distal ends of the guard member are triangular, in accordance with another embodiment of the present disclosure;

[0036] FIG. 10B is a perspective view of a guard member, where the distal ends of the guard member include twin triangular tips, in accordance with another embodiment of the present disclosure; and

[0037] FIG. IOC is a perspective view of a guard member, where the distal ends of the guard member are semi-circular, in accordance with another embodiment of the present disclosure.

[0038] The figures depict preferred embodiments of the present disclosure for purposes of illustration only. One skilled in the art will readily recognize from the following discussion that alternative embodiments of the structures and methods illustrated herein may be employed without departing from the principles of the present disclosure described herein.

DETAILED DESCRIPTION [0039] Particular embodiments of the present disclosure are described hereinbelow with reference to the accompanying drawings. However, it is to be understood that the disclosed embodiments are merely exemplary of the disclosure and may be embodied in various forms. Well-known functions or constructions are not described in detail to avoid obscuring the present disclosure in unnecessary detail. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a basis for the claims and as a representative basis for teaching one skilled in the art to variously employ the present disclosure in virtually any appropriately detailed structure.

[0040] For the purposes of promoting an understanding of the principles of the present disclosure, reference will now be made to the exemplary embodiments illustrated in the drawings, and specific language will be used to describe the same. It will nevertheless be understood that no limitation of the scope of the present disclosure is thereby intended. Any alterations and further modifications of the inventive features illustrated herein, and any additional applications of the principles of the present disclosure as illustrated herein, which would occur to one skilled in the relevant art and having possession of this disclosure, are to be considered within the scope of the present disclosure.

[0041] The cannula assembly of the present disclosure, in combination with a seal system internal to the cannula assembly, provides a substantial seal between a body cavity of a patient and the outside atmosphere before, during and after insertion of a surgical instrument through the cannula assembly. Moreover, the seal assembly of the present disclosure is capable of accommodating surgical instruments of varying diameters, e.g., from 5 mm to 15 mm, by providing a fluid tight seal with each instrument when inserted. The flexibility of the present seal assembly greatly facilitates endoscopic surgery where a variety of instruments having differing diameters are often used during a single surgical procedure.

[0042] The seal assembly contemplates the introduction and manipulation of various types of instrumentation adapted for insertion through a trocar and/or cannula assembly while maintaining a fluid tight interface about the instrumentation to preserve the atmospheric integrity of a surgical procedure from gas and/or fluid leakage. Specifically, the seal assembly accommodates angular manipulation of the surgical instrument relative to the seal housing axis. This feature of the present disclosure desirably minimizes the entry and exit of gases and/or fluids to/from the body cavity. Examples of instrumentation include clip appliers, graspers, dissectors, retractors, staplers, laser probes, photographic devices, endoscopes and laparoscopes, tubes, and the like. Such instruments will be collectively referred to herein as "instruments or instrumentation . ' '

[0043] The word "exemplary" is used herein to mean "serving as an example, instance, or illustration." Any embodiment described herein as "exemplary" is not necessarily to be construed as preferred or advantageous over other embodiments. The word "example" may be used interchangeably with the term "exemplary."

[0044] Embodiments of the presently disclosed apparatus will now be described in detail with reference to the drawings, in which like reference numerals designate identical or corresponding elements in each of the several views. As used herein, the term "distal" refers to that portion of the tool, or component thereof which is farther from the user while the term "proximal" refers to that portion of the tool or component thereof which is closer to the user. [0045] Reference will now be made in detail to embodiments of the present disclosure.

While certain embodiments of the present disclosure will be described, it will be understood that it is not intended to limit the embodiments of the present disclosure to those described embodiments. To the contrary, reference to embodiments of the present disclosure is intended to cover alternatives, modifications, and equivalents as may be included within the spirit and scope of the embodiments of the present disclosure as defined by the appended claims.

[0046] For exemplary purposes, the access apparatus will be described in terms of a cannula assembly, which is adapted for introduction, typically utilizing a trocar, within the abdominal cavity during a laparoscopic surgical procedure. However, it is appreciated that the access apparatus may be any apparatus suitable for introduction and passage of surgical objects into underlying tissue including, e.g., catheters, trocar assemblies, endoscopic portals, hand access devices, etc., through an incision or through a natural body opening.

[0047] Referring now to the drawings, in which like reference numerals identify identical or substantially similar parts throughout the several views, FIGS. 1-4 illustrate a seal assembly 100.

[0048] Referring to FIG. 1, the seal assembly 100 of the present disclosure is shown with a cannula assembly 200. Cannula assembly 200 may be any conventional cannula assembly suitable for the intended purpose of accessing a body cavity and permitting introduction of instruments therethrough. Cannula assembly 200 is particularly adapted for use in laparoscopic surgery where the peritoneal cavity is insufflated with a suitable gas, e.g., C0₂, to raise the cavity wall from the internal organs therein. The cannula assembly 200 is typically used with an obturator assembly 300 which is an elongate instrument positionable within the cannula assembly 200. The obturator assembly 300 may have a sharp end or a blunt end and is utilized to pass through, e.g., abdominal tissue, to facilitate introduction of the cannula assembly 200 within the abdominal cavity. Once access to the abdominal cavity is achieved, the obturator assembly 300 is removed from the cannula assembly 200 leaving the cannula assembly 200 in place for introduction of the surgical instrumentation utilized to perform the procedure.

[0049] Cannula assembly 200 includes cannula sleeve 202 and cannula housing 204 mounted to an end of the sleeve 202. Cannula sleeve 202 defines a longitudinal axis "a" extending along the length of sleeve 202. Sleeve 202 further defines an internal longitudinal passage 206 dimensioned to permit passage of surgical instrumentation.

[0050] Cannula housing 204 may be a multi-component element secured via a snap fit, ultrasonic welding or any other means envisioned by one skilled in the art including, e.g., adhesive means. Cannula housing 204 may further include diametrically opposed housing grips 208 dimensioned and arranged for gripping engagement by the fingers of the user. Cannula housing 204 may further include an internal duck bill or zero closure valve 210. Such zero closure valve 210 opens to permit passage of the surgical instrumentation and closes in the absence of the instrumentation. The valve may be preferably adapted to close upon exposure to the forces exerted by the insufflation gases in the internal cavity. Other zero closure valves are also contemplated including single or multiple slit valve arrangements, trumpet valves, flapper valves, etc.

[0051] Cannula sleeve 202 and cannula housing 204 may 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 may be clear or opaque. The diameter of sleeve 202 may vary, but typically ranges from 10 to 15 mm for use with the seal assembly 100 of the present disclosure.

[0052] Obturator assembly 300 includes obturator housing 302 and obturator member

304 extending from the housing 302. Obturator member 304 includes a penetrating end 306 adjacent its distal end. Penetrating end 306 may be sharp or blunt. An obturator sleeve 308 is coaxially mounted about obturator member 304. Obturator sleeve 308 may retract to expose piercing end 306. Alternatively, obturator member 304 may be advanced within obturator sleeve 308 to expose piercing end 306. Other alternate obturator mechanisms for exposing penetrating end 306 are also envisioned.

[0053] Referring now to FIGS. 2-4, top and side cross-sectional views of the seal assembly 100 of FIG. 1, illustrating the guard member 160 positioned adjacent to an inner seal 150 of the seal assembly 100, in accordance with the present disclosure is presented.

[0054] Referring now to FIG. 2, in conjunction with FIG. 1, seal assembly 100 will be discussed in detail. Seal assembly 100 includes seal housing, generally identified as reference numeral 102, and longitudinal opening 104 extending through seal housing 102. Seal housing 102 houses the sealing components of the assembly and defines central seal housing axis "b" which is preferably parallel to the axis "a" of cannula sleeve 202 and, more preferably, coincident with the axis "a" of the cannula when the seal assembly 100 is mounted to the cannula assembly 200. In one embodiment, seal housing 102 may incorporate upper and lower housing components 106, 108 which, when assembled together, form the seal housing 102. Assembly of upper and lower housing components 106, 108 may be effected by any suitable adhesive means including adhesives, cements or the like or mechanical means including tongue groove arrangements, bayonet couplings, interference fits, etc. Alternatively, seal housing 102 may be monolithically formed as a single unit.

[0055] Seal housing 102 defines proximal and distal ends 110, 112, respectively.

Adjacent proximal end 110 is internal tapered wall 114 which extends radially inwardly toward seal housing axis "b" from proximal to distal, i.e., tapered wall 114 has both longitudinal and radial components of direction, and terminates in internal annular wall 116. Annular wall 116 serves to restrict the internal dimension of longitudinal opening 104 to at least partially constrain lateral movement of a surgical instrument (not shown) introduced through seal housing 102.

[0056] Seal housing 102 may be constructed of a plurality of different materials, including, but not limited to, polymeric, metallic, or elastomeric. Preferably, the components of seal housing 102 are formed of a polycarbonate material such as ABS available from the General Electric Company. Seal housing 102 may further include a handle which may be of any suitable ergonomic design. Moreover, seal housing 102 may be used in conjunction with, or detachably mounted, to cannula assembly 200 such as those described hereinabove.

[0057] Seal assembly 100 includes seal 150 mounted within seal housing 102 in suspended relation. Seal 150 may be mounted within seal housing 102 through conventional means such as for example with the use of adhesives, cements or the like. Alternatively, or in conjunction with the aforementioned adhesive means, seal 150 may be disposed or trapped between housing components 106,108 of seal housing 102 to effect the mounting.

[0058] Seal 150 may be a septum seal incorporating a circular aperture 155 formed of any suitable elastomeric material. In one alternative embodiment, seal 150 is preferably a fabric seal and is desirably arranged so as to have a constriction. The fabric is desirably constructed of a material that forms a constriction or closure. The seal may also be molded with a resilient material so as to have a constriction. Other arrangements for seal 150 are also envisioned.

[0059] Although seal 150 is disclosed as an impregnated fabric arrangement, it is appreciated that other seal types may be used and still achieve the objectives of the present disclosure. For example, seal 150 may be fabricated from an elastomeric material without the embedded fabric. Gel, foams, or other fluid- filled bladder seal arrangements are also envisioned.

[0060] Referring now to FIGS. 2-4, seal assembly 100 further includes generally compliant guide 124 which is mounted to an exterior surface of seal housing 102 preferably adjacent internal tapered wall 114. Compliant guide 124 may be secured to the exterior surface, e.g., internal tapered wall 114 of seal housing 102 or mounted in suspended relation to the internal tapered wall 114. Compliant guide 124 is generally tapered in configuration, e.g., generally frusto-conical shaped, having proximal entry opening 126 and distal exit opening 128, and inner guide portion 130 defining internal channel 132. Preferably, distal exit opening 128 defines an internal dimension greater than a corresponding internal dimension of aperture 155 of seal 150. In a preferred embodiment, inner guide portion 130 is dimensioned to permit passage of the surgical instrument through internal channel 132 without forming a seal about the surgical instrument.

[0061] In use, compliant guide 124 is adapted to generally direct the instrument toward the aperture 155 of seal 150 upon advancement of the instrument through longitudinal opening 104 of seal housing 102. In one preferred embodiment, compliant guide 124 has a compliant characteristic which permits the compliant guide 124 to deflect upon engagement by a surgical instrument, such as, e.g., when an instrument is initially introduced off axis or angulated with respect to the seal housing axis "b," to substantially prevent lodging of the instrument within the compliant guide 124. Thereafter, the tapered orientation of compliant guide 124 guides the instrument along the seal axis "b." Compliant guide 124 may be constructed of a number of different compliant or flexible materials. In a preferred embodiment, compliant guide 124 is formed of an elastomeric material. Compliant guide 124 is preferably longitudinally spaced from seal 150 so as to not interfere with the functioning of the seal 150.

[0062] It is envisioned that seal assembly 100 may be detachably connected to cannula assembly 200. Preferably, seal housing 102 is dimensioned to be releasably mounted to cannula housing 204. In this regard, it is appreciated that seal housing 102 and cannula housing 204 may incorporate means for facilitating the re leasable connection of seal assembly 100 to cannula assembly 200 including, e.g., an interference fit, bayonet coupling, screw arrangement, etc. on corresponding structure of the seal housing 102 and cannula housing 204.

[0063] For example, seal housing 102 may include locking detents 136 (see FIGS. 1 and

2) which engage corresponding structure on cannula housing 204 to secure seal assembly 100 to cannula assembly 200. Thus, the surgeon may remove seal assembly 100 from the cannula assembly 200 at any time during the surgical procedure and similarly, mount the seal assembly 100 to the cannula when desired in order to provide a sealing engagement with an instrument to be inserted through the cannula. In addition, seal assembly 100 may be readily adapted for mounting to conventional cannula of differing structures. Alternatively, seal housing 102 may be permanently secured to cannula housing 204 if desired. [0064] Referring back to the seal 150 illustrated in FIGS. 2-4, the seal may include a connection member 152. The connection member 152 may engage a portion of housing component 109. The connection member 152 is configured to secure the seal 150 to the seal housing 102. The top, cut-away view 100A and the side, cross-section view 100B further illustrate the seal 150 having the connection member 152 securing the seal 150 to the housing component 109. Moreover, the cross-sectional view 100B of FIG. 4 also depicts a seal guard connection member 162 engaging the seal housing component 109. The seal guard connection member 162 is in the vicinity of the connection member 152 of the seal 150. It is contemplated that the seal guard connection member 162 is in abutting relationship to the connection member 152 of the seal 150. However, one skilled in the art may contemplate a different configuration where such elements do not abut each other. Regardless, the plurality of teeth or protrusions or fingers 163, 165, 167 of the guard member 160 are configured to assume the shape of the seal 150, which in this exemplary case, is a frusto-conical shape. In other words, the guard member 160 is configured to transition or transform or deform from a flat strip (as shown in FIG. 5) into a conical configuration that assumes the shape of the seal 150. Furthermore, as shown in FIG. 4, the plurality of teeth 163, 165, 167 do not frictionally engage the top portion 153 of seal 150. In other words, a gap 156 may be present between the plurality of teeth 165 and the seal 150.

[0065] The housing component 109 may also be arranged to engage with or cooperate with or be associated with bellows 140. Bellows 140 may aid in centering the housing component 109, which in turn centers the seal 150 with respect to the seal housing axis "b." As illustrated bellows 140 are connected to the side wall of the seal housing 102. Of course, the bellows 140 may be optional. [0066] Additionally, seal 150 is adapted and dimensioned to define a general frusto- conical shape extending radially inwardly relative to the seal housing axis "b" from proximal to distal end. A guard structure 160, as will be discussed in detail below with reference to FIGS. 5- 8B, may include a plurality of teeth 163, 165, 167 separated from each other by a plurality of slits 161. The plurality of adjacent teeth 163, 165, 167 are in overlapping or partial overlapping relation with each other when they transition into a conical configuration that assumes the shape of the seal 150. The plurality of teeth 163, 165, 167 are flexible to deflect, bend, etc. upon engagement with the inserted surgical object and are preferably fabricated from one elastomeric material. Any shape, including, but not limited to, rectangular, rounded, triangular, etc. is envisioned for the plurality of teeth 163, 165, 167, as will be described below with reference to FIGS. 1 OA- IOC.

[0067] Referring to FIGS. 5-8B, guard structure or guard member 160 is described. In particular, referring to FIG. 5, the guard structure 160 is shown in a first configuration, that is, a straight configuration, as a flat element. The guard structure 160 may be a flexible material, such as a plastic material. The guard structure 160 includes a body portion 169 extending from a proximal end 170 to a distal end 180 of the guard structure 160. The guard structure 160 also includes a plurality of teeth or protrusions 163, 165, 167. The plurality of adjacent teeth or protrusions or fingers 163, 165, 167 may create a multi-leafed effect. The plurality of teeth or protrusions or fingers 163, 165, 167 may be separated from each other by a plurality of grooves 161 (or slots 161). The guard structure 160 may also be referred to as a flexible, slitted, multi- leafed guard member. [0068] Stated differently, the guard structure 160 (or guard member 160) includes an upper portion 169 and lower portions 163, 165, 167, the upper portion 169 configured to be an elongated strip 169 and the lower portions 163, 165, 167 configured to be a plurality of equally spaced apart protrusions 163, 165, 167. The plurality of equally spaced apart protrusions 163, 165, 167 are configured to be separated from each other via a plurality of slits 161. The equally spaced apart protrusions or fingers 163, 165, 167 may be rectangular in nature. However, one skilled in the art may contemplate using teeth or protrusions or fingers having a plurality of different shapes and of a plurality of different sizes, as discussed below with reference to FIGS. 1 OA- IOC. Additionally, as shown, the first protrusions 163 have a first length, L_ls the second protrusions 165 have a second length, L₂, and the third protrusions 167 have a third length, L₃. The third length may be greater than the second length, and the second length may be greater than the first length. Thus, the teeth may be divided into sections or segments of varying lengths. One skilled in the art may contemplate a plurality of different teeth profiles to achieve a desired leak-free relationship between a seal and a guard member, as well as to achieve an air-tight seal to prevent air from escaping during a surgical procedure.

[0069] In one embodiment, the upper portion 169 has a first thickness and the lower portions 163, 165, 167 have a second thickness, where the first thickness is greater than the second thickness.

[0070] The guard member 160 is provided for protecting or shielding the elastomeric seal

150 from puncture or tearing by a surgical instrument. The guard member 160 may eliminate the need for a fabric impregnated elastomeric seal and enables the use of a seal 150 that is merely made of elastomeric material, since the protective function of the fabric is being replaced by the plastic seal. The guard member 160 is configured to be more rigid than the elastomeric seal 150.

[0071] The guard member 160 may have various portions that are in an overlapping configuration when assembled within seal housing, but which are not overlapping when initially constructed. In other words, the guard member 160 is initially in a flat configuration and transitions or transforms or deforms into a conical configuration upon placement on the seal 150. This overlapping arrangement of the guard member 160 enables the guard member 160 to be fabricated (e.g., punched) as a flat element or component, which is cheaper and easier than molding the guard member 160 as a frusto-conical piece, while still enabling the guard member

160 to be subsequently used as a frusto-conical shaped guard member positioned adjacent to the elastomeric seal 150.

[0072] Moreover, when the conical configuration is constructed, as shown in FIGS. 7,

8 A, and 8B, the plurality of grooves (or slots) 161, as well as the plurality of teeth (or fingers) 163, 165, 167 are not aligned on top of each other. Stated differently, the plurality of teeth 163, 165, 167 are offset from each other. Similarly, the plurality of grooves 161 are also offset from each other. Thus, the plurality of grooves (or slots) 161 in each respective layer are misaligned with the grooves (or slots) 161 of each of the other layers (as illustrated in FIGS. 7 and 8A). Therefore, when a surgical instrument is inserted through opening 104 of seal housing 102 (see FIGS. 2-4) and approaches the seal guard 160, the surgical instrument does not go through the grooves (or slots) 161 of the seal guard 160 because, as shown in FIG. 8B, underneath the groove

161 is layer 165. In other words, after rolling or transitioning the flat strip into a conical configuration, the teeth or fingers 163, 165, 167 overlap each other in a conical configuration (see FIG. 8 A), such that no openings are formed therethrough due to the grooves 161. Thus, the outer grooves 161 expose a layer underneath (i.e., layer 165 shown in FIG. 8B), not an opening for the surgical instrument to go through. As a result of the misalignment of the teeth 163, 165, 167 when they are overlapped, the surgical instrument does not travel through the slots 161 of the guard member 160.

[0073] Additionally, it is noted that the elastomeric seal 150 is sealed to the housing and the opening in the elastomeric seal 150 seals with an instrument inserted therethrough. The guard member 160, on the other hand, is positioned adjacent to the elastomeric seal 150, but need not form a sealing relationship therewith. Thus, one purpose of the guard member 160 is to protect the seal 150 from being ripped or damaged by a surgical instrument by merely overlapping the seal 150 in a non-connecting manner.

[0074] Moreover, it is contemplated that the guard member 160 could be positioned on one or both sides (proximal and distal) of the seal 150, since there is a possibility that a sharp surgical instrument could pierce or rip or damage the seal 150 from either side during use.

[0075] Referring now to FIG. 6, the guard structure 160 is shown in a second configuration, that is, a partially bent configuration. As stated above, the guard structure 160 is a flexible member capable of being deformed into a circular configuration for insertion onto, for example, the seal 150, as shown above with reference to FIGS. 1-4. Thus, the guard member 160 cooperates with the seal 150, the guard member 160 constructed as a flat element that is subsequently deformed (see FIGS. 6 and 7) to assume the shape of the seal 150. For example, the seal 150 may define a general frusto-conical configuration. As such, the guard member 160 may be deformed to assume the general frusto-conical configuration of the seal 150, as the guard member 160 is positioned or placed or located or disposed adjacent to the seal 150. The guard member 160, upon being positioned adjacent to the seal 150, assumes the shape of the seal 150 such that the plurality of protrusions or teeth or fingers 163, 165, 167 overlap each other to establish a leak- free relationship between the seal 150 and the guard member 160. It is noted that the guard member 160 and the seal 150 do not affix or connect or bind or fixedly secure to each other. The guard member 160 and the seal 150 contact each other in a non-connecting manner or fashion.

[0076] As shown in FIG. 7, the guard member 160 may be twisted or bent several times around itself, in a fully bent configuration, in order to maintain a leak-free relationship between the seal 150 and the guard member 160. In order to achieve the leak- free relationship, the fingers 163, 165, 167 of the guard member 160 are offset from each other once the conical configuration is constructed. This also results in the slots 161 being offset from each other once the conical configuration is constructed. As noted in FIG. 7, underneath groove 161 of layer 163 is layer 165 (an overlapped layer). Thus, in the conical configuration, the fingers 163, 165, 167 and the slots 161 are offset from each other to avoid creating an opening directly through the newly constructed conical seal guard 160.

[0077] The guard member 160 may be bent so that it overlaps itself at least two times. In

FIG. 7, the guard member 160 overlaps itself 3 times, such that the teeth or protrusions or fingers 163, 165, 167 are offset from each other (or in a misaligned relationship). For example, the first protrusions 163 may be adapted and dimensioned to create a first circle, whereas the second protrusions 165 may be adapted and dimensioned to create a second circle, the second circle overlapping the first circle. Subsequently, the third protrusions 167 may be adapted and dimensioned to create a third circle, the third circle overlapping the first circle and the second circle, each layer in a misaligned or offset relationship with respect to the other layers. Stated differently, the guard structure 160 may wrap around itself 3 times (such that fingers 163, 165, 167 and slots 161 are misaligned or offset with respect to each other) in order to create a leak- free and air-tight relationship between the seal 150 and the guard member 160.

[0078] FIGS. 8A-8B are side and top views 800, 900, respectively, of the overlapping guard structure of FIG. 7, in accordance with an embodiment of the present disclosure. FIG. 8A is a side cross-sectional view 800 depicting how the first protrusions 163 are adapted and dimensioned to create a first circle, whereas the second protrusions 165 are adapted and dimensioned to create a second circle, the second circle overlapping the first circle. Additionally, the side, cross-sectional view 800 depicts the third protrusions 167 adapted and dimensioned to create a third circle, the third circle overlapping the first circle and the second circle. As such, the guard structure 160 wraps around itself 3 times in order to create a leak-free relationship between the seal 150 and the guard member 160. Additionally, the protrusions or fingers or layers 163, 165, 167 are shown in a misaligned or offset relationship with respect to each other to avoid creating an opening directly through the newly constructed conical configuration of the seal member or seal guard 160. Thus, an air-tight seal is created that prevents air from escaping during a surgical procedure. FIG. 8B illustrates a top view 900 of the seal structure 160 in the fully bent configuration, where all three teeth sections or segments 163, 165, 167 overlap each other, in a misaligned or offset manner, such that the guard member 160 deforms or transforms or transitions into a frusto-conical shaped guard member to assume the shape of the seal 150. The misalignment of the teeth 163, 165, 167, as well as the misalignment of the grooves 161 enables this leak- free relationship and air-tight seal.

[0079] FIGS. 9A-9B illustrate side views of the guard member 160. FIG. 9A illustrates the guard member 160 in a slightly bent configuration 950A, whereas FIG. 9B illustrates the guard member 160 in a fully bent configuration 950B. In the slightly bent configuration 900 A, the guard member 160 assumes a general frusto-conical configuration upon being positioned adjacent to the seal 150. It is noted that the plurality of protrusions 163, 165, 167 may be constructed at an angle between 90° and 180°.

[0080] In operation, the guard member 160, upon positioned adjacent to the seal 150, assumes the shape of the seal 150 such that the plurality of protrusions 163, 165, 167 overlap each other (or wrap around each other) at least twice, in order to establish a leak-free relationship between the seal 150 and the guard member 160 to prevent air escaping during a surgical procedure. Therefore, in the bent configuration 950A, the guard member 160 assumes the shape of the seal 150 such that the plurality of teeth or protrusions 163, 165, 167 substantially overlap each other to prevent slits of the seal or damage of the seal as surgical instruments engage the seal 150 as they are inserted through the opening 104 of the seal housing 102.

[0081] Referring to FIGS. 1 OA- IOC, alternative embodiments of a guard member are presented. In FIG. 10A, a guard structure 1000A is shown, where the guard structure 1000A includes an upper portion 1003 and three lower portions 1005, 1007, 1009. The lower portions 1005, 1007, 1009 include triangular teeth or protrusions (instead of the rectangular teeth of FIGS. 5-8B). The first lower portion 1005 includes teeth 1005' having a first length, L_ls the second lower portion 1007 includes teeth 1007' having a second length, L₂, and the third lower portion 1009 includes teeth 1009' having a third length, L₃. In one embodiment, the third length is greater than the second length, and the second length is greater than the first length.

[0082] In FIG. 10B, a guard structure 1000B is shown, where the guard structure 1000B includes an upper portion 1013 and three lower portions 1015, 1017, 1019. The lower portions 1015, 1017, 1019 include dual triangular teeth or protrusions (instead of the rectangular teeth of FIGS. 5-8B). The first lower portion 1015 includes teeth 1015' having a first length, L_ls the second lower portion 1017 includes teeth 1017' having a second length, L₂, and the third lower portion 1019 includes teeth 1019' having a third length, L₃. In one embodiment, the third length is greater than the second length, and the second length is greater than the first length.

[0083] In FIG. IOC, a guard structure lOOOC is shown, where the guard structure lOOOC includes an upper portion 1023 and three lower portions 1025, 1027, 1029. The lower portions 1025, 1027, 1029 include semi-circular teeth or protrusions (instead of the rectangular teeth of FIGS. 5-8B). The first lower portion 1025 includes teeth 1025' having a first length, L_ls the second lower portion 1027 includes teeth 1027' having a second length, L₂, and the third lower portion 1029 includes teeth 1029' having a third length, L₃. In one embodiment, the third length is greater than the second length, and the second length is greater than the first length.

[0084] Therefore, in summary the guard member or guard structure protects the seal from instrument insertion and maintains separation of the instrument from the seal. Additionally, the guard member is one flat strip that is easy to roll into a desired shape (e.g., a frusto-conical shape), where the roll overlaps itself several times. The guard member is constructed to overlap the seal, multiple times, such that the seal is protected from damage caused due to constant insertion of the surgical instrument therethrough.

[0085] One skilled in the art may also contemplate the teeth having the same length across the length of the guard structure. Of course, one skilled in the art may contemplate a plurality of different shapes and sizes for the plurality of teeth or protrusions in order to establish a leak-free relationship between the seal (or the shape of the seal) and the guard structure or guard member positioned or placed or located or disposed adjacently thereon. One advantage of positioning or placing a guard structure adjacent to a seal is that the guard structure prevents damage of the seal as surgical instruments are inserted therethrough. Another advantage pertains to the non-connecting, yet overlapping relationship established between the guard member 160 and the seal 150, which enables the guard member 160 to be fabricated as a flat component, which is cheaper and easier than molding it as a frusto-conical piece, while still enabling the guard member 160 to be used as a frusto-conically shaped protective component. This advantage is further achieved by positioning the fingers 163, 165, 167 in an offset or misaligned relationship with respect to each other, as well as positioning the grooves 161 in an offset or misaligned relationship with respect to each other, thus preventing openings from being formed when the conical configuration of the guard member 160 is constructed to assume the shape of the seal 150.

[0086] While several embodiments of the disclosure have been shown in the drawings, it is not intended that the disclosure be limited thereto, as it is intended that the disclosure be as broad in scope as the art will allow and that the specification be read likewise. Therefore, the above description should not be construed as limiting, but merely as exemplifications of presently disclosed embodiments. Thus the scope of the embodiments should be determined by the appended claims and their legal equivalents, rather than by the examples given.

[0087] Persons skilled in the art will understand that the devices and methods specifically described herein and illustrated in the accompanying drawings are non-limiting exemplary embodiments. The features illustrated or described in connection with one exemplary embodiment may be combined with the features of other embodiments. Such modifications and variations are intended to be included within the scope of the present disclosure. As well, one skilled in the art will appreciate further features and advantages of the present disclosure based on the above-described embodiments. Accordingly, the present disclosure is not to be limited by what has been particularly shown and described, except as indicated by the appended claims.

Claims

WHAT IS CLAIMED IS:

1. A surgical seal assembly, comprising:

a seal defining a passage and being adapted to form a substantial seal about a surgical instrument disposed within the passage; and

a guard member cooperating with the seal, the guard member comprising a monolithic structure including a plurality of segments, each segment comprising two or more protrusions, the guard member having a first, generally flat shape when in an unrolled position and prior to being mounted within the surgical seal assembly, and the guard member having a second, generally non-flat shape when in a rolled position and subsequent to being mounted within the surgical seal assembly.

2. The surgical seal assembly according to claim 1, wherein the guard member is adapted and dimensioned to protect the seal during insertion of the surgical instrument.

3. The surgical seal assembly according to claim 1, wherein the guard member is a flexible, slitted, multi-leafed guard member.

4. The surgical seal assembly according to claim 1, wherein the guard member, when in the rolled position, defines a generally frusto-conical configuration.

5. The surgical seal assembly according to claim 1, wherein the seal defines a generally frusto-conical configuration.

6. The surgical seal assembly according to claim 5, wherein the guard member assumes a general frusto-conical configuration upon being positioned adjacent to the seal.

7. The surgical seal assembly according to claim 1, wherein, when the guard member is in the rolled position, the segments overlap each other such that the protrusions of a first segment are positioned at least partially longitudinally relative to the protrusions of a second segment.

8. The surgical seal assembly according to claim 1, wherein the guard member includes an upper portion and a lower portion, the upper portion configured to be an elongated strip and the lower portion configured to include a plurality of equally spaced apart protrusions separated from each other via a plurality of slits.

9. The surgical seal assembly according to claim 8, wherein the upper portion has a first thickness and the lower portion has a second thickness, the first thickness being greater than the second thickness.

10. The surgical seal assembly according to claim 8, wherein a first portion of the plurality of protrusions has a first length, a second portion of the plurality of protrusions has a second length, and a third portion of the plurality of protrusions has a third length, the third length being greater than the second length and the second length being greater than the first length.

11. The surgical seal assembly according to claim 8, wherein the plurality of protrusions are constructed at an angle between 90° and 180°.

12. The surgical seal assembly according to claim 8, wherein distal ends of the plurality of protrusions are one of rectangular, semi-circular, and triangular.

13. A method for manufacturing a surgical seal assembly, the method comprising the steps of:

providing a monolithic, generally flat guard member, the guard member having a plurality of segments, each segment including two or more protrusions;

rolling the guard member such that it adopts a generally non-flat shape, at least one of the protrusions of a first segment overlapping with at least one of the protrusions of a second segment;

mounting the guard member, when in the rolled position, within the surgical seal assembly and adjacent to a seal within the surgical seal assembly.