US20150112280A1

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Publication number: US20150112280A1
Application number: US14/590,220
Authority: US
Inventors: Robert C. Smith
Original assignee: Covidien LP
Current assignee: Covidien LP
Priority date: 2006-07-07
Filing date: 2015-01-06
Publication date: 2015-04-23
Also published as: US20090005740A1; US8932275B2

Abstract

A surgical seal assembly, includes a seal housing defining a longitudinal housing axis and having a longitudinal opening therethrough, a seal having an inner seal portion defining a passage and being adapted to form a substantial seal about a surgical instrument disposed within the passage and a guide mounted to the seal housing. The guide has an inner guide portion proximal of the inner seal portion of the seal and spaced therefrom. The inner guide portion defines 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 inner guide portion is relatively compliant to accommodate initial offset or angled entry of the surgical instrument.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No. 11/823,560, filed Jun. 28, 2007, which claims the benefit of and priority to U.S. Provisional Patent Application No. 60/819,434, filed Jul. 7, 2006, the entire disclosures of which are incorporated by reference herein.

BACKGROUND

1. Technical Field

The present disclosure relates to a surgical device and, more particularly, relates to a surgical seal assembly for a cannula assembly and having a compliant guide for directing a surgical instrument along a path generally coincident with a seal axis.

2. Description of the Prior Art

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.

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 several 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. 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. 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

Accordingly, a surgical seal assembly for use with a cannula assembly is disclosed. The surgical seal assembly includes a seal housing defining a longitudinal housing axis and having a longitudinal opening therethrough, a seal having an inner seal portion defining a passage and being adapted to form a substantial seal about a surgical instrument disposed within the passage and a guide mounted to the proximal end of the seal housing. The guide has an inner guide portion proximal of the inner seal portion of the seal and spaced therefrom. The inner guide portion defines 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 inner guide portion is relatively compliant to accommodate initial offset or angled entry of the surgical instrument. The inner guide portion of the guide may include an elastomeric material.

The channel of the guide is generally tapered in configuration, having a proximal entry opening and a distal exit opening. The distal exit opening defines an internal dimension less than a corresponding internal dimension of the proximal exit opening. The channel may define a general frusto-conical configuration. The inner guide portion of the guide is adapted to permit passage of the surgical instrument through the channel without forming a seal about the surgical instrument. The guide may include a plurality of compliant members. The compliant members preferably extend at least radially inwardly relative to the longitudinal axis. Preferably, the compliant members extend in a general direction having radial and longitudinal components of direction relative to the longitudinal axis. The compliant members may be mounted in cantilevered relation to the seal housing and may pivot slightly upon engagement with the surgical instrument. The compliant members may be arranged such that adjacent compliant members are in partial overlapping relation.

The seal housing includes an internal wall defining an internal dimension less than the internal dimension of the proximal entry opening of the channel of the guide to generally restrict the internal dimension of the longitudinal opening of the seal housing.

In another embodiment, a surgical assembly includes a cannula assembly and a seal assembly. 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 to the cannula housing and having a longitudinal opening therethrough, a seal having inner seal portions adapted to form a substantial seal about a surgical instrument and a guide connected to an exterior surface of the seal housing. The guide includes a relatively compliant inner guide portion adapted to accommodate initial offset entry of the surgical instrument within the seal housing and being mounted with respect 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 isolated from the inner seal portion of the seal to not interfere with the functioning of the seal. The guide may include a plurality of compliant members coaxially arranged about the longitudinal axis. The inner guide portion of the guide is adapted to permit passage of the surgical instrument through the channel without forming a seal about the surgical instrument. The guide may be disposed proximal of the seal.

A method for performing a surgical procedure is also disclosed. 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, a seal mounted within the seal housing and a guide mounted to the seal housing proximal of the seal;

introducing a surgical instrument within the seal assembly whereby the guide generally directs the surgical instrument toward an internal passage of the seal without forming a seal thereabout, the guide being spaced from the internal passage so as to not interfere with the functioning of the seal; and

performing a surgical procedure with the surgical instrument

BRIEF DESCRIPTION OF THE DRAWINGS

Preferred embodiments of the present disclosure are described hereinbelow with references to the drawings, wherein:

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

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

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

FIG. 4 is a side cross-sectional 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 another alternate embodiment of the surgical seal assembly.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT(S)

The surgical seal assembly of the present disclosure provides a substantial seal between a body cavity of a patient and the outside atmosphere during insertion of a surgical instrument through the assembly. Moreover, 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 where surgical instruments may be introduced off-axis or angulated with respect to the seal axis and as a result could become lodged within the seal assembly. The surgical seal assembly may be adapted for mounting to a conventional cannula assembly as will be described hereinbelow.

The presently disclosed seal assembly contemplates the introduction of various types of surgical instruments adapted for insertion through an elongated trocar assembly. Some possible examples of such instruments may include clip appliers, graspers, dissectors, retractors, staplers, laser fibers, photographic devices, endoscopes and laparoscopes, tubes etc. Such instruments are collectively referred to herein as instruments.

In the following description, the term “proximal” refers to the portion of the instrument closest to the operator, while the term “distal” refers to the portion of the instrument remote from the operator.

Referring toFIG. 1, theseal assembly100 of the present disclosure is shown with acannula assembly200.Cannula assembly200 may be any conventional cannula assembly suitable for the intended purpose of accessing a body cavity and permitting introduction of instruments therethrough.Cannula assembly200 is particularly adapted for use in laparoscopic surgery where the peritoneal cavity is insufflated with a suitable gas, e.g., CO₂, to raise the cavity wall from the internal organs therein. Thecannula assembly200 is typically used with anobturator assembly300 which is an elongate instrument positionable within the cannula assembly. Theobturator assembly300 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 within the abdominal cavity. Once access to the abdominal cavity is achieved, theobturator assembly300 is removed from thecannula assembly200 leaving thecannula assembly200 in place for introduction of the surgical instrumentation utilized to perform the procedure. Examples of cannula assemblies in which thepresent seal assembly100 may be utilized are disclosed in commonly assigned U.S. Pat. No. 5,603,702 to Smith et al., which issued on Feb. 18, 1997, and commonly assigned U.S. Pat. No. 5,807,338 to Smith et al., which issued on Sep. 15, 1998, the entire contents of each disclosure being hereby incorporated by reference herein.

Cannula assembly

200 includescannula sleeve202 andcannula housing204 mounted to an end of thesleeve202.Cannula sleeve202 defines a longitudinal axis “a” extending along the length ofsleeve202.Sleeve202 further defines an internallongitudinal passage206 dimensioned to permit passage of surgical instrumentation.

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 housing204 may further include diametricallyopposed housing grips208 dimensioned and arranged for gripping engagement by the fingers of the user.Cannula housing204 may further include an internal duck bill or zeroclosure valve210. Such zeroclosure valve210 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.

Cannula sleeve

202 andcannula housing204 may be formed of stainless steel or other rigid materials such as a polymeric material or the like.Cannula sleeve202 and/orcannula housing204 may be clear or opaque. The diameter ofsleeve202 may vary, but typically ranges from 10 to 15 mm for use with theseal assembly100 of the present disclosure.

Obturator assembly

300 includesobturator housing302 andobturator member304 extending from thehousing302.Obturator member304 includes apenetrating end306 adjacent its distal end.Penetrating end306 may be sharp or blunt. Anobturator sleeve308 is coaxially mounted aboutobturator member304.Obturator sleeve308 may retract to expose piercingend306. Alternatively,obturator member304 may be advanced withinobturator sleeve308 to expose piercingend306. Other alternate obturator mechanisms for exposingpenetrating end306 are also envisioned.

Referring now toFIG. 2, in conjunction withFIG. 1,seal assembly100 will be discussed in detail.Seal assembly100 includes seal housing, generally identified asreference numeral102, andlongitudinal opening104 extending throughseal housing102.Seal housing102 houses the sealing components of the assembly and defines central seal housing axis “b” which is preferably parallel to the axis “a” ofcannula sleeve202 and, more preferably, coincident with the axis “a” of the cannula when theseal assembly100 is mounted to thecannula assembly100. In one embodiment, sealhousing102 may incorporate

several housing components

106,108 which, when assembled together, form theseal housing102. Assembly of

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, sealhousing102 may be monolithically formed as a single unit.

Seal housing

102 defines proximal and

distal ends

110,112, respectively. Adjacentproximal end110 is internal taperedwall114 which extends radially inwardly toward seal housing axis ‘b” from proximal to distal, i.e., taperedwall114 has both longitudinal and radial components of direction, and terminates in internalannular wall116.Annular wall116 serves to restrict the internal dimension oflongitudinal opening104 to at least partially constrain lateral movement of a surgical instrument introduced throughseal housing102.

Seal housing

102 may be constructed of a plurality of different materials, including, but not limited to, polymeric, metallic, or elastomeric. Preferably, the components ofseal housing102 are formed of a polycarbonate material such as ABS available from the General Electric Company.Seal housing102 may further include a handle which may be of any suitable ergonomic design. Moreover, sealhousing102 may be used in conjunction with, or detachably mounted, tocannula assembly200 such as those described hereinabove.

Seal assembly

100 includesseal118 mounted withinseal housing102 in suspended relation.Seal118 may be mounted withinseal housing102 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, seal118 may be disposed or trapped between

housing components

106,108 ofseal housing102 to effect the mounting. It is also envisioned thatseal118 may be mounted in a manner which permits radial or lateral movement of theseal118 withinseal housing102.

Seal

118 preferably includesinner seal portion120 defining a passage adapted to form a substantial seal about a surgical instrument.Seal118 may be a septum seal incorporating acircular aperture122 formed of any suitable elastomeric material. In one embodiment,seal118 is the fabric seal disclosed in commonly assigned U.S. Pat. No. 6,702,787 to Racenet et al., the entire contents of which are incorporated herein by reference. The seal disclosed in the '787 patent may be a flat septum seal having a first layer of resilient material and a second fabric layer juxtaposed relative to the first layer. The fabric layer may include a SPANDEX material containing 20% LYCRA from Milliken. In yet another alternative,seal118 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 forseal110 are also envisioned.

Althoughseal118 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, seal118 may be fabricated from an elastomeric material without the embedded fabric. Gel, foams, or other fluid-filled bladder seal arrangements are also envisioned.

Referring now toFIGS. 2-3,seal assembly100 further includes generallycompliant guide124 which is mounted to an exterior surface ofseal housing102 preferably adjacent internal taperedwall114.Compliant guide124 may be secured to the exterior surface, e.g., internal taperedwall114 ofseal housing102 or mounted in suspended relation to the internal taperedwall114.Compliant guide124 is generally tapered in configuration, e.g., generally frusto-conical shaped, havingproximal entry opening126 anddistal exit opening128, andinner guide portion130 defininginternal channel132. Preferably,distal exit opening128 defines an internal dimension greater than a corresponding internal dimension ofaperture122 ofseal118. In a preferred embodiment,inner guide portion130 is dimensioned to permit passage of the surgical instrument throughinternal channel132 without forming a seal about the surgical instrument.

In use,compliant guide124 is adapted to generally direct the instrument toward theinner seal portion120 ofseal118 upon advancement of the instrument throughlongitudinal opening104 ofseal housing102. In one preferred embodiment,compliant guide124 has a compliant characteristic which permits thecompliant guide124 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 thecompliant guide124. Thereafter, the tapered orientation ofcompliant guide124 guides the instrument along the seal axis “b”.Compliant guide124 may be constructed of a number of different compliant or flexible materials. In a preferred embodiment,compliant guide124 is formed of an elastomeric material.Compliant guide124 is preferably longitudinally spaced fromseal118 so as to not interfere with the functioning of theseal118.

It is envisioned thatseal assembly100 may be detachably connected tocannula assembly200. Preferably, sealhousing102 is dimensioned to be releasably mounted tocannula housing204. In this regard, it is appreciated thatseal housing102 andcannula housing204 may incorporate means for facilitating the releasable connection ofseal assembly100 tocannula assembly200 including, e.g., an interference fit, bayonet coupling, screw arrangement, etc. . . . on corresponding structure of theseal housing102 andcannula housing204. For example, sealhousing102 may include locking detents136 (FIG. 1) which engage corresponding structure oncannula housing204 to secureseal assembly100 tocannula assembly100. One suitable means for connecting the seal and

cannula assemblies

100,200 is disclosed in the aforementioned U.S. Pat. No. 5,603,702 to Smith et al. Thus, the surgeon can removeseal assembly100 from thecannula assembly200 at any time during the surgical procedure and similarly, mount theseal assembly100 to the cannula when desired in order to provide a sealing engagement with an instrument to be inserted through the cannula. In addition,seal assembly100 may be readily adapted for mounting to conventional cannula of differing structures. Alternatively, sealhousing102 may be permanently secured tocannula housing204 if desired.

Referring now toFIG. 4, another embodiment of the seal assembly of the present disclosure will be discussed.Seal assembly140 is substantially similar to sealassembly100 discussed hereinabove. However, in accordance with this embodiment,seal assembly140 includescompliant guide142.Compliant guide142 is mounted in cantilever manner to sealhousing106 to provide a greater degree of flexing capability to thecompliant guide142. In this regard,compliant guide142 is spaced from internal taperedwall114. In addition, the effective internal dimension adjacent the distal end ofcompliant guide142 is less than the internal dimension or diameter ofannular wall116, i.e.,compliant guide142 is spaced a distance “d” fromannular wall116 such that thecompliant guide142 does not necessarily restrict the diameter of the opening ofhousing component106. Any means for mountingcompliant guide142 in a pivotal manner may be appreciated by one skilled in the art. In one preferred embodiment,compliant guide142 includesflange144 which is affixed through conventional means to proximalexterior surface110 ofhousing component106. In other respects,seal assembly140 operates in a similar manner to that described hereinabove.

FIG. 5 illustrates an alternate embodiment of a compliant guide for incorporation with the seal assembly of the present disclosure. Compliant guide150 includes a plurality ofcompliant members152 coaxially arranged about seal axis “s” to defineopening154. Compliant guide150 may be mounted to sealhousing106 in pivotal relation substantially in the same manner as discussed in connection with the embodiment ofFIG. 4 so as to provide a greater degree of flexibility upon engagement and initial entry of the surgical instrument. In this regard, compliant guide150 includesflange156 which is secured toproximal surface110 of housing component106 (seeFIG. 4).Compliant members152 may be spaced from internal taperedwall114 in suspended pivotal manner to provide a greater degree of deflection upon offset entry of the surgical instrument.Compliant members152 are arranged to define a general frusto-conical shape extending radially inwardly relative to the seal axis “s” from proximal to distal, and may be further arranged such that adjacentcompliant members152 are in overlapping or partial overlapping relation with each other.Compliant members152 are flexible to deflect, bend, etc. upon engagement with the inserted surgical object and are preferably fabricated from on elastomeric material. Any shape, including, but not limited to, rectangular, rounded, triangular, etc. are envisioned forcomplaint members152.

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

Claims

1. (canceled)

2. A surgical seal assembly, comprising:

a seal housing defining a longitudinal axis;

a seal having an inner seal portion defining a passage and being adapted to seal about a surgical instrument disposed within the passage; and

a guide mounted adjacent an internal tapered wall of the seal housing and longitudinally fixed relative to the seal, at least a portion of the guide being longitudinally aligned with and disposed radially inward of the internal tapered wall of the seal housing.

3. The surgical seal assembly according toclaim 2, wherein the guide includes an inner guide portion proximal of the inner seal portion of the seal and spaced therefrom, and wherein the inner guide portion of the guide includes an elastomeric material.

4. The surgical seal assembly according toclaim 3, wherein the inner guide portion defines a channel adapted to direct the surgical instrument toward the inner seal portion of the seal upon entry of the surgical instrument within an opening of the seal housing, and wherein the channel of the inner guide portion is tapered in configuration, having a proximal entry opening and a distal exit opening, the distal exit opening defining an internal dimension less than a corresponding internal dimension of the proximal entry opening.

5. The surgical seal assembly according toclaim 4, wherein the channel defines a frusto-conical configuration.

6. The surgical seal assembly according toclaim 2, wherein the guide includes a plurality of compliant members, each compliant member of the plurality of compliant members extending radially inwardly relative to the longitudinal axis.

7. The surgical seal assembly according toclaim 6, wherein each compliant member of the plurality of compliant members is mounted in a cantilevered relation to the seal housing.

8. The surgical seal assembly according toclaim 7, wherein the plurality of compliant members is arranged such that adjacent compliant members of the plurality of compliant members at least partially overlap each other.

9. The surgical seal assembly according toclaim 6, wherein each compliant member of the plurality of compliant members extends in a direction having radial and longitudinal components of direction relative to the longitudinal axis.

10. The surgical seal assembly according toclaim 4, wherein the seal housing includes an internal wall defining an internal dimension less than an internal dimension of a proximal entry opening of the channel of the inner guide portion to restrict an internal dimension of a longitudinal opening of the seal housing.

11. The surgical seal assembly according toclaim 2, wherein the seal housing defines a channel including a tapered section, and wherein the guide is spaced from the tapered section along the longitudinal axis.

12. The surgical seal assembly according toclaim 2, wherein the guide defines surfaces extending along axes intersecting the longitudinal axis.

13. The surgical seal assembly according toclaim 2, wherein the guide is spaced from the seal along the longitudinal axis in a manner preventing interference with functioning of the seal.

14. The surgical seal assembly according toclaim 2, wherein the guide is suspended from the internal tapered wall of the seal housing.

15. The surgical seal assembly according toclaim 2, wherein the internal tapered wall of the seal housing is positioned and arranged to be prevented from contacting the surgical instrument during insertion of the surgical instrument.

16. A surgical seal assembly, comprising:

a seal housing having a longitudinal opening therethrough;

a seal having an inner seal portion adapted to seal about a surgical instrument; and

a guide mounted to an internal tapered wall of the seal housing and longitudinally fixed relative to the seal.

17. The surgical seal assembly according toclaim 16, wherein an inner guide portion of the guide is isolated from the inner seal portion of the seal to not interfere with functioning of the seal.

18. The surgical seal assembly according toclaim 16, wherein the guide includes a plurality of compliant members coaxially arranged about a longitudinal axis defined by the seal housing.

19. The surgical seal assembly according toclaim 16, wherein the guide is disposed proximally of the seal.

20. The surgical seal assembly according toclaim 16, wherein the guide is spaced from the seal along a longitudinal axis defined by the seal housing in a manner preventing interference with functioning of the seal.