Patent Publication Number: US-9402611-B2

Title: Surgical portal with rotating seal

Description:
CROSS REFERENCE TO RELATED APPLICATION 
     The present application is a divisional application of U.S. application Ser. No. 12/961,531, filed on Dec. 7, 2010, which claims the benefit of and priority to U.S. Provisional Application Ser. No. 61/287,829, filed on Dec. 18, 2009, the entire contents of which are incorporated herein by reference. 
    
    
     BACKGROUND 
     1. Field of the Disclosure 
     The present disclosure relates to surgical devices and, more particularly, relates to a surgical portal apparatus incorporating a rotating seal adapted for use during a minimally invasive surgical procedure. 
     2. Description of the Related Art 
     Minimally invasive surgical procedures, including endoscopic, arthroscopic, and laparoscopic procedures, permit surgery to be performed on organs, tissues, and vessels far removed from an opening within the tissue. These procedures generally require that any instrumentation inserted into the body be sealed, e.g., provisions may be made to ensure that gases do not enter or exit the body through the incision as, for example, in surgical procedures utilizing insufflating or irrigating fluids. These procedures typically employ surgical instruments which are introduced into the body through a cannula. The cannula has a seal assembly associated therewith. The seal assembly is intended to form a substantially fluid tight seal about the instrument to preserve the integrity of the established surgical site. 
     Seals may be limited by their ability to sustain a seal when it is moved off-axis relative to a central axis of a cannula. Seals may also be limited by their ability to sustain their integrity when an inserted surgical instrument is angulated. Such motions can create a “cat eye” or crescent shaped gap in the seal that can result in a loss of seal integrity. Additional problems include the flexibility of the seal in maintaining its integrity when both small diameter and large diameter surgical instruments are used. 
     SUMMARY 
     Accordingly, a surgical portal apparatus includes a portal housing, a portal sleeve, and a seal. The portal housing defines a central housing axis and a central housing channel. The portal sleeve extends from the portal housing and is dimensioned to pass through tissue to provide access to underlying tissue via a longitudinal opening. The central housing channel of the portal housing and the longitudinal opening of the portal sleeve define a passageway for reception and passage of a surgical object. The seal has inner surfaces defining a seal passage for establishing a general sealed relation about the surgical object. The seal passage is radially offset with respect to the central housing axis. The seal is adapted to rotate about the central housing axis to vary positioning of the seal passage to substantially maintain the substantial sealed relation upon manipulation of the surgical object within the portal housing. 
     A ball bearing assembly is mounted within the portal housing and is operably coupled to the seal to permit rotational movement of the seal about the seal axis. The ball bearing assembly includes a fixed ring, a rotating ring, and at least two ball bearings disposed within a track formed by the rings. The rotating ring is in communication with the seal so that the seal passage of the seal rotates about the central housing axis. In embodiments, the fixed ring of the ball bearing assembly is an outer ring affixed to the portal housing and the rotating ring is an inner ring that freely rotates radially with the ball bearings. In other embodiments, the fixed ring is a distal ring affixed to the portal housing and the rotating ring is a proximal ring that freely rotates radially over the ball bearings. 
     The portal apparatus may include a manually engageable actuator operatively coupled to the seal and extending from the portal housing. The actuator is movable to cause corresponding rotational movement of the seal about the central housing axis. 
     In embodiments the seal is substantially planar and defines an aperture, the aperture being the seal passage. The seal may be substantially orthogonal to the central housing axis or may be substantially obliquely arranged with respect to the central housing axis. In other embodiments, the seal defines a general funneled profile, such as an oblique circular cone, having an aperture, the aperture being the seal passage. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       Embodiments of the present disclosure will be better appreciated by reference to the drawings wherein: 
         FIG. 1  is a perspective view of a portal apparatus in the form of a seal assembly and a sleeve in accordance with the principles of the present disclosure; 
         FIG. 2  is a perspective view, with parts separated, of the seal assembly and the sleeve of  FIG. 1 ; 
         FIG. 3  is a side cross-sectional view of the portal apparatus of  FIGS. 1 and 2 ; 
         FIG. 4  is a side cross-sectional view of the portal apparatus of  FIG. 1  with an alternative ball bearing assembly arrangement; 
         FIG. 5  is an enlarged cross-sectional view of the seal assembly depicted in  FIG. 3  with an instrument inserted therethrough; 
         FIG. 6  is a side cross-sectional view of  FIG. 5  with the instrument rotated therein; 
         FIG. 7  is a perspective view of an alternate embodiment of a portal apparatus in accordance with the principles of the present disclosure; 
         FIG. 8  is a perspective view, with parts separated, of the seal assembly and the sleeve of  FIG. 7 ; 
         FIG. 9  is a perspective cross-sectional view of the portal apparatus of  FIG. 7 ; 
         FIG. 10  is a side cross-sectional view of the portal apparatus of  FIG. 7  taken along line  10 - 10  of  FIG. 9  with an instrument inserted therethrough; 
         FIG. 11  is a perspective view of a seal in accordance with the present disclosure; 
         FIG. 12  is a side-cross-sectional view of the portal apparatus of  FIG. 7  utilizing the seal of  FIG. 11 ; 
         FIG. 13  is a side cross-sectional view of the portal apparatus of  FIG. 12  having an instrument inserted therethrough; 
         FIG. 14  is a perspective of an alternate embodiment of a portal apparatus in accordance with the principles of the present disclosure; 
         FIG. 15  is a perspective view, with parts separated, of the seal assembly and the sleeve of  FIG. 14 ; 
         FIG. 16  is a perspective cross-sectional view of the portal apparatus of  FIG. 14 ; 
         FIG. 17  is a side cross-sectional view of the portal apparatus of  FIG. 14  taken along line  17 - 17  of  FIG. 16 ; 
         FIG. 18  is a top view of the portal apparatus of  FIG. 14  taken along line  18 - 18  of  FIG. 17 ; and 
         FIG. 19  is a side cross-sectional view of the portal apparatus of  FIG. 14  with an instrument inserted therethrough. 
     
    
    
     DETAILED DESCRIPTION 
     The portal apparatus of the present disclosure incorporates a seal assembly either alone or in combination with a sleeve for introduction into a body cavity of a patient. The portal apparatus is adapted for receiving objects therethrough. The seal assembly incorporates a seal which, either alone or in combination with a valve, provides a substantial seal between a body cavity of a patient and the outside atmosphere before, during, and after insertion of an object through the portal assembly. The seal assembly includes a ball bearing assembly for rotating the seal, and thus objects inserted therethrough, to different positions without compromising the integrity of the seal. 
     The seal assembly contemplates the introduction and manipulation of various types of instrumentation adapted for insertion through a trocar, cannula, or other portal assembly. A fluid tight interface is maintained via the seal about the inserted instrumentation. This substantially prevents gas and/or liquid leakage from the established surgical site so as to preserve the atmospheric integrity of a surgical procedure. 
     The seal is capable of accommodating objects of varying diameters, e.g., instruments from about 3 mm to about 18 mm, by providing a fluid tight seal with each object when inserted. The flexibility of the seal greatly facilitates endoscopic surgery where a variety of instruments having differing diameters are often needed during a single surgical procedure. Examples of surgical instrumentation which may be introduced through the portal apparatus include clip appliers, graspers, dissectors, retractors, staplers, laser probes, photographic devices, endoscopes, laparoscopes, arthroscopes, tubes, electrosurgical cutting, coagulating, and ablation devices, and other tools within the purview of those skilled in the art. Such instruments will be collectively referred to herein as “instruments” or “instrumentation.” 
     Embodiments of the presently disclosed surgical portal apparatus will now be described in detail with reference to the drawing figures wherein like reference numerals identify similar or identical elements. As used herein and as is traditional, the term “distal” refers to that portion which is furthest from the user while the term “proximal” refers to that portion which is closest to the user. 
     Referring now to the drawings,  FIG. 1  illustrates a portal apparatus  10  of the present disclosure incorporating seal assembly  12  mounted to portal sleeve  14 . In embodiments, the portal apparatus  10  is particularly adapted for use in laparoscopic surgery where the peritoneal cavity is insufflated with a suitable gas, e.g., CO 2 , to raise the cavity wall from the internal organs therein. The sleeve  14  is typically used with an obturator assembly (not shown) which may be a blunt, non-bladed, or sharp pointed instrument positionable within the passageway of the sleeve  14 . The obturator assembly is utilized to penetrate a body wall or introduce the sleeve  14  through the body wall, and then subsequently is removed from the sleeve  14  to permit introduction of surgical instrumentation  16  utilized to perform the procedure through the passageway and body wall. Instrument  16  is shown rotating in phantom within seal assembly  12  and sleeve  14 . 
     Seal housing  70  and end cap  20  define a portal housing  78  for housing the components of the seal assembly  12  as will be discussed. Portal housing  78  define a central housing axis “t” extending along the length of the seal assembly  12  and mounted sleeve  14  such that a central housing channel  79  of the portal housing  78  is in general alignment with passageway  92  of sleeve  14  for passage of surgical instruments  16  to underlying tissue. 
     With reference now to  FIGS. 2-3 , in conjunction with  FIG. 1 , an embodiment of a portal apparatus  10  of the present disclosure will be discussed. Portal apparatus  10  includes seal assembly  12  which includes end cap  20 , instrument seal  30 , attachment plate  40 , ball bearing assembly  50 , and seal housing  70 . Sleeve  14  is detachably mountable to seal housing  70  of seal assembly  12  and duck bill valve  80  may optionally be configured to be in mechanical cooperation with both the seal assembly  12  and the sleeve  14 . 
     End cap  20  is generally tubular in shape and includes a proximal end portion  22  and a distal end portion  24 . An opening  26  is defined within proximal end portion  22  and is aligned with central housing axis “t” for receiving a surgical instrument. Opening  26  has a sufficient diameter to permit passage of relatively large sized instruments into central housing channel  79 . End cap  20  may be removably coupled with seal housing  70  of seal assembly  12 . 
     Instrument seal  30  is disposed distal to end cap  20  and may be any conventional type of seal as within the purview of those skilled in the art. Instrument seal  30  may be formed from a single material or combinations thereof. Instrument seal  30  may be fabricated from a suitable biocompatible relatively rigid material such as polypropylene, nylon, ABS, polycarbonate, stainless steel, titanium or any other suitable material. Instrument seal  30  may also be composed of fabric, elastomers, foam, combinations thereof, or combinations with other materials. 
     Instrument seal  30  is generally disc-shaped and defines an aperture, slit, or other seal passage  32  for reception and passage of surgical object or instrument  16 . Seal passage  32  is configured to form a fluid-tight fit with surgical instrument  16 . Seal passage  32  is off-set from the longitudinal mid-point of axis “t” such that it is off-axis and may rotate radially around central housing axis “t” while maintaining a substantially sealed relation with an inserted surgical instrument as will be discussed. 
     Instrument seal  30  is releasably couplable to a proximal surface of attachment plate  40  via joining members  34 . The joining members  34  may be mechanically couplable to complementary joining members  44  on attachment plate  40  as illustrated in the current embodiment by way a pin  34  and slot  44  arrangement. Instrument seal  30  may be releasably secured or connected to attachment plate  40  by other conventional mechanical means including, for example, other male/female fasteners, bayonet couplings, threaded connections, snap fit, friction fit, tongue and groove arrangements, and cam-lock mechanisms. Instrument seal  30  may be chemically couplable to attachment plate  40  via use of adhesives or permanently couplable via ultrasonic welding or the like. Alternatively, instrument seal  30  may have no mating members but be frictionally engaged with attachment plate  40 . 
     Attachment plate  40  is an annular plate including central opening  42  which is substantially aligned with opening  26  of end cap  20  and has a diameter of a sufficient size to accommodate the off-set and rotatable seal passage  32  of the instrument seal  30  in order to maintain the passageway for a surgical instrument. Attachment plate  40  includes mating features on both proximal and distal surfaces. Joining members  44  to instrument seal  30  are disposed on the proximal surface and means for coupling to ball bearing assembly  50  are disposed on the distal surface. Attachment plate  40  may be coupled to ball bearing assembly  50  by any of the means, such as those discussed above with respect to instrument seal  30 . 
     Ball bearing assembly  50  includes two concentric rings including fixed ring  52  and rotating ring  54  defining opening  56  along longitudinal axis “t.” Fixed ring  52  and rotating ring  54  each include a recess  58 ,  60  respectively, defined in facing walls  62 ,  64  to form track  66  for ball bearings  68 . In the current embodiment, fixed ring  52  is an outer ring in communication with and attached to the seal housing  70  and rotating ring  54  is an inner ring operably connected to attachment plate  40  and thus seal  30  for free rotation of the seal  30 . Other orientations are envisioned, such as shown in  FIG. 4 .  FIG. 4  illustrates a stacked configuration where fixed ring  52   a  is distal to rotating ring  54   a . Fixed ring  52   a  is attached to seal housing  70  and rotating ring  154  is free to rotate. 
     At least two ball bearings  68  are disposed between fixed and rotating rings  52 ,  54 . Ball bearings  68  may be freely disposed within track  66  to travel around track  66  and radially rotate about the longitudinal axis “t,” as well as spin about themselves. Ball bearings  68  may be held constant by a ball bearing holder (not shown) within track  66  so that the ball bearings  68  may only spin, for example, in an internal ring such as in thrust, rolling, or ball and groove bearing assembly. Alternatively, fixed ring  52  may include the ball bearing holders so that an area of the ball bearings  68  is exposed for contact with rotating ring  54 . 
     Ball bearings  68  may be formed from metals, such as stainless steel, iron, and aluminum, as well as polymers, ceramics, and other rigid materials capable of supporting the rotating ring and permitting free rotation thereof with minimum friction. Ball bearings  68  may be spherical, ovoid, or other shapes which reduces the rotational friction of the rotating ring. In embodiments, a lubricant, such as grease, may be utilized to assist with smooth rotational movement of seal  30 . 
     Seal housing  70  houses the components of the seal assembly  12  and also includes sleeve mounting collar  72  for joining the seal assembly  12  with sleeve  14 . An annular septum  74  separates the sleeve mounting collar  72  from the rest of the components of the seal assembly  12 . Sleeve mounting collar  72  may be selectively releasably connectable to sleeve  14  to cooperatively releasably couple seal assembly  12  to sleeve  14 . Various means for releasably securing or connecting sleeve mounting collar  72  to proximal end  94  of sleeve  14  are envisioned including a bayonet coupling, snap-fit, frictional fit, tongue and groove arrangement, threaded arrangement, cam-lock mechanisms or the like. As illustrated in the current embodiment, sleeve mounting collar  72  is secured to sleeve  14  via friction fit. Seal assembly  12  may be mounted to sleeve  14  before, during, or after, application of sleeve  14  within the operative site. Alternatively, seal assembly  12  may be permanently secured to sleeve  14  by conventions means, such as for example, ultrasonic welding, use of adhesives, or by monolithically forming seal housing  70  with sleeve  14 . 
     Optionally, a valve  80  may be disposed between seal housing  12  and sleeve  14 . Annular septum  74  of seal housing  70  may include a notch  76  for securing valve  80  and sleeve  14  may include a channel  90  in proximal end  94  in which lip  82  of valve  80  may be seated. Valve  80  may be a zero-closure valve such as a duck-bill valve having a slit  84  which is adapted to close in the absence of a surgical object and/or in response to insufflation gases of the pressurized cavity. In the alternative, valve  80  may be a gel seal, balloon valve, or a flapper valve. Valve  80  may be fabricated from a relatively rigid material such as medical grade stainless steel or a biocompatible polymeric material. Valve  80  may also be formed from a flexible material such as a fabric, foam, or elastomeric material in order to bend or deform about an inserted instrument while absorbing off-axis motion. Further, valve  80  can minimize formation or gaps around an inserted instrument and prevents fluid or debris from entering seal assembly  12  when the valve  80  is closed. Fluid pressure on valve  80  will close slit  84  thereby sealing seal assembly  12  from fluids. When an instrument is inserted through valve  80 , however, a seal is not always formed around the instrument thereby allowing some fluid to enter seal housing  70  wherein seal  30  prevents the fluid from exiting seal assembly  12 . 
     Sleeve  14  may be any portal member suitable for the intended purpose of accessing a body cavity and typically defines a passageway  92  permitting introduction of instruments  16  therethrough. Sleeve  14  has proximal (or leading) and distal (or trailing) ends  94 ,  96 . Sleeve  14  may be formed of any suitable medical grade material, such as metal materials like stainless steel, titanium, and aluminum; polymeric materials like acrylonitrile-butadiene-styrene, polycarbonate, and polystyrene; and other rigid materials and combinations thereof as envisioned by one skilled in the art. 
     Sleeve  14  may be transparent, translucent, or opaque. The diameter of sleeve  14  may vary, but, typically ranges from about 3 to about 18 mm. Sleeve  14  may or may not include means for facilitating retention of the sleeve  14  within tissue. Such means include a plurality of locking elements, ribs, or other locking arrangements within the purview of those skilled in the art. 
     The assembly of portal apparatus  10  will now be discussed. Attachment plate  40  is secured to rotating ring  54  of ball bearing assembly  50  as well as seal  30 . The joined components are advanced within seal housing  70 . Fixed ring  52  may be affixed to seal housing  70  and end cap  30  may be secured thereon. Assembled seal assembly  12  may then be secured to sleeve  14  as discussed above, optionally with valve  80  secured therebetween. 
     In use, as illustrated in  FIGS. 5 and 6 , instrument  16  is advanced distally through opening  26  of end cap  20  through seal passage  32  of seal  30 , opening  42  of attachment plate  40 , opening  56  of ball bearing assembly  50 , through annular septum  74  of seal housing  70 , slit  84  of valve  80 , and passageway  92  of sleeve  14 . The desired surgical task is performed with instrument  16 . Instrument  16  may be re-positioned during the surgical procedure by rotating the instrument  16  about the central housing axis “t” thereby rotating the rotating ring  54  which contacts and spins ball bearings  68 . Free rotation of ball bearings  68  reduces rotational friction and allows smooth movement and rotation of seal  30  and thus instrument  16 . 
     Alternatively, as depicted in  FIG. 7 , the portal apparatus may contain a feature that allows rotation of the instrument about axis “t” without having to manually turn the instrument itself.  FIGS. 8-10 , in conjunction with  FIG. 7 , illustrate another embodiment of the presently described portal apparatus  110 . Portal apparatus  110  includes seal assembly  112  and portal sleeve  114 . Like components are similarly numbered as those illustrated in  FIGS. 1-6 . Seal assembly  112  includes a manually engageable actuator  128  disposed between end cap  120  and seal  130 . Actuator  128  may be any mechanical device, such as a knob, dial, or lever which a user may move to rotate surgical instrument  114 . Actuator  128  includes an upper portion  121  for placement through opening  126  of end cap  120  such that it extends from portal housing  178  for gripping by the user and a lower portion  123  for contacting seal  130 . Upper portion  121  includes a central aperture  125  for passing surgical instruments. Lower portion  123  may include a lip  127 , or other joining means, for retaining seal  130 . Accordingly, manual rotation of upper portion  121  of actuator  128  will cause corresponding rotational movement of seal  130  thereby rotating instrument  116  passed therethrough about axis “t.” 
     Additionally, attachment plate  140  may include a lower collar  146  to aid in proper alignment of attachment plate  140  with rotating ring  154  of ball bearing assembly  150 . Alternatively, lower collar  146  may also provide a friction fit with rotating ring  154  thereby obviating the need for a mechanical or chemical attachment as described above. 
     As illustrated in the current embodiments, seal  130  is flat or planar. It is envisioned that the seal may define different shapes having an off-set opening, such as that shown in  FIG. 11 , for sealing and maintaining the integrity of the established surgical site.  FIGS. 11-13  illustrates seal  230  defining a generally tapered or funneled conical profile in the form of an oblique circular cone whereby the inner area of the seal  230  slopes at an oblique angle with respect to the central housing axis “t” to define aperture  232  which is off-axis from axis “t.” The funneled characteristic may assist in guiding the instrument toward aperture  232  during initial introduction of the instrument or object and may substantially minimize the potential of inversion of seal  230  during withdrawal of the instrument. The conical seal may also flex in addition to rotate thereby allowing some additional off-axis motion as illustrated by the arrows in  FIG. 13 . 
     Seal  130  of  FIGS. 7-10  is also illustrated as being substantially orthogonal to the central housing axis “t.” In embodiments, however, the seal may be angulated and substantially obliquely arranged with respect to the central housing axis “t.”  FIGS. 14-19  illustrate another embodiment of the presently described portal apparatus  310 . Portal apparatus  310  includes seal assembly  312  and portal sleeve  314 , with like components similarly numbered as the previous figures. Seal  330  may be positioned between and in contact with end cap  320  and attachment plate  340 . Both the end cap  320  and the attachment plate  340  include an angulated surface  329 ,  348  respectively, between which seal  330  may be disposed at an oblique angle relative to the longitudinal axis “t.” 
     To use seal assembly  112 ,  212 ,  312  and sleeve  114 ,  214   314  of the present disclosure in connection with the performance of a surgical task during a laparoscopic procedure, the peritoneal cavity is insufflated to establish the pneumoperitonum. Seal assembly  112  is mounted to sleeve  114  as discussed hereinabove. The assembled portal system  110  is introduced into an insufflated abdominal cavity typically utilizing a sharp or non-blade trocar obturator to access the cavity and the obturator is removed. An instrument  116  may be advanced through portal system  110  by inserting the instrument  116  into the seal assembly  112  via the openings defined by the actuator  128 , end cap  120 , seal  130 , attachment plate  140 , ball bearing assembly  150 , and seal housing  170 . The instrument  116  is then distally passed through sleeve  114  and into the body cavity. During performance of a surgical task, the instrument  116  may be manipulated and re-positioned by rotating either the instrument  116  or the actuator  128  about the longitudinal axis “t.” Rotation of the instrument  116  or knob  128  rotates seal  130 , attached attachment plate  140 , and rotating ring  154  of ball bearing assembly  150 . Radial movement of rotating ring  154  of the ball bearing assembly  150  spins ball bearings  168 . Movement and rotation of the ball bearings  168  reduces the rotational friction on the rotating ring  154  and allows smooth movement and rotation of seal  130  and thus instrument  116 . 
     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 but merely as exemplifications of embodiments of the present disclosure. Those skilled in the art will envision other modifications within the scope and spirit of the present disclosure as defined by the claims appended hereto.