Patent Document

BACKGROUND OF THE INVENTION 
       [0001]    1. Field of the Invention 
         [0002]    The invention relates to laparoscopic devices. In particular, the invention relates to a laparoscopic seal assembly permitting the use of hands in assisting during laparoscopic procedures. 
         [0003]    2. Description of the Prior Art 
         [0004]    During laparoscopic procedures, it is often desirable for the surgeon to place his or her hand within the patient in a manner manipulating the instruments positioned within the patient. When this occurs, it is desirable to separate the external environment from the internal portion of the patient. For example, when hand assisted laparoscopic procedures are performed within the abdominal cavity, it is desirable to perform hand exchanges with minimal loss of abdominal pressure. 
         [0005]    As such, a need exists for skin mountable seals permitting hand assisted laparoscopic procedures without fear that the abdominal pressure will be compromised. The present invention provides such an apparatus. 
       SUMMARY OF THE INVENTION 
       [0006]    It is, therefore, an object of the present invention to provide a hand assisted laparoscopic seal apparatus. The apparatus includes a first seal, a second seal and a housing supporting the first seal relative to the second seal. One of the first seal or the second seal is shaped and dimensioned for engaging and sealing around an arm of a medical practitioner and the other seal is shaped and dimensioned for sealing a body cavity from an external environment. 
         [0007]    It is also an object of the present invention to provide a seal apparatus wherein the first seal is a lip seal having a central opening. 
         [0008]    It is also another object of the present invention to provide a seal apparatus wherein the second seal is a duckbill seal. 
         [0009]    It is also a further object of the present invention to provide a seal apparatus wherein the first seal is an outer seal and the second seal is an inner seal. 
         [0010]    It is another object of the present invention to provide a seal apparatus wherein the lip seal includes a flexible annular membrane with the central opening formed therein. 
         [0011]    It is a further object of the present invention to provide a seal apparatus wherein the central opening is approximately 2.00 inches or less. 
         [0012]    It is yet a further object of the present invention to provide a seal apparatus wherein the central opening ranges between approximately 1.25 inches to approximately 1.5 inches. 
         [0013]    It is still another object of the present invention to provide a seal apparatus wherein the first seal is an overlapping seal having a central opening. 
         [0014]    It is also an object of the present invention to provide a seal apparatus wherein the second seal includes first and second seal bodies, each of the first and second seal bodies include an upper surface and a lower surface, and the respective first and second seal bodies includes a thickened section adjacent a meeting point of the first and second seal bodies. 
         [0015]    It is another object of the present invention to provide a seal apparatus wherein the thickness of the first and second seal bodies is approximately 0.540 inch along the thickened section. 
         [0016]    It is a further object of the present invention to provide a seal apparatus wherein the first and second seal bodies are approximately less than 0.10 inch thick along a remainder thereof. 
         [0017]    It is also an object of the present invention to provide a seal apparatus including a seal and a housing supporting the seal, wherein the seal is composed of open cell foam impregnated with silicone. 
         [0018]    It is still another object of the present invention to provide a seal apparatus wherein the seal is manufactured by casting the open cell foam within a mold and then pouring silicone therein to produce seal bodies exhibiting softness and durability. 
         [0019]    It is yet a further object of the present invention to provide a seal apparatus wherein the open cell foam is polyurethane, urethane-ether or polyolefin. 
         [0020]    Other objects and advantages of the present invention will become apparent from the following detailed description when viewed in conjunction with the accompanying drawings, which set forth certain embodiments of the invention. 
     
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0021]      FIG. 1  is a perspective view of the present seal apparatus adjacent an incision in accordance with a preferred embodiment of the present invention. 
           [0022]      FIG. 2  is a perspective view of the seal apparatus shown in  FIG. 1  mounted at a predetermined tissue location. 
           [0023]      FIG. 3  is a bottom perspective view of the inner seal of the seal apparatus shown with reference to  FIG. 1 . 
           [0024]      FIG. 4  is a partially exploded view of the seal apparatus shown in  FIG. 1 . 
           [0025]      FIG. 5  is an exploded view of the seal apparatus shown in  FIG. 1 . 
           [0026]      FIG. 6  is a cross sectional view of the seal apparatus shown in  FIG. 1 . 
           [0027]      FIGS. 7 and 8  are cross sectional views showing use of the seal apparatus shown in  FIG. 1 . 
           [0028]      FIG. 9  is a perspective view of the present seal apparatus in accordance with an alternate embodiment of the present invention. 
           [0029]      FIG. 10  is an exploded view of the seal apparatus shown in  FIG. 9 . 
           [0030]      FIGS. 11 and 12  are cross sectional views showing use of the seal apparatus shown in  FIG. 9 . 
       
    
    
     DESCRIPTION OF THE PREFERRED EMBODIMENTS 
       [0031]    The detailed embodiments of the present invention are disclosed herein. It should be understood, however, that the disclosed embodiments are merely exemplary of the invention, which may be embodied in various forms. Therefore, the details disclosed herein are not to be interpreted as limiting, but merely as the basis for teaching one skilled in the art how to make and/or use the invention. 
         [0032]    Referring to  FIGS. 1 to 12 , a seal apparatus  10  for permitting hand assisted laparoscopic procedures is disclosed. The seal apparatus  10  generally employs a two-seal design to ensure abdominal pressure is not compromised during hand exchanges while hand assisted laparoscopic procedures are performed. As such, the seal apparatus  10  includes an outer seal  12  and an inner seal  14 . Although a two-seal design is disclosed in accordance with a preferred embodiment of the present invention, those skilled in the art will appreciate the concepts underlying the present invention may be applied to apparatuses employing additional seal layers without departing from the spirit of the present invention. 
         [0033]    The outer seal  12  is shaped and dimensioned to create a gas tight barrier around the surgeon&#39;s wrist when inserted through the seal apparatus  10 , while the inner seal  14  is shaped and dimensioned to create a gas tight barrier between the interior abdominal space and the external environment when a hand is not inserted through the seal apparatus  10 . 
         [0034]    Referring to the various figures, both the inner seal  14  and the outer seal  12  are positioned within a housing  16 . In accordance with a preferred embodiment, the housing  16  is made of polyurethane, polycarbonate, and soft elastomers, such as, EPDM (Ethylene Propylene Dimonomer) and SANTOPRENE (that is, a thermoplastic elastomer), although those skilled in the art will appreciate a variety of materials may be used without departing from the spirit of the present invention. The housing  16  preferably supports the outer and inner seals  12 ,  14  in a concentric manner, although noncentric constructions may be employed without departing from the spirit of the present invention. More particularly, the housing  16  includes an annular base member  18 . The annular base member  18  includes an inwardly directed rim  20  and a circumferentially extending outer border  22 . Positioned along the inner rim  20  is a lower gasket member  24  upon which is placed the inner seal  14 . Positioned directly upon the inner seal  14  is the outer seal  12 , and an upper closure gasket  26  is positioned thereabove. The upper closure gasket  26  is secured to the outer seal  12 , inner seal  14  and lower gasket member  24  in a manner securing all components of the present apparatus together. In accordance with a preferred embodiment, the various components are held together using mechanical attachment structures, such as, press fit rivets, adhesive, welds, or other suitable securing mechanism known to those skilled in the art. 
         [0035]    The housing  16  is secured to the skin of an individual by first creating an incision and positioning the housing  16  adjacent the incision. Thereafter, a retractor (or wound protector)  28 , which is coupled to the housing  16  at housing end  80  by an O-ring  82 , is inserted into the body cavity. The skirt  29  of the retractor  28  is then drawn about the lower end of the housing  16  with the skin therebetween. As such, the housing  16  is securely supported on the skin with the retractor  28  resiliently holding the skin therebetween. Although a fixed length retractor is disclosed in accordance with a preferred embodiment of the present invention, it is contemplated adjustable retractors may be used without departing from the spirit of the present invention. For example, an adjustable retractor may be employed which allows for one to “roll-up” the free end of the retractor, or otherwise adjust the length of the retractor, for proper positioning of the present seal apparatus relative to an incision. 
         [0036]    More particularly, and in accordance with one technique for the performance of hand assisted laparoscopic procedures, the surgical site is prepared in accordance with conventional standard hospital procedures, making sure the skin is clean and dry. Thereafter, a template is placed over the incision site and an incision line is marked upon the template using a sterile skin marker. As those skilled in the art will appreciate, the glove size dictates the size of the incision. For example, if the surgeon&#39;s glove size is 7, a 7 cm incision is usually appropriate. Thereafter, an incision is made along the marked incision line. The incision size is thereafter verified by inserting the surgeon&#39;s hand into the abdomen prior to attaching the present seal apparatus  10 . If the incision is too small, the incision is extended as required on each end to maintain the central position of the incision relative to the placement of the present seal apparatus  10 . Thereafter, the retractor  28  is inserted through the incision. Using one&#39;s fingers, the retractor  28  is seated evenly under the peritoneum and the area is swept to ensure that tissue is not trapped between the retractor  28  and the abdominal cavity. Thereafter, the housing  16  is pulled down into contact with the skin with the patient&#39;s tissue between the retractor  28  and the housing  16 . 
         [0037]    In accordance with a preferred embodiment, it is contemplated the outer seal  12  may be constructed with either a lip seal design or an overlapping seal design (respectively see  FIGS. 1-8  and  9 - 12 , where similar numerals are used for similar elements). However, and as those skilled in the art will certainly appreciate, other similar seal constructions, for example, an iris seal, may be employed without departing from the spirit of the present invention. 
         [0038]    Where a lip seal  30  is employed, the lip seal  30  is shaped and dimensioned to seal about the surgeon&#39;s wrist thereby creating a gas tight barrier thereabout when inserted through the seal apparatus  10 . With this in mind, the lip seal  30  includes a flexible annular membrane  32  with a central opening  34 . In accordance with a preferred embodiment, the central opening  34  is approximately 2.0 inches or less, and more preferably between approximately 1.25 inches to approximately 1.5 inches. The size is chosen to comfortably accommodate a wide range of wrist and forearm sizes ensuring that most doctors will be readily able to insert their hand and wrist/forearm through the central opening  34  while allowing the central opening  34  to return to its unstressed configuration wrapped about the wrist of the doctor. The lip seal  30  is manufactured of a material allowing for the creation of contact pressure about the wrist sufficient to form a gas tight barrier without undue pressure upon the user&#39;s wrist. As such, it is contemplated the lip seal  30  will be composed of polyisoprene, urethane, neoprene, silicone, or similar materials offering desirable resilience and comfort. 
         [0039]    Where an overlapping seal  36  is contemplated, the overlapping seal  36  is composed of multiple seal members  38  positioned about the central opening  40  in a manner creating an opening as the various seal members are pushed downwardly as one&#39;s hand is pushed therethrough. As those skilled in the art will appreciate, the various seal members  38  making up the overlapping seal  36  are shaped and dimensioned in a manner allowing them to be coupled together to create an annular space similar to the lip seal  30 . However, because multiple seal members  38  are used in the construction of an overlapping seal  36 , and the seal members  38  are fixedly coupled along the peripheral edge of the overlapping seal  36 , the central opening  40  readily flexes to permit passage of a hand therethrough. As such, the overlapping seal  36  will open as a surgeon forces his wrist through the present seal apparatus  10  and the resiliency of the various seal members  38  will close upon the surgeon&#39;s wrist as he passes through the outer seal  12 . With this in mind, and as with the lip seal construction, the overlapping seal  36  will be composed of polyisoprene, urethane, neoprene, silicone or similar materials offering desirable resilience and comfort. 
         [0040]    While both a lip seal  30  and an overlapping seal  36  are contemplated in accordance with preferred embodiments of the present invention, it is contemplated an overlapping seal  36  will offer advantages over the lip seal  30 . In particular, the contact pressure on the surgeon&#39;s wrist will be less when an overlapping seal  36  is utilized (although the gas tight barrier will be equivalent). In addition, an overlapping seal  36  will permit adjustment of the opening size to accommodate various wrist sizes and instrument sealing. 
         [0041]    Although a lip seal and an overlapping seal are disclosed above in accordance with a preferred embodiment, those skilled in the art will appreciate various seal designs may be employed without departing from the spirit of the present invention. For example, an iris seal may be employed. In addition, it is contemplated layered seal designs may be employed within the spirit of the present invention. Specifically, a layered design might employ multiple overlapping seals as discussed above placed upon each other with their opening (and seal members) angularly offset to enhance the seals&#39; ability to create a barrier when an individual&#39;s hand is passed therethrough. 
         [0042]    With regard to the inner seal  14 , it is preferably a duckbill seal design. Generally, the duckbill inner seal  14  includes a pair of opposed valve members  42  which open and close in much the same manner a duck opens and closes its bill. In accordance with a preferred embodiment of the present invention, the duckbill inner seal  14  includes first and second seal bodies  44 ,  46  extending from a circumferential flange member  48  shaped and dimensioned for mounting within the housing  16 . Each of the first and second seal bodies  44 ,  46  includes an upper surface  50 ,  52  and a lower surface  54 ,  56 . The upper surface  50 ,  52  is substantially smooth and consistently flat as it extends from the perimeter of the inner seal  14  to the central slit  58  where the first and second seal bodies  44 ,  46  meet. As will be discussed below, the lower surfaces  54 ,  56  of the respective first and second seal bodies  44 ,  46  include a thickened section  60 ,  62  adjacent the meeting point of the first and second seal bodies  44 ,  46 . 
         [0043]    The first and second seal bodies  44 ,  46  are mounted within the housing  16  for movement as a surgeon&#39;s hand and/or an instrument is passed therethrough. With this in mind, the proximal end of each of the first and second seal bodies  44 ,  46  is coupled to the housing  16  via the circumferential flange member  48 , while the distal ends of the first and second seal bodies  44 ,  46  intersect to define an abutment face  64 . The abutment face  64  is generally positioned within the center of the housing  16 , and in line with the outer seal  12 , to permit the passage of a hand and/or instrument therethrough. In the absence of the passage of a hand and/or instrument therethrough, the abutment face  64  is closed via the resilience of the first and second seal bodies  44 ,  46  as they are biased under the pressure generated from the body cavity in which the present seal apparatus  10  is positioned, for example, biased under the pressure from the abdominal insufflation gas pressure. This pressure causes the duckbill inner seal  14  to move to a closed position with the distal ends of the first and second seal bodies  44 ,  46  in contact. 
         [0044]    As briefly mentioned above, the first and second seal bodies  44 ,  46  are formed with a thickened section  60 ,  62  adjacent the abutment face  64 . In particular, the thickness of the first and second seal bodies  44 ,  46  is approximately 0.540 inch thick along the abutment face  64 , while the remainder of the first and second seal bodies  44 ,  46  is preferably less than approximately 0.1 inch thick, and more preferably approximately 0.080 inch thick. Each of the first and second seal bodies  44 ,  46  is further provided with a plurality of radially extending reinforcement ribs  66  extending between the distal end of the seal bodies  44 ,  46  and the thickened section  60 ,  62  adjacent the abutment face  64 . 
         [0045]    In accordance with a preferred embodiment of the present invention, the inner seal is constructed to offer a soft yet durable construction. With this in mind, and in accordance with a preferred embodiment, the seal bodies are composed of open cell foam, for example, polyurethane, urethane-ether or polyolefin, impregnated with silicone. The seal bodies are manufactured by casting the open cell foam within a mold and then pouring silicone therein to produce seal bodies which exhibit desirable softness with durability as one passes his or her hand therethrough. As those skilled in the art will appreciate, the thickened sections  60 ,  62  of the first and second seal bodies  44 ,  46  are manufactured from silicone (or other elastomer materials, such as, urethane) reinforced with polyurethane foam while the remainder of the seal bodies  44 ,  46  is composed of silicone (or other elastomer materials, such as, urethane). In particular, the first and second seal bodies  44 ,  46  are made entirely from silicone and the thickened sections  60 ,  62  thereof are reinforced with polyurethane open cell foam. In addition, it is contemplated the duckbill portion may include fabric or open cell lattice structure as a reinforcement. This will provide durability while maintaining flexibility. As with the open cell foam employed in accordance with a preferred embodiment, the silicone (or other elastomer) can be combined with the reinforcement to fill the lattice structure or spaces. 
         [0046]    In accordance with a preferred embodiment, the wall angle of the upper surface  50 ,  52  of the first and second seal bodies  44 ,  46  is maintained at an angle of approximately 30 degrees to approximately 45 degrees so as to balance the ease of passage through the inner seal  14  with the seal&#39;s ability to fully close when not in use. 
         [0047]    It is further contemplated forces between the duckbill seal and a hand and/or instrument passing therethrough may be further minimized by adjusting wall thickness, rib geometry, surface coatings and material properties. 
         [0048]    The positioning of the lip or overlapping seal as the outer seal and the duckbill seal as the inner seal is disclosed in accordance with a preferred embodiment. However, those skilled in the art will certainly appreciate the seal types may be reversed without adversely affecting the functionality of the present seal apparatus. 
         [0049]    While the preferred embodiments have been shown and described, it will be understood that there is no intent to limit the invention by such disclosure, but rather, is intended to cover all modifications and alternate constructions falling within the spirit and scope of the invention.

Technology Category: a