Skin seal

Abstract

A skin seal or trocar stabilizer with an inflatable membrane disposed inside, whereby medical instruments may be passed through the skin seal into a endoscopic work space while the inflatable membrane is inflated, thereby allowing the use of normal short conventional open surgery instruments during endoscopic procedures and during insufflation.

What is claimed is: 
     
       1. A method of sealing a skin incision for performing a minimally invasive surgical procedure at a surgical site in a body, said method comprising:
 providing a sealing device comprising a tube having a proximal end and a distal end, an inner bore and an outer surface, said proximal end having a larger outer diameter than said distal end, and an inflatable membrane disposed within said inner bore, said sealing device further comprising a plurality of protrusions extending inwardly from said inflatable membrane, said plurality of protrusions extending inwardly engaging one another to form a seal upon inflation of the inflatable membrane;   making an incision in the body;   inserting said distal end of said sealing device through said incision;   advancing said sealing device through said incision to form a seal between said incision and said outer surface of said outer bore; and   inflating said inflatable membrane.   
     
     
       2. The method of  claim 1  wherein said sealing device further comprises a fastening means on said outer surface of said tube. 
     
     
       3. The method of  claim 2  wherein said fastening means comprises screw threads. 
     
     
       4. The method of  claim 2  wherein said fastening means comprises circumferential ribs. 
     
     
       5. The method of  claim 1  wherein said sealing device further comprises a plurality of protrusions extending from said outer surface of said tube. 
     
     
       6. The method of  claim 1  further comprising:
 insufflating the surgical site. 
 
     
     
       7. The method of  claim 1  further comprising:
 inserting a surgical instrument through said sealing device and into the surgical site. 
 
     
     
       8. The method of  claim 1  further comprising:
 deflating the inflatable member sufficiently to allow passage of a surgical tool through said inner bore of the sealing device while substantially maintaining a seal between said inflatable membrane and said surgical tool; and 
 performing a surgical procedure through the incision with said surgical tool. 
 
     
     
       9. A method of sealing a skin incision for performing a minimally invasive surgical procedure at a surgical site in a body, said method comprising:
 providing a sealing device comprising a tube having a proximal end and a distal end, an inner bore and an outer surface, said proximal end having a larger outer diameter than said distal end, an inflatable membrane disposed within said inner bore, said inflatable membrane being adapted to completely fill said inner bore when inflated and to leave an open lumen through said inner bore when deflated, said sealing device further comprising a plurality of protrusions extending inwardly from said inflatable membrane, said plurality of protrusions extending inwardly engaging one another to form a seal upon inflation, wherein said tube further comprises a plurality of protrusions extending from said outer surface of said tube;   making an incision in the body;   inserting said distal end of said sealing device through said incision;   advancing said sealing device through said incision to form a seal between said incision and said outer surface of said outer bore; and   inflating said inflatable membrane.   
     
     
       10. The method of  claim 9  wherein said plurality of protrusions on the outer surface of the tube comprises screw threads. 
     
     
       11. The method of  claim 10  wherein said plurality of protrusions on the outer surface of the tube comprises circumferential ribs. 
     
     
       12. The method of  claim 9  further comprising:
 insufflating the surgical site. 
 
     
     
       13. The method of  claim 9  further comprising:
 inserting a surgical instrument through said sealing device and into the surgical site. 
 
     
     
       14. The method of  claim 9  further comprising:
 deflating the inflatable member sufficiently to allow passage of a surgical tool through said inner bore of the sealing device while substantially maintaining a seal between said inflatable membrane and said surgical tool; and 
 performing a surgical procedure through the incision with said surgical tool. 
 
     
     
       15. A skin seal comprising:
 a housing having at least a portion configured and dimensioned to be mounted in an incision through a patient's skin and having a top surface lying in a first plane and defining a width, the housing defining a proximalmost opening having a first dimension and a distal opening, the proximalmost opening and distal opening being interconnected by an inner bore for communicating through the patient's skin to a working space under the patient's skin, the proximalmost opening defined in the first plane and spanning the width of the top surface of the housing;   a seal member positioned across the inner bore at the proximalmost opening of the housing so the seal member extends distally from the first plane into the inner bore, the seal member comprising a packing of gel material capable of conforming around a surgical instrument, the gel material extending distally from the first plane, a surface of the gel material being configured and dimensioned to be exposed and directly accessible when the skin seal is positioned in an incision through the patient's skin, wherein direct contact between the gel material and the surgical instrument allows surgery to be performed in the working space through the skin seal while maintaining the work space in an insufflated condition, at least a portion of the gel material having a dimension less than the first dimension of the proximalmost opening.   
     
     
       16. The skin seal of claim 15, wherein the packing comprises a gel having a slit therethrough. 
     
     
       17. The skin seal of claim 15, wherein at least portion of the seal member is positioned within the inner bore. 
     
     
       18. The skin seal of claim 15, wherein at least a portion of the seal member is positioned within the portion of the housing mounted through the patients skin. 
     
     
       19. The skin seal of claim 15, wherein the housing comprises a rigid cannula. 
     
     
       20. The skin seal of claim 19, wherein said rigid cannula includes an external thread. 
     
     
       21. The skin seal of claim 15, wherein the housing is flexible. 
     
     
       22. A skin seal as in claim 15, wherein the housing has an internal wall and the inner bore is bounded by the internal wall, the packing of gel material having an upper surface, a lower surface, and an outer surface having a length extending from the upper surface to the lower surface, the outer surface contiguous with the internal wall of the inner bore along its length. 
     
     
       23. A skin seal comprising a housing having at least a portion configured and dimensioned to be mounted in an incision through a patient's skin, and having a top surface lying in a first plane and defining a width, the housing defining a proximalmost opening having a first dimension and a distal opening, the proximalmost opening and distal opening being interconnected by an inner bore for communicating through the patient's skin to a working space under the patient's skin, the proximalmost opening defined in the first plane and spanning the width of the top surface of the housing;
 a seal member positioned within the inner bore at the proximalmost opening of the housing so the seal member extends distally from the first plane into the inner bore, the seal member comprising a packing of a gel capable of conforming around a surgical instrument, the gel material extending distally from the first plane, a surface of the gel being configured and dimensioned to be exposed and directly accessible when the skin seal is positioned in an incision through the patient's skin, wherein direct contact between the gel and the surgical instrument allows surgery to be performed in the working space through the skin seal while maintaining the work space in an insufflated condition, at least a portion of the packing of a gel having a dimension less than the first dimension of the proximalmost opening.   
     
     
       24. The skin seal of claim 23, further comprising a slit through the packing material. 
     
     
       25. The skin seal of claim 23, wherein the housing comprises a rigid cannula. 
     
     
       26. The skin seal of claim 25, wherein said rigid cannula includes an external thread. 
     
     
       27. The skin seal of claim 23, wherein the housing is flexible. 
     
     
       28. The skin seal of claim 23, wherein at least a portion of the seal member is positioned within the portion of the housing mounted in the incision through the patient's skin. 
     
     
       29. A skin seal comprising:
 a housing having at least a portion configured and dimensioned to be mounted in an incision through a patient's skin, and having a top surface lying in a first plane and defining a width, the housing defining a proximalmost opening having a first dimension and a distal opening, the proximalmost opening and distal opening being interconnected by an inner bore for communicating through the patient's skin to a working space under the patient's skin, the proximalmost opening defined in the first plane and spanning the width of the top surface of the housing:   a gel seal positioned across the inner bore at the proximalmost opening of the housing so the gel seal extends distally from the first plane into the inner bore, a surface of the gel seal being configured and dimensioned to be exposed and directly accessible when the skin seal is positioned in an incision through the patient's skin, the gel seal being capable of conforming around an object inserted through and in direct contact with the gel seal and maintaining a substantially fluid-tight barrier in both the presence and the absence of the object, the gel seal extending distally from the first plane, at least a portion of the gel seal having a dimension less than the first dimension of the proximalmost opening.   
     
     
       30. A skin seal as in claim 29, wherein the object is a surgical instrument selected from graspers, scissors, obturators, trocars, forceps, endoscopes, laparoscopes or clamps. 
     
     
       31. A skin seal as in claim 29, wherein the object is a laparoscopic surgical instrument. 
     
     
       32. A skin seal as in claim 29, wherein the housing is rigid. 
     
     
       33. A skin seal as in claim 32, wherein the rigid housing includes an external thread. 
     
     
       34. A skin seal as in claim 29, wherein the housing is flexible. 
     
     
       35. An apparatus comprising:
 a housing supporting a seal adjacent a surface of a patient's skin the housing having a top surface lying in a first plane and defining a width, the housing defining a proximalmost opening having a first dimension and a distal opening, the proximalmost opening and distal opening being interconnected by an inner bore, the proximalmost opening defined in the first plane and spanning the width of the top surface of the housing;   the seal comprising gel positioned across the inner bore at the proximalmost opening of the housing so the gel extends distally from the first plane into the inner bore, and which, when directly contacted by an object inserted therethrough, conforms around the object to maintain a substantially fluid-tight barrier in both the presence and the absence of the object, a surface of the gel being configured and dimensioned to be exposed and directly accessible when the skin seal is positioned in an incision through the patient's skin, the gel extending distally from the first plane, at least a portion of the gel having a dimension less than the first dimension of the proximalmost opening.   
     
     
       36. An apparatus as in claim 35, wherein the object is a surgical instrument selected from graspers, scissors, obturators, trocars, forceps, endoscopes, laparoscopes or clamps. 
     
     
       37. An apparatus as in claim 35, wherein the object is a laparoscopic surgical instrument. 
     
     
       38. An apparatus as in claim 35, wherein the housing is rigid. 
     
     
       39. An apparatus as in claim 38, wherein the rigid housing includes an external thread. 
     
     
       40. An apparatus as in claim 35, wherein the housing is flexible. 
     
     
       41. An apparatus comprising:
 a seal member consisting essentially of gel, the seal having an upper surface and a lower surface, the seal member being capable of conforming around an object inserted therethrough and in direct contact with the gel, the seal maintaining a substantially fluid-tight barrier in both the presence and the absence of the object; and   a housing dimensioned and configured to support the seal adjacent to the skin of the patient with the upper surface of the gel being exposed and directly accessible when the skin seal is positioned in an incision through the patient's skin, the having a top surface lying in a first plane and defining a width, the housing defining a proximalmost opening defined in the first plane, spanning the width of the top surface of the housing and having a first dimension and a distal opening, the proximalmost opening and distal opening being interconnected by an inner bore and the seal member being positioned across the inner bore at the proximalmost opening of the housing so the gel extends distally from the first plane into the inner bore with the gel extending distally from the first plane, at least a portion of the gel material having a dimension less than the first dimension of the proximalmost opening.   
     
     
       42. An apparatus as in claim 41, wherein the object is a surgical instrument selected from graspers, scissors, obturators, trocars, forceps, endoscopes, laparoscopes or clamps. 
     
     
       43. An apparatus as in claim 41, wherein the object is a laparoscopic surgical instrument. 
     
     
       44. An apparatus as in claim 41, wherein the housing is rigid. 
     
     
       45. An apparatus as in claim 44, wherein the rigid housing includes an external thread. 
     
     
       46. An apparatus as in claim 41, wherein the housing is flexible. 
     
     
       47. A skin seal as in claim 41, wherein the object is an obturator including a lip defining a proximally oriented recess, the lip configured to engage a distal end of the housing. 
     
     
       48. A skin seal comprising:
 a seal member comprising a gel that is mountable adjacent to a skin incision, wherein a surface of the gel is configured and dimensioned to be exposed and directly accessible when the skin seal is positioned in an incision through the patient's skin, the gel, when directly contacted by an object inserted therethrough, conforms around the object so as to seal an insufflated workspace under the skin; and a housing dimensioned and configured to mount the seal member adjacent to a skin incision, the housing having a top surface lying in a first plane and defining a width, the housing defining a proximalmost opening defined in the first plane, spanning the width of the top surface of the housing and having a first dimension and a distal opening, the proximalmost opening and distal opening being interconnected by an inner bore and the seal member being positioned across the inner bore at the proximalmost opening of the housing so the gel extends distally from the first plane into the inner bore with the gel extending distally from the first plane, at least a portion of the gel material having a dimension less than the first dimension of the proximalmost opening.   
     
     
       49. A skin seal as in claim 48, wherein the object is a surgical instrument selected from graspers, scissors, obturators, trocars, forceps, endoscopes, laparoscopes or clamps. 
     
     
       50. A skin seal as in claim 48, wherein the object is a laparoscopic surgical instrument. 
     
     
       51. A skin seal as in claim 48, wherein the housing is rigid. 
     
     
       52. A skin seal as in claim 51, wherein the rigid housing includes an external thread. 
     
     
       53. A skin seal as in claim 48, wherein the housing is flexible. 
     
     
       54. A skin seal as in claim 48, wherein the housing is soft and pliable. 
     
     
       55. An apparatus comprising:
 a housing supporting a seal adjacent a surface of a patient's skin the housing having a top surface lying in a first plane and defining a width, the housing defining a proximalmost opening having a first dimension and a distal opening, the proximalmost opening and distal opening being interconnected by an inner bore, the proximalmost opening defined in the first plane and spanning the width of the top surface of the housing;   the seal comprising gel positioned across the inner bore at the proximalmost opening of the housing so the gel extends distally from the first plane into the inner bore, and which, when directly contacted by an object inserted therethrough, conforms around the object to maintain a substantially fluid-tight barrier in both the presence and the absence of the object, a surface of the gel being configured and dimensioned to be exposed and directly accessible when the skin seal is positioned in an incision through the patient's skin, the gel extending distally from the first plane.   
     
     
       56. An apparatus as in claim 55, wherein the object is a surgical instrument selected from graspers, scissors, obturators, trocars, forceps, endoscopes, laparoscopes or clamps. 
     
     
       57. An apparatus as in claim 55, wherein the object is a laparoscopic surgical instrument. 
     
     
       58. An apparatus as in claim 55, wherein the housing is rigid. 
     
     
       59. An apparatus as in claim 58, wherein the rigid housing includes an external thread. 
     
     
       60. An apparatus as in claim 55, wherein the housing is flexible. 
     
     
       61. An apparatus as in claim 55, wherein the top surface of the housing is flat. 
     
     
       62. An apparatus as in claim 55, wherein the gel seal has a top surface that is positioned below the top surface of the housing. 
     
     
       63. An apparatus as in claim 55, wherein the gel is positioned entirely below the top surface of the housing.