Surgical access apparatus and method
CAFC
First Claim
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1. A surgical access device for laparoscopic surgical procedures in which an abdominal cavity of a patient is pressurized with an insufflation gas, wherein the access device is adapted to form a sealing relationship with an instrument extending through the access device and into an incision in a body wall of the patient, and is removably connectable to an incision seal support structure comprising a working channel, wherein the incision seal support structure is dimensioned and configured for forming a seal with the body wall of the patient, the incision seal support structure comprising a retaining member dimensioned and configured for insertion through the incision, the access device comprising:
- a valve structure comprising an unencapsulated gel material and adapted to be disposed relative to an incision seal support structure, generally closing a proximal end of a working channel thereof;
at least one self-sealing valve included in the unencapsulated gel material of the valve structure, whereinthe at least one self-sealing valve is generally aligned with a longitudinal axis of the working channel, andthe at least one self-sealing valve has a first state in the absence of an instrument extending through the gel material of the valve structure, and a second state in the presence of an instrument extending through the gel material of the valve structure; and
a gel support structure at least partially surrounding and supporting the unencapsulated gel material, wherein the gel support structure is dimensioned and configured for removable coupling to the incision seal support structure, whereinthe at least one self-sealing valve in the first state forms a seal in the absence of the instrument extending through the gel material of the valve structure; and
the at least one self-sealing valve in the second state forms a seal with the instrument in the presence of the instrument extending through the gel material of the valve structure, wherein the seal with the instrument is formed by direct contact between the gel material and the instrument when the instrument extends through the valve structure.
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Accused Products
Abstract
A surgical access device includes a single valve forming a seal with the body wall and providing an access channel into a body cavity. The valve has properties for creating a zero-seal in the absence of an instrument and an instrument seal with instruments. The valve can include a gel comprised of an elastomer and oil providing elongation greater than 1000 percent and durometer less than 5 Shore A. The single valve can be used as a hand port where the instrument comprises the arm of a surgeon. A method for making the surgical access device includes combining a gelling agent with oil, preferably in a molding process. A method for using the device includes creating an opening with the instrument. An organ can be removed from the body cavity through the single valve to create an organ seal while the organ is addressed externally of the body cavity.
1283 Citations
23 Claims
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1. A surgical access device for laparoscopic surgical procedures in which an abdominal cavity of a patient is pressurized with an insufflation gas, wherein the access device is adapted to form a sealing relationship with an instrument extending through the access device and into an incision in a body wall of the patient, and is removably connectable to an incision seal support structure comprising a working channel, wherein the incision seal support structure is dimensioned and configured for forming a seal with the body wall of the patient, the incision seal support structure comprising a retaining member dimensioned and configured for insertion through the incision, the access device comprising:
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a valve structure comprising an unencapsulated gel material and adapted to be disposed relative to an incision seal support structure, generally closing a proximal end of a working channel thereof; at least one self-sealing valve included in the unencapsulated gel material of the valve structure, wherein the at least one self-sealing valve is generally aligned with a longitudinal axis of the working channel, and the at least one self-sealing valve has a first state in the absence of an instrument extending through the gel material of the valve structure, and a second state in the presence of an instrument extending through the gel material of the valve structure; and a gel support structure at least partially surrounding and supporting the unencapsulated gel material, wherein the gel support structure is dimensioned and configured for removable coupling to the incision seal support structure, wherein the at least one self-sealing valve in the first state forms a seal in the absence of the instrument extending through the gel material of the valve structure; and the at least one self-sealing valve in the second state forms a seal with the instrument in the presence of the instrument extending through the gel material of the valve structure, wherein the seal with the instrument is formed by direct contact between the gel material and the instrument when the instrument extends through the valve structure. - View Dependent Claims (2, 3, 4, 5, 14, 15, 16, 17, 18, 19, 20)
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6. A medical access assembly for laparoscopic surgical procedures in which an abdominal cavity of a patient is pressurized with an insufflation gas, wherein the access assembly is adapted to form a seal with an instrument extending through the assembly and into an incision in a body wall of the patient, and adapted to form a seal with the body wall of the patient, the access assembly comprising:
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an incision seal support structure comprising a tubular retraction sheath, a retaining member disposed at a distal portion of the retraction sheath, and a base, wherein the base is dimensioned and configured for coupling to the tubular retraction sheath, the incision seal support structure is dimensioned and configured for retracting an incision and for forming a seal with a body wall of a patient, the retaining member is dimensioned and configured for removable insertion through the incision, and at least one wall of the tubular retraction sheath at least partially defines a working channel sized and configured to receive an instrument when the tubular retraction sheath is positioned within the patient during use; a gel cap comprising an ultragel coupled to a cap ring, wherein the cap ring is dimensioned and configured for coupling to the base of the incision seal support structure; an access channel extending through the ultragel and communicating with the working channel, wherein the access channel is adapted to form a seal with an instrument disposed at least in part in the access channel, wherein the gel cap has a first state in the absence of the instrument extending through the access channel, and a second state in the presence of the instrument extending through the access channel, the gel cap in the first state forms a seal in the absence of the instrument extending through the access channel, the gel cap in the second state forms a seal with the instrument in the presence of the instrument extending through the access channel, and the seal with the instrument formed between the ultragel and the instrument when the instrument extends through the access channel. - View Dependent Claims (7, 8, 9, 10, 11, 12, 13)
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21. A surgical hand port for laparoscopic surgical procedures in which an abdominal cavity of a patient is pressurized with an insufflation gas, wherein the hand port is adapted for the insertion of a hand of a surgeon through the hand port in a sealing relationship with an arm of the surgeon during laparoscopic surgery through an incision in an abdominal wall of a patient and is adapted for connection to an incision seal support structure comprising a working channel and a retaining member, wherein the incision seal support structure is dimensioned and configured for forming a seal with the abdominal wall of the patient, and the retaining member is dimensioned and configured for insertion through the incision, the hand port comprising:
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a valve structure adapted to be disposed relative to an incision seal support structure to generally close a proximal end of a working channel of the incision seal support structure, the valve structure comprising a gel material; a valve included in the gel material of the valve structure defining a sealable opening adapted to provide access through the incision; and a gel support structure at least partially surrounding and supporting the gel material, wherein the gel support structure is configured for connection to the incision seal support structure, wherein the gel material is configured for sealing the opening in the absence of any object extending through the opening, and for sealing the opening around an arm of a surgeon extending through the opening, the seal with the surgeon'"'"'s arm being formed between the gel material and the surgeon'"'"'s arm when the surgeon'"'"'s arm is extending through the opening; and the gel material comprises an elastomeric oil mixture. - View Dependent Claims (22, 23)
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Specification
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Litigation Data
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Current AssigneeApplied Medical Resources Corporation (Applied Medical Corporation)
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Original AssigneeApplied Medical Resources Corporation (Applied Medical Corporation)
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InventorsBowes, Robert R., Dulak, Gary R., Pingleton, Edward D., Brustad, John R., Hilal, Nabil, Adlparvar, Payam, Ewers, Richard C.
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Primary Examiner(s)Manahan; Todd E
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Assistant Examiner(s)NGUYEN, TUAN VAN
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Application NumberUS10/381,220Publication NumberTime in Patent Office2,664 DaysField of Search606/1, 606/191, 606/108, 606/213, 604/164.04, 604/288.02, 600/206, 600/208US Class Current600/208CPC Class CodesA61B 17/0218 for minimally invasive surg...A61B 17/0293 with ring member to support...A61B 17/3423 Access ports, e.g. toroid s...A61B 17/3474 Insufflating needles, e.g. ...A61B 17/3498 Valves therefor, e.g. flapp...A61B 2017/00265 Hand assisted surgery, i.e....A61B 2017/00526 Methods of manufacturingA61B 2017/3419 Sealing means between cannu...A61B 2017/3445 used as instrument channel ...A61B 2017/3492 against the outside of the ...A61M 13/003 Blowing gases other than fo...
