SURGICAL ACCESS APPARATUS AND METHOD
First Claim
1. A surgical hand port for laparoscopic surgical procedures wherein an incision is made in a body wall of a patient and an abdominal cavity is pressurized with an insufflation gas, the hand port is adapted to provide access to the abdominal cavity for surgical procedures while maintaining insufflation pressure in the abdominal cavity, comprising:
- a gel seal valve, comprising;
a support ring, wherein the support ring is configured to be aligned with an axis of an access channel defined at least in part by the incision extending through the body wall of a patient; and
a gel pad coupled with the support ring, the gel pad being disposed substantially within the support ring and supported at least partially thereby, the gel pad comprising a molded mixture of an elastomer and an oil, wherein the elastomer comprises at least one of polyurethane, polyvinylchloride, polyisoprene, a thermoset elastomer, a thermoplastic elastomer, a tri-block copolymer, styrene-ethylene/butylene-styrene block copolymer, styrene-isoprene-styrene, styrene-butadiene-styrene, styrene-ethylene/propylene-styrene, and wherein the oil comprises at least one of mineral oil, vegetable oil, petroleum oil, and silicone oil, the gel pad having an ultimate elongation greater than about 1000 percent and a durometer less than about 5 Shore A, the gel pad being sized and shaped for disposition relative to the access channel defined at least in part by the incision extending through the body wall of the patient, the gel pad is configured to form a seal with an instrument extending through the gel pad and form a seal in the absence of any instrument extending through the gel pad, the gel pad is adapted to accommodate a range of instrument sizes from about the size of a guidewire to about the size of a surgeon'"'"'s arm.
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Accused Products
Abstract
A surgical access device includes a single valve that forms a seal with the body wall and provides an access channel into a body cavity. The valve has properties for creating a zero seal in the absence of an instrument as well as an instrument seal with instruments having a full range of instrument diameter. The valve can include a gel and preferably an ultragel comprised of an elastomer and an 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, thereby providing hand access into the cavity.
A method for making the surgical access device includes the combining of a gelling agent with an oil, preferably in a molding process. A method for using the device includes steps for creating an opening with the instrument. In a particular process, 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. The valve and method are particularly adapted for laparoscopic surgery wherein the abdominal cavity is insufflated with a gas thereby requiring the zero seal, the instrument seal, and the organ seal in various procedures.
205 Citations
38 Claims
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1. A surgical hand port for laparoscopic surgical procedures wherein an incision is made in a body wall of a patient and an abdominal cavity is pressurized with an insufflation gas, the hand port is adapted to provide access to the abdominal cavity for surgical procedures while maintaining insufflation pressure in the abdominal cavity, comprising:
a gel seal valve, comprising; a support ring, wherein the support ring is configured to be aligned with an axis of an access channel defined at least in part by the incision extending through the body wall of a patient; and a gel pad coupled with the support ring, the gel pad being disposed substantially within the support ring and supported at least partially thereby, the gel pad comprising a molded mixture of an elastomer and an oil, wherein the elastomer comprises at least one of polyurethane, polyvinylchloride, polyisoprene, a thermoset elastomer, a thermoplastic elastomer, a tri-block copolymer, styrene-ethylene/butylene-styrene block copolymer, styrene-isoprene-styrene, styrene-butadiene-styrene, styrene-ethylene/propylene-styrene, and wherein the oil comprises at least one of mineral oil, vegetable oil, petroleum oil, and silicone oil, the gel pad having an ultimate elongation greater than about 1000 percent and a durometer less than about 5 Shore A, the gel pad being sized and shaped for disposition relative to the access channel defined at least in part by the incision extending through the body wall of the patient, the gel pad is configured to form a seal with an instrument extending through the gel pad and form a seal in the absence of any instrument extending through the gel pad, the gel pad is adapted to accommodate a range of instrument sizes from about the size of a guidewire to about the size of a surgeon'"'"'s arm. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12)
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13. A surgical access device adapted to provide access to a cavity in a patient while maintaining a seal between the cavity and an area outside the patient, comprising:
a gel seal, comprising a ring and a gel pad; wherein the ring is configured for alignment with an axis of an access channel defined at least in part by an incision extending through a body wall of a patient, and wherein the gel pad is coupled with the ring, disposed substantially within the ring and supported at least partially thereby, the gel pad comprises a mixture of an elastomer and an oil, the gel pad comprises a self-sealing valve and defines at least a portion of an access channel, the self-sealing valve is configured to conform around an object extending through the self-sealing valve and seal the working channel in the absence of an object extending through the self-sealing valve, the gel pad is adapted to accommodate a range of instrument sizes. - View Dependent Claims (14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27)
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28. A surgical valve assembly, comprising:
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a gel seal comprising an ultra gel material, wherein the gel seal is configured to seal an incision in a body wall of a patient; and an access channel defined at least in part by the ultra gel material, wherein the ultra gel material is configured to seal the access channel in the absence of any object extending through the ultra gel material and form an instrument seal with a range of instruments sizes. - View Dependent Claims (29, 30, 31, 32, 33, 34, 35, 36, 37, 38)
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Specification