Continent ostomy port
First Claim
1. A self-retaining continent ostomy port device comprising:
- (a) a face plate defining a selectively sealable aperture which is alignable with the opening of a stoma formed in the body of a user of the port device when the face plate of the port device is disposed substantially parallel to the body wall of the user, over the site of the stoma, to thereby provide access to the inside of the stoma;
(b) a closure portion connectable to the face plate adjacent to the aperture and adapted to permit selective and repeatable covering and uncovering of the aperture in the face plate;
(c) a catheter portion having a first end and a second end, the first end of the catheter portion being connected to and extending from a side of the face plate which is disposed proximally when the port device is in normal use position, the catheter portion extending proximally and the second end of the catheter portion being disposed interior of the user'"'"'s body, within the ostomy site when the port device is in normal use, the catheter portion having a continuous exterior side wall, and a continuous interior side wall defining a major lumen, the major lumen extending continuously from the aperture in the face plate to the second end of the catheter portion, the catheter portion being sized and shaped appropriately for non-surgical installation through a stoma to a sufficient distance that the presence of the catheter portion within the stoma provides a physical barrier which reduces prolapse without the use of extraneous, externally applied materials and devices or additional surgery; and
(d) a retaining structure on the exterior side wall of the catheter, the retaining structure being a bolster formed around at least a portion of the exterior side wall of the catheter, the bolster being formed of a foam material which expands upon installation of the port device into the body of a user and formed to provide a secure but comfortable seal internally of the body of the user, proximal to the stoma site at which the port device is installed and being snugly fittable within the stoma, the bolster being formed in a cone shape and disposed coaxially on the exterior side wall of the catheter, the small end of the cone shape being disposed distally and the large end of the cone shape being disposed proximally when the port device is in a normal use position, the retaining structure being adapted to thereby permit the port device to be indwelling for at least a period of days, without the need for extraneous fixation devices such as tape, belts, and adhesives or revisionary surgery.
1 Assignment
0 Petitions
Accused Products
Abstract
A continent ostomy port device has a face plate defining a selectively sealable aperture which is alignable with the opening of a stoma formed in the body of a user of the device. A closure portion is adapted to permit selective and repeatable covering and uncovering of the aperture in the face plate. A catheter portion extends from one side of the face plate and extends proximally, and one end of the catheter portion is disposed interior of the user'"'"'s body, within the ostomy site, when the port device is in normal use position. The catheter portion has continuous exterior and interior side walls, the latter defining a major lumen. The catheter portion is sized and shaped appropriately for non-surgical installation through a stoma to a sufficient distance that the presence of the catheter portion within the stoma provides a physical barrier which reduces the incidence of stoma prolapse, without the use of extraneous, externally applied materials or additional surgery. Retaining structure is connected to the catheter of the continent ostomy port and is non-surgically, snugly fittable into the stoma, to cause the port device to be self-retaining in a normal use position within a stoma of the user, without the need for special surgery or extraneous, external fixation materials such as tape, belts, and adhesives. The retaining structure is also usefully connected to other medical catheters.
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Citations
23 Claims
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1. A self-retaining continent ostomy port device comprising:
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(a) a face plate defining a selectively sealable aperture which is alignable with the opening of a stoma formed in the body of a user of the port device when the face plate of the port device is disposed substantially parallel to the body wall of the user, over the site of the stoma, to thereby provide access to the inside of the stoma;
(b) a closure portion connectable to the face plate adjacent to the aperture and adapted to permit selective and repeatable covering and uncovering of the aperture in the face plate;
(c) a catheter portion having a first end and a second end, the first end of the catheter portion being connected to and extending from a side of the face plate which is disposed proximally when the port device is in normal use position, the catheter portion extending proximally and the second end of the catheter portion being disposed interior of the user'"'"'s body, within the ostomy site when the port device is in normal use, the catheter portion having a continuous exterior side wall, and a continuous interior side wall defining a major lumen, the major lumen extending continuously from the aperture in the face plate to the second end of the catheter portion, the catheter portion being sized and shaped appropriately for non-surgical installation through a stoma to a sufficient distance that the presence of the catheter portion within the stoma provides a physical barrier which reduces prolapse without the use of extraneous, externally applied materials and devices or additional surgery; and
(d) a retaining structure on the exterior side wall of the catheter, the retaining structure being a bolster formed around at least a portion of the exterior side wall of the catheter, the bolster being formed of a foam material which expands upon installation of the port device into the body of a user and formed to provide a secure but comfortable seal internally of the body of the user, proximal to the stoma site at which the port device is installed and being snugly fittable within the stoma, the bolster being formed in a cone shape and disposed coaxially on the exterior side wall of the catheter, the small end of the cone shape being disposed distally and the large end of the cone shape being disposed proximally when the port device is in a normal use position, the retaining structure being adapted to thereby permit the port device to be indwelling for at least a period of days, without the need for extraneous fixation devices such as tape, belts, and adhesives or revisionary surgery.
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2. A self-retaining continent ostomy port device comprising:
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(a) a face plate defining a selectively sealable aperture which is alignable with the opening of a stoma formed in the body of a user of the port device when the face plate of the port device is disposed substantially parallel to the body wall of the user, over the site of the stoma, to thereby provide access to the inside of the stoma;
(b) a closure portion connectable to the face plate adjacent to the aperture and adapted to permit selective and repeatable covering and uncovering of the aperture in the face plate;
(c) a catheter portion having a first end and a second end, the first end of the catheter portion being connected to and extending from a side of the face plate which is disposed proximally when the port device is in normal use position, the catheter portion extending proximally and the second end of the catheter portion being disposed interior of the user'"'"'s body, within the ostomy site when the port device is in normal use, the catheter portion having a continuous exterior side wall, and a continuous interior side wall defining a major lumen, the major lumen extending continuously from the aperture in the face plate to the second end of the catheter portion, the catheter portion being sized and shaped appropriately for non-surgical installation through a stoma to a sufficient distance that the presence of the catheter portion within the stoma provides a physical barrier which reduces prolapse without the use of extraneous, externally applied materials and devices or additional surgery; and
(d) a retaining structure on the exterior side wall of the catheter, the retaining structure being a bolster formed around at least a portion of the exterior side wall of the catheter, the bolster being formed of a foam material which expands upon installation of the port device into the body of a user and formed to provide a secure but comfortable seal internally of the body of the user, proximal to the stoma site at which the port device is installed and being snugly fittable within the stoma, the bolster being formed in a bell-shape disposed coaxially around the catheter with the large end of the bell being disposed on the end of the catheter which is proximal in use and the small end of the bell being spaced proximally from the proximal side of the face plate, the retaining structure being adapted to thereby permit the port device to be indwelling for at least a period of days, without the need for extraneous fixation devices such as tape, belts, and adhesives or revisionary surgery.
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3. A self-retaining continent ostomy port device comprising:
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(a) a face plate defining a selectively sealable aperture which is alignable with the opening of a stoma formed in the body of a user of the port device when the face plate of the port device is disposed substantially parallel to the body wall of the user, over the site of the stoma, to thereby provide access to the inside of the stoma;
(b) a closure portion connectable to the face plate adjacent to the aperture and adapted to permit selective and repeatable covering and uncovering of the aperture in the face plate;
(c) a catheter portion having a first end and a second end, the first end of the catheter portion being connected to and extending from a side of the face plate which is disposed proximally when the port device is in normal use position, the catheter portion extending proximally and the second end of the catheter portion being disposed interior of the user'"'"'s body, within the ostomy site when the port device is in normal use, the catheter portion having a continuous exterior side wall, and a continuous interior side wall defining a major lumen, the major lumen extending continuously from the aperture in the face plate to the second end of the catheter portion, the catheter portion being sized and shaped appropriately for non-surgical installation through a stoma to a sufficient distance that the presence of the catheter portion within the stoma provides a physical barrier which reduces prolapse without the use of extraneous, externally applied materials and devices or additional surgery; and
(d) a retaining structure on the exterior side wall of the catheter, the retaining structure being a bolster formed around at least a portion of the exterior side wall of the catheter, the bolster being formed of a foam material which expands upon installation of the port device into the body of a user and formed to provide a secure but comfortable seal internally of the body of the user, proximal to the stoma site at which the port device is installed and being snugly fittable within the stoma, the bolster having a plurality of portions, each of the portions being formed of a foam substance having different properties than the foam substance of the other portions, the retaining structure being adapted to thereby permit the port device to be indwelling for at least a period of days, without the need for extraneous fixation devices such as tape, belts, and adhesives or revisionary surgery. - View Dependent Claims (4, 5, 6)
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7. A self-retaining continent ostomy port device comprising:
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(a) a face plate defining a selectively sealable aperture which is alignable with the opening of a stoma formed in the body of a user of the port device when the face plate of the port device is disposed substantially parallel to the body wall of the user, over the site of the stoma, to thereby provide access to the inside of the stoma;
(b) a closure portion connectable to the face plate adjacent to the aperture and adapted to permit selective and repeatable covering and uncovering of the aperture in the face plate;
(c) a catheter portion having a first end and a second end, the first end of the catheter portion being connected to and extending from a side of the face plate which is disposed proximally when the port device is in normal use position, the catheter portion extending proximally and the second end of the catheter portion being disposed interior of the user'"'"'s body, within the ostomy site when the port device is in normal use, the catheter portion having a continuous exterior side wall, and a continuous interior side wall defining a major lumen, the major lumen extending continuously from the aperture in the face plate to the second end of the catheter portion, the catheter portion being sized and shaped appropriately for non-surgical installation through a stoma to a sufficient distance that the presence of the catheter portion within the stoma provides a physical barrier which reduces prolapse without the use of extraneous, externally applied materials and devices or additional surgery; and
(d) a retaining structure on the exterior side wall of the catheter, the retaining structure being a bolster formed around at least a portion of the exterior side wall of the catheter, the bolster being formed to provide a secure but comfortable seal internally of the body of the user, proximal to the stoma site at which the port device is installed, the bolster comprises elongated flexible members, the elongated flexible members being disposed longitudinally and circumferentially spaced apart around the exterior side wall of the catheter, and being connected at opposed ends of each of the flexible members to the exterior side wall of the catheter, the elongated flexible members being capable of being twisted from an original uncompressed state for installation into the stoma, followed by immediate and automatic return to the original uncompressed state when circumferential force, which is applied for installation of the port device into the stoma, is removed, the bolster being snugly fittable within the stoma, to thereby permit the port device to be indwelling for at least a period of days, without the need for extraneous fixation devices such as tape, belts, and adhesives or revisionary surgery. - View Dependent Claims (8, 9)
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10. A self-retaining continent ostomy port device comprising:
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(a) a face plate defining a selectively sealable aperture which is alignable with the opening of a stoma formed in the body of a user of the port device when the face plate of the port device is disposed substantially parallel to the body wall of the user, over the site of the stoma, to thereby provide access to the inside of the stoma;
(b) a closure portion connectable to the face plate adjacent to the aperture and adapted to permit selective and repeatable covering and uncovering of the aperture in the face plate;
(c) a catheter portion having a first end and a second end, the first end of the catheter portion being connected to and extending from a side of the face plate which is disposed proximally when the port device is in normal use position, the catheter portion extending proximally and the second end of the catheter portion being disposed interior of the user'"'"'s body, within the ostomy site when the port device is in normal use, the catheter portion having a continuous exterior side wall, and a continuous interior side wall defining a major lumen, the major lumen extending continuously from the aperture in the face plate to the second end of the catheter portion, the catheter portion being sized and shaped appropriately for non-surgical installation through a stoma to a sufficient distance that the presence of the catheter portion within the stoma provides a physical barrier which reduces prolapse without the use of extraneous, externally applied materials and devices or additional surgery; and
(d) a retaining structure on the exterior side wall of the catheter, the retaining structure being a bolster formed around at least a portion of the exterior side wall of the catheter, the bolster being formed to provide a secure but comfortable seal internally of the body of the user, proximal to the stoma site at which the port device is installed, the bolster being formed of a plurality of elongated flexible members being fixed to the proximal end of the catheter in circumferentially spaced relation to one another, and a ring member connected to the second ends of the flexible members and disposed coaxially and slidably on the catheter portion, the second ends of the flexible members being circumferentially spaced apart around the ring member and the elongated flexible members each being foldable upon themselves so as to be obturatable to permit non-surgical installation of the port device into a stoma of the user, and the elongated flexible members being capable of automatically returning to the normal folded state thereof after being obturated, the flexible members in the folded state having a greater diameter than in the obturated unfolded state so that the folded elongated flexible members press outwardly from the ring member against an inside wall of tissue of which the stoma is formed, the bolster being snugly fittable within the stoma, to thereby permit the port device to be indwelling for at least a period of days, without the need for extraneous fixation devices such as tape, belts, and adhesives or revisionary surgery. - View Dependent Claims (11)
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12. A self-retaining continent ostomy port device comprising:
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(a) a face plate defining a selectively sealable aperture which is alignable with the opening of a stoma formed in the body of a user of the port device when the face plate of the port device is disposed substantially parallel to the body wall of the user, over the site of the stoma, to thereby provide access to the inside of the stoma;
(b) a closure portion connectable to the face plate adjacent to the aperture and adapted to perm it selective and repeatable covering and uncovering of the aperture in the face plate;
(c) a catheter portion having a first end and a second end, the first end of the catheter portion being connected to and extending from a side of the face plate which is disposed proximally when the port device is in normal use position, the catheter portion extending proximally and the second end of the catheter portion being disposed interior of the user'"'"'s body, within the ostomy site when the port device is in normal use, the catheter portion having a continuous exterior side wall, and a continuous interior side wall defining a major lumen, the major lumen extending continuously from the aperture in the face plate to the second end of the catheter portion, the catheter portion being sized and shaped appropriately for non-surgical installation through a stoma to a sufficient distance that the presence of the catheter portion within the stoma provides a physical barrier which reduces prolapse without the use of extraneous, externally applied materials and devices or additional surgery; and
(d) a retaining structure on the exterior side wall of the catheter, the retaining structure being a bolster formed around at least a portion of the exterior side wall of the catheter, the bolster being formed to provide a secure but comfortable seal internally of the body of the user, proximal to the stoma site at which the port device is installed, the bolster comprises elongated flexible members formed into loops and disposed circumferentially spaced apart around the exterior side wall of the catheter, each loop penetrating the side wall of the catheter, the loops being capable of being deformed from an original uncompressed state into an elongated state for easy installation or removal of the catheter portion of the port evice into or from a stoma, and the loops further being capable of returning to an original uncompressed state when circumferential force, which is applied for installation of the port device into the stoma, is removed, the bolster being snugly fittable within the stoma, to thereby permit the port device to be indwelling for at least a period of days, without the need for extraneous fixation devices such as tape, belts, and adhesives or revisionary surgery.
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13. A self-retaining continent ostomy port device comprising:
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(a) a face plate defining a selectively sealable aperture which is alignable with the opening of a stoma formed in the body of a user of the port device when the face plate of the port device is disposed substantially parallel to the body wall of the user, over the site of the stoma, to thereby provide access to the inside of the stoma;
(b) a closure portion connectable to the face plate adjacent to the aperture and adapted to permit selective and repeatable covering and uncovering of the aperture in the face plate;
(c) a catheter portion having a first end and a second end, the first end of the catheter portion being connected to and extending from a side of the face plate which is disposed proximally when the port device is in normal use position, the catheter portion extending proximally and the second end of the catheter portion being disposed interior of the user'"'"'s body, within the ostomy site when the port device is in normal use, the catheter portion having a continuous exterior side wall, and a continuous interior side wall defining a major lumen, the major lumen extending continuously from the aperture in the face plate to the second end of the catheter portion, the catheter portion being sized and shaped appropriately for non-surgical installation through a stoma to a sufficient distance that the presence of the catheter portion within the stoma provides a physical barrier which reduces prolapse without the use of extraneous, externally applied materials and devices or additional surgery; and
(d) a retaining structure on the exterior side wall of the catheter, the retaining structure being a bolster formed around at least a portion of the exterior side wall of the catheter, the bolster being formed to provide a secure but comfortable seal internally of the body of the user, proximal to the stoma site at which the port device is installed, the bolster having an overall shape that is asymetric relative to the axis of the catheter, the bolster being snugly fittable within the stoma, to thereby permit the port device to be indwelling for at least a period of days, without the need for extraneous fixation devices such as tape, belts, and adhesives or revisionary surgery.
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14. A self-retaining continent ostomy port device comprising:
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(a) a face plate defining a selectively sealable aperture which is alignable with the opening of a stoma formed in the body of a user of the port device when the face plate of the port device is disposed substantially parallel to the body wall of the user, over the site of the stoma, to thereby provide access to the inside of the stoma;
(b) a closure portion connectable to the face plate adjacent to the aperture and adapted to permit selective and repeatable covering and uncovering of the aperture in the face plate;
(c) a catheter portion having a first end and a second end, the first end of the catheter portion being connected to and extending from a side of the face plate which is disposed proximally when the port device is in normal use position, the catheter portion extending proximally and the second end of the catheter portion being disposed interior of the user'"'"'s body, within the stomy site when the port device is in normal use, the catheter portion having a continuous exterior side wall, and a continuous interior side wall defining a major lumen, the major lumen extending continuously from the aperture in the face plate to the second end of the catheter portion, the catheter portion being sized and shaped appropriately for non-surgical installation through a stoma to a sufficient distance that the presence of the catheter portion within the stoma provides a physical barrier which reduces prolapse without the use of extraneous, externally applied materials and devices or additional surgery; and
(d) a retaining structure on the exterior side wall of the catheter, the retaining structure being a bolster formed around at least a portion of the exterior side wall of the catheter, the bolster being formed to provide a secure but comfortable seal internally of the body of the user, proximal to the stoma site at which the port device is installed, the bolster having a plurality of portions, each of the bolster portions being formed of a separate biocompatible membrane and being in fluid communication with each of the other bolster portions, the bolster being snugly fittable within the stoma, to thereby permit the port device to be indwelling for at least a period of days, without the need for extraneous fixation devices such as tape, belts, and adhesives or revisionary surgery. - View Dependent Claims (15, 16)
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17. A self-retaining continent ostomy port device comprising:
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(a) a face plate defining a selectively sealable aperture which is alignable with the opening of a stoma formed in the body of a user of the port device when the face plate of the port device is disposed substantially parallel to the body wall of the user, over the site of the stoma, to thereby provide access to the inside of the stoma;
(b) a closure portion connectable to the face plate adjacent to the aperture and adapted to permit selective and repeatable covering and uncovering of the aperture in the face plate;
(c) a catheter portion having a first end and a second end, the first end of the catheter portion being connected to and extending from a side of the face plate which is disposed proximally when the port device is in normal use position, the catheter portion extending proximally and the second end of the catheter portion being disposed interior of the user'"'"'s body, within the ostomy site when the port device is in normal use, the catheter portion having a continuous exterior side wall, and a continuous interior side wall defining a major lumen, the major lumen extending continuously from the aperture in the face plate to the second end of the catheter portion, the catheter portion being sized and shaped appropriately for non-surgical installation through a stoma to a sufficient distance that the presence of the catheter portion within the stoma provides a physical barrier which reduces prolapse without the use of extraneous, externally applied materials and devices or additional surgery; and
(d) a retaining structure on the exterior side wall of the catheter, the retaining structure being a bolster formed around at least a portion of the exterior side wall of the catheter, the bolster being formed to provide a secure but comfortable seal internally of the body of the user, proximal to the stoma site at which the port device is installed, the bolster comprises a bulbous portion disposed over the second end of the catheter portion, and at least one protrusion formed on an outside wall of the bulbous portion, to the thereby grip the interior of the stoma and enhance the securement of the device within the stoma, the bolster being snugly fittable within the stoma, to thereby permit the port device to be indwelling for at least a period of days, without the need for extraneous fixation devices such as tape, belts, and adhesives or revisionary surgery.
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18. A self-retaining continent ostomy port device comprising:
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(a) a face plate defining a selectively sealable aperture which is alignable with the opening of a stoma formed in the body of a user of the port device when the face plate of the port device is disposed substantially parallel to the body wall of the user, over the site of the stoma, to thereby provide access to the inside of the stoma;
(b) a closure portion connectable to the face plate adjacent to the aperture and adapted to permit selective and repeatable covering and uncovering of the aperture in the face plate;
(c) a catheter portion having a first end and a second end, the first end of the catheter portion being connected to and extending from a side of the face plate which is disposed proximally when the port device is in normal use position, the catheter portion extending proximally and the second end of the catheter portion being disposed interior of the user'"'"'s body, within the ostomy site when the port device is in normal use, the catheter portion having a continuous exterior side wall, and a continuous interior side wall defining a major lumen, the major lumen extending continuously from the aperture in the face plate to the second end of the catheter portion, the catheter portion being sized and shaped appropriately for non-surgical installation through a stoma to a sufficient distance that the presence of the catheter portion within the stoma provides a physical barrier which reduces prolapse without the use of extraneous, externally applied materials and devices or additional surgery; and
(d) a retaining structure on the exterior side wall of the catheter, the retaining structure being a bolster formed around at least a portion of the exterior side wall of the catheter, the bolster being formed to provide a secure but comfortable seal internally of the body of the user, proximal to the stoma site at which the port device is installed, the bolster comprises;
(i) a neck portion disposed around the catheter portion of the port device, the neck portion having a first end and a second end, the first end of the neck portion extending distally and terminating substantially adjacent to the opening of a stoma in which the port device is disposed in normal use position;
(ii) a bulbous portion disposed over the second end of the catheter portion, the second end of the neck portion being connected to and in fluid communication with the bulbous portion; and
(iii) at least one protrusion formed on an outside wall of at least one of the neck portion and the bulbous portion, to thereby grip the interior of the stoma and enhance the securement of the device within the stoma;
the bolster being snugly fittable within the stoma, to thereby permit the port device to be indwelling for at least a period of days, without the need for extraneous fixation devices such as tape, belts, and adhesives or revisionary surgery.- View Dependent Claims (19, 20, 21)
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22. A self-retaining continent ostomy port device comprising:
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(a) a face plate defining a selectively sealable aperture which is alignable with the opening of a stoma formed in the body of a user of the port device when the face plate of the port device is disposed substantially parallel to the body wall of the user, over the site of the stoma, to thereby provide access to the inside of the stoma, a portion of the face plate is adapted in the area of the defined aperture for the attachment of a hose nozzle, to thereby permit the user to selectively attach a hose for purposes of irrigation, drainage and treatment;
(b) a closure portion connectable to the face plate adjacent to the aperture and adapted to permit selective and repeatable covering and uncovering of the aperture in the face plate;
(c) a catheter portion having a first end and a second end, the first end of the catheter portion being connected to and extending from a side of the face plate which is disposed proximally when the port device is in normal use position, the catheter portion extending proximally and the second end of the catheter portion being disposed interior of the user'"'"'s body, within the ostomy site when the port device is in normal use, the catheter portion having a continuous exterior side wall, and a continuous interior side wall defining a major lumen, the major lumen extending continuously from the aperture in the face plate to the second end of the catheter portion, the catheter portion being sized and shaped appropriately for non-surgical installation through a stoma to a sufficient distance that the presence of the catheter portion within the stoma provides a physical barrier which reduces prolapse without the use of extraneous, externally applied materials and devices or additional surgery; and
(d) a retaining structure on the exterior side wall of the catheter, the retaining structure being snugly fittable within the stoma, to thereby permit the port device to be indwelling for at least a period of days, without the need for extraneous fixation devices such as tape, belts, and adhesives or revisionary surgery.
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23. A self-retaining continent ostomy port device comprising:
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(a) a face plate defining a selectively sealable aperture which is alignable with the opening of a stoma formed in the body of a user of the port device when the face plate of the port device is disposed substantially parallel to the body wall of the user, over the site of the stoma, to thereby provide access to the inside of the stoma;
(b) a closure portion connectable to the face plate adjacent to the aperture and adapted to permit selective and repeatable covering and uncovering of the aperture in the face plate;
(c) a catheter portion having a first end and a second end, the first end of the catheter portion being connected to and extending from a side of the face plate which is disposed proximally when the port device is in normal use position, the catheter portion extending proximally and the second end of the catheter portion being disposed interior of the user'"'"'s body, within the ostomy site when the port device is in normal use, the catheter portion having a continuous exterior side wall, and a continuous interior side wall defining a major lumen, the major lumen extending continuously from the aperture in the face plate to the second end of the catheter portion, the catheter portion being sized and shaped appropriately for non-surgical installation through a stoma to a sufficient distance that the presence of the catheter portion within the stoma provides a physical barrier which reduces prolapse without the use of extraneous, externally applied materials and devices or additional surgery; and
(d) a retaining structure on the exterior side wall of the catheter, the retaining structure being bioresponsive, to thereby permit the port device to be indwelling for extended periods of time, at least in the order of days, without causing tissue irritation or damage around the stoma and being snugly fittable within the stoma, to thereby permit the port device to be indwelling for at least a period of days, without the need for extraneous fixation devices such as tape, belts, and adhesives or revisionary surgery.
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Specification