Speculum

Surgery – Specula

Reexamination Certificate

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Details

C600S210000, C600S219000

Reexamination Certificate

active

06761687

ABSTRACT:

The invention relates to a speculum, particularly, though not exclusively to a gynaecological speculum for assisting in the identification and repair of vaginal and cervical lacerations.
A speculum is used in a variety of medical procedures to dilate an orifice to a cavity in order to examine or operate within the cavity. A number of different types of gynaecological speculum are used to dilate the vaginal orifice to allow access to the vaginal cavity for medical examinations or surgical procedures. The most commonly used type is known as a duck-billed speculum which has two portions that are inserted into the vaginal cavity and separated from one another by the action of closing a handle portion. This type of speculum is often uncomfortable for the patient and also allows tissue to protrude into the gap between the duck-bills and to be exposed on each side of the duck-bills. Various types of speculum have been proposed that comprise a tubular section for insertion into the vaginal cavity. These types of speculum have an open insertion end for insertion into the vaginal cavity and an open user end allowing access into the vaginal cavity through the speculum during medical examinations or surgical procedures.
A particular requirement for a vaginal speculum is to allow access to the vagina for repair of tears in the vaginal wall following the birth of a baby. Occasionally after a normal delivery of a baby and often after an assisted delivery using, for example, forceps or vacuum extraction, there are tears or lacerations along the lateral walls of the vagina. These tears can become quite difficult to detect after a delivery as the tissue in the vagina is oedematous and haemorrhagic. As well as bleeding from the tears themselves, there is usually bleeding from the contracting uterus. All this makes it difficult for the tears in the wall to be seen and repaired if necessary.
It is an object of the present invention to provide a speculum, and in particular a speculum suitable for use as a vaginal speculum, that provides improved visibility and access for repair of torn tissue or other surgical procedures.
The invention provides a speculum comprising:
an outer member comprising a tubular body having an anterior end, a posterior end and a side wall, the anterior end having an opening and the posterior end having an opening and the side wall of the tubular body comprising a slot opening extending along a portion of the side wall of the tubular body; and
an inner member comprising a cup-shaped body having an anterior end and a posterior end and a side wall, the cup-shaped body being insertable within the tubular body of the outer member, the anterior end being closed and the posterior end having an opening.
Preferably the slot in the outer member tubular body extends from the posterior opening along the side wall in the direction of the interior opening.
Preferably the inner member cup-shaped body comprises a key member extending along side wall of the cup-shaped body and corresponding to the slot opening in the side wall of the tubular body.
Preferably the key member in the inner member cup-shaped body extends from the posterior opening along the side wall in the direction of the closed anterior end. Preferably the key member comprises a protrusion on the outer surface of the side wall of the cup-shaped body.
Preferably means are provided to rotate the outer member tubular body within a cavity within which it may be inserted such that the slot in the side wall may be aligned with any site of a required examination or surgical procedure in the wall of the cavity.
Preferably the outer member further comprises handle means at the posterior end. The handle means provides improved ease of insertion by a user and allows the speculum to be rotated within the cavity when inserted.
The cup-shaped body of the inner member is inserted into the interior of the tubular body of the outer member. Advantageously the cup-shaped body is sized to form a close fit within the tubular body. Preferably the closed anterior end of the cup-shaped body forms a seal within the opening in the anterior end of the tubular body. Advantageously the closed anterior end of the cup-shaped body is shaped with a ridge to co-operate with the rim of the opening in the anterior end of the tubular body. Alternatively a sealing ring or gasket may be provided.
In use, the cup-shaped body of the inner member is inserted into the tubular member. The assembled cup shaped body and tubular body are inserted into an orifice such that the outer tubular body dilates the orifice in which it is inserted and maintains the tissue within the cavity around the outer surface of the tubular body. The key member in the side wall of the cup-shaped body is positioned in correspondence with the slot in the tubular body. Once the speculum is in position within the cavity, the inner cup-shaped body is removed. The tubular body can be rotated within the cavity to align the slot in the tubular body with any site of a required examination or surgical procedure in the cavity wall either in combination with the cup-shaped body inserted therein or when the cup-shaped body has been removed.
Advantageously resilient retention means are provided to retain the cup-shaped body within the tubular body. Preferably the cup-shaped body is provided with resilient retention means to retain the cup-shaped body within the tubular body. Advantageously the resilient retention means comprise resilient latch means and the tubular body further comprises co-operating retention means. Advantageously the latch means and the retention means also serve as alignment means to align the key member in the side wall of the cup-shaped body with the slot in the side wall of the tubular body when the cup-shaped body is inserted therein.
Preferably the edges of the anterior and posterior openings on the tubular body are smooth to assist with insertion and removal of the speculum into and from the cavity and to minimise discomfort to the patient. Advantageously the tubular body is provided with a lip to assist in position the tubular body within the cavity and to provide resistance against the tubular body slipping out of the cavity in use.
Advantageously the outer member and/or the inner member are formed from injection moulded plastics material.
Preferably the outer member and/or the inner member are formed from transparent materials.
Advantageously the speculum further comprises a light source to aid and/or enhance the visual examination of sites of interest within the body orifice (
FIG. 1
a
). Preferably the light source comprises a fibre-optic or LED type light source. Advantageously the light source
25
is positioned within the side the wall
12
of the outer member
1
. If the light source
25
is a fibre optic, it is preferably fed through the handle
10
of the outer member
1
and extends within the side wall
12
of the tubular body
3
. If the light source
25
is an LED, it is preferably positioned within the side wall
12
of the tubular body
3
and is connected to a power source via a connection fed through the handle
10
of the outer member
1
.
The invention further provides a method of inserting a spectrum within a body cavity comprising steps of:
assembling an inner member comprising a cup-shaped body within an outer member comprising a tubular body, the tubular body having an anterior end, a posterior end and a side wall, the anterior end having an opening, the posterior end having an opening and the side wall of the outer member tubular body comprising a slot opening extending along a portion of the side wall of the tubular body, the cup-shaped body having an anterior end, a posterior end and a side wall;
inserting the assembled inner and outer members within a body cavity;
removing the inner member from the outer member; and
positioning the slot opening in the outer member with respect to a site in a wall of the cavity.
Preferably the side wall if the inner member cup-shaped body comprises a key member extending along a portion of the side wall of the cup-shape

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