Dilators

Details Dilators Dilators

2002-01-04

2003-09-23

Truong, Kevin T. (Department: 3731)

Surgery

Instruments

Internal pressure applicator

C606S197000

Reexamination Certificate

active

06623503

ABSTRACT:

This invention relates to dilators.
The present invention will be described hereinafter with particular reference to vaginal dilators. However, it is not to be construed as being limited thereto and dilators according to the present invention may, in appropriate circumstances, be suitable for use in connection with other orifices of the human or animal body, including artificial orifices which are responsive to dilation.
Vaginal dilators have been used for many years in medicine for a wide variety of applications including oncology, radiotherapy, gynaecology, obstetrics and sex therapy. In gynaecology, for example, sufferers from vaginismus may use a small dilator initially and gradually accustom themselves to its feel and size in an unpressured environment. As they become used to a small dilator they may then use a larger dilator until they reach an ability to tolerate their desired size.
A known type of dilator (sometimes called a “trainer” or “cone”) comprises an elongate hollow cylinder having a “closed” end and an “open” end. The diameter of the cylinder progressively reduces towards the “closed” end so that the dilator has a tapering configuration. The “open” end of the cylinder is provided with one or more external circumferential lugs which are adapted, in use, to engage a handle. The handle is used for insertion and removal of the dilator.
Dilators are provided in varying lengths and diameters: a typical “set” of dilators generally consists of four or more dilators (e.g. of lengths 9 cm, 11 cm, 14 cm and 16 cm and respective diameters 20 mm, 25 mm, 30 mm and 35 mm). In dilators of the known type described in the immediately-preceding paragraph, the tapering configuration at the “closed” end can result in the smaller dilators in the “set” having a “closed” end which is almost “pointed”, while the need to provide a universally-applicable handle results in the circumferential lugs at the “open” end being disproportionately large relative to the dimensions of the dilator. Both the aforesaid features of the known dilators can lead to aggravation of existing medical conditions and/or to physical injury. This is especially likely if a patient or surgeon, inserts the handle portion by mistake. Such mistakes are known to occur, especially under conditions of home use.
As dilators are frequently used by patients in their home environment it is important to provide a dilator which is intuitively easy and inherently safe to use. The dilator or set of dilators should be compact, attractive, and easy to clean.
We have devised dilators in which the disadvantages mentioned hereinabove are avoided.
Accordingly, in a first embodiment, the present invention provides a dilator comprising an elongate member having an “open” end and a “closed” end, and the inner surface of an aperture at the “open” end is so internally configured as to be adapted, in use, to engage a corresponding external configuration of a handle.
The present invention also provides, in a second embodiment, a dilator comprising an elongate member having an “open” end and a “closed”end, in which the outer surface of the member at the “closed” end is of arcuate longitudinal section and in which the outer surface of the member at the “open” end is so externally configured as to be adapted, in use, to engage the inner surface of the member of a dilator as described in the immediately-preceding paragraph.
Preferably, the elongate member is of substantially cylindrical configuration. Preferably, the member is hollow. Again preferably, the handle has a section substantially similar to that of the dilator for at least a portion of its axial length where it engages the dilator. Preferably, the handle comprises another dilator.
Preferably, the outer surface of the member at the “closed” end is of arcuate longitudinal section.
The outer surface of the member at the “open” end is preferably also of arcuate longitudinal section. This may be achieved, for example, by moulding in a suitably-configured mould or by processes such as chamfering, bevelling or the like.
Preferably, at least the outer surface of the member at the “closed” end has a radius of curvature substantially equal to the outer radius of the member, whereby the outer surface of the member at the “closed” end is of generally hemispherical configuration.
In addition, the inner surface of the member at the “closed” end may have a radius of curvature substantially equal to the inner radius of the cylinder.
With reference to the dilator according to the first embodiment of the present invention, the internal configuration at the “open” end of the member preferably comprises threading.
With reference to the dilator according to the second embodiment of the present invention, the external configuration at the “open” end preferably comprises threading which is complementary to the threading on the internal surface of the dilator according to the first embodiment.
Preferably, the dilator according to the second embodiment is provided with an annular flange which is adapted, in use, to abut the outer surface of the dilators when the dilators are engaged together.
Thus, a first and a second dilator may be joined together so that a “double-ended” dilator is formed. Alternatively, one of the two dilators so joined together can constitute a handle for the insertion and removal of the other dilator.
The dilator may further comprise a passageway to allow fluid (e.g. air) communication between the “open” and “closed” ends of the dilator in use. Preferably this is a hole through the “closed” end of the dilator. Alternatively a groove may be formed in the external surface of the dilator for this purpose, to prevent a vacuum from forming when the dilator is in use.
The present invention also provides a set of dilators, the set comprising two or more first dilators and two or more corresponding second dilators, the dimensions of each member of the set being different.
For example, a set of dilators may comprise two first dilators of length 128 mm and 110 mm and respective outer diameters of 30 mm and 25 mm, together with two second dilators of length 130 mm and 111 mm and respective outer diameters of 20.5 mm and 13.7 mm.
The dilators may be made of any suitable plastics material which is non-toxic and non-allergenic and which can be provided with a substantially perfectly smooth outer surface.
The set of dilators may be stackable such that the smaller dilators fit substantially inside the larger dilators for ease of packing and transportation of the dilator set.
Preferably the dilator or set of dilators further comprises a lubricant. This may be of any suitable non-toxic and non-allergenic lubricating material. It may be an integral part of the dilators, dispensed by use of the dilator or applied by the user. Preferably, the lubricant is water based, particularly for applications in gynaecology or sex therapy, as this enables the user to continue existing condom use. In an alternative embodiment, the lubricant may be glycerine. This is particularly advantageous in radiotherapy applications and provides smooth lubrication which does not cause discomfort by drying out or becoming excessively sticky.
Advantageously, the dilator or set of dilators according to the present invention may be accompanied by training information in the use of the dilator. This may take the form of an information booklet, but any form of recorded information such as a videotape, audiotape, CD-ROM or instructions for accessing a relevant internet site may accompany the dilator or set of dilators. In a preferred embodiment the training information is specific to the particular application and the recording medium is coded appropriately.
Preferably the dilator or set of dilators is also accompanied by means for relaxing the dilator's user. This may take any form designed to engage or distract the user while the dilator is in use. It may take the form of music recorded on any appropriate medium, preferably on an audiotape.
Alternatively a stress ball or similar relaxing tactile stimulus could be provided.
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