WO2014174490A1

WO2014174490A1 - Cervical access device

Info

Publication number: WO2014174490A1
Application number: PCT/IB2014/061007
Authority: WO
Inventors: Michael Owen Richards
Original assignee: Individual
Current assignee: Individual
Priority date: 2013-04-26
Filing date: 2014-04-25
Publication date: 2014-10-30
Anticipated expiration: 2015-10-26

Abstract

The invention relates to a cervical access device (1) comprising an elongate handle (2) having a distal end (4) and a proximal end (3) with guide means for the shaft (10) of a tool (8) with a tool head (9) releasably secured to the shaft, the proximal end (3) of the handle (2) extending into a base (5) with a cervical guide ring (6) at its end, the base (5) angled above the the central axis of the handle (2) operatively to align the cervical guide ring (6) with a cervix, the tool shaft (10) being rotatable and/or axially movable with respect to the handle (2) to allow the tool head (9) to be rotated with respect to the guide ring (6) and a cervix aligned with the guide ring. The tool head (9) may comprise a brush, or other type of medicine dispenser or other mechanical device to act on a cervix.

Description

CERVICAL ACCESS DEVICE

FIELD OF THE INVENTION This invention relates to a cervical access device for cervical cell sampling and cervical treatment intended for personal and assisted use by women. Specifically, it is intended to obtain cervical cell and other biological material samples for subsequent analysis to establish the presence, or absence, of certain medical conditions. BACKGROUND TO THE INVENTION

It is common practice for medical doctors to test for the presence of certain medical conditions such as cervical cancer and sexually transmitted diseases by obtaining a sample of cervical cells from a female patient. This is done by performing a Papanicolou test, commonly known as a Pap smear test.

Current practice involves a patient visiting a gynaecologist in his consulting rooms to enable him to obtain a sample of the cervical cells for laboratory analysis. The test involves inserting a speculum into the patient's vagina to access the cervix, from which a tissue sample may then be collected by means of a light brush.

This method is uncomfortable and obtrusive for many women. As a result many women forego these crucial tests. This problem is exacerbated in some cultures or areas by conservative religious and cultural beliefs.

Furthermore, in some areas or countries medical facilities are not within easy reach of all citizens. Women in such areas are also less likely to undergo Pap smear tests.

Some women with exposure to various subtypes of the Human Papilloma Virus are recognized to fall into a category at greater risk to conditions that may be identified by a Pap smear test. These women should, ideally, have annual Pap smear tests. There is another category of monogamous women who are less at risk for such conditions, and for them it is recommended having a Pap smear test every three years after three normal Pap smear tests. For many women, the screening for the above mentioned conditions would be conducted regularly if it could be conducted in a private non-intrusive manner.

Several prior art devices and methods to obtain cervical cell samples have been proposed. These include the device and method according to patent US5121752. This discloses a device and method which will have a woman in an upright position insert a rigid cylindrical speculum in her vagina. The speculum includes an angled circular orifice designed to fit over the cervix. The device further includes an angled endocervical sampler and an angled spatula. With the speculum inserted the woman uses a mirror to visually confirm correct placement of the orifice around the cervix.

In practice obtaining a clear view of the cervix is difficult even under direct vision. The length and rigidity of the speculum prevent the use of digital assistance to confirm the proper placement of the orifice.

Further prior art includes USA patent 6402700 by this applicant. This introduced the concept of a handle terminating in a foldable orifice intended to ensure easier insertion into a vagina and digital alignment of the orifice over the cervix. The device also included a retractable sheath within which a sample collector could travel to prevent contamination of the sample collector with cells of the vagina.

US6926677, also by this applicant, improved on this by aligning the handle with the centre of the orifice and providing a travel mechanism for a sample collector. This was intended to ensure the easier insertion of the foldable orifice along with proper alignment of the sample collector with the cervix, which also served to prevent contact of the sample collector with cells of the vagina.

A problem with these last two devices is that they do not fully compliment the general female anatomy. Specifically, these devices do not allow for the change in angle between the vagina and the cervix. This could in some instances result in the sample collector being aimed below the cervix, and not directly onto the cervix. This could result in difficult alignment of these devices with the cervix and makes difficult the accurate placement of the orifice over the cervix. This is detrimental to the reliability of samples taken using such devices. A further problem is that it is difficult for a woman to know at which depth to take a sample. This is especially true where such a cervical cell sampling is done by a medically untrained woman on herself. Another problem exists with respect to testing for and treatment of gynaecological conditions, which typically have to be done in a doctor or gynaecologist's consulting room. These tests and treatments include taking biological samples such as biopsies (other than Pap smears), laser and electro cautery treatments. Although these are done using specialized equipment, obtaining adequate access to the cervix is similarly problematic as with taking a Pap smear.

A further problem exists in administering cervical medicaments, such as creams. To ensure accurate application of the desired medication it has to reach the intended treatment area. If some of the medication is mistakenly applied to the vaginal walls then the amount of medication applied to the intended treatment area is less. To compensate for this the medicament is applied in excess, on the assumption that enough will reach the intended treatment area. This is less than optimal.

OBJECT OF THE INVENTION It is an object of the invention to provide a cervical access device that at least partly overcomes the abovementioned problems.

SUMMARY OF THE INVENTION In accordance with this invention there is provided a cervical access device comprising an elongate handle having a distal end and a proximal end with guide means for the shaft of a tool with a tool head releasably secured to the shaft, the proximal end of the handle extending into a base with a cervical guide ring at its end, the base angled above the central axis of the handle operatively to align the cervical guide ring with a cervix, the tool shaft being rotatable with respect to the handle to allow the tool head to be rotated with respect to the guide ring and a cervix aligned with the guide ring, the tool shaft alternatively being axially movable with respect to the handle to allow the tool head to be moved between a stowed position distal from the guide ring and an operative position proximate the guide ring and a cervix aligned with the guide ring. There is further provided for the tool shaft to be rotatable and axially movable as defined above.

There is further provided for the base to extend above the central axis of the handle operatively to co-axially align the cervical guide ring with the external os of a cervix.

According to a further feature of the invention there is provided for the base to be angled with respect to the handle between 20 to 50 degrees, and preferably about 40 degrees. There is also provided for the guide means to comprise a passage extending between the distal and proximal ends of the handle, and for the passage to be complimentary shaped and sized to the tool shaft, preferably for the passage to extend also at least partly along the base, and further preferably for the guide means to also include a collar extending from the base and being axially aligned with the guide ring, the collar having an inner diameter complimentary shaped and sized to the tool shaft.

There is further provided for the tool to comprise a cervical cell sampling tool, for the tool head to comprise a cervical cell sampling brush, and preferably for the tool shaft to have a greater length than the passage length operatively to allow the brush to be pushed from the distal end of the handle to extend to the guide ring whilst still providing purchase for a user on the shaft extending from the passage at the distal end of the handle.

According to a further feature of the invention there is provided for the tool head to comprise a medicine dispenser or other mechanical device to act on a cervix, including a laser or an electrocautery device, or a mechanical, cellular, biological or chemical biopsy device, or an imaging device, or a diagnostic or therapeutic device, or a device that accesses the endometrial cavity or uterus.

The invention further provides for the passage and the tool shaft to have circular cross sections and for the shaft to include an annular collar located at a predetermined distance from its distal end and to have an outer diameter greater than the inner diameter of the distal opening of the passage, operatively to limit the distance to which the shaft can be inserted into the passage to prevent the brush from extending further from the passage than the centre of the guide ring. There is still further provided for the proximate opening of the passage, located at the base, to be axially aligned with the centre of the guide ring, alternatively with the base collar, and preferably for the passage and the tool shaft to have circular cross sections. The invention further provides for the access device to include storage means for at least part of the tool head, the storage means comprising a complimentary shaped recess extending from the base between the proximate opening of the passage and distal from the guide ring, preferably located between the base collar and the guide ring, operatively allowing the tool head to be axially moved between a stowed position in the recess and an operative position proximate the guide ring.

There is also provided for the access device to include a handgrip extending from the distal end of the handle, preferably with the passage opening above the handgrip. These and other features of the invention are described in more detail below.

BRIEF DESCRIPTION OF THE DRAWINGS

A preferred embodiment of the invention is described by way of example only and with reference to the accompanying drawings in which:

Figure 1 is a side elevation of a cervical cell sampling device according to the invention;

Figure 2 is a proximal end top perspective view of the sampling device of Figure 1 ; Figure 3 is a plan view of the sampling device of Figure 1 ;

Figure 4 is a part sectional and semi-transparent distal end top perspective view of the sampling device of Figure 1 ; and

Figure 5 is a graphical representation showing a sectional side view of a woman with the sampling device of Figure 1 inserted into her and its guide ring aligned with her cervix.

DETAILED DESCRIPTION OF THE INVENTION

A preferred embodiment of a cervical access device according to the invention, in the form of a cervical cell sampling device (1 ), is shown in Figures 1 to 4. As shown in Figures 1 to 4, the sampling device (1 ) comprises an elongate handle (2) which has proximal (3) and distal (4) ends. The handle (2) extends at its proximal end (3) into a base (5) with a cervical guide ring (6) at its end. The base (5) is angled above the central axis of the handle (2) operatively to align the cervical guide ring (6) with a cervix (7), as shown in Figure 5.

The sampling device (1 ) is configured to allow operation of a sampling tool (8) in the form of a sampling brush head (9) releasably secured on a brush shaft (10). The sampling device (1 ) includes guide means for the shaft (10) in the form of a passage (1 1 ) that extends between the distal end (4) and proximal end (5) of the handle (2).

The passage (1 1 ) is shaped to include a distal collar (12) at the distal end (4) of the handle, and a proximal collar (13) and the proximal end (5) of the handle (2). The collars (12, 13) have circular cross sections, complimentary to the shaft (10), which also has a circular cross section. The base (5) is also provided with a collar (23), with a similar complimentary circular cross section, which further assists in guiding the shaft (10). The shaft (10) is axially movable and rotatable within the passage (1 1 ), which allows for controlled axial and rotational movement of the brush (9). The brush (9) is removably secured to the shaft (10). The shaft (10) is extended through the passage from its distal collar (12) through its proximate collar (13). The free end of the shaft extends through the proximate collar (13) and the base collar (23) and the brush (9) is secured on this free end of the shaft (10). This locates the brush within the base (5), between the base collar (23) and the guide ring (6).

The shaft (10) includes at its distal end an annular collar (14) with an outer diameter greater than the inner diameter of the distal collar (12) of the passage (1 1 ). The shaft collar (14) thus acts a stop to limit the axial movement of the shaft in the passage (10). When the shaft (10) is axially pushed to its limit, with the shaft collar (14) thus being in abutment with the distal collar (12) of the passage (1 1 ), the brush (9) is extended to its operational position within the cervical guide ring (6).

The base (5) is complimentary shaped and sized to the brush (9) and forms a storage recess (15) for the brush (9). The recess (15) is formed between the base collar (23) and the guide ring (6).The brush (9) is thus axially movable between the base collar (23) and the guide ring (6). The brush (9) may be retracted into the recess (15) by retracting the shaft (10), thus moving the shaft collar (14) out of abutment with the distal collar (12) of the passage (1 1 ).

The handle (2) is formed at its distal end (4) into an ergonomic handgrip (16). The shaft (10) is similarly formed at its distal end into a handgrip (17). The shaft (10) extends above the handle (2) at its distal end (4).

As shown in Figure 5, which is a sectional view of the lower abdomen of a female patient (19), the cervical cell sampling tool (1 ) is intended operatively to be inserted into the vagina (18) of the female patient (19), from whom a cervical cell sample is to be obtained, to align the guide ring (6) with the external os (20), i.e. the opening, of the patient's cervix (7). The sample so obtained may also include other biological materials.

The base (5) and the handle (2) are angled with respect to each other at substantially the same angle as the average angle between the vaginal axis (21 ) and the endocervical axis (22) in a woman.

Since the actual angle between the vaginal axis (21 ) and the endocervical axis (22) is unique to each woman, in the clinically observed range of between 20 degrees and 50 degrees, it is envisaged that different versions of the cervical sampling device (1 ) may be provided with angles between the handle (2) and extension (5) that are set at various intervals in this range, to allow a woman to use one that suits her specific anatomy best.

In this preferred embodiment the angle in the sampling device (1 ) is set at 40 degrees. This will in the experience and opinion of the applicant provide suitably accurate alignment of the guide ring (6) with the external os (20) for a majority of female patients to allow for samples to be reliably collected from them using the sampling device (1 ).

In use the brush (9) is advanced into the sampling position, i.e. the shaft (10) is pushed forward to its limit to push the brush (9) out of the recess (15) and locate the brush (9) proximate the guide ring (6). The sampling device (1 ) is then inserted into a female patient's vagina (18), either by a medically trained person such as a doctor, nurse or other caregiver, or by the patient herself.

To insert it the woman (19), or the doctor, nurse, or caregiver on her behalf, places an index fingertip (obviously wearing surgical gloves) through the guide ring (6), pushing the brush (9) fibres aside in doing so, and inserts the sampling device (1 ) into her vagina (18). With the fingertip on the cervix (7), the guide ring (6) is advanced off the finger to encircle and capture the cervix (7) and to thus align the guide ring with the external os (20). The brush (9) fibres will now be in contact with the cervix (7) and sampling will consist of merely rotating the brush handle (10) five times to gather a sample of the cells lining the cervix (7).

The woman (19) then extracts the sampling device (1 ) from her vagina (18) with the brush (9) located in the recess (15) and the guide ring (6) assisting in opening the vagina (18) for its extraction. This minimises contaminating the brush (9) with other biological material from the vagina (14). This similarly also minimises contamination of the brush upon entry into the vagina (18) at the outset of the sampling procedure.

The procedure thus consist of inserting the sampling device, capturing the cervix (7), rotating the brush five times, withdrawing the device (1 ) from the vagina (18), removing the brush (9) from the shaft (10) and depositing the brush (9) into a sealable container for carrying the sample in a conventional liquid preservative for later analysis. Samples obtained in this manner are well preserved and may still be examined up to several months later.

The initial conceptions of a mobile, slidable brush carrier, and then the subsequent slidable brush in a tubular handle (from a position in a brush head recess), have been eliminated as not necessary, and this design simplifies the procedure and minimizes the amount of material required. The realization that the brush does not prevent the finger being simultaneously in the ring has made this simplification possible. The cervical sampling device (1 ) according to the invention thus utilises its angled base (5) above the axis of the handle (2) to positively align the guide ring (6) with the cervix (7) of a woman (19) from which a biological sample is to be obtained. The passage (1 1 ) that extends onto the angled base (5) aligns the brush (9) with the centre of the guide ring (6). The flexible brush shaft (10) allows rotation of the brush (9) through the angled passage (1 1 ).

As mentioned, the sampling device may be operated by a woman herself or by another person, such as a caregiver or a medically trained person such as a nurse or a doctor. It is envisaged that the sampling device (1 ) will provide great benefits especially with its use by nurses who will be well skilled in its use and in respect of which female patients are less likely to harbour an aversion in respect of this type of test. It is further envisaged that especially in rural areas nurses may provide such tests either at a clinic or at home to patients. The sampling devices (1 ) are easily packed in a sterile container to include all of its required associated items such as the sterile container for the brush. A nurse could visit a remote village with a suitable supply of these sampling devices and obtain Pap smear samples from all women in the village in a very short time, without exposing the women to the normal discomfort of a Pap smear test at a doctor's room or a hospital and saving them the often time consuming and arduous trip to such facilities.

It will be appreciated that the embodiment described above is given by way of example only and is not intended to limit the scope of the invention. It is possible to alter aspects thereof without departing from the essence of the invention.

It is for example possible to utilise tool heads other than a brush with the cervical access device. These may include any one of a medicine dispenser or other mechanical device to act on a cervix, including a laser or an electrocautery device, or a mechanical, cellular, biological or chemical biopsy device, or an imaging device, or a diagnostic or therapeutic device, or a device that accesses the endometrial cavity or uterus.

The use of the access device with such other tools and for such other tests provides the benefit of the correct anatomical design of the access device to allow the cervix to be captured upon insertion of the device into a patient's vagina.

This allows accurate testing and reliable treatment to be conducted for a range of gynaecological conditions using a range of tools that may be secured to the tool shaft.

It is envisaged that this will include electrical imaging and treatment devices, for which the electrical power and data communication will be provided either through the tool shaft, or where a cable carrying such services will be utilised as a shaft. Such a device may thus then be axially and rotationally controlled using the cable or shaft, in addition to other controls integral with such a tool. Such other controls may, for example, include a cutting tool for taking biopsies or removing tissue and imaging controls allowing focussing of a camera carried on the shaft as part of the tool head.

Claims

A cervical access device comprising an elongate handle having a distal end and a proximal end with guide means for the shaft of a tool with a tool head releasably secured to the shaft, the proximal end of the handle extending into a base with a cervical guide ring at its end, the base angled above the central axis of the handle operatively to align the cervical guide ring with a cervix, the tool shaft being rotatable with respect to the handle to allow the tool head to be rotated with respect to the guide ring and a cervix aligned with the guide ring.

A cervical access device comprising an elongate handle having a distal end and a proximal end with guide means for the shaft of a tool with a tool head releasably secured to the shaft, the proximal end of the handle extending into a base with a cervical guide ring at its end, the base angled above the central axis of the handle operatively to align the cervical guide ring with a cervix, the tool shaft being axially movable with respect to the handle to allow the tool head to be moved between a stowed position distal from the guide ring and an operative position proximate the guide ring and a cervix aligned with the guide ring.

A cervical access device as claimed in claim 1 or claim 2 in which the base extends above the central axis of the handle operatively to co-axially align the cervical guide ring with the external os of a cervix.

A cervical access device as claimed in any one of claims 1 to 3 in which the base is angled with respect to the handle between 20 to 50 degrees.

A cervical access device as claimed in any one of claims 1 to 3 in which the base is angled with respect to the handle at about 40 degrees.

A cervical access device as claimed in any one of claims 1 to 5.

A cervical access device as claimed in any one of claims 1 to 6 in which the guide means comprises a passage extending between the distal and proximal ends of the handle, and the passage is complimentary shaped and sized to the tool shaft.

8. A cervical access device as claimed in claim 7 in which the passage extends also at least partly along the base.

9. A cervical access device as claimed in claim 8 in which guide means also includes a collar extending from the base and which is axially aligned with the guide ring, the collar having an inner diameter complimentary shaped and sized to the tool shaft.

10. A cervical access device as claimed in claim 7 to 9 in which the tool shaft has a greater length than the passage length operatively to allow the tool head to be pushed from the distal end of the handle to extend to the guide ring whilst still providing purchase for a user on the shaft extending from the passage at the distal end of the handle.

1 1 . A cervical access device as claimed in any one of claim 7 to 10 in which the passage and the tool shaft have circular cross sections and the shaft includes a collar located at a predetermined distance from its distal end and has an outer diameter greater than the inner diameter of the distal opening of the passage, operatively to limit the distance to which the shaft can be inserted into the passage to prevent the tool head from extending further from the passage than the centre of the guide ring.

12. A cervical access device as claimed in claim 1 1 in which the proximate opening of the passage, located at the base, is axially aligned with the centre of the guide ring.

13. A cervical access device as claimed in any one of the previous claims in which the passage and the tool shaft have circular cross sections.

14. A cervical access device as claimed in any one of the previous claims which includes storage means for at least part of the tool head, the storage means comprising a complimentary shaped recess extending from the base between the proximate opening of the passage and distal from the guide ring, operatively allowing the tool head to be axially moved between a stowed position in the recess and an operative position proximate the guide ring.

15. A cervical access device as claimed in any one of the previous claims which includes a handgrip extending from the distal end of the handle.

16. A cervical access device as claimed in any one of claims 7 to 15 in which the passage opens above the handgrip.

17. A cervical access device as claimed in any one of the previous claims which includes a handgrip on the distal end of the tool shaft.

18. A cervical access device as claimed in any one of the previous claims in which the tool comprises a cervical cell sampling tool and the tool head comprises a cervical cell sampling brush.

19. A cervical access device as claimed in any one of claims 1 to 17 in which the tool head comprises a medicine dispenser or other mechanical device to act on a cervix, including a laser or an electrocautery device, or a mechanical, cellular, biological or chemical biopsy device, or an imaging device, or a diagnostic or therapeutic device, or a device that accesses the endometrial cavity or uterus.