GB2580407A

GB2580407A - A rectal insertion device

Info

Publication number: GB2580407A
Application number: GB1900355.7A
Authority: GB
Inventors: Ghareeb Essam
Original assignee: HAEMOBAND SURGICAL Ltd
Current assignee: HAEMOBAND SURGICAL Ltd
Priority date: 2019-01-10
Filing date: 2019-01-10
Publication date: 2020-07-22
Anticipated expiration: 2039-01-10
Also published as: GB2580407B; GB201900355D0

Abstract

A rectal insertion device comprising a generally tubular outer sleeve 11 having first 12 and second 13 open ends, the first end being dimensioned for insertion into the rectum of a patient. A tubular inner tube 14 is provided comprising first and second open ends 15, 16, the first open end shaped and dimensioned for slidable insertion into the second open end 13 of the outer sleeve. The inner tube is axially slidable and rotatable within the outer sleeve when it is received therein. The inner and outer sleeves comprise engagement means, preferably taking the form of inner and outer flanges 17, 18 respectively, to prevent movement of the second open end of the inner tube into the second open end of the outer sleeve in a manner which would allow the inner tube to pass through the outer sleeve. In use, retention by a physician of the inner tube in the rectum of a patient acts to also retain the outer sleeve in the rectum of a patient.

Description

A Rectal Insertion Device

Field of the Invention

This invention relates to a rectal insertion device and in particular to a rectal insertion device for carrying out medical procedures on the rectum, anus, or associated anatomy.

Background of the invention

Common medical procedures exist which require a physician to access internal tissues for treatment or inspection. One example of such a procedure is the treatment of haemorrhoids wherein access is gained through the rectum of a patient such that the haemorrhoids may be treated by the application of bands or otherwise. Procedures which require such access typically utilise a device having one or more tubular inserts which creates an opening through which a physician my work to administer a treatment or inspect a portion of internal tissue.

Existing devices take the form of anoscopes or proctoscopes which always comprise a single tube, which is inserted into the anus. These devices are usually used in outpatient procedures for inspection of the anus and lower rectum, taking a biopsy or banding haemorrhoids. These procedures are performed through the aforementioned single tube. These procedures always involve rotating, extraction and reinsertion of the tube to achieve better views and perform the procedure. Such physical manipulations of the device cause pain and discomfort to patients.

The second group of anal and rectal exploration devices is used when the patient is fully anaesthetized. These devices use "Anal Speculae" and some are to be fixed to the skin by sutures, to perform per anal surgery. Some of these devices are tubular and others have crocodile-like jaws 25 to open the anus.

It is desirable to provide a rectal insertion device which provides access to internal tissues of the rectum or associated anatomy yet is minimally invasive and can be controlled easily by a physician whilst carrying out medical procedures.

Summary of the Invention

According to the invention there is provided a rectal insertion device comprising: a tubular outer sleeve having first open end shaped and dimensioned for insertion into the rectum of a patient and a second open end distal the first open end; and an inner tube comprising first and second open ends, the inner tube being shaped and dimensioned for insertion into the outer sleeve, and being slidable within the outer sleeve in an axial direction and rotatable with respect to the sleeve about the sliding axis; the inner and outer sleeve comprising engagement means therebetween shaped and dimensioned to prevent movement of the second open end of the inner tube into the second open end of the outer sleeve.

Ideally, in use, retention by a physician of the inner tube in the rectum of a patient acts to also retain the outer sleeve in the rectum of a patient.

Ideally, the outer sleeve is not attached to the patient by sutures, adhesive, or otherwise.

Advantageously, the outer sleeve is not required to be sutured or otherwise attached to the patient in order that it remains in the rectum, increasing the comfort of any procedure carried out with the device, and negating or reducing the requirement for anaesthesia.

Further advantageously, a physician may utilise one hand to manipulate the inner tube, which acts to retain both sleeves in the rectum, this permitting a second hand of a physician to be free for other aspects of a procedure.

Preferably, the outer sleeve is configured such that it is encouraged to remain in the rectum by the muscles of the patients' anus and/or associated muscles thereof.

Ideally, the outer sleeve comprises an insertion limitation feature engagable with a patient externally of the rectum and configured to limit the extent of insertion of the outer sleeve into the rectum.

Preferably, in use, internal tissue of a patient is accessible through the inner tube.

Advantageously, surgical procedures, treatment, or examination may be carried out on the internal tissue accessible through the inner tube.

Ideally, the inner tube is an inspection tube.

Preferably, the device comprises a user operable control member configured to control movement of the inner tube.

Ideally, the operable control member is a handle attachable to or formed integrally with the inner tube.

Preferably, the control member is attachable to or formed integrally with the second end of the inner tube.

Ideally, the engagement means comprises corresponding engagement features locatable on the inner tube and outer sleeve configured to limit relative axial movement in a first direction between the inner tube and outer sleeve.

Preferably, the sizing/dimensioning of the inner tube and outer sleeve is such that, upon engagement of the corresponding engagement features, the inner tube protrudes from the first open end of the outer sleeve a predetermined distance.

Preferably, the first direction is a direction where the second end of the inner tube movies axially towards the second end of the outer sleeve.

Ideally, the first direction is a direction wherein, in use, axial movement of the inner tube in the first 10 direction results in the inner tube being further inserted into the rectum of a patient.

Preferably, the inner tube and outer sleeve include mutually engagable formations that limit axial movement in a second direction when they engage.

Preferably, the mutually engagable formations comprise a movement restrictor between the inner tube and outer sleeve configured to limit relative axial movement in at least the second direction between the inner tube and outer sleeve.

Preferably, the second direction is a direction wherein the inner tube moves axially in a direction 20 opposite to the first direction.

Ideally, the inner tube is axially slidable within the outer sleeve in the first direction until engagement of the corresponding engagement features prevents further axial movement in the first direction.

Preferably, the inner tube is axially slidable within the outer sleeve in the second direction until the engagement of the mutually engagable formations prevents further axial movement in the second direction.

Ideally, the corresponding engagement features comprise an inner tube flange locatable 30 substantially at the second end of the inner tube.

Preferably, the corresponding engagement features comprise an outer sleeve flange locatable substantially at the second end of the outer sleeve.

Ideally, the insertion limitation feature forms the outer sleeve flange.

Ideally, the inner tube flange is configured to engage with the outer sleeve flange such that slidable axial movement of the inner tube in the first direction is restricted by said engagement with the outer sleeve flange.

Alternatively, or in combination, axial movement of the inner tube in the first direction is restricted by engagement between the user operable control member and the outer sleeve flange.

Preferably, the movement restrictor comprises a protrusion formed on an outer surface of the inner 5 tube.

Ideally, the protrusion is configured to engage with the outer sleeve such that relative axial movement between the inner tube and outer sleeve is restricted in the second direction.

Preferably, the protrusion is configured to engage with the inner surface of the outer tube, or with a feature formed therein.

Alternatively, the protrusion is configured to engage with an edge of the open first end of the outer sleeve.

Ideally, in use, the protrusion is locatable on a portion of the inner tube which projects from the open second end of the outer sleeve.

Advantageously, the protrusion prevents unwanted removal of the inner tube from the outer sleeve.

Ideally, the open first end of the inner tube comprises an oblique opening being oblique to the axial direction.

Preferably, the oblique opening forms a first leading edge of the inner tube and a second leading 25 edge of the inner tube.

Ideally, the first leading edge extends further from the second end of the inner tube than the second leading edge.

Advantageously, as the inner tube is rotated with the rectum of a patient, the angled oblique nature of the opening at the first end of the inner tube is such that the first leading edge acts to retain a portion of the rectum such that a portion of rectum located thereunder is accessible for surgery or treatment.

Alternatively, a window or aperture may be formed in the portion of the wall of inner tube which projects from the first end of the outer sleeve.

Ideally, an insertion assistance shaft is insertable through the inner tube.

Preferably, the insertion assistance shaft comprises a first end which, in use, protrudes form the first end of the inner tube.

Ideally, the first end of the insertion assistance shaft is configured to ease insertion of the rectal insertion device.

Preferably, the insertion assistance shaft is removable once the rectal insertion device is inserted into the rectum of a patient.

Ideally, in use, the second open end of the inner tube protrudes from the second open end of the outer sleeve.

Preferably, in use, the first open end of the inner tube protrudes from the first open end of the outer sleeve.

Ideally, the device comprises an illumination device configured to illuminate the interior of the inner 15 tube and any internal tissue of a patient visible therethrough.

Brief description of the drawings

An embodiment of the invention is now described by way of example and with reference to the accompanying drawings in which: Figure 1 is a perspective view of a rectal insertion device; Figure 2 is an exploded perspective view of the rectal insertion device; Figure 3 is a rear view of the rectal insertion device; Figure 4 is a plan view of the rectal insertion device; Figure 5 is a front view of the rectal insertion device; Figure 6 is a sectional view of section B-B of Figure 5; Figure 7 is a sectional detail view of detail C of Figure 6; Figure 8 is a perspective view of a second embodiment of a rectal insertion device; and Figure 9 is a perspective cross-sectional view of Figure 8.

Detailed Description of the drawings

The present teaching will now be described with reference to an exemplary rectal insertion device. It will be understood that the exemplary rectal insertion device is provided to assist in an understanding of the present teaching and are not to be construed as limiting in any fashion. Furthermore, elements or components that are described with reference to any one Figure may be interchanged with those of other Figures or other equivalent elements without departing from the spirit of the present teaching.

Referring now to the Figures there is illustrated a rectal insertion device 10 comprising a generally tubular outer sleeve 11 having first open end 12 configured, for example shaped and/or dimensioned, for insertion into the rectum of a patient. The outer sleeve 11 has a second open end 13 distal the first open end 11.An inner tube 14 is provided comprising first and second open ends 15, 16, the first open end configured for slidable insertion into the second open end 13 of the outer sleeve 11. The inner tube 14 is axially slidable and rotatable with respect to, and within, the outer sleevel 1. The inner tube and outer sleeve comprise inner and outer engagement means 17, 18, being engagable with each other to prevent movement of the second open end 16 of the inner tube 14 into the second open end 13 of the outer sleeve 11 in a manner which would allow the inner tube 14 to pass through the outer sleeve 11. The engagement means takes any form such that it creates a stop arrangement between the inner tube 14 and the outer sleeve 11. In a preferred embodiment, the engagement means are corresponding engagement features such as flanges 17, 18 formed on the inner tube 14 and outer sleeve 11 respectively. The flanges 17, 18, may also be annular flanges 17, 18 which extend around the circumference of the inner tube 14 and outer sleeve 11. In the embodiments shown in the drawings, the flange 18 of the outer sleeve 11 is formed integrally with the outer sleeve 11. The flange 17 of the inner tube 14 is preferably formed on a handle assembly 20 which is attachable to, and preferably irremovably attachable to, the second end 16 of the inner tube 14. In some embodiments, the fiangel 7 of the inner tube 14 may be formed integrally of the inner tube 14. In use, retention by a physician of the inner tube 14 in the rectum of a patient acts to also retain the outer sleeve 11 in the rectum of a patient such that the outer sleeve 11 is not required to be sutured or otherwise attached to a patient in order that it remains in the rectum, increasing the comfort of any procedure carried out with the device 10, and negating or reducing the requirement for anaesthesia. The physician may therefore utilise one hand to manipulate the inner tube 14, which acts to retain both sleeves 11, 14 in the rectum, this permitting a second hand of a physician to be free for other aspects of a procedure. In use, internal tissue of a patient is accessible through the second open end 16 of the inner tube 14. The outer sleeve flange 18 forms an insertion limitation feature such that it is engagable with a patient externally of the rectum and limits the extent of insertion of the outer sleeve 11 into the rectum. Advantageously, surgical procedures, treatment, or examination may be carried out on the internal tissue accessible through the inner tube 14.

The preferred device 10 has a handle 21 configured to control movement of the inner tube. The handle 21 may be formed integrally the handle assembly 20 and is attached therewith to the second end 16 of the inner tube. In the embodiment as shown in the drawings, the handle 21 forms an extension of the inner tube flange 17. In some embodiments, the handle 21 is formed integrally with the second end 16 of the inner tube 14.

The flanges 17, 18 of the inner and outer sleeves 14, 11 are engagable such that their engagement acts to limit relative axial movement in a first direction between the inner tube and outer sleeve 14, 11. The flanges 17, 18 are radial flanges which extend from the inner tube 14 and outer sleeve 11. Advantageously, the flanges 17, 18 extend from the second ends 13, 16 of the inner tube and outer sleeve 14, 11, obliquely disposed in relation to the remainder of the respective tube or sleeve. As is best viewed in Figure 7, the angles at which the inner and outer flanges 17, 18 extend from the inner tube and outer sleeve 14, 11, are complementary such that the flanges 17, 18 align when in abutment. The first direction is a direction where the second end 16 of the inner tube 14 moves axially towards the second end 18 of the outer sleeve 11, and wherein, in use, axial movement of the inner tube 14 in the first direction results in the inner tube 14 being further inserted into the rectum of a patient. The inner tube 14 and outer sleeve 11 include mutually engagable formations that limit axial movement in the second direction when they engage. Therefore, the mutually engagable formations act in conjunction with the engagement means to allow restricted movement in both the first and second directions while keeping the inner tube 14 and outer sleeve 11 together. In some embodiments, as shown in Figures 8 and 9, the mutually engagable formations preferably comprise a movement restrictor 22 mutually engagable with the inner surface of the outer sleeve 14, the movement restrictor therefore being disposed between the inner tube 14 and outer sleeve 11 and configured to limit relative axial movement in at least a second direction between the inner tube 14 and outer sleeve 11. The second direction is a direction wherein the inner tube 14 moves axially in a direction opposite to the first direction, or in use wherein the inner tube 14 moves axially such that it is retracted from the rectum of a patient. The inner tube 14 is axially slidable within the outer sleeve 11 in the second direction until the movement restrictor 22 prevents further axial movement in the second direction. Movement of the inner tube 14 axially in the second direction causes the movement restrictor 22 to move into the first end of the outer sleeve 11 and engage with an inner surface of the outer sleeve, the inner surface of the outer sleeve acting to prevent further movement of the inner tube 14 in the second direction. The inner surface of the outer sleeve may also be provided with a notch or indent feature into which the movement restrictor is received, the engagement between the movement restrictor 22 and the notch or indent feature preventing further movement of the inner tube 14 in the second direction. As is best seen in Figure 7, the walls of the outer sleeve 11 may also be offset and/or flared relative to the inner tube 14 such that a gap exists between the inner and outer sleeves into which the movement restrictor 22 may pass when moving in the second direction. The offset and/or flared walls of the outer sleeve 11 result in the inner surface of the outer sleeve being in engagement with the outer surface of the inner tube at or about the second end 13 of the outer sleeve 11, the inner surface of the outer sleeve and the outer surface of the inner tube having a gap therebetween at the first end 12 of the outer sleeve 11.

In some embodiments, as best seen in Figures 8 and 9, The mutually enagable formations comprise a movement restrictor 22 and an edge 23 of the first open end 12 of the outer sleeve 11. The movement restrictor 22 prevents further axial movement in the second direction as a result of its engagement with an edge 23 of the first open end 12 of the outer sleeve 11. The movement restrictor comprises a protrusion 22 formed on an outer surface 24 of the inner tube 14 and is locatable on a portion of the inner tube 14 which projects from the open second end 12 of the outer sleeve 11. Advantageously, the protrusion 22 prevents unwanted removal of the inner tube 14 from the outer sleeve 11.The inner tube flange 17 is engages with the outer sleeve flange 18 such that slidable axial movement of the inner tube 14 in the first direction is restricted by said engagement with the outer sleeve flange 18. Alternatively, or in combination, axial movement of the inner tube 14 in the first direction is restricted by engagement between the handle 21 and the outer sleeve flange 18 In preferred embodiments, the open first end 15 of the inner tube 14 comprises an opening 25 oblique to the axial direction, the opening 25 forming a first leading edge 26 of the inner tube 14 and a second leading edge 27 of the inner tube 14. The first leading edge 26 extends further from the second end 16 of the inner tube than the second leading edge 27. Advantageously, the oblique nature of the opening 25 at the first end 15 of the inner tube is such that the first leading edge 26 acts to retain a portion of the rectum such that a portion of rectum located thereunder is accessible for surgery or treatment. Rotation of the inner tube 14 causes a different portion of the internal tissue to be exposed such that full 360 degree rotation of the inner tube 14 permits accessibility to the entire inner wall of a portion of rectum extending between the first and second leading edges 26, 27 of the inner tube 14. Advantageously, different sites of internal tissue may be treated or examined without the requirement to remove and reinsert the device 10. Alternatively, a window or aperture may be formed in the portion of the wall of inner tube 14 which projects from the first end 12 of the outer sleeve 11.

The outer sleeve 11 is dimensioned such that it covers the dentate line in the anus which marks the change of the type of cells lining the anus and the start of the area of sensation. The outer sleeve 11 therefore covers this area of sensation to prevent inadvertent treatment that would cause discomfort, such as the application of bands for the treatment of haemorrhoids. Furthermore, the sizing of the inner and outer sleeves 14, 11 is such that, upon engagement of the flanges 17, 18 of the inner and outer sleeves 14, 11, the inner tube protrudes from the first end 12 of the outer sleeve 11 a predetermined distance and as such, in use, the inner tube 14 is inserted in to the rectum of a patient a pre-determined distance. In the embodiments shown in the drawings, where the inner flange 17 forms part of the handle assembly 20 the pre-determined length the inner tube protrudes from the first end 12 of the outer sleeve 11when the flanges 17, 18 are in abutment may be adjusted by adjusting the length of an intermediate joining portion 33 of the handle assembly 20. In this manner a physician may have several handle assemblies permitting differing levels of insertion of the inner tube 14 into the rectum of a patient.

An insertion assistance shaft 28 is insertable through the inner tube 14 and comprises a first end 29 which, in use, protrudes form the first end of the inner tube. The first end 29 of the insertion assistance shaft 28 is contoured so as to ease insertion of the rectal insertion device 10. The insertion assistance shaft 28 is removable once the rectal insertion device 10 is inserted into the rectum of a patient, permitting access to the interior of the inner tube 14. In use, the second open end 16 of the inner tube 14 protrudes from the second open end 13 of the outer sleeve 11 and the first open end 15 of the inner tube 14 protrudes from the first open end 12 of the outer sleeve 11.

In the embodiment shown in the drawings, the device 10 is provided with an illumination device 30 which illuminates the interior 31 of the inner tube 14 and any internal tissue of a patient visible therethrough. In the embodiment shown in the drawings, the illumination device 30 is mounted on the handle 21such that it is easily operable with the same hand of a physician utilised to manipulate the inner tube 14, thus maintaining a second hand free for other aspects of a procedure. The illumination has an activation switch 32 which may be utilised to switch on or off the illumination device.

The invention is not limited to the embodiment(s) described herein but can be amended or modified without departing from the scope of the present invention. 1. 3. 4. 5. 6. 7. 8.

Claims

CLAIMSA rectal insertion device comprising: a tubular outer sleeve having first open end shaped and dimensioned for insertion into the rectum of a patient and a second open end distal the first open end; and an inner tube comprising first and second open ends, the inner tube being shaped and dimensioned for insertion into the outer sleeve, and being slidable within the outer sleeve in an axial direction and rotatable with respect to the sleeve about the sliding axis; wherein the inner and outer sleeve comprise engagement means therebetween shaped and dimensioned to prevent movement of the second open end of the inner tube into the second open end of the outer sleeve.
The rectal insertion device of claim 1, wherein the outer sleeve comprises an insertion limitation feature engagable with a patient externally of the rectum and configured to limit the extent of insertion of the outer sleeve into the rectum.
The rectal insertion device of claim 1, wherein, in use, internal tissue of a patient is accessible through the inner tube.
The rectal insertion device of claim 1, comprising a user operable control member configured to control movement of the inner tube.
The rectal insertion device of claim 4, wherein the operable control member is a handle attachable to or formed integrally with the inner tube.
The rectal insertion device of claim 4, wherein the control member is attachable to or formed integrally with the second end of the inner tube.
The rectal insertion device of claim 1, wherein the engagement means comprises corresponding engagement features locatable on the inner and outer sleeves configured to limit relative axial movement in a first direction between the inner and outer sleeves.
The rectal insertion device of claim 1, wherein the device comprises a movement restrictor between the inner and outer sleeve configured to limit relative axial movement in at least a second direction between the inner and outer sleeves.
9. The rectal insertion device of claim 7, wherein the inner tube is axially slidable within the outer sleeve in the first direction until engagement of the corresponding engagement features prevents further axial movement in the first direction.
10. The rectal insertion device of claim 8, wherein the inner tube is axially slidable within the outer sleeve in the second direction until the movement restrictor prevents further axial movement in the second direction.
11. The rectal insertion device of claim 7, wherein the corresponding engagement features comprise an inner tube flange locatable substantially at the second end of the inner tube and an outer sleeve flange locatable substantially at the second end of the outer sleeve.
12. The rectal insertion device of claim 11, wherein the outer sleeve flange is formed by the insertion limitation feature.
13. The rectal insertion device of claim 11, wherein the inner tube flange is configured to engage with the outer sleeve flange such that slidable axial movement of the inner tube in the first direction is restricted by said engagement with the outer sleeve flange.
14. The rectal insertion device of claim 8, wherein the movement restrictor comprises a protrusion formed on an outer surface of the inner tube, the protrusion configured to engage with the outer sleeve such that relative axial movement between the inner and outer sleeves is restricted in the second direction.
15. The rectal insertion device of any preceding claim, wherein the open first end of the inner tube comprises an angled transverse opening.
16. The rectal insertion device of claim 15, wherein the angled transverse opening forms a first leading edge of the inner tube and a second leading edge of the inner tube, the first leading edge extending further from the second end of the inner tube than the second leading edge.
17. The rectal insertion device of any preceding claim, wherein an insertion assistance shaft is insertable through the inner tube and comprises a first end which, in use, protrudes form the first end of the inner tube, the first end being configured to ease insertion of the rectal insertion device.
18. The rectal insertion device of claim 17. wherein the insertion assistance shaft is removable once the rectal insertion device is inserted into the rectum of a patient.
19. The rectal insertion device of any preceding claim, wherein, in use, the second open end of the inner tube protrudes from the second open end of the outer sleeve.
20. The rectal insertion device of any preceding claim, wherein, in use, the first open end of the inner tube protrudes from the first open end of the outer sleeve.