Digital Endoscope

Abstract

A portable digital rectosigmoidoscope single-handed, digital intestinal endoscope, used by suitably trained healthcare workers to digitally view the anus, rectum and distal sigmoid colon in people with anorectal symptoms at point of care.

Claims

1. A rigid scope (125) comprising: a rigid shaft (1) and a handle (100) for releasable attachment to the rigid shaft (1); and wherein the handle (100) comprises a detachable lumened manifold (5), wherein the detachable lumened manifold (5) comprises more than one lumen; and an integrated pressurised gas supply.

2. A rigid scope (125) as claimed in claim 1, wherein the manifold comprises a dome valve.

3. A rigid scope (125) as claimed in claim 1 or claim 2 wherein the gas supply is provided by: a bellows (6), a hand pump, an electric pump, a gas cartridge, or a gas canister.

4. A rigid scope (125) as claimed in any preceding claim wherein the lumened manifold (5) comprises one or more channel (13,14,15) for receiving one or more of: a camera; a surgical instrument, a biopsy forceps, pressurised gas, a cauterising coil and a light source.

5. A rigid scope (125) as claimed in claim 4 wherein one or more of the channels further comprise a one-way valve.

6. A rigid scope (125) as claimed in claim 5 wherein the valve is a dome valve.

7. A rigid scope as claimed in any preceding claim wherein the one or more channels (13,14,15) comprise one or more microfilter.

8. A rigid scope as claimed in any preceding claim further comprising one or more of: a lens; and a port for accessing the one or more channel.

9. A rigid scope as claimed in any preceding claim further comprising a gas releaser (7) for use in releasing gas from the patient.

10. A rigid scope as claimed in any preceding claim wherein one or more of the shaft and the manifold are single use.

11. A rigid scope as claimed in any preceding claim wherein the shaft (1) is tapered the proximal end of the shaft having a diameter which exceeds the diameter of the distal end of the shaft.

12. A rigid scope as claimed in any preceding claim wherein the shaft (1) and the handle (100) are arranged at an approximately 20° angle to one another.

13. A rigid scope as claimed in any preceding claim wherein the shaft (1) further comprises a biopsy channel (4).

14. A rigid scope as claimed in any preceding claim wherein the shaft (1) further comprises a graticule.

15. A lumened manifold (5) for use with a rigid scope (125) as claimed in any preceding claim.

16. A scope as claimed in any one of claims 1-14 for use in a one-handed method of viewing the anus, rectum or lower colon.

17. A scope as claimed in any one of claims 1 to 14 for use in the sampling of the rectum and sigmoid colon.

18. A method of treatment comprising inserting a rigid scope as claimed in any one of claims 1 to 13 into the lower colon and sampling, performing biopsy, removing, cauterizing or otherwise treating the lower colon.

19. A method of anorectal diagnosis comprising inserting a rigid scope as claimed in any one of claims 1 to 14 into the anus, rectum or lower colon, viewing, performing biopsy or otherwise examining the anus, rectum or lower colon, and comparing the results with images or biopsies of known normal anus, rectum or lower colon to diagnose disease.

20. A method of diagnosis and treatment, optionally to the anorectal region, comprising a) inserting a rigid scope as claimed in any one of claims 1 to 14 into the anus, rectum or lower colon, viewing, performing biopsy or otherwise examining the anus, rectum or lower colon, and comparing the results with images or biopsies of known normal anus, rectum or lower colon to diagnose disease; and b) treating the anus, rectum or lower colon according to the disease diagnosis in a).

Description

DESCRIPTION OF THE FIGURES

[0075] The invention will now be described with reference to the accompanying diagrammatic drawings in which:

[0076] FIG. 1 is a schematic overview of the invention assembled and disassembled to show the separate components of the device.

[0077] FIG. 2 is an exploded view of the key elements of the device.

[0078] FIG. 3 is view showing the bellows arrangement in the handle in a preferred embodiment.

[0079] FIGS. 4 and 5 is an exploded view of the manifold assembly from a variety of different angles.

[0080] FIG. 6 shows the shaft from a variety of different angles.

DETAILED DESCRIPTION

[0081] The invention relates to a portable digital device. It may be described as a sigmoidoscope, for example a rectosigmoidoscope device. It may be used single-handedly. It may also be described as a digital intestinal endoscope. Optionally, it may be used by suitably trained healthcare workers to digitally view the anus, rectum and colon (optionally the distal sigmoid colon) in people with some or no anorectal symptoms at point of care. In some embodiments, the rigid scope is a digital endoscope.

[0082] The invention will now be described with reference to the figures.

[0083] As shown in FIGS. 1, 2 and 3 the invention comprises a reusable rigid scope, proctoscope, rectoscope, sigmoidoscope, endoscope (these terms will be used interchangeably herein).

[0084] The sigmoidoscope 125 comprises a disposable rigid outer shaft 1 for insertion into the anus and a reusable handle 100.

[0085] Preferably the shaft 1 is sized and shaped to allow it to be comfortably inserted into a patient's lower colon, without risking damage to the structures.

[0086] The disposable rigid sigmoidoscope shaft 1 releasably engages with the reusable handle 100.

[0087] The handle 100 further comprises a disposable manifold 5 a camera channel 24 and a reusable handgrip 8 sized and shaped to be held and operated by a single hand of the operator.

[0088] The handle 100 remains outside the patient throughout the procedure.

[0089] Preferably the shaft 1 has a circular cross section and is tapered so that the distal end of the shaft is narrower than the proximal end of the shaft closest to the handle. A narrower distal end makes it more comfortable for the patient during insertion. A wider proximal end permits the introduction and manipulation of surgical instruments and provides capacity to accommodate a three or more lumened disposable manifold 5.

[0090] The shaft 1 for use in adults is preferably approximately 18 cm in length to allow the 25 cm of the lower colon closest to the anal verge to be examined, sampled or treated.

[0091] More preferably the shaft is less than 21 cm with a graduated diameter from proximal to distal ends as shown in FIG. 6.

[0092] The shaft for use in adults is preferably approximately between 3 and 5 cm in diameter at its widest proximal end and between 1 and 3 cm at its narrowest distal end.

[0093] Other shaft lengths and widths are envisaged for use in smaller or larger patients or for use in paediatrics.

[0094] Optionally the exterior of the shaft may have number markings or a graticule to act as a guide and assist the user when inserting and positioning the shaft in the desired location.

[0095] Achieving control of instruments during procedures is critical for safe execution as shown in FIGS. 1 and 6 the shaft 1 includes an internal biopsy channel 4 which provides a controlled passage for surgical instruments such as biopsy forceps or the like.

[0096] The biopsy channel 4 shown in FIG. 6 is provided inside the shaft 1 and extends from the proximal end of the shaft approximately two thirds of the full length of the shaft. The biopsy channel 4 as may be sized and shaped to receive and guide a variety of different surgical instruments. Surgical instruments are introduced into the biopsy channel 4 and exit the shaft through an opening at the distal end.

[0097] Sheathed within the shaft is an inner obturator 3. The obturator helps guide the sigmoidoscope shaft into position and reduce the discomfort of insertion.

[0098] The obturator comprises a curved elongate U shaped channel, and a solid tip portion of 0.5 to 5 cm in length. The U shaped channel is sized and shaped to accommodate the biopsy channel 4 within the shaft and to enable the obturator to be withdrawn without: being impeded by; or causing damage to the biopsy channel.

[0099] The solid tip protrudes from the distal end of the shaft as shown in FIG. 1 this makes insertion of the shaft into the anus more comfortable. Preferably the solid tip extends between approximately 1-5 cm from the shaft. More preferably the solid tip extends between approximately 2-3 cm from the shaft.

[0100] The obturator is sized and shaped to permit it to be easily withdrawn from the shaft after the sigmoidoscope has been inserted into a patient, leaving the shaft in place inside the patient.

[0101] The obturator is sized and shaped so that is can be easily withdrawn from the shaft without altering the position of the shaft.

[0102] The obturator is formed of a material which has sufficient flexibility to permit it to be easily withdrawn from the shaft without altering the position of the shaft.

[0103] In use the rigid disposable shaft 1 of the sigmoidoscope is inserted into the patient's rectum the obturator is withdrawn and discarded and the reusable handle 100 is releasably attached to the shaft 1.

[0104] More preferably the tip is hinged or otherwise deformable to allow the obturator to be easily withdrawn from the shaft after the sigmoidoscope has been inserted into a patient.

[0105] In an especially preferred embodiment a hinged closure 2 is provided on the tip of the obturator to close the end of the shaft and prevent the shaft becoming blocked with faeces during insertion. After insertion is complete the hinged closure flexes as the obturator is withdrawn from the shaft to allow the obturator to be retracted without damaging or being impeded by the biopsy channel.

[0106] Referring to FIGS. 1, 2 4 and 5.

[0107] The reusable handle 100 comprises a disposable lumened manifold 5 having 3 or more openings to channels 13, 14 and 15 as shown in FIGS. 4 and 5.

[0108] Preferably the disposable lumened manifold 5 is attached to a handgrip 8 by a push-fit arrangement, screw fitting, bayonet fitting or like connection or other types of attachment are also envisaged.

[0109] Preferably the push-fit arrangement is provided by an air barb suitably fashioned to prevent air leaks during insufflation.

[0110] In an especially preferred embodiment the manifold 5 is releasably attached to the handgrip 8 by means of winged projections along the body of the manifold which integrate with the handgrip 8. In an alternative arrangement the reverse configuration is present, with the winged projections are provided on handgrip 8.

[0111] Each of the three or more openings in the disposable lumened manifold 5 shown in FIGS. 4 and 5 are sized and shaped for receiving a device selected from: a camera, a biopsy forceps, a light source, a gas supply, a cauterising tool and a flatus tube.

[0112] The one or more channels 13,14,15 are accessed via a biopsy port 130 shown in FIGS. 1 and 5.

[0113] Preferably adjacent the biopsy port 130 is a recess formed by a curved wall or lip 12 which improves the control and reduces excessive flapping of the end of the biopsy forceps or other instruments as they are withdrawn from the biopsy channel 4.

[0114] This is especially important when retrieving biopsy tissue. As it is difficult to identify the end of the forceps as they are being withdrawn from the biopsy channel and there is a high risk of the end flicking uncontrollably as it is removed leading to the loss of the tissue sample,

[0115] In a preferred embodiment a dome valve is provided in the manifold 5 to receive biopsy forceps or like surgical instruments. The dome valve forms an air tight seal around the biopsy forceps or like surgical instrument as it is inserted into one or the channels 13, 14 or 15 in manifold 5.

[0116] The biopsy forceps are introduced into the manifold through the biopsy port 130. The biopsy forceps extend through the manifold 5 and enter the shaft 1. The biopsy forceps are retained by biopsy channel 4 in the shaft which helps guide the forceps along the shaft to the desired sampling location.

[0117] After sampling is complete the biopsy forceps are withdrawn and back pressure closes the dome valve to provide an air tight seal as the forceps or like surgical instrument are removed to prevent contamination on the reusable elements of the sigmoidoscope.

[0118] Preferably three channels 13, 14 and 15 are provided in the manifold 5 and are positioned as shown in FIG. 5 at an approximately 120° angle to one another.

[0119] The channels may be the same or different sizes. Any suitable arrangement of one or more channel is envisaged. The channels may be equally or unequally spaced.

[0120] Each channel may be dedicated to receive a specific single type of device, alternatively a single channel may be sized to receive any one of a number of different devices.

[0121] Alternatively, a single channel may receive two or more devices.

[0122] Preferably a single channel is shaped and sized to receive a pressurised gas supply and a second device selected from a camera housing, a biopsy forceps, a light source, a flatus tube, and a cauterising/snare coil.

[0123] In a preferred embodiment the manifold is provided with a fourth or more additional channels.

[0124] Preferably each channel is provided with one or more valve to prevent dirty air and liquid expelled from the colon being introduced into the reusable handle 100

[0125] Gas is pumped into the colon to aid viewing. Preferably the gas is air.

[0126] Preferably a bellows 6 is provided in the handgrip 8 as shown in FIGS. 1 and 2 for insufflating air into the bowel in a one handed operation.

[0127] The air travels to the colon via one or more of the channels.

[0128] One or more micro filter is provided in the manifold 5 to prevent dirty air and liquid expelled from the colon being introduced into the reusable handle 100.

[0129] Alternatively, one or more micro filter is located in the reusable handle 100 where it can be changed periodically between sessions.

[0130] The disposable rigid shaft 1 releasably engages with the reusable handle via the disposable manifold 5.

[0131] The disposable manifold 5 releasably engages with the reusable handle 100.

[0132] Preferably the reusable handle 100 further comprises a fixed fully encased camera housing channel 24 for receiving a camera lens. The camera channel is introduced into manifold 5 through one of openings 13, 14 and 15 and extends along shaft 1.

[0133] Preferably a light source is associated with the camera and moves in concert with camera.

[0134] Preferably the light source is an LED light source

[0135] Preferably the camera and/or light source are powered by one or more battery (not shown) which is located internal or external to the device so that the device can be used anywhere.

[0136] Optionally the one or more lumens is sealed at its distal end to retain the camera or other device within the lumen. Preferably the one or more lumens is sealed with a lens.

[0137] In a preferred embodiment two channels 13,14,15 each suited for receiving a camera are provided. The two channels are positioned at an approximately 180° angle to one another.

[0138] The first channel being in the 12 O'clock position and the second being in the 6 O'clock position to ensure that a complete 360° view of the lower colon is possible.

[0139] Alternatively, in use the sigmoidoscope is rotated to obtain a complete 360° view using a single camera channel. Alternatively, in use the manifold 5 is rotated to obtain a complete 360° view using a single camera channel.

[0140] The handgrip 8 is sized and shaped to sit comfortably in the palm of the user.

[0141] The sigmoidoscope provides a closed system for insufflating air into a patient. There is no need for an external air supply. The handgrip comprises a self-contained means for supplying air to the shaft 1. Pressurised air is generated by a bellows 6, electric pump, pressurised air cartridge, canister or the like.

[0142] Preferably the means for supplying air is partially or fully enclosed within the handgrip. More preferably the means for supplying air is actuated by actuating means located on the handle.

[0143] In a preferred embodiment a button not shown in or on the handle may be used to actuate an electric pump or release an air cartridge.

[0144] In an especially preferred embodiment pressurised air is provided by a bellows 6 located in a rigid handgrip 8. Preferably the bellows are located fully or partially within the rigid handgrip. In use the bellows are compressed against the handgrip to insufflate air into the patient in a one-handed procedure.

[0145] The size of the bellows is chosen to optimise the number of compressions required to insufflate the site to be viewed. The larger the bellows the fewer the compressions required to insufflate. In certain conditions, smaller patients or paediatrics smaller bellows may be preferred to provide greater control of the insufflation.

[0146] Preferably a portion of the bellows protrudes from the rigid handgrip 8 and a larger portion of the bellows is contained within a recess in the rigid handgrip. This arrangement enables the bellows to be compressed against a larger surface area of the handgrip during each compression and reduces the number of compressions needed to fully insufflate the patient.

[0147] Preferably the bellows are shaped and sized such that when they are urged against the rigid handgrip fewer than 10, more preferably fewer than 5, and more preferably between 1 and 3 compressions are required to fully insufflate the patient.

[0148] In a preferred embodiment the bellows have a recess 105 for receiving the index finger of the user to improve grip and therefore safety.

[0149] Optionally the handgrip is shaped to include a bump opposite the protruding portion of the bellows for receiving the palm of the user to further improve grip.

[0150] A button 7 is provided on the handle for releasing air from the patient at the end of the procedure. Preferably the button 7 is located to enable it to be easily accessible to the users thumb or fore finger.

[0151] In use air is pumped into the patient from the sigmoidoscope in a single handed procedure. After the examination and any treatment has been completed the button 7 is released in a single handed procedure and the air is expelled from the patient.

[0152] In a first embodiment the handle 100 and the camera housing channel 24 are rigidly connected in a broadly linear arrangement. To enhance user comfort the handgrip 8 is rigidly fixed at a slight angle relative to the camera housing channel 24 and thus in use to the shaft 1 of the sigmoidoscope. Preferably the angle between the handgrip 8 and the camera housing channel 24 is between approximately: 10° and 30° more preferably 15° and 25° more preferably 18° and 23°. More preferably the angle between the handgrip 8 and the camera housing channel 24 is approximately 20°.

[0153] In another embodiment an articulating handle portion (not shown) is connected to the fixed camera housing channel 24. Articulation between the handgrip 8 and the camera housing channel 24 may be achieved using deformable, flexible or plastic materials. Alternatively, articulation between the handgrip and the camera housing channel may be achieved by any movable joint. More preferably the joint should be moveable in 3 planes. More preferably the joint is rotatable such as a ball and socket joint, a swivel joint or the like.

[0154] Preferably the joint is a ball and socket joint.

[0155] In a preferred embodiment the handle portion articulates about a ball and socket joint to aid insertion into the rectum and manipulation thereafter. More preferably the ball and socket joint has a rotation of 20°-25°, 25°-30°, 30°-35°, 35°-40°, 40°-45°, 45°-50°, 50°-55°, 55°-60°, 60°-65°.

[0156] More preferably the ball and socket joint has a rotation of approximately 45° to prevent twisting of the handle relative to the shaft.

[0157] Preferably the joint has a locking means which can be applied before during or after insertion of the sigmoidoscope. Applying the locking means to restrict the movement of the handle may assist with attachment or removal of the component parts.

[0158] More preferably the locking means is located on the handle 100 to enable one handed operation of the sigmoidoscope.

[0159] Applying the locking means to restrict the movement of the handle may assist with insertion of the sigmoidoscope into the rectum.

[0160] Applying the locking means to restrict the movement of the handle portion may assist with removal of the sigmoidoscope from the rectum.

[0161] Applying the locking means to restrict the movement of the handle portion may assist with manipulating, positioning or repositioning the sigmoidoscope to obtain a better, complete or different view of the lower colon.

[0162] Applying the locking means to restrict the movement of the handle portion may assist with manipulating, positioning or repositioning the sigmoidoscope when sampling different sites within the lower colon either by taking one or more biopsy or otherwise.

[0163] Applying the locking means to restrict the movement of the handle portion may assist with manipulating, positioning or repositioning the sigmoidoscope when treating the patient.

[0164] A patient is positioned on an examination couch, preferably in the left lateral position with their knees drawn up and tucked into their chest.

[0165] Optionally the device may be inserted with the patient unconscious in a supine or prone position and the user standing by their side.

[0166] Suitable lubrication is applied to the anus.

[0167] A finger rectal examination is performed to rule out very distal lesions.

[0168] A single-use disposable lumened manifold 5 is connected to the reusable handle 100.

[0169] A rigid disposable shaft is inserted into the patient's rectum with the tip pointing towards the umbilicus.

[0170] The obturator 3 is withdrawn and discarded as clinical waste the camera housing channel 24 is introduced into the shaft and the reusable handle 100 is attached to the shaft via the disposable manifold 5.

[0171] Air is insufflated to distend the rectum sufficiently to permit a 360° examination of the bowel but not to cause discomfort to the patient. Using a screen (not shown) as a guide, the scope is manoeuvred to approximately 25 cm from the anal verge. Additional air can be insufflated to aid the view at this depth.

[0172] The scope is withdrawn preferably at a rate of 0.5 cm per second and a 4-quadrant examination of the bowel is performed every 3 cm by rotating the handle circumferentially.

[0173] Insertion, insufflation, withdrawal, rotation and release of the air are all performed in a one handed operation.

[0174] If a lesion or abnormal cells are identified, a conventional flexible pre-existing biopsy forceps may be inserted into manifold 5 through biopsy port 130. Tissue is sampled or removed in its entirety and retrieved through the biopsy port 130.

[0175] If a lesion or abnormal cells are identified, a range of different conventional surgical instruments such as by way of example only snare forceps, catheter, Raphaelo radio frequency ablation probe etc may be introduced into manifold 5 via one of channels 13, 14 or 14. The instrument is guided along the shaft 1 by biopsy channel 4 to the desired site and the tissue ablated or otherwise treated.

[0176] After the examination and any treatment has been completed button 7 is released in a single-handed procedure and the air is expelled from the patient through one of the channels 13,14,15.

[0177] The camera housing channel 24 camera, and handgrip are released from the shaft and withdrawn from the patient either as a single unit or separately.

[0178] The disposable manifold 8 and shaft 1 are withdrawn from the patient's anus as a single unit and discarded as clinical waste.

[0179] The procedure is easy and comfortable for both the patient and the clinician or user.

[0180] The camera and handgrip are minimally cleaned preferably with Tristel™ trio anti-sporicidal wipes or the like.

[0181] The present invention provides a digital device which can be used to examine, the anus rectum and lower colon and permit abnormal tissue to be sampled or treated in a cost-efficient, rapid, safe, and convenient manner by trained clinicians of either low skill or high skill, in general practice, community or hospital settings.

[0182] The device is safe and comfortable to use for both the patient and the user it provides excellent visualisation of the lower colon in a primary healthcare setting and thus has the potential to reduce colonoscopy referrals.

[0183] High quality digital images captured using the invention can be shared or stored on any USB enabled device.

[0184] The digital images captured using the invention can be used by clinicians to survey, monitor and make new diagnoses.

[0185] Sharing the digital images enables diagnosis and/or training to be provided remotely.

[0186] The digital images obtained using the invention can be used train individuals or machines in how to recognise one or more disease of the lower colon.

[0187] The invention is portable, easy to train and permits immediate examination which improves patient experience and compliance.

[0188] The invention is portable, easy to train and permits immediate examination which improves patient experience and compliance.

[0189] The following is a non-exhaustive list of embodiments: [0190] 1. A reusable rigid scope comprising: [0191] a head portion for releasable attachment to: a conventional single use rigid sigmoidoscope; [0192] a single use lumened manifold; and [0193] an articulated handle. [0194] 2. A scope as claimed in claim 1 wherein the articulated handle is lockable. [0195] 3. A scope as claimed in claim 1 or claim 2 wherein the articulated handle comprises a ball and socket joint. [0196] 4. A scope as claimed in any preceding claim further comprising bellows. [0197] 5. A scope as claimed in any preceding claim wherein the lumened manifold comprises one or more channel for receiving one more of: a camera; a biopsy forceps, a source of pressurised gas a flatus tube, a cauterising coil and a light source. [0198] 6. A scope as claimed in claim 5 wherein the pressurised gas is air. [0199] 7. A scope as claimed in any preceding claim further comprising one or more of: a lens; a light source; a one way valve; a port for accessing the one or more channel of the lumened manifold; and an air filter. [0200] 8. A single use lumened manifold for use with a reusable rigid scope as claimed in any preceding claim. [0201] 9. A scope as claimed in any preceding claim for use in a one-handed method of internal examination of the lower colon. [0202] 10. A scope as claimed in any one of claims 1 to 8 for use in the sampling of the rectum and sigmoid colon. [0203] 11. A method of treatment comprising inserting a scope as claimed in any one of claims 1 to 8 into the lower colon and sampling, biopsying, removing, cauterizing or otherwise treating the lower colon. [0204] 12. A method of diagnosis comprising inserting a scope as claimed in any one of claims 1 to 8 into the lower colon, viewing, biopsying or otherwise examining the lower colon, comparing the results with images or biopsies of known normal lower colon to diagnose disease.