Digital endoscope

Abstract

A portable, digital sigmoidoscope, a single-handed, digital enteroscope used by appropriately trained healthcare personnel to digitally view the anus, rectum, and distal sigmoid colon of patients with anorectal symptoms at the point of care.

Description

Technical Field

[0001] The present invention relates to a digitally enhanced optical rigid sigmoidoscope that provides illumination and digital visualization of the anus, rectum, and sigmoid colon at the point of care.

[0002] The present invention enables the acquisition, storage, and sharing of digital images of the lower colon, rectum, and anus for diagnostic, training, and evidentiary purposes and for surveillance to track disease progression and treatment outcomes. Preferably, through a customized integrated imaging software platform. Background Art

[0003] Colorectal cancer (CRC) is the third most commonly diagnosed malignancy in the world and the fourth leading cause of cancer-related deaths. Incidence varies widely geographically, with a ten-fold difference between men and women worldwide.

[0004] By 2030, the number of new cases is expected to increase by 60%, exceeding 2.2 million cases, with 1.1 million cancer deaths.

[0005] Survival rates are directly proportional to early diagnosis.

[0006] The survival rate for detecting the disease at stage I is as high as 94%.

[0007] The survival rate for detecting the disease at stage II is as high as 82%.

[0008] The survival rate for detecting the disease at stage III is as high as 67%.

[0009] The survival rate for detecting at stage IV is as high as 11%.

[0010] Approximately half of bowel cancers are diagnosed at an advanced stage; at stages 3 and 4, the treatment outcome is poor and the likelihood of premature death is higher.

[0011] Screening is a general term used to describe the assessment of patients for pre-cancerous or early cancer before the onset of symptoms. The purpose of screening is to detect early disease with a more favorable survival and outcome. Patients who meet one or more eligibility criteria should be routinely screened for bowel cancer. Alternatively, screening can be performed at the request of the patient or clinician. Bowel screening may be requested with or without symptoms.

[0012] Alternatively, bowel screening can be carried out as part of a national screening program.

[0013] Screening programs operate in some countries (notably the United States and the United Kingdom). However, New Zealand does not have a screening program, even though rectal cancer deaths are the leading cause of cancer-related deaths among Maori.

[0014] In countries where screening is available, screening usually starts at or around 55 years of age and is repeated regularly (usually every two years) until 74 years of age. Screening can detect bowel cancer or pre-cancerous conditions at an early stage when treatment is more effective. Bowel screening can also be used to identify and remove growths or polyps that are pre-cancerous in the bowel, thus preventing the onset of cancer. There is an established and widely accepted evidence base that screening can save lives and prevent premature death.

[0015] The incidence of bowel cancer in younger populations is rising, and the incidence in those under 45 years of age doubles every year.

[0016] Up to 42% of malignancies occur within 25 cm of the anal verge. These are known as rectal cancers. The prognosis for rectal cancers is worse than for tumours of the same grade and stage that occur more than 25 cm from the anal verge.

[0017] Currently, a range of invasive and non-invasive bowel cancer screening tests are available by way of example only.

[0018] Fecal Immunochemical Test (FIT)

[0019] The FIT test is a simple, reliable and inexpensive laboratory-based analysis for home testing.

[0020] Patients collect a single stool sample at home and send it to the laboratory for analysis. There is minimal embarrassment, and the compliance rate is reasonable, ranging from 60% to 70%.

[0021] The FIT test can identify the presence of blood in the stool, which may be a sign of cancer. If a positive result is obtained, it indicates that further tests are required, which usually include a colonoscopy (examination) or a CT scan of the colon.

[0022] Earlier stool testing kits used guaiac-based technology (gFOBT), which could detect blood in three separate stool samples. In the UK, the guaiac test has been gradually replaced by FIT, which is more acceptable to patients as it relies on a single test. In the UK alone, the adoption of FIT is expected to improve compliance with screening and lead to at least 100,000 additional endoscopic examinations per year.

[0023] Flexible sigmoidoscopy / colonoscopy screening Is an invasive screening test that can examine and biopsy the lower colon if necessary.

[0024] A flexible sigmoidoscope is inserted through the anus for examination. The colon is insufflated with air from an external source to insufflate the colon with gas and open mucosal folds for better visualization. A flexible sigmoidoscope can be used to examine and biopsy the rectum, sigmoid colon, and descending colon. Forty-nine to sixty-two percent of all colorectal malignancies can be detected by flexible sigmoidoscopy.

[0025] The Bowel Endoscopy Programme in the UK currently offers one endoscopic examination to all patients at the age of 55 years, using a flexible sigmoidoscope. This screening intervention can reduce a person's lifetime risk of dying from colorectal cancer by 40%. See Atkin WS, Edwards R, Kralj-Hans I, Wooldrage K, Hart AR, Northover JM et al., Once-only flexible sigmoidoscopy screening in prevention of colorectal cancer: a multicentre randomised controlled trial, Lancet, 2010; 375(9726): 1624 - 33.

[0026] During a flexible sigmoidoscopy, polyps or precancerous growths can be identified and removed, and / or one or more biopsies can be taken if an abnormal area of the colon is seen.

[0027] Flexible sigmoidoscopy is an invasive procedure that is only available in accredited endoscopy units, where strict management and quality performance frameworks must be met annually. Endoscopic equipment must be highly disinfected and sterilized between each patient, which is both time-consuming and expensive.

[0028] When the risk of malignancy is 3% or higher, regulatory bodies in the UK (such as NICE) recommend the use of endoscopy. Therefore, in most developed countries, endoscopy services remain the single most strained diagnostic service within the NHS and healthcare systems.

[0029] Access to the endoscopy department requires a separate hospital appointment, and the patient must be counselled and give their consent prior to this.

[0030] The patient must have mechanical bowel preparation 24 hours before the examination.

[0031] These limitations prevent clinicians from making a diagnosis immediately when the patient first presents at the outpatient clinic. Due to these limitations, risk-averse clinicians cannot safely rule out the disease, especially in very young or other low-risk patients, and thus tend to over-refer to colonoscopy, an expensive and unpleasant procedure.

[0032] The huge referral burden places great pressure on colonoscopy kits, which are scarce, costly to set up, operate, and staff.

[0033] Rigid sigmoidoscopy / proctoscopy

[0034] Traditional bedside examinations of the anus and rectum are limited to proctoscopes and rigid sigmoidoscopes. These practices rely on the use of inert disposable plastic tubes, which are proctoscopes and rigid sigmoidoscopes with built-in or external light sources.

[0035] In current clinical practice, rigid sigmoidoscopes are commonly used for intraluminal evaluation of the distal gastrointestinal tract; up to 25 cm from the anal verge. A typical instrument setup includes four main components: a light source (internal or external), a rigid tube / sheath with a stuffing piece, a head with a sealed viewing window and a fiber optic light connection, and a blowing bellows. A typical system allows the introduction of biopsy forceps, tubes, needles, and other instruments, but when the viewing window is opened, the line of sight is blocked and it is performed in a non-airtight state, so intestinal insufflation is lost, which may lead to missed cancer diagnoses and sampling errors. An increasing number of rigid sigmoidoscope assemblies are single-use disposable systems, produced by companies such as Rocket Medical Ltd and THD-UK Ltd. Most are self-lubricating, and the average length of the endoscope is between 20 and 25 cm, with a diameter of up to 24 cm. The rigid tube is first inserted into the anus through the stuffing piece, which acts as a smooth trocar to guide the tough anal muscles. Once inserted, the stuffing piece is moved away from the proximal end, and the glass window is closed. The glass window is also the light transmission mechanism for the internal or external light source. Then, the connected bellows is squeezed with the other hand to deliver air into the rectum, and look directly down through the optical window to obtain the field of view.

[0036] Reusable rigid sigmoidoscopes made of stainless steel are also well-known and require a high level of disinfection between uses.

[0037] Conventional rigid sigmoidoscopes and proctoscopes are impractical due to prohibitively high post - processing costs, difficult to use, and have low patient satisfaction and diagnostic value. See Rao VS, Ahmad N, Al - Mukhtar A, Stojkovic S, Moore PJ, Ahmad SM's Comparison of rigid vs flexible sigmoidoscopy in detection of significant anorectal lesions, Colorectal disease: the official journal of the Association of Coloproctology of Great Britain and Ireland, 2005; 7(1):61 - 4.

[0038] Anderson O, Afolayan JO, Ni Z, Bates T, Surgical vs general practitioner assessment: diagnostic accuracy in 2 - week - wait colorectal cancer referrals, Colorectal disease: the official journal of the Association of Coloproctology of Great Britain and Ireland, 2011; 13(8):e212 - 5.

[0039] Due to the inherent challenges in performing these procedures, most experts have largely abandoned them.

[0040] Even a skilled surgeon may find the process clumsy, uncomfortable, and difficult to perform. Rigid sigmoidoscopes have a fixed handle that requires the clinician to bend excessively, use both hands, and rotate the wrist with high tension to maneuver the sigmoidoscope into position.

[0041] Similarly, in larger patients, the buttocks may impede the accurate positioning of the sigmoidoscope.

[0042] If it is necessary to reposition the sigmoidoscope to ensure a complete 360° view of the lower colon and rectum, or if a biopsy specimen needs to be taken, it is common to rest on the patient's anus and pivot the endoscope, which can be painful for the patient.

[0043] Air is pumped into the rectum using a device configured as a manual pump (bellows) using a bladder and awkward hand manipulation, which is even more difficult in larger patients in whom the buttocks must be supported to allow accurate positioning of the sigmoidoscope.

[0044] The operator must position themselves appropriately to allow observation through the sigmoidoscope, which can be difficult, obscured, localized, or embarrassing for the operator depending on the patient's specific anatomy. This also makes the procedure inevitably unhygienic as it requires the operator's face to be close to the patient's buttocks and anus.

[0045] Examinations using this technique are basic and generally unreliable as clinicians have only small and embarrassing fields of view.

[0046] In addition, reusable components are difficult to clean and pose an infection risk, while disposable components are expensive. The air filter, which must be replaced between each patient, is difficult to remove and replace, so surgeons may be reluctant to change the filter, which presents an additional risk of cross-infection.

[0047] Conventional rigid sigmoidoscopes have only ever been used as an adjunct to detailed examinations using colonoscopes.

[0048] The need to admit the patient to hospital is expensive, time-consuming, embarrassing, and further reduces patient compliance.

[0049] The inability to acquire, store, or share images with the patient or colleagues or for surveillance purposes can compromise patient and clinician satisfaction with the procedure.

[0050] Colonoscopy

[0051] Colonoscopy is an invasive, expensive, hospital-based examination that can only be performed by an experienced gastroenterologist during surgery because of its low risk of perforation that may require surgery.

[0052] Before the procedure, the patient must undergo bowel preparation by taking oral preparations to mechanically empty the bowel. This is disturbing and not suitable for patients with limited mobility and poor kidney function. It can also cause fecal incontinence. On the day of the procedure, the gastroenterologist inserts an observation tube (colonoscope) into the rectum to examine the colon. During colonoscopy, polyps or precancerous growths can be removed, bleeding may be cauterized, and a biopsy can be taken if an abnormal area of the colon is seen.

[0053] Colonoscopy is a procedure that enables a gastroenterologist to evaluate the interior of the entire length of the colon (large intestine or large bowel). A colonoscope is a four-foot-long flexible tube, about the thickness of a finger, with a camera and light source at the tip. The tip of the colonoscope is inserted into the anus and slowly advanced under visual control into the rectum and through the colon, typically as far as the cecum, which is the first part of the colon.

[0054] Colonoscopy may be performed for a variety of reasons. The vast majority of colonoscopies are performed as part of a colon cancer screening program or to rule out cancer when symptoms occur. These include blood in the stool, abdominal pain, diarrhea, changes in bowel habits, and abnormalities detected on a colon X-ray or computed axial tomography (CT) scan.

[0055] Colonoscopy is embarrassing, invasive, inconvenient, and unpleasant for the patient and requires full or partial sedation with associated costs and risks.

[0056] Depending on the nature of any symptoms, one or more bowel screening tests may be offered to the patient.

[0057] FIT / FOBt screening can also be used to assess the suitability for colonoscopy. Sigmoidoscopy screening can also be used to assess the suitability for colonoscopy.

[0058] The global demand for colonoscopies is increasing year by year. Using current screening programs, in the UK alone, the estimated referral rate for colonoscopies is expected to reach 1.7 million by 2020. There is a need to reduce the number of colonoscopy referrals.

[0059] To reduce unnecessary colonoscopy referrals and improve the diagnostic accuracy for a range of life-threatening and serious diseases, there is an urgent need for a comfortable, reliable, efficient, cost-effective, and simple screening method for classifying anorectal symptoms. The procedure should be safely performed by less skilled non-experts. Providing these procedures in primary healthcare settings can also improve patient compliance and provide rapid, reliable diagnosis without the need to attend a hospital or undergo further tests.

[0060] There is a further need for a procedure that can identify, monitor, and treat rectal lesions, malignancies, or other diseases. There is also a need for a device that can rapidly and easily obtain high-quality endoscopic visualization data at the bedside by relatively low-skilled healthcare professionals, thus avoiding referral to a formal endoscopy suite.

[0061] US 6,447,444 describes a video endoscope having a generally rigid, elongated insertion member having a distal end and a proximal end; and a video camera head fixed to the distal end of the insertion member. A sheath is fitted over the insertion member and covers the insertion member, the sheath having a distal portion covering the video camera head, at least a portion of the distal portion being substantially transparent. The distal portion of the sheath also includes a narrowed tip including two or more vanes that close during insertion through the anus and open after insertion to expose the transparent portion of the distal portion of the sheath. Summary of the Invention

[0062] According to the present invention, there is provided a rigid endoscope (125) comprising:

[0063] a rigid shaft (1) and a handle (100) for releasably attaching to the rigid shaft (1); and

[0064] wherein the handle (100) includes a detachable, lumen-containing manifold (5); and an integral pressurized gas supply.

[0065] In some embodiments, the gas supply is provided by one of the following means: a bellows (6), a manual pump, an electric pump, a syringe, or a gas cylinder.

[0066] In some embodiments, the lumen-containing manifold (5) includes one or more channels (13, 14, 15) for receiving one or more of the following: a camera; a surgical instrument, a biopsy forceps, a pressurized gas, a cautery coil, and a light source.

[0067] In some embodiments, one or more of the channels also include a one-way valve. In some embodiments, the valve is a dome valve. In some embodiments, one or more of the channels (13, 14, 15) include one or more microfilters.

[0068] In some embodiments, the rigid endoscope further includes one or more of the following: a lens; and a port for accessing one or more channels. In some embodiments, the rigid endoscope further includes a gas release device (7) for releasing gas from the patient.

[0069] In some embodiments, one or more of the shaft and the manifold are single-use. In some embodiments, the shaft (1) is tapered, the proximal end of the shaft having a diameter greater than the diameter of the distal end of the shaft.

[0070] In some embodiments, the shaft (1) and the handle (100) are arranged at an angle of approximately 20 degrees to each other. In some embodiments, the shaft (1) further includes a biopsy channel (4). In some embodiments, the shaft (1) further includes scale marks.

[0071] In another aspect of the present invention, there is provided a lumen-containing manifold for use with a rigid endoscope (125) as described herein.

[0072] In another aspect, the present invention relates to a single-handed method of viewing the anus, rectum or lower colon.

[0073] In another aspect, the present invention relates to a rigid endoscope for sampling of the rectum and sigmoid colon.

[0074] In another aspect, the present invention relates to a method of treatment which comprises inserting an endoscope into the lower colon and taking a sample; performing a biopsy; removing, cauterizing or otherwise treating the lower colon.

[0075] In another aspect, the present invention relates to a method of diagnosing the anorectum which comprises inserting a rigid endoscope into the anus, rectum or lower colon; observing, performing a biopsy or otherwise examining the anus, rectum or lower colon and comparing the results with images or biopsies of a known normal anus, rectum or lower colon in order to diagnose a disease.

[0076] In another aspect, the present invention relates to a method of diagnosis or treatment which comprises the methods described herein. In one aspect, there is provided a method of optionally diagnosing and treating the anorectal region which comprises:

[0077] a) inserting a rigid endoscope as described in any of the foregoing aspects into the anus, rectum or lower colon, observing, performing a biopsy or otherwise examining the anus, rectum or lower colon and comparing the results with images or biopsies of a known normal anus, rectum or lower colon in order to diagnose a disease; and

[0078] b) treating the anus, rectum or lower colon according to the disease diagnosis in a). BRIEF DESCRIPTION OF THE DRAWINGS

[0079] The present invention will now be described with reference to the accompanying schematic drawings, in which:

[0080] Figure 1 is a schematic general view of the present invention assembled and disassembled, the latter being shown disassembled to illustrate the separate components of the device.

[0081] Figure 2 is an exploded view of the key elements of the device.

[0082] Figure 3 is a view showing the bellows arrangement in the handle in one preferred embodiment.

[0083] Figure 4 and Figure 5 are exploded views of the manifold assembly viewed from various different angles.

[0084] Figure 6The shaft is shown from various different perspectives. Detailed Description

[0085] The present invention relates to a portable digital device. It can be described as a sigmoidoscope, for example a rectosigmoidoscope device. It can be used with one hand. It can also be described as a digital enteroscope. Optionally, it can be used by appropriately trained healthcare personnel for digitally viewing the anus, rectum, and colon (optionally the distal sigmoid colon) in people with some or no anorectal symptoms at the point of care. In some embodiments, the rigid endoscope is a digital endoscope.

[0086] The present invention will now be described with reference to the accompanying drawings.

[0087] As Figure 1 、 2 and 3 show, the present invention includes a reusable rigid endoscope, a proctoscope, a rectoscope, a sigmoidoscope, an endoscope (these terms will be used interchangeably herein).

[0088] The sigmoidoscope 125 includes a disposable rigid outer shaft 1 for insertion into the anus and a reusable handle 100.

[0089] Preferably, the size and shape of the shaft 1 allow it to be comfortably inserted into the lower colon of a patient without damaging the structure.

[0090] The shaft 1 of the disposable rigid sigmoidoscope is releasably engaged with the reusable handle 100.

[0091] The handle 100 further includes a disposable manifold 5, a camera channel 24, and a reusable handle 8, the size and shape of the handle being designed to be held and operated by an operator's single hand.

[0092] During the entire procedure, the handle 100 remains outside the patient's body.

[0093] Preferably, the shaft 1 has a circular cross-section and is tapered such that the distal end of the shaft is narrower than the proximal end of the shaft closest to the handle. The narrower distal end makes it more comfortable for the patient during insertion. The wider proximal end allows the introduction and manipulation of surgical instruments and provides the ability to accommodate three or more disposable lumen manifolds 5.

[0094] The length of the shaft 1 for use in adults is preferably about 18 cm to allow examination, sampling, or treatment of the 25 cm closest to the anal margin of the lower colon.

[0095] More preferably, the shaft is less than 21 cm and has a tapered diameter from the proximal end to the distal end, as Figure 6 shown.

[0096] The shaft for adults preferably has a diameter between about 3 and 5 cm at its widest proximal end and between about 1 and 3 cm at its narrowest distal end.

[0097] It is contemplated that other shaft lengths and widths can be used for smaller or larger patients or for pediatrics.

[0098] Optionally, the exterior of the shaft can have numerical markings or graduations to serve as a guide and assist the user when inserting and positioning the shaft in the desired location.

[0099] As Figure 1 and 6 shown, achieving control of the instrument during the surgical procedure is crucial for safe execution. The shaft 1 includes an internal biopsy channel 4 that provides a controlled passage for surgical instruments (such as biopsy forceps or the like).

[0100] Figure 6 The biopsy channel 4 shown is disposed inside the shaft 1 and extends from the proximal end of the shaft to approximately two-thirds of the full length of the shaft. The size and shape of the biopsy channel 4 can be configured to receive and guide various different surgical instruments. The surgical instrument is introduced into the biopsy channel 4 and exits the shaft through an opening at the distal end.

[0101] Inside the shaft is an inner sheath with an internal packing member 3. The packing member helps guide the sigmoidoscope shaft into place and reduces the discomfort of insertion.

[0102] The packing member includes a curved, elongated U-shaped channel and a solid tip portion that is 0.5 to 5 cm in length. The size and shape of the U-shaped channel are designed to accommodate the biopsy channel 4 within the shaft and to allow the packing member to be withdrawn without being obstructed by or damaging the biopsy channel.

[0103] As Figure 1 shown, the solid tip protrudes from the distal end of the shaft, which makes the insertion of the shaft into the anus more comfortable. Preferably, the solid tip extends from the shaft between about 1 - 5 cm. More preferably, the solid tip extends from the shaft between about 2 - 3 cm.

[0104] The size and shape of the packing member are designed to allow it to be easily withdrawn from the shaft after the sigmoidoscope has been inserted into the patient while leaving the shaft in the proper position within the patient.

[0105] The size and shape of the packing member are designed to be easily withdrawn from the shaft without changing the position of the shaft.

[0106] The packing member is formed of a material with sufficient flexibility to allow it to be easily withdrawn from the shaft without changing the position of the shaft.

[0107] In use, the rigid disposable shaft 1 of the sigmoidoscope is inserted into the rectum of a patient, the packing member is withdrawn and discarded, and the reusable handle 100 is releasably attached to the shaft 1.

[0108] More preferably, the tip is articulated or otherwise deformable so that after the sigmoidoscope is inserted into the patient, the packing member can be easily withdrawn from the shaft.

[0109] In a particularly preferred embodiment, an articulated closure 2 is provided at the tip of the packing member to close the end of the shaft and prevent the shaft from being blocked by feces during insertion. After insertion is complete, as the packing member is withdrawn from the shaft, the hinged closure will bend to allow the packing member to retract without damaging or being impeded by the biopsy channel.

[0110] Refer to Figure 1 、 2 、4 and 5.

[0111] The reusable handle 100 includes a disposable, lumen-containing manifold 5 having three or more openings leading to channels 13, 14, and 15, as Figure 4 and 5 shown.

[0112] Preferably, it is also contemplated that the disposable, lumen-containing manifold 5 is attached to the handle 8 by a push-fit device, screw fit, bayonet fit, or similar connection or other type of attachment.

[0113] Preferably, the push-fit device is provided by an air barb that is suitably configured to prevent air leakage during insufflation.

[0114] In a particularly preferred embodiment, the manifold 5 is releasably attached to the handle 8 by means of wing-like protrusions along the body of the manifold that are integral with the handle 8. In an alternative arrangement, the opposite configuration is presented, with wing-like protrusions provided on the handle 8.

[0115] In Figure 4 and Figure 5 each of the three or more openings in the disposable, lumen-containing manifold 5 shown is sized and shaped to receive a device selected from the group consisting of: a camera, biopsy forceps, a light source, a gas supply, a cautery tool, and an exhaust tube.

[0116] Via Figure 1 and Figure 5 shown biopsy port 130, one or more channels 13, 14, 15 are accessed.

[0117] Preferably, near the biopsy port 130 is a recess formed by a curved wall or lip 12 that improves control and reduces excessive flapping of the end of the biopsy forceps or other instrument when the biopsy forceps or other instrument is withdrawn from the biopsy channel 4.

[0118] This is particularly important when retrieving biopsy tissue. Since it is difficult to determine the end of the forceps when withdrawing it from the biopsy channel, and there is a high risk of uncontrollable flicking of the end during removal, which can result in loss of the tissue sample.

[0119] In a preferred embodiment, a dome valve is provided in the manifold 5 to receive the biopsy forceps or a similar surgical instrument. When the biopsy forceps or a similar surgical instrument is inserted into one or more of the channels 13, 14, or 15 in the manifold 5, the dome valve forms an airtight seal around the biopsy forceps or a similar surgical instrument.

[0120] The biopsy forceps are introduced into the manifold through the biopsy port 130. The biopsy forceps pass through the manifold 5 and into the shaft 1. The biopsy forceps are held in the shaft by the biopsy channel 4, which helps to guide the forceps along the shaft to the desired sampling location.

[0121] After sampling is completed, the biopsy forceps are removed, and backpressure closes the dome valve to provide an airtight seal when removing the forceps or a similar surgical instrument to prevent contamination of the reusable elements of the sigmoidoscope.

[0122] Preferably, three channels 13, 14, and 15 are provided in the manifold 5 and are positioned at approximately 120° angles to each other as Figure 5 shown.

[0123] The channels can have the same or different sizes. Any suitable arrangement of one or more channels is contemplated. The channels can be equally or unequally spaced.

[0124] Each channel can be dedicated to receiving a specific single type of device, or the size of a single channel can be set to receive any one of a plurality of different devices.

[0125] Alternatively, a single channel can receive two or more devices.

[0126] Preferably, the shape and size of a single channel are designed to receive a pressurized gas supply and a second device selected from a camera housing, biopsy forceps, light source, exhaust pipe, and cautery / snare coil.

[0127] In a preferred embodiment, the manifold is provided with a fourth or more additional channels.

[0128] Preferably, each channel is provided with one or more valves to prevent dirty air and liquid discharged from the colon from being introduced into the reusable handle 100.

[0129] Gas is pumped into the colon to assist with visualization. Preferably, the gas is air.

[0130] Preferably, as Figure 1 and Figure 2 shown, a bellows 6 is provided in the handle 8 for injecting air into the intestine with one - hand operation.

[0131] Air enters the colon through one or more channels.

[0132] One or more micro - filters are provided in the manifold 5 to prevent dirty air and liquid discharged from the colon from being introduced into the reusable handle 100.

[0133] Alternatively, one or more micro - filters are located in the reusable handle 100 at a position where it can be periodically changed between stages.

[0134] The disposable rigid shaft 1 is releasably engaged with the reusable handle via a disposable manifold 5.

[0135] The disposable manifold 5 is releasably engaged with the reusable handle 100.

[0136] Preferably, the reusable handle 100 further includes a fixed fully - encapsulated camera housing channel 24 for receiving the camera lens. The camera channel is introduced into the manifold 5 through one of the openings 13, 14, and 15 and extends along the shaft 1.

[0137] Preferably, the light source is associated with the camera and moves in unison with the camera.

[0138] Preferably, the light source is an LED light source.

[0139] Preferably, the camera and / or the light source is powered by one or more batteries (not shown) located inside or outside the device, such that the device can be used anywhere.

[0140] Optionally, one or more cavities are sealed at their distal ends to hold a camera or other device within the cavity. Preferably, one or more cavities are sealed with a lens.

[0141] In a preferred embodiment, two channels 13, 14, 15 are provided, each suitable for receiving a camera. The two channels are positioned at an angle of approximately 180° to each other. The first channel is located at the 12 o'clock position and the second channel is located at the 6 o'clock position to ensure a complete 360° view of the lower colon.

[0142] Alternatively, in use, the sigmoidoscope is rotated to obtain a complete 360° field of view using a single camera channel. Alternatively, in use, the manifold 5 is rotated to obtain a complete 360° field of view using a single camera channel.

[0143] The size and shape of the handle 8 are designed to be comfortably placed in the user's palm.

[0144] The sigmoidoscope provides a closed system for blowing air into the patient's body. No external air supply is required. The handle includes a separate device for supplying air to the shaft 1. Compressed air is generated by the bellows 6, an electric pump, a compression cylinder, a tank or the like.

[0145] Preferably, the device for supplying air is partially or completely enclosed within the handle. More preferably, the device for supplying air is actuated by an actuating device located on the handle.

[0146] In a preferred embodiment, a button (not shown) in or on the handle can be used to actuate the electric pump or release the cylinder.

[0147] In a particularly preferred embodiment, compressed air is provided by the bellows 6 located within the rigid handle 8. Preferably, the bellows is completely or partially located within the rigid handle. In use, the bellows is pressed against the handle to blow air into the patient in a one-handed manner.

[0148] The size of the bellows is selected to optimize the number of compressions required to blow air into the area to be observed. The larger the bellows, the fewer compressions required to blow air. In some cases, for smaller or pediatric patients, a smaller bellows is preferably used to better control the air blowing.

[0149] Preferably, a portion of the bellows protrudes from the rigid handle 8 and a larger portion of the bellows is received within a recess of the rigid handle. This arrangement allows the bellows to be pressed against a larger surface area of the handle during each compression and reduces the number of compressions required to fully inflate the patient.

[0150] Preferably, the shape and size of the bellows are such that when they are pressed against the rigid handle, less than 10 compressions, more preferably less than 5 compressions, and even more preferably between 1 and 3 compressions are required to fully inflate the patient.

[0151] In a preferred embodiment, the bellows has a recess 105 for receiving the user's index finger to improve the grip and thus improve safety.

[0152] Optionally, the shape of the handle is such that it includes a bulge opposite the protruding portion of the bellows to receive the user's palm to further improve the grip.

[0153] A button 7 is provided on the handle for releasing air from the patient at the end of the operation. Preferably, the button 7 is positioned such that it can be easily accessed by the user's thumb or index finger.

[0154] In use, air is pumped into the patient from the sigmoidoscope by a one-handed method. After the examination and any treatment have been completed, the button 7 is released by a one-handed method and the air is expelled from the patient.

[0155] In the first embodiment, the handle 100 and the camera housing passage 24 are rigidly connected in a substantially linear arrangement. To improve the user's comfort, the grip 8 is rigidly fixed at a slight angle relative to the camera housing passage 24 and is thus fixed to the axis 1 of the sigmoidoscope in use. Preferably, the angle between the grip 8 and the camera housing passage 24 is between about 10° and 30°, more preferably between 15° and 25°, and even more preferably between 18° and 23°. Even more preferably, the angle between the grip 8 and the camera housing passage 24 is about 20°.

[0156] In another embodiment, a hinged handle portion (not shown) is connected to the fixed camera housing passage 24. The hinge between the grip 8 and the camera housing passage 24 can be achieved using a deformable, flexible or plastic material. Alternatively, the hinge between the handle and the camera housing passage can be achieved by any movable joint. More preferably, the joint should be movable in three planes. More preferably, the joint is rotatable, such as a ball and socket joint, a swivel joint or the like.

[0157] Preferably, the joint is a ball and socket joint.

[0158] In a preferred embodiment, the handle portion is hinged about a ball and socket joint to assist in insertion into the rectum and subsequent manipulation. More preferably, the rotational angle of the ball and socket joint is 20° - 25°, 25° - 30°, 30° - 35°, 35° - 40°, 40° - 45°, 45° - 50°, 50° - 55°, 55° - 60°, 60° - 65°.

[0159] Even more preferably, the ball and socket joint has a rotation of about 45° to prevent twisting of the handle relative to the axis.

[0160] Preferably, the joint has a locking device that can be used before, during or after insertion of the sigmoidoscope. Applying the locking device to restrict the movement of the handle can assist in the attachment or removal of the components.

[0161] Even more preferably, the locking device is located on the handle 100 to enable one-handed operation of the sigmoidoscope.

[0162] Applying the locking device to restrict the movement of the handle can assist in inserting the sigmoidoscope into the rectum.

[0163] Applying the locking device to restrict the movement of the handle portion can assist in removing the sigmoidoscope from the rectum.

[0164] Applying a locking device to restrict movement of the handle portion can assist in the manipulation, positioning, or repositioning of the sigmoidoscope to obtain a better, complete, or different field of view of the lower colon.

[0165] When sampling different sites within the lower colon by performing one or more biopsies or otherwise, applying a locking device to restrict movement of the handle portion can assist in the manipulation, positioning, or repositioning of the sigmoidoscope.

[0166] Applying a locking device to restrict movement of the handle portion can assist in the manipulation, positioning, or repositioning of the sigmoidoscope when treating a patient.

[0167] Place the patient on the examination table, preferably in the left lateral decubitus position, with the knees raised and tucked into the chest.

[0168] Optionally, the device can be inserted with the patient unconscious in the supine or prone position and the user standing beside them.

[0169] Properly lubricate the anus.

[0170] Perform a digital rectal examination to rule out very distal lesions.

[0171] The single-use disposable cannulated manifold 5 is connected to the reusable handle 100.

[0172] Insert the rigid disposable shaft into the patient's rectum with its tip pointing towards the umbilicus.

[0173] 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 through the disposable manifold 5.

[0174] Blow air to fully distend the rectum to allow a 360° examination of the bowel without causing discomfort to the patient. Using a screen (not shown) as a guide, manoeuvre the endoscope to a position approximately 25 cm from the anal verge. Additional air can be insufflated to aid in visualization at this depth.

[0175] Preferably, withdraw the endoscope at a rate of 0.5 cm per second and perform a four - quadrant examination of the bowel every 3 cm by rotating the handle circumferentially.

[0176] Insertion, insufflation, withdrawal, rotation, and release of air are all performed with a single hand.

[0177] If a lesion or abnormal cells are identified, a conventional flexible pre - existing biopsy forceps can be inserted into the manifold 5 through the biopsy port 130. The tissue is sampled en bloc or removed and then retrieved through the biopsy port 130.

[0178] If a lesion or abnormal cells are identified, a variety of different conventional surgical instruments can be introduced into the manifold 5 through one of the channels 13, 14 or 15, for example: by way of example only, snare forceps, catheters, Raphaeloradio frequency ablation probes, etc. The instrument is guided along the axis 1 by the biopsy channel 4 to the desired site, and the tissue is ablated or otherwise treated.

[0179] After the examination and any treatment have been completed, the release button 7 is released with a single-handed operation, and air is discharged from the patient through one of the channels 13, 14, 15.

[0180] The camera housing channel 24, the camera and the handle are released from the axis and then withdrawn from the patient either as a single unit or separately.

[0181] The disposable manifold 8 and the axis 1 are removed from the patient's anus as a single unit and discarded as clinical waste.

[0182] For the patient as well as the clinician or user, the operation is easy and comfortable.

[0183] Preferably, TristelTM trio anti-sporicidal wipes or the like are used to minimally clean the camera and the handle.

[0184] The present invention provides a digital device that can be used to examine the anorectum and lower colon and allows abnormal tissue to be sampled or treated in a cost-effective, rapid, safe and convenient manner by less skilled or experienced trainee clinicians in a general practice, community or hospital setting.

[0185] The device is safe and comfortable for both the patient and the user, and it can well display the lower colon in major medical institutions, so it is possible to reduce referrals for colonoscopy.

[0186] The high-quality digital images obtained using the present invention can be shared or stored on any USB-enabled device.

[0187] The digital images obtained using the present invention can be used by clinicians to investigate, monitor and make new diagnoses.

[0188] Sharing the digital images enables remote diagnosis and / or training to be provided.

[0189] The digital images obtained using the present invention can be used to train individuals or machines on how to identify one or more diseases of the lower colon.

[0190] The present invention is portable, easy to train, and allows for immediate inspection, which improves the patient experience and compliance.

[0191] The present invention is portable, easy to train, and allows for immediate inspection, which improves the patient experience and compliance.

[0192] The following is a non-exhaustive list of examples:

[0193] Example 1. A reusable rigid endoscope, comprising:

[0194] A head portion for releasably attaching to: a conventional single-use rigid sigmoidoscope;

[0195] A single-use lumen manifold; and

[0196] An articulated handle.

[0197] In one embodiment, the articulated handle is lockable.

[0198] In one embodiment, the articulated handle includes a ball and socket joint.

[0199] In one embodiment, a bellows is further included.

[0200] In one embodiment, the lumen manifold includes one or more channels for receiving one or more of the following: a camera; biopsy forceps, a pressurized gas source, an exhaust pipe, a cautery coil, and a light source.

[0201] In one embodiment, the pressurized gas is air.

[0202] In one embodiment, one or more of the following are further included: a lens; a light source; a one-way valve; ports for accessing one or more channels of the lumen manifold; and an air filter.

[0203] A single-use lumen manifold for use with the reusable rigid endoscope according to any of the above embodiments.

[0204] Use of the endoscope according to any of the above embodiments in a one-handed method for internal examination of the lower colon.

[0205] Use of the endoscope according to any of the above claims in sampling of the rectum and sigmoid colon.

[0206] A treatment method, comprising inserting the endoscope according to any of the above embodiments into the lower colon and sampling, biopsying, removing, cauterizing, or otherwise treating the lower colon.

[0207] A diagnostic method includes inserting the endoscope according to any of the above embodiments into the lower colon, observing, biopsying, or otherwise examining the lower colon, and comparing the results with images or biopsies of a known normal lower colon to diagnose a disease.

Claims

1. A rigid endoscope (125), comprising: a rigid shaft (1); and a handle (100) for releasably attaching to the rigid shaft (1), the handle (100) comprising: a detachable lumen manifold (5) that is detachably coupled to the rigid shaft (1) at its distal end, the detachable lumen manifold (5) including a plurality of channels; a bellows (6) that is compressible to blow gas into a patient's rectum through at least one of the plurality of channels in the detachable lumen manifold (5) to assist in observation; and a grip (8), the detachable lumen manifold (5) being releasably attached to the grip, and a portion of the bellows protruding from the grip and a majority of the bellows being received within a recess of the grip, wherein the rigid endoscope (125) is suitable for anal, rectal, and / or lower colon examinations.

2. The rigid endoscope (125) according to claim 1, wherein, the lumen manifold includes a dome valve.

3. The rigid endoscope (125) according to claim 1 or 2, wherein, the plurality of channels (13, 14, 15) are for receiving one or more of the following: a camera; a surgical instrument, a biopsy forceps, gas from the bellows, a cautery coil, and a light source.

4. The rigid endoscope (125) according to claim 3, wherein, one or more of the channels further includes a one-way valve.

5. The rigid endoscope (125) according to claim 4, wherein, the valve is a dome valve.

6. The rigid endoscope (125) according to claim 3, wherein, the plurality of channels (13, 14, 15) includes one or more microfilters.

7. The rigid endoscope (125) according to claim 1 or 2, further comprising one or more of the following: a lens; and a port for accessing the one or more channels.

8. The rigid endoscope (125) according to claim 1 or 2, further comprising a gas release device (7) for releasing gas from the patient.

9. The rigid endoscope (125) according to claim 1 or 2, wherein, one or more of the rigid shaft and the lumen manifold are single-use.

10. The rigid endoscope (125) according to claim 1 or 2, wherein, the rigid shaft (1) is tapered, and the diameter of the proximal end of the rigid shaft exceeds the diameter of the distal end of the rigid shaft.

11. The rigid endoscope (125) according to claim 1 or 2, wherein, the rigid shaft (1) and the handle (100) are arranged at an angle of 20° relative to each other.

12. The rigid endoscope (125) according to claim 1 or 2, wherein, the rigid shaft (1) further includes a biopsy channel (4).

13. The rigid endoscope (125) according to claim 1 or 2, wherein, the rigid shaft (1) further includes scale lines.

14. The rigid endoscope (125) according to claim 1, wherein, The bellows includes a recess configured to receive a user's finger to improve the grip of the handle.

15. The rigid endoscope (125) according to claim 1, wherein, the handle includes a recessed port for introducing a surgical instrument into the rigid shaft.

16. The rigid endoscope (125) according to claim 1, wherein, the detachable lumen manifold includes a button thereon for releasing air from the patient.

17. The rigid endoscope (125) according to claim 1, wherein, the handle extends at an angle relative to the detachable lumen manifold.

18. The rigid endoscope (125) according to claim 1, wherein, the rigid endoscope is used in sampling of the rectum and sigmoid colon.

Images