rectoscope

Abstract

Provided is a speculum for insertion into the anus, wherein the speculum comprises: (a) a tubular housing (10) having a proximal end (10a), a distal end (10b), an internal volume (V1), a longitudinally extending axis (X) extending from the proximal end (10a) to the distal end (10b), a perpendicular axis (Y) extending perpendicular to the extending axis (X), and one or more apertures (10c) along a length L of the longitudinally extending axis (X); (b) a handle (12) having a proximal end (12a) and a distal end (12b); and (c) one or more image acquisition devices (14) located towards the distal end (10b) of the tubular housing (10) and within the internal volume (V1) of the tubular housing (10), wherein the one or more image acquisition devices (14) are rear-facing cameras (14a) taken along an axis (b) extending between the longitudinally extending axis (X) and the perpendicular axis (Y). Also provided is a tubular housing (10) for the speculum having a longitudinally extending axis (X), a proximal end (10a), a distal end (10b), an internal volume (V1), and one or more apertures (10c) along a length L of the longitudinally extending axis (X), and methods of diagnosis and treatment.

Description

Technical Field

[0001] This invention provides an improved endoscope for medical investigations and surgical procedures. Specifically, the endoscope is inserted into the anus and can be used by a physician to investigate the internal structures of the anus and rectum, and further, it can be used by a physician to perform surgical procedures. Background Technology

[0002] The anal canal is the terminal segment of the gastrointestinal tract. It extends 2 cm from the dentate line to the edge of the anus (the outermost tissue visible from the outside) and is typically measured to be 3.5 to 4 cm in length. The anal canal is generally longer in men than in women. The anus forms part of the anal canal complex, which also includes the external and internal sphincter muscles and the distal rectum. Its primary function is to provide restraint and to transmit feedback to higher brain centers when rectal emptying is required. The anal canal complex is a coordinating system that provides reflexive information to automatically manage its terminal functions. The rectoanal inhibitory reflex is a good example of this structure; a sudden increase in rectal pressure leads to a reflexive relaxation of the internal sphincter, allowing rectal emptying to occur, but this is inhibited by the external sphincter, which maintains voluntary control; this allows individuals to confirm they are in a socially appropriate position to allow rectal emptying.

[0003] Disorders of the anal canal complex lead to incontinence, pain, bleeding, itching, constipation, and incomplete defecation. The anus and sphincter muscles provide sufficient resistance to high rectal pressure, thus maintaining restraint. Therefore, it is not surprising that prolonged abnormal pressure leads to diseases of the anal canal, including hemorrhoids, anal fissures, anal fistulas, infections, pruritus, and hematomas. Although other factors contribute to the development of each condition (including systemic diseases), poor toileting habits and a lack of fiber in the diet have significant implications for the pathogenesis of these diseases.

[0004] Anal canal appearance and functional disorders can serve as surrogate markers of general rectal and / or gastrointestinal health. For example, anal fissures are defined as linear tears in the anal canal and are commonly seen in inflammatory bowel diseases such as ulcerative colitis, and should be ruled out when observed in a patient. Perianal infections and abscesses can be caused by Crohn's disease and rectal tuberculosis, while hemorrhoids can be secondary to rectal growths such as cancer. Examination of the rectum is of paramount importance in diagnosing anal diseases.

[0005] Although rare, anal cancer accounts for approximately 1% of all colorectal cancer cases. In the UK, about 1,500 cases are diagnosed annually, and in the US, about 8,000, with an incidence rate that has risen sharply since the 1990s. Risk factors include smoking, older age, weakened immune system, HPV exposure, and certain sexual behaviors (including multiple partners). Assessing the extent of anal cancer spread is important because some tumors extend into the rectum, and conversely, rectal cancer can extend into the anus, which can be mistaken for primary anal cancer. Making this distinction during examination is crucial as it determines the treatment strategy.

[0006] Benign conditions affecting the anus are extremely common, causing thousands of emergency and outpatient visits each year. In the United States, approximately 4.4% of adults report having symptoms of hemorrhoids, and the cost of treating these conditions reaches millions of dollars annually.

[0007] Anoscopy (sometimes called proctoscopy) is an examination of the anus, anal canal, and distal rectum using a proctoscopy. It involves inserting a hollow sheath into the anus to fully separate the tissues so that target anatomical structures can be directly observed within the sheath's lumen. No special preparation is usually required for proctoscopy, but an enema may be administered if appropriate. During the examination, the patient is placed in a relaxed position, such as the left lateral decubitus or lithotomy position. The proctoscopy is carefully inserted into the anus; different sizes of instruments may be used depending on the anatomy. The proctoscopy has an internal tampon to provide internal illumination when the light source is withdrawn, and its conical tip facilitates insertion. The instrument is adequately lubricated during insertion and inserted into the perineum along the umbilicus direction, rotating as needed. It is helpful to ask the patient to lower their body to relax the sphincter muscles. Digital rectal examination also facilitates the insertion process as it has already caused mild dilation of the anal canal and anesthesia. After passing through the sphincter region (3-5 cm from the anus), the rectoscope / anoscope is tilted along the sacrum to follow the anatomical route of the rectum (the anorectal bend). The rectoscope should be heated to a warm temperature, and there should be no blind resistance during insertion. The rectoscope should be introduced to the stop ring to ensure a complete assessment of the anal canal, even in the presence of a funnel-shaped anus. The rectoscope is slowly withdrawn in a rotating motion to allow for observation of the entire surrounding area. Due to its length, the rectoscope is easier to guide than a rectoendoscopy. The light output is also superior to that of a rectoendoscopy due to the shorter instrument. Nevertheless, it is difficult to expose discontinuous findings, so prominent locations in a digital examination require particularly careful evaluation. Furthermore, it is best to evaluate predisposed sites of rectal disease separately (crypts, hemorrhoid clusters at the 3 o'clock, 7 o'clock, and 11 o'clock positions, fissures at the 6 o'clock position, etc.).

[0008] Proctoscopy is performed concurrently with rigid proctoscopy; the latter refers to a similar instrument, but much longer (20-25 cm), which allows visualization of the rectum and distal colon through a closed, airtight seal. Both methods have specific indications and should not be considered complementary. In recent years, the utility of rigid proctoscopy has declined, with colonoscopy becoming more favored, primarily due to poor visualization and low diagnostic value. It continues to be valuable only in specific indications, such as measuring the distance between rectal tumors and the anal margin, and identifying rectal cancer and intestinal obstruction. In contrast, proctoscopy offers unique advantages over proctoscopy and is superior for assessing diseases within the anal canal. Flexible endoscopes are far superior to rigid proctoscopy, but even colonoscopy cannot achieve the same level of visualization as proctoscopy. Proctoscopy physically keeps the anal canal open without insufflation, making the assessment of hemorrhoids particularly easy; however, the lack of insufflation makes assessment of the anorectal junction (the point where the anal complex and rectum connect) difficult. This area may harbor malignant tumors, and without proper insufflation, occult lesions may be hidden behind rectal folds and in the anorectal groove. A drawback of proctoscopy and proctoscopy is that they do not provide a full view of the anorectal junction. In colonoscopy, this view is typically obtained through J-maneuver, allowing for unobstructed observation of this area. Furthermore, recording and presenting the results of rigid proctoscopy and proctoscopy is very difficult because conventional techniques do not include video connectivity.

[0009] Historically, surgical failure rates in the management of anal diseases have been high, often requiring repeat surgeries—a common experience for physicians handling these conditions. The advent of improved proctoscopy instruments has led to higher rates of disease healing, improved assessment of the anatomical and functional integrity of the anal canal, and made these surgeries more acceptable to patients. A turning point has been a better understanding of the anatomy. However, this level of detail is currently only achievable through magnetic resonance imaging (MRI) and endorectal ultrasound. The latter is becoming the most important diagnostic instrument used by colorectal surgeons because it provides a clear view of potential anatomical defects. With the use of new diagnostic techniques (2D-3D endorectal ultrasound and pelvic-perineal MRI) and morphological-functional diagnostic methods (anorectal radiography, defecation radiography, anal electromyography, and assessment of the motor latency of the pudendal nerve), anatomical and physiological definitions are better established, allowing for a better identification of clinical features and thus the selection of appropriate treatment methods.

[0010] Unfortunately, the aforementioned examinations (such as MRI and anoscopy) cannot be performed at the point of care; they are expensive and contraindicated for patients with internal metal objects (MRI), and anoscopy is highly user-dependent. Clinicians currently cannot accurately assess the entire anal complex using existing bedside instruments. Anatomically, the anal complex consists of multiple vectors and planes, and these views are not possible with proctoscopy. Variables contributing to this situation include:

[0011] Anatomy: The anus closes naturally, requiring the examiner to forcefully open it to view the internal mucosa. The anal complex has multiple planes and vectors, and is partially located internally. Diseases can be hidden in any surrounding location, thus requiring a 360-degree assessment. This presents ergonomic challenges, and patients experience discomfort when twisting and rotating the endoscope during the procedure.

[0012] Patient Positioning: The position chosen during the examination depends on the available equipment, the examiner's preferences and experience, and the patient's body size. The three most commonly used positions for rectal examination are the lithotomy position, the prone knee-elbow position, and the left lateral decubitus position. The lithotomy position allows for direct communication and eye contact between the doctor and patient, and is comfortable for the patient, but requires a specialized bed; the prone knee-elbow position is beneficial for examining the perianal area, and the buttocks can be retracted well, but it is relatively uncomfortable and embarrassing for the patient; the left lateral decubitus position is comfortable and easy to operate, but for larger patients, the buttocks need to be spread apart to observe the anus.

[0013] Current limitations of the instrument: The limitations of the proctoscopy include insufficient illumination when deeper structures need to be observed. When removing the insert tampon, the open, hollow sheath allows feces to pass through the channel, obstructing vision and making the procedure very unhygienic for the user. In some series, up to one-third of physicians have found fecal microbiota on their faces after the examination. The proctoscopy handle is positioned close to the insert, meaning that for patients with larger hips, the operator's hand must be pressed tightly against the patient's perineum. This is uncomfortable for both the user and the patient.

[0014] Examiner positioning: The doctor must peer directly into the sheath to determine the pathology. This makes the procedure unpleasant due to direct exposure to odors and feces.

[0015] Limitations of Intervention: During proctoscopy, identified lesions can be treated, including rubber band ligation of hemorrhoids. Almost all anal treatments are performed with poor visibility because the inherent nature of the instruments means that the field of vision is obstructed by the performing hand when the treatment is being performed. Furthermore, treatment above the anatomical line known as the dentate line is crucial. This line divides the embryonic hindgut and ectoderm, which are innervated by visceral and somatic nerves, respectively. This means there is no sensation above the dentate line, but sensation is enhanced below it. Inadvertently performing treatment below the dentate line can be extremely painful and may cause the patient to faint. Current proctoscopy cannot provide a proper view of the dentate line during treatment. An ideal view of the dentate line is achieved during the J-manoeuvre procedure, which, as mentioned earlier, is impossible with any rigid endoscope. Seeing the dentate line from above during anal interventions offers significant advantages, especially if performed in an ideal patient and user position and comfort.

[0016] Clearly, there is a need to provide an improved endoscope, particularly an improved anoscope, to overcome the current limitations of conventional endoscope devices. Summary of the Invention

[0017] In one aspect, a speculum for insertion into the anus is provided, wherein the speculum comprises:

[0018] (a) A tubular shell (10), a proximal end (10a), a distal end (10b), an internal volume (V1), a longitudinal extension axis (X) extending from the proximal end (10a) to the distal end (10b), a vertical axis (Y) extending perpendicular to the extension axis (X), and one or more openings (10c) of length L along the longitudinal extension axis (X).

[0019] (b) A handle (12) having a proximal end (12a) and a distal end (12b); and

[0020] (c) One or more image acquisition devices (14) positioned toward the distal end (10b) of the tubular housing (10) and within the internal volume (V1) of the tubular housing (10),

[0021] One or more of the image acquisition devices (14) are rear-facing cameras (14a) that observe (take pictures) along an axis (b) extending between a longitudinally extending axis (X) and a vertical axis (Y).

[0022] In some embodiments, the endoscope includes a middle portion (16) having a proximal end (16a) and a distal end (16b), wherein the distal end (16b) of the middle portion (16) is connected to the proximal end (10a) of the tubular housing (10), and the proximal end (16a) of the middle portion (16) is connected to a handle (12).

[0023] In some embodiments, the endoscope further includes a lateral camera (14b) located within the internal volume (V1) of the tubular housing (10), wherein the lateral camera takes pictures along the vertical axis (y) and through an opening (10c) in the tubular housing (10).

[0024] In some embodiments, the endoscope further includes a forward-facing camera (14c) that captures images from the proximal end (10a) to the distal end (10b) of the tubular housing (10) along a longitudinally extending axis (X). The forward-facing camera (14c) is located within the internal volume of the tubular housing (10) and provides a viewing angle from the proximal end (10a) to the distal end (10b) along the longitudinally extending axis (X) through the internal space of the tubular housing (10).

[0025] In some embodiments, the endoscope further includes:

[0026] a) A lateral camera (14b) located within the internal space (V1) of the tubular housing (10), wherein the lateral camera takes pictures along the vertical axis (Y) and through an opening (10c) in the tubular housing (10); and

[0027] b) A forward-facing camera (14c) taking pictures from the proximal end (10a) to the distal end (10b) of the tubular shell (10) along the longitudinally extending axis (X).

[0028] In some embodiments, the endoscope further includes a protrusion (18) having a first end (18a) mounted on the distal end (16b) of the intermediate portion and extending distally (10b) within the tubular housing (10) along an axis (X), wherein a rear-facing camera (14a) is mounted on the protrusion (18). In some embodiments, the protrusion is bifurcated. In some embodiments, a side-facing camera (14b) is additionally mounted on the protrusion (18).

[0029] In some embodiments, the endoscope further includes a protrusion (18) having a first end (18a) mounted on the distal end (16b) of the intermediate portion and extending distally (10b) within the tubular housing (10) along an axis (X), wherein a lateral camera (14b) is mounted on the protrusion (18). In some embodiments, the protrusion is bifurcated.

[0030] In some embodiments, such as Figure 15As shown, the endoscope includes two protrusions (27, 28), each having a first end mounted on the distal end (16b) of the intermediate portion and extending distally (10b) within the tubular housing (10) along the axis (X). A rearward camera (14a) and an optional side camera (14b) are mounted on the first protrusion (27), and a forward camera (14c) is mounted on the second protrusion (28). The protrusions can also be mounted on the distal end of the intermediate portion via a connecting assembly (29). In some embodiments, the protrusions are extendable and can project forward and backward along the axis (X).

[0031] In some embodiments, the intermediate portion (16) further includes an outer surface, an inner surface, and a support member (24) attached to the inner surface, wherein a forward-facing camera (14c) is mounted on the support member. The support member is located within the internal volume of the tubular housing (10). In some embodiments, the tubular housing (10) is rigid.

[0032] In some embodiments, the intermediate portion (16a) further includes a conduit (20) having a first outer end (20a) and a second inner end (20b) and extending from the exterior of the endoscope into the interior of the tubular housing (10) for inserting surgical instruments into the internal volume (V2). In some embodiments, the first outer end (20a) is within the intermediate portion (16). In some embodiments, the intermediate portion (16) further includes a cap (22) for covering the first outer end (20a) of the conduit (20). In some embodiments, the endoscope further includes a latch for releasably securing the cap (22) to the intermediate portion (16). In some embodiments, the endoscope further includes a latch release device (26) for releasing the latch and positioned on the handle portion (12).

[0033] In some embodiments, the endoscope further includes a pressurizing mechanism (28) for pressurizing the interior of the tubular housing (10). In some embodiments, the pressurizing mechanism (28) is housed within a handle (12) and includes a bellows (30).

[0034] In some embodiments, the cross-sectional profile of the tubular housing (10) has a maximum diameter (D2) at the proximal end (10a) of the tubular housing (10) and tapers to a minimum diameter (D1) at the distal end (10b) of the tubular body. In some embodiments, the endoscope further includes one or more caps for one or more openings (1c) in the tubular housing (10). In some embodiments, the tubular housing (10) is detachably connected to the intermediate portion (16a).

[0035] In some embodiments, the endoscope further includes a light source for projecting light into the interior of the housing (10). In some embodiments, the intermediate portion (16) is rotatably mounted on the handle (12) for rotating about the longitudinally extending axis (X).

[0036] In one aspect, a tubular housing (10) for an endoscope as defined herein is provided, having a longitudinally extending axis (X), a proximal end (10a), a distal end (10b), an internal volume (V1), and one or more openings (10c) of length L along the longitudinally extending axis (X).

[0037] In one aspect, a speculum for insertion into the anus is provided, wherein the speculum comprises:

[0038] (a) A handle (12) having a proximal end (12a) and a distal end (12b) and a longitudinally extending axis (X) extending from the proximal end (12a) to the distal end (12b); and

[0039] (b) A protrusion (18) having a first end (18a) mounted on the distal end (12b) of the handle and projecting in the opposite direction to the proximal end (12a) of the handle, wherein a rear camera is mounted on the protrusion and wherein the rear camera takes pictures toward the proximal end (12a) of the handle along a longitudinally extending axis (X).

[0040] In another aspect, the present invention relates to a speculum for anal sampling. In a further aspect, the present invention relates to a speculum for rectal sampling.

[0041] In a further aspect, the present invention relates to a treatment method comprising: inserting a speculum into the anus, and taking, performing a biopsy, excising, cauterizing, or otherwise treating the anal canal.

[0042] In a further aspect, the present invention relates to a method for anorectal diagnosis, comprising: inserting a rigid endoscope into the anus; observing, performing a biopsy or otherwise examining the anus; and comparing the results with images or biopsies of a known normal anus to diagnose a disease.

[0043] In a further aspect, the present invention relates to a method for determining the presence of anorectal disease, comprising: inserting a rigid endoscope into the anus; observing, performing a biopsy, or otherwise examining the anus; and comparing the results with images or biopsies of a known normal anus to determine whether the patient's anus is diseased or at risk of developing disease, and optionally determining whether appropriate treatment is required.

[0044] In another aspect, a method for diagnosis and treatment is provided, optionally including methods for diagnosing and treating the anorectal region, including

[0045] a) Inserting the endoscope described herein into the anus to view, perform a biopsy, or otherwise examine the anus, and comparing the results with images or biopsies of a known normal anus to diagnose disease; and

[0046] b) Treat the anus according to the disease diagnosis in a). Attached Figure Description

[0047] The invention will now be described with reference to the accompanying schematic diagrams, in which:

[0048] Figure 1 This is a perspective view of one embodiment of a hysteroscope.

[0049] Figure 2 This is a side view of one embodiment of a hysteroscope.

[0050] Figure 3 This is an exploded view showing components of one embodiment of a hysteroscope.

[0051] Figure 4 This is a perspective view of the handle and middle section of one embodiment of the endoscope and shows the position of the rear camera.

[0052] Figure 5 The first is a cross-sectional view of the tubular housing (10), and shows an example of a rear-facing camera (14a) positioned within the internal volume (V1) of the tubular housing. Several examples of the axis (b) are shown in the second cross-sectional view.

[0053] Figure 6 This is a perspective view of the handle and middle portion of one embodiment of the endoscope, and shows the position of a rear-facing camera. The field of view of the rear-facing camera is shown within a circle.

[0054] Figure 7 This is a perspective view of the handle and middle section of one embodiment of the endoscope, and shows the position of a side camera. The field of view of the side camera is shown within a circle.

[0055] Figure 8 This is a perspective view of the handle and middle section of one embodiment of the endoscope, and shows the position of a forward-facing camera. The field of view of the forward-facing camera is shown within a circle.

[0056] Figure 9 This is a side view of the handle and middle portion of one embodiment of a hysteroscope.

[0057] Figure 10 This is a top view of the handle and middle section of one embodiment of a hysteroscope.

[0058] Figure 11 This is a top view of one embodiment of a hysteroscope.

[0059] Figure 12 A bottom view of the hysteroscope is provided.

[0060] Figure 13 A side view of the endoscope is provided, and the working channel inside the endoscope is shown.

[0061] Figure 14 A front view of the endoscope is provided.

[0062] Figure 15 A perspective view is provided of two protrusions that can be accommodated within the tubular housing.

[0063] Figure 16 A perspective view of the tubular shell and pipes is provided. Detailed Implementation

[0064] WO 2007 / 087421 describes a flexible endoscope used in colonoscopy / sigmoidoscopy. This is a conventional type of endoscope that uses a camera on the outer surface of the flexible tube of the device to visualize the inner surface or tissues of the body. Notably, these types of endoscopes do not include one or more openings, specifically one or more orifices, within the tubular housing of the device. Therefore, this type of endoscope does not allow visualization of the body surface or tissues within the internal volume of the tube of the device.

[0065] In one aspect, an improved endoscope is provided. In a preferred embodiment, the endoscope is an anoscope primarily used for examining the anus. However, the endoscope may also be other types of endoscopes, such as endoscopes, proctoscopes, or rectal endoscopes. The invention will now be described with reference to figures.

[0066] like Figure 1 , 2 As shown in Figure 5, the endoscope includes a tubular housing (10), wherein the tubular housing (10) includes a proximal end (10a), a distal end (10b), and an internal volume (V1). As used herein, the term "proximal end" refers to the part of the device closest to the user, physician (which may be used interchangeably with the term surgeon), or operator of the device, and the term "distal end" refers to the part of the device furthest from the physician or operator.

[0067] The tubular shell (10) has a longitudinally extending axis (X) extending from a proximal end (10a) to a distal end (10b). The tubular shell (10) defines a hollow, elongated body, wherein the proximal end (10a) and the distal end (10b) are located at opposite ends of the longitudinally extending axis (X). Figure 2 As shown, the tubular housing (10) further has a vertical axis (Y) extending perpendicular to the extending axis (X). Figure 2 and Figure 3As shown, the tubular housing also includes one or more openings (10c) of length L along a longitudinally extending axis (X).

[0068] In use, the tubular housing is inserted into the patient's anus and serves to separate the anal canal. Essentially, the tubular housing (10) has both an inner and an outer surface. When the endoscope is inserted into the anus, the outer surface of the tubular housing (10) contacts the anal cavity and / or rectal cavity. The inner surface of the tubular housing (10) defines an internal volume V1. The internal volume (V1) accommodates one or more image acquisition devices of the present invention. One or more openings (10c) expose a portion of the anatomical structure of the anus or rectum into the internal volume (V1), which can be acquired by one or more image acquisition devices.

[0069] The tubular shell (10) may be cylindrical or conical. The proximal end (10a) and distal end (10b) of the tubular shell together form a hollow cylindrical or conical shape with a circular cross-section. In one embodiment, the width of the cross-section of the proximal end (10a) is substantially equal to the width of the cross-section of the distal end (10b) (i.e., the tubular shell (10) is cylindrical).

[0070] Preferably, such as Figure 5 As shown, the cross-sectional profile of the tubular housing has a maximum width (W2) at the proximal end (10a) of the tubular housing, and the width decreases (i.e., tapers) to a minimum width (W1) at the distal end (10b) of the tubular housing, thereby facilitating the insertion of the endoscope into the anal canal. Therefore, the width of the cross-section at the proximal end (10a) of the tubular housing (10) is greater than the width of the cross-section at the distal end (10b) of the tubular housing (10). In this embodiment, the tubular housing tapers from the proximal end (10a) to the distal end (10b). A tapered or gradually tapering tubular housing is preferred because the tapered shape facilitates the insertion of the endoscope into the anal canal.

[0071] In one embodiment, the width (W1 or W2) of the cross-sectional profile of the tubular shell is between 0.5 cm and 6 cm, optionally between 1 cm and 5 cm, and further optionally between 2 cm and 4 cm. In another embodiment, the width (W1) of the cross-sectional profile of the tubular shell is between 0.5 cm and 6 cm, optionally between 1 cm and 5 cm, and further optionally between 2 cm and 4 cm. In yet another embodiment, the width (W2) of the cross-sectional profile of the tubular shell is between 0.5 cm and 6 cm, optionally between 1 cm and 5 cm, and further optionally between 2 cm and 4 cm.

[0072] The tubular housing (10) may be open at its distal end (10b). Alternatively, in a preferred embodiment, the tubular housing may be sealed or capped at the distal end. The cap may be dome-shaped or bullet-shaped to facilitate insertion of the tubular housing (10) into the anus.

[0073] Preferably, the size and shape of the tubular housing of the endoscope allow for comfortable insertion into the patient's anus without the risk of damaging surrounding structures. Therefore, the endoscope can be of the size of a conventional anoscope. In one embodiment, the tubular housing (10) has a length of 4 to 11 cm, optionally 7 to 10 cm. In one embodiment, the endoscope is a rectoscope. Therefore, the endoscope can be of the size of a conventional rectoscope. In one embodiment, the tubular housing (10) has a length of 12 to 18 cm, optionally 13 to 14 cm. In one embodiment, the endoscope is a rectal endoscope. Therefore, the endoscope can be of the size of a conventional rectal endoscope. In one embodiment, the tubular housing (10) has a length of 17 to 27 cm, optionally 18 to 26 cm. Other lengths and widths of the tubular housing are contemplated for use with smaller or larger patients or for pediatric purposes. In one embodiment, the endoscope is used for humans. In one embodiment, the endoscope is used for adults. In one embodiment, the endoscope is used for children. In one embodiment, the tubular housing (10) has a length sufficient for insertion into the patient's anus. In one embodiment, the tubular housing (10) has a length sufficient to be inserted into the patient's rectum.

[0074] The tubular housing (10) includes one or more openings (10c) of length L extending along a longitudinal axis (X). In use, a rigid endoscope is inserted into the patient's anus, and the openings expose the target portion of the anal canal to the internal space of the tubular housing. Exposure of the mucosa or tissue of the anal or rectal anatomy allows the physician to examine these areas or perform surgery on the exposed areas. It is highly desirable to expose only discrete areas of the anatomy, as this allows the physician to perform surgery only on the areas of interest while shielding the remaining tissue from damage by the surgical instruments. The one or more openings (10c) may be gaps, notches, or slots, and are of sufficient size to expose the anatomical site of interest, such as a portion of the anal canal.

[0075] One or more openings (10c) can be one or more holes, i.e., one or more openings that completely penetrate the tubular housing. Using one or more holes is particularly advantageous because it allows discontinuous portions of the anal canal to enter the tubular housing through the holes. The image-acquiring device of the present invention can then be used to observe, from multiple angles, the portion of the anal canal that has entered the internal volume of the tubular housing (10). Furthermore, the portion of the anal canal that has been isolated and located within the internal volume of the tubular housing can become the target of surgical instruments passing through the device, thereby allowing seamless surgical intervention on this target area of ​​the anal canal. Allowing a portion of the anal canal to enter the device through the holes has a surprising advantage because it enables the operator of the device to see the dentate line, thereby determining the boundary between somatically innervated tissue and visceral tissue. A particularly beneficial clinical use of this device is the surgical treatment of hemorrhoids. By using a device with a tubular housing comprising one or more holes of length L along a longitudinally extending axis (X), the device can be aimed at the hemorrhoids. Once located, the hemorrhoid can be guided and positioned within the tubular shell by placing the incision directly above it. Once inside the tubular shell, the hemorrhoid can be seen and surgical intervention is easier than leaving the tissue outside the shell.

[0076] In one embodiment, the edge of the orifice may be arcuate, providing a convex surface between the outer and inner surfaces of the tubular housing (10). The convex surface allows the anal passage to enter the internal volume of the tubular housing (10) without damaging tissue.

[0077] In one embodiment, the orifice is elongated, having a first end (30) and a second end (31), wherein the first end is located at the distal end (10b) toward the tubular housing. In some embodiments, the tubular housing may be sealed or capped at the distal end, and the first end of the orifice is located toward the seal or cap (10). Figure 16 As shown, the width of the first end (30) of the elongated hole can be narrower than that of the second end (31) of the elongated hole. In one embodiment, the hole gradually tapers from the second end to the first end. In this embodiment, the shape of the hole facilitates the anal passage into the internal volume of the tubular housing (10).

[0078] In one embodiment, the length of one or more openings is approximately 0.5 cm to 5 cm, optionally 1 cm to 4 cm. The one or more openings (10c) are also large enough to allow medical instruments (e.g., forceps and biopsy forceps, catheters, radiofrequency ablation probes, aspiration hemorrhoid devices, needles, and syringes) to pass through the openings from the internal volume (V1) of the tubular housing (10) to the anal canal or rectum. The endoscope may further include one or more caps for the one or more openings (10c) in the tubular housing (10). In one embodiment, the one or more caps for the one or more openings (10c) in the tubular housing (10) may be made of a transparent or partially transparent material, thereby acting as windows to the one or more openings (10c). In one embodiment, the one or more openings (10c) are transparent windows in the tubular housing (10). In one embodiment, the one or more caps for the one or more openings (10c) in the tubular housing (10) are retractable.

[0079] The tubular shell can be made of a rigid, non-flexible material, such as medical-grade plastic or biocompatible metal. In one embodiment, both the proximal (10a) and distal (10b) ends of the tubular shell can be made of a rigid, non-flexible material. In another embodiment, either the proximal (10a) or distal (10b) end of the tubular shell can be made of a rigid, non-flexible material. In yet another embodiment, both the proximal (10a) and distal (10b) ends of the tubular shell can be made of a transparent or partially transparent material. In yet another embodiment, either the proximal (10a) or distal (10b) end of the tubular shell can be made of a transparent or partially transparent material. Using a rigid material for the tubular shell is advantageous because it allows the device to be used as a proctoscopy or anoscope, allowing observation of the anal passage with the image acquisition device of the present invention, providing a unique perspective that is not possible with existing proctoscopy and anoscope devices lacking image acquisition capabilities.

[0080] like Figure 1 As shown, the endoscope may further include an intermediate portion (16) having a proximal end (16a) and a distal end (16b), wherein the distal end (16b) of the intermediate portion (16) is connected to the proximal end (10a) of the tubular housing (10), and the proximal end (16a) of the intermediate portion (12a) is connected to the handle (12). The intermediate portion may extend along the longitudinal extension axis (x) of the tubular housing (10). Alternatively, the intermediate portion may deviate from the longitudinal extension axis (x) of the tubular housing (10). When using the device, the intermediate portion does not enter the anus.

[0081] The intermediate portion (16) can have any number of shapes. The intermediate portion (16) can be formed into a cylindrical or conical shape with a circular cross-section. In one embodiment, the diameter of the cross-section of the proximal end (16a) is substantially equal to the diameter of the cross-section of the distal end (16b) (i.e., the intermediate portion (16) is cylindrical). In another embodiment, the diameter of the cross-section of the distal end (16b) is smaller than the diameter of the cross-section of the proximal end (16b) (i.e., the intermediate portion is conical). In this embodiment, the intermediate portion tapers from the distal end (16b) to the proximal end (16a). The flared or conical shape prevents the intermediate portion (16) from entering the anus when using the speculum. Additionally, or furthermore, the intermediate region may also include an enlarged area or flange forming a stop. This stop prevents the speculum from being fully inserted into the anal canal and ensures that only the tubular housing (10) enters the anal canal.

[0082] The middle portion is preferably hollow. In this embodiment, the middle portion (16) has both an inner surface and an outer surface, and includes an internal volume (V2), such as Figure 3 and 13 As shown. Figure 13 As shown, the intermediate portion (16a) may further include a conduit (20) having a first outer end (20a) and a second inner end (20b), extending from the outside of the endoscope into the interior of the tubular housing (10) for inserting surgical instruments into the internal volume (V2). This conduit provides a working channel, such as... Figure 13 As indicated by the arrows, this allows surgical instruments to pass through the device and allows the operator or physician to examine or manipulate portions of tissue or mucosa exposed by one or more openings (10c) in the tubular housing. In one embodiment, the tubing is biased relative to the handle (see [reference]). Figure 16 The intermediate portion may have a proximal end (16a), a distal end (16b), a longitudinally extending axis (x), and one or more openings (16c) along a length L of the longitudinally extending axis (x). One or more openings (16c) may be located at the proximal end (16a) or distal end (16b) of the intermediate portion and provide an entry point into the internal volume (V2) of the device. An operator or physician may insert surgical instruments (e.g., forceps and biopsy forceps, catheters, radiofrequency ablation probes, aspiration hemorrhoid devices, needles, and syringes) into the endoscope through one or more openings (16c) in the intermediate portion (16) and manipulate the surgical instruments through the internal space (V2) in the intermediate portion and the internal space (V1) in the tubular housing, and then approach the site of interest through one or more openings (10c) in the tubular housing. Advantageously, the invention allows for surgery to be performed simultaneously with or shortly after examination of the site of interest.

[0083] The intermediate portion (16) may further include a cover (22) for covering one or more openings (16c) in the intermediate portion (16). The cover (22) may be in an open position, allowing access to the internal space (V2) of the endoscope, or in a closed position, sealing the internal space of the device. Advantageously, closing the cover (22) can seal the intermediate portion and provide a closed system. Figure 1 and Figure 2 The endoscope is shown with the cover (22) in the closed position, the cover sealing one or more openings (16c) in the middle portion (16). Figure 3 An exploded view of the endoscope is shown, illustrating the cover (22) and one or more openings (16c) in the intermediate portion. A latching mechanism may be provided for releasably securing the cover to the intermediate portion (16) and allowing the cover to open and close. In one embodiment, this mechanism is a push latch. Alternatively, the mechanism for opening and closing the cover (22) may be a pull latch or a magnet. The latching mechanism may be located at the proximal end (16a) or distal end (16b) of the intermediate portion. In a preferred embodiment, the latching mechanism is flush with the outer surface of the intermediate portion.

[0084] The endoscope also includes a handle (12) having a proximal end (12a) and a distal end (12b). When using the endoscope, the handle remains outside the body and is not inserted into the anus. The handle may include a gripping device.

[0085] The tubular housing (10) can be detachably attached to the middle section (16) of the device or the handle (12). This allows the tubular housing to be replaced between patients or cleaned before reuse. Figure 4 , 6 Figures 8, 9, and 10 show the endoscope with the tubular housing (10) removed, and only the intermediate portion (16) and handle (12) are shown. In one embodiment, the tubular housing (10) may be disposable and thus replaceable between patients. In one embodiment, the intermediate portion may be detachably connected to the handle (12) of the device. In another embodiment, the tubular housing (10) and the intermediate portion may be detachably connected to the handle (12) of the device.

[0086] The endoscope further includes one or more image acquisition devices (14) positioned toward the distal end (10b) of the tubular housing (10) and within the internal volume (V1) of the tubular housing (10), and one or more of the image acquisition devices (14) are rear-facing cameras (14a) that observe (capture) along an axis (b) extending between a longitudinally extending axis (X) and a vertical axis (Y). Figure 3As detailed, the rear-facing camera (14a) is located within the internal volume (V1) of the tubular housing, and thus the tubular housing (10) provides a barrier between the camera and the anal anatomy. The field of view of the rear-facing camera (14a) includes the viewing angle along an axis (z) extending from the internal volume (V1) of the tubular housing through one or more openings (10c) to the outside of the endoscope.

[0087] In use, the distal end (10b) of the tubular housing is inserted furthest into the anal canal, while the proximal end (10a) is the end of the tubular housing located at the entrance to the anus. The view along the device, from the proximal end (10a) to the distal end (10b) of the tubular housing towards the anal canal, can be considered the "forward" direction. The rear-facing camera (14a) faces the opposite direction, thus away from the distal end (10b) of the tubular housing, and instead, the lens of the rear-facing camera (14a) typically faces the proximal end (10a) of the tubular housing (i.e., from inside the anal canal towards the external portion of the device). The rear-facing camera provides a rearward view for the doctor or operator, eliminating the need for the doctor or operator to be close to the device. Figure 3 and 11 As shown, the rear-facing camera (14a) is preferably positioned to acquire images through one or more openings (10c) in the tubular housing. Therefore, the rear-facing camera (14a) also provides a view of the internal volume of the tubular housing (10). In this respect, the rear-facing camera (14a) observes along an axis (b) extending between a longitudinally extending axis (X) and a vertical axis (Y). This axis can be an axis (y) extending from the distal end (10b) to the proximal end (10a) of the tubular housing (10). Figure 5 As shown, it can be understood that the axis (b) extending between the longitudinal extension axis (X) and the vertical axis (Y) has many variations. The axis extending between the longitudinal extension axis (X) and the vertical axis (Y) can extend from any point on the inner surface of the distal end (10b) of the tubular housing to any point on the inner surface of the proximal end (10a). Thus, the rear-facing camera (14a) generally points towards the proximal end (10a) of the tubular housing.

[0088] Preferably, the field of view of the rear-facing camera (14a) may include an angle of view observed through one or more openings (10c) along an axis (b) extending from the internal volume (V1) of the tubular housing to the exterior of the endoscope. This field of view refers to the observable area in an image acquired by the image acquisition device of the present invention. The term field of view is used interchangeably with the terms angle of view or angular field of view. As used herein, field of view can be understood to refer to a horizontal field of view (observable area in a horizontal plane) or a vertical field of view (observable area in a vertical plane). The field of view can be quantified by measuring the angle in degrees. It is understood that a specific field of view will be determined by the specific length of the specific image sensor and lens used in one or more image acquisition devices of the present invention. It is understood that various CMOS-based cameras, image sensors, and lenses are contemplated for use in the present invention, and the image acquisition device of the present invention may include sensors and / or lenses that provide full HD (1080p) image acquisition. It is further understood that the endoscope may be provided with a suitable power source, such as a battery, cable, and wire, to provide power to the camera. Furthermore, it is understood that the endoscope may be equipped with suitable cables, leads, and connections to allow images to be transmitted from the camera to an external observation platform, such as an external display screen or computer. The endoscope may be equipped with one or more buttons, preferably located on the handle (12), to allow image acquisition.

[0089] It will be further understood that many possible axes (b) are possible. In one embodiment, the field of view of the rear-facing camera (14a) includes at least a portion of one or more openings. In one embodiment, the field of view of the rear-facing camera (14a) includes one or more openings. In one embodiment, the field of view of the rear-facing camera (14a) includes a field of view observed through one or more openings (10c) along an axis (b) extending from the inner surface of the proximal end (10a) of the tubular housing to the outside of the endoscope. In one embodiment, the field of view of the rear-facing camera (14a) includes a field of view observed through one or more openings (10c) along an axis (b) extending from the inner surface of the distal end (10b) of the tubular housing to the outside of the endoscope.

[0090] In one embodiment, the axis (b) for the rear-facing camera (14a) is a longitudinally extending axis (x) from the distal end (10b) to the proximal end (10a) of the tubular housing (10), i.e., an axis that longitudinally passes through the center of the tubular housing (10). In one embodiment, the rear-facing camera (14a) views from the distal end (10b) to the proximal end (10a) of the tubular housing (10) along axis (b); and wherein the field of view of the camera includes a field of view observed through one or more openings (10c) along axis (b) extending from the internal volume (V1) of the tubular housing to the outside of the endoscope.

[0091] It is understood that the rear-facing camera can also observe along an axis (c) extending between the longitudinal extension axis (X) and the lateral axis (Z). The lateral axis (Z) extends perpendicular to the longitudinal extension axis (X) and perpendicular to the vertical axis (Y). In some embodiments, the rear-facing camera observes along an axis (c) extending between the longitudinal extension axis (X) and the lateral axis (Z), wherein this axis falls within 75 degrees of the longitudinal extension axis (X). In some embodiments, this axis falls within 60 degrees, 45 degrees, 30 degrees, or 15 degrees.

[0092] In some embodiments, the rear-facing camera (14a) can provide a view of the anorectal junction and the dentate line. This is a particularly unique perspective that cannot be viewed with conventional anoscopes.

[0093] It is understood that a rear-facing camera (14a) can be positioned within the tubular housing (10) in many different locations to provide a specific viewing angle. In one embodiment, the rear-facing camera (14a) is mounted on the inner surface of the distal end (10b) of the tubular housing (10). In another embodiment, the rear-facing camera (14a) is mounted on a support member attached to the inner surface of the distal end (10b) of the tubular housing (10). In one embodiment, the endoscope includes a protrusion having a first end mounted on the inner surface of the proximal end (10a) of the tubular housing (10) and extending toward the distal end (10b) of the tubular housing (10). In one embodiment, as Figure 3 As shown, the endoscope includes a protrusion (18) having a first end (18a) mounted on the distal end (16b) of the intermediate portion and extending along the X-axis toward the distal end (10b) within a tubular housing (10), wherein a rear-facing camera (14a) is mounted on the protrusion (18). The protrusion (18) may be bifurcated, such as... Figure 3 As shown in the image.

[0094] The rear-facing camera (14a) can be fixed in place. Therefore, no manipulation device is required to obtain the viewpoint provided by the rear-facing camera (14a). In one embodiment, the camera is fixedly attached to the inner surface of the tubular housing. In another embodiment, the camera is fixedly attached to a support member of the protrusion described herein.

[0095] Traditional proctoscopy devices are limited by the field of view they provide, often confined to a single view and / or a very narrow field of view. This means that physicians may miss areas of important clinical features or abnormalities. The unique feature of this invention is that one or more image acquisition devices of the endoscope can provide multiple simultaneous images. This allows for multidimensional visualization of areas of interest in the anal canal or rectum using a simple, portable device. Acquiring multiple complementary images in different planes of view using the endoscope of this invention is highly advantageous for physicians, as it allows for close observation of the anatomical structures of the area of ​​interest and can lead to the identification of features or clinical abnormalities that might otherwise be missed. It also allows for faster examination of the anus, thus reducing the time spent inserting the device into the anus. This reduces patient discomfort and allows physicians to perform more examinations and surgical procedures in less time.

[0096] like Figure 7 As shown, the endoscope may optionally further include a side camera (14b) located within the internal volume (V1) of the tubular housing (10), wherein the side camera observes along the vertical axis (y) and through an opening (10c) in the tubular housing (10). The lens of the side camera (14b) faces one or more openings (10c).

[0097] like Figure 8 As shown, the endoscope optionally further includes a forward-facing camera (14c) that provides observation along a longitudinally extending axis (X) from the proximal end (10a) to the distal end (10b) of the tubular housing (10). The forward-facing camera (14c) provides a view from the proximal end (10a) to the distal end (10b) of the tubular housing, thus allowing forward viewing into the anal canal from the middle portion or handle. The lens of the forward-facing camera (14c) faces the distal end (10b) of the tubular housing and acquires images along the direction of the distal end (10b) of the tubular housing. In use, the forward-facing camera can be used to acquire views of the perineum and the area around the anus. This can be performed by a physician using the endoscope to examine the area outside the anus before insertion into the anus. When the tubular housing (10) is inserted into the anus, the forward-facing camera will look forward through the device, thus also acquiring images of the anal camera and the anal border.

[0098] The forward-facing camera can be located within the internal volume (V1) of the tubular housing. Alternatively, the forward-facing camera can be located within the internal volume (V2) of the intermediate portion. In one embodiment, as... Figure 8 As shown, the intermediate portion (16) further includes an outer surface, an inner surface, and a support member (24) attached to the inner surface, wherein a forward-facing camera (14c) is mounted on the support member (24). The support member may extend across the entire cross-section of the intermediate portion (16).

[0099] In some embodiments, one or more image acquisition devices of the endoscope include a field of view of 45 degrees or less. Figure 6 The image shows that the field of view of the rear-facing camera (14a) is approximately 45 degrees. Figure 7 The image shows a side-facing camera (14b) with a field of view of approximately 45 degrees. In some embodiments, one or more image acquisition devices of the endoscope include a field of view of 45 degrees or greater. In some embodiments, one or more image acquisition devices of the endoscope include a field of view of 90, 120, 150, or 180 degrees or less. In some embodiments, one or more image acquisition devices of the endoscope include a field of view of 90, 120, 150, or 180 degrees or greater. In some embodiments, one or more image acquisition devices of the endoscope have a field of view between 45 and 90 degrees, between 45 and 120 degrees, between 45 and 150 degrees, or between 45 and 180 degrees.

[0100] The lens of the rear-facing camera (14a) and the lens of the front-facing camera (14c) of the endoscope can be substantially pointing towards each other along the longitudinal extension axis (X).

[0101] In some embodiments, the pointing directions of the rear camera (14a) and the side camera (14b) are substantially perpendicular to each other. Accordingly, the rear camera (14a) and the side camera (14b) will have a vertical field of view. In some embodiments, the rear camera (14a) and the side camera (14b) are pointed at approximately 90 degrees relative to each other: the rear camera (14a) points toward the proximal end (10a) of the tubular housing (10), and the side camera (14b) points toward one or more openings (10c) in the tubular housing.

[0102] In some embodiments, the rear camera (14a) and the side camera (14b) are at an angle of approximately 45 degrees relative to each other: the rear camera (14a) is generally pointed toward the proximal end (10a) of the tubular housing (10) and also toward one or more openings (10c) in the tubular housing, while the side camera (14b) is pointed toward one or more openings (10c) in the tubular housing.

[0103] In some embodiments, the pointing directions of the forward-facing camera (14c) and the side-facing camera (14b) are substantially perpendicular to each other. Therefore, the forward-facing camera (14c) and the side-facing camera (14b) will have a vertical field of view. In some embodiments, the forward-facing camera (14c) and the side-facing camera (14b) are pointed at approximately 90 degrees relative to each other: the forward-facing camera (14c) points towards the distal end (10b) of the tubular housing (10), and the side-facing camera (14b) points towards one or more openings (10c) in the tubular housing. It should be understood that the angles of the cameras relative to each other can vary; for example, the pointing angles of the two cameras relative to each other can be approximately 60, 70, 80, 90, 100, 110, or 120 degrees.

[0104] In some embodiments, the pointing directions of the rear camera (14a) and the side camera (14b) are substantially perpendicular to each other, and the pointing directions of the front camera (14c) and the side camera (14b) are substantially perpendicular to each other. In this embodiment, the pointing directions of the front camera and the rear camera (14a) may point substantially towards each other along a longitudinally extending axis (X).

[0105] In some embodiments, the fields of view of one or more image acquisition devices overlap or partially overlap. Advantageously, the fields of view of one or more, two or more, or three or more cameras overlap or partially overlap, such that each camera observes the same target of interest through one or more openings (10c) in the tubular housing (10). In this case, the target of interest is the same, but the cameras advantageously provide different perspectives of the target to assist a physician in examining the target or abnormality and / or surgically intervening. In one embodiment, the fields of view of the rear camera (14a) and the lateral camera (14b) overlap at least partially. In one embodiment, the fields of view of the rear camera (14a) and the lateral camera (14b) overlap. In one embodiment, the fields of view of the rear camera (14a), the front camera (14c), and the lateral camera (14b) overlap at least partially. In one embodiment, the fields of view of the rear camera (14a), the front camera (14c), and the lateral camera (14b) overlap. In a preferred embodiment, one or more openings in the tubular housing (10) are one or more holes, and the image acquisition device of the present invention provides overlapping views of the internal volume of the tubular housing, thereby allowing multiple views of discrete portions of the anal canal through one or more holes into the internal space of the tubular housing.

[0106] In one embodiment, the endoscope includes a rear-facing camera (14a), a side-facing camera (14b), and a front-facing camera to provide images in three planes.

[0107] Traditional proctoscopy utilizes a tampon to aid in insertion into the anal canal. The tampon is detachably positioned within the hollow tube of the proctoscopy, with its head extending beyond the end of the tube. During use, both the proctoscopy and the tampon are inserted into the anus, with the tampon head aiding insertion by dilating the anal canal. The tampon is a removable component of the proctoscopy and is removed after insertion, allowing the physician to view or access the anal cavity. Because the tampon is in contact with the tissues of the anal cavity, removal of the tampon can cause bodily fluids and feces to be drawn out through the hollow tube of the proctoscopy. This is unpleasant for the operator and hinders observation of the internal structures of the anal cavity, as feces or bodily fluids may adhere to the inner surface of the proctoscopy and obstruct the physician's view.

[0108] The unique feature of this invention is that the device does not use a removable tampon. The tubular housing (10) for inserting the image acquisition device into the anal cavity remains during use of the claimed endoscope. This advantageously means that during use of the endoscope, the components of the claimed endoscope will not be contaminated or obscured by bodily fluids, feces, or other substances. In one embodiment, the device is a single unit. In one embodiment, the endoscope does not include a tampon.

[0109] The middle portion (16) of the endoscope is optionally rotatably mounted on the handle (12) so as to rotate about the longitudinal axis X. Figure 3 As shown, a turntable (26) may be provided on the handle or the intermediate portion to allow the intermediate portion (16) and the tubular housing (10) to rotate relative to the handle. The intermediate portion (16) or the handle (12) may include a spindle or plug around which the tubular housing (10) can rotate. By rotating the tubular housing (10), a lateral camera (14b) can acquire images circumferentially in the anal canal or rectum through one or more openings (10c) in the device. The turntable (26) can be rotated manually, allowing the physician to carefully control the viewing angle of one or more image acquisition devices. Alternatively, the turntable may be rotated automatically or electronically or via firmware control.

[0110] The endoscope may further include a light source for projecting light into the interior of the tubular housing (10). The light source may be any light source known to those skilled in the art, including light-emitting diodes (LEDs) or ring lights. One or more light sources may be enclosed within the tubular housing (10) and thus located within the internal volume (V1) of the tubular housing. The light source may be placed near or around one or more image acquisition devices of the invention to provide light within the field of view of the camera.

[0111] The endoscope may further include a pressurization mechanism (28) for pressurizing the interior of the tubular housing (10). In one embodiment, the pressurization mechanism (28) is a gas delivery mechanism. In another embodiment, the pressurization mechanism is a bellows. The pressurization device may also be a ball pump, an electric pump, a pressurizing cylinder, a canister, or the like. Advantageously, the endoscope provides a closed system for inflating air into the patient's anus. Inflating the air causes the tissue of interest to expand, thus allowing it to be better observed. Inflating the air may also reduce or eliminate any tissue folds in the anal canal or rectum, which may reveal abnormalities or areas of interest that were previously hidden in the folds. The pressurization mechanism may be independent within the handle, meaning that an external air supply is not required. Preferably, the pressurization mechanism for supplying air is partially or completely enclosed within the handle. The handle may further be provided with an actuation device to operate the pressurization mechanism and control the air supply to the tubular housing (10).

[0112] In one aspect, a tubular housing (10) for an endoscope as defined herein is provided, having a longitudinally extending axis (X), a proximal end (10a), a distal end (10b), an internal volume (V1), and one or more openings (10c) of length L along the longitudinally extending axis (X).

[0113] In one aspect, a speculum for insertion into the anus is provided, wherein the speculum comprises:

[0114] (a) A handle (12) having a proximal end (12a) and a distal end (12b) and a longitudinally extending axis (X) extending from the proximal end (12a) to the distal end (12b); and

[0115] (b) A protrusion (18) having a first end (18a) mounted on the distal end (12b) of the handle and protruding in the opposite direction to the proximal end (12a) of the handle, wherein a rear camera is mounted on the protrusion and wherein the rear camera takes pictures toward the proximal end (12a) of the handle along a longitudinally extending axis (x).

[0116] In a further aspect, the present invention relates to a speculum for anal sampling. In another aspect, the present invention relates to a speculum for rectal sampling.

[0117] In a further aspect, the present invention relates to a treatment method comprising: inserting a speculum into the anus, and sampling, performing a biopsy, excising, cauterizing, or otherwise treating the anal canal.

[0118] In a further aspect, the present invention relates to a method for anorectal diagnosis, comprising: inserting a rigid endoscope into the anus, observing, performing a biopsy or otherwise examining the anus, and comparing the results with images or biopsies of a known normal anus to diagnose a disease.

[0119] On the other hand, a diagnostic and treatment method is provided, which can be selected for diagnosis and treatment of the anorectal region, including...

[0120] a) Inserting the endoscope described herein into the anus to observe, perform biopsies, or otherwise examine the anus, and comparing the results with images or biopsies of a known normal anus to diagnose disease; and

[0121] b) Treat the anus according to the disease diagnosis in a).

Claims

1. A speculum for insertion into the anus, characterized in that, The scope includes: a tubular housing (10) having a proximal end (10a), a distal end (10b), an internal volume (V1), a longitudinally extending axis (X) extending from the distal end (10b) to the proximal end (10a), a perpendicular axis (Y) extending perpendicular to the longitudinally extending axis (X) and one or more apertures (10c) along the length L of the longitudinally extending axis (X); a handle (12) having a proximal end (12a) and a distal end (12b); and three image acquisition devices (14), each positioned within the internal volume (V1) of the tubular housing (10), wherein the three image acquisition devices (14) are a rear-facing camera (14a), a side-facing camera (14b) and a forward-facing camera (14c), the rear-facing camera (14a) having a field of view through the one or more apertures (10c) in the tubular housing (10) in a direction between the longitudinally extending axis (X) and the perpendicular axis (Y), the side-facing camera (14b) having a field of view through the one or more apertures (10c) in the tubular housing (10) in a direction along the perpendicular axis (Y), the forward-facing camera (14c) having a field of view through the one or more apertures (10c) in the tubular housing (10) in a direction along the longitudinally extending axis (X) from the proximal end (10a) to the distal end (10b) of the tubular housing (10).

2. The scope of claim 1 and including an intermediate portion (16) having a proximal end (16a) and a distal end (16b) and wherein the distal end (16b) of the intermediate portion (16) is connected to the proximal end (10a) of the tubular housing (10) and the proximal end (16a) of the intermediate portion (16) is connected to the handle (12).

3. The scope of claim 1 or claim 2 and including a protrusion (18) having a first end (18a) mounted on the distal end of the intermediate portion (16) and extending within the tubular housing (10) along the longitudinally extending axis (X) towards the distal end (10b) and wherein the rear-facing camera (14a) is mounted on the protrusion (18).

4. The scope of claim 1 or claim 2 and including a protrusion (18) having a first end (18a) mounted on the distal end of the intermediate portion (16) and extending within the tubular housing (10) along the longitudinally extending axis (X) towards the distal end (10b) and wherein the side-facing camera (14b) is mounted on the protrusion (18).

5. The scope of claim 1, wherein, the aperture (10c) is elongate having a first end (30) and a second end (31) and wherein the aperture (10c) tapers from the second end to the first end of the aperture, wherein the first end is positioned towards the distal end (10b) of the tubular housing (10).

6. The scope of claim 2, wherein, the intermediate portion (16) further includes an outer surface, an inner surface and a support member (24) attached to the inner surface and wherein the forward-facing camera (14c) is mounted on the support member (24).

7. The scope of claim 1 or 2, wherein, the tubular housing (10) is rigid.

8. The scope of claim 2, wherein, The intermediate portion (16) further comprises a conduit (20) having a first outer end (20a) and a second inner end (20b) and extending from the outside of the scope into the inside of the tubular housing (10) for inserting a surgical instrument into the internal volume (V2).

9. The scope of claim 8, wherein, The first outer end (20a) is within the intermediate portion (16).

10. The scope of claim 8, wherein, The intermediate portion (16) further comprises a cover (22) for covering the first outer end (20a) of the conduit (20).

11. The scope of claim 10 and comprising a latch for releasably securing the cover (22) to the intermediate portion (16).

12. The scope of claim 11 and comprising a latch release device (26) for releasing the latch and positioned on the handle portion (12).

13. The scope of claim 1 or 2, wherein, The scope further comprises a pressurization mechanism (28) for pressurizing the inside of the tubular housing (10).

14. The scope of claim 13, wherein, The pressurization mechanism (28) is housed within the handle (12) and comprises a bellows (30).

15. The scope of claim 1 or 2, wherein, The cross-sectional profile of the tubular housing (10) has a maximum diameter (D2) at the proximal end (10a) of the tubular housing (10) and tapers to a minimum diameter (D1) at the distal end (10b) of the tubular body.

16. The scope of claim 1 or 2, wherein, The scope further comprises one or more covers for one or more apertures (10c) in the tubular housing (10).

17. The scope of claim 2, wherein, The tubular housing (10) is detachably connected to the intermediate portion (16).

18. The scope of claim 1 or 2 and further comprising a light source for projecting light into the inside of the tubular housing (10).

19. The scope of claim 2 and further characterized by, The intermediate portion (16) is rotatably mounted on the handle (12) for rotation about the longitudinally extending axis (X).

20. The scope of claim 1 or 2 wherein: The handle (12) having a proximal end (12a) and a distal end (12b) further comprises a longitudinally extending axis (X) extending from the proximal end (12a) to the distal end (12b); and a protrusion (18) having a first end (18a) mounted on the distal end (12b) of the handle and protruding in a direction opposite to the proximal end (12a) of the handle, and wherein the rear-facing camera (14a) is mounted on the protrusion (18), and wherein the rear-facing camera (14a) takes pictures along the longitudinally extending axis (X) towards the proximal end (12a) of the handle (12).

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