Hemorrhoidal repair system with a multi-stage proctoscope-guided surgical mechanism

Abstract

A transanal hemorrhoid treatment system comprising: (a) a sacrorectopexy unit comprising a proctoscope having a tubular body, a side access window, and a light source port, the proctoscope being configured for insertion into the rectum and allowing the targeted application of presacral fixation sutures by a curved suturing needle, the sutures being anchored to the sacral fascia to fix the inner rectal wall and reduce rectal prolapse; (b) a suture rectopexy unit operable by the same or an interchangeable proctoscope, the unit comprising a suture guide adapted to place a series of overlapping sutures in a circular pattern through the rectal mucosa, submucosa, and a partial layer of rectal muscle, approximately 4 cm proximal to the dentate line, so as to fix the mucosa to the underlying muscle to occlude afferent branches of the superior rectal artery; and (c) a mucopexy unit comprising a butterfly-shaped proctoscope for radial expansion and a suture applicator configured to apply single U-shaped sutures to anatomically prominent hemorrhoidal locations above the dentate line, including but not limited to the 3, 7, and 11 o'clock positions, thereby reducing prolapsed hemorrhoidal tissue without excision.

Description

Technical area:

[0001] The present invention relates to medical devices, and in particular to instruments for proctology and colorectal surgery. It relates to a specific system for hemorrhoid reconstruction with a multi-stage, proctoscope-guided surgical mechanism. Background of the invention:

[0002] Conventional proctoscopes have been used for decades to examine and treat anorectal conditions such as internal hemorrhoids, rectal bleeding, anal fissures, mucosal prolapse, polyps, and fistulas. However, these traditional instruments have significant limitations regarding the field of view, easy access to internal structures, and adequate illumination of the rectal canal. External light sources are often awkward to position, and the restricted aperture configurations of standard proctoscopes limit maneuverability for both diagnostic and surgical procedures. Therefore, there is an urgent clinical need for a redesigned proctoscope with an integrated illumination mechanism and an anatomically appealing open window configuration that enables focused intervention and clear visualization of the affected rectal tissue during surgical or diagnostic procedures.

[0003] The most common form of a conventional proctoscope consists of a tubular instrument made of metal or plastic with an obturator and a proximal attachment for a light source. Illumination is often provided by external halogen or LED sources connected to the instrument via fiber optic cables. These setups have several disadvantages. Fiber optic cables can be fragile and expensive and are often subject to repeated sterilization cycles, causing their light transmission efficiency to decrease over time. The reliance on external light sources also introduces logistical complexities in settings without modern infrastructure, such as rural clinics or mobile health units. Furthermore, external light systems must be constantly adjusted and calibrated to ensure adequate brightness and focus within the rectal canal, leading to inefficiencies during time-critical procedures.

[0004] Existing illuminated proctoscopes with integrated illumination, such as models with battery-powered LED modules at the distal tip, have been gradually improved but still suffer from design and functional limitations. The distal LEDs often emit unidirectional or poorly scattered light, resulting in shadows and uneven illumination of the mucosal surface. This partial illumination significantly complicates the detection of subtle lesions or vascular abnormalities. Furthermore, these designs are often limited by fixed light intensity settings that do not allow for adjustment to the procedural requirements or individual patient anatomy. Some proctoscope variants attempt to mitigate this by incorporating adjustable optical lenses or reflectors.However, such additions increase device complexity and production costs, often making them less affordable for resource-poor facilities.

[0005] From a procedural perspective, stable and uniformly bright illumination is critical not only for diagnostic visualization but also for therapeutic procedures such as rubber band ligation, sclerotherapy, polypectomy, and biopsy collection. Inadequate illumination can lead to procedural errors, misdiagnosis, or complications due to incomplete treatment. Surgeons and gastroenterologists frequently report difficulty maintaining consistently clear visibility during surgery in deep anorectal cavities, especially in patients with narrow or tortuous rectal anatomy. Reflective and moist mucosal surfaces further exacerbate this problem, causing glare or scattering of the light beam with conventional sources.

[0006] Sterility and reusability pose another major challenge with existing proctoscope models. Instruments that require extensive disassembly for cleaning and sterilization often experience wear and tear on the light guide systems, necessitating frequent maintenance. The integration of electronic components such as external light cables or removable LED heads also raises concerns about protection against media ingress and compatibility with autoclave sterilization procedures. While disposable proctoscopes with integrated illumination have already been introduced in some markets, these are often environmentally harmful, expensive per unit, and lack brightness or battery life for longer treatment procedures.

[0007] From an ergonomic perspective, the use of external light sources connected to power supplies via cables places additional strain on clinical staff, often requiring awkward hand positions or adjustments during the procedure. This not only increases treatment time but also impairs the overall user experience. Outpatient clinicians require tools that are self-contained, portable, and quickly ready for use. The lack of these features in existing lighting systems leads to operator fatigue and reduces treatment throughput, especially in high-volume practices.

[0008] Another major limitation of current designs is the lack of intelligent feedback or the integration of digital imaging technologies. Most illuminated proctoscopes are standalone optical devices and do not offer the capability for real-time data acquisition, image optimization, or procedure documentation. With the increasing importance of evidence-based diagnostics and digital medical records, there is a growing demand for diagnostic tools that not only visualize findings but also record, analyze, and store them for later review or remote consultation. The integration of camera modules or wireless imaging systems is largely not possible in low- to mid-range proctoscopes due to cost, performance, and space constraints.

[0009] In recent years, attempts have been made to integrate light-emitting diodes (LEDs) into the tip of proctoscopes to create a direct, localized light source. However, these innovations still face limitations due to power supply issues, battery heating, and limited battery life.

[0010] While miniature batteries increase the compact design, they often lack sufficient capacity for longer procedures, while larger batteries increase the size of the device and compromise insertion comfort. Furthermore, heat dissipation remains a concern, as prolonged LED operation in a confined body space can lead to thermal discomfort or mucosal irritation, especially if not prevented by thermal insulators or advanced circuit design.

[0011] Furthermore, the reliability of these devices in diverse clinical settings is questionable. In developing countries or field hospitals, reliable access to electricity or sophisticated light modules is not guaranteed. Devices that rely on mains power or complex charging systems are inherently less practical in these scenarios. Likewise, reusable devices that require complex sterilization protocols face limitations in resource-poor settings where autoclaving equipment is unavailable or where high sterilization volumes are required.

[0012] The clinical need for a self-illuminating proctoscope that combines optimal illumination, ergonomic design, thermal safety, digital integration, and procedural flexibility remains unmet. Furthermore, there is a need for innovations in patient comfort through innovations in device materials, insertion dynamics, and illumination that minimizes thermal stress without compromising clarity. A self-contained illumination system using efficient, low-heat, and high-output LEDs with rechargeable power sources, integrated into a reusable or semi-disposable format, would be highly beneficial. Ideally, such a device would support modular attachments for digital imaging, feature dimmable illumination control, and be compatible with standard sterilization protocols to ensure longevity and hygiene compliance. Summary of the invention:

[0013] The present invention relates to a transanal system and device for the treatment of hemorrhoidal disease using a structured, multi-stage fixation method that minimizes recurrence, pain, and procedural complexity. The system integrates three key techniques—sacrorectopexy, suture rectopexy, and mucopexy—performed through a proctoscopic approach to enable anatomical correction and secure fixation of prolapsed rectal tissue without tissue excision. The device includes a set of specialized proctoscopes, long needle holders, knot pushers, sutures of varying thicknesses, and light sources for precise transanal access and optimal visualization. Sacrorectopexy utilizes PDS sutures to anchor the internal rectum to the presacral fascia through a unique fixation strategy, thus avoiding presacral vascular injury.Suture rectopexy involves the controlled placement of absorbable sutures to fix the mucosa-submucosa to the rectal muscle layer, ligate the afferent vessels, and minimize prolapse. Mucopexy enhances tissue repositioning above the dentate line, particularly at typical hemorrhoid sites. The system ensures fixation in a pain-free area, minimizes postoperative discomfort, and effectively reduces hemorrhoid symptoms. The device-based approach offers reproducibility, reduced recurrence, and improved patient recovery without the use of staplers or excisional techniques. SHORT DESCRIPTION OF THE FIGURE

[0014] These and other features, aspects, and advantages of the present invention will become more readily understood when the following detailed description is read in conjunction with the accompanying drawings, in which like characters represent like parts throughout. Fig. Figure 1 shows a block diagram of a transanal hemorrhoid treatment system.

[0015] Those skilled in the art will also appreciate that the elements in the drawings are shown for convenience and are not necessarily to scale. For example, the flowcharts illustrate the method by key steps to enhance understanding of aspects of the present disclosure. Furthermore, with respect to device construction, one or more components of the device may be represented in the drawings by conventional symbols. The drawing may show only the specific details relevant to understanding embodiments of the present disclosure in order not to clutter the drawing with details that would be readily apparent to those skilled in the art from the present description. Detailed description of the invention:

[0016] To facilitate understanding of the principles of the invention, reference will now be made to the embodiment illustrated in the drawings and a clear description will be given. However, the scope of the invention is not limited thereby. Changes and further modifications to the illustrated system, as well as further applications of the principles of the invention, are possible, as would normally occur to one skilled in the art to which the invention pertains.

[0017] It will be understood by those skilled in the art that the foregoing general description and the following detailed description are exemplary and explanatory of the invention and are not intended to be limiting thereof.

[0018] References in this specification to "one aspect," "another aspect," or similar language mean that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment of the present disclosure. Therefore, the language "in one embodiment," "in another embodiment," and similar language throughout this specification may or may not refer to the same embodiment.

[0019] The terms "comprises," "comprising," or other variations thereof are intended to cover non-exclusive inclusion, such that a process or method comprising a list of steps may include not only those steps, but also additional steps not expressly listed or inherent in that process or method. Likewise, the statement "comprises" for one or more devices, subsystems, elements, structures, or components does not exclude, without further limitation, the existence of other devices, subsystems, elements, structures, components, or additional devices, subsystems, elements, structures, or components.

[0020] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the invention pertains. The systems, methods, and examples provided herein are for illustrative purposes only and should not be considered limiting.

[0021] Embodiments of the present disclosure will be described in detail below with reference to the accompanying drawings.

[0022] Fig.Figure 1 shows a block diagram of a transanal hemorrhoid treatment system. The system includes: (a) a sacrorectopexy unit (102) with a proctoscope with a tubular body, side access window, and light source port. The proctoscope is configured for insertion into the rectum and allows for the targeted delivery of presacral fixation sutures through a curved suture needle. The sutures are anchored to the sacral fascia to fixate the inner rectal wall and reduce rectal prolapse.(b) a suture rectopexy unit (104) operable via the same or an interchangeable proctoscope, the unit comprising a suture guide for placing a series of overlapping sutures in a circular pattern through the rectal mucosa, submucosa, and a partial layer of rectal muscle, approximately 4 cm proximal to the dentate line, so as to fix the mucosa to the underlying muscle to occlude the feeding branches of the superior rectal artery; and (c) a mucopexy unit (106) comprising a butterfly-shaped proctoscope for radial expansion and a suture applicator capable of placing individual U-shaped sutures at anatomically prominent hemorrhoidal locations above the dentate line, including, but not limited to, the 3, 7, and 11 o'clock positions, thereby reducing prolapsed hemorrhoidal tissue without excision.

[0023] In one embodiment, the sacrorectopexy unit uses a PDS No. 1 monofilament suture with a 40 mm round-bodied needle to suture approximately two-thirds of the rectal circumference to the presacral fascia between the third sacral vertebra and the sacrococcygeal junction.

[0024] In one embodiment, the proctoscope of the sacrorectopexy unit includes a lateral window having a width of approximately 2.8 cm and a total length of approximately 14 cm, allowing complete visualization and passage of instruments without rotating the proctoscope body.

[0025] In one embodiment, each suture is placed in the suture rectopexy unit using a 2-0 polyglactin suture mounted on an atraumatic 30 mm ½ circle needle with double locking overlap to prevent purse-string effects.

[0026] In one embodiment, the mucopexy unit uses 2-0 Vicryl quick-cut sutures mounted on 30 mm round-bodied needles, with each suture positioned 2 cm to 3 cm above the dentate line.

[0027] In one embodiment, the suture rectopexy unit further comprises a long needle holder and a laparoscopic knot pusher for internal fixation of the placed sutures in the limited rectal lumen.

[0028] In one embodiment, the mucopexy unit includes an additional suture positioning mechanism adapted to accommodate additional hemorrhoids outside the standard 3, 7, and 11 o'clock positions.

[0029] In one embodiment, the proctoscope used in each of the units can be connected to an external cold light source via a fiber optic cable for improved visualization.

[0030] In one embodiment, an electrocautery, stapler, or excision device is used, and all fixation is accomplished using atraumatic suturing techniques to minimize postoperative pain and promote natural tissue healing.

[0031] In one embodiment, the system is suitable for the treatment of grade II, III and IV hemorrhoidal disease without the need for hemorrhoidectomy or resection of the anal mucosa.

[0032] The present disclosure relates to a multifunctional transanal surgical system for the treatment of hemorrhoidal disease and internal rectal prolapse, specifically designed for the treatment of mass prolapse, recurrences, and vascular strictures through a structured, hardware-assisted configuration. The system includes a modular, self-illuminating rectal fixation and mucosal anchoring device integrally designed for diagnostic and surgical purposes and intended for use in minimally invasive surgical environments.

[0033] The main component of the system is a cylindrical proctoscope with a length of approximately 14 cm and a diameter of 4 cm, as well as a lateral window opening of 2.8 cm. This transanally inserted proctoscope allows complete visual and mechanical access to the internal prolapsed rectal segment. It is designed for external illumination via a removable light source with a fiber optic cable to enable shadow-free visualization of deep mucosal structures.

[0034] The rectal wall is anchored to the presacral fascia using a fixation module consisting of a curved surgical needle mounted on a long needle holder, compatible with the limited access of the proctoscope. Absorbable PDS No. 1 suture material is used, mounted on a 40 mm round-bodied needle. The fixation points are located between the anterior rectal surface and the sacral periosteum and extend from the third sacral vertebra to the sacrococcygeal junction. Secure anchorage is achieved using laparoscopic knot pushers, which facilitate the tying of the tensioned knot in the narrow surgical channel.

[0035] Additionally, a circumferential mucosal-submucosa anchoring subsystem is integrated. This system uses a 2.0 polyglactin suture mounted on a 30 mm long, atraumatic semicircular needle and is passed through the same proctoscope. The system allows for precise bite placement with partial muscularis propria attack without fully penetrating the rectal wall. The anchoring path follows a 360-degree spiral suture approximately 4 cm proximal to the dentate line, ensuring uniform mucosal fixation. The device is configured to maintain a suture overlap of 1-2 mm between consecutive placements to avoid purse-string effects. It features a mechanism for double-locking each knot, improving suture purchase and preventing ischemic constriction.

[0036] For targeted correction of hemorrhoidal vascular congestion, a mucopexy unit is integrated. This includes a butterfly proctoscope for visualizing hemorrhoid zones at typical 3, 7, and 11 o'clock positions. The mucopexy subsystem uses a 2-0 Vicryl rapid suture on a 30 mm round-bodied needle to apply U-shaped traction sutures at defined points 2-3 cm above the dentate line. The design allows for the application of additional U-shaped sutures to accessory hemorrhoid zones without repositioning the main unit. This improves surgical efficiency and reduces trauma.

[0037] The entire system is modular and includes accessories such as precision scissors, long-reach needle holders, knot pushers, and lighting connectors. Each unit is sterilizable and compatible with standard surgical operating room infrastructure. The system design ensures anatomically separate fixation and mucopexy zones with a 3 cm buffer area between rectopexy and mucopexy sites. This minimizes the risk of ischemia or fibrotic stenosis. Furthermore, the device is designed to eliminate the need for proprietary staple cartridges, electrocautery devices, or expensive consumables, making it suitable for cost-effective use in diverse clinical settings.

[0038] The surgical system was shown to be compatible with the anatomical characteristics of a broad demographic spectrum, including men and women aged 23 to 82 years. The device enabled effective reduction of prolapse and hemorrhoids, which was confirmed intraoperatively and by proctoscopic follow-up examinations, without compromising anorectal continence or causing pain, ischemia, or restenosis. The integration of standardized surgical instruments and reusable proctoscopic systems into a unified surgical platform represents a novel, resource-efficient solution for the sustainable treatment of hemorrhoidal disease with minimized postoperative complications.

[0039] The special self-illuminating proctoscope is designed as a hollow, elongated cylindrical tube with an outer diameter of approximately 4 cm and a length of approximately 14 cm. The main body is tubular, and the inner surface is polished to allow gentle insertion into the anal canal. A special longitudinal section of the cylindrical wall, representing approximately one-eighth of the total circumference, is surgically removed or omitted during manufacture to create a special open window. This open window has a width of approximately 2.8 cm along its longitudinal axis and is positioned to conform to the internal rectal anatomy after insertion of the device. This strategic opening provides direct visual and instrumental access to targeted internal structures such as internal hemorrhoids or mucosal lesions.The open window allows for real-time monitoring and manipulation of tissue during procedures such as transanal suturing, polypectomy, mucosal lifting, and bleeding control without the need for repositioning or excessive angulation.

[0040] To overcome the limitations of conventional lighting, the proctoscope incorporates an internal illumination mechanism. This system includes at least one miniature LED light source embedded in or near the open window area or along the inner circumference of the cylindrical tube. The LED system is powered by a compact battery pack located in a sealed compartment at the proximal end of the device. An integrated control switch, accessible from the external handle, allows the user to activate, deactivate, and adjust the light intensity. Self-illumination ensures a uniform and shadow-free field of view within the rectal canal, even in conditions of limited ambient lighting or when positioning the external light is difficult.The light source is configured to operate safely within medical sterilization limits and does not generate significant heat that could damage mucosal tissue.

[0041] The proctoscope can be manufactured from medical-grade polymer, surgical stainless steel, or a hybrid biocompatible composite material, ensuring durability, ease of sterilization, and patient safety. The cylindrical body is smooth and can be coated with a lubrication or anti-reflective coating to reduce insertion resistance and glare. The proximal end of the proctoscope features an ergonomically designed handle that allows for controlled insertion, angle adjustment, and stable one-handed operation during complex surgical procedures. Optional finger rests or grip contours can be integrated into the handle for increased comfort. The device can also be equipped with accessory ports or attachment devices for suction catheters, biopsy instruments, or sutures, transforming the proctoscope into a multifunctional surgical access device.

[0042] The present invention offers a significant clinical advantage through improved visibility, access, and surgical ergonomics during procedures involving the lower rectum and anal canal. The open window configuration allows for precise identification and intervention at specific mucosal sites without the need to reposition the endoscope. The integrated illumination system eliminates shadows and provides uniform illumination, thereby improving diagnostic accuracy and surgical safety. The device is particularly useful in outpatient facilities, ambulatory surgical units, and resource-limited settings where conventional proctoscopic illumination systems are unavailable or impractical. The proctoscope is ideal for procedures such as transanal mucopexy, hemorrhoid ligation or suturing, mucosal prolapse repair, rectal biopsy, and the evaluation or closure of deep fistula tracts.

[0043] The special self-illuminating proctoscope is used in various medical and surgical fields, including proctology, gastroenterology, general surgery, and colorectal diagnostics. Its design increases procedural efficiency, minimizes patient discomfort, and expands the spectrum of therapeutic options through a single, compact, and user-friendly instrument. The invention supports both routine examinations and advanced procedures with improved safety, visibility, and anatomical precision.

[0044] The drawings and the foregoing description illustrate examples of embodiments. Those skilled in the art will recognize that one or more of the described elements may well be combined to form a single functional element. Alternatively, certain elements may be separated into multiple functional elements. Elements of one embodiment may be added to another embodiment. For example, the order of the processes described herein may be changed and is not limited to the manner described herein. Furthermore, the actions of a flowchart need not be performed in the order shown; nor do all actions need to be performed. Also, actions that are not dependent on other actions may be performed in parallel with the other actions. The scope of the embodiments is in no way limited by these specific examples.Numerous variations, whether explicitly stated in the specification or not, such as differences in structure, dimensions, and use of materials, are possible. The scope of the embodiments is at least as broad as indicated in the following claims.

[0045] Advantages, further benefits, and solutions to problems have been described above with reference to specific embodiments. However, the advantages, advantages, solutions to problems, and any components that may result in or enhance an advantage, advantage, or solution are not to be construed as critical, required, or essential features or components of any or all of the claims. REFERENCES 100 Block diagram of a transanal hemorrhoid treatment system. 102 Sacrorectopexy Unit 104 Suture Rectopexy Unit 106 Mucopexy Unit

Claims

[1] A transanal hemorrhoid treatment system comprising: (a) a sacrorectopexy unit comprising a proctoscope having a tubular body, a side access window, and a light source port, the proctoscope being configured for insertion into the rectum and allowing the targeted application of presacral fixation sutures by a curved suturing needle, the sutures being anchored to the sacral fascia to fix the inner rectal wall and reduce rectal prolapse; (b) a suture rectopexy unit operable by the same or an interchangeable proctoscope, the unit comprising a suture guide adapted to place a series of overlapping sutures in a circular pattern through the rectal mucosa, submucosa, and a partial layer of rectal muscle, approximately 4 cm proximal to the dentate line, so as to fix the mucosa to the underlying muscle to occlude afferent branches of the superior rectal artery; and (c) a mucopexy unit comprising a butterfly-shaped proctoscope for radial expansion and a suture applicator configured to apply single U-shaped sutures to anatomically prominent hemorrhoidal locations above the dentate line, including but not limited to the 3, 7, and 11 o'clock positions, thereby reducing prolapsed hemorrhoidal tissue without excision. [2] The system of claim 1, wherein the sacrorectopexy unit uses a polydioxanone monofilament suture with a 40 mm round-bodied needle to fix approximately two-thirds of the rectal circumference to the presacral fascia between the third sacral vertebra and the sacro-coccygeal junction. [3] The system of claim 1, wherein the proctoscope of the sacrorectopexy unit includes a lateral window having a width of approximately 2.8 cm and a total length of approximately 14 cm, thereby allowing complete visualization and passage of instruments without rotating the proctoscope body. [4] The system of claim 1, wherein each suture in the suture rectopexy unit is placed using a 2-0 polyglactin suture mounted on a 30 mm ½ circle atraumatic needle with double locking overlap to prevent purse-string effects. [5] The system of claim 1, wherein the mucopexy unit uses 2-0 Vicryl quick-action sutures mounted on 30 mm round-bodied needles, and wherein each suture is positioned 2 cm to 3 cm above the dentate line. [6] The system of claim 1, wherein the suture rectopexy unit further comprises a long needle holder and a laparoscopic knot pusher for internal fixation of the placed sutures within the confined rectal lumen. [7] The system of claim 1, wherein the mucopexy unit includes an additional suture positioning mechanism adapted to accommodate additional hemorrhoids outside the standard 3, 7, and 11 o'clock positions. [8] The system of claim 1, wherein the proctoscope is connectable to an external cold light source via a fiber optic cable for improved visualization.

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