Visual medical probe
By designing a flexible probe tube with an outer diameter of 2mm, equipped with a macro wide-angle lens and image guide bundle, a visual medical probe has been developed. This solves the problem that existing anal fistula probes cannot observe the internal structure of the fistula, enabling efficient and accurate diagnosis and minimally invasive treatment of anal fistulas while protecting the function of the anal sphincter.
Patent Information
- Application Number
- CN202210276872.5
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- Filing Date
- 2022-03-21
- Publication Date
- 2025-11-11
- Estimated Expiration
- 2042-03-21
AI Technical Summary
Existing anal fistula probes lack visualization capabilities, leading to the risk of misprobing during diagnosis and treatment. Furthermore, existing visualization equipment is not suitable for anal fistulas that are winding, tortuous, and have narrow tracts, making it impossible to effectively observe the internal anatomical structure of the fistula.
A visual medical probe was designed, which uses a soft probe tube with an outer diameter of 2mm, equipped with a macro wide-angle lens and image guide beam. Combined with the beam guide beam and injection tube, it can observe the internal structure of the fistula in real time, and perform drug flushing and biopsy through the injection tube. It can also be used in conjunction with a medical laser or high-frequency electrosurgical unit for minimally invasive treatment.
It significantly improves the accuracy and precision of anal fistula diagnosis and treatment, reduces the risk of misprobing, and is suitable for the diagnosis and treatment of most anal fistulas. In particular, it protects the function of the anal sphincter through minimally invasive surgery, shortens the healing time, and reduces scar formation.
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Figure CN114532963B_ABST
Abstract
Description
Technical Field
[0001] This invention relates to medical probes, and more particularly to a visual medical probe. Background Technology
[0002] An anal fistula, also known as anorectal fistula or simply anal fistula, is an abnormal channel formed between the anal canal or lower rectum and the skin around the anus or adjacent tissues and organs due to pathological reasons. A typical anal fistula generally includes an external opening, a fistula tract, and an internal opening. In some cases, it occurs atypically, with varying degrees of pseudo-healing of the internal and external openings and fistula tract; these situations occur in combination or concurrently. The fistula tract is irregular in shape, either straight or tortuous, sometimes branched, or multiple fistula tracts may coexist or be interconnected. Clinically, it is classified into high-level complex anal fistulas, high-level simple anal fistulas, low-level complex anal fistulas, and low-level simple anal fistulas. Cases of these types coexisting are also frequently observed in clinical practice.
[0003] Anal fistula is a common and frequently occurring surgical condition, primarily treated surgically. The principles of surgical treatment for anal fistula include locating the fistula tract and internal opening, eliminating the internal opening and any communicating fistula tracts, while maximizing the preservation of anal sphincter function. Anal fistulas located deep within the perianal skin and high-level anal fistulas require diagnosis and treatment using existing instruments and equipment. Commonly used methods include MRI, ultrasound, X-ray fistula imaging, and probes. MRI, ultrasound, and X-ray fistula imaging can be used as preoperative diagnostic aids, while probes are commonly used instruments during surgery.
[0004] The probe is small and simple in structure, mostly a thin metal rod or tube with a rigid or flexible oval tip. It is inserted into the fistula tract, and the doctor's diagnostic experience, combined with palpation, is used to determine the location of the fistula tract, the internal opening, and the external outline for diagnosis and treatment. Normally, the probe enters from the external opening, passes through the fistula tract, and exits from the internal opening. This provides a clear understanding of the entire fistula, including its external opening, fistula tract, and internal opening, allowing the doctor to perform surgical treatment. However, currently used probes lack visual capabilities, failing to observe the internal anatomical structures of the fistula tract or the internal opening. Probing within the fistula tissue is essentially blind probing, carrying the risk of misprobing and misdirection. This can lead the doctor to mistakenly believe they have found the fistula tract and internal opening, resulting in the removal of healthy tissue while leaving the actual fistula tract and internal opening intact, ultimately leading to surgical failure.
[0005] Because fistulas and other fistula diseases often involve very thin tracts, typically less than 3mm in diameter, there are currently no domestically produced instruments for inserting into the fistula to observe its internal structure and anatomical opening. Internationally, research in this field is still in its early stages. In 2011, Professors Meiero and Mori of Italy first publicly proposed the VAFFT (Video-assisted anal fistula treatment) procedure. This video-assisted anal fistula treatment kit was developed and manufactured by the German company Karl Storz, and is also known as the Karl Storz kit. Domestically, it is commonly referred to as an "anal fistula endoscope." The German-developed anal fistula endoscope has an 8° oblique viewing angle, a diameter of 3.3–4.7 mm, an operating length of 18 cm, and a field of view that can be simultaneously observed between 70 and 90 degrees. The endoscope is a straight, rigid structure that does not bend with the direction of the fistula, and its outer diameter is relatively large, reaching 4.7mm, making it more suitable for anal fistulas with larger and straighter tracts. However, in actual clinical practice, this type of anal fistula is relatively rare in the domestic population. Most anal fistulas have a meandering and irregular fistula tract, some of which have branches, and the inner diameter of the fistula tract is relatively small, mostly less than 3mm, and most are around 2mm. This makes it impossible to insert the fistula endoscope, which limits the use of this type of fistula endoscope and prevents its widespread adoption.
[0006] Chinese patent CN201910680869.8 discloses a video-assisted endoscope kit for treating anal fistulas. This kit has a relatively complex structure and can perform surgery on some anal fistulas. However, its core invention is an improvement on existing rigid endoscopes, rather than an invention of the endoscope itself. Furthermore, this endoscope kit has a relatively large outer diameter of 4mm and is a rigid tube structure. The endoscope used is also a rigid endoscope, making it unsuitable for most anal fistulas with thin or meandering fistula tracts (because insertion is impossible). It is more suitable for larger anal fistulas with straight tracts.
[0007] Some patent documents concern anal fistula probes, such as patent document CN108992102A which discloses a medical anal fistula probe, patent document CN208709893U which discloses an improved anal fistula probe, and patent document CN108201436A which discloses a disposable multifunctional soft anal fistula probe. Other patents concern surgical instruments for anal fistula setons, such as document CN109223105A which discloses a medical multifunctional seton holder, patent document CN108888304A which discloses an anal fistula seton device, and patent document CN108852430A which discloses a seton tightening device for anal fistula seton surgery.
[0008] Currently, there is no literature documenting a flexible fistula endoscope or visual probe with a small diameter (2mm outer diameter) suitable for anal fistula tracts. Summary of the Invention
[0009] The purpose of this invention is to provide a visual medical probe suitable for visual medical exploration and treatment of anal fistula tracts.
[0010] To achieve the above objectives, the technical solution of the present invention is: a visual medical probe, comprising a probe outer tube, an injection tube, an examination lens, an image guide bundle, a light-transmitting lens, and a light guide beam. The light-transmitting lens is disposed at the front end of the probe outer tube, the examination lens is disposed on the light-transmitting lens, the front end of the examination lens protrudes from the light-transmitting lens, the light guide beam passes through the probe outer tube and connects to the light-transmitting lens, and the image guide bundle passes through the probe outer tube and connects to the examination lens.
[0011] Furthermore, in order to insert a thinner fistula, the outer diameter of the probe outer tube is 2mm ± 0.005mm, the wall thickness of the probe outer tube is 0.1mm ± 0.005mm, the length of the probe outer tube is 200mm to 500mm, and the material of the probe outer tube is mild steel.
[0012] Furthermore, a preferred structure for the light-transmitting lens is that the diameter of the light-transmitting lens is 1.8 mm ± 0.005 mm, the thickness of the light-transmitting lens is 3.0 mm, the front end of the light-transmitting lens is flush with the front end of the probe outer tube, and the light guide beam includes 3000 single optical fibers with a diameter of 12 μm.
[0013] Furthermore, a preferred probe lens structure is that the probe lens is a macro wide-angle lens, the probe lens has a diameter of 0.55 mm ± 0.005 mm, the probe lens has a thickness of 2.0 mm, the outer diameter of the probe lens is covered with a lens sleeve, the lens sleeve is a stainless steel sleeve with a wall thickness of 0.1 mm, the front edge of the probe lens is flush with the front surface of the light-transmitting lens, and the image guide bundle includes 8000 single optical fibers with a diameter of 7 μm to 8 μm.
[0014] Furthermore, in order to pass the liquid and surgical equipment through the probe, an injection tube is provided inside the outer tube of the probe, and the front end of the injection tube is inserted into the light-transmitting lens, with the front end of the injection tube flush with the front surface of the light-transmitting lens.
[0015] Furthermore, a preferred injection tube structure is that the outer diameter of the injection tube is 0.9 mm ± 0.005 mm, the wall thickness of the injection tube is 0.1 mm ± 0.005 mm, and the injection tube is a soft steel tube or a plastic flexible tube.
[0016] Furthermore, in order to make full and reasonable use of the space inside the probe outer tube, the light-transmitting lens is provided with a lens mounting hole and an injection tube mounting hole. The lens mounting hole and the injection tube mounting hole are located on both sides of the center of the light-transmitting lens. The probe lens is installed in the lens mounting hole, and the front end of the injection tube is installed in the injection tube mounting hole. The guide beam passes through the probe outer tube in the space left between the injection tube and the image guide bundle, and the front end of the guide beam is close to the rear end face of the light-transmitting lens.
[0017] Furthermore, to enhance the structural strength of the probe outer tube head and improve the flushing effect and cleaning of the probe connector, the front end of the probe outer tube is provided with a head outer sleeve. The front end of the head outer sleeve is flush with the front end of the probe outer tube, and the front end of the head outer sleeve and the front end of the probe outer tube are polished rounded. The head outer sleeve is a titanium alloy tube with a length of 4.0 mm and a wall thickness of 0.1 mm. The front end of the head outer sleeve is provided with a splashing tongue that bends towards the center of the probe outer tube, and the position of the splashing tongue corresponds to the outlet of the injection tube.
[0018] Furthermore, a preferred splash tongue structure is that the width of the splash tongue is 0.7 mm, and the splash tongue protrudes 0.8 mm beyond the front end of the head outer sleeve.
[0019] Furthermore, in order to connect to external devices, the tails of the image guide bundle, the beam guide, and the injection tube extend beyond the end of the probe outer tube. The end of the probe outer tube is provided with a probe connector, which is provided with an image interface, a light source interface, and an injection interface. The image guide bundle is connected to the image interface, the beam guide is connected to the light source interface, and the injection tube is connected to the injection interface.
[0020] The beneficial effects of this invention are as follows: It employs a probe tube with a small outer diameter and moderate flexibility, and has an examination lens at the front end, making it particularly suitable for fistula exploration. The injection tube allows for drug flushing within the fistula and cleaning of the examination lens. The splashing tongue at the probe tip significantly improves the effectiveness of fistula flushing and lens cleaning. Furthermore, the injection tube allows for biopsy and pathological examination of the fistula and its internal opening. Combined with a medical laser or high-frequency electrosurgical unit, it enables precise and minimally invasive treatment of anal fistulas. This invention significantly improves the diagnostic and treatment methods for anal fistulas and other fistula tracts.
[0021] The present invention will now be described in detail with reference to the accompanying drawings and embodiments. Attached Figure Description
[0022] Figure 1 This is a structural diagram of the present invention;
[0023] Figure 2 This is a cross-sectional view of the structure of the present invention;
[0024] Figure 3 This is an exploded view of the probe head structure of the present invention;
[0025] Figure 4 This is a structural diagram of the probe head of the present invention;
[0026] Figure 5 This is a structural diagram of the probe head of the present invention. Figure 4 The AA cross-sectional view hides the beam guide;
[0027] Figure 6 yes Figure 5 BB cross-sectional view;
[0028] Figure 7 This is a structural diagram of the probe connector of the present invention;
[0029] Figure 8 This is a schematic diagram of the connection between the probe connector of the present invention and the device.
[0030] Because the optical fibers of the image guide bundle and beam are too thin, the image guide bundle and beam in the figure are depicted in an exaggerated manner. Detailed Implementation
[0031] like Figures 1 to 6 A visual medical probe includes a probe outer tube 10, a probe lens 20, an image guide beam 30, a light-transmitting lens 40, and a light guide beam 50. The probe lens is disposed on the light-transmitting lens, with its front end exposed. The light-transmitting lens is disposed at the front end of the probe outer tube. The light guide beam passes through the probe outer tube and connects to the light-transmitting lens. The image guide beam passes through the probe outer tube and connects to the probe lens.
[0032] The outer diameter d1 of the probe outer tube is 2mm ± 0.005mm, the wall thickness S1 of the probe outer tube is 0.1mm ± 0.005mm, the length L of the probe outer tube is 200mm to 500mm, and the material of the probe outer tube is mild steel.
[0033] The diameter d4 of the light-transmitting lens is 1.8 mm ± 0.005 mm, the thickness S4 of the light-transmitting lens is 3.0 mm, the front of the light-transmitting lens is flush with the front end of the probe outer tube, and the light guide beam includes 3000 single optical fibers with a diameter of 12 μm.
[0034] The probing lens is a macro wide-angle lens. The diameter d2 of the probing lens is 0.55 mm ± 0.005 mm, and the thickness S2 of the probing lens is 2.0 mm. The outer diameter of the probing lens is covered by a lens sleeve 21, which is a stainless steel sleeve with a wall thickness of 0.1 mm. The front edge of the probing lens is flush with the front surface of the light-transmitting lens. The image guide bundle includes 8000 single optical fibers with a diameter of 7 μm to 8 μm.
[0035] The probe outer tube is equipped with an injection tube 60, the front end of which is inserted into the light-transmitting lens, and the front end of the injection tube is flush with the front surface of the light-transmitting lens.
[0036] The outer diameter d6 of the injection tube is 0.9 mm ± 0.005 mm, the wall thickness S6 of the injection tube is 0.1 mm ± 0.005 mm, and the injection tube is a soft steel tube or a plastic flexible tube.
[0037] The light-transmitting lens 40 is provided with a lens mounting hole 41 and an injection tube mounting hole 42. The lens mounting hole and the injection tube mounting hole are located on both sides of the center of the light-transmitting lens. The probe lens is installed in the lens mounting hole, and the front end of the injection tube is installed in the injection tube mounting hole. The guide beam passes through the probe outer tube in the space left between the injection tube and the image guide bundle, and the front end of the guide beam is in close contact with the rear end face of the light-transmitting lens 40.
[0038] The probe outer tube has a head sleeve 70 at its front end. The front end of the head sleeve is flush with the front end of the probe outer tube. The front end of the head sleeve and the front end of the probe outer tube are polished round. The head sleeve is a titanium alloy tube with a length L7 of 4.0 mm and a wall thickness S7 of 0.1 mm. The front end of the head sleeve has a splash tongue 71 that bends towards the center of the probe outer tube. The position of the splash tongue corresponds to the outlet of the injection tube.
[0039] The width W7 of the spray tongue is 0.7mm, and the spray tongue protrudes 0.8mm beyond the front end of the head outer sleeve.
[0040] like Figure 7 The tail of the image guide bundle, the beam guide, and the injection tube extends out of the end of the probe outer tube. The end of the probe outer tube is provided with a probe connector 80. The probe connector is provided with an image interface 81, a light source interface 82, and an injection interface 83. The image guide bundle is connected to the image interface, the beam guide is connected to the light source interface, and the injection tube is connected to the injection interface.
[0041] Example 1:
[0042] like Figures 1 to 6A visual medical probe includes a probe tube 10, a probe lens 20, an image guide bundle 30, a light-transmitting lens 40, a light guide beam 50, and an injection tube 60.
[0043] The outer diameter d1 of the probe outer tube 10 is 2mm ± 0.005mm, and the wall thickness S1 is 0.1mm ± 0.005mm. The length L of the probe outer tube can be selected from 200mm to 500mm as needed, with 200mm, 250mm, 300mm, 400mm, and 500mm being preferred in actual manufacturing. The outer wall of the probe outer tube has graduation lines 11 in 1mm increments. In this embodiment, the length L of the probe outer tube is 300mm. To ensure the probe outer tube has appropriate bending characteristics, it is made of mild steel, such as low-carbon steel or 304 stainless steel, annealed at high temperature. Its mechanical properties are close to those of a 2mm diameter silver wire, allowing it to be bent into a certain arc and straightened, while also possessing good toughness and resistance to breakage.
[0044] A light-transmitting lens 40 is disposed at the front end of the probe outer tube 10. The diameter of the light-transmitting lens d4 = 1.8 mm ± 0.005 mm, and the thickness of the light-transmitting lens S4 = 3.0 mm. The light-transmitting lens 40 is a high-transmittance cylindrical planar protective lens made of quartz glass. The light-transmitting lens is axially installed in the inner hole of the probe outer tube, and its front edge is flush with the front edge of the probe outer tube. The light-transmitting lens 40 has a lens mounting hole 41 and an injection tube mounting hole 42. The lens mounting hole 41 and the injection tube mounting hole 42 are axial through holes, and the lens mounting hole and the injection tube mounting hole are symmetrically arranged on both sides of the center of the light-transmitting lens. The diameter of the injection tube mounting hole is 0.9 ± 0.005 mm, and the diameter of the lens mounting hole is 0.75 ± 0.005 mm.
[0045] The probing lens 20 is a macro wide-angle lens with a diameter d2 = 0.55 mm ± 0.005 mm and a thickness S2 = 2.0 mm. It is a quartz glass convex lens with a convex front end and a flat rear end, achieving macro focusing with a focal length ≤ 5 mm and an angle of view ≥ 160°. This lens serves as the objective lens for the image guide bundle and also as the objective lens for the visual medical probe, providing clear magnification of near objects. The lens is encased in a lens sleeve 21, a stainless steel tube with a wall thickness of 0.1 ± 0.005 mm and an outer diameter of 0.75 mm, corresponding to the diameter of the lens mounting hole 41 on the transparent lens. The front edge of the probing lens is flush with the front surface of the transparent lens. The front end of the image guide bundle is axially fitted into the lens housing, tightly against the back of the probe lens. The center of the image guide bundle's cross-section is concentric with the convex lens for optical path coupling correction. Peripheral gaps are sealed and fixed with epoxy resin. The probe lens 20 is mounted in the lens mounting hole 41 through the lens housing and passes through the light-transmitting lens. The convex surface of the probe lens's front end protrudes from the end face of the light-transmitting lens. The lens housing 21 protects the probe lens and ensures a more reliable connection between the probe lens and the image guide bundle. Another important function of the lens housing is to effectively prevent halos, resulting in a clear and stable image.
[0046] The injection tube 60 is placed inside the probe outer tube. The outer diameter of the injection tube d6 = 0.9 mm ± 0.005 mm, corresponding to the diameter of the injection tube mounting hole 42 of the light-transmitting lens. The wall thickness of the injection tube S6 = 0.1 mm ± 0.005 mm. The injection tube can be made of soft steel or plastic tubing. The injection tube is installed in the injection tube mounting hole 42 and passes through the light-transmitting lens 40, with the front end of the injection tube flush with the front end of the light-transmitting lens.
[0047] The image guide bundle 30 passes through the probe outer tube and connects to the probe lens 20. The tail of the image guide bundle exits from the tail of the probe outer tube 10. The outer diameter of the image guide bundle 30 is no greater than 0.75 mm. The image guide bundle includes 8000 single optical fibers with a diameter of 7 μm to 8 μm, which can transmit high-resolution probe images.
[0048] The beam guide 50 passes through the probe outer tube and connects to the light-transmitting lens 40. The tail of the beam guide exits from the tail of the probe outer tube 10. The beam guide consists of 3000 single optical fibers with a diameter of 12µm. The beam guide passes through the probe outer tube within the space left between the injection tube 60 and the image guide bundle 30, with the front end of the beam guide closely attached to the rear end face of the light-transmitting lens 40. Figure 6 As shown.
[0049] The probe outer tube has a head sleeve 70 at its front end, which fits onto the probe outer tube 10. The front end of the head sleeve is flush with the front end of the probe outer tube and is rounded. The length of the head sleeve L7 = 4.0 mm, the wall thickness S7 = 0.1 mm, and the head sleeve is made of titanium alloy. A sputtering tongue 71, bent towards the center of the probe outer tube, is located at the front end of the head sleeve. The position of the sputtering tongue corresponds to the outlet of the injection tube 60. The width of the sputtering tongue 71 is W7 = 0.7 mm, and the sputtering tongue protrudes approximately 0.8 mm beyond the front end E7 of the head sleeve. The bending amount of the tip of the sputtering tongue does not exceed the center of the injection tube 60. The method for manufacturing the splash tongue in this embodiment is as follows: Select a titanium alloy round tube with a length of 4.5 mm, an inner diameter of 2 ± 0.005 mm, and a wall thickness of 0.1 ± 0.005 mm. One end is the front end, and the other end is the rear end. Cut a section of tube wall with a width of 0.7 mm and a length of 0.8 mm at the front end. Grind the edges of this section of tube wall until rounded, and then bend it in an arc shape towards the axis of the round tube with a radius of 1.10 mm to form the splash tongue 71. The remaining 4 mm long round tube serves as the head outer sleeve. Grind the edges of the tube wall until rounded. At this point, the integrated structure of the splash tongue and the head outer sleeve is complete.
[0050] The probe outer tube 10, probe lens 20, image guide bundle 30, light-transmitting lens 40, light guide beam 50, and injection tube 60 are precisely fitted together, with tiny gaps sealed with epoxy resin for waterproofing. The head outer tube 70 is welded or bonded to the probe outer tube. This design ensures the entire head is waterproof, allowing the instrument to be submerged in water for convenient drug or gas sterilization and clinical use.
[0051] The visual medical probe of this invention makes reasonable use of the internal space of the probe outer tube. Within the inner hole of the probe outer tube, which has a diameter of only 1.8 mm, a guide beam, an injection tube, and an image guide bundle need to be inserted. This invention innovates the installation method of the image guide bundle, employing a method where the image guide bundle and the injection tube are symmetrically positioned on both sides of the center of the light-transmitting lens. The image guide bundle 30 and the injection tube 60 are inserted parallel to each other into the inner hole of the probe outer tube. From a cross-sectional perspective, the image guide bundle and the injection tube form two approximately circumscribed circles, and the image guide bundle and the injection tube form an approximately inscribed circle with the inner hole of the probe outer tube. Since the image guide bundle only conducts visible light for illumination and does not conduct images, and does not require a neat and orderly arrangement, the image guide bundle is divided into two beams and clustered in an umbrella shape around the image guide bundle and the injection tube within the inner hole of the probe outer tube. This maximizes the installation of more image guide bundles, achieving an ideal illumination effect.
[0052] The head sheath 70 enhances the structural strength of the probe outer tube 10. Another important function of the head sheath 70 is to provide a splashing tongue 71. The functions of the splashing tongue include: firstly, when water is sprayed through the injection tube 60, the water jet hits the splashing tongue, causing the water to spray in all directions and flushing the probe lens, thus improving its visibility. Secondly, the water or medication sprayed forward and in all directions has a good flushing and therapeutic effect on the fistula wall and internal opening. Thirdly, when therapeutic laser fibers or other optical fibers pass through the injection tube and encounter the splashing tongue, they bend to the side, which is beneficial for treating the fistula wall. Fourthly, the splashing tongue can be used to attach a suture to the probe head for seton placement surgery of the anal fistula.
[0053] The basic principle of this invention is to diagnose and treat fistulas by observing the anatomical structure and morphological characteristics of the fistula wall and internal opening by inserting the probe into the fistula. The outer diameter of the head tube inserted into the human body is preferably 2.2 mm, and the outer diameter of the probe tube is preferably 2.0 mm. This fistula endoscope can be inserted into fistulas with a diameter ≥1.5 mm after anesthesia. Furthermore, this medical probe has a soft structure and a smooth surface, allowing it to follow the curves of the fistula to reach the internal opening. This is more delicate and ingenious than video-assisted endoscope kits, making it suitable for the diagnosis and treatment of most anal fistulas. The visual medical probe of this invention provides real-time color optical imaging with a 0-degree frontal viewing angle and a field of view width ≥160 degrees, close to the viewing angle and field of view width of a normal human eye. These parameters are superior to an 8-degree oblique viewing angle and a field of view width between 70° and 90°, essentially bringing the doctor's eye into the fistula for observation, providing clear real-time optical images and photographs of the anatomical structure and morphology of the fistula wall and internal opening.
[0054] The visual medical probe of this invention does not require any cannula and can be applied directly. It is suitable for the diagnosis and treatment of anal fistula (including complex anal fistula), as well as other fistula (sinus) diseases such as sacrococcygeal sinus infection (also known as sacrococcygeal pilonidal sinus), purulent hidradenitis, fistulas or sinuses leading to the body surface caused by infection in other parts of the body or poor healing of surgical incisions.
[0055] The technology of this invention can extract or scrape out the fistula and internal opening tissue for biopsy to further understand the cellular properties of the fistula wall and internal opening tissue. Combined with medical lasers (such as holmium lasers) or high-frequency electrosurgical units, it can precisely treat anal fistulas in a minimally invasive manner without damaging the anal sphincter, preserving the function of the anus, resulting in small wounds and rapid recovery.
[0056] Example 2:
[0057] A visual medical probe connector device. It includes the visual medical probe described in Embodiment 1.
[0058] like Figure 7 , Figure 8The tails of the image guide bundle 30, the beam guide 50, and the injection tube 60 of the visual medical probe extend out of the end of the probe outer tube 10. The end of the probe outer tube is provided with a probe connector 80, which is provided with an image interface 81, a light source interface 82, and an injection interface 83.
[0059] The end of the probe connector 80 is connected to the end of the probe outer tube 10.
[0060] The image interface 81 faces the probe outer tube 10, and the image guide bundle 30 is connected to the image interface. A miniature camera assembly is housed within the image interface 81, including a camera lens 81a, a CCD image sensor 81b, and a video data cable 81c. The camera lens 81a is aligned with the end of the image guide bundle 30. The miniature camera assembly has macro shooting capabilities, with a minimum shooting distance ≤5mm, a cylindrical camera outer diameter ≤15mm, and a resolution ≥1280*1024. The camera lens assembly has external threads, allowing for rotation and focusing. The video data cable 81c extends from the tail of the image interface 81 and can be connected to video and data processing equipment, such as a monitor and computer, to enable real-time observation and data recording within the fistula.
[0061] A light source interface 82 is located on one side of the probe connector 80. A beam guide 50 connects to the light source interface 82, and an illumination source 82a is located within the interface to provide light for the visual medical probe. The illumination source 82a is an LED light, which can be powered by a power cord or integrated into a single unit using a built-in battery. The illumination source can be installed or removed via internal / external threaded connections or a snap-on connection. Alternatively, a medical cold light source with fiber optic transmission can be used, and the fiber optic output head can be installed or removed via internal / external threaded connections or a snap-on connection.
[0062] The injection interface 83 is located on the opposite side of the probe connector 80 from the light source interface 82. The injection tube 60 is connected to the injection interface 83. The injection interface 83 can be connected to various devices that use the injection tube 60, such as syringes, aspiration pumps, fine biopsy forceps, fine needle aspiration instruments, high-frequency knives, and medical laser devices.
[0063] The present invention provides an innovative minimally invasive surgical procedure for treating anal fistulas that preserves the sphincter muscle, namely, "Visual Probe (Fistula Endoscope) Sphincter-Preserving Tunnel-Type Anal Fistula Excision and Radical Treatment". This procedure utilizes the unique minimally invasive technique developed in this invention, which treats the fistula from the inside. Compared with the existing traditional surgical methods that treat the fistula from the outside, this procedure is more minimally invasive and precise, with a focus on protecting the anal sphincter muscle. The wound is small, recovery is fast, pain is minimal, and there is no anal deformity after healing.
[0064] The basic principle of existing surgical procedures is to remove, cut, or suture the fistula along with its internal opening from the outside after clearly identifying the location of the fistula and its internal opening. This inevitably involves cutting or removing the muscle, subcutaneous fat, and skin tissue on the side of the fistula that is exposed to the skin (suture removal is also a form of chronic cutting). It can be understood as cutting or removing a piece of flesh or a chunk of flesh. Postoperative pain is severe, requiring frequent use of painkillers, and the wound healing time is long, generally one to three months or longer. After healing, linear or sheet-like scars are formed. Sometimes, large scars can lead to anal or buttock deformities, and excessive tissue removal can also carry the risk of anal incontinence. In contrast, the minimally invasive surgery using a visual probe, "Visual Probe (Fistula Endoscope) Sphincter-Preserving Tunnel Anal Fistula Excision and Radical Treatment," performs precise and minimally invasive treatment inside the fistula, perfectly preserving (without damaging) the anal sphincter, greatly protecting anal function. Furthermore, it involves a small incision, resulting in minimal trauma and pain, and rapid healing. The resulting scar is small, possibly just a spot, and the healing time is about 7 days. Based on trauma theory and clinical experience, the above-mentioned minimally invasive surgery was compared with traditional surgery in several important indicators during scientific research. Indicator 1: In terms of wound size, the degree of trauma was reduced to 1 / 5 to 1 / 20; Indicator 2: The wound healing speed was increased, and the healing time was shortened to 1 / 4 to 1 / 12.
[0065] The innovative application of advanced holmium laser technology to the treatment of fistula diseases makes surgical treatment more minimally invasive and efficient. The holmium laser is a novel laser generated by a pulsed solid-state laser device made of yttrium aluminum garnet (YAG) as the activating medium and doped with sensitized ions chromium (Cr), energy-transfer ions thulium (Tm), and activating ions holmium (Ho) (Cr:Tm:Ho:YAG). It is applied in surgeries in urology, hepatobiliary surgery, minimally invasive spinal surgery, ENT, dermatology, gynecology, and other departments. This laser surgery is minimally invasive, with very little patient discomfort. Its main characteristics are: the laser has excellent cutting and tissue resection capabilities, good hemostasis during tissue cutting, even for blood vessels with a diameter of 1mm, and can be performed in water. It has shown excellent results in the treatment of benign prostatic hyperplasia enucleation, urethral stricture and urinary tract tumor resection, urethral stones, bile duct stones, and bile duct tumors. Another characteristic of holmium laser is that its light waves can be transmitted through silica quartz optical fibers. These fibers are flexible, making them very suitable for treatment under endoscopy or microneedle endoscopy. Combined with endoscopic or microneedle endoscopy techniques, holmium laser can be transmitted through quartz fibers with a diameter of 200-1000μm, facilitating precise operation. The surgery generally takes 5-30 minutes and can be completed in one spot. This can (1) greatly shorten the operation time; (2) cause less damage to surrounding normal tissues, have mild postoperative reactions, and result in faster wound healing and smaller scars; (3) have a good hemostatic effect, with a hemostatic time that is one-fourteenth that of electrocautery and a hemostatic effect that is 2-4 times that of electrocautery. Therefore, it is expected to achieve minimal or even bloodless surgery during the operation. The surgical field is free of bleeding and clearly visible, which can also greatly shorten the operation time; (4) treatment is performed through vaporization during the operation, and the edges of the tissue are smooth and sloped, unlike mechanical cleaning which leaves steps and does not form soft tissue scars; (5) laser surgery does not interfere with various monitoring instruments during the operation. The widespread application of holmium lasers in biliary tract surgery, urology, and minimally invasive spinal surgery has further advanced the minimally invasive techniques in these disciplines. However, until now, there has been no application of holmium lasers in the field of proctology. This fistula minimally invasive surgical device applies advanced holmium laser technology to the diagnosis and treatment of fistula diseases in the field of proctology, expanding the application scope of holmium lasers and pioneering a method of internal treatment by combining a visual probe (fistula endoscope) with holmium laser minimally invasive fistula surgery.
[0066] In addition, it should be noted that, besides internal surgical treatment of fistula diseases, this visual probe can also be used to perform traditional fistula surgeries after accurately locating the fistula, such as the traditional Chinese medicine seton technique for treating complex high-level anal fistulas, which improves the cure rate and is an example of the combination of traditional Chinese medicine and minimally invasive surgery.
[0067] This visual probe allows for real-time observation of the fistula's internal anatomical structure, enabling people to gain a more detailed understanding and mastery of the fistula's internal structure, further improving theoretical and scientific research levels, and facilitating knowledge transfer and teaching.
Claims
1. A visual medical probe, characterized in that, The device includes a probe outer tube, an injection tube, an examination lens, an image guide bundle, a light-transmitting lens, and a light guide beam. The light-transmitting lens is located at the front end of the probe outer tube. The examination lens is mounted on the light-transmitting lens, with the front end of the lens protruding from the lens. The light guide beam passes through the probe outer tube and connects to the lens. The image guide bundle passes through the probe outer tube and connects to the lens. An injection tube is located inside the probe outer tube, with its front end inserted into the light-transmitting lens, the front end of which is flush with the front surface of the lens. The light-transmitting lens has a lens mounting hole and an injection tube mounting hole, which are located on both sides of the center of the light-transmitting lens. The probing lens is installed in the lens mounting hole, and the front end of the injection tube is installed in the injection tube mounting hole. The beam guide passes through the probe outer tube in the space between the injection tube and the image guide bundle, and the front end of the beam guide is in close contact with the rear end face of the light-transmitting lens. The probe outer tube has a head sleeve at its front end, the front end of which is flush with the front end of the probe outer tube. The front end of the head sleeve and the front end of the probe outer tube are both rounded. The head sleeve is a titanium alloy tube with a length of 4.0 mm and a wall thickness of 0.1 mm. The front end of the head sleeve has a sputtering tongue that bends towards the center of the probe outer tube. The position of the sputtering tongue corresponds to the outlet of the injection tube. The width of the sputtering tongue is 0.7 mm, and the sputtering tongue protrudes 0.8 mm beyond the front end of the head sleeve.
2. The visual medical probe according to claim 1, characterized in that, The outer diameter of the probe outer tube is 2mm ± 0.005mm, the wall thickness of the probe outer tube is 0.1mm ± 0.005mm, the length of the probe outer tube is 200mm to 500mm, and the material of the probe outer tube is mild steel.
3. The visual medical probe according to claim 1, characterized in that, The diameter of the light-transmitting lens is 1.8mm ± 0.005mm, the thickness of the light-transmitting lens is 3.0mm, the front of the light-transmitting lens is flush with the front end of the probe outer tube, and the beam guide includes 3000 single optical fibers with a diameter of 12um.
4. A visual medical probe according to claim 1, characterized in that, The probing lens is a macro wide-angle lens with a diameter of 0.55 mm ± 0.005 mm and a thickness of 2.0 mm. The outer diameter of the probing lens is covered by a lens sleeve, which is a stainless steel tube with a wall thickness of 0.1 mm. The front edge of the probing lens is flush with the front surface of the light-transmitting lens. The image guide bundle includes 8000 single optical fibers with a diameter of 7 μm to 8 μm.
5. A visual medical probe according to claim 1, characterized in that, The outer diameter of the injection tube is 0.9 mm ± 0.005 mm, the wall thickness of the injection tube is 0.1 mm ± 0.005 mm, and the injection tube is a soft steel tube or a plastic flexible tube.
6. A visual medical probe according to claim 1, characterized in that, The tails of the image guide bundle, the beam guide, and the injection tube extend beyond the end of the probe outer tube. The end of the probe outer tube is provided with a probe connector, which is provided with an image interface, a light source interface, and an injection interface. The image guide bundle is connected to the image interface, the beam guide is connected to the light source interface, and the injection tube is connected to the injection interface.
Citation Information
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