Internal hemorrhoid ligation component and internal hemorrhoid ligation device adapted to the volume of hemorrhoids

Abstract

The present invention relates to an internal hemorrhoid ligation component and an internal hemorrhoid ligation device that can adapt to the size of hemorrhoids, and belongs to the field of medical device technology. The component body includes a flexible ligation head; a variable diameter skeleton assembly connected to the ligation head, and the variable diameter skeleton assembly includes: a plurality of support arms arranged in a ring array; a driving mechanism linked to the plurality of support arms; a differential adjustment member, and the differential adjustment member is a flexible transmission connection arranged between the support arms and the driving mechanism. When facing hemorrhoids of different sizes, the doctor can conveniently expand or contract the caliber of the ligation opening by operating the driving mechanism to overcome the defects of large hemorrhoids that cannot be ligated and small hemorrhoids that cannot be firmly sucked in due to the fixed caliber, thereby broadening the scope of application of a single ligation device.

Description

Technical Field

[0001] The invention belongs to the technical field of medical devices, and in particular relates to an internal hemorrhoid ligation component and an internal hemorrhoid ligation device that are adapted to the volume of hemorrhoids. Background Art

[0002] Internal hemorrhoids are a very common anorectal disease. Their main clinical symptoms include bleeding, prolapse, swelling, and pain, which seriously impact patients' quality of life. Among the many treatment options, rubber band ligation is widely recommended as the preferred non-surgical treatment for Grade II and III internal hemorrhoids due to its ease of use, minimal invasiveness, rapid recovery, and proven efficacy.

[0003] However, in long-term clinical practice, the existing internal hemorrhoid ligation devices, especially the core ligation head, have exposed some inherent defects that are difficult to overcome. Specifically, the existing ligation heads have the following major problems:

[0004] For smaller hemorrhoids, a fixed large-caliber ligation head is difficult to form an effective closed suction cavity with the root of the hemorrhoids, which can easily lead to negative pressure leakage, making it impossible for the hemorrhoidal tissue to be fully and stably sucked in, resulting in ligation failure or too shallow ligation, and the rubber band is prone to fall off prematurely, leading to ineffective treatment and recurrence of the disease.

[0005] However, for larger or irregularly shaped hemorrhoids, the fixed, small-caliber ligature tip cannot fully accommodate the entire base of the hemorrhoid at once, resulting in incomplete ligation. This forces doctors to perform multiple ligatures on the same hemorrhoid or to only partially ligate it, increasing the complexity of the procedure and significantly reducing treatment effectiveness, leading to high recurrence rates. Summary of the Invention

[0006] In order to solve the above-mentioned problems in the prior art, the present invention provides an internal hemorrhoid ligation component and an internal hemorrhoid ligation device that are adaptable to the volume of hemorrhoids.

[0007] In order to achieve the above object, the technical solution adopted by the present invention is:

[0008] Provided is an internal hemorrhoid ligation component adapted to the volume of hemorrhoids, comprising a component body, an end of which is provided with a release mechanism for releasing a rubber band, characterized in that the component body further comprises:

[0009] A flexible ligation head having a ligation opening for accommodating internal hemorrhoidal tissue, the ligation opening being connected to a negative pressure suction passage;

[0010] A variable diameter skeleton assembly is connected to the tying head, and the variable diameter skeleton assembly includes:

[0011] a plurality of support arms arranged in a circular array;

[0012] a driving mechanism linked to the plurality of support arms, the driving mechanism being used to drive the plurality of support arms to radially expand or contract so as to change the diameter of the ligation opening;

[0013] A differential adjustment member, the differential adjustment member being a flexible transmission connection provided between the support arm and the drive mechanism;

[0014] The differential adjustment member is configured to allow each of the support arms to generate uneven differential displacements due to different local resistances encountered, so that the ligation opening can adaptively fit irregular tissue contours.

[0015] Preferably, the driving mechanism comprises:

[0016] A driving component, used to accept a driving operation from a user;

[0017] A push rod assembly, linked to the drive assembly;

[0018] a slider assembly connected to the plurality of support arms;

[0019] Furthermore, the support arm is hinged to the slider assembly to convert the linear motion of the slider assembly into the radial motion of the support arm.

[0020] Preferably, the variable diameter skeleton assembly includes a fixing seat;

[0021] The fixing seat is fixedly arranged on the base of the tying head, and the roots of the plurality of support arms are pivotally connected to the fixing seat;

[0022] The slider assembly is capable of axially sliding relative to the fixing seat;

[0023] The middle parts of the arm bodies of the plurality of support arms are hinged to the slider assembly;

[0024] The movement of the slider assembly is used to force the support arm to swing with its root as the fulcrum.

[0025] Preferably, the slider assembly includes a slip ring, and the inner wall surface of the slip ring is provided with a plurality of hinge stations;

[0026] A follower pin is hingedly connected to the middle portion of the arm body of each support arm;

[0027] Wherein, the driven pin is hinged to the hinge station of the support arm.

[0028] Preferably, it also includes:

[0029] A status indication component, which is used to provide visual feedback to the user on two different working states during the attraction process;

[0030] The two working states include:

[0031] The first working state is a suction ready state in which negative pressure has been established but airflow still exists at the ligature opening;

[0032] The second working state is the suction completion state when the internal hemorrhoid tissue has closed the ligation opening and the airflow has stopped.

[0033] Preferably, the status indication component includes:

[0034] a throttle portion disposed in the negative pressure suction passage and configured to generate a pressure drop when airflow exists in the negative pressure suction passage;

[0035] a first state indicator, disposed in the negative pressure suction passage and located between the throttling portion and the negative pressure source, for indicating the first working state;

[0036] a second status indicator disposed in the negative pressure suction passage and located between the throttling portion and the ligature head;

[0037] The second state indicator is configured to be untriggered due to the pressure drop when airflow exists in the negative pressure suction passage, and to be triggered when airflow stops in the negative pressure suction passage to indicate the second working state.

[0038] Preferably, the throttling portion is an integrally formed reduced diameter pipe section in the negative pressure suction passage, and the inner diameter of the reduced diameter pipe section is smaller than the inner diameter of other parts of the negative pressure suction passage;

[0039] Alternatively, the throttling portion is a flow-limiting plug-in, which is fixed in the negative pressure suction passage and is provided with a flow-limiting hole whose inner diameter is smaller than that of the negative pressure suction passage.

[0040] Preferably, the first status indicator and / or the second status indicator comprises:

[0041] a sealed indicating cavity in communication with the negative pressure suction pipeline;

[0042] an elastic indicating diaphragm disposed in the sealed indicating cavity;

[0043] When the negative pressure suction line establishes an effective negative pressure, the elastic indicator diaphragm is deformed to provide a visual signal.

[0044] Preferably, the elastic indicator membrane comprises:

[0045] an outer surface exhibiting a first color when no negative pressure is applied;

[0046] and an inner structure having a second color different from said first color;

[0047] Wherein, when the elastic indicating diaphragm is deformed, the second color of the inner layer structure can be visually identified through the outer surface.

[0048] The present invention also provides an internal hemorrhoid ligation device, comprising at least:

[0049] An internal hemorrhoid ligation component adapted to the volume of hemorrhoids as described in any of the above technical solutions.

[0050] The present invention provides an internal hemorrhoid ligation component and an internal hemorrhoid ligation device that are adapted to the volume of hemorrhoids. The beneficial effects of the present invention are embodied in:

[0051] When faced with hemorrhoids of different sizes, doctors can easily expand or contract the diameter of the ligation opening by operating the driving mechanism to overcome the defects of large hemorrhoids that cannot be ligated and small hemorrhoids that cannot be firmly sucked in due to fixed diameter, thereby broadening the scope of application of a single ligation device.

[0052] Secondly, when dealing with irregularly shaped hemorrhoids, the differential adjustment element ensures that the final ligation opening 201 is no longer a standard circle, but instead adaptively outlines the true shape of the irregular hemorrhoid base. This contour-fitting capability ensures that the entire hemorrhoid base is completely and tightly accommodated within the ligation opening, avoiding suction gaps caused by shape mismatches. This allows for a complete, one-time ligation of irregular hemorrhoids, improving the success rate and thoroughness of treatment and reducing the risk of postoperative recurrence. BRIEF DESCRIPTION OF THE DRAWINGS

[0053] Figure 1 This is a front view of the internal hemorrhoid ligation component adapted to the size of hemorrhoids proposed by the present invention;

[0054] Figure 2 A cross-sectional view of the internal hemorrhoid ligation component adapted to the volume of hemorrhoids proposed by the present invention;

[0055] Figure 3 for Figure 2 A local enlarged schematic diagram at point A;

[0056] Figure 4 This is one of the structural schematic diagrams of the status indicator component in the internal hemorrhoid ligation component that adapts to the volume of hemorrhoids proposed by the present invention;

[0057] Figure 5 This is the second structural diagram of the status indicator component in the internal hemorrhoid ligation component adapted to the volume of hemorrhoids proposed by the present invention;

[0058] Figure 6 This is a schematic structural diagram of the elastic indicator membrane in the internal hemorrhoid ligation component that adapts to the volume of hemorrhoids proposed by the present invention.

[0059] Description of reference numerals:

[0060] 1. Component body; 2. ligation head; 201. ligation opening; 3. Negative pressure suction passage; 4. Variable diameter skeleton assembly; 401. Support arm; 4011. Follower pin; 402. Drive mechanism; 4021. Drive assembly; 4022. Push rod assembly; 4023. Slider assembly; 403. Fixed seat; 5. Differential adjustment member; 6. Status indication assembly; 601. Throttle portion; 602. First status indicator; 603. Second status indicator; 701. Sealed indication chamber; 702. Elastic indication diaphragm; 7021. Outer surface; 7022. Inner layer structure; 8. Release mechanism. DETAILED DESCRIPTION

[0061] The following will clearly and completely describe the technical solutions in the embodiments of the present invention in conjunction with the accompanying drawings. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative efforts are within the scope of protection of the present invention.

[0062] See also Figures 1-6 As shown, the specific embodiments provided by the present invention are as follows:

[0063] like Figures 1 to 3 As shown, an embodiment of the present invention provides an internal hemorrhoid ligation component that adapts to the size of hemorrhoids. The component comprises a component body 1. Component body 1 may be a handle that is easily grasped and operated by a physician. Its end, i.e., the end closest to the operator, is integrated with a release mechanism 8 for releasing the rubber band from the front end of the ligation head 2. This release mechanism 8 may be, but is not limited to, a mechanical structure activated by pressing a trigger or a push button.

[0064] The component body 1 further includes a flexible tying head 2 and a variable diameter skeleton assembly 4.

[0065] The ligature head 2 is a hollow component designed to directly contact and accommodate internal hemorrhoidal tissue. In this preferred embodiment, the ligature head 2 is made of a biocompatible and flexible material, such as medical-grade silicone or thermoplastic elastomer. This flexibility ensures a gentler contact with the delicate rectal mucosa and hemorrhoidal tissue, reducing patient discomfort and the risk of secondary injury.

[0066] The ligation head 2 has a ligation opening 201 at its distal end for accommodating internal hemorrhoidal tissue. The hollow structure of the ligation head 2 forms part of a negative pressure suction passage 3, which is connected to an external negative pressure device (such as a vacuum pump or syringe) through an interface on the component body 1 to generate suction.

[0067] The variable diameter skeleton assembly 4 is used to change the diameter of the ligation opening 201. The variable diameter skeleton assembly 4 specifically includes:

[0068] Multiple support arms 401 are arranged in a circular array and evenly distributed around the circumference of the ligature opening 201. The ends of these support arms 401 collectively define the contour of the ligature opening 201. The support arms 401 can be made of a medical-grade polymer material or metal with a certain degree of rigidity and elasticity to ensure structural stability during expansion and contraction.

[0069] And a drive mechanism 402, which is linked to the multiple support arms 401 and is used to synchronously drive the support arms 401 to radially expand or contract. The doctor can control the drive mechanism 402 by operating the drive assembly 4021 on the component body 1 (such as a sliding button or a rotatable dial), thereby actively adjusting the diameter of the ligation opening 201. This allows the component body 1 to be pre-adjusted to an appropriate initial diameter before use based on the doctor's preliminary assessment of the patient's hemorrhoid size. For example, for larger hemorrhoids, the diameter can be increased; for smaller hemorrhoids, the diameter can be decreased.

[0070] In addition to the above, a differential adjustment member 5 is further included. The differential adjustment member 5 is configured as a flexible transmission connection between the support arm 401 and the drive mechanism 402. In this embodiment, the differential adjustment member 5 can be specifically implemented as an elastomeric bushing or micro spring provided at the connection point between each support arm 401 and the drive mechanism 402.

[0071] First, when faced with hemorrhoids of different sizes, the doctor can conveniently expand or contract the diameter of the ligation opening 201 by operating the driving mechanism 402, so as to overcome the defects of large hemorrhoids not being able to be ligated and small hemorrhoids not being able to be firmly sucked in due to the fixed diameter, thereby broadening the scope of application of a single ligation device.

[0072] Secondly, and more importantly, the adaptive function of the differential adjustment member 5 comes into play when dealing with irregularly shaped hemorrhoids. It works as follows: When the expanded ligation opening 201 contacts the irregular base of the hemorrhoid, the more convex portion of the hemorrhoid's contour creates greater local resistance to one or two support arms 401 at that location. At this point, the differential adjustment member 5 connected to these support arms 401 undergoes elastic deformation due to the pressure. This deformation absorbs some of the driving force from the drive mechanism 402, causing the travel and speed of these obstructed support arms 401 to be less than that of the other unobstructed or less obstructed support arms 401.

[0073] This differential displacement results in the final ligation opening 201 being no longer a standard circle, but rather adaptively outlining the true shape of the irregular hemorrhoid base. This contour-fitting capability ensures that the entire hemorrhoid base is completely and tightly accommodated within the ligation opening 201, avoiding suction gaps caused by shape mismatches. This allows for a complete, one-time ligation of irregular hemorrhoids, improving the success rate and thoroughness of treatment and reducing the risk of postoperative recurrence.

[0074] It should be noted that the adjustable range of the ligation opening 201 of the present invention is suitable for treating Grade II and Grade III internal hemorrhoids using rubber band ligation. According to clinical observations and statistics, smaller Grade II hemorrhoids may have a base diameter of only 5 to 8 mm, while larger, more prolapsed Grade III hemorrhoids often have a base diameter exceeding 15 mm, or even exceeding 20 mm.

[0075] Based on this, an important consideration of the present invention is that the maximum expansion diameter of the ligature opening 201 is limited by the inner diameter of the release sleeve for pre-loading the rubber band, because the support arm 401 of the variable diameter skeleton assembly 4 performs the opening and closing movement inside the sleeve.

[0076] Therefore, in a preferred embodiment, the inner diameter of the release sleeve can be set to, for example, about 22 mm. This means that the maximum ligation opening 201 caliber that can be achieved by the variable diameter skeleton assembly 4 can reach about 20 to 21 mm.

[0077] Therefore, the caliber of the ligation opening 201 of the internal hemorrhoid ligation component adapted to the volume of the hemorrhoids of the present invention can be adjusted within a range of, for example, 5 mm to 21 mm.

[0078] In this embodiment, the driving mechanism 402 may specifically adopt a mechanical transmission structure composed of a driving assembly 4021 , a push rod assembly 4022 and a slider assembly 4023 .

[0079] The drive assembly 4021 is an interface for the user to interact with the component body 1. It is arranged on the outside of the component body 1 (such as a handle) so that the operator can easily reach it when holding it. In this embodiment, the drive assembly 4021 includes a nut, a screw, and a knob for user operation. Specifically, the drive assembly 4021 includes a knob for the operator to twist or rotate with his fingers, and a nut and a screw that cooperate with the knob. Specifically, the knob is fixedly assembled at an appropriate position of the handle portion of the component body 1, such as the end of the handle portion, and is coaxially connected to the screw. The nut is connected to the rod body of the push rod assembly 4022. Therefore, when the user turns the knob, the screw is driven to rotate, which in turn drives the nut to move axially, thereby driving the rod body of the push rod assembly 4022 to move axially.

[0080] The push rod assembly 4022, comprised of one or more sufficiently rigid rods, is located within the component body 1. The proximal end of the push rod assembly 4022 (the end closest to the operator) is mechanically linked to the drive assembly 4021. The distal end of the push rod assembly 4022 (the end closest to the ligating head 2) is connected to the slider assembly 4023. When the user operates the drive assembly 4021, this movement is directly translated into reciprocating linear motion of the push rod assembly 4022 within the component body 1.

[0081] The slider assembly 4023 is an actuator that directly acts on the multiple support arms 401 and has a ring-shaped or disc-shaped structure that can stably slide around and along the central axis of the tying head 2. The main body of the slider assembly 4023 is connected to the distal end of the push rod assembly 4022, thereby receiving the driving force from the user.

[0082] When the operator drives the driving assembly 4021 forward, the push rod assembly 4022 moves axially, and the axial movement is transmitted to the slider assembly 4023, causing the slider assembly 4023 to also move linearly along the axis.

[0083] In this embodiment, the variable diameter skeleton assembly 4 includes a fixing seat 403 .

[0084] In a specific embodiment, the fixing seat 403 is a rigid annular member, which is fixedly assembled on the base of the tying head 2. The fixing seat 403 has a plurality of pivot structures evenly distributed around its circumference for mounting the root of the support arm 401.

[0085] Furthermore, the middle portion of each support arm 401 is hinged to a slider assembly 4023 via a follower pin 4011. Specifically, the slider assembly 4023 is a slip ring with multiple hinged positions on its inner wall. A follower pin 4011 is hinged to the middle portion of the support arm 401, and the other end of the follower pin 4011 is hinged to a hinged position.

[0086] Among them, in this specific embodiment, the differential adjustment member 5 should be arranged in the rigid force transmission path from the driving source (slider assembly 4023) to the driven member (support arm 401) so that when encountering uneven local overload (that is, a certain support arm 401 is blocked), it can absorb energy and generate displacement through its own deformation.

[0087] In one structural form, the driven pin 4011 (connecting rod) itself is a rigid component. The differential adjustment member 5 is provided as a connecting medium between the driven pin 4011 and the middle portion of the support arm 401 .

[0088] Specifically, instead of directly drilling a hole at the middle hinge point of the support arm 401, an elastic base made of medical-grade silicone or polyurethane elastomer can be pre-embedded. One end of the follower pin 4011 is hinged to the elastic base, rather than being directly hinged to the rigid body of the support arm 401. When a support arm 401 encounters significant local resistance during expansion, the driving force from the follower pin 401 first causes the elastic base corresponding to that support arm 401 to compress and deform, thereby allowing the expansion stroke of that support arm 401 to be smaller than that of the other support arms 401, resulting in differential displacement.

[0089] In another structural form, the differential adjustment member 5 is configured as a connecting medium between the driven pin 4011 and the slider assembly 4023 .

[0090] Specifically, the driving hinge point on the slider is not rigidly set on the slip ring. Instead, the hinge point is set at the end of an elastically retractable buffer structure, and the buffer structure, for example, a plunger mechanism with a built-in spring, is installed on the slip ring. One end of the follower pin 4011 is hinged to the movable end of the buffer structure. When a support arm 401 encounters a large resistance, the resistance will be transmitted back to the slider connection through the support arm 401 and the follower pin 4011, causing the buffer structure at that location to undergo compression deformation, thereby also achieving the function of differential adjustment.

[0091] In another structural form, the differential adjustment member 5 directly constitutes a part of the driven pin 4011, making it itself an elastic connecting rod.

[0092] Specifically, the rod body of the follower pin 4011 can be composed of two rigid sections connected by an elastic section. This elastic section can be a bellows structure with axial expansion and contraction capabilities, a flexible joint co-molded from materials of varying hardness (e.g., metal and rubber), or a telescopic sleeve structure with a built-in miniature compression / extension spring. When the elastic connecting rod is subjected to a pressure or tension exceeding a preset threshold during transmission, this elastic section undergoes axial compression or extension deformation, dynamically changing the effective length of the connecting rod and achieving differential displacement.

[0093] When the slip ring is driven externally and displaced axially along the central axis of the component body 1, it exerts a driving force on the middle portion of each support arm 401. Since the base of each support arm 401 is constrained to pivot on the fixed seat 403, and the middle portion of the arm is hinged to the slip ring via the driven pin 4011, the slip ring drives the support arm 401 to expand or contract radially via the driven pin 4011.

[0094] Specifically, when the slip ring moves toward the distal end (toward the ligation opening 201), it drives the support arm 401 to swing inward, causing its distal end to contract radially. Conversely, when the slip ring moves toward the proximal end, it drives the support arm 401 to swing outward, causing its distal end to expand radially. This allows the caliber of the ligation opening 201 to be adjusted.

[0095] On the basis of the above, it is further found that although the component body 1 can be used in combination with an endoscope or equipped with an endoscope to determine the timing of ligation by visual observation, in the actual clinical operation process, it is completely dependent on the visual feedback of the endoscope:

[0096] First, there is the unreliability and risk of obstruction of the intraoperative visual field. The endoscope's field of view is easily disrupted by various factors, preventing the operator from clearly seeing the true situation within the ligation head 2, leading to misjudgment. This is primarily manifested in the fact that during the suction and ligation process, hemorrhoidal tissue is mechanically stimulated and prone to oozing or active bleeding. Even trace amounts of bleeding can cause "red vision" within the confined space of the ligation head 2, or directly contaminate the endoscope's front lens, preventing effective observation of the critical tissue suction status.

[0097] In addition, impurities such as mucus and fecal residue inherent in the rectal environment may also be absorbed under the action of negative pressure, further interfering with the clarity of the field of vision.

[0098] Finally, once the hemorrhoidal tissue is successfully drawn into the ligature head 2, the drawn-in portion itself becomes the largest obstruction, preventing the operator from clearly seeing whether the root of the tissue has completely and adequately crossed the pre-set ligature line. The doctor can see the tissue being drawn in, but cannot accurately determine its depth and completeness, which is the direct cause of shallow or incomplete ligatures.

[0099] Secondly, the assessment of the degree of attraction is highly subjective and lacks quantification. The endoscope provides two-dimensional planar images, which makes it difficult for the operator to make accurate quantitative judgments on the volume and depth of the soft and easily deformable tissue being sucked in.

[0100] Based on this, Figures 4 to 6 As shown, this embodiment also includes:

[0101] The status indication component 6 is used to provide the user with visual feedback on two different working states during the attraction process; wherein the two working states include:

[0102] The first working state is a suction ready state where negative pressure has been established but the ligation opening 201 is still in an airflow state;

[0103] The second working state is the suction completion state when the internal hemorrhoid tissue has closed the ligature opening 201 and the airflow has stopped.

[0104] To achieve the above functions, this embodiment provides a state indicating component 6. The state indicating component 6 is used to detect the state of the airflow (existence or stop) in the negative pressure suction passage 3.

[0105] In a preferred embodiment, the status indication assembly 6 specifically includes a throttling portion 601 , a first status indicator 602 , and a second status indicator 603 , which are arranged in series in the negative pressure suction passage 3 .

[0106] The throttle 601 is a fixed, narrow passage with a preset resistance, located within the negative pressure suction passage 3. For example, it can be a reduced-diameter pipe section or a plug with a flow-restricting orifice. Its function is to generate a significant and stable pressure drop within its location, when and only when there is sustained airflow within the passage. This means that the vacuum level upstream (near the negative pressure source) and downstream (near the ligature port) will differ significantly.

[0107] The first status indicator 602 is positioned between the throttle 601 and the negative pressure source. Located upstream of the throttle 601, it immediately and continuously senses the system's baseline negative pressure as soon as the negative pressure pump is activated. Therefore, its function is to confirm that the device is powered on and the negative pressure system is functioning properly. When a valid negative pressure is sensed, a visual signal (for example, an indicator window changes from clear to green) is provided, clearly indicating to the operator that the device has entered and remains in the first operating state, or suction-ready state.

[0108] The second state indicator 603 is located between the throttle portion 601 and the ligation opening 201. It is the key to distinguishing the two working states. Its triggering logic is as follows:

[0109] In the first operating state, due to the airflow in the passage, the throttle portion 601 generates a significant pressure drop. Therefore, the second state indicator 603, located downstream of the throttle portion 601, senses a very weak vacuum, insufficient to be triggered, and maintains its initial state (e.g., the indicator window is colorless).

[0110] When suction reaches the second operating state, hemorrhoidal tissue completely blocks ligation opening 201, instantly halting airflow within the passageway. Based on the principles of fluid statics, pressure rapidly equalizes throughout the passageway, and the pressure drop across throttle 601 disappears. At this point, second status indicator 603 immediately senses the same negative pressure as the first indicator, triggering it and providing a different or additional visual signal (e.g., the indicator window changes from clear to red).

[0111] As a result, the operator's surgical process experience will become extremely clear and safe. When the negative pressure is turned on, the operator sees the first status indicator 602 turn green, and obtains a clear signal that suction can begin.

[0112] Apply suction to the hemorrhoids and continue to observe.

[0113] When the second status indicator 603 also turns red, an objective signal is obtained, that is, the suction is completed and the ligation can be performed.

[0114] Based on this, the complex and easily misjudged doctor's experience judgment and possible obstructed visual judgment are transformed into objective mechanical signal confirmation, greatly improving the standardization, success rate and safety of the operation.

[0115] In a specific embodiment, the throttling portion 601 is a section of reduced diameter pipe that is directly formed integrally on the negative pressure suction passage 3 by mold injection molding or mechanical processing. The internal aperture of the reduced diameter pipe section is smaller than the common inner diameter of other parts of the negative pressure suction passage 3. For example, if the common inner diameter of the negative pressure suction passage 3 is 5 mm, the inner diameter of the reduced diameter pipe section can be 1-3 mm. When there is airflow in the negative pressure suction passage 3, the flow rate of the air will increase sharply when flowing through this suddenly narrowed pipe section, and the pressure will drop significantly, thereby forming a stable pressure difference between its downstream (the side close to the tying head 2) and upstream (the side close to the negative pressure source). To ensure smooth airflow, smooth transition chamfers are provided at the inlet and outlet of the reduced diameter pipe section.

[0116] In this alternative preferred embodiment, the throttling portion 601 is an independent, assembleable flow-limiting plug-in. The flow-limiting plug-in is a short, cylindrical or truncated cone-shaped rigid component, for example, made of medical-grade polycarbonate or metal. A through-flow limiting hole is provided on its central axis. During assembly, the flow-limiting plug-in is fixedly mounted to a preset position inside the negative pressure suction passage 3. The inner diameter of the negative pressure suction passage 3 itself can be kept at a uniform size, and a throttling effect can be locally formed by embedding the flow-limiting plug-in in the passage.

[0117] It should be noted that during the initial stage of the suction process, i.e., before the hemorrhoidal tissue has completely closed the ligature opening 201, high-speed airflow exists within the negative pressure suction passage 3. During this stage, the throttle portion 601, as a fixed resistance element within the negative pressure suction passage 3, does create a certain resistance to the flowing air, which could theoretically slightly reduce the tissue suction speed.

[0118] Thus, the power of the negative pressure source (e.g., a vacuum pump) matched with the main body 1 of the present invention can be set to have sufficient margin to fully compensate for the slight energy loss caused by the throttle portion 601. Therefore, in actual use, for the operator, the tissue suction speed is no significantly different from that of a device without the throttle portion 601, fully meeting the requirements of clinical rapid operation.

[0119] During the suction completion phase, air flow within the negative pressure suction passage 3 completely ceases because the hemorrhoidal tissue has completely sealed the ligation opening 201. According to the fundamental principles of fluid dynamics, when the flow rate of the fluid in the pipeline is zero, any throttle 601 in the passage will no longer produce a pressure drop. At this point, the pressure in the entire sealed cavity from the enclosed tissue to the negative pressure source will quickly reach equilibrium, with the vacuum level equal to the maximum static vacuum level that the negative pressure source can produce. Therefore, the presence of throttle 601 has no effect on the maximum suction force ultimately used to securely clamp the tissue.

[0120] In this embodiment, the first status indicator 602 and the second status indicator 603 preferably adopt a purely mechanical indicating structure with the same structure.

[0121] Specifically, each status indicator includes a sealed indicating cavity 701 and an elastic indicating diaphragm 702 .

[0122] The sealed indicating cavity 701 means that the indicator includes a sealed indicating cavity 701 with a preset volume. The indicating cavity can be integrally formed on the component body 1, and an observation window will be correspondingly opened on the outer shell of the component body 1 so that the operator can clearly see the changes inside the indicating cavity.

[0123] This sealed indicator chamber 701 is in pneumatic communication with the negative pressure suction passage 3 via an internal passage at its respective predetermined position (i.e., upstream or downstream of the throttle portion 601, respectively). This ensures that the pressure within the indicator chamber accurately and in real time reflects the pressure state at that point in the negative pressure suction passage 3 to which it is connected.

[0124] The elastic indicator diaphragm 702 is located at or within the opening of the sealed indicator cavity 701. The outer edge of the elastic indicator diaphragm 702 is airtightly fixed to the cavity wall of the indicator cavity, isolating it from the external environment or the observation window, thereby forming a closed space with only a single air path inlet.

[0125] In the initial state, for example, before the negative pressure is activated, when the pressure in the sealed indicator chamber 701 is close to the external atmospheric pressure, the elastic indicator diaphragm 702 assumes its preset first shape, for example, remaining flat or slightly arched. In this shape, the operator sees an untriggered signal.

[0126] In the triggered state, when an effective negative pressure is established within the negative pressure suction passage 3 at the location of the status indicator, that is, when the vacuum reaches its triggering threshold, this negative pressure acts on the sealed indicator cavity 701 through the communication channel. Under the influence of the huge pressure difference between the inside and outside of the diaphragm, the elastic indicator diaphragm 702 overcomes its own elastic resistance and undergoes significant geometric deformation, presenting a second form that is completely different from the first form.

[0127] In a specific embodiment, the elastic indicator film 702 adopts a dual-color stacked structure based on the change of optical properties due to the tensile deformation of the material.

[0128] Specifically, the elastic indicator membrane 702 includes an outer surface 7021 layer. This layer directly faces the observation window for viewing by the operator. This layer is made of a translucent or thin layer of opaque elastomer. In its natural, unstretched state, the outer surface 7021 layer itself is colored a first color. In a preferred embodiment, the first color can be a color indicating a safe, standby, or untriggered state, such as green or white.

[0129] The elastic indicator membrane 702 also includes an inner layer structure 7022. Adhering closely to the outer surface 7021, the inner layer structure 7022 is formed from an opaque, highly saturated elastomer and exhibits a second color that contrasts highly with the first color. For example, if the first color is green, the second color can be designed to be red or bright orange, indicating a warning, a triggered state, or an operation completed.

[0130] In the first, untriggered operating state, when there's no negative pressure in the indicator chamber or the negative pressure is insufficient to trigger deformation, the elastic indicator membrane 702 is in its naturally relaxed state. At this point, the outer surface 7021 maintains its original thickness and color, and its color (e.g., green) completely covers or obscures the underlying inner structure 7022. Therefore, the operator sees the first color, representing the suction-ready state, through the observation window.

[0131] When the second operating state is triggered, effective negative pressure acts on the diaphragm, causing it to undergo significant stretching deformation. For example, it is drawn into the sealed indicator cavity 701, forming a depression. The translucent or thin outer surface 7021 is stretched and thinned. This reduction in thickness increases its light transmittance or decreases its inherent color saturation. As a result, the highly saturated second color (e.g., red) beneath it can pass through the thinned first color layer and be clearly visually recognized by the operator.

[0132] At this point, the overall color of the status indicator will suddenly change from the first color (green) to the second color (red), or at least a mixture of the two colors (for example, dark red or orange). By observing this color change, the operator can confirm that the suction operation is complete and the device has entered the second operating state.

[0133] The present invention also provides an internal hemorrhoid ligation device, which integrates the internal hemorrhoid ligation component adapted to the volume of hemorrhoids in any of the aforementioned embodiments as its core operating end.

[0134] In a specific embodiment, the overall structure of the internal hemorrhoid ligation device, except for the internal hemorrhoid ligation component that adapts to the volume of the hemorrhoids as its core innovation, the remaining structures can adopt any conventional design known in the art.

[0135] Specifically, the internal hemorrhoid ligation device may include a handle for the operator to grasp, a slender tubular sheath connecting the handle to the distal operating end, and a release mechanism 8 for driving the release of the rubber band. The structure, materials, and linkage of these components are common knowledge to those skilled in the art and can be implemented with reference to any existing internal hemorrhoid ligation device.

[0136] The key and essence of the present invention lies in replacing the fixed ligation head 2 of the existing ligation device with the internal hemorrhoid ligation component provided by the present invention, which has caliber adjustment and adaptive fitting functions and is adapted to the volume of hemorrhoids.

[0137] While embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that various changes, modifications, substitutions, and variations may be made to these embodiments without departing from the principles and spirit of the invention, and that the scope of the invention is defined by the appended claims and their equivalents.

Claims

1. An internal hemorrhoid ligation component adapted to the volume of hemorrhoids, comprising a component body, characterized in that: The component body also includes: A flexible ligation head having a ligation opening for accommodating internal hemorrhoidal tissue, the ligation opening being connected to a negative pressure suction passage; A variable diameter skeleton assembly is connected to the tying head, and the variable diameter skeleton assembly includes: a plurality of support arms arranged in a circular array; a driving mechanism linked to the plurality of support arms, the driving mechanism being used to drive the plurality of support arms to radially expand or contract so as to change the diameter of the ligation opening; A differential adjustment member, the differential adjustment member being a flexible transmission connection provided between the support arm and the drive mechanism; Wherein, the differential adjustment member is configured to allow each of the support arms to generate uneven differential displacement due to different local resistances, so that the ligature opening can adaptively fit irregular tissue contours; The driving mechanism comprises: A driving component, used to accept a driving operation from a user; A push rod assembly, linked to the drive assembly; a slider assembly connected to the plurality of support arms; Furthermore, the support arm is hinged to the slider assembly to convert the linear motion of the slider assembly into radial motion of the support arm; The variable diameter skeleton assembly includes a fixing seat; The fixing seat is fixedly arranged on the base of the tying head, and the roots of the plurality of support arms are pivotally connected to the fixing seat; The slider assembly is capable of axially sliding relative to the fixing seat; The middle parts of the arm bodies of the plurality of support arms are hinged to the slider assembly; The movement of the slider assembly is used to force the support arm to swing with its root as the fulcrum.

2. The internal hemorrhoid ligation component adapted to the volume of hemorrhoids according to claim 1, characterized in that: The slider assembly includes a slip ring, and the inner wall surface of the slip ring is provided with a plurality of hinge stations; A follower pin is hingedly connected to the middle portion of the arm body of each support arm; Wherein, the driven pin is hinged to the hinge station of the support arm.

3. The internal hemorrhoid ligation component adapted to the volume of hemorrhoids according to claim 1, characterized in that: Also includes: A status indication component, which is used to provide visual feedback to the user on two different working states during the attraction process; The two working states include: The first working state is a suction ready state in which negative pressure has been established but airflow still exists at the ligature opening; The second working state is the suction completion state when the internal hemorrhoid tissue has closed the ligation opening and the airflow has stopped.

4. The internal hemorrhoid ligation component adapted to the volume of hemorrhoids according to claim 3, characterized in that: The status indication component includes: a throttle portion disposed in the negative pressure suction passage and configured to generate a pressure drop when airflow exists in the negative pressure suction passage; a first state indicator, disposed in the negative pressure suction passage and located between the throttling portion and the negative pressure source, for indicating the first working state; a second status indicator disposed in the negative pressure suction passage and located between the throttling portion and the ligature head; The second state indicator is configured to be untriggered due to the pressure drop when airflow exists in the negative pressure suction passage, and to be triggered when airflow stops in the negative pressure suction passage to indicate the second working state.

5. The internal hemorrhoid ligation component adapted to the volume of hemorrhoids according to claim 4, characterized in that: The throttling portion is an integrally formed reduced diameter pipe section in the negative pressure suction passage, and the inner diameter of the reduced diameter pipe section is smaller than the inner diameter of other parts of the negative pressure suction passage; Alternatively, the throttling portion is a flow-limiting plug-in, which is fixed in the negative pressure suction passage and is provided with a flow-limiting hole whose inner diameter is smaller than that of the negative pressure suction passage.

6. The internal hemorrhoid ligation component adapted to the volume of hemorrhoids according to claim 5, characterized in that: The first status indicator and / or the second status indicator comprises: a sealed indicating cavity in communication with the negative pressure suction pipeline; an elastic indicating diaphragm disposed in the sealed indicating cavity; When the negative pressure suction line establishes an effective negative pressure, the elastic indicator diaphragm is deformed to provide a visual signal.

7. The internal hemorrhoid ligation component adapted to the volume of hemorrhoids according to claim 6, characterized in that: The elastic indicator diaphragm comprises: an outer surface exhibiting a first color when no negative pressure is applied; and an inner structure having a second color different from said first color; Wherein, when the elastic indicating diaphragm is deformed, the second color of the inner layer structure can be visually identified through the outer surface.

8. An internal hemorrhoid ligation device, characterized in that: At least: An internal hemorrhoid ligation component adapted to the volume of hemorrhoids according to any one of claims 1 to 7.

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