A hemostatic device for use after breast minimally invasive rotary cutting surgery

Abstract

The present application belongs to the field of medical devices, and particularly relates to a hemostatic device for breast minimally invasive rotary cutting operation, which comprises a catheter, the catheter has an accommodation channel penetrating in the axial direction; a filling tube arranged in the accommodation channel, the filling tube has a first channel and a second channel separated in the radial direction, one end of the filling tube is fixedly sleeved with an elastic balloon, the end of the first channel of the other end is provided with an exhaust element, and the end of the second channel serves as a filling injection port; a cutter located in the accommodation channel; titanium clips including a first titanium clip and a second titanium clip located on both sides of the cutter in the axial direction of the catheter; a driving mechanism drivingly connected with the cutter and the titanium clips; and a negative pressure mechanism including a negative pressure aspirator and a guide core, the guide core is arranged in the accommodation channel and extends to a compression area outside the elastic balloon along the accommodation channel, and the negative pressure aspirator communicates with the compression area through the guide core.

Description

Technical Field

[0001] This invention relates to the field of medical devices, and in particular to a hemostatic device for use after minimally invasive breast excision surgery. Background Technology

[0002] Minimally invasive breast excision has gradually become a routine procedure for treating benign breast tumors (such as fibroadenomas and cystic breast lesions) in recent years. This type of surgery uses a rotary excision instrument to remove lesions within the breast tissue and surrounding soft tissue, reducing the trauma of traditional incisions. However, breast tissue has a rich blood supply and a dense network of small blood vessels, making it prone to low-pressure venous bleeding or small vessel bleeding after excision. The narrow surgical channel, limited surgical field, and small space for hemostasis in breast excision procedures also increase the difficulty of the procedure.

[0003] Current hemostasis techniques after minimally invasive breast excision surgery mainly include:

[0004] Physical compression hemostasis (gauze or cotton pads): Reduces bleeding by applying pressure, but it is difficult to place and remove within the rotary cutting channel, the pressure surface is uneven, and it is difficult to maintain continuously;

[0005] Energy-based hemostasis: Electrocoagulation or ultrasonic scalpel can be used for hemostasis, but the risk of thermal damage increases when the hemostasis is near the skin or nipple area.

[0006] Negative pressure suction for hemostasis: negative pressure suction is used to remove accumulated blood, but it often cannot achieve effective compression and fixation at the same time.

[0007] Therefore, current minimally invasive breast excision surgery still has the following shortcomings in hemostasis:

[0008] It requires the alternating use of multiple instruments, resulting in longer operation time and increased risk of surgical field contamination;

[0009] It is difficult to simultaneously meet the combined hemostasis requirements of cavity clearing, compression, and fixation;

[0010] Frequent instrument changes in narrow passages increase mechanical interference and affect the continuity of surgery. Summary of the Invention

[0011] In order to solve the above-mentioned problems in the prior art, the present invention provides a hemostatic device for use after minimally invasive breast excision surgery.

[0012] The present invention provides a hemostatic device for use after minimally invasive breast excision surgery, including a catheter having an axially penetrating receiving channel;

[0013] A filling tube is disposed within the receiving channel and is radially separated into a first channel and a second channel. An elastic balloon is fixedly sleeved at one end of the filling tube, and an exhaust element is provided at the end of the first channel at the other end. The end of the second channel serves as a filling injection port.

[0014] The cutting tool is located within the receiving channel;

[0015] The titanium clips include a first titanium clip and a second titanium clip located along the axial direction of the conduit and on both sides of the cutter.

[0016] The driving mechanism drives the connection between the cutter and the titanium clips to activate the titanium clips to clamp the proximal port portion of the elastic balloon after filling is completed, so as to fix the position of the elastic balloon, and to drive the cutter to cut the elastic balloon portion between the two titanium clips.

[0017] The negative pressure mechanism includes a negative pressure suction device and a guide core, the guide core being disposed within a receiving channel and extending along the receiving channel to a compression area outside the elastic balloon, the negative pressure suction device communicating with the compression area via the guide core.

[0018] In one embodiment, the drive mechanism includes a rotating shaft, a movable sleeve, a protective cover, and a handle assembly;

[0019] The protective cover is fixedly connected to a proximal fixing seat and a distal fixing seat at both ends, and the proximal fixing seat is provided with a travel chamber facing the distal fixing seat;

[0020] The two ends of the rotating shaft are rotatably supported between the proximal fixed seat and the distal fixed seat, respectively, and the outer peripheral surface of the rotating shaft is provided with a spiral groove extending along the axial direction.

[0021] The movable sleeve is axially slidably disposed in the travel chamber, and at least one limiting rod is fixedly provided on the outer periphery of the movable sleeve, the limiting rod extending into the spiral groove;

[0022] The handle assembly is driven to connect to the movable sleeve;

[0023] When the handle assembly drives the movable sleeve to move axially along the rotating shaft, the limiting rod slides along the spiral groove, thereby driving the rotating shaft to rotate. The rotation of the rotating shaft further drives the first titanium clip and the second titanium clip to perform clamping actions, and the tool to perform shearing actions.

[0024] In one embodiment, the travel chamber includes a support plate circumferentially distributed around the outer periphery of the rotating shaft and connected to the proximal fixing seat, and a housing disposed around the outer periphery of the support plate and connected to the proximal fixing seat. A partition space for the movement of the limiting rod is provided between adjacent support plates, and a moving cavity for the sliding of the moving sleeve is provided between the support plate and the housing.

[0025] A retaining ring is provided between the end of the support plate away from the proximal fixing seat and the outer shell, and the retaining ring is fixedly connected to the outer shell.

[0026] In one embodiment, the proximal fixing seat is provided with an axial mounting hole, and a limiting spring is provided between the movable sleeve and the retaining ring;

[0027] The handle assembly includes a fixed handle and a movable handle;

[0028] The fixing handle is connected to the outside of the proximal fixing seat, and a fixing block is provided at one end of the fixing handle;

[0029] The movable handle is provided with a connecting block, which is rotatably connected to the fixed block by a pin, and the movable handle is fixedly connected to the movable sleeve by a pull rope passing through the mounting hole.

[0030] In one embodiment, the cutting tool includes a first blade and a second blade;

[0031] One end of the first blade is hinged to one end of the second blade, and the first blade is sleeved on the outer circumference of the rotating shaft and fixedly connected to the rotating shaft;

[0032] The second blade is rotatably sleeved on the outer circumference of the rotating shaft and connected to the stroke chamber via a connecting rod.

[0033] In one embodiment, the drive mechanism further includes a first titanium clamp and a second titanium clamp with the same structure, wherein the first titanium clamp and the second titanium clamp respectively clamp the first titanium clip and the second titanium clip;

[0034] The first titanium clamp includes a first fixed clamp arm and a first rotating clamp arm sleeved on the outer periphery of the rotating shaft, and the rotating shaft is fixedly connected to the first rotating clamp arm, the rotating shaft is rotatably connected to the first fixed clamp arm, and the fixed clamp arm is rotatably connected to the rotating clamp arm. The first fixed clamp arm and the first rotating clamp arm are respectively provided with placement grooves for clamping the first titanium clamp.

[0035] In one embodiment, the first titanium clip and the second titanium clip have the same structure;

[0036] The first titanium clip includes a first clamping arm, a second clamping arm, and a bent portion;

[0037] The two ends of the bent portion are respectively connected to one end of the first clamping arm and one end of the second clamping arm;

[0038] There is a clamping space between the first clamping arm and the second clamping arm.

[0039] In one embodiment, the exhaust element includes a one-way exhaust valve;

[0040] The one-way exhaust valve is fixedly installed at the proximal end of the first channel. It includes a valve body and an elastic valve disc. The elastic valve disc automatically opens to discharge gas when the pressure in the first channel is higher than the external atmospheric pressure, and automatically closes to prevent backflow when the pressure is balanced or lower than the external atmospheric pressure.

[0041] In one embodiment, the one-way exhaust valve is a medical silicone duckbill valve or an umbrella valve.

[0042] In one embodiment, the negative pressure suction device is an electric negative pressure suction device.

[0043] The advantages of this invention compared to the prior art are as follows:

[0044] The hemostatic device provided by this invention integrates all operations of negative pressure cavity clearing, elastic balloon compression hemostasis, titanium clip fixation, and disconnection of excess elastic balloon, without the need to change instruments midway or enter and exit the rotary cutting channel multiple times, significantly shortening the operation time.

[0045] By integrating a dual-channel filling tube, a rotating helical drive, titanium clips, and a cutting tool within the same catheter, the titanium clip clamping and elastic balloon shearing actions can be completed simultaneously with a single handle in one operation. This makes the operation extremely simple and reliable, avoiding the chaotic surgical rhythm and surgical field contamination risks caused by the need for multiple instruments such as pushers and scissors in traditional methods.

[0046] The rotary transmission mechanism, which combines a spiral groove and a limiting rod, efficiently converts the linear thrust of the proximal handle into a large torque output from the distal shaft. This allows for easy clamping of medical titanium clips while simultaneously enabling the blade to rotate and shear at 360°, ensuring a smooth cut surface for the elastic balloon with no residual tail. Attached Figure Description

[0047] To more clearly illustrate the technical solutions of the embodiments of the present invention, the accompanying drawings used in the embodiments will be briefly introduced below. It should be understood that the following drawings only show some embodiments of the present invention and should not be regarded as a limitation on the scope. For those skilled in the art, other related drawings can be obtained based on these drawings without creative effort.

[0048] Figure 1 According to an embodiment of the present invention, a schematic diagram of a hemostatic instrument for use after minimally invasive breast excision surgery in a first state is shown.

[0049] Figure 2 According to an embodiment of the present invention, a schematic diagram of a hemostatic instrument for use after minimally invasive breast excision surgery in a second state is shown.

[0050] Figure 3 for Figure 2 Schematic diagram of the cross section along section AA.

[0051] Figure 4 According to an embodiment of the present invention, a schematic diagram of a hemostatic instrument for use after minimally invasive breast excision surgery in a third state is shown.

[0052] Figure 5 According to an embodiment of the present invention, a three-dimensional schematic diagram of a combination of a drive mechanism and a cutting tool is shown.

[0053] Figure 6 According to an embodiment of the present invention, a front view schematic diagram of a drive mechanism and a cutting tool combination is shown.

[0054] Figure 7 According to an embodiment of the present invention, a bottom view schematic diagram of a drive mechanism and a cutting tool combination is shown.

[0055] Figure 8 for Figure 7 Schematic diagram of the sectional view along the BB line.

[0056] Figure 9 According to an embodiment of the present invention, a three-dimensional schematic diagram of a rotating shaft is shown.

[0057] Figure 10 According to an embodiment of the present invention, a three-dimensional schematic diagram of a travel chamber is shown.

[0058] Figure 11 According to an embodiment of the present invention, a three-dimensional schematic diagram of a combination of a travel chamber and a movable sleeve is shown.

[0059] Figure 12 for Figure 11 A cross-sectional view of the CC section.

[0060] Figure 13 Figure 8 An enlarged schematic diagram of part A in the middle.

[0061] Figure 14 According to an embodiment of the present invention, a perspective schematic diagram of a drive mechanism for removing a protective cover is shown.

[0062] Figure 15 for Figure 14 Enlarged diagram of part B.

[0063] Figure 16 According to an embodiment of the present invention, a three-dimensional schematic diagram of an injection device is shown.

[0064] Figure 17 According to an embodiment of the present invention, a front view schematic diagram of a first titanium clip is shown.

[0065] In the diagram: 1. Catheter; 11. Receptacle channel; 2. Filling tube; 21. First channel; 22. Second channel; 23. Elastic balloon; 221. Filling injection port; 211. Exhaust element; 3. Cutting tool; 31. First blade; 32. Second blade; 41. First titanium clamp; 42. Second titanium clamp; 411. First fixed clamp arm; 412. First rotating clamp arm; 413. Placement slot; 414. Connecting protrusion; 415. Clamping plate; 416. Rotating rod; 5. Drive mechanism; 51. Rotating shaft; 52. Protective cover; 53. Moving sleeve; 54. Handle assembly; 55. Stroke chamber; 511, Limiting spring; 512, Spiral groove; 521, Distal fixing seat; 522, Proximal fixing seat; 531, Limiting rod; 541, Fixed handle; 542, Movable handle; 543, Elastic element; 544, Pull rope; 545, Pin; 5411, Fixing block; 5421, Connecting block; 551, Support plate; 552, Outer shell; 553, Moving cavity; 554, Mounting hole; 61, Guide core; 7, Connecting rod; 8, Injection device; 9, First titanium clip; 91, First clamping arm; 92, Second clamping arm; 93, Bending part; 94, Clamping space. Detailed Implementation

[0066] The following specific examples illustrate the implementation of the present invention. Those skilled in the art can easily understand other advantages and effects of the present invention from the content disclosed herein. The present invention can also be implemented or applied through other different specific embodiments, and various details in the present invention can be modified or changed according to different viewpoints and application systems without departing from the spirit of the present invention. It should be noted that, unless otherwise specified, the embodiments and features in the embodiments of the present invention can be combined with each other.

[0067] The present invention will now be described in detail with reference to the accompanying drawings, so that those skilled in the art can readily implement it. The present invention can be embodied in many different forms and is not limited to the embodiments described herein.

[0068] In the representation of this invention, the terms "one embodiment," "some embodiments," "example," "specific example," or "some examples," etc., refer to specific features, structures, materials, or characteristics represented in connection with that embodiment or example, which are included in at least one embodiment or example of the invention. Furthermore, the specific features, structures, materials, or characteristics represented may be combined in any suitable manner in one or more embodiments or examples. Moreover, those skilled in the art can combine and integrate different embodiments or examples represented in this invention, as well as features of different embodiments or examples, without contradiction.

[0069] Furthermore, the terms "first" and "second" are used for illustrative purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of indicated technical features. Thus, a feature defined as "first" or "second" may explicitly or implicitly include at least one of that feature. In the representation of this invention, "a plurality of" means two or more, unless otherwise explicitly specified.

[0070] To clearly illustrate the present invention, components unrelated to the description are omitted, and the same or similar constituent elements throughout the specification are given the same reference numerals.

[0071] Throughout this specification, when it is said that a device is "connected" to another device, this includes not only "direct connection" but also "indirect connection" by placing other components in between. Furthermore, when it is said that a device "comprises" a certain constituent element, unless otherwise stated otherwise, this does not exclude other constituent elements, but rather implies that other constituent elements may be included.

[0072] When we say that a device is "above" another device, this can mean that it is directly above the other device, or it can mean that other devices are present in between. Conversely, when we say that a device is "directly" "above" another device, there are no other devices present in between.

[0073] Although the terms first, second, etc., are used in some instances herein to refer to various elements, these elements should not be limited by these terms. These terms are used only to distinguish one element from another. For example, first interface and second interface, etc., are used. Furthermore, as used herein, the singular forms “a,” “an,” and “the” are intended to also include the plural forms unless the context indicates otherwise. It should be further understood that the terms “comprising,” “including,” indicate the presence of features, steps, operations, elements, components, items, kinds, and / or groups, but do not exclude the presence, occurrence, or addition of one or more other features, steps, operations, elements, components, items, kinds, and / or groups. The terms “or” and “and / or” as used herein are interpreted as inclusive, or mean any one or any combination thereof. Thus, “A, B, or C” or “A, B, and / or C” means “any one of: A; B; C; A and B; A and C; B and C; A, B, and C.” Exceptions to this definition will only occur if the combination of elements, functions, steps, or operations is inherently mutually exclusive in some way.

[0074] The technical terms used herein are for reference only to specific embodiments and are not intended to limit the invention. The singular form used herein includes the plural form unless the statement explicitly indicates otherwise. The word "comprising" as used in this specification means to specify a particular characteristic, region, integer, step, operation, element, and / or component, and does not exclude the presence or addition of other characteristics, regions, integers, steps, operations, elements, and / or components.

[0075] Although not explicitly defined, all terms, including technical and scientific terms used herein, shall have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. Terms defined in commonly used dictionaries shall be further interpreted as having a meaning consistent with relevant technical literature and the content of this present instruction, and shall not be over-interpreted as having an ideal or overly formulaic meaning unless otherwise defined. References below... Figures 1 to 17 The technical solution of this application is illustrated with examples.

[0076] like Figures 1 to 4 As shown, this application provides a hemostatic device for use after minimally invasive breast excision surgery, including a catheter 1 with an axially penetrating receiving channel 11; a filling tube 2 disposed within the receiving channel 11 and radially separated by a first channel 21 and a second channel 22, wherein the first channel 21 and the second channel 22 are axially connected along the filling tube 2; an elastic balloon 23 is fixedly sleeved at one end of the filling tube 2; an exhaust element 211 is provided at the end of the first channel 21 at the other end; and the end of the second channel 22 serves as a filling injection port 221; a cutting tool 3 located within the receiving channel 11; and titanium clips including first titanium clips 9 located on both sides of the cutting tool 3 along the axial direction of the catheter 1 (see...). Figure 17 The system includes a second titanium clip; a drive mechanism 5, which drives the connecting cutter 3 and the titanium clips to activate the titanium clips to clamp the proximal port portion of the elastic balloon 23 after filling, so as to fix the position of the elastic balloon, and to drive the cutter 3 to cut the portion of the elastic balloon 23 between the two titanium clips; and a negative pressure mechanism, including a negative pressure aspirator and a guide core 61, which is disposed in the receiving channel 11 and extends along the receiving channel to the compression area outside the elastic balloon 23, and the negative pressure aspirator communicates with the compression area through the guide core 61.

[0077] Understandably, catheter 1 enters the target cavity through a channel formed by rotary cutting, and filling tube 2 is placed within the receiving channel 11 of catheter 1. Elastic balloon 23 is advanced along with filling tube 2 to the compression area within the cavity. External filling medium enters the second channel 22 through filling injection port 221 via injection device 8 and is injected into elastic balloon 23, causing the elastic balloon to inflate and provide adjustable support to the compression area. During filling, gas within elastic balloon 23 and filling tube 2 can be discharged through the first channel 21, and the venting element 211 facilitates venting and prevents backflow, thereby reducing filling air resistance and improving the stability of elastic balloon inflation. Simultaneously, a negative pressure suction device communicates with the compression area via guide core 61 to suction and discharge liquid outside the elastic balloon, reducing liquid accumulation in the compression area and maintaining effective adhesion of the elastic balloon to the tissue. Once the elastic balloon is inflated to a predetermined state, the drive mechanism 5 drives the first and second titanium clips to clamp the proximal port portion of the elastic balloon 23 to mechanically lock the position of the elastic balloon. Subsequently, the drive mechanism 5 drives the cutter 3 to cut the elastic balloon material between the first and second titanium clips, separating the elastic balloon from the filling tube 2. After separation, the elastic balloon remains closed under the clamping action of the titanium clips and remains in the compression area. The catheter 1 and the filling tube 2 can be withdrawn, and the negative pressure suction device can continue to drain the compression area continuously or intermittently through the guide core 61.

[0078] In this application, the integrated system of catheter 1, filling, venting, clamping, shearing, and negative pressure drainage reduces instrument switching and connection steps, thereby improving operational efficiency and reducing the risk of connection contamination or misconnection. The first channel 21 and the second channel 22 are independent and used for venting and injecting filling media respectively, reducing air resistance and cavity residue during filling, thus improving the consistency of elastic balloon inflation and compression stability. After filling, the titanium clips clamp and lock the proximal port of the elastic balloon, and the cutter 3 shears the elastic balloon material between the two titanium clips, enabling separation of elastic balloon placement and tubing removal, thereby reducing disturbance to the compression area and lowering the risk of elastic balloon displacement. The guide core 61 extends the accommodating channel to the compression area outside the elastic balloon and connects to the negative pressure aspirator, allowing drainage of fluid in the compression area, reducing the impact of fluid accumulation on the compression effect, and providing observable drainage feedback for postoperative bleeding.

[0079] like Figures 5 to 12As shown, in a specific example provided in this application, the drive mechanism 5 includes a rotating shaft 51, a movable sleeve 53, a protective cover 52, and a handle assembly 54; the two ends of the protective cover 52 are respectively fixedly connected to a proximal fixing seat 522 and a distal fixing seat 521, and the proximal fixing seat 522 is provided with a travel chamber 55 facing the distal fixing seat 521; the two ends of the rotating shaft 51 are respectively rotatably supported between the proximal fixing seat 522 and the distal fixing seat 521, and the outer peripheral surface of the rotating shaft 51 is provided with a spiral groove 512 extending along the axial direction; The movable sleeve 53 is axially slidably disposed in the stroke chamber 55. At least one limiting rod 531 is fixedly provided on the outer periphery of the movable sleeve 53, and the limiting rod 531 extends into the spiral groove 512. The handle assembly 54 is driven to the movable sleeve 53. When the handle assembly 54 drives the movable sleeve 53 to move axially along the rotating shaft 51, the limiting rod 531 slides along the spiral groove 512, thereby driving the rotating shaft 51 to rotate. The rotation of the rotating shaft 51 further drives the first titanium clamp and the second titanium clamp to perform clamping actions and the tool 3 to perform shearing actions.

[0080] Understandably, after the elastic balloon is filled, the operator moves the movable sleeve 53 towards the proximal fixation seat 522 via the handle assembly 54. The movable sleeve 53 moves smoothly along the axial direction within the stroke chamber 55. The limiting rod 531 fixed on the movable sleeve 53 then slides along the spiral groove 512 on the outer circumference of the rotating shaft 51. Since the spiral groove 512 is an oblique structure, the limiting rod 531 generates a tangential torque on the rotating shaft 51 while being subjected to axial force, thereby driving the rotating shaft 51 to rotate in the set direction. The rotation angle of the rotating shaft 51 and the axial displacement of the movable sleeve 53 correspond precisely to the lead of the spiral groove 512, making the operating stroke controllable and the feel uniform.

[0081] Furthermore, after the rotating shaft 51 rotates, it achieves linkage through the first titanium clip, the second titanium clip, and the cutter 3, which are fixed or connected to it: In the initial stage of the rotation of the rotating shaft 51, the first titanium clip and the second titanium clip are driven to close synchronously or sequentially, firmly clamping and locking the proximal port of the elastic balloon 23; the gripping handle assembly 54 causes the rotating shaft 51 to drive the cutter 3 to be triggered at the same time, and precisely shears the elastic balloon material located between the first titanium clip and the second titanium clip, thereby completing the fixation of the elastic balloon position and the separation of the tubing in one go. The whole process can be completed by gripping the handle assembly 54 with one hand, which significantly simplifies the operation steps and improves the reliability and consistency of the action.

[0082] It is worth mentioning that, in another embodiment of this application, the drive mechanism 5 includes a pull cable, a first pulley group, a second pulley group, a first torsion spring, and a second torsion spring; one end of the pull cable is connected to the handle assembly 54, and the other end passes around the pulley group and is fixed to the proximal fixing seat 522; the first pulley group is coaxially fixed with a first ratchet that drives the titanium clamp to close, and the second pulley group is coaxially fixed with a second ratchet that drives the cutter 3 to cut. Pulling the movable handle 542 pulls the pull cable, the first pulley group rotates and stores energy through the first torsion spring, while the first ratchet drives the titanium clamp to close and lock; continuing to pull to a predetermined stroke releases the tension of the pull cable, the second ratchet stops, and the second torsion spring instantly releases its stored energy to drive the cutter 3 to cut rapidly. Therefore, this application does not limit the specific structure of the drive mechanism 5; any structure capable of achieving the cutting of the cutter 3 and the clamping of the first and second titanium clamps is within the protection scope of this application.

[0083] like Figures 8 to 13 As shown, in a specific example provided in this application, the travel chamber 55 includes a support plate 551 circumferentially distributed around the outer periphery of the rotating shaft 51 and connected to the proximal fixing seat 522, and a housing 552 disposed around the outer periphery of the support plate 551 and connected to the proximal fixing seat 522. A partition space for the movement of the limiting rod 531 is provided between adjacent support plates 551, and a moving cavity 553 for the sliding of the moving sleeve 53 is provided between the support plate 551 and the housing 552. A retaining ring is provided between the end of the support plate 551 away from the proximal fixing seat 522 and the housing 552, and the retaining ring is fixedly connected to the housing 552.

[0084] Understandably, the support plate 551 and the outer shell 552 together constitute the radial constraint and axial guiding structure of the movable sleeve 53. The partition space provides a dedicated sliding channel for the limiting rod 531, preventing it from interfering with other components. The movable cavity 553 ensures that the movable sleeve 53 can only slide smoothly along the axial direction without swaying. The retaining ring acts as a stop, limiting the maximum stroke of the movable sleeve 53 and preventing it from disengaging from the stroke chamber 55. The above structure enables the movable sleeve 53 to maintain high coaxiality and smooth movement when pushed by force, thereby ensuring the accuracy and reliability of the transmission of the spiral groove 512. It significantly improves the transmission stability and anti-eccentric load capacity of the drive mechanism 5, reduces the risk of incomplete clamping or shearing failure due to shaking or jamming, and makes the clamping force of the titanium clamp and the shearing action of the tool 3 more uniform and controllable.

[0085] like Figure 13As shown, in a specific example provided in this application, the proximal fixing seat 522 is provided with an axial mounting hole, and a limiting spring 511 is provided between the movable sleeve 53 and the retaining ring; the handle assembly 54 includes a fixed handle 541 and a movable handle 542; the fixed handle 541 is connected to the outside of the proximal fixing seat 522, and a fixing block 5411 is provided at one end of the fixed handle 541; a connecting block 5421 is provided on the movable handle 542, and the connecting block 5421 and the fixing block 5411 are rotatably connected by a pin 545, and the movable handle 542 is fixedly connected to the movable sleeve 53 by a pull rope 544 passing through the mounting hole. Specifically, an arc-shaped elastic element 543 is provided between the movable handle 542 and the fixed handle 541. One end of the arc-shaped elastic element 543 is fixed to the fixed handle 541, and the other end abuts against or engages with the movable handle 542. This is used to limit the maximum opening angle and closing stroke of the movable handle 542 relative to the fixed handle 541, thereby enabling precise limitation of the reciprocating rotation range of the movable handle 542 when the operator holds it with one hand, improving the comfort and safety of the operation.

[0086] Understandably, when the operator holds the fixed handle 541 and pulls the movable handle 542, the movable handle 542 rotates around the pin 545. This rotation is converted into an axial pulling force on the movable sleeve 53 via the pull rope 544, causing the movable sleeve 53 to overcome the resistance of the limiting spring 511 and move distally. After releasing the movable handle 542, the limiting spring 511 pushes the movable sleeve 53 back to its original position, preparing it for the next operation. This design combines the lever principle of a trigger-type handle with the automatic spring reset, conforming to clinical single-handed operation habits.

[0087] In actual use, the operation is more labor-saving and ergonomic. A single click is enough to complete the clamping and shearing action, and the device automatically resets when released. This facilitates quick and repeated operation or continuous use in emergency situations, while also reducing operator fatigue and the probability of misoperation.

[0088] like Figure 14 and Figure 15 As shown, in a specific example provided in this application, the cutting tool 3 includes a first blade 31 and a second blade 32; one end of the first blade 31 is hinged to one end of the second blade 32, the first blade 31 is sleeved on the outer periphery of the rotating shaft 51 and is fixedly connected to the rotating shaft 51; the second blade 32 is rotatably sleeved on the outer periphery of the rotating shaft 51 and is connected to the stroke chamber 55 through the connecting rod 7.

[0089] Understandably, when the rotating shaft 51 rotates, the first blade 31 rotates synchronously with the rotating shaft 51, and the second blade 32 is constrained by a hinge at one end and fixed by the connecting rod 7 at the other end, forming an opening and closing action similar to scissors, thereby achieving precise shearing of the elastic balloon material located between the two titanium clips; the fixed connection between the connecting rod 7 and the stroke chamber 55 ensures the stability of the movement trajectory of the second blade 32 and avoids shearing deviation.

[0090] In actual use, the shearing action is stable and reliable, and the shearing surface is neat, which can effectively prevent residual burrs in the elastic balloon or leakage of the filling medium. At the same time, the structure is simple and has few parts, making it easy to assemble and disinfect.

[0091] like Figure 14 and Figure 15 As shown, in a specific example provided in this application, the drive mechanism 5 further includes a first titanium clamp 41 and a second titanium clamp 42 with the same structure. The first titanium clamp 41 and the second titanium clamp 42 respectively clamp the first titanium clip and the second titanium clip. The first titanium clamp 41 includes a first fixed clamp arm 411 and a first rotating clamp arm 412 sleeved on the outer periphery of the rotating shaft 51. The rotating shaft 51 is fixedly connected to the first rotating clamp arm 412, and the rotating shaft 51 is rotatably connected to the first fixed clamp arm 411. The first fixed clamp arm 411 and the first rotating clamp arm 412 are rotatably connected. The first fixed clamp arm 411 and the first rotating clamp arm 412 are respectively provided with placement grooves 413 for clamping the first titanium clip. Specifically, the first fixed clamp arm 411 is provided with a connecting protrusion 414, and the first rotating clamp arm 412 is provided with two clamping plates 415 in parallel. There is a placement space between the two clamping plates 415 for placing the connecting protrusion 414. The clamping plates 415 and the connecting protrusion 414 are connected by a rotating rod 416, and the clamping plates 415 and the connecting protrusion 414 can be rotatably connected around the rotating rod 416.

[0092] Understandably, when the rotating shaft 51 rotates under the drive of the handle assembly 54, the first rotating clamp arm 412, which is fixedly connected to the rotating shaft 51, rotates accordingly. Through the rotating rod 416, it drives the two clamping plates 415 to gradually close relative to the connecting protrusion 414 on the first fixed clamp arm 411, causing the placement groove 413 to close synchronously and apply a continuously increasing compressive force to the first titanium clip placed therein. As the rotating shaft 51 continues to rotate to the preset angle, the placement groove 413 is completely closed, and the first titanium clip undergoes permanent plastic deformation under strong compression. Its clamping arms firmly bite and seal the proximal port of the elastic balloon 23, achieving reliable mechanical locking. The structure and operating principle of the second titanium clip 42 are exactly the same. The two sets of titanium clips are staggered along the axial direction of the rotating shaft 51, so that the rotating shaft 51 can complete the clamping of the two titanium clips sequentially or simultaneously with a single rotation, ensuring that the proximal end of the elastic balloon is uniformly and reliably double-clamped.

[0093] Furthermore, through the rigid transmission connection between the titanium clips and the rotating shaft 51, and the mature principle of titanium clip plastic deformation, this application achieves a strong clamping force, irreversible locking, and excellent sealing effect for the elastic balloon fixation, effectively preventing displacement or leakage of the filling medium due to tissue rebound, changes in patient position, or fluctuations in intracavitary pressure. At the same time, the two sets of titanium clips share the same rotating shaft 51 for drive, resulting in a compact structure and high synchronization of actions, further improving the reliability and consistency of operation and significantly reducing the clinical risks caused by clamping failure.

[0094] like Figure 17 As shown, in a specific example provided in this application, the first titanium clip 9 and the second titanium clip have the same structure; the first titanium clip 9 includes a first clamping arm 91, a second clamping arm 92 and a bent portion 93; the two ends of the bent portion 93 are respectively connected to one end of the first clamping arm 91 and the second clamping arm 92; there is a clamping space 94 between the first clamping arm 91 and the second clamping arm 92.

[0095] Understandably, this structure is a standard medical titanium clip configuration. The bent portion 93 provides elastic pre-tension, allowing the titanium clip to remain closed and firmly grip the elastic balloon material after being deformed by the clamp arm. The titanium clip has good biocompatibility, small size, strong clamping force, and requires no additional locking structure. It can achieve a reliable seal at the elastic balloon port without increasing the volume of indwelling foreign body, effectively reducing postoperative discomfort and infection risk.

[0096] In one specific example provided in this application, the exhaust element 211 includes a one-way exhaust valve. The one-way exhaust valve is fixedly disposed at the proximal end of the first channel 21, and includes a valve body and a resilient valve disc. The resilient valve disc automatically opens to discharge gas when the pressure within the first channel 21 is higher than the external atmospheric pressure, and automatically closes to prevent backflow when the pressure is balanced or lower than the external atmospheric pressure. Specifically, in this application, the one-way exhaust valve is a medical silicone duckbill valve or an umbrella valve.

[0097] Understandably, when the filling medium is injected into the elastic balloon 23 through the second channel 22, the gas pressure inside the elastic balloon 23 and the first channel 21 increases, and the elastic valve automatically opens, rapidly expelling gas from the first channel 21. Upon completion of filling or during negative pressure suction, the elastic valve automatically closes to prevent external air or contaminants from flowing back into the elastic balloon 23 through the first channel 21. This structure ensures a smooth, airtight filling process while achieving unidirectional aseptic protection, preventing backflow of the filling medium or contamination within the cavity, significantly improving operational safety and the inflation quality of the elastic balloon.

[0098] Alternatively, to improve safety and convenience in the surgical environment, the exhaust element 211 is provided with a screw-on protective cap. Before surgery, the protective cap can be tightened to maintain a seal and keep the exhaust path sterile; when exhaust is required during surgery, simply unscrew the protective cap, and the one-way exhaust valve will automatically operate; after exhaust is completed or the instrument is used up, the protective cap can be tightened again to close the exhaust passage.

[0099] In addition, the exhaust element 211 can also integrate a pressure indicator color ring. When gas is still being discharged from the first channel 21, the color ring is red. When the gas is basically discharged and the internal pressure is balanced, the color ring automatically switches to green to intuitively reflect the exhaust status and reduce human judgment errors.

[0100] Furthermore, a Luer interface can be provided at the proximal end of the first channel 21, allowing an external syringe to be connected to assist in thoroughly emptying the residual gas inside the elastic balloon 23 and the channel through reverse suction, thereby further improving the uniformity of elastic balloon inflation and the stability of the fit.

[0101] In one specific example provided in this application, the negative pressure aspirator is an electric negative pressure aspirator. It is understood that an electric negative pressure aspirator can provide a stable, adjustable negative pressure value and has an automatic collection bottle and overflow protection, enabling continuous or intermittent aspiration of fluid accumulated in the compressed area, achieving precise intracavitary pressure management and exudate monitoring.

[0102] It should be further noted that, in order to make the technical solution of this application more complete and the scope of protection broader, although in the above preferred embodiment the clamping action of the titanium clip and the cutting action of the tool 3 can be completed sequentially by a single drive mechanism 5 (i.e. the continuous rotation of the rotating shaft 51), realizing the simplest single-handed continuous operation, this application does not limit this, that is, the clamping of the titanium clip and the cutting of the tool 3 do not have to be completed synchronously or sequentially by the same drive mechanism 5.

[0103] Based on the technical inspiration of this application, those skilled in the art can easily conceive of and implement the following separate drive scheme: the titanium clamping mechanism and the cutting tool 3 shearing mechanism are driven separately by independent drive mechanisms. For example:

[0104] The titanium clamp is retained to be driven by the rotation of the pivot 51 to complete the clamping, while the cutting of the tool 3 is changed to be driven by an independent push rod along the axis and triggered by the inclined plane or linkage mechanism.

[0105] Alternatively, the cutting of the blade 3 can still be driven by the cam at the end of the pivot 51, while the titanium clamping can be completed by the handle assembly 54 directly pushing the independent extrusion slider or wedge.

[0106] Alternatively, the shearing action can be designed as an independent mechanism triggered by a pull wire, released by a safety pin, or released instantaneously by the energy stored in a spring.

[0107] In the above-mentioned separate implementation scheme, mechanical or electronic safety mechanisms can be further set up, such as secondary triggers, safety pins, and travel stops, to ensure that the shearing action can only be triggered after confirming that the titanium clip is fully clamped, thereby further improving operational safety and completely avoiding the risk of accidental shearing.

[0108] All combinations and substitutions of the aforementioned driving methods fall within the technical concept of this application. The core of this application lies in providing a medical device capable of achieving two main functions: "reliable clamping and fixation of the proximal port of the elastic balloon" and "precise shearing and separation of excess tubing." No mandatory limitation is made regarding whether these two functions share the same driving mechanism 5 or whether they are completed within the same operating stroke. Accordingly, in the claims, "driving mechanism 5" can be defined as a broad functional limitation, effectively covering all equivalent or comparable technical solutions involving sequential driving by a single driving mechanism 5 and separate driving by multiple sub-driving mechanisms, significantly enhancing the scope of patent protection and its resistance to invalidation.

[0109] like Figures 1 to 4 The illustration shows different operational stages of the postoperative hemostatic device of this application; the details are as follows:

[0110] Deployment phase (corresponding to) Figure 1 The surgeon inserts catheter 1 into the target area along the surgical cavity, while filling tube 2 is simultaneously advanced within the receiving channel 11, allowing the distal elastic balloon 23 to precisely locate the compression site. Key coordinated action: the guide core 61 simultaneously extends to the tissue area outside the elastic balloon, and the negative pressure suction device immediately activates the pre-drainage mode to initially eliminate intracavitary hemorrhage.

[0111] Dynamic filling stage (corresponding to) Figure 2 Medical silicone is injected through the second channel 22 of the filling tube 2, and the elastic balloon 23 gradually expands to fit the wound surface. Simultaneous dual-path management is implemented: the inflation gas is discharged unidirectionally through the first channel 21 from the exhaust element 211 (medical silicone duckbill valve) to avoid air resistance interference; the negative pressure suction device continuously aspirates bloody exudate through the guide core 61, maintaining the compression tightness between the elastic balloon 23 and the tissue in real time.

[0112] Mechanical locking phase (corresponding) Figure 4 After the elastic balloon 23 is fully inflated, the surgeon pulls the movable handle 542 of the handle assembly 54. The pull cord 544 pulls the moving sleeve 53 axially, and the limiting rod 531 slides along the spiral groove 512 of the rotating shaft 51, driving the rotating shaft 51 to rotate. This mechanical transmission triggers in sequence: the first titanium clip 41 and the second titanium clip 42 close, firmly clamping the proximal port of the elastic balloon 23; the rotating shaft 51, in conjunction with the first blade 31 and the second blade 32 of the cutting tool 3, performs precise cutting, separating the elastic balloon 23 from the filling system. Negative pressure coordination ensures: continuous suction maintains a clear surgical field and avoids fluid accumulation interfering with the accuracy of the titanium clip closure.

[0113] During the indwelling monitoring phase, catheter 1 and filling tube 2 are removed, and the closed elastic balloon 23 is left in place in the compression area. The guide core 61 remains in place as a drainage channel, and the negative pressure suction device is switched to continuous monitoring mode.

[0114] Assess the color and flow rate of the drainage fluid every 30 minutes;

[0115] Dynamically adjust suction pressure (-80 to -120 mmHg) to balance tissue compression.

[0116] If the drainage volume is less than 5ml in 24 hours, it indicates that hemostasis has been successful, and the guide core 61 can be removed.

[0117] It is worth mentioning that in this embodiment, the elastic balloon is made of medical-grade polyether block amide or liquid silicone rubber. The titanium clip is made of pure titanium or titanium alloy (Ti-6Al-4V, ELI grade).

[0118] The specific application of the technical solution in this application after breast excision surgery is as follows:

[0119] After minimally invasive breast resection surgery removes benign breast tumors (such as fibroadenomas and cystic breast lesions) and related lesions, the surgical area is located within the breast gland and the space behind it. During the resection process, after removing the lesion and some surrounding glandular tissue and fat, irregular cavities may form locally, which not only affects the appearance of the breast but may also lead to continuous bleeding from surrounding small veins and capillaries.

[0120] This technical solution uses a medical elastic balloon system that can be placed in breast tissue. The elastic balloon is made of high-molecular medical liquid silicone rubber, which has excellent biocompatibility and corrosion resistance. It has been verified by the ISO10993 biological evaluation standard and is compatible with MRI examinations, with no risk of electromagnetic interference.

[0121] During the surgery, a folded elastic balloon is inserted into the target cavity after the breast lesion has been removed via a minimally invasive channel. Medical-grade silicone is then injected into the elastic balloon through the first channel of the filling tube, allowing it to unfold evenly within the breast tissue to provide flexible support and gentle pressure. This achieves continuous hemostasis of the bleeding surface and fills the irregular cavities caused by tissue removal, maintaining the fullness of the breast appearance. The outer end of the filling tube is locked with a titanium clip to ensure the long-term stability of the filling medium. The elastic balloon has a built-in micro-drainage channel, which can be connected to a drainage system when needed to drain blood and exudate, reducing the risk of postoperative fluid accumulation and infection.

[0122] As a long-term implantable device, the elastic balloon can gradually form a stable adhesion and fusion with the surrounding breast and adipose tissue, without the need for short-term removal; it can be safely removed only in special circumstances (such as infection or equipment upgrade) by releasing the titanium clip and emptying the filling medium.

[0123] This approach balances functional hemostasis and breast shape maintenance after minimally invasive breast excision, avoiding the risk of thermal damage that may occur near the skin or nipple area with traditional energy hemostasis. It is especially suitable for patients who have high requirements for breast aesthetics and postoperative quality of life.

[0124] The above are merely specific embodiments of the present invention, but the scope of protection of the present invention is not limited thereto. Any variations or substitutions that can be easily conceived by those skilled in the art within the technical scope disclosed in the present invention should be included within the scope of protection of the present invention. Therefore, the scope of protection of the present invention should be determined by the appended claims.

Claims

1. A hemostatic instrument for use after minimally invasive breast excision surgery, characterized in that, include: A catheter having an axially penetrating receiving channel; A filling tube is disposed within the receiving channel and is radially divided into a first channel and a second channel. An elastic balloon is fixedly sleeved at one end of the filling tube, and an exhaust element is provided at the end of the first channel at the other end. The end of the second channel serves as a filling injection port. The cutting tool is located within the receiving channel; The titanium clips include a first titanium clip and a second titanium clip located along the axial direction of the conduit and on both sides of the cutter. The driving mechanism drives the connection between the cutter and the titanium clips to activate the titanium clips to clamp the proximal port portion of the elastic balloon after filling is completed, so as to fix the position of the elastic balloon, and to drive the cutter to cut the elastic balloon portion between the two titanium clips. The negative pressure mechanism includes a negative pressure suction device and a guide core, the guide core being disposed within the receiving channel and extending along the receiving channel to a compression area outside the elastic balloon, the negative pressure suction device communicating with the compression area via the guide core.

2. The hemostatic device for postoperative minimally invasive breast excision surgery as described in claim 1, characterized in that, The drive mechanism includes a rotating shaft, a movable sleeve, a protective cover, and a handle assembly; The protective cover is fixedly connected to a proximal fixing seat and a distal fixing seat at both ends, and the proximal fixing seat is provided with a travel chamber facing the distal fixing seat; The two ends of the rotating shaft are rotatably supported between the proximal fixed seat and the distal fixed seat, respectively, and the outer peripheral surface of the rotating shaft is provided with a spiral groove extending along the axial direction. The movable sleeve is axially slidably disposed in the travel chamber, and at least one limiting rod is fixedly provided on the outer periphery of the movable sleeve, the limiting rod extending into the spiral groove; The handle assembly is driven to connect to the movable sleeve; When the handle assembly drives the movable sleeve to move axially along the rotating shaft, the limiting rod slides along the spiral groove, thereby driving the rotating shaft to rotate. The rotation of the rotating shaft further drives the first titanium clip and the second titanium clip to perform clamping actions, and the tool to perform shearing actions.

3. The hemostatic instrument for use after minimally invasive breast excision surgery as described in claim 2, characterized in that, The travel chamber includes a support plate circumferentially distributed around the outer periphery of the rotating shaft and connected to the proximal fixed seat, and a shell disposed around the outer periphery of the support plate and connected to the proximal fixed seat. A partition space for the movement of the limiting rod is provided between adjacent support plates, and a moving cavity for the sliding of the moving sleeve is provided between the support plate and the shell. A retaining ring is provided between the end of the support plate away from the proximal fixing seat and the outer shell, and the retaining ring is fixedly connected to the outer shell.

4. The hemostatic instrument for use after minimally invasive breast excision surgery as described in claim 3, characterized in that, The proximal fixing seat is provided with an axial mounting hole, and a limiting spring is provided between the movable sleeve and the retaining ring; The handle assembly includes a fixed handle and a movable handle; The fixing handle is connected to the outside of the proximal fixing seat, and a fixing block is provided at one end of the fixing handle; The movable handle is provided with a connecting block, which is rotatably connected to the fixed block by a pin, and the movable handle is fixedly connected to the movable sleeve by a pull rope passing through the mounting hole.

5. The hemostatic instrument for minimally invasive breast excision surgery as described in claim 2 or 3, characterized in that, The cutting tool includes a first blade and a second blade; One end of the first blade is hinged to one end of the second blade, and the first blade is sleeved on the outer circumference of the rotating shaft and fixedly connected to the rotating shaft; The second blade is rotatably sleeved on the outer circumference of the rotating shaft and connected to the stroke chamber via a connecting rod.

6. The hemostatic instrument for use after minimally invasive breast excision surgery as described in claim 2 or 3, characterized in that, The drive mechanism also includes a first titanium clamp and a second titanium clamp with the same structure, wherein the first titanium clamp and the second titanium clamp respectively clamp the first titanium clip and the second titanium clip. The first titanium clamp includes a first fixed clamp arm and a first rotating clamp arm sleeved on the outer periphery of the rotating shaft, and the rotating shaft is fixedly connected to the first rotating clamp arm and rotatably connected to the first fixed clamp arm. The first fixed clamp arm is rotatably connected to the first rotating clamp arm, and the first fixed clamp arm is provided with a placement groove for clamping the first titanium clamp on the first fixed clamp arm and the first rotating clamp arm respectively.

7. The hemostatic device for postoperative minimally invasive breast excision surgery as described in claim 6, characterized in that, The first titanium clip and the second titanium clip have the same structure; The first titanium clip includes a first clamping arm, a second clamping arm, and a bent portion; The two ends of the bent portion are respectively connected to one end of the first clamping arm and one end of the second clamping arm; There is a clamping space between the first clamping arm and the second clamping arm.

8. The hemostatic device for use after minimally invasive breast excision surgery as described in claim 1, characterized in that, The exhaust element includes a one-way exhaust valve; The one-way exhaust valve is fixedly installed at the proximal end of the first channel. It includes a valve body and an elastic valve disc. The elastic valve disc automatically opens to discharge gas when the pressure in the first channel is higher than the external atmospheric pressure, and automatically closes to prevent backflow when the pressure is balanced or lower than the external atmospheric pressure.

9. The hemostatic device for minimally invasive breast excision surgery as described in claim 8, characterized in that, The one-way exhaust valve is a medical silicone duckbill valve or an umbrella valve.

10. The hemostatic device for minimally invasive breast excision surgery as described in claim 1, characterized in that, The negative pressure suction device is an electric negative pressure suction device.

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