Uterine cavity drug multi-point release device

Abstract

The application discloses a kind of uterine cavity medicine multi-point release device, including support, support includes uterine bottom section, left branch arm section and right branch arm section, uterine bottom section, left branch arm section and right branch arm section are jointly enclosed and form uterine type contour, uterine type contour is sequentially provided with several medicine release bags, medicine release bag is opened with medicine cavity, injection structure is opened on medicine release bag, slit is arranged on medicine release bag, suture line is arranged on medicine release bag, the end of several suture lines extends operation end, the position corresponding each medicine release bag on uterine type contour is provided with guiding structure for being limited to suture line when support is not placed into patient body outside to avoid suture line displacement by external stress and adaptive structure for cooperating with guiding structure to drive guiding structure to remove the limitation of suture line after support is placed into patient body outside self-adapting.The application solves the problem that existing uterine cavity drug delivery device is difficult to achieve multi-point drug release accurately and controllably in operation.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to a multi-point intrauterine drug release device. Background Technology

[0002] In clinical practice of intrauterine surgeries (such as myomectomy, intrauterine adhesion separation, and endometrial polyp removal) or in the pre-implantation uterine cavity preparation for embryo transfer in patients with recurrent implantation failure or thin endometrium, in order to prevent postoperative intrauterine adhesions, inhibit local inflammatory reactions, promote wound healing, or achieve targeted drug therapy in the lesion area, it is usually necessary to deliver drugs precisely, orderly, and controllably to different target locations in the uterine cavity during the operation to meet the treatment needs corresponding to different stages of the operation.

[0003] Traditional intrauterine drug administration often employs methods such as single-use irrigation, local spraying, or postoperative indwelling administration. The distribution range of the drug within the uterine cavity is uncontrollable, and local concentrations are prone to being too high or too low. It is difficult to achieve synchronous, fractional, or quantitative release to multiple areas such as the fundus, uterine horn, and left and right lateral walls of the uterine cavity according to the progress of the surgery. The drug utilization rate is low, the treatment effect is unstable, and it may also cause unnecessary stimulation to normal tissues in non-target areas, increasing the risk of postoperative complications.

[0004] To improve the accuracy of drug delivery, pre-stored intrauterine delivery devices have emerged in existing technologies. However, these devices still have many technical limitations: Firstly, the device structure often adopts a rigid or semi-rigid design, which cannot form a stable fit with the natural shape of the uterine cavity. During insertion, it is easy to cause mechanical scratches and compression damage to the endometrium, affecting postoperative wound recovery. The device's positioning stability is also poor, and it is prone to problems such as displacement and dislodgement. Secondly, most existing devices use a fixed release structure, which makes it difficult to open and close on demand during the procedure. Some structures that use a pull-string controlled release do not have an effective preoperative limiting protection structure. During the device's production, packaging, transportation, and operation before insertion into the human body, the pull-string is easily affected by external forces. Unexpected loosening, displacement, or even expulsion due to stress from traction or compression can lead to premature opening of the drug storage cavity and drug leakage, compromising the reliability and controllability of intraoperative drug release. Furthermore, these devices generally lack an adaptive unlocking structure that adapts to the internal environment, making it difficult to automatically release the restraints on the suture structure after insertion into the uterine cavity. This necessitates either additional steps to unlock, reducing surgical efficiency, or the restraint structure cannot be reliably released, affecting the medical staff's control over the timing and pace of drug release. Consequently, they fail to simultaneously meet the requirements of preoperative structural stability, intraoperative maneuverability, and postoperative safety, and cannot meet the clinical needs of modern minimally invasive uterine surgery for precise, controllable, and safe drug administration. Summary of the Invention

[0005] To address the shortcomings of existing technologies, this invention provides a multi-point intrauterine drug delivery device, which solves the problem that existing intrauterine drug delivery devices are unable to accurately and controllably achieve multi-point drug delivery during surgery.

[0006] To achieve the above objectives, the present invention provides a uterine drug multi-point release device, comprising a stent for insertion into a patient's body and adapted to the shape of the human uterine cavity. The stent includes a laterally extending fundus segment, a left support segment extending longitudinally from the fundus segment, and a right support segment. The fundus segment, left support segment, and right support segment together form a uterine contour. A plurality of drug release bags are sequentially arranged along the uterine contour, each drug release bag having a drug cavity. Each drug release bag also has an injection structure for unidirectional injection of external drugs into the drug cavity. The drug release bag is equipped with a useful... At the tear communicating with the drug release cavity, the drug release bag is provided with sutures for closing the tear. Several of the sutures extend to an operating end for external medical personnel to pull, loosen the sutures, and open the tear. The uterine contour is provided with a guide structure corresponding to each drug release bag position for limiting the sutures to prevent them from shifting due to external stress when the stent is not placed in the external patient's body, and an adaptive structure that cooperates with the guide structure to adaptively drive the guide structure to release the limitation on the sutures after the stent is placed in the external patient's body.

[0007] The advantages of adopting the above technical solution are as follows: By setting a uterine contour support adapted to the shape of the uterine cavity, the device's fit and positioning stability with the uterine wall are improved, reducing the risk of mechanical damage to the endometrium during insertion and enhancing the device's adaptability and safety within the uterine cavity. Furthermore, the sequential arrangement of several drug release bags along the uterine contour allows for the orderly and targeted distribution of drugs at multiple points within the uterine cavity, meeting the need for simultaneous or fractional drug administration to different target areas during surgery. The independently designed drug chamber, combined with a unidirectional injection structure, achieves stable pre-storage and targeted injection of drugs, preventing backflow or leakage and improving the sealing and reliability of the drug injection process. Finally, the use of a slit and sutures allows for controllable adjustment of the drug chamber's opening and closing state, facilitating precise control of the timing and amount of drug release by medical personnel according to the surgical progress. This technology addresses the uneven drug distribution issue inherent in traditional infusion methods. The extended suture end facilitates drug release for medical staff, simplifying intraoperative procedures and improving the convenience and controllability of drug release. The guiding structure stabilizes the suture before the stent is inserted, preventing loosening or displacement during production, transport, and preoperative procedures, ensuring the stability of the pre-assembled device. The adaptive and guiding structures work together to automatically release the suture constraint after insertion, requiring no additional intervention. This balances preoperative structural stability with intraoperative operational flexibility, effectively resolving the limitations of traditional intrauterine drug delivery devices in achieving precise and controllable multi-point drug release during surgery. This enhances the accuracy, safety, and clinical applicability of intrauterine drug delivery.

[0008] The invention further comprises: the slit and the injection structure are arranged opposite each other; the drug release bag has a plurality of first perforations arranged along the direction of the slit for sutures to pass through; all the first perforations are located on the left side of the slit; one end of each first perforation is connected to the outer surface of the drug release bag, and the other end is connected to the inner wall of the left side of the slit; the radial cross-section of each first perforation is arc-shaped; the drug release bag has a plurality of second perforations arranged along the direction of the slit for sutures to pass through; all the second perforations are located on the right side of the slit; one end of each second perforation is connected to the inner wall of the left side of the slit. On the outer surface of the drug release bag, one end is connected to the inner wall on the right side of the slit. The radial cross-section of the second perforation is arc-shaped. Several first perforations and several second perforations are arranged in a staggered manner and correspond one-to-one. The suture is alternately passed through the corresponding first perforation and second perforation. The drug release bag has a movable hole for the operating end of the suture to pass through. One end of the movable hole is connected to the outer surface of the drug release bag, and the other end is connected to the adjacent first perforation. The adaptive structure is set on the surface of the drug release bag and away from the movable hole. The adaptive structure is configured to cooperate with the beginning of the suture.

[0009] The advantages of adopting the above technical solution are as follows: The relative arrangement of the tear and injection structure optimizes the spatial layout of the drug injection and release paths, avoiding interference from injection pressure on the tear closure state and improving the sealing stability of the drug cavity and the reliability of drug pre-storage. Furthermore, by staggering the arrangement of several arc-shaped first and second perforations on both sides of the tear, a stable and regular path for the suture is provided, ensuring uniform suture tension distribution, reducing suture jamming or wear, and the sutures alternately passing through the corresponding perforations to form a stable constraint structure, improving the tightness and reliability of tear closure and reducing the possibility of premature drug leakage. The system allows for smooth suture delivery through a movable hole, ensuring the continuity and stability of the pulling operation and preventing interference or jamming at the operating end. The adaptive structure is positioned away from the movable hole, optimizing the spatial distribution of each structure and preventing motion interference between the adaptive structure and the operating end. This improves the overall coordination of the structure's operation. Furthermore, the adaptive structure works in conjunction with the suture's starting point to achieve stable positioning, ensuring reliable suture positioning and preventing loosening or displacement. This further enhances the precision of tear opening and closing control, making the drug release process more stable and controllable, thus meeting the clinical needs for precise and orderly drug delivery during uterine procedures.

[0010] The present invention further comprises: the guiding structure including a pressure plate, the pressure plate being disposed on the drug release bag, the radial cross-section of the bottom wall of the pressure plate being arc-shaped, and a pressure hole being formed between the bottom wall of the pressure plate and the drug release bag for accommodating and adapting the beginning of the suture; the adaptive structure including a first deformation strip, the radial cross-section of the first deformation strip being U-shaped and consisting of a connecting part and two ends, the two ends being embedded in the drug release bag, a smooth arc connecting the ends and the connecting part being a transition part, the connecting part being embedded in the pressure plate; the first deformation strip being made of shape memory alloy; the first deformation strip having a first shape in a first temperature range; the first deformation strip having a second shape in a second temperature range; in the first shape, the angle between the end and the connecting part of the first deformation strip is an obtuse angle and the pressure plate is pressed against the outer surface of the drug release bag; in the second shape, the transition part of the first deformation strip bends so that the angle between the end and the connecting part is an acute angle and the pressure plate swings to cause the pressure hole to expand.

[0011] The advantages of adopting the above technical solution are as follows: In this technology, the tablet and drug release bag work together to form a pressure hole structure, providing a stable accommodating and constraining space for the suture beginning, improving the positioning accuracy and limiting reliability of the suture beginning. Furthermore, the tablet bottom wall uses an arc-shaped cross-section, reducing shear stress on the suture, minimizing the risk of suture wear or breakage, and improving structural service life and operational stability. The above technology uses a U-shaped first deformation strip as an adaptive driving structure, optimizing stress distribution through smooth arc-shaped connections at the connecting part, end, and transition part, improving the strength and deformation consistency of the deformation structure. The shape memory alloy material enables adaptive shape switching based on the body's internal temperature environment, allowing for automatic unlocking without external energy. This simplifies the device structure and improves the reliability of the unlocking action. The first deformation strip exhibits different shapes in different temperature ranges, achieving clamping constraint and swing expansion control of the compression plate. This precisely completes the expansion of the pressure hole and the release of the suture limit, ensuring stable execution of the unlocking action after the device is inserted into the body. This effectively solves the defects of traditional suture structures that lack preoperative limitation and in vivo adaptive unlocking, balancing preoperative stability and intraoperative operational flexibility, and improving the overall safety and reliability of the device.

[0012] The present invention further comprises: each of the drug release bags is connected to the support; the guide structure further comprises a plurality of guide plates disposed on the support; the plurality of guide plates are disposed in one-to-one correspondence with the plurality of drug release bags; the inner wall of the starting end of the guide plate is configured to fit with the outer peripheral wall of the support and forms a through groove for sutures to pass through.

[0013] The advantages of adopting the above technical solution are as follows: The integrated connection of the drug release bag and the stent enhances the overall structural strength and integrity of the device, preventing displacement, detachment, or shaking of the drug release bag and improving the device's positioning stability within the uterine cavity. By setting guide plates on the stent that correspond one-to-one with the drug release bags, stable guidance and constraint are provided for the middle section of the suture, ensuring a neat and orderly suture path and preventing entanglement or interference between multiple sutures. The guide plate's starting point forms a groove structure with the outer wall of the stent, providing stable space for the suture to pass through, optimizing the suture constraint state, ensuring both positioning effectiveness and preventing excessive pressure that could damage the suture. Furthermore, the use of multiple independent guide plates corresponding to each drug release bag enables independent guidance and control of each suture, improving the independence and stability of each drug release unit and preventing mutual interference.

[0014] The invention further includes the following configuration: the adaptive structure also includes a plurality of second deformation strips, each of which corresponds one-to-one with a plurality of guide plates, and each second deformation strip is embedded in its corresponding guide plate. The end of the second deformation strip extends out of the guide plate and is connected to the bracket. The beginning of the second deformation strip is positioned at the beginning of the guide plate. The second deformation strip is made of shape memory alloy. The second deformation strip has a third form in a first temperature range and a fourth form in a second temperature range. In the third form, the inner wall of the beginning of the guide plate and the outer peripheral wall of the bracket combine to clamp the suture. In the fourth form, the second deformation strip bends to enlarge the groove to relieve the pressure of the guide plate on the suture.

[0015] The advantages of adopting the above technical solution are as follows: By setting a second deformation strip corresponding one-to-one with the guide strip, independent adaptive drive control of each guide strip is achieved, improving the accuracy and independence of the movement of each guide strip and avoiding mutual interference. Simultaneously, embedding the second deformation strip inside the guide strip optimizes the structural spatial layout, reduces the overall size of the device, and enhances the device's adaptability to the confined space of the uterine cavity. The end of the second deformation strip is fixedly connected to the support, ensuring the stability of the deformation drive foundation and preventing loosening or displacement of the drive structure. Furthermore, the second deformation strip uses a shape memory alloy material to achieve self-adaptation based on body temperature. The device automatically unlocks the guide strip without external control by changing its shape, improving ease of use and surgical efficiency. The second deformation strip presents different shapes in different temperature ranges, realizing the release of the clamping constraint and pressure on the suture by the guide strip, and accurately completing the unlocking action of the suture. By changing its shape, the groove space is expanded, and the pressure constraint on the suture is released, thus ensuring that the suture can be loosened smoothly when medical staff pull the operating end, improving the smoothness and reliability of drug release control, effectively solving the problem that the limiting structure of traditional devices is difficult to automatically release, and improving the stability and accuracy of intraoperative drug release control.

[0016] The present invention further comprises: a plurality of first protrusions protruding from the left inner wall of the rift along the rift opening direction; a plurality of second protrusions protruding from the right inner wall of the rift along the rift opening direction; the plurality of first protrusions and the plurality of second protrusions corresponding one-to-one and staggered; adjacent first protrusions gap-fitting to form a first groove; the first groove and adjacent first protrusions being connected by a smooth arc surface; adjacent second protrusions gap-fitting to form a second groove; the second groove and adjacent second protrusions being connected by a smooth arc surface; the plurality of first protrusions and the plurality of second grooves corresponding one-to-one and engaging; the plurality of second protrusions and the plurality of first grooves corresponding one-to-one and engaging; both the first and second protrusions being located away from the rift opening; both the first and second protrusions being integrally formed with the drug release bag; and the plurality of first protrusions and the plurality of second protrusions combined in a wave-like arrangement.

[0017] The advantages of adopting the above technical solution are as follows: The technology uses staggered first and second protrusions on the inner walls of both sides of the tear to form an interlocking sealing structure, improving the sealing performance when the tear is closed and thus preventing premature leakage of the drug cavity. The first protrusion and the first groove, and the second protrusion and the second groove are connected by a smooth arc surface, optimizing stress distribution, reducing the risk of structural damage or tearing during tear opening and closing, and improving structural durability. Simultaneously, the first protrusion and the corresponding second groove, and the second protrusion and the corresponding first groove, interlock, enhancing the tightness and stability of tear closure and further improving the sealing effect. The protrusion structure is positioned away from the tear opening, optimizing the distribution of the sealing area and improving the reliability of the sealing inside the drug cavity. Furthermore, the first and second protrusions are integrally formed with the drug release bag, improving the overall structural integrity and connection strength, and preventing protrusion detachment or breakage. The technology uses multiple sets of first and second protrusions combined to form a wave-like interlocking structure, increasing the closure contact area, improving sealing reliability and structural stability, effectively improving the problems of loosening and leakage in traditional sealing structures, and ensuring the stability of drug pre-storage and controllable intraoperative release.

[0018] The present invention further comprises: the fundus segment, the left support segment, and the right support segment are all connected by a smooth arc surface and form an arc-shaped segment for contacting the inner wall of the patient's uterine cavity; the stent is made of medical-grade thermoplastic polyurethane elastomer material by injection molding.

[0019] The advantages of adopting the above technical solution are as follows: In this technology, the fundus segment is connected to the left and right branch segments by a smooth arc surface to form an arc-shaped segment. This improves the fit and compatibility between the stent and the uterine cavity wall, reducing the risk of scraping, squeezing, or damaging the endometrium during placement, thus improving the safety of the device. Furthermore, the arc-shaped segment maintains stable contact with the uterine cavity wall, enhancing the positioning stability after placement and preventing device displacement, shaking, or dislodgement, ensuring accurate and reliable drug release. The stent is made of medical-grade thermoplastic polyurethane elastomer, improving its biocompatibility. This reduces the risk of tissue irritation or rejection after implantation. The material is both flexible and supportive, allowing the stent to adapt to different uterine cavity structures, thus improving the device's versatility. Injection molding ensures the shaping accuracy and structural consistency of the uterine shape, improving product processing quality and stability. The material also has good deformation recovery capabilities, facilitating minimally invasive insertion of the device into the uterine cavity. After insertion, it can quickly return to the preset shape, improving the device's ease of operation and clinical applicability. This effectively solves the defects of traditional rigid or semi-rigid devices, such as poor adaptability and easy damage to uterine cavity tissues.

[0020] The invention further comprises: a positioning groove is provided on the drug release bag, and an injection hole for communicating with the drug cavity is passed through the center of the positioning groove; the injection structure includes several thin sheets, which are arranged in a ring and located in the positioning groove; the starting ends of the thin sheets are stacked sequentially along the circular arrangement path of the thin sheets; the ends of the thin sheets are all connected to the bottom wall of the positioning groove; the starting ends of the thin sheets are all covered and shielded from the opening of the injection hole; the thin sheets are medical-grade silicone rubber sheets; and a medical-grade rubber puncture membrane is provided at the opening of the injection hole.

[0021] The advantages of adopting the above technical solution are as follows: The positioning groove enables precise positioning and stable arrangement of the thin-film structure, ensuring a neat and orderly arrangement. Several thin films are arranged in a circular pattern and stacked sequentially to form a valve structure, achieving unidirectional drug injection. This effectively prevents drug backflow and leakage within the drug cavity, improving the sealing and reliability of the injection process. Furthermore, the ends of the thin films are fixedly connected to the bottom wall of the positioning groove, increasing the connection strength and service life of the valve structure and preventing the films from falling off or failing. The beginning of the thin films covers the injection hole opening, achieving stable closure under normal conditions, further improving the sealing effect of the drug cavity. The thin films are made of medical-grade silicone rubber, enhancing their elastic deformation capacity and biocompatibility, ensuring smooth valve opening and closing and safe use in vivo. A medical-grade rubber puncture membrane is placed at the injection hole opening to strengthen the sealing performance of the injection area, preventing external impurities from entering or drug leakage. Through the synergistic effect of these multiple sealing structures, the overall sealing reliability of the injection structure is improved, meeting the multiple requirements of drug pre-storage, intraoperative injection, and controlled release, thus enhancing the overall stability and safety of the device.

[0022] The present invention further specifies that the suture is a medical-grade polydioxanone absorbable suture.

[0023] The advantages of adopting the above technical solution are: the use of medical-grade polydioxanone absorbable sutures improves the biocompatibility of the sutures, reduces the risk of tissue irritation, inflammatory reactions or rejection reactions after implantation, and improves the safety of the device. At the same time, the sutures can be gradually degraded and absorbed in the body environment, eliminating the need for secondary surgery to remove them, reducing patient trauma and surgical burden, and meeting the clinical needs of minimally invasive intrauterine surgery. Furthermore, the material has stable physical and mechanical properties, ensuring that the sutures maintain sufficient structural strength and restraint within their effective service life, ensuring reliable tear closure and stable release control.

[0024] The invention further comprises: the drug release bag is formed by hot pressing medical-grade low-density polyethylene film.

[0025] The advantages of adopting the above technical solution are: the drug release bag in the above technology is made of medical-grade low-density polyethylene film material, which improves the biocompatibility and chemical stability of the drug release bag, reduces the risk of reaction with drugs, ensures the stability of drug activity and safety of use, and its material is soft and thin, which improves the adaptability of the drug release bag to the uterine cavity space, reduces the pressure and stimulation on the uterine cavity tissue, and improves the comfort and safety of device insertion. At the same time, the material has good flexibility and deformation adaptability, which allows the drug release bag to deform synchronously with the shape of the stent and the uterine cavity, improving the overall fit stability and positioning reliability of the device. Attached Figure Description

[0026] Figure 1 This is a three-dimensional perspective diagram of the present invention; Figure 2 This is a top three-dimensional view of the present invention; Figure 3 This is a partial three-dimensional perspective view of the drug release bag and stent in this invention; Figure 4 This is a simplified three-dimensional view of the drug release bag and tablet in use according to the present invention; Figure 5 This is a simplified perspective 3D view of the drug release bag and tablet in use according to the present invention; Figure 6 This is a top three-dimensional view of the drug release bag in this invention; Figure 7 This is a three-dimensional view of the suture in this invention; Figure 8 This is a simplified three-dimensional view of the first and second convex strips in the separated state in this invention. Figure 9 This is a three-dimensional view of the tablet and the first deformation strip in the state used in this invention. Figure 10 This is a three-dimensional view of the tablet and the first deformation strip in the unused state of this invention. Figure 11 This is a three-dimensional view of the guide plate and the second deformation strip in the state of use in this invention. Detailed Implementation

[0027] This invention provides a multi-point intrauterine drug release device, comprising a support 1 for insertion into a patient's body and adapted to the shape of the human uterine cavity. The support 1 includes a transversely extending fundus segment 11, a left support segment 12 and a right support segment 13 extending longitudinally from the fundus segment 11. The fundus segment 11, the left support segment 12 and the right support segment 13 together form a uterine shape outline. A plurality of drug release bags 2 are sequentially arranged along the opening direction of the uterine shape outline. Each drug release bag 2 has a drug cavity 21. The drug release bag 2 has an injection structure for unidirectional injection of external drugs into the drug cavity 21. The drug release bag 2 is provided with a slit 22 for communicating with the drug cavity 21. The drug release bag 2 is provided with a suture 3 for closing the slit 22. The suture 3 extends to an operating end 31 for external medical personnel to pull, loosening the suture 3 and widening the tear 22. The uterine contour, corresponding to each drug release pouch 2, is equipped with a guide structure to limit the suture 3 before the stent 1 is inserted into the patient's body, preventing displacement due to external stress, and an adaptive structure that works with the guide structure to release the suture 3's limitation after the stent 1 is inserted into the patient's body. The tear 22 is positioned opposite the injection structure. Several first perforations 23 for the suture 3 to pass through are arranged along the opening direction of the tear 22 on the drug release pouch 2. All first perforations 23 are located on the left side of the tear 22. One end of the first perforation 23 is connected to the outer surface of the drug release bag 2, and the other end is connected to the inner wall of the left side of the slit 22. The radial cross-section of the first perforation 23 is arc-shaped. Several second perforations 24 for suture 3 are arranged along the opening direction of the slit 22 on the drug release bag 2. These second perforations 24 are all located on the right side of the slit 22. One end of each second perforation 24 is connected to the outer surface of the drug release bag 2, and the other end is connected to the inner wall of the right side of the slit 22. The radial cross-section of each second perforation 24 is arc-shaped. The first perforations 23 and the second perforations 24 correspond one-to-one and are staggered. The suture 3 is alternately passed through the corresponding first perforation 23 and second perforation 24. The drug release bag 2 has... An active hole 25 is provided for the operating end 31 of the suture 3 to pass through. One end of the active hole 25 is connected to the outer surface of the drug release bag 2, and the other end is connected to the adjacent first perforation 23. The adaptive structure is disposed on the surface of the drug release bag 2 and away from the active hole 25. The adaptive structure is configured to cooperate with the beginning end of the suture 3. The guiding structure includes a pressure plate 4, which is disposed on the drug release bag 2. The radial cross-section of the bottom wall of the pressure plate 4 is arc-shaped. A pressure hole 41 is formed between the bottom wall of the pressure plate 4 and the drug release bag 2 for accommodating and adapting the beginning end of the suture 3. The adaptive structure includes a first deformation strip 42, which has a radial cross-section in the shape of a "U" and is composed of a connecting part 421 and two ends 422.The two ends 422 are embedded in the drug release bag 2. A transition portion 423 is smoothly connected between the ends 422 and the connecting portion 421. The connecting portion 421 is embedded in the pressure plate 4. The first deformation strip 42 is made of shape memory alloy. The first deformation strip 42 has a first shape in a first temperature range and a second shape in a second temperature range. In the first shape, the angle between the ends 422 and the connecting portion 421 is obtuse, and the pressure plate 4 is pressed against the outer surface of the drug release bag 2. In the second shape, the transition portion 423 of the first deformation strip 42 bends, making the angle between the ends 422 and the connecting portion 421 acute, and the pressure plate 4 swings to drive the pressure hole. 41. Expanding, each of the drug release bags 2 is connected to the support 1. The guiding structure also includes several guide pieces 5 disposed on the support 1, with each guide piece 5 corresponding to one of the drug release bags 2. The inner wall of the starting end of the guide piece 5 is fitted with the outer peripheral wall of the support 1 with a clearance and forms a through groove 51 for the suture 3 to pass through. The adaptive structure also includes several second deformation strips 52, each of the second deformation strips 52 corresponding to one of the guide pieces 5, and each second deformation strip 52 is embedded in its corresponding guide piece 5. The end of the second deformation strip 52 protrudes from the guide piece 5 and is connected to the support 1. The starting end of the second deformation strip 52 is located at the starting position of the guide piece 5. The second deformation strip 52 is formed by the shape of... Made of shape memory alloy, the second deformation strip 52 has a third shape in the first temperature range and a fourth shape in the second temperature range. In the third shape, the inner wall of the guide plate 5 combines with the outer peripheral wall of the bracket 1 to clamp the suture 3. In the fourth shape, the second deformation strip 52 bends to enlarge the groove 51 to relieve the pressure of the guide plate 5 on the suture 3. The left inner wall of the rift 22 has several first protrusions 6 along the opening direction of the rift 22, and the right inner wall of the rift 22 has several second protrusions 62 along the opening direction of the rift 22. The several first protrusions 6 and several second protrusions 62 are one-to-one corresponding and staggered. Adjacent first protrusions 6 and second protrusions 62 are staggered. The protrusions 6 are fitted with a clearance and form a first groove 61. The first groove 61 is smoothly connected to the adjacent first protrusion 6 with an arc surface. The adjacent second protrusions 62 are fitted with a clearance and form a second groove 621. The second groove 621 is smoothly connected to the adjacent second protrusion 62 with an arc surface. A plurality of first protrusions 6 and a plurality of second grooves 621 are corresponding one-to-one and engagingly fitted. A plurality of second protrusions 62 and a plurality of first grooves 61 are corresponding one-to-one and engagingly fitted. The first protrusions 6 and the second protrusions 62 are both located away from the opening of the slit 22. The first protrusions 6 and the second protrusions 62 are integrally formed with the drug release bag 2. The plurality of first protrusions 6 and the plurality of second protrusions 62 are combined in a wave-like arrangement.The fundus segment 11 is connected to the left and right support segments 12 and 13 by a smooth arc surface, forming an arc-shaped segment 14 for contact with the inner wall of the patient's uterine cavity. The support 1 is made of medical-grade thermoplastic polyurethane elastomer by injection molding. The drug release bag 2 has a positioning groove 28, and an injection hole 26 for communication with the drug cavity 21 is passed through the center of the positioning groove 28. The injection structure includes several thin sheets 27, which are arranged in a ring and located in the positioning groove 28. The starting ends of the thin sheets 27 are stacked sequentially along a circular arrangement path. The ends of each thin sheet 27 are connected to the bottom wall of the positioning groove 28. The starting ends of each thin sheet 27 cover and shield the opening of the injection hole 26. The thin sheets 27 are medical-grade silicone rubber sheets. A medical-grade rubber puncture membrane 261 is provided at the opening of the injection hole 26. The suture 3 is a medical-grade polydioxanone absorbable suture 3. The drug release bag 2 is formed by hot pressing from medical-grade low-density polyethylene film.

[0028] Overall usage process: During the preoperative preparation phase, the integrity of each structure of the device is checked to ensure that the guide structure reliably limits the suture, the first and second deformation strips are in their initial form within the first temperature range, the tear is closed under the constraint of the suture, and the drug release bag's cavity remains sealed. Subsequently, a preset dose of drug is injected unidirectionally into the drug release bag's cavity through the injection structure. After injection, the thin sheet of the injection structure and the rubber puncture membrane automatically close to prevent drug backflow and leakage. During the surgical procedure, the stent is placed into the patient's uterine cavity, ensuring that the uterine contour formed by the fundus segment, left arm segment, and right arm segment stably conforms to the uterine cavity wall, with each drug release bag corresponding to a preset target point within the uterine cavity. After stent placement, the first and second deformation strips of the adaptive structure and the patient's... The device comes into contact with the patient's internal environment or is heated externally to reach a preset deformation temperature, completing the shape change. The adaptive drive guide structure releases the constraint on the suture. According to the progress of the surgery, medical staff pull the operating end of the suture to loosen the suture from the first perforation, the second perforation, and the groove of the guide plate, thereby driving the tear to open and releasing the drug into the target area in the uterine cavity. After the drug is released, the suture can degrade naturally in the body or be directly pulled out by medical staff when the tear is opened. The stent and drug release bag can be left in place after surgery until complete degradation or removed after surgery, depending on clinical needs. The entire process does not require complex auxiliary instruments, taking into account preoperative stability, intraoperative controllability, and postoperative safety.

[0029] Based on the deformation characteristics of the first and second deformation strips and combined with the clinical needs for intraoperative drug administration, this patent designs multiple application methods. Each method clearly defines the deformation temperature range and operating logic to ensure that the technical solution is reproducible and implementable, as detailed below: In this design, all first and second deformation strips utilize medical-grade nickel-titanium shape memory alloys with a single-pass shape memory effect. Their core phase transformation characteristics are: the alloy can stably maintain its pre-set initial limiting shape in a low-temperature martensitic state below the phase transformation temperature; when heated to above the austenitic phase transformation endpoint temperature Af, it completes an irreversible phase transformation to the pre-set unlocking shape. Even if the ambient temperature subsequently drops below the phase transformation temperature, the alloy will not spontaneously return to its initial limiting shape; it can only be forcibly deformed and reset by external force, completely avoiding the risk of temperature fluctuations during intraoperative procedures such as uterine irrigation causing the deformation strip to reset and lock the suture. Simultaneously, the phase transformation temperature of all deformation strips in this design is precisely adapted to the entire clinical process, exceeding the conventional ambient temperature (18℃~25℃) of production, transportation, and preoperative preparation stages, ensuring no premature unlocking risk and complete preservation of the limiting protection function, while also remaining within the physiologically safe temperature range for the human body, eliminating the risk of tissue thermal damage.

[0030] Application Method 1: Multi-point synchronous release (the deformation temperatures of the first and second deformation bars are the same): This application method is suitable for scenarios where drugs need to be released simultaneously to multiple target areas within the uterine cavity during surgery. The specific settings are as follows: Both the first and second deformation strips are made of medical-grade nickel-titanium shape memory alloy with a single-pass shape memory effect. Their austenitic phase transformation endpoint temperature (Af) is the same, set at 28℃~32℃. Before surgery, the first deformation strip is in its first form (the angle between the end and the connecting part is obtuse), with the pressure plate pressed against the surface of the drug release bag. The pressure hole limits the beginning of the suture. The second deformation strip is in its third form, with the guide plate's beginning clamping the suture against the outer wall of the stent. All deformation strips stably maintain their initial limited form, with no risk of premature unlocking. The standard clinical operation sequence for this device is "precise placement of the device into the uterine cavity → completion of adaptive unlocking → uterine cavity irrigation and subsequent surgical procedures." After the stent is placed into the uterine cavity, relying on the basic physiological temperature of the uterine cavity (above 36℃), the deformation strips maintain their initial limited form for 1~2... Within minutes, the temperature rapidly rises above the phase transition temperature, simultaneously switching to the second and fourth states to complete an irreversible adaptive unlocking: the first deformation strip drives the pressure plate to swing and the pressure hole to expand, while the second deformation strip drives the guide plate to swing and the groove to expand, simultaneously releasing the limiting constraints on all sutures. This unlocking state is irreversible, and the temperature fluctuations caused by subsequent intraoperative room temperature saline irrigation to ensure clear vision and reduce bleeding will not affect the already completed unlocking state. Medical staff pull the operating ends of all sutures to simultaneously expand the openings of each drug release bag, achieving simultaneous drug release at multiple target areas within the uterine cavity, meeting the clinical need for simultaneous intraoperative drug administration. Furthermore, the phase transition temperature is completely adapted to the clinical scenario and will not cause thermal damage to the patient's uterine cavity tissue.

[0031] Application Method 2: Multi-point sequential release (the deformation temperatures of each first deformation bar are inconsistent and increase sequentially): This method is suitable for scenarios where medication needs to be released in stages to multiple target areas within the uterine cavity according to a preset sequence during surgery. The specific settings are as follows: The first deformation strip corresponding to each medication release bag is made of medical-grade nickel-titanium shape memory alloy with a single-pass shape memory effect. The austenitic phase transformation endpoint temperature (Af) of each first deformation strip is different. The deformation temperature increases sequentially according to the release order within the uterine cavity target area. Specifically, the deformation temperature of the first deformation strip corresponding to the first target area requiring medication release is 28℃, the second is 30℃, the third is 32℃, and the fourth is 34℃. This temperature range is within the physiologically safe temperature range for the human body and is higher than the normal environmental temperature during delivery, transportation, and before surgery, eliminating the risk of premature unlocking. The deformation temperature of the second deformation strip is consistent with the deformation temperature of the corresponding first deformation strip, ensuring that the guiding structure and adaptive structure of the same medication release bag unlock synchronously. Before surgery, all first deformation strips are in the first state, and the second deformation strips are in the third state. This system reliably limits the positioning of each suture. During clinical operation, the stent is first precisely placed into the uterine cavity. Relying on the basic physiological temperature of the uterine cavity, the first and second deformation strips, with a deformation temperature of 28°C, reach their phase transition temperatures, completing an irreversible morphological switch and releasing the corresponding suture. Medical staff then pull the suture to release the drug at the first target point. Subsequently, existing mature medical devices such as medical precision temperature control probes and wireless temperature-controlled micro-heating pads can be used to precisely and locally raise the temperature of subsequent target points, causing the first and second deformation strips, with even higher deformation temperatures, to reach their preset phase transition temperatures in sequence, completing the irreversible unlocking in sequence. Medical staff then pull the operating end in the corresponding order to release the drug in stages according to the preset sequence, meeting the drug administration needs of different surgical stages and ensuring that the timing of drug release is precisely matched with the surgical progress. All unlocking actions are irreversible, and temperature fluctuations during uterine cavity irrigation will not interfere with the release operation of unlocked target points, ensuring stable and reliable function.

[0032] Method 3: Mixed release (partially synchronous, partially sequential): This method is suitable for complex clinical scenarios where intraoperative drug delivery to some targets needs to be performed simultaneously or sequentially. The specific setup is as follows: All deformation strips are made of medical-grade nickel-titanium shape memory alloy with a single-pass shape memory effect. The intrauterine targets are divided into two groups. For the drug release bags corresponding to the first group of targets, the austenitic phase transformation endpoint temperature Af of the first and second deformation strips is set to be the same (28℃), achieving simultaneous drug release from this group of targets. For the drug release bags corresponding to the second group of targets, the deformation temperatures of the first deformation strips are set sequentially to 30℃ and 32℃, and the deformation temperature of the second deformation strip is consistent with the corresponding first deformation strip. During clinical operation, the stent is first precisely... The drug is inserted into the uterine cavity and, relying on the basic physiological temperature of the uterine cavity, firstly raises the deformation strip corresponding to the first set of target points to a phase transition temperature of 28°C, completing irreversible unlocking and releasing the drug synchronously. Subsequently, through precise external heating (medical temperature control probe or miniature heating pad), the deformation strip corresponding to the second set of target points sequentially raises the temperature to the preset phase transition temperatures of 30°C and 32°C, completing irreversible unlocking in sequence and achieving sequential drug release for this set of target points. This method can flexibly adapt to the drug delivery needs of different surgeries, combining the advantages of synchronous and sequential drug delivery. Moreover, all deformation temperatures are controlled within a safe range, the unlocking state is irreversible, and it is not affected by intraoperative temperature fluctuations, ensuring the practicality and safety of the technical solution.

[0033] The device described above can be placed in the body using medical instruments commonly used in existing intrauterine surgeries, such as uterine inserters, hysteroscopic pushers, and gynecological catheter pushers. It is a conventional technique used in the field, requiring no additional specialized instruments. Furthermore, to further enhance the stability and accuracy of the placement process, a rigid extension tube can be integrally installed in the middle of the fundus section of the stent. This rigid extension tube extends outwards along a direction away from the uterine contour and possesses structural strength, allowing medical personnel to directly hold or use conventional surgical instruments for clamping and pushing, thus achieving precise stent placement. After placement, the rigid extension tube can be removed or left outside the body as an operational marker. The overall placement method is simple, intuitive, and reliable, and is a routine operation that can be directly performed by those skilled in the art, without any implementation obstacles.

[0034] This device can be directly inserted and used during intrauterine surgery, and is also suitable for clinical drug administration needs for a period of time after surgery. It can be selectively inserted and release drugs during the postoperative recovery period according to the patient's actual treatment needs such as postoperative wound recovery, inflammation control, or adhesion prevention. The timing of use is flexible and adjustable. At the same time, the device has a compact overall structure, is easy to operate, and the insertion process is gentle. It can be successfully inserted under local anesthesia or spinal anesthesia in the uterine cavity without the need for general anesthesia. It has a wide range of applications and flexible anesthesia options, which can effectively reduce surgical trauma and treatment costs for patients. It is a method of use that can be directly implemented by those skilled in the art according to clinical needs, and there are no implementation obstacles.

[0035] The sutures in the aforementioned technology are automatically threaded, braided, and pre-tightened during the manufacturing stage, eliminating the need for medical personnel to perform any threading, suturing, or pretreatment operations before surgery. The sutures form a stable constraint structure within the first and second perforations, and their closure constraint on the tear is similar to the suturing and tightening state of skin wounds in existing technologies, ensuring stable closure of the tear before surgery and in the early stages of implantation. The threading and fixation process of the sutures is achieved using existing mature production technologies, such as automated threading processes for medical absorbable sutures and integrated suturing and molding processes for medical film components, which are all conventional processing methods in the field, ensuring stable and reliable production processes. This device is manufactured with all structural assembly and pre-suturing completed, and can be used directly after unpacking without preoperative assembly, temporary suturing, or additional adjustments, effectively simplifying the surgical procedure, reducing intraoperative operational errors, and improving the convenience and reliability of the device.

[0036] The sutures shown in the accompanying drawings are for structural illustration only. In the actual product, the sutures are thin and firmly attached to the outer surface of the drug release bag. The diameter of the sutures in the drawings is appropriately enlarged only to clearly illustrate the path of the sutures, their positional relationship, and their cooperation with adjacent structures. It is not a limitation on the actual size or thickness ratio and does not affect the accurate understanding and implementation of the device structure by those skilled in the art.

[0037] The length of the suture end shown in the attached diagram of the above instruction manual is for illustrative purposes only. Its length can be adjusted according to actual needs to facilitate use by medical personnel.

[0038] The components shown in the accompanying drawings of the above instruction manual are only schematic diagrams of structural and positional relationships, and do not limit the actual size, shape, proportion, or specific layout angle of each component. They can be adaptively adjusted according to actual clinical use needs and production and processing requirements. When performing unidirectional drug injection, the slit of the drug release bag can be set downwards, making it easier for medical staff to stably complete the drug injection operation through the drug injection structure. After the drug injection is completed, the slit remains closed. When the stent is placed in the patient's body, the slit of the drug release bag can be set downwards or upwards according to clinical drug administration needs. When the slit is downwards, the drug can be stably released under its own gravity or the drug can be directly injected into the uterine cavity wound. Alternatively, the slit can be set upwards according to the actual patient position to fit the required wound position, thereby meeting the drug release method requirements in different surgical scenarios.

[0039] The foregoing has shown and described the basic principles and main features of the present invention, as well as its advantages. Those skilled in the art should understand that the present invention is not limited to the above embodiments. The embodiments and descriptions in the specification are merely illustrative of the principles of the present invention. Various changes and modifications can be made to the present invention without departing from its spirit and scope. All such changes and modifications fall within the scope of the present invention as claimed, which is defined by the appended claims and their equivalents.

Claims

1. A multi-point intrauterine drug release device, characterized in that: The device includes a stent for insertion into a patient's body and adapted to the shape of the uterine cavity. The stent comprises a transversely extending fundus segment, a left support segment extending longitudinally from the fundus segment, and a right support segment. The fundus segment, left support segment, and right support segment together form a uterine contour. Several drug release pouches are sequentially arranged along the opening direction of the uterine contour. Each drug release pouch has a drug cavity and an injection structure for unidirectional injection of external drugs into the drug cavity. Each drug release pouch has a slit for communicating with the drug cavity and a suture for closing the slit. Several sutures have operating ends extending from their ends for external medical personnel to pull, loosen the sutures, and open the slits. Corresponding to each drug release pouch position on the uterine contour, a guide structure is provided to limit the sutures before the stent is inserted into the patient's body to prevent the sutures from shifting due to external stress, and an adaptive structure is provided to cooperate with the guide structure to adaptively drive the guide structure to release the suture limitation after the stent is inserted into the patient's body.

2. The intrauterine drug multi-point release device according to claim 1, characterized in that: The slit is positioned opposite the injection structure. The drug release bag has several first perforations arranged along the slit's opening direction for sutures to pass through. These first perforations are all located on the left side of the slit. One end of each first perforation connects to the outer surface of the drug release bag, and the other end connects to the inner wall of the left side of the slit. The radial cross-section of each first perforation is arc-shaped. The drug release bag also has several second perforations arranged along the slit's opening direction for sutures to pass through. These second perforations are all located on the right side of the slit, and one end of each second perforation connects to the outer surface of the drug release bag. On the surface, the other end is connected to the inner wall on the right side of the tear. The radial cross-section of the second perforation is arc-shaped. Several first perforations and several second perforations are arranged in a staggered manner and correspond one-to-one. The suture is alternately passed through the corresponding first perforation and second perforation. The drug release bag has a movable hole for the operating end of the suture to pass through. One end of the movable hole is connected to the outer surface of the drug release bag, and the other end is connected to the adjacent first perforation. The adaptive structure is set on the surface of the drug release bag and away from the movable hole. The adaptive structure is matched with the beginning of the suture.

3. The intrauterine drug multi-point release device according to claim 2, characterized in that: The guiding structure includes a pressure plate disposed on a drug release bag. The radial cross-section of the bottom wall of the pressure plate is arc-shaped. A pressure hole is formed between the bottom wall of the pressure plate and the drug release bag to accommodate and adapt to the beginning of the suture. The adaptive structure includes a first deformation strip. The radial cross-section of the first deformation strip is U-shaped and consists of a connecting part and two ends. The two ends are embedded in the drug release bag. A smooth arc surface connects the ends and the connecting part to a transition part. The connecting part is embedded in the pressure plate. The first deformation strip is made of shape memory alloy. The first deformation strip has a first shape in a first temperature range and a second shape in a second temperature range. In the first shape, the angle between the end and the connecting part of the first deformation strip is obtuse and the pressure plate is pressed against the outer surface of the drug release bag. In the second shape, the transition part of the first deformation strip bends so that the angle between the end and the connecting part is acute and the pressure plate swings to expand the pressure hole.

4. The intrauterine drug multi-point release device according to claim 1, characterized in that: Each of the drug release bags is connected to the support. The guide structure also includes several guide plates disposed on the support. Each of the guide plates corresponds to one of the drug release bags. The inner wall of the starting end of the guide plate is fitted with the outer peripheral wall of the support and forms a groove for the suture to pass through.

5. The intrauterine drug multi-point release device according to claim 4, characterized in that: The adaptive structure further includes several second deformation strips, each corresponding to a guide plate, with each second deformation strip embedded within its corresponding guide plate. The ends of the second deformation strips extend through the guide plates and are connected to the bracket. The beginnings of the second deformation strips are positioned at the beginning of the guide plates. The second deformation strips are made of shape memory alloy. The second deformation strips have a third shape within a first temperature range and a fourth shape within a second temperature range. In the third shape, the inner wall of the beginning of the guide plate combines with the outer peripheral wall of the bracket to clamp the suture. In the fourth shape, the second deformation strip bends to enlarge the groove, thereby relieving the pressure of the guide plate on the suture.

6. The intrauterine drug multi-point release device according to claim 1, characterized in that: The inner wall on the left side of the rift has several first protrusions along the rift opening direction, and the inner wall on the right side of the rift has several second protrusions along the rift opening direction. The first protrusions and the second protrusions are one-to-one correspondences and staggered. Adjacent first protrusions are gap-fitted to form a first groove. The first groove is connected to the adjacent first protrusion with a smooth arc surface. Adjacent second protrusions are gap-fitted to form a second groove. The second groove is connected to the adjacent second protrusion with a smooth arc surface. The first protrusions and the second grooves are one-to-one correspondences and are snap-fitted. The second protrusions and the first grooves are one-to-one correspondences and are snap-fitted. The first and second protrusions are both located away from the rift opening. The first and second protrusions are both integrally formed with the drug release bag. The combination of the first and second protrusions is arranged in a wave-like shape.

7. The intrauterine drug multi-point release device according to claim 1, characterized in that: The fundus segment is connected to the left and right support segments by a smooth arc surface and forms an arc-shaped segment for contact with the inner wall of the patient's uterine cavity. The stent is made of medical-grade thermoplastic polyurethane elastomer material by injection molding.

8. The intrauterine drug multi-point release device according to claim 1, characterized in that: The drug release bag has a positioning groove with an injection hole through the center of the positioning groove for communicating with the drug cavity. The injection structure includes several thin sheets arranged in a ring and located in the positioning groove. The starting ends of the thin sheets are stacked sequentially along the circular arrangement path of the thin sheets. The ends of the thin sheets are connected to the bottom wall of the positioning groove. The starting ends of the thin sheets cover and shield the opening of the injection hole. The thin sheets are medical-grade silicone rubber sheets, and a medical-grade rubber puncture membrane is provided at the opening of the injection hole.

9. A uterine drug multi-point release device according to claim 1, characterized in that: The suture is a medical-grade absorbable polydioxanone suture.

10. A uterine drug multi-point release device according to claim 1, characterized in that: The drug release bag is formed by hot pressing medical-grade low-density polyethylene film.

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