Fascia closure, minimally invasive surgical closure device and use thereof

Abstract

The application relates to a fascia closer, a minimally invasive surgical closing device and application thereof, and belongs to the medical instrument field. The fascia closer comprises a closer shaft sleeve and a closing rod. The closing rod comprises a puncture needle guide rail. The puncture needle guide rail comprises a straight section and a bending section. The inlet of the straight section is arranged at the top end of the closing rod. The outlet of the bending section which is smoothly connected with the straight section is arranged on the side wall of the closing rod. The included angle between the tangent direction of the outlet of the bending section and the straight section is 15-35 degrees. The fascia closer can effectively improve the suture effect of the puncture hole under the condition that the abdominal wall thickness is large and reduce the risk of the puncture hole hernia.

Description

Technical Field

[0001] This invention belongs to the field of medical devices, specifically relating to a fascia closure device, a minimally invasive surgical closure device, and their applications. Background Technology

[0002] Laparoscopic surgery, with its advantages of minimal trauma, rapid recovery, and high efficiency, has gained increasingly widespread clinical application. After laparoscopic surgery, the puncture site needs to be closed to reduce the risk of puncture site hernia. To facilitate postoperative puncture site closure, some techniques utilize fascia closure devices with integrated puncture clamping functions, allowing for direct puncture site closure after the surgical procedure. However, in clinical application, some overweight patients have abdominal wall thicknesses exceeding the allowable length of existing fascia closure devices, leading to poor puncture site closure and affecting postoperative recovery. Therefore, providing a fascia closure device with a longer usable length has significant practical value. Summary of the Invention

[0003] The purpose of this invention is to provide a fascia closure device to improve wound closure in cases of thick abdominal walls. This invention also provides a minimally invasive surgical closure device.

[0004] According to one aspect of the present invention, a fascial closure device is provided, comprising a closure device sleeve, wherein the closure device sleeve is configured as a hollow rod for insertion into a patient's body and for guiding surgical instruments. The fascial closure device further comprises a closure rod, the outer diameter of which matches the inner diameter of the closure device sleeve to allow one end of the closure rod to pass through the closure device sleeve. The closure rod further comprises a puncture needle guide, the puncture needle guide comprising a straight section and a bent section to allow a puncture needle to enter through an inlet in the straight section and exit through an outlet in the bent section; the straight section is arranged parallel to the axis of the closure rod, the inlet of the straight section being located at the other end of the closure rod; the bent section is at least partially configured as an arcuate section, the bent section smoothly transitioning to the straight section through the arcuate section, the outlet of the bent section being located on a side wall of the closure rod, and the angle between the tangent of the bent section at the outlet and the straight section being 15°-35°. The closure sleeve wall is provided with a puncture window. When the closure rod is inserted into the closure sleeve, the puncture window cooperates with the outlet of the bent section to allow the puncture needle to pass through the puncture window.

[0005] This fascia closure device, by setting a puncture needle guide with a bent section, allows the elastic puncture needle to be inserted along the axial direction of the closure rod and guided by the bent section to exit at an appropriate angle to complete the suturing. This effectively solves the problem of mismatch between the puncture position and depth when the puncture needle is inserted in a straight line in scenarios with excessively thick abdominal walls, which affects the suturing effect.

[0006] Furthermore, in some embodiments, the straight segment is configured as a pipe, and the bent segment is configured as a bent metal sheet or metal groove.

[0007] Furthermore, in some embodiments, the puncture needle guide includes at least two.

[0008] Furthermore, in some embodiments, one end of the closing rod is also provided with a puncture head for puncturing the patient's body wall.

[0009] Furthermore, in some embodiments, the radius of curvature of the bent segment is 60-80 mm.

[0010] Furthermore, in some embodiments, the maximum diameter of the puncture needle that the puncture needle guide rail allows to pass through is 2mm-4mm.

[0011] Furthermore, in some embodiments, the length of the closing rod is 60mm-180mm.

[0012] Furthermore, in some embodiments, the closure sleeve also includes a positioning and fixing balloon, the distance between the positioning and fixing balloon and the end of the closure sleeve is 5mm-30mm, and the distance between the puncture window and the positioning and fixing balloon is 20mm-40mm.

[0013] Furthermore, in some embodiments, a sheath cap is also included, which can be snapped onto the top of the closing rod.

[0014] Furthermore, in some embodiments, the angle between the bent section at the outlet tangential and the straight section is 15°-25°.

[0015] According to another aspect of the present invention, a minimally invasive surgical closure device is provided, the device comprising a fascia closure device and a puncture needle, wherein the fascia closure device is the fascia closure device provided in any of the foregoing embodiments, and the puncture needle is configured as an elastic suture needle, which is capable of passing through the bending section of the fascia closure device without undergoing plastic deformation.

[0016] According to another embodiment of the present invention, a method for using a minimally invasive surgical closure device is provided. The method employs the minimally invasive surgical closure device provided in the foregoing embodiments and includes the following steps: Step a): Locate the perforation position on the patient's body wall and position the closure device sleeve, form a puncture hole at the perforation position, insert the closure device sleeve into the puncture hole and fix it; Step b): Insert the surgical instrument into the closure sleeve to perform the surgical operation, and remove the surgical instrument after the surgical operation is completed; Step c): Insert the closing rod into the closure device sleeve, and insert the elastic suture needle into the puncture needle guide rail to close the puncture hole. Attached Figure Description

[0017] Figure 1 This is a schematic diagram of the cross-sectional structure of the fascia closure device in one embodiment; Figure 2 A schematic diagram of a pair of proportional fascia closure devices; Figure 3 This is a schematic diagram showing the sutured state of a pair of proportionally thick abdominal walls; Figure 4 This is a schematic diagram of the closing rod structure in one embodiment; Figure 5 This is a schematic diagram of the sheath cap structure in one embodiment; Figure 6 This is a schematic diagram of the closure bushing structure in one embodiment; Figure 7 This is a schematic cross-sectional view of the fascia closure device in another embodiment.

[0018] Meaning of the reference numerals in the attached figures: 1-Sheath cap; 2-Closing device sleeve; 3-Closing rod; 4-Puncture needle guide rail; 5-Straight section; 6-Bent section; 7-Positioning and fixing balloon; 8-Puncture blade; 9-Abdominal wall tissue; 10-Puncture needle; 11-Central hole; 12-Snap fastener; 13-Puncture window; 14-Through hole; 15-Closing device.

[0019] The purpose of the above-described drawings is to provide a detailed description of the present invention so that those skilled in the art can understand the technical concept of the invention, and is not intended to limit the invention. For the sake of brevity, the above-described drawings only schematically depict the structures related to the technical features of the present invention, and do not depict the complete structure and all details strictly according to actual scale. Detailed Implementation

[0020] The present invention will now be described in further detail with reference to specific embodiments and accompanying drawings.

[0021] The term "embodiment" as used herein means that a particular feature, structure, or characteristic described in connection with an embodiment may be included in at least one embodiment herein. The phrase appearing in various places in the specification does not necessarily refer to the same embodiment, nor is it limited to mutually exclusive, independent, or alternative embodiments. Those skilled in the art will understand that the embodiments herein can be combined with other embodiments without causing structural conflicts.

[0022] In this description, unless otherwise explicitly specified and limited, the technical terms "installation," "connection," "joining," etc., should be interpreted broadly, for example, referring to movable connections, fixed connections, or integration. Those skilled in the art can understand the specific meaning of the above terms in the embodiments of this application based on the specific circumstances.

[0023] In this description, terms such as "upper," "lower," "left," "right," "lateral," "longitudinal," "height," "length," and "width," which indicate orientation or positional relationships, are intended to accurately describe the embodiments and simplify the description, rather than limiting the parts or structures involved to have a specific orientation, or to be installed or operated in a specific orientation, and should not be construed as limiting the embodiments in this document.

[0024] In this description, terms such as "first" and "second" are used only to distinguish different objects and should not be construed as indicating relative importance or limiting the number, specific order, or primary / secondary relationship of the described technical features. In this description, "multiple" means at least two.

[0025] Currently, a type of closure device 15 with integrated puncture device puncture function has a structure such as Figure 2 As shown, it can guide the puncture needle 10, facilitating the closure of the puncture hole in the abdominal wall tissue 9 after minimally invasive surgery, thus promoting wound healing and reducing the risk of puncture hole hernia. Clinically, the optimal distance between the exit point of the puncture needle 10 from the abdominal wall tissue and the fascia closure device is approximately 1 cm, while the optimal insertion point in the thickness direction should be approximately 3 cm from the bottom of the abdominal wall tissue 9, allowing the suture to achieve a secure closure relying on the muscle tissue in the abdominal wall. However, in clinical practice, as... Figure 3As shown, the suture needle is inserted along the dotted line A of the closure device 15. For a normal patient with an abdominal wall thickness of D1, the horizontal distance L0 between the suture position (the point where the puncture needle exits the abdominal wall) and the closure device 15 is about 1 cm, and the vertical distance H0 between the suture position and the needle exit point is about 3 cm, which can achieve a good suture effect. However, for overweight patients with an abdominal wall thickness of D2, if the needle is still inserted along the dotted line A, the horizontal distance L1 between the suture position and the closure device 15 will significantly exceed the optimal suture distance of 1 cm. If the distance H1 between the needle exit point and the bottom of the abdominal wall tissue 9 is too large, the puncture needle will penetrate into the soft adipose tissue, which will seriously affect the suture quality and even cause the risk of suture dehiscence. However, if the position of the needle inlet in the axial direction of the closure device 15 remains unchanged, and the angle α between the needle insertion direction and the vertical direction is reduced to obtain the dashed line B, and the abdominal wall tissue 9 is sutured along the needle insertion path shown by the dashed line B, keeping the distance L2 between the puncture needle exit point and the fascia closure device at approximately 1 cm, the distance H2 between the puncture needle entry point and the bottom of the abdominal wall tissue 9 will still be greater than 3 cm due to the reduced angle α. This will still cause the suture to extend beyond the muscle tissue and penetrate into the low-strength abdominal wall fat, thus failing to guarantee the suture's firmness and affecting the patient's postoperative recovery. Furthermore, the reduction of the angle α may also cause the needle insertion path to interfere with the closure device 15 in region C. In summary, the existing technical solutions lack a fascia closure device suitable for overweight patients undergoing laparoscopic surgery, which is detrimental to improving the surgical experience and prognosis of overweight patients.

[0026] To overcome the aforementioned problems of the prior art, one embodiment of the present invention provides a fascia closure device that can effectively improve the poor closure effect of puncture sites when the abdominal wall tissue is too thick in overweight patients. The structure of this fascia closure device is as follows: Figure 1 As shown, it includes a closing bushing 2 and a closing rod 3. Wherein, as... Figure 6 As shown, the closure sleeve 2 has a through hole 14 at its center. The closure sleeve 2 is used to penetrate the patient's body and guide surgical instruments through the through hole 14 to complete the surgical procedure. The structure of the closure rod 3 is as follows: Figure 4As shown, its outer diameter matches the inner diameter of the through hole 14, allowing it to pass through the through hole 14 into the closure sleeve 2 and be fixed. The lower end of the closing rod 3 can pass into the closure sleeve 2 to complete the puncture closure. In a preferred embodiment, the lower end of the closing rod 3 is provided with a puncture head 8, which is used to cut the patient's body wall to create a puncture hole. A puncture needle guide 4 is also provided inside the closing rod 3. The puncture needle guide 4 includes a straight section 5 and a bent section 6. When performing puncture hole suturing, an elastic puncture needle can enter from the entrance of the straight section 5 and exit from the exit of the bent section 6 under the guidance of the puncture needle guide 4. The straight segment 5 is arranged parallel to the axis of the closing rod 3, and its inlet is located at the end above the closing rod 3. The bent segment 6 is at least partially configured as an arc segment, which smoothly transitions to the straight segment 5. The outlet of the bent segment 6 is located on the side wall of the closing rod 3, and the angle between the tangent at the outlet and the straight segment is 15°-35°. In a preferred embodiment, the angle range is 15°-25°. In a further preferred embodiment, the angle range is 18°-19°. Correspondingly, the side wall of the closing device sleeve 2 is provided with a puncture window 13. When the closing rod 3 is inserted into the closing device sleeve 2 and reaches the fixed position, the outlet position of the bent segment 6 falls within the range of the puncture window 13, so that the puncture needle can pass through the puncture window.

[0027] In a preferred embodiment, the straight section 5 is a pipe structure, which can be made of plastic or metal pipe; the bent section 6 can be configured as a bent metal sheet or metal groove. When the puncture needle passes through the straight section, it abuts against the bent section 6, is guided by the bent metal sheet or metal groove and undergoes elastic bending, and finally passes out tangentially along the bent section 6 at the outlet.

[0028] In a preferred embodiment, a fascia closure device is provided with two puncture needle guides 4, and the outlets of the two puncture needle guides 4 are respectively located on both sides of the axial direction of the closing rod 3, so as to suture the tissue on both sides of the puncture hole and improve the suturing effect.

[0029] In a preferred embodiment, the radius of curvature of the bending segment 6 is 60mm-80mm, and the maximum diameter of the puncture needle that the puncture needle guide rail 4 allows to pass through is 2mm-4mm. For example, when the straight segment 5 adopts a tubular structure, its aperture can be set to 2mm-4mm.

[0030] In some specific embodiments, the length of the closure rod 3 is 60mm-180mm to accommodate the thicker abdominal wall tissue of overweight patients. In a preferred embodiment, a positioning and fixation balloon 7 is also provided at the lower end of the closure sleeve 2. When the closure sleeve 2 is inserted into the patient's body, the positioning and fixation balloon 7 can be inflated to axially fix the closure sleeve. The distance between the positioning and fixation balloon 7 and the end of the closure sleeve 2 is 5mm-30mm, and the distance between it and the puncture window 13 is 20mm-40mm.

[0031] In a preferred embodiment, the fascia closure device further includes a sheath cap 1, combined with... Figure 5 The sheath cap 1 can be snapped onto the top of the closing rod 3 via the buckle 12. The sheath cap 1 has a central hole 11. When the sheath cap 1 is snapped onto the closing rod 3 via the buckle 12, the entrance of the straight section 5 of the puncture needle guide rail 4 is within the range of the central hole 11, so that the puncture needle can enter the puncture needle guide rail 4 through the central hole 11.

[0032] In different embodiments, the closing rod 3 can be customized according to the design of the above embodiments, or it can be modified using existing minimally invasive surgical puncture rods. A puncture needle guide rail 4 is set inside the metal rod of the puncture rod, and a hole is opened on the side wall to achieve the same technical effect.

[0033] In other embodiments, such as Figure 7 As shown, the lower end of the closure rod 3 can also be designed as a bladeless structure. During minimally invasive surgery, an existing minimally invasive surgical puncture rod can be used to puncture the patient's body wall first, and then the closure rod 3 can be used for suturing after the surgery. In this case, the rod body of the closure rod 3 can be made of plastic to further reduce material costs.

[0034] Another embodiment of the present invention provides a minimally invasive surgical closure device, which includes the fascia closure device and puncture needle provided in any of the above embodiments. The puncture needle is configured as an elastic suture needle, which can pass through the puncture needle guide 4 of the fascia closure device without undergoing plastic deformation. The puncture needle 10 can be made of a medical alloy with good elasticity, such as medical shape memory alloy, medical titanium alloy, or medical stainless steel.

[0035] Another embodiment of the present invention provides a method of using the minimally invasive surgical closure device described in the above embodiments, the method comprising the following steps: First, determine and mark the puncture location on the patient's body surface. Fix the closure sleeve 2 to the location on the patient's body wall where the puncture is needed. Attach the sheath cap 1 to the top of the closure rod 3. Pass the closure rod 3 through the through hole 14 and assemble it with the closure sleeve 2. Use the puncture head 8 to create a puncture hole on the patient's body surface. Then, insert the closure sleeve 2 into the puncture hole and inflate the positioning and fixing balloon 7 for fixation.

[0036] Next, the closing rod 3 is pulled out from the closing sleeve 2, the surgical instrument is inserted into the through hole 14, and the surgical procedure is performed inside the patient's body. The surgical instrument is removed after the surgery is completed.

[0037] Finally, the closing rod 3 is inserted into the closing device sleeve 2 again, the elastic suture needle is inserted into the central hole 11 and enters the puncture needle guide 4. After the elastic suture needle with suture thread undergoes elastic bending deformation, it passes through the bent section 6 and passes through the puncture window 13 at the tangential direction of the exit of the bent section 6 to puncture the patient's abdominal wall tissue to complete the suture.

[0038] The purpose of the above embodiments is to provide a further detailed description of the present invention in conjunction with the accompanying drawings, so that those skilled in the art can understand the technical concept of the present invention. Within the scope of the present invention, optimization or equivalent substitution of the involved part structures or method steps, as well as combination of implementation methods in different embodiments without causing structural and principle conflicts, all fall within the protection scope of the present invention.

Claims

1. A fascia closure device, comprising a closure device sleeve, wherein the closure device sleeve is configured as a hollow rod for insertion into the patient's body and for guiding surgical instruments through, characterized in that, It also includes a closing rod, the outer diameter of which matches the inner diameter of the closing device sleeve to allow one end of the closing rod to pass through the closing device sleeve. The closing rod includes a puncture needle guide rail, which includes a straight section and a bent section to allow a puncture needle to enter through the inlet of the straight section and exit through the outlet of the bent section. The straight section is arranged parallel to the axis of the closing rod, and the inlet of the straight section is located at the other end of the closing rod. The bent section is at least partially configured as an arc segment, and the bent section smoothly transitions to the straight section through the arc segment. The outlet of the bent section is located on the side wall of the closing rod, and the angle between the tangent of the bent section at the outlet and the straight section is 15°-35°. The closure sleeve wall is provided with a puncture window. When the closure rod is inserted into the closure sleeve, the puncture window cooperates with the outlet of the bent section to allow the puncture needle to pass through the puncture window.

2. The fascia closure device according to claim 1, characterized in that, The straight segments are configured as pipes, and the bent segments are configured as bent metal sheets or metal channels.

3. The fascia closure device according to claim 1, characterized in that, The puncture needle guide includes at least two.

4. The fascia closure device according to claim 1, characterized in that, One end of the closing rod is also provided with a puncture blade for making a puncture in the patient's body wall.

5. The fascia closure device according to claim 1, 2, or 3, characterized in that, The radius of curvature of the bent section is 60-80 mm.

6. The fascia closure device according to claim 2 or 3, characterized in that, The maximum diameter of the puncture needles that can pass through the puncture needle guide rail is 2mm-4mm.

7. The fascia closure device according to claim 1, 2, or 3, characterized in that, The length of the closing rod is 60mm-180mm.

8. The fascia closure device according to claim 7, characterized in that, The closure device bushing also includes a positioning and fixing balloon, the distance between the positioning and fixing balloon and the end of the closure device bushing is 5mm-30mm, and the distance between the puncture window and the positioning and fixing balloon is 20mm-40mm.

9. The fascia closure device according to claim 1, 2, or 3, characterized in that, It also includes a sheath cap that can be snapped onto the top of the closing rod.

10. The fascia closure device according to claim 1, 2, or 3, characterized in that, The angle between the bent section and the straight section at the outlet is 15°-25°.

11. A minimally invasive surgical closure device, comprising a fascia closure device and a puncture needle, characterized in that, The fascia closure device is the fascia closure device as described in any one of claims 1 to 10, and the puncture needle is configured as an elastic suture needle, which is capable of passing through the bending section of the fascia closure device without undergoing plastic deformation.

12. A method of using a minimally invasive surgical closure device, characterized in that, The minimally invasive surgical closure device is the same as described in claim 11, and includes the following steps: Step a): Locate the perforation position on the patient's body wall and position the closure device sleeve, form a puncture hole at the perforation position, insert the closure device sleeve into the puncture hole and fix it; Step b): Insert the surgical instrument into the closure sleeve to perform the surgical operation, and remove the surgical instrument after the surgical operation is completed; Step c): Insert the closing rod into the closure device sleeve, and insert the elastic suture needle into the puncture needle guide rail to close the puncture hole.

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