Urethral mesh for female urinary incontinence and moderate pelvic organ prolapse

Abstract

The present application relates to a urethral mesh for female urinary incontinence and moderate pelvic organ prolapse, which comprises a middle support sheet, a first wing sheet and a second wing sheet; a first preset mesh fixing line and a second preset mesh fixing line are arranged on the front side of the middle support sheet; a third preset mesh fixing line and a fourth preset mesh fixing line are arranged on the back side of the middle support sheet; a fifth middle mark traction line is arranged between the first preset mesh fixing line and the second preset mesh fixing line; and a sixth middle mark traction line is arranged between the third preset mesh fixing line and the fourth preset mesh fixing line. The advantages are that the urethral tip can be provided with support strength to prevent the anterior pelvic organ from bulging; meanwhile, the bladder neck and the posterior urethral segment are reconstructed, and the middle urethral support is strengthened, which is particularly suitable for patients with larger urethral activity, wider vaginal split, recurrent cases and shorter anterior vaginal wall, so as to reduce the operation difficulty and the incidence of complications, and can become a new type of medical instrument with wide application prospect.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to a urethral mesh for female urinary incontinence and moderate pelvic organ prolapse. Background Technology

[0002] Urinary incontinence and pelvic organ prolapse are both stress injuries of the pelvic floor. These diseases have a high incidence and many treatment options. Mid-urethral sling is the "gold standard" for treating stress urinary incontinence, while anterior pelvic mesh is an important method for treating moderate to severe anterior pelvic organ prolapse. However, in some cases of stress urinary incontinence combined with moderate pelvic organ prolapse, the choice between an incontinence sling and a full pelvic mesh often presents a clinical dilemma.

[0003] The existing meshes used for stress urinary incontinence and moderate pelvic organ prolapse have the following defects and shortcomings:

[0004] head Firstly, existing urinary incontinence slings are mainly made of polypropylene and are less than 1 cm wide. After implantation, they shrink, becoming only 50-80% of their original width. This can easily lead to kinking and compression of the urethra, causing difficulty in urination. Furthermore, the narrow sling cannot simultaneously suspend the 4 cm distance from the mid-urethra to the bladder neck, resulting in poor urinary control in some patients after surgery.

[0005] Secondly, in cases of pelvic organ prolapse combined with stress urinary incontinence, simply using a conventional TVT sling may result in insufficient support and a high risk of relapse. Some cases of refractory urinary incontinence also require a wider sling. Existing mesh panels are too large, and consist of four meshes, making surgery difficult, more invasive, inconvenient to use, and ultimately leading to poor treatment outcomes.

[0006] Chinese patent document CN201720088071.0 discloses a urinary incontinence suspension belt with a braided structure, belonging to the field of medical devices. This invention provides a urinary incontinence suspension belt with a braided structure, comprising a mesh sheet with woven mesh openings and several parallel braided structures. The extension direction of the braided structures on the mesh sheet is consistent with the direction of force applied after the suspension belt is implanted.

[0007] The aforementioned patent literature describes a urinary incontinence sling with a braided structure, which significantly reduces the elongation rate of the sling mesh under stress, lowering the postoperative recurrence rate. Furthermore, the large mesh design effectively improves the biocompatibility of the mesh after implantation, reducing the risk of infection and preventing complications such as mesh exposure and erosion. However, no corresponding technical solution has been disclosed for improving the treatment effect of urinary incontinence combined with moderate anterior pelvic organ prolapse and refractory stress urinary incontinence, while simultaneously treating anterior pelvic organ prolapse and reducing trauma.

[0008] In summary, there is an urgent need for a urethral mesh that can improve the treatment efficacy of urinary incontinence, treat anterior pelvic organ prolapse, and reduce trauma, specifically for cases of urinary incontinence complicated by moderate anterior pelvic organ prolapse and refractory stress urinary incontinence. However, no such urethral mesh has been reported to date. Summary of the Invention

[0009] The purpose of this invention is to address the shortcomings of existing technologies by providing a urethral mesh that improves the treatment effect of urinary incontinence in cases of urinary incontinence complicated with moderate anterior pelvic organ prolapse and refractory stress urinary incontinence, while simultaneously treating anterior pelvic organ prolapse and reducing trauma.

[0010] To achieve the above objectives, the technical solution adopted by the present invention is as follows:

[0011] A urethral mesh for female urinary incontinence and moderate pelvic organ prolapse, comprising a central support piece, a first wing, and a second wing; the central support piece has the first wing at one end and the second wing at the other end; the rear edge of the central support piece extends outward relative to the first or second wing; the rear edge of the central support piece has a first and a second pre-set mesh fixing line; and the front ends of the central support piece have a third and a fourth pre-set mesh fixing line, respectively. The No. 1, No. 2, No. 3, and No. 4 pre-installed mesh fixing lines are all fixed to the intermediate support plate by passing them through. The No. 1 and No. 3 pre-installed mesh fixing lines correspond to each other. The No. 2 and No. 4 pre-installed mesh fixing lines correspond to each other. A No. 5 intermediate marker traction line is set between the No. 1 and No. 2 pre-installed mesh fixing lines. A No. 6 intermediate marker traction line is set between the No. 3 and No. 4 pre-installed mesh fixing lines.

[0012] As a preferred technical solution, the widths of the first wing and the second wing are equal; the length of the first wing is less than the length of the second wing.

[0013] As a preferred technical solution, the first wing, the second wing, and the intermediate support piece are integrally formed.

[0014] As a preferred technical solution, the lower edge surfaces of the first wing, the second wing, and the intermediate support piece are on the same straight line.

[0015] As a preferred technical solution, the width of the intermediate support piece is 4cm; the width of the first wing piece and the second wing piece is 2cm.

[0016] As a preferred technical solution, the urethral mesh is made of polypropylene.

[0017] As a preferred technical solution, the extended portion of the intermediate support sheet adopts a form that is narrower at the front and wider at the back; the center of gravity of the urethral mesh is located behind the center line between the first wing and the second wing.

[0018] As a preferred technical solution, the No. 1, No. 2, No. 3, No. 4, No. 5, and No. 6 pre-set mesh fixing lines all use 2-0 antibacterial polydioxane wire.

[0019] As a preferred technical solution, the No. 1, No. 2, No. 3, No. 4, No. 5, and No. 6 pre-set mesh fixing lines all have two free ends.

[0020] As a preferred technical solution, the urethral mesh further includes transverse braided wires, longitudinal braided wires, a first oblique braided wire, and a second oblique braided wire; the longitudinal braided wire is fixed at both ends of the transverse braided wire; the transverse braided wires are distributed in a parallel and spaced manner; the first oblique braided wire and the second oblique braided wire fix the transverse braided wire and / or the longitudinal braided wire together from different directions; the transverse braided wire, the longitudinal braided wire, the first oblique braided wire, and the second oblique braided wire form a polygonal hole structure.

[0021] The advantages of this invention are:

[0022] 1. The urethral mesh of the present invention for female urinary incontinence and moderate pelvic organ prolapse is specifically designed for the physiological structure used to treat stress urinary incontinence and moderate pelvic organ prolapse. It effectively ensures tension-free suspension of the mid-urethra and proper placement and flat coverage of the sling mesh during surgery, thereby improving the cure rate and reducing the incidence of complications. It can be a new type of medical device with broad application prospects.

[0023] 2. The mesh is provided with an intermediate support piece, the rear edge of which extends outward relative to the first or second wing piece. This extension design increases the width of the intermediate support piece, extending the force-bearing surface from the middle of the urethra to the bladder neck, thus acting on the two "valves" of urethral control.

[0024] 3. By using pre-installed mesh fixing lines, the correct placement and flattening of the sling mesh during surgery can be ensured, effectively improving the cure rate and reducing the incidence of complications.

[0025] 4. By using pre-installed mesh fixing lines, the correct placement and flattening of the sling mesh during surgery can be ensured, effectively improving the cure rate and reducing the incidence of complications.

[0026] 5. The asymmetrical design between the first and second wing plates helps to increase the support for the bladder neck; secondly, it ensures that the sling has a large force-bearing surface on the descending pubic ramus, preventing sling movement and thus reducing the recurrence rate.

[0027] 6. The center of gravity of the urethral mesh is located behind the center line between the first and second wings. The effect of this design is that the sling support point is mainly at the rear, which ensures the support strength for the top of the urethra and prevents the anterior pelvic organs from bulging. At the same time, it completes the reconstruction of the bladder neck and the posterior urethra and strengthens the support of the middle urethra. It is especially suitable for patients with greater urethral mobility, widened vaginal fissure, recurrent cases, and short anterior vaginal walls. Attached Figure Description

[0028] Appendix Figure 1 This is a schematic diagram of the urethral mesh for female urinary incontinence and moderate pelvic organ prolapse according to the present invention.

[0029] Appendix Figure 2 This is a partially enlarged schematic diagram of the weaving of the urethral mesh of the present invention. Detailed Implementation

[0030] The specific embodiments provided by the present invention will be described in detail below with reference to the accompanying drawings.

[0031] The reference numerals and components involved in the accompanying drawings are shown below:

[0032] 1. Intermediate support plate 2. First wing plate

[0033] 3. Second wing piece; 4. First pre-set mesh fixing line.

[0034] 5. Pre-installed wire mesh fixing line No. 2 6. Pre-installed wire mesh fixing line No. 3

[0035] 7. No. 4 pre-installed mesh fixing line; 8. No. 5 intermediate marker traction line.

[0036] 9. No. 6 center marker traction line 10. Horizontal braided wire

[0037] 11. Longitudinal braiding yarn 12. First diagonal braiding yarn

[0038] 13. Second oblique braided yarn

[0039] To more clearly describe the technical solution, the terms "before" and "after" are used in the following solution; the term "before" refers to... Figure 1 The direction of the upper middle end face; the term "back" is a reference. Figure 1 The direction of the lower middle end face.

[0040] Please refer to Figure 1 , Figure 1 This is a schematic diagram of the structure of a urethral mesh for female urinary incontinence and moderate pelvic organ prolapse according to the present invention. The urethral mesh for female urinary incontinence and moderate pelvic organ prolapse includes a central support piece 1, a first wing piece 2, and a second wing piece 3. One end of the central support piece 1 has the first wing piece 2; the other end of the central support piece 1 has the second wing piece 3. The front edge of the central support piece 1 extends outward relative to either the first wing piece 2 or the second wing piece 3. The widths of the first wing piece 2 and the second wing piece 3 are equal. The length of the first wing piece 2 is less than the length of the second wing piece 3. The first wing piece 2, the second wing piece 3, and the central support piece 1 are integrally formed. The lower edges of the first wing piece 2, the second wing piece 3, and the central support piece 1 are on the same straight line.

[0041] The front side of the intermediate support plate 1 is provided with a first pre-set mesh fixing line 4 and a second pre-set mesh fixing line 5; the rear side of the intermediate support plate 1 is provided with a third pre-set mesh fixing line 6 and a fourth pre-set mesh fixing line 7; a fifth intermediate marker traction line 8 is provided between the first pre-set mesh fixing line 4 and the second pre-set mesh fixing line 5; and a sixth intermediate marker traction line 9 is provided between the third pre-set mesh fixing line 6 and the fourth pre-set mesh fixing line 7.

[0042] The width of the intermediate support piece 1 is 4cm; the width of the first wing piece 2 and the second wing piece 3 is 2cm. The urethral mesh is made of polypropylene.

[0043] The extended portion of the intermediate support piece 1 is narrower at the front and wider at the back; the center of gravity of the urethral mesh is located behind the center line between the first wing piece 2 and the second wing piece 3.

[0044] The No. 1 pre-set mesh fixing line 4, the No. 2 pre-set mesh fixing line 5, the No. 3 pre-set mesh fixing line 6, the No. 4 pre-set mesh fixing line 7, the No. 5 intermediate mark traction line 8, and the No. 6 intermediate mark traction line 9 all use 2-0 antibacterial polydioxane wire.

[0045] The No. 1 pre-set mesh fixing line 4, the No. 2 pre-set mesh fixing line 5, the No. 3 pre-set mesh fixing line 6, the No. 4 pre-set mesh fixing line 7, the No. 5 intermediate marker traction line 8, and the No. 6 intermediate marker traction line 9 all have two free ends.

[0046] Please refer to Figure 2 , Figure 2This is a partially enlarged schematic diagram of the urethral mesh of the present invention. The urethral mesh includes transverse braided wires 10, longitudinal braided wires 11, a first oblique braided wire 12, and a second oblique braided wire 13. The longitudinal braided wires 11 are fixed at both ends of the transverse braided wires 10. The transverse braided wires 10 are distributed in a parallel and spaced manner. The first oblique braided wires 12 and the second oblique braided wires 13 fix the transverse braided wires 10 and / or the longitudinal braided wires 11 together from different directions. The transverse braided wires 10, longitudinal braided wires 11, first oblique braided wires 12, and second oblique braided wires 13 form a polygonal hole structure, wherein the polygonal hole structure specifically includes triangles, tetragonals, and polygons without borders. In addition, the longitudinal braided wires 11 are not limited to being located at the ends of the transverse braided wires 10, but can also be located in the middle of the transverse braided wires 10, which can be selected as needed, thereby establishing a longitudinal support skeleton for the entire mesh.

[0047] It should be noted that the following is an explanation of this embodiment:

[0048] A middle support piece 1 is provided on the urethral mesh, and the front edge of the middle support piece 1 extends outward relative to the first wing piece 2 or the second wing piece 3. The extension design increases the width of the middle support piece 1, so that the force-bearing surface extends from the middle of the urethra to the bladder neck, and at the same time acts on the two "valves" of urethral urination control.

[0049] The urethral mesh is provided with a first wing 2 and a second wing 3. The first wing 2 and the second wing 3 are used to establish a connection with the pubic bone. This creates two fixation points after insertion into the human body, which helps to ensure that the mesh is firmly fixed.

[0050] The intermediate support piece 1 has a first pre-set mesh fixing line 4 and a second pre-set mesh fixing line 5 on its front side; and a third pre-set mesh fixing line 6 and a fourth pre-set mesh fixing line 7 on its rear side. The effect of this design is that the sling has pre-set mesh fixing lines in both the front and rear directions, ensuring the mesh remains fixed and does not shrink for up to six months. This ensures both the flatness of the mesh and tension-free suspension of the mid-urethra, thus catering to patients with female urinary incontinence and moderate pelvic organ prolapse.

[0051] A fifth intermediate marker traction line 8 is installed between the first pre-placed mesh fixing line 4 and the second pre-placed mesh fixing line 5; a sixth intermediate marker traction line 9 is installed between the third pre-placed mesh fixing line 6 and the fourth pre-placed mesh fixing line 7. The effect of this design is to ensure the correct placement and flattening of the sling mesh during surgery through the pre-placed mesh fixing lines, effectively improving the cure rate and reducing the incidence of complications.

[0052] The first, second, third, and fourth pre-installed mesh fixing lines 4, 5, 6, and 7 are all fixed to the intermediate support plate 3 by threading through them. The effect of this design is that each pre-installed fixing line has two traction ends, making it easy to pull.

[0053] The first pre-set mesh fixing line 4 corresponds to the third pre-set mesh fixing line 6; the second pre-set mesh fixing line 5 corresponds to the fourth pre-set mesh fixing line 7. The effect of this design is that, through this corresponding design, forty traction points are established in a plane, and the lines connecting four traction points form a trapezoidal shape. This facilitates the focusing of the four traction forces into a single point and the establishment of balance, ensuring the correct placement and flat coverage of the sling mesh.

[0054] The widths of the first wing 2 and the second wing 3 are equal; the length of the first wing 2 is less than the length of the second wing 3. The effect of this design is that it achieves an asymmetrical design between the first wing 2 and the second wing 3, which helps to increase the support strength for the bladder neck; secondly, it ensures that the sling has a large force-bearing surface on the descending pubic ramus, preventing sling movement and thus reducing the recurrence rate.

[0055] The first wing 2, the second wing 3, and the intermediate support piece 1 are integrally formed. This integral design provides excellent load-bearing capacity.

[0056] The lower edges of the first wing 2, the second wing 3, and the intermediate support piece 1 are all on the same straight line. This provides a positioning and reference function, making it easier for surgeons to place the piece in the correct position.

[0057] The width of the intermediate support piece 1 is 4cm; the width of the first wing piece 2 and the second wing piece 3 is 2cm. This size specification is designed based on clinical experience. Compared with previous slings, the intermediate support piece 1 is 4cm long, which covers the middle of the urethra to the bladder neck, according to the length of the urethra.

[0058] The urethral mesh is made of polypropylene. The design results in a thin, smooth, soft implant that is easy to handle.

[0059] The extended portion of the intermediate support piece 1 adopts a narrower front and wider rear design. The center of gravity of the urethral mesh is located behind the center line between the first wing piece 2 and the second wing piece 3. This design ensures that the sling support point is primarily at the rear, guaranteeing support for the urethral apex and maintaining effective functional urethral length, preventing anterior pelvic organ prolapse. The pre-installed mesh fixing lines 4, 5, 6, 7, 8, and 9 are all made of 2-0 antibacterial polydioxane sutures. This design eliminates the need for removal or knotting of these sutures, effectively avoiding significant rejection reactions caused by knots.

[0060] The pre-installed mesh fixing lines 4, 5, 6, 7, 8, and 9 (including the intermediate marker traction line 8 and 9) all have two free ends. This design allows for bidirectional traction of the mesh seams, ensuring the mesh is fully flattened.

[0061] The urethral mesh further includes transverse braided wires 10, longitudinal braided wires 11, a first oblique braided wire 12, and a second oblique braided wire 13; the longitudinal braided wires 11 are fixed at both ends of the transverse braided wires 10; the transverse braided wires 10 are distributed in a parallel and spaced manner; the first oblique braided wires 12 and the second oblique braided wires 13 fix the transverse braided wires 10 and / or the longitudinal braided wires 11 together from different directions; the transverse braided wires 10, the longitudinal braided wires 11, the first oblique braided wires 12, and the second oblique braided wires 13 form a polygonal perforated structure. The design achieves the following effects: First, the transverse braided wires 10 and longitudinal braided wires 11 primarily provide skeletal support for the entire mesh, while the first oblique braided wires 12 and the second oblique braided wires 13 provide load-bearing capacity in two oblique directions, thus providing strong tension to heterogeneous tissues to adapt to the mesh's stretching direction during use. Second, the entire mesh forms a polygonal perforated structure, which is suitable for fibroblast implantation and has excellent clumping properties, making it particularly useful for tissue reinforcement and reconstruction in cases of moderate pelvic organ prolapse, and providing permanent support.

[0062] The method of using the urethral mesh for female urinary incontinence and moderate pelvic organ prolapse of the present invention is as follows: A 4cm incision is made on the anterior vaginal wall, and the index finger is used to free the mesh above and behind the pubic bone to the obturator foramen; a 2mm incision is made 0.5cm lateral to the junction of the descending pubic ramus and the pubic symphysis, and a spiral needle is inserted close to the descending pubic ramus, passing through the fascia lata and obturator membrane of the thigh in one go, and then inserted into the vagina under the guidance of the finger; the first wing 2 and the second wing 3 of the sling mesh are introduced into the spiral puncture needle through the guide line, and the sling mesh is pulled out from the root of the thigh; the finger is inserted into the vagina to lift the vagina, and the sling mesh is laid flat and tightened in a natural state; the traction line of the middle marker is pulled to ensure that the sling mesh is placed symmetrically; the front end of the sling mesh is fixed to the anterior segment of the urethra with 2-0 antibacterial polydioxane suture (PDS), and the rear end is fixed to the bladder neck to ensure that the mesh is laid flat; the front end of the sling mesh is fixed to the anterior segment of the urethra with 2-0 antibacterial polydioxane suture (PDS). The anterior vaginal wall was sutured with 2-0 absorbable sutures, and the mesh exposing the groin was removed.

[0063] This invention relates to a urethral mesh for female urinary incontinence and moderate pelvic organ prolapse. It is specifically designed for cases of stress urinary incontinence and moderate pelvic organ prolapse, including POP grade II and III stress urinary incontinence with significant anterior vaginal wall mobility, recurrent urinary incontinence, and cases requiring anterior wall mesh implantation after cervical transection where the anterior vaginal wall is short. It provides support to the urethral apex, preventing anterior pelvic organ prolapse. Simultaneously, it reconstructs the bladder neck and posterior urethra, and strengthens support in the mid-urethra. It is particularly suitable for patients with significant urethral mobility, widened vaginal cleft, recurrent cases, and short anterior vaginal walls. The implanted mesh ensures flatness, effectively guaranteeing tension-free suspension of the mid-urethra and proper placement and flattening of the sling mesh during surgery, providing effective suspension support area, thereby improving the cure rate and reducing the incidence of complications.

[0064] The above description is only a preferred embodiment of the present invention. It should be noted that those skilled in the art can make several improvements and additions without departing from the method of the present invention, and these improvements and additions should also be considered within the scope of protection of the present invention.

Claims

1. A urethral mesh for female urinary incontinence and moderate pelvic organ prolapse, characterized in that, The urethral mesh includes a central support piece, a first wing, and a second wing. The first and second wing pieces are used to establish a connection with the pubic bone. One end of the central support piece has the first wing piece, and the other end has the second wing piece. The lower edges of the first, second, and central support pieces are aligned. The upper edge of the central support piece extends outward relative to the first and second wing pieces, increasing its width and extending the force-bearing surface from the mid-urethra to the bladder neck, simultaneously acting on the two "valves" of urethral control. The width of the central support piece is 4 cm. The center of gravity of the urethral mesh is located below the centerline between the first and second wing pieces, thus the support point of the urethral mesh is mainly posterior, ensuring support for the apex of the urethra, preventing anterior pelvic organ prolapse, simultaneously completing the reconstruction of the bladder neck and posterior urethra, and strengthening the mid-urethral support. The intermediate support plate has a first and a second pre-set mesh fixing line at its upper edge and a third and a fourth pre-set mesh fixing line at its lower edge. All four pre-set mesh fixing lines are fixed to the intermediate support plate by passing through it. The first and third pre-set mesh fixing lines correspond to each other. A fifth intermediate marker traction line is positioned between the first and second pre-set mesh fixing lines. A sixth intermediate marker traction line is positioned between the third and fourth pre-set mesh fixing lines. The widths of the first and second wing pieces are equal. The length of the first wing piece is less than the length of the second wing piece.

2. The urethral mesh according to claim 1, characterized in that, The first wing, the second wing, and the intermediate support piece are integrally formed.

3. The urethral mesh according to claim 1, characterized in that, The width of both the first and second winglets is 2cm.

4. The urethral mesh according to claim 1, characterized in that, The urethral mesh is made of polypropylene.

5. The urethral mesh according to claim 1, characterized in that, The extended portion of the intermediate support piece is narrower at the top and wider at the bottom.

6. The urethral mesh according to claim 1, characterized in that, The No. 1, No. 2, No. 3, No. 4, No. 5, and No. 6 intermediate marker traction lines all use 2-0 antibacterial polydioxane wire.

7. The urethral mesh according to claim 1, characterized in that, The No. 1, No. 2, No. 3, No. 4, No. 5, and No. 6 intermediate marker traction lines all have two free ends.

8. The urethral mesh according to claim 1, characterized in that, The urethral mesh further includes transverse braided wires, longitudinal braided wires, a first oblique braided wire, and a second oblique braided wire; the longitudinal braided wire is fixed at both ends of the transverse braided wire; the transverse braided wires are distributed in a parallel and spaced manner; the first oblique braided wire and the second oblique braided wire fix the transverse braided wire and / or the longitudinal braided wire together from different directions; the transverse braided wire, the longitudinal braided wire, the first oblique braided wire, and the second oblique braided wire form a polygonal hole structure.

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