Transvaginal lifting device for pelvic organ prolapse

Abstract

A transvaginal lift device includes a speculum having an upper blade and a lower blade. The upper blade and the lower blade are elongated, each having a leading end and a trailing end. Further, the upper and lower blades are attached at the rear end such that the two blades move between a closed position and an open position. Specifically, the upper blade has an opening / window configured to allow prolapsed tissue to protrude through the opening / window into an interior portion of the speculum. The suturing instrument comprises a puncture needle sleeve and a suture. The stapling instrument is attached to the speculum. Further, the stapling instrument is configured to place a suture in prolapsed tissue protruding through the opening / window.

Description

Technical Field

[0001] The present invention relates generally to medical devices and, in particular, to medical devices for inspecting, positioning, suturing, repairing, and tensioning tissue. Background Art

[0002] In a Women's Health Initiative study, researchers found that the prevalence of pelvic organ prolapse during standard physical examinations in postmenopausal women over 60 who had not undergone hysterectomy was 41%. In the United States alone, approximately 300,000 surgeries are performed each year to correct pelvic organ prolapse, costing more than $1 billion.

[0003] Non-surgical treatments for this condition include the use of vaginal pessaries for diagnosis and treatment. Pessaries are commonly used to relieve symptoms of prolapse and stress urinary incontinence. They offer a lower cost than surgery for treating pelvic organ prolapse. However, in up to 30% of cases, pessaries are not properly fitted. Furthermore, 25% to 40% of patients treated with this approach experience no relief from pelvic organ prolapse symptoms. Therefore, a method and device for treating pelvic organ prolapse that is more effective and less costly than the aforementioned methods and devices is desirable.

[0004] Embodiments of the present invention provide such methods and apparatus for treating pelvic organ prolapse.These and other advantages of the present invention, as well as additional inventive features, will be apparent from the description of the invention provided herein. Summary of the Invention

[0005] Embodiments of the present invention relate to a medical device, and more particularly to a vaginal speculum device, which is designed to lift and prepare prolapsed tissue for suturing with a device designed to repair vaginal prolapse. The suturing device and vaginal speculum are used together to dilate the vagina, create a vacuum through an opening in the speculum to expose a specific portion of the vaginal prolapse, and perform suturing and tensioning of the prolapse using different types of sutures with anchors or implants with anchors. The purpose of the vaginal speculum is to dilate the vagina and prepare the tissue for repair by the suturing device (by deploying the sutures or implants along the vaginal wall inside the prolapsed tissue). The anchors are attached to the sutures or implants, or are part of the sutures or implants. Once the sutures with anchors or implants with anchors are placed inside the prolapsed tissue, the sutures or implants are pulled to tension the tissue and lift the folds of the prolapsed tissue so that the correct, natural vaginal morphology is restored. The sutures, implants, and anchors may be permanent implants or may be made of bioabsorbable materials that will be absorbed after the prolapsed tissue is corrected. Furthermore, the suture or implant may be made of a material with or without elastomeric properties.

[0006] In one aspect, the present invention provides a medical device comprising two main instruments or devices. The first device is a suturing instrument; and the second device is a speculum, which is specifically designed to lift tissue and prepare it for repair, and to support the suturing instrument in a specific and desired position during the suturing process. The structure of these two elements is designed to provide safe, effective and standardized suturing. More specifically, the speculum has features designed to position prolapsed tissue in a specific position, prepare prolapsed tissue for repair, and control and standardize the placement of puncture needle cannulas and sutures. As shown below, the speculum is designed so that it can be fixed in a specific position to lift tissue, position tissue in the opening or window of the speculum blades, prepare tissue for repair, and allow precise and repeatable suturing.

[0007] In particular, the first and second devices are designed to be used together to repair pelvic organ prolapse. Suturing instruments can have different configurations depending on the type of suture used in the instrument and the suturing technique to be used. Some configurations deploy the suture during needle insertion, while other configurations insert the needle and deploy the suture upon needle withdrawal. The invention is not intended to limit the different suturing configurations and techniques that can be developed and performed using the device.

[0008] As will be explained below, embodiments of the transvaginal lifting device may include a low-cost, disposable or reusable speculum that works in conjunction with a suturing instrument to dilate the vaginal area and perform suturing through an innovative window and vacuum system located on the upper leaf portion of the speculum to address the problem of accessing the prolapsed tissue and standardizing its position. The size of the window is not limited because it can be adjusted to repair different levels of prolapsed tissue. In a specific embodiment, the speculum includes two interconnected vanes or blades. In certain embodiments, the speculum has an adjustment screw so that the vanes or blades can be opened and fixed in a specific open position (i.e., so that the amplitude of the opening remains unchanged) to dilate the vagina to observe the condition of the vaginal prolapse through the innovative opening / window located on the upper leaf portion of the speculum. In addition, in some embodiments, the speculum has a vacuum system to ensure that the tissue is pulled into the window and is ready for repair.

[0009] In another aspect, the present invention provides a transvaginal lifting device comprising a speculum having an upper blade and a lower blade. The upper blade and the lower blade are attached to a rear end that allows movement, so that the blades move between a closed position and an open position. In addition, in certain embodiments, the upper blade has a window that is configured to allow prolapsed tissue to protrude into the interior portion of the speculum through the window. The suturing instrument includes an internal puncture needle cannula. As described below, some embodiments include an external propulsion cannula and suture for tensioning the tissue. The suturing instrument can be attached to the speculum. In addition, the suturing instrument is configured to place suture in the prolapsed tissue that protrudes through the opening / window.

[0010] In certain embodiments, the lifting device has a vacuum system to pull the prolapsed tissue into the window and position it in a specific position to be repaired, and a syringe or compressed air can be used to create the vacuum. In a specific embodiment, the vacuum system is located in the upper blade with the opening / window, while in an alternative embodiment, the vacuum system is located between the upper blade and the lower blade, or in the opening / window. When in the upper blade, the vacuum system can include a speculum cover attached to the upper blade. The speculum cover is configured to provide a vacuum seal at the position where it is attached to the upper blade. In addition, the vacuum system can be adjustable or removable relative to the speculum.

[0011] In a particular embodiment, the suturing instrument includes an external propulsion cannula with a puncture needle cannula disposed therein, the external propulsion cannula being configured to support the tissue during the tensioning step while the suture or implant is tensioned. In certain embodiments, the external propulsion cannula has a handle for manually manipulating the external propulsion cannula. Additionally, in some embodiments, the suturing instrument includes an internal push rod disposed within the puncture needle cannula that is configured to deploy the anchor and suture or implant during the procedure.

[0012] In certain embodiments, the inner push rod has a handle for manually manipulating the inner push rod. In other embodiments, the puncture needle cannula and the inner push rod are configured to deploy a suture or implant having one or more attached anchors for tensioning the prolapsed tissue. The one or more anchors can be cylindrical or spherical to facilitate insertion into and deployment from the puncture needle cannula. In other embodiments, the one or more anchors can each be made of one or more wires. An alternative embodiment of the transvaginal lifting device includes a puncture needle cannula and an inner push rod configured to deploy a suture having one or more knots along its length. The one or more knots are used for tensioning the prolapsed tissue.

[0013] In addition, the puncture needle cannula may also include a handle for manually manipulating the puncture needle cannula. In a more specific embodiment of the present invention, the speculum includes a handle to control the opening and closing of the upper and lower blades. In addition, the speculum handle may include an adjustment screw configured to fix the amplitude of the open position of the upper and lower blades.

[0014] The shape and size of the window can vary. In certain embodiments, the window is rectangular, while in alternative embodiments, the window is circular or oval, and in more specific embodiments, the window is adjustable to improve positioning and access to prolapsed tissue. In some embodiments of the lifting device, the speculum includes a lighting element, which can be an LED lighting element. In more specific embodiments, the lighting element is battery powered.

[0015] The shape, size, and pressure of the vacuum system as part of the speculum can vary. In certain embodiments, the vacuum system can be located in the upper blade to ensure that the tissue is drawn into the window, and the element that creates the vacuum can be adjusted and removed as needed, while in alternative embodiments, the vacuum system is located between the blades or in the window, and in more specific embodiments, the vacuum system is adjustable, removable, or used during the suturing process to ensure that the tissue is positioned in the correct position and to ensure precise penetration of the tissue.

[0016] In yet another embodiment, the speculum includes a guide for securing the position of the puncture needle cannula. The guide can be attached to the upper blade of the speculum. In a specific embodiment, the guide has an opening through which the puncture needle cannula is positioned or inserted. In a more specific embodiment, an external pusher cannula can be inserted through the guide opening, and the internal pusher rod is internal to the puncture needle cannula.

[0017] The suture or implant can include one or more anchors for tensioning the prolapsed tissue. Furthermore, the one or more anchors can be formed in a variety of shapes, with the particular shape depending on the suturing application and the technique used. Furthermore, the suture or implant can be made of absorbable or non-absorbable materials, and can be made of elastomeric or non-elastomeric materials.

[0018] Other aspects, objects and advantages of the present invention will become more apparent from the following detailed description taken in conjunction with the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] The accompanying drawings, which are incorporated in and form a part of the specification, illustrate several aspects of the invention and, together with the description, serve to explain the principles of the invention. In the drawings:

[0020] Figure 1 is a perspective view of a transvaginal lifting device having a speculum with an upper window and an assembled suturing instrument according to one embodiment of the present invention;

[0021] Figure 2 is a side view of a transvaginal lifting device according to one embodiment of the present invention, including an enlarged view of a speculum, the transvaginal lifting device being used with a suturing instrument and a puncture needle cannula passed through the speculum;

[0022] Figure 3 is a perspective view of a speculum for use with a suturing instrument and a puncture needle cannula extending through the speculum; and

[0023] Figure 4 is a plan view showing various parts of a transvaginal lifting device according to one embodiment of the present invention;

[0024] Figure 5Ais a rear view of a speculum constructed in accordance with one embodiment of the present invention;

[0025] Figure 5B is a perspective view of a speculum constructed in accordance with one embodiment of the present invention;

[0026] Figure 6 is an exemplary embodiment of a suturing device according to one embodiment of the present invention, wherein the suture is assembled inside the cannula of the puncture needle;

[0027] Figure 7 is an alternative embodiment of a suturing device according to one embodiment of the present invention, wherein the suture is assembled inside the cannula of the puncture needle;

[0028] Figure 8 is a perspective view of a transvaginal lifting device with a push rod according to one embodiment of the present invention;

[0029] Figure 9 An exemplary suturing or implant device according to one embodiment of the present invention is shown;

[0030] Figure 10 Another exemplary suturing or implant device according to one embodiment of the present invention is shown;

[0031] Figure 11 shows a rear view of a speculum including a vacuum system using a syringe according to one embodiment of the present invention;

[0032] Figure 12 shows a side view of an embodiment component removed from a speculum for creating a vacuum inside an upper blade according to an embodiment of the present invention;

[0033] Figure 13 is a plan view showing an exemplary arrangement of a speculum according to one embodiment of the present invention, wherein a vacuum system is provided between an upper blade and a lower blade;

[0034] Figure 14 is a plan view showing an exemplary arrangement of a speculum according to one embodiment of the present invention, wherein the vacuum system is provided in an opening / window in the upper blade; and

[0035] Figure 15 is a plan view illustrating an exemplary arrangement of a speculum according to an embodiment of the present invention, wherein a vacuum system uses compressed air to create a vacuum.

[0036] While the invention will be described in conjunction with certain preferred embodiments, it is not intended to be limited to those embodiments. On the contrary, the intention is to cover all alternatives, modifications, and equivalents included within the spirit and scope of the invention as defined by the appended claims. DETAILED DESCRIPTION

[0037] Embodiments of the invention disclosed herein include a transvaginal lifting device that can be used to treat two conditions: pelvic organ prolapse and stress urinary incontinence. As will be explained in detail below, the transvaginal lifting device is used in conjunction with a unique, improved speculum that provides lighting and support for precise suturing. In some embodiments, the improved speculum has specific guides for standardized needle placement. As will be explained below, this improved speculum provides visibility and freedom to suturing at specific points and in a standardized manner using the speculum. Therefore, this will demonstrate that the transvaginal lifting device is a cost-effective device that reduces the risks and surgical time of treating pelvic organ prolapse or stress urinary incontinence.

[0038] Figure 1 is a perspective view of a transvaginal lifting device 100 showing a speculum 102 having an opening / window 104 assembled to a stapling instrument 110, according to one embodiment of the present invention. Figure 2 is a side view of the transvaginal lifting device 100 when used with the stapling instrument 110 and the puncture needle cannula 112 through the speculum 102, and shows an enlarged view of the speculum 102, and Figure 3 is a perspective view of a speculum 102 in use with a stapling instrument 110 and an introducer needle cannula 112 passing through the speculum 102, according to one embodiment of the present invention. Figure 5A and Figure 5B Shown are a rear view and a perspective view, respectively, of a speculum 102 constructed in accordance with one embodiment of the present invention.

[0039] Figure 11 and Figure 12 1 and 2 are rear and side views, respectively, of the speculum 102, including a vacuum system 142 in the upper blade 106 of the speculum 102. In certain embodiments, the vacuum system 142 uses a syringe 144 to create the vacuum. In alternative embodiments, compressed air is used to create the vacuum. Figure 12 , the speculum cover 148 is also shown before it is attached to the upper blade 106. In operation, the syringe 144 is coupled to the tube 146, which is connected to the opening into the interior space of the upper blade 106 (as defined by the upper blade 106 and the attached speculum cover 148) so as to create a suction or pulling force at the opening / window 104 into the interior space.

[0040] The speculum 102 has an upper blade 106 (which includes the aforementioned opening or opening / window 104), a lower blade 108, and a handle 116 with a vacuum system 142. The upper blade 106 and the lower blade 108 are connected at the rear ends of the two blades 106, 108. The two blades 106, 108 are movable relative to the rear ends of the aforementioned connection. The blades 106, 108 are used to expand and close the vagina, so that a diagnostic channel is formed between the two blades 106, 108, and the prolapsed tissue is pulled into the opening / window 104 using the vacuum system 142 located in the upper blade 106. In the embodiment shown, the upper blade 106 and the lower blade 108 are attached at the rear ends so that the two blades 106, 108 move between a closed position and an open position. In an alternative embodiment, the vacuum system 142 is located between the upper blade 106 and the lower blade 108 or in the opening / window 104.

[0041] In an alternative embodiment, for example Figure 13 , which is a plan view of a transvaginal lifting device 100 having a vacuum system 142 disposed between the upper blade 106 and the lower blade 108. In the illustrated embodiment, the vacuum system 142 includes a vacuum chamber 152 extending from the upper blade 106 to the lower blade 108. The vacuum chamber 152 has an opening that coincides with the opening / window 104. In addition, the vacuum chamber 152 has an airtight seal with the upper blade 106, most likely at or near the perimeter of the opening / window 104. Figure 13 As shown, a tube 146 for drawing air from the vacuum chamber 152 may be connected to the proximal end of the vacuum chamber 152. The end of the tube 146 opposite to the end connected to the vacuum chamber 152 may be connected to a syringe 150 (see Figure 11 ) or compressed air vacuum device.

[0042] Figure 14 is a plan view of the transvaginal lifting device 100 showing another alternative embodiment in which the vacuum system 142 is positioned at the opening / window 104. In this embodiment, a smaller vacuum chamber 154 ( Figure 13 The vacuum chamber 152 is mainly limited to the upper blade 106. Figure 14 As shown, a tube 146 for drawing air from the vacuum chamber 154 may be connected to the middle portion of the vacuum chamber 154. The end of the tube 146 opposite to the end connected to the vacuum chamber 154 may be connected to a syringe 150 (see FIG. Figure 11 ) or compressed air vacuum device.

[0043] Figure 15is a plan view of a transvaginal lifting device 100 having a vacuum system 142 generated using a compressed air system. The vacuum system 142 includes a venturi tube 158 (i.e., a tube having a short, relatively narrow center portion and relatively wide end portions). One end of the venturi tube 158 is connected to a compressed air source 160. The vacuum system 142 may also include Figure 13 and Figure 14 Any of the vacuum chambers 152, 154 shown in FIG, or Figure 11 and Figure 12 The vacuum chamber shown in . Figure 15 In the vacuum system of FIG. 1 , a venturi tube 158 is coupled to a vacuum chamber in the upper vane 106 via a tube 146, which is also coupled to a relatively narrow center portion of the venturi tube 158. A compressed air source 160 provides an air flow to an inlet 162 of the venturi tube 158. As the air flows through the venturi tube 158 through the narrow center portion toward an outlet 164, a vacuum is created, which creates suction in the vacuum chamber of the upper vane 106 via the tube 146.

[0044] In the embodiment shown, the upper blade 106 and the lower blade 108 are elongated and slightly curved. The upper blade 106 and the lower blade 108 shown are convex or outwardly curved so that even when the two blades 106, 108 are in a closed position, that is, when the two blades 106, 108 are in contact or are at their closest distance along the entire length of the blades 106, 108, an internal space is created between the blades 106, 108. The stapling instrument 110 operates within this internal space. Although the lengths of the two blades 106, 108 can be approximately equal, in the embodiment shown, the lower blade 108 is slightly longer than the upper blade 106 with the vacuum system 142, however, in alternative embodiments, the situation may be the opposite.

[0045] In addition, the upper blade 106 with the vacuum system 142 has an opening / window 104 designed to draw and approximate the prolapsed tissue. In the illustrated embodiment, the opening / window 104 is rectangular, however, it is contemplated that in other embodiments, the opening / window 104 is circular or oval. In a particular embodiment, the lower blade 108 has an adjustment screw 114 that sets the amplitude of the open position of the speculum 102. In a particular embodiment, tightening the adjustment screw 114 sets the position of the upper blade 106 and the lower blade 108 so that the position of the upper blade 106 with the vacuum system 142 relative to the lower blade 108 does not change, and the distance between the front ends of the two blades 106, 108 is fixed and constant.

[0046] In other embodiments, the upper blade 106 and / or the lower blade 108 with the vacuum system 142 include lighting elements to enhance visibility for the surgeon. The lighting elements may be LEDs or similar energy-efficient light sources. In certain specific embodiments of the present invention, the lower blade 108 is provided with a lighting element to provide illumination for the surgeon to facilitate medical procedures. In certain embodiments, the lighting element is powered by a battery in the speculum handle 116 or in one of the blades 106, 108.

[0047] Figure 4 is a plan view showing various portions of a transvaginal lifting device 100 having a speculum 102 and a stapling instrument 110 according to one embodiment of the present invention. Figure 6 is an exemplary embodiment of a suturing device 110 according to one embodiment of the present invention, wherein the suture 118 is assembled inside the puncture needle cannula 112. Figure 4 and Figure 6 As can be seen in FIG, the medical suturing instrument 110 has a puncture needle cannula 112 and a puncture needle cannula handle 126, an external pusher cannula 120 and an external pusher cannula handle 124, an inner pusher rod 122 and an inner pusher rod handle 128, and a suture 118.

[0048] The medical suturing device 110 functions by tensioning the vaginal wall using a suture or implant 118 to reduce vaginal prolapse. The transvaginal lifting device 100 deploys and tensions the suture or implant 118. Depending on the system configuration, the suture 118 can be deployed during insertion of the needle cannula 112 or upon withdrawal from the cannula 112. The implanted suture or implant 118 is biocompatible (bioabsorbable, non-absorbable, elastomeric, or non-elastomeric). The suture 118 is preassembled within the cannula 112 and freely passes inside or outside the cannula 112. The suture 118 may have knots, beads, or variously shaped anchors 138 along its length to improve tension on the vaginal wall, and these knots, beads, or anchors 138 operate to tension or adjust the prolapsed tissue, with the knots, beads, or anchors 138 positioned at both the proximal and distal ends to maintain tension.

[0049] The shape of the anchor 138 can vary depending on the specific suturing technique or application being used. For example, the anchor 138 can be cylindrical or spherical like the bead 138. In this manner, the bead 138 is simply a specific type of anchor 138. The anchor 138 is not limited to these shapes; however, a cylindrical or spherical anchor 138 can be easily moved through the tubular introducer cannula 112 when deployed using the inner push rod 122. The anchor or knot 138 (knot / bead) can be placed along the entire length of the suture 118 or only at the distal and proximal ends of the suture 118.

[0050] exist Figure 6 In the configuration of the present invention, the lifting device 100 is activated by inserting the puncture needle cannula 112 through a guide 130 included in the speculum 102. In the embodiment shown, the guide 130 is formed on the inner surface of the rear end of the upper blade 106. The guide 130 (at Figure 5A and Figure 5B ) has an opening 132 (also shown in Figure 5A and Figure 5B ), the introducer needle cannula 112 (along with the inner push rod 122 and suture 118 disposed within the introducer needle cannula 112) is inserted through the opening 132 to ensure that the suturing element is correctly positioned to pass through the exposed / prolapsed tissue. Figure 11 and Figure 12 In the embodiment shown, prolapsed tissue is drawn into the opening / window 104 at a specific location by the vacuum system 142. Figure 11 and Figure 12 In an embodiment, a syringe 144 is used to create a vacuum.

[0051] As shown, syringe 144 is coupled to tube 146, which is connected to guide 130. Speculum cover 148 is attached to upper blade 106 and provides a vacuum seal where it is attached to upper blade 106. In the illustrated embodiment, the vacuum seal is located at the bottom and rear portions of upper blade 106. However, in alternative embodiments, tube 146 can be coupled to any opening that accesses the interior space between upper blade 106 and speculum cover 148. Thus, when plunger 150 is removed from syringe 144, suction is generated at opening / window 104 to pull the prolapsed tissue into the opening, allowing it to be sutured and / or anchored to repair the prolapsed tissue. This reduces the risk of inadvertently puncturing other organs during the suturing process. An external push cannula 120 can also be inserted through opening 132. In this way, speculum 102 provides the necessary support in the form of guide 130 to hold and secure or place suture 118 in a specific position, thereby standardizing the placement of suture 118. Figure 6 The embodiment of FIG. 1 shows a suture 118 having a knot or spherical anchor / bead 138 for tensioning or tensioning prolapsed tissue.

[0052] During use of the lifting device 100, the puncture needle cannula 112 is inserted into the prolapsed tissue that has protruded due to vacuum or gravity through the opening / window 104 of the speculum 102. The puncture needle cannula 112 first penetrates the prolapsed tissue at the proximal end 134 of the opening / window 104 until it emerges from the tissue at the distal end 136 of the opening / window 104. Figure 6As shown, a portion of the suture 118 positioned outside of the introducer cannula 112 may be free of the knot or bead 138. During insertion of the introducer cannula 112 through the prolapsed tissue, the outer portion of the suture 118 rests on the outer surface of the introducer cannula 112. After the introducer cannula 112 is removed and the proximal knot or anchor 136 is deployed, this outer portion of the suture 118 typically remains in the tissue.

[0053] The needle cannula 112 is manually manipulated and inserted into the tissue using the needle cannula handle 126. The inner push rod 122 is used to initially deploy one or more anchors or knots 138 at the distal end of the needle cannula 112 to tension that end of the prolapsed tissue. The inner push rod handle 128 is used to manually manipulate the inner push rod 122. The needle cannula 112 is then further inserted until it is fully inserted and reaches the distal end 136 of the opening / window 104 of the speculum 102. After the needle cannula 112 is inserted, the inner push rod 122 is used to deploy the suture 118 and any knots or anchors 138 at the distal end. Following this deployment, the user can rotate the needle cannula handle 126 to increase the size of the knot 138 in the suture 118. After deploying the distal anchors 138, the needle cannula is removed from the prolapsed tissue.

[0054] When the puncture needle cannula 112 and the inner push rod 122 are removed, the external push cannula 120 is used to support the tissue. In addition, the external push cannula 120 is used in vivo to tension the suture 118 in the prolapsed tissue, which can be aspirated as described above. This can be achieved with the help of a push rod 140 at the distal end of the external push cannula 120 to secure and support (via suction or gravity) the prolapsed tissue during the tensioning process. Figure 8 An embodiment of the lifting device 100 is shown that includes a push rod 140. Once suturing is complete, the outer pusher sleeve 120 is removed and the anchor or knot 138 is designed to support tension and create a lifting line that tensions and lifts the prolapsed tissue.

[0055] As described above, the suturing components of the lifting device 100 function in different ways and in many different configurations. All methods and configurations rely on the speculum 102 to dilate the vagina. When the speculum 102 is used to dilate the vagina, an opening / window 104 in the speculum 102 with a vacuum system 142 draws in and exposes excess or prolapsed tissue. Figure 7 is an alternative embodiment of suturing apparatus 110 according to one embodiment of the present invention, wherein suture 118 is assembled inside introducer needle cannula 112 .

[0056] exist Figure 7In the illustrated configuration, the lifting device 100 is activated by inserting the introducer cannula 112 through a guide 130 included in the speculum 102. As described above, the guide 130 ensures that the introducer cannula 112 passes through the exposed prolapsed tissue. The introducer cannula 112 is inserted through the tissue proximal end 134 near the window 104 of the speculum 102. An inner push rod 122 and a suture 118 with a designated number of anchors or knots 138 are preassembled inside the introducer cannula 112. When the introducer cannula 112 is fully inserted and reaches the distal end 136 of the opening / window 104, the inner push rod 122 deploys the suture 118 with the distal anchor or knot 138 at the distal end 136. The introducer needle cannula 112 and inner push rod 122 are then removed, leaving the suture 118 within the tissue and allowing the proximal anchor or knot 138 to be deployed at the proximal end 134 of the opening / window 104 .

[0057] When the puncture needle cannula 112 and the inner push rod 122 are removed, the outer push cannula 120 is used to support the tissue. In addition, the outer push cannula 120 remains in the vagina to lift and tension the tissue. Finally, the outer push cannula 120 is removed and the anchor or knot 138 is designed to support the tension and create a lifting line that tensions and lifts the prolapsed tissue.

[0058] In any of the above configurations, the delivery system for the suture 118 is a puncture needle cannula 112 (e.g., having different sizes ranging from 80 mm to 200 mm) having an internal push rod 122 for deploying the suture 118, and an external push cannula 120 for advancing and tensioning the tissue. The external push cannula 120 is manually manipulated using an external push cannula handle 124. The lifting device 100 contains a quantity of suture 118 (e.g., bioabsorbable or non-absorbable), which is placed inside the vaginal wall using the puncture needle cannula 112 and then pulled to tension and lift the prolapsed vaginal wall.

[0059] During the procedure, the puncture needle cannula 112, holding a suture 118, is inserted along the target area. One end of the suture 118 is carefully anchored to a more robust underlying structure, while the other end of the suture 118 is guided along a predetermined path into the interior of the vaginal wall until the suture 118 reaches the desired endpoint. When the puncture needle cannula 112 is withdrawn, the suture 118 and the anchor 138 contained therein are effectively embedded in the vaginal wall. During the procedure, the surgeon can pull and rotate the puncture needle cannula 112 to improve the elevation of the prolapsed tissue, allowing the tissue to be positioned in a tensioned, more elevated position.

[0060] Typically, sutures or implants 118 vary depending on type and brand, being either bioabsorbable or nonabsorbable, elastomeric or non-elastomeric. Placed within the vaginal wall, sutures or implants 118 induce a mild inflammatory response, leading to collagenization and increased blood circulation. Thus, a scaffold is formed in the vaginal wall region, maintaining tension in the vaginal wall. If sutures 118 are absorbable, the collagen produced after the absorption process is responsible for improving or lifting the vaginal wall.

[0061] Figure 9 and Figure 10 An exemplary suture arrangement slightly different from that described above is shown. Figure 9 In the arrangement of FIG. 1 , the suture 118 has a series of attached cylindrical anchors 138 that are staged within the introducer cannula 112. In the embodiment shown, the cylindrical anchors 138 are placed end to end so that they fill the entire introducer cannula 112. However, it is also contemplated that some arrangements will have the cylindrical anchors 138 more numerous than the cylindrical anchors 138. Figure 9 are shown spaced further apart.

[0062] Figure 9 The top image shows the introducer needle cannula 112 prior to insertion through the aspirated / prolapsed tissue. Figure 9 The middle image shows the needle cannula 112 after being inserted through the prolapsed tissue. The inner push rod 122 is used to deploy one or more cylindrical anchors 138 at the distal end. After deployment, the cylindrical anchor 138 (which is attached to the suture 118 at the center portion of the cylinder) is slightly rotated so that the circular wall of the cylinder abuts the prolapsed tissue. Figure 9 The bottom image shows the puncture needle cannula 112 after it has been removed from the prolapsed tissue. Anchor 138 is deployed at the proximal end and cooperates with the distal anchor 138 to tension the prolapsed tissue. Figure 9 As shown, after suturing, a plurality of anchors 138 remain within the prolapsed tissue.

[0063] exist Figure 10 In the arrangement of the present invention, the suture 118 has a series of cylindrical anchors 138 attached in stages within the puncture needle cannula 112, similar to Figure 9 In the embodiment shown, the cylindrical anchors 138 are also placed end to end so that they fill the entire introducer needle cannula 112. However, as mentioned above, it is contemplated that some arrangements will have the cylindrical anchors 138 smaller than the cylindrical anchors 138. Figure 10 shown in . But with Figure 9 different, Figure 10 The suture arrangement includes a portion of suture 118 located outside of introducer needle cannula 112 , the portion having one or more attached knots or beads 138 .

[0064] Figure 10The top image shows the introducer needle cannula 112 prior to insertion through the prolapsed tissue. Figure 10 The middle image shows the puncture needle cannula 112 after being inserted through the prolapsed tissue. The inner push rod 122 is used to deploy one or more cylindrical anchors 138 at the distal end. As shown, there will also be one or more knots or beads 138 at the outer surface of the distal end of the prolapsed tissue. Figure 10 The bottom image shows the puncture needle cannula 112 after it has been removed from the prolapsed tissue. The anchor 138 is deployed proximal to the prolapsed tissue and cooperates with the distal anchor 138 to tension the prolapsed tissue. The distal knot or bead 138 also helps to tension the distal prolapsed tissue. Figure 10 As shown, after suturing, the plurality of anchors and knots / beads 138 remain within the prolapsed tissue.

[0065] Another possible suturing arrangement not shown in the drawings but contemplated by one of ordinary skill in the art involves the use of one or more wires attached to the suture 118 to serve as anchors. Figure 9 and Figure 10 , the attached wires 138 can be connected end to end in stages within the introducer needle cannula 112. After insertion into the introducer needle cannula 112, the one or more wires 138 are deployed distally. After exiting the introducer needle cannula 112, the one or more wires 138 attached to the suture 118 at the central portion of the wires 138 are slightly rotated, as with the cylindrical anchors 138, so that the entire length of the wires 138 abuts the prolapsed tissue.

[0066] All references, including publications, patent applications, and patents, cited herein are hereby incorporated by reference to the same extent as if each reference were individually and specifically indicated to be incorporated by reference and were set forth in its entirety herein.

[0067] In the context of describing the present invention (particularly in the context of the following claims), the use of the terms "a" and "an" and "the" and similar indicators should be interpreted as covering the singular and plural, unless otherwise stated herein or clearly contradictory with the context. Unless otherwise stated, the terms "comprise", "have", "include" and "contain" should be interpreted as open terms (that is, meaning "including but not limited to"). Unless otherwise stated herein, the enumeration of numerical ranges herein is only intended to be used as a shorthand method for individually referring to each individual value falling into the scope, and each individual value is incorporated into the specification as if it is individually quoted in this article. Unless otherwise stated herein or clearly contradictory with the context, all methods described herein can be performed in any suitable order. The use of any and all examples or exemplary languages ​​(e.g., "such as") provided herein is only intended to better illustrate the present invention, and unless otherwise required, the scope of the present invention is not limited. Any language in the specification should not be interpreted as indicating that any unclaimed element is necessary for the practice of the present invention.

[0068] Preferred embodiments of the present invention are described herein, including the best mode known to the inventor for carrying out the present invention. After reading the foregoing description, variations of those preferred embodiments will be apparent to those of ordinary skill in the art. The inventors expect that the skilled person will adopt such variations where appropriate, and the inventors intend to practice the present invention in a manner different from that specifically described herein. Therefore, the present invention includes all modifications and equivalents of the subject matter described in the appended claims as permitted by applicable law. Furthermore, unless otherwise indicated herein or clearly contradicted by context, the present invention encompasses any combination of the above-mentioned elements in all their possible variations.

Claims

1. A transvaginal lifting device comprising: a speculum having upper and lower blades, each of the upper and lower blades being elongated with a front end and a rear end, the upper and lower blades being attached to the rear end such that the blades move between a closed position and an open position, and wherein the upper blade has an opening / window configured to allow prolapsed tissue to protrude through the opening / window into an interior portion of the speculum; A suturing instrument having a puncture needle cannula and a suture, wherein the suturing instrument is attached to the speculum, the suturing instrument being configured to place the suture in the prolapsed tissue protruding through the opening / window.

2. The transvaginal lifting device according to claim 1, wherein The stapling instrument includes an external pusher cannula, the puncture needle cannula is disposed inside the external pusher cannula, and the external pusher cannula is configured to support the prolapsed tissue during a tension adjustment step.

3. The transvaginal lifting device according to claim 2, wherein: The outer propulsion sheath has a handle for manually manipulating the outer propulsion sheath.

4. The transvaginal lifting device according to claim 1, wherein The suturing instrument includes an inner push rod configured to be inserted into the puncture needle cannula, and the inner push rod is configured to deploy the suture during suturing of the prolapsed tissue.

5. The transvaginal lifting device according to claim 4, wherein: The inner push rod has a handle for manually operating the inner push rod.

6. The transvaginal lifting device according to claim 4, wherein: The introducer needle cannula and inner push rod are configured to deploy the suture having one or more attached anchors for tensioning of the prolapsed tissue.

7. The transvaginal lifting device according to claim 6, wherein: The one or more anchors are cylindrical or spherical in shape.

8. The transvaginal lifting device according to claim 6, wherein: The one or more anchors are each made of one or more metal wires.

9. The transvaginal lifting device according to claim 4, wherein: The introducer needle cannula and inner push rod are configured to deploy the suture having one or more knots therein along its length, the one or more knots being used for tensioning of the prolapsed tissue.

10. The transvaginal lifting device according to claim 1, wherein The puncture needle cannula has a handle for manually manipulating the puncture needle cannula.

11. The transvaginal lifting device according to claim 1, wherein The speculum includes a handle to control the opening and closing of the front ends of the upper blade and the lower blade.

12. The transvaginal lifting device of claim 1, further comprising a vacuum system assembled to the speculum, the vacuum system configured to pull the prolapsed tissue through the opening / window.

13. The transvaginal lifting device according to claim 12, wherein: The vacuum system is located in the upper blade having the opening / window.

14. The transvaginal lifting device of claim 12, wherein: The vacuum system includes a speculum cover attached to the upper blade, the speculum cover being configured to provide a vacuum seal at the location where the speculum cover is attached to the upper blade.

15. The transvaginal lifting device of claim 12, wherein: The vacuum system is located between the upper and lower blades.

16. The transvaginal lifting device of claim 12, wherein: The vacuum system is located in the opening / window.

17. The transvaginal lifting device of claim 12, wherein: The vacuum system may be adjustable or removable relative to the speculum.

18. The transvaginal lifting device of claim 12, wherein: The vacuum system uses a syringe to create the vacuum.

19. The transvaginal lifting device of claim 17, wherein: The syringe is coupled via a tube to an opening into the upper blade.

20. The transvaginal lifting device of claim 1, wherein The speculum handle includes an adjustment screw configured to fix the amplitude of the open position of the upper and lower blades.

21. The transvaginal lifting device of claim 1, wherein: The speculum includes an illumination element.

22. The transvaginal lifting device of claim 21, wherein The lighting element is powered by a battery.

23. The transvaginal lifting device of claim 1, wherein: The speculum includes a guide for fixing the position of the puncture needle cannula.

24. The transvaginal lifting device of claim 18, wherein The guide is attached to the upper blade.

25. The transvaginal lifting device of claim 18, wherein The guide has an opening through which the puncture needle cannula is inserted.

26. The transvaginal lifting device of claim 20, wherein: The guide has an opening through which the outer propulsion cannula is inserted.

27. The transvaginal lifting device of claim 20, wherein: The guide has an opening through which the inner push rod is inserted.

28. The transvaginal lifting device of claim 1, wherein The sutures may be made of absorbable or non-absorbable, elastomeric or non-elastomeric material.

Images