prosthesis

Abstract

This invention relates to a prosthesis. In particular, a prosthesis for repairing a hernia is disclosed. In some embodiments, the prosthesis includes a patch body (22), a frame (34) to help unfold the patch body from a reduced configuration to an expanded configuration, and a plurality of tethers (302) attached to the patch body at a location between the frame and the periphery of the patch body. In various embodiments, the tethers can be tensioned to reduce curling or wrinkling in the patch body, thereby flattening the patch for easy attachment to tissue.

Description

[0001] This application is a divisional application of the application filed on September 18, 2018, with application number 201880065801.2 (international application number PCT / US2018 / 051460) and entitled "Repairing and Reducing Prosthetic Curvature". Technical Field

[0002] An implementation method for reducing prosthesis curling has been disclosed. Background Technology

[0003] A hernia is an opening or weakness in tissue or muscle wall, such as the abdominal wall. One method of repairing a hernia is to cover the tissue or muscle wall defect with a patch made of repair fabric or mesh. This patch can be placed during open surgery or through minimally invasive procedures, such as laparoscopic techniques.

[0004] In laparoscopic hernia repair, the patch can be rolled up and delivered through a narrow cannula to the treatment site. After laparoscopic deployment, an elastic support member, such as an elastic frame, associated with the patch expands it into an enlarged, deployed configuration. The expanded patch, including the elastic support member, is then secured to the tissue or muscle wall located on the defect using sutures, U-shaped staples, pins, and / or other fixation elements. For example, such fixation elements can be applied to healthy tissue surrounding the defect around the patch's boundary area and / or at other locations. In some cases, the prosthesis may include a central tether attached to the frame, the free end of which can be pulled through the abdominal wall to outside the patient's body. Continued pulling of the central tether causes the frame and the associated patch body of the prosthesis to be biased upward against the abdominal wall. Biasing the prosthesis against the abdominal wall facilitates holding the prosthesis in place during fixation. Summary of the Invention

[0005] In one embodiment, a prosthesis for repairing a hernia defect may include a patch body with a periphery and a frame attached to the patch body. The frame facilitates the expansion of the patch body from a reduced configuration to an extended configuration. The prosthesis also includes a main tether extending away from the patch body and a plurality of tethers attached to the main tether, wherein each tether extends from the main tether to an attachment location positioned radially outward of the frame for attachment to the patch body. Pulling the main tether in a direction away from the patch body tensions the plurality of tethers.

[0006] In another embodiment, the prosthesis for repairing a hernia defect includes: a patch body having a periphery; a frame attached to the patch body that facilitates the unfolding of the patch body from a reduced configuration to an expanded configuration; and a plurality of tethers. The plurality of tethers are attached to the patch body at locations between the frame and the periphery of the patch body, or at locations between the frame and the periphery of the patch body. At least two of the plurality of tethers are located on opposite sides of the patch body.

[0007] In another embodiment, the prosthesis for repairing a hernia defect is applied as follows: The prosthesis, in a reduced configuration, is delivered through an opening into the patient's body, wherein the prosthesis includes a patch body with a periphery. The patch body is then expanded into an extended configuration around the hernia defect using a frame attached to it. The main tether is then pulled in a direction away from the patch body to tension the plurality of tethers attached to the patch body at locations between the frame and the periphery of the patch body.

[0008] In another embodiment, the prosthesis for repairing a hernia defect is applied as follows: The prosthesis, in a reduced configuration, is delivered through an opening into the patient's body, wherein the prosthesis includes a patch body with a periphery. The patch body is then expanded into an extended configuration around the hernia defect using a frame attached to it. A plurality of tethers attached to the patch body are then pulled at a location between the frame and the periphery of the patch body, or at a location between the frame and the periphery of the patch body. At least two of the tethers are located on opposite sides of the patch body.

[0009] It should be understood that the foregoing concepts and the additional concepts discussed below can be arranged in any suitable combination, as this disclosure is not limited in this respect. Furthermore, other advantages and novel features of this disclosure will become apparent from the following detailed description of various non-limiting embodiments when considered in conjunction with the accompanying drawings. Attached Figure Description

[0010] The accompanying drawings are not intended to be drawn to scale. In the drawings, each identical or nearly identical component illustrated in various figures may be indicated by similar labeling. For clarity, not every component is labeled in every drawing. In the drawings:

[0011] Figure 1A A top view of the prosthesis and guide is shown during the process of rolling up the prosthesis for insertion in a reduced configuration;

[0012] Figure 1B A top view of the reconstructive prosthesis and guide in a rolled-up configuration is shown;

[0013] Figure 2 A perspective view of the repaired prosthesis after it has been rolled up and expanded into an extended configuration is shown;

[0014] Figure 3A A top perspective view of a restorative prosthesis including a curling relief system according to one embodiment is shown;

[0015] Figure 3B It shows including Figure 3A A three-dimensional view of the prosthesis repaired by the curling relief system;

[0016] Figure 4 A top right perspective view shows an embodiment of a prosthesis including a curling relief system;

[0017] Figure 5 A top left perspective view of another embodiment of a restorative prosthesis including a curling relief system is shown;

[0018] Figure 6 The top right perspective view shows an embodiment of a prosthetic prosthesis, which includes a curling relief system and a frame with separate movable parts.

[0019] Figure 7A A schematic cross-sectional view of an embodiment of a prosthesis including a curling relief system before tensioning is shown;

[0020] Figure 7B It shows Figure 7A A schematic cross-sectional view of the reconstructive prosthesis after tensioning.

[0021] Figure 8 A top left perspective view of another embodiment of a prosthesis including a curl-off relief system with adjustable tension is shown;

[0022] Figure 9 It shows Figure 8 A schematic cross-sectional view of the curling mitigation system;

[0023] Figure 10 This is a schematic cross-sectional view of the tether attached to the prosthesis using a knot;

[0024] Figure 11 It is a schematic cross-sectional view of the tether attached to the prosthesis using a resiliently release coil fastener; and

[0025] Figure 12 This is a schematic cross-sectional view of the tether attached to the prosthesis via sutures.

[0026] It should be understood that aspects of the invention have been described herein with reference to certain illustrative embodiments and accompanying drawings. The illustrative embodiments described herein are not necessarily intended to illustrate all aspects of the invention, but are intended to describe some illustrative embodiments. Therefore, in view of the illustrative embodiments, aspects of the invention are not intended to be interpreted narrowly. Furthermore, it should be understood that aspects of the invention can be used alone or in any suitable combination with other aspects of the invention. Detailed Implementation

[0027] In minimally invasive surgical techniques, and in certain open surgeries, the size of prosthetic prostheses, including those with a patch body, can be reduced to facilitate delivery to the treatment site. For example, in laparoscopic surgery, the prosthesis may be rolled into a cylindrical shape or otherwise folded into a smaller, reduced configuration suitable for passage through a cannula to the surgical site. However, the prosthesis, once expanded into its expanded configuration, may exhibit curling, wrinkling, and / or other surface irregularities of the patch body. The amount of curling, wrinkling, and / or other surface irregularities can be attributed to numerous variables, including, but not limited to, the material, thickness, size, and shape of the patch and associated frame, and the diameter to which the prosthesis is reduced during delivery to the surgical site. In either case, the inventors have recognized that reducing the amount of curling, i.e., flattening the unfolded prosthesis, can help ensure proper contact between the prosthesis and adjacent tissues.

[0028] In view of the foregoing, the inventors have anticipated that when a prosthesis is expanded from a reduced configuration to an expanded configuration via an associated frame, it may be desirable to reduce or eliminate curling and / or other surface irregularities of the patch body of the prosthesis. Specifically, the inventors have recognized the benefits associated with a prosthesis comprising a plurality of tethers connected to different portions of the patch body of the prosthesis located between the associated frame and the outer periphery of the patch body. As described in detail below with respect to specific embodiments, the tension of these tethers can help the surgeon reduce or eliminate the presence of curling and other surface irregularities of the patch body of the prosthesis. In some embodiments, these tethers can also be used to assist in positioning the prosthesis during use. Thus, the patch body of the prosthesis can remain relatively taut and / or flat against the tissue surface, which facilitates fixation of the prosthesis to the tissue.

[0029] In one embodiment, the prosthesis includes a patch body and a frame attached to the patch body. The frame assists in expanding the patch body from a reduced configuration, such as a rolled-up configuration, to an expanded configuration, in which the prosthesis is attached to tissue after delivery to the surgical site. The prosthesis may include at least two tethers connected to different portions of the patch body. In some embodiments, the at least two tethers are attached to diametrically opposed portions of the patch body located on either side of the center of the patch body. The tethers may also be attached to the patch body at a location between the frame and the outer periphery of the patch body. Thus, once the patch body is positioned against a tissue surface including a defect—such as a hernia in the abdominal wall—the user can tension two or more tethers to reduce any curling or wrinkling of the patch body before securing the prosthesis to the tissue.

[0030] Although only two tethers are mentioned above, any number of tethers can be used. Alternatively, various tethers can include pairs of tethers positioned diametrically opposite each other on opposite portions of the patch body. Alternatively, multiple tethers can simply be spaced apart around any portion of the patch body or around the entire perimeter of the patch body. Therefore, it should be understood that any number of tethers can be used, and tethers can be attached at any desired location along the perimeter of the patch body, as this disclosure is not limited thereto.

[0031] In some embodiments, it may be desirable to have a single master tether that can be manipulated to reduce curling of the prosthesis during deployment, instead of manipulating multiple individual tethers sequentially or simultaneously. Similar to the embodiments described above, in some embodiments, the prosthesis may include at least two tethers attached to opposite portions of the patch body at locations between the outer periphery of the patch body and the associated frame to which it is attached. The tethers extend in an inwardly pointing direction from the periphery of the patch body toward the inner portion of the patch body—and in some embodiments toward the center of the patch body. The ends of individual tethers or the ends of the single master tether to which individual tethers are attached may extend through openings formed in the frame and / or patch body. Thus, individual tethers or master tethers can be pulled through these openings to tension at least two tethers, which, due to the presence of the frame, applies forces and / or torques to bias the patch body into an uncurled or flattened configuration.

[0032] In the above embodiments, it may be desirable to have a tethering device that allows the user to selectively adjust the amount of tension of each tether applied to the prosthesis, and thus adjust the anti-coiling force applied to different portions of the patch body of the prosthesis. In one such embodiment, the tethers extend from the periphery of the patch body toward and through an opening in the frame and / or patch body of the prosthesis. The tethers may include stops located on either side of the opening to allow adjustment of the tension of each tether within a range defined by the position of the stops along the length of the tether. In some embodiments, the two tethers may be formed from a single piece of material including two independent pairs of associated stops. In such an embodiment, the tether including a first pair of stops located on either side of the opening may form a loop extending rearward through the opening, wherein a second pair of stops is located on either side of the opening. That portion of the tether is then connected to the opposite portion of the patch body. Due to the presence of the two pairs of stops, the tension and / or displacement of the two tethers can be adjusted individually within the range defined by the stops.

[0033] In some embodiments, it may be necessary to keep the prosthesis abutting against the tissue surface to which it is to be secured. In one such embodiment, the prosthesis may include a main tether or central tether attached to the frame and / or patch body of the prosthesis. In use, the user may use a suture threader or other suitable device to capture the main tether and pull it through the patient's tissue to keep the prosthesis abutting against a tissue surface, such as the abdominal wall. In some embodiments, the main tether may be formed by a plurality of other separate tethers. In any of the above embodiments, the ends of the main tether and / or the separate tethers attached to the patch body may be used to keep the prosthesis abutting against the tissue while simultaneously applying tension to the separate tethers. This configuration can advantageously allow the surgeon to adjust the amount of tension applied to the tethers by manipulating the ends of the main tether or the separate tethers located outside the patient to help position and flatten the prosthesis. However, it should be understood that a main tether separate from the separate tethers attached to the patch body may also be used, as this disclosure is not limited thereto.

[0034] In some embodiments, it may be desirable to increase the area where forces are applied to the prosthesis to reduce curling. In one such embodiment, the prosthesis may include multiple extensions, i.e., tethers extending from separate tethers used to apply forces to the patch body of the prosthesis to reduce curling. These extensions may be attached to the patch body at different locations along its periphery, between the frame of the prosthesis and the periphery of the patch body. When forces are applied to the separate tethers, the associated extensions will apply forces to the patch body at each location to which the extensions are attached. Thus, the extensions apply the required force to a larger portion of the patch body, which may allow for the use of fewer tethers to provide the required amount of curl reduction for the prosthesis.

[0035] The inventors also anticipate that in some applications, a frame removable from the patch body of the prosthesis can be desired. For example, in some embodiments, sutures can be used to connect the frame and the patch body. The sutures can be cut at one or more locations such that the frame can be pulled away from the patch body. Alternatively, the sutures can be sufficiently weak or can be modified to include one or more localized weaknesses that will fail when sufficient tension is applied. In a separate embodiment, the frame can be adhered to the patch body with a relatively weak adhesive such that, after the patch body is attached to the tissue, the frame can be peeled off from the patch body by a peeling force. In another embodiment, the frame and / or patch body can be releasably engaged with each other. In one such arrangement, the patch body can include one or more slits that releasably receive corresponding portions of the frame, such as protrusions received in the slits, from which the protrusions can be pulled out when sufficient force is applied to the frame. In yet another embodiment, a flexible coil fastener can be used to attach the frame to the patch body such that, when sufficient force is applied, the flexible fastener deforms and disengages from the patch body, thereby releasing the frame. Of course, while several attachment methods have been listed, other removable attachment methods can also be considered.

[0036] In some applications, it may also be desirable to include removable tethers in the prosthesis. In such embodiments, the tethers can be attached to the patch body of the prosthesis in a manner similar to that described above for removable frames, including but not limited to adhesives, sutures, weakened sutures that break under tension, deformable fasteners, and other suitable types of attachment. For example, after the patch body is secured, the non-absorbable tether can be removed from the subject's body by cutting the attachment point with a surgical cutter, pulling the tether to break the weakened sutures, and / or pulling the tether to remove one or more associated removable fasteners. In specific embodiments, the tethers can be attached to or otherwise secured to flexible coil fasteners, which are in turn inserted into the patch body. These flexible coil fasteners can have an extended linear configuration when tensioned, which facilitates release of the flexible coil fasteners from the patch body. The flexible coil fasteners can also have a retracted coil configuration when not tensioned to retain the tethers on the patch body. Therefore, after the prosthesis has been properly positioned and attached to the tissue, the tether can be selectively removed.

[0037] While removable frames and / or tethers have been described above, embodiments in which the frames and / or tethers of a particular prosthesis are absorbable have also been considered. In such embodiments, the frames and / or tethers of the prosthesis can remain in the subject's body and will be absorbed over time.

[0038] In some embodiments, the frame may be a thin, flat fabric structure having a bottom surface and a top surface, and at least one of the top and bottom surfaces may have a substantially flat shape. In one embodiment, the bottom surface of the frame faces the patch body and may have a flat shape, while the top surface may have a curved profile. In other embodiments, walls may be located between the long edges of the top and bottom surfaces of the frame. The frame may also be solid. The frame may be formed of any suitable material, including but not limited to nylon, other synthetic polymers, and natural materials. The frame may also be flexible to allow it to fold to the desired size and shape when the assembled patch body and frame are rolled up or otherwise reduced in size for minimally invasive delivery.

[0039] The various tethers described herein can be made of any biocompatible, absorbable or non-absorbable elongated material, including, for example, sutures, fabrics, meshes, polymer films, threads, cables, combinations of the above materials, and / or any other suitable elongated planar or filament-type materials. Possible non-absorbable materials include, but are not limited to, polypropylene, nylon, polyester, polyvinylidene fluoride (PVDF), filaments, or metal wires such as stainless steel or titanium alloys. Absorbable materials include, but are not limited to, various polyethylene glycols, gut, polyglactins, and vicryl.

[0040] In some embodiments described herein, the use of a main tether and individual tethers attached to the patch body of the prosthesis is described. However, it should be understood that these main tethers and individual tethers can be provided in any number and manner. For example, in one embodiment, the main tether is a single tether attached to a separate individual tether, which is directly attached to the patch body or indirectly attached to the patch body using an intermediate component or material. Alternatively, in another embodiment, the main tether can be integrally formed with the individual tethers. In one such embodiment, the ends of the main tether can split to form individual tethers extending from the main tether to their attachment points with the patch body. In yet another embodiment, the free ends of the individual tethers can be braided, tied, or otherwise gathered together to form a main tether from which the individual tethers extend. In view of the foregoing, it should be understood that various arrangements of tethers, main tethers, and other similar structures can be individually connected components, or various arrangements of tethers, main tethers, and other similar structures can be integrally formed, as this disclosure is not limited thereto.

[0041] It is conceivable that some implementations could utilize tethers coated or treated with compounds to increase their biocompatibility or impart additional functionality. For example, the tether could be coated with anti-adhesive or antibacterial materials to mitigate potential postoperative complications.

[0042] The thickness and length of the tether used with a particular prosthesis can vary based on the size and type of the prosthesis used for a particular surgical procedure. However, suitable tether thicknesses include, but are not limited to, thicknesses between 0.01 mm and 1 mm, between 0.01 mm and 0.8 mm, between 0.02 mm and 0.7 mm, or equal to these thicknesses, or any other suitable thickness.

[0043] The tether can also be attached to the patch body using any suitable method, including but not limited to knots, stitches, adhesives, solder joints, coil fasteners, nails and / or any other suitable attachment method.

[0044] For clarity, the various embodiments described herein are described in conjunction with prosthetic devices for repairing hernias, particularly abdominal hernias. However, this disclosure is not necessarily limited thereto and can be used in other patch systems for other hernias, other soft tissue or muscle wall defects, and in other types of surgical or medical treatments. Regarding the repair of abdominal hernias, the tethering system and patch body can be placed intraperitoneally, preperitoneally, retromuscularly, or in other anatomical spaces, as this disclosure is not limited thereto. For ease of understanding, the prosthesis is described in conjunction with laparoscopic surgery for applying the prosthesis; however, the disclosed device can be used in other minimally invasive surgeries, open surgeries, or other techniques for repairing hernias or other soft tissue defects, as this disclosure is not limited thereto.

[0045] In the various embodiments described herein, the prosthesis may include a patch body having a first side portion intended for positioning against a tissue or muscle wall, such as the abdominal wall, which includes a defect. The first side portion of the patch body may be configured for inward tissue growth. In some applications, opposing sides of the patch may be positioned adjacent to an organ, such as the intestine or other viscera, and may therefore include a barrier, such as a barrier material layer or barrier coating, to prevent adhesion between that side of the patch and the organ.

[0046] The patch body can be formed from a porous material such as a knitted, woven, or non-woven fabric, or can include solid, substantially non-porous, or microporous materials. The patch body can be formed from one or more layers of the same or different materials, and these layers can be stacked one on top of another, side-to-side, or a combination of both stacking arrangements. The patch body can form tissue-infiltrate portions and other portions with less tissue-infiltrate or no tissue-infiltrate, thereby providing different tissue-in-growing and anti-adhesion properties to selected areas of the repair device. The patch body can be formed from permanent materials, reabsorbable materials, or a combination of permanent and reabsorbable materials. It should be understood that the patch body can be formed from any synthetic or natural biocompatible material suitable for repairing tissue or muscle wall defects, as will be apparent to those skilled in the art.

[0047] According to embodiments, the patch body may comprise only a tissue-infiltrate layer, only a solid or non-tissue-infiltrate layer, or a combination of tissue-infiltrate and non-tissue-infiltrate aspects located in the same layer. Additionally, various components may be described as being positioned on one side or the other side of the patch body. However, the disclosed embodiments are not limited to any particular side of the patch body. Therefore, it should be understood that the various components described herein can be located on any side of the patch body, as this disclosure is not limited thereto.

[0048] Turning to the accompanying drawings, specific non-limiting embodiments are described in further detail. It should be understood that the various systems, components, features, and methods described with respect to these embodiments can be used individually and / or in any desired combination, as this disclosure is not limited to the specific embodiments described herein.

[0049] Various techniques can be used to reduce the size of the prosthesis to a smaller configuration suitable for delivery through narrow openings—such as via a laparoscopic cannula. Figure 1A and Figure 1B In one embodiment shown, the guide 10 may include a patch receiving area defined by two fork-shaped members 12, with a portion of the patch body positioned between the two fork-shaped members 12. The patch body is then rolled up around the fork-shaped members of the guide to receive the prosthesis as shown. Figure 1B The reduced configuration shown is then placed. The prosthesis can then be inserted into the cannula of the medical device for delivery.

[0050] After the prosthesis has been inserted through the cannula and expanded within the body cavity, the material forming the prosthesis, i.e. the frame and / or patch body, may have a tendency to curl at least partially in the direction of material curling, or may form permanent wrinkles or curls due to a rolling tool that folds the mesh toward the front surface of the patch. Figure 2 An enlarged example of the patch body 22 of the prosthetic prosthesis, exhibiting curling and wrinkling, is shown. Wrinkles 23 appear at the position where the fork 12 of the guide 10 grasps the patch body to begin rolling it up for delivery. Individually, due to the curling, the edges of the patch body are curled upwards to form curls 21. As previously mentioned, the presence of this curling can make it difficult to secure the patch body 22 to the abdominal wall or other tissues. In embodiments where the patch body 22 is folded or otherwise reduced in size for delivery into the body, the patch body may also exhibit wrinkles or other topological defects.

[0051] Figure 3A and Figure 3BThis document details one embodiment of a prosthetic prosthesis 20 for repairing hernias or other soft tissue defects. The prosthetic prosthesis 20 may include a patch body 22 having a first surface or tissue-infiltrate side 24 arranged for inward tissue growth, and a second opposing surface or non-tissue-infiltrate side 26. A frame 34 may be arranged on the second surface 26 of the patch body 22. Additionally, two or more tethers 102 are attached to the patch body 22 at attachment points 104 located between the frame and the outer periphery of the patch body. The two or more tethers are attached to two opposing portions of the patch body, and in some embodiments, the tethers may be located on diametrically opposed sides of the central axis of the patch body. Although two tethers have been shown, in some embodiments, multiple tethers may be attached to the patch body at different locations extending around the periphery of the patch body between the frame and the periphery. As further detailed below, these tethers may be tensioned during surgery to position and / or reduce curling of the patch body.

[0052] As described above, the frame 34 can be arranged on the second surface 26 of the patch body 22. The frame can also be spaced inward from the periphery of the patch body and extend generally around the periphery of the patch body, such as... Figure 3A and Figure 3B As shown in the diagram. For example, frame 34 may include an outer frame component 38 that defines a generally open internal space 40 through which the patch body can be secured to the abdominal wall using fixation elements such as sutures, pins, U-shaped staples, or other devices. The frame may also include a crossbar 42 that extends across the open frame interior and connects to an opposite portion of the outer frame component. Alternatively or additionally, the crossbar 42 may connect to a portion 44 of the frame, where fasteners 62 connect the frame to the patch body and / or other portions of the frame. The frame may have a thin or reduced profile. For example, but not limited to, the frame may be in the form of a flat sleeve or sheet to minimize the overall thickness of the prosthesis when the frame is assembled in a reduced configuration to deliver through an opening such as a narrow incision or cannula to the treatment site. The frame may be a continuous component or may include two or more separate portions that may be continuous and / or spaced apart from each other.

[0053] In some embodiments, the main tether 46 may be attached to and extend from a central region of the frame 34. The free end 48 of the main tether may pass through the thickness of the patch body 22 such that the free end extends beyond the side of the patch body opposite the frame, through an opening 49 formed in the frame and / or patch body. In some cases, this opening may be a central opening formed through the frame. During surgery, a suture puller or other device may be used to pull the main tether through the abdominal wall or other tissues to the outside of the patient. A pulling force acting on the free end of the main tether in an outward direction away from the frame and patch body facilitates biasing of the frame and associated patch body toward the abdominal wall or other tissues and maintains contact between the patch body and the abdominal wall or other tissues.

[0054] In the above embodiment, after the prosthesis 20 has been delivered to the surgical site, the frame 34 expands the prosthesis from a reduced configuration to an expanded configuration. The user can then use a suture threader or other suitable tool to pull the main tether 46 outside the patient's body cavity. Once outside the body cavity, the main tether can be pulled to bring the frame 34 and patch body 22 into contact with the abdominal wall or other tissue. The user can then use a gripper or other suitable clamping device to tension one, two, or any number of tethers 102 as needed to position and / or tension the patch body 22, thereby reducing any curling or wrinkling of the prosthesis before securing the patch body to the abdominal wall or other tissue. With a single tether tensioned, the main tether 46 can help hold the patch body in the desired position. Therefore, even tensioning a single tether 102 can apply tension to the patch body, thereby helping to reduce curling of the prosthesis. With the patch body positioned flat against the abdominal wall or other tissue, surgical fasteners such as sutures, pins, U-bolts, or any other suitable components capable of securing the prosthesis to the tissue can be applied around the periphery of the patch body and / or within the opening of the frame inside the internal portion of the patch body. Once the patch body 22 of the prosthesis is securely fixed to the tissue, the frame 34 and tether 102 can be optionally separated from the anchored patch body and removed from the body cavity, as described in further detail below.

[0055] The depicted embodiment shows the tether 102 knotted between the periphery of the frame and the patch body at a diametrically opposed portion of the patch body. However, it should be understood that the tether can be attached in various ways and at various locations. For example, in some embodiments, the tether 102 is instead attached to the frame 34, or secured to the frame using suitable fasteners. In embodiments where the tether is attached to the frame, the tether can be sewn to the patch body such that the tether weaves in and out of the patch body as it extends radially outward from the frame to the edge of the patch body, wherein the end of the tether can hang freely from the edge of the patch body at that edge for easy manipulation. In these embodiments, tensioning the tether tensions the patch body between the edge and the location where the tether is attached to the frame.

[0056] In another embodiment, the tether 102 may be sewn to the patch body at a location at the periphery of the frame and the patch body, or at a location between the periphery of the frame and the patch body. The sewn portion of the tether may extend radially outward and may extend beyond the periphery of the patch body, as previously described. In some embodiments, the sewn portion of the tether may be attached to the frame of the prosthesis, and the sewn portion of the tether may extend radially outward from the frame. Alternatively, in another embodiment, the sewn portion of the tether may extend from a first portion of the patch body across the patch body to a radially opposite second portion of the patch body, wherein the free end of the tether extends from either sewn end to form two tethers located on opposite sides of the patch body. According to embodiments, the sewn portion of the tether may extend completely or only partially between the two opposite edges of the patch body. In embodiments where the tether extends across an inner portion of the patch body, the tether may not be attached to the frame.

[0057] Figure 4Another embodiment of the prosthesis 200 is shown. In this embodiment, two or more tethers 202 are attached to opposing portions of the patch body 22 at locations 204a and 204b between the frame 34 disposed on the patch body and the outer periphery of the patch body. The tethers may extend inward toward the inner portion or center of the patch body, wherein the tethers pass through an opening 49 formed in a portion of the frame, such that the tethers extend away from the patch body and the frame. Alternatively, individual tethers may be attached to a main tether 46 passing through the opening, and / or the main tether may be formed by individual tethers. According to an embodiment, the tethers and / or the main tethers may pass from the second non-tissue-infiltrating side 26 of the patch body through the patch body and / or the frame to the first tissue-infiltrating surface 24 of the patch body. Alternatively, the tethers and / or the main tethers extend away from the second non-tissue-infiltrating surface 26 of the prosthesis. In either case, the individual tethers and / or the main tether can be tensioned to apply tension to the portions of the tethers attached to the patch body, thereby applying force to the patch body and reducing curling present in the prosthesis. In embodiments where the main tether and / or the individual tethers extend from the tissue-permeable side of the patch body, a suture threader can be used to turn the main tether and / or the individual tethers to the outside of the surgical cavity to bias the prosthesis against the abdominal wall or other tissue and to apply tension to the tethers to decurve the prosthesis.

[0058] exist Figure 4 In the embodiments depicted, only a single pair of tethers 202 extends to opposite portions of the patch body, and in some embodiments, they extend to opposite, diametrically opposed portions of the patch body. However, in other embodiments, multiple pairs of tethers may be present extending between the same opposite point and the opening in the frame. For example, tethers in the form of elongated loops may extend between the opening and the attachment point to the patch body. In yet another embodiment, multiple tethers may be spaced apart around the perimeter of the patch body to allow force to be applied to the patch body at any number of locations, thereby helping to reduce curling.

[0059] In practice, after the prosthesis 200 is delivered into the patient's body, the user can use a suture threader or other suitable tool to pull the ends of the main tether 46 and / or individual tethers to the outside of the patient's body. Once outside the body cavity, the ends of the main tether 46 and / or individual tethers 202 can be pulled to bring the frame 34 and patch body 22 into contact with the abdominal wall or other tissue. Once in contact, the user can pull the ends of the main tether and / or individual tethers 202 to tension the appropriate tethers, thereby uncoiling or loosening the desired portion of the patch body. With the patch body positioned flat against the abdominal wall, the prosthesis 200 can then be secured to the tissue.

[0060] Figure 5Another embodiment of the restorative prosthesis 300 is shown, which applies force to a larger portion of the patch body 22 to reduce curling or wrinkling of the patch body. Figure 4 Similarly, two or more tethers 302 extend radially outward away from the main tether 46 and the opening 49 formed in the frame 34. Individual tethers may include two or more extensions 302 extending from the end of the tether and attaching at several anchor points 304 at locations between the frame and the outer periphery of the patch body. These extensions can increase the area of ​​the patch body where forces are applied to the patch body via the individual tethers. Thus, when the main tether 46 or an individual tether is pulled, the individual tethers and associated extensions can be tensioned to apply force to the patch body at each location where the extensions are attached to the patch body. Although only two extensions and tethers are depicted in the figures, it should be understood that any number of tethers and any number of extensions associated with each tether can be used, as this disclosure is not limited thereto.

[0061] In some implementations, it may be desirable to include a frame that is assembled after delivery to the surgical device to facilitate placement of the prosthesis in a reduced configuration. Figure 6 One such implementation is shown. Similar to... Figure 4 In one embodiment, the prosthesis 200 includes a frame 34 and a patch body 22. However, in the depicted embodiment, the frame 34 includes two or more crossbars 42 that are disconnected from each other. During use, these disconnected crossbars are connected to each other to strengthen the frame and help to expand the prosthesis into an expanded configuration. To facilitate the placement of the different crossbars together, the separate crossbars may include separate openings 49a and 49b. Individual tethers 202 and / or separate main tethers 46 may pass through these individual openings. Thus, when the main tethers and / or the individual tethers are tensioned in a given direction, such as in reducing curl and / or biasing the prosthesis against tissue with the central tether extending outside the patient, the separate portions of the frame, such as the separate crossbars, may be biased toward each other to expand the frame. This can help to unfold the patch body from a reduced configuration to an expanded configuration while tensioning the associated tethers to reduce curl.

[0062] Although the above is about Figure 6 Multiple main tethers are described, but in some embodiments, a single main tether separated near the patch body may pass through each of the orifices and be attached to the separate tethers, as this disclosure is not limited thereto.

[0063] Figure 7A and Figure 7B A cross-sectional view of the repair prosthesis during the curling relief process is shown. Figure 7AThe patch body 22 before curling relief is shown, as demonstrated by the curled portion 21. When the user pulls the free end 48 of the main tether 46, the individual tethers 302 attached at the anchor points 304 located between the outer periphery of the patch body and the frame are also tensioned. With the frame 34 keeping the central portion of the patch body relatively flat and rigid, an anti-curling force and / or torque is applied to the patch body at the anchor points 304 to pull the edges of the patch 22 downwards, at least partially removing the anti-curling force and / or torque of the curled portion 21, as shown. Figure 7B As shown in the image.

[0064] Figure 8 and Figure 9 Another embodiment of the prosthesis 400 is shown, which includes a system that can be used to adjust the tension of one or more tethers for relieving curling of the prosthesis. In this embodiment, a loop-shaped main tether 446 is used instead of a single main tether. The loop-shaped main tether 446 can extend through an opening 49 formed in the frame and / or patch body as described above. Individual tethers 402, attached to separate portions of the loop-shaped main tether, can then be attached to the patch body at locations between the periphery of the patch body and the frame. For example, in the depicted embodiment, the tether 402 extends from the opening and passes through the patch body 22 at a first location 404a, then extends back through the patch body 22 at a second location 404b and then returns to the opening 49. The two ends of the tethers extending through the opening can then be joined together to form the loop extending from the opening. Similar loop arrangements can also be used with other pairs of tethers. As described further in detail below, the ring device allows the user to grasp the ring and pull the entire loop-shaped main tether 446 to apply tension to the individual tethers. The user can then pull the separating portion of the ring to change the tension applied to the separate tethers, thereby applying different amounts of force and / or displacement to different sides of the patch body 22. The user can clamp or otherwise secure the tethers to maintain a desired level of tension and / or displacement. Alternatively, the orifices and tethers can be sized and shaped or otherwise configured to use, for example, friction to maintain the desired displacement and / or tension of the tethers.

[0065] like Figure 9 As best illustrated, the looped main tether 446 may include two or more stops, such as knots or beads of material, located on either side of the opening formed in the frame for connection to the loop. The stops prevent the looped main tether 446 from slipping through the opening 49. The stops may also be positioned along individual tethers to prevent the user from applying excessive tension and / or displacement to the tethers, thus helping to prevent relative curling around the patch body.

[0066] In practice, after the prosthesis 400 is delivered into the patient, the user can pull the looped main tether 446, which typically tensions the individual tethers 402. This action applies an uncurled force to the corresponding side of the patch 22. The user can then pull different sides of the loops associated with the different tethers to adjust the tension and / or displacement applied to the individual tethers. As described above, the stops 406 and 408 prevent the looped main tether from slipping through the prosthesis and / or applying a reverse curl to the patch body. Once the patch body has been flattened to the user's satisfaction, the patch body can then be secured to the abdominal wall or other tissues.

[0067] It should be understood that while embodiments including a looped main tether have been described, embodiments using separate main tethers and loops for tensioning individual tethers are also contemplated, as this disclosure is not limited thereto. For example, the main tether can still be used to bring the prosthesis into contact with the tissue, and the separate tether system and loop arrangement can allow the user to adjust the tension of the tethers. Additionally, while a stop associated with the looped main tether has been described, it should be understood that the stop can be associated with each individual tether such that the stop is located on either side of the hole through which the tether passes. Therefore, tension and / or displacement can be adjusted individually for each tether.

[0068] It should be understood that the various tethers described herein can be attached to the patch body in any number and manner. For example, Figure 10 One embodiment for anchoring a tether to the patch body 22 is shown. In this arrangement, the tether 502 passes through the patch body 22 at an anchoring point 504. The tether 502 is then knotted on both the first side 24 and the second side 26 of the patch body 22 to prevent slippage from either side. Alternatively, material beads for attaching to the tether can be used on either side of the patch body. Other types of attachment methods that can be used include, but are not limited to, stitching, adhesives, welds, mechanical fasteners such as coil fasteners and nails, and / or any other suitable method for attaching a tether to the patch body 22, as this disclosure is not limited thereto.

[0069] like Figure 11As observed, the tether 502 can be releasably attached to the patch body 22 via one or more flexible coil fasteners 62. In one embodiment, the coil fasteners have a relaxed configuration, such as a generally coiled configuration as shown, to hold the tether to the patch body. The coil fasteners can also have a loaded configuration, wherein the coil fasteners can become elongated and / or substantially straight when tensioned. When loaded in this manner, the coil fasteners can detach from the patch body. Thus, the flexible coil fasteners allow for selective attachment and release of the tether from the patch body. In some cases, the flexible coil fasteners can attach both the tether and the frame of the prosthesis to the patch body. For example, Figure 3A The frame 38 is shown connected to the patch body 22 via a coil fastener 62, which can be located anywhere along the frame, including at various portions 64 of the frame. Thus, a user can use a gripper or other laparoscopic instrument to grasp and pull the frame and / or tether away from the patch with force exceeding that required to relieve curling. In response to the pulling force, the coil fastener extends into a loaded or straight configuration (i.e., linear or substantially linear), allowing the coil fastener to slide out of the secured patch body, thereby releasing the frame and / or tether according to a particular implementation. The currently unattached tether and / or frame can then be easily removed from the surgical cavity through a minimally invasive opening, such as a laparoscopic cannula, a cannula needle, or a narrow incision, through which the assembled frame and patch were initially delivered to the surgical site.

[0070] Figure 12 Another embodiment for anchoring a tether to the patch body 22 is shown. In the depicted embodiment, the tether 502 is sewn to the patch body 22 such that the tether passes through and out of the patch body to form a sewn length of tether attached to the patch body. Similar to the embodiment described above, the end of the suture may include a knot to anchor the end of the tether to the patch body. Alternatively, different types of attachment methods may be used, or the tether may be sewn to the patch body using sutures that do not allow the tether to be pulled out of the patch body. In the case of using a loose form of suturing, the tether can be pulled out of the patch body to allow selective removal of the tether after the prosthesis has been unfolded.

[0071] The above description of various embodiments is intended to be illustrative only, and other embodiments, modifications, and equivalents are also within the scope of the invention as set forth in the appended claims.

Claims

1. A prosthesis comprising: a patch body having a perimeter; a frame attached to the patch body, wherein the frame assists in deploying the patch body from a reduced configuration to an expanded configuration, and wherein the frame comprises one orifice or two orifices; and a plurality of tethers, wherein the plurality of tethers are attached to the patch body at different locations extending around the perimeter of the patch body between the frame and the perimeter of the patch body, and wherein a portion of each tether of the plurality of tethers extends through at least one of the one orifice or the two orifices, wherein pulling the plurality of tethers in a direction away from the patch body tensions the patch body.

2. The prosthesis of claim 1, further comprising an adjustable ring that selectively adjusts tension of at least one tether of the plurality of tethers.

3. The prosthesis of claim 1, wherein, the plurality of tethers comprises at least two tethers attached to the patch body at attachment locations on opposite sides of the patch body.

4. The prosthesis of claim 1, wherein, the plurality of tethers are releasably attached to the patch body.

5. The prosthesis of claim 4, wherein, the frame is releasably attached to the patch body.

6. The prosthesis of claim 1, wherein, the one orifice or the two orifices are positioned radially inward relative to the attachment locations.

7. The prosthesis of claim 1, wherein, a first end of each tether of the plurality of tethers is connected to the patch body, and at least a portion of each tether of the plurality of tethers is connected together to form a main tether.

8. The prosthesis of claim 1, wherein, each tether of the plurality of tethers comprises a plurality of extensions attached to the patch body, wherein the plurality of extensions extend from the associated tether of the plurality of tethers in different directions radially outward.

9. The prosthesis of claim 1, wherein, the frame comprises at least two frame portions, and wherein pulling the plurality of tethers biases the two frame portions toward each other to expand the frame and assist in deploying the patch body from a reduced configuration to an expanded configuration.

10. The prosthesis of claim 1, wherein, the plurality of tethers comprises a material selected from the group consisting of suture, fabric, mesh, polymeric film, cable.

11. The prosthesis of claim 1, wherein, the two orifices comprise a first orifice and a second orifice, wherein a portion of a first tether of the plurality of tethers extends through the first orifice, and wherein a portion of a second tether of the plurality of tethers extends through the second orifice.

12. The prosthesis of claim 1, wherein, the plurality of tethers comprises a material selected from a wire.

13. A prosthesis comprising: a patch body having a perimeter; a frame attached to the patch body, wherein the frame assists in deploying the patch body from a reduced configuration to an expanded configuration, and wherein the frame comprises one orifice or two orifices; and a plurality of tethers, wherein the plurality of tethers are attached to the patch body at different locations extending around the perimeter of the patch body between the frame and the perimeter of the patch body, and wherein a portion of each tether of the plurality of tethers extends through at least one of the one orifice or the two orifices, wherein pulling the plurality of tethers in a direction away from the patch body tensions the patch body. a plurality of tethers attached to the patch body at attachment locations between the frame and a perimeter of the patch body, wherein at least two of the plurality of tethers are on opposite sides of the patch body, and wherein a portion of each tether of the plurality of tethers extends through at least one of the one aperture or the two apertures, wherein pulling the plurality of tethers in a direction away from the patch body tensions the patch body.

14. The prosthesis of claim 13, wherein, The plurality of tethers are releasably attached to the patch body.

15. The prosthesis of claim 14, wherein, The frame is releasably attached to the patch body.

16. The prosthesis of claim 13, wherein, The plurality of tethers are evenly distributed along a perimeter of the patch body.

17. The prosthesis of claim 13, wherein, The plurality of tethers comprise a material selected from the group consisting of: sutures, fabric, mesh, polymeric film, cable.

18. The prosthesis of claim 13, wherein, The plurality of tethers are sutured on the patch body.

19. The prosthesis of claim 13, wherein, The plurality of tethers comprise a material selected from a thread.

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