Bidirectional barbed suture with custom suture segments
By designing a multifunctional suture, combining multiple suture segments and connection segments, the problem of requiring multiple sutures during surgery is solved, and surgical efficiency and flexibility of tissue layer closure are improved.
Patent Information
- Application Number
- CN202080047701.4
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- Priority Date
- 2019-06-28
- Filing Date
- 2020-06-12
- Publication Date
- 2025-03-25
- Estimated Expiration
- 2040-06-12
AI Technical Summary
During the surgery, surgeons need to select multiple sutures or wound closure devices according to different tissue layers, resulting in an increase in closure time and thus prolong the surgery and anesthesia time.
A multifunctional suture is provided, including multiple suture segments with different configurations and characteristics, connected by connection segments or transition zones to form a bidirectional wound closure device, which can be used for multi-layer tissue closure.
The device enables surgeons to close multiple tissue layers at a time using one device, improving surgical efficiency, reducing the time the patient is in anesthesia, and reducing the use of packaging materials.
Smart Images

Figure CN114206232B_ABST
Abstract
Description
Background Art
[0001] Many wounds and surgical incisions are closed using surgical sutures or some other wound closure devices. For example, surgeons can use sutures, barbed sutures, etc. to close wounds or surgical incisions. Typically, in surgical operations, surgeons need to use a variety of sutures or wound closure devices to close wounds or surgical incisions according to the different tissue layers that are part of the wound or surgical incision. For example, the surgeon may need to select a suture or wound closure device with a first set of characteristics such as appropriate size, length, material, construction (such as barbs), needle characteristics, antibacterial properties, etc. based on a given tissue layer of the wound or surgical incision being closed, and select another suture or wound closure device with a different set of characteristics for another tissue layer of the wound or surgical incision being closed. Unfortunately, having to select and use a variety of sutures or wound closure devices during surgery may increase the time required for closing a wound or surgical incision, thereby increasing the time of the operation itself, the time when the patient is in an anesthetized state, etc. Summary of the invention
[0002] Sutures for approaching tissues can be provided. In an example, a suture may include a plurality of suture segments having the same or different suture segment configurations, so that a bidirectional wound closure device for multiple functions or multi-layer tissue closure can be produced. For example, a suture includes suture segments such as a first suture segment and a second suture segment. In an example, the suture segments may be made of a thermoplastic material such as polydioxanone (PDS). The suture segments may have a suture configuration. For example, a first suture segment may have a first suture configuration and a second suture segment may have a second suture configuration. Suture configurations such as a first suture configuration and a second suture configuration may be the same or different. In an example, suture segments such as a first suture segment and a second suture segment may be interconnected by a connecting segment or a transition zone (e.g., a joining member).
[0003] In an example, one or more of the suture segments and their configurations may include a knotless tissue control device or a barbed suture. Typically, a barbed suture is configured to have a series of "barbs," "protrusions" (e.g., interchangeably used herein) extending outwardly from a filament or thread-like element of the suture (e.g., to form a suture segment). These barbs or protrusions are used to increase the fixing strength of the suture and / or eliminate the need for knotting. In an example, the barbs may be made of a thermoplastic material (e.g., absorbable and / or non-absorbable) such as PDS.
[0004] In addition, in an example, one or more of the suture segments may include an anchor, a tab, etc. at its end. Anchors, tabs, etc. may provide a "stop" (e.g., a stop element) at the end, which may increase the fixing strength of the suture and further eliminate the need for knotting to fix the suture. Anchors, tabs, etc. may be made of thermoplastic materials (e.g., absorbable and / or non-absorbable) such as PDS. In addition, anchors, tabs, etc. may provide a transition zone or a connecting segment between the suture segments. For example, each of the anchors, tabs, etc. at the end of each of the suture segments (e.g., the first stop element and the second stop element at the end of the corresponding first suture segment and the second suture segment) may be joined together to form a connecting segment or a transition zone between the suture configurations. According to an example, radio frequency (RF) energy or other appropriate energy sources, heat sources, etc. may be used to join anchors, tabs, etc. together, thereby joining the suture segments together and forming a connecting segment or a transition zone.
[0005] Thus, according to examples herein, two or more sutures or suture segments or legs (e.g., barbed and / or non-barbed suture segments or legs) having different materials (e.g., absorbable or non-absorbable polymers), sizes, lengths, anchor geometries, needles, properties (e.g., antimicrobial properties), configurations (e.g., monofilament or multifilament), etc., can be joined by a lamination or welding process. In such examples, each resulting segment or leg of the suture can be individually customized to have the appropriate set of features required to perform a specific tissue closure, which may be different for each segment or leg of the device. For example, one segment may include a barbed suture that may be symmetrical, made of PDS, undyed, and of a specific size (e.g., 3-0), and another segment or leg may include a barbed suture that may be symmetrical, made of PDS, dyed, and of the same size (e.g., 3-0). In other examples, a suture segment may include a combination of type (e.g., barbed and / or unbarbed), material (e.g., absorbable or non-absorbable polymer), size, length, anchor geometry, needle, properties (e.g., antimicrobial properties), construction (e.g., monofilament or multifilament), etc.
[0006] A wound closure or suturing device with multiple suture segments as described herein can enable a surgeon to close multiple tissue layers and / or complete multiple tasks at once using one device. In addition, a wound closure or suturing device as described herein can enable multiple surgeons to suturing simultaneously, which, for example, can increase efficiency and / or reduce the amount of time a patient may be under anesthesia.
[0007] In addition, the exemplary wound closure or suturing devices described herein can reduce the amount of packaging material. For example, as described herein, multiple wound closure devices can be used to close different tissue layers, and each of those devices can be in its own packaging. In the examples herein, wound closure devices that can be customized for a patient can be packaged together to reduce the amount of packaging material.
[0008] Additionally, the equipment and tools may limit the length of a suture segment in a wound closure device. Exemplary wound closure devices and methods or processes for producing the same or different suture segments may enable the length of the same or different suture segments to be longer than currently available suture segments. For example, a lamination process or method for producing a wound closure device as described herein may enable the total length of a bidirectional chain or device to be, for example, up to twice the maximum length of a single chain without having to invest in equipment or tools to produce an integrally formed bidirectional chain of the same length or features. BRIEF DESCRIPTION OF THE DRAWINGS
[0009] Figure 1 A wound closure device according to at least one example herein is shown.
[0010] Figure 2 Shows Figure 1 An enlarged view of a portion of a wound closure device.
[0011] Figure 3 For example, before forming the connecting section Figure 1 Exploded view of a stop element of a wound closure device.
[0012] Figure 4 Shows Figure 1 Top view of a connecting segment of a wound closure device.
[0013] Figure 5A-Figure 5B Shows Figure 1 Cross-section of a connecting segment of a wound closure device.
[0014] Figure 6A-6B They are shown respectively Figure 1 Perspective and side views of a connecting segment of a wound closure device.
[0015] Figure 7 Another example of a wound closure device and connecting segments thereof according to examples herein is shown.
[0016] Figure 8 Another example of a wound closure device and connecting segments thereof according to examples herein is shown.
[0017] Figure 9-11 For example, before forming the connecting section Figure 8 An exploded view of a stop element and / or tab of a wound closure device.
[0018] Fig.12 Shows Figure 8 A top perspective view of a connecting segment of a wound closure device.
[0019] Figure 13A-13B Shows Figure 8 Cross-section of a connecting segment of a wound closure device.
[0020] Fig.14 Another example of a wound closure device and connecting segments thereof according to examples herein is shown.
[0021] Fig.15 Another example of a wound closure device and connecting segments thereof according to examples herein is shown.
[0022] Fig.16 Another example of a wound closure device and connecting segments thereof according to examples herein is shown.
[0023] Fig.17 Another example of a wound closure device and connecting segments thereof according to examples herein is shown.
[0024] Fig.18 Another example of a wound closure device and connecting segments thereof according to examples herein is shown.
[0025] The drawings are not intended to be limiting in any way, and it is contemplated that various embodiments of the technology may be performed in a variety of other ways, including those not necessarily shown in the drawings. The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate several aspects of the technology and, together with the description, serve to explain the principles of the technology; however, it should be understood that the technology is not limited to the precise arrangements shown. DETAILED DESCRIPTION
[0026] The following description of certain examples of the present technology should not be used to limit the scope of the present technology. Other examples, features, aspects, embodiments and advantages of the present technology will become apparent to those skilled in the art from the following description, which is by way of example, one of the best ways contemplated for implementing the present technology. As will be appreciated, the technology described herein can have other different and obvious aspects, all of which do not depart from the present technology. Therefore, the drawings and descriptions should be considered to be illustrative in nature and not restrictive.
[0027] It should also be understood that one or more of the teachings, expressions, implementations, examples, etc. described herein may be combined with one or more of the other teachings, expressions, implementations, examples, etc. described herein. Therefore, the following teachings, expressions, implementations, examples, etc. should not be considered isolated from each other. Various suitable ways in which the teachings herein can be combined will be apparent to those of ordinary skill in the art based on the teachings herein. Such modifications and variations are intended to be included within the scope of the claims.
[0028] Figure 1-Figure 2 Different views of a wound closure device 100 according to one or more examples herein are shown. The wound closure device 100 may include a first suture segment 102a and a second suture segment 102b, and a connecting segment or transition segment 107 therebetween. The first suture segment 102a and the second suture segment 102b may include filamentary elements 103a, 103b according to examples herein. The first suture segment 102a and the second suture segment 102b may be composed of any suitable surgical suture material (i.e., absorbable and non-absorbable polymer materials, metals, or ceramic materials). Figure 1 As shown, in one example, the first suture segment 102a may include a plurality of barbs or protrusions 104a extending outwardly from the filamentary element 103a. In addition, as shown in the example, the second suture segment 102b may include a plurality of barbs or protrusions 104b extending outwardly from the filamentary element 103b. As described herein, the barbs or protrusions may be used to increase the fixing strength of the suture and / or eliminate the need for knotting. In addition, in Figure 1-Figure 2 In the example shown, the barbs or projections 104a, 104b can be symmetrical. For example, one of the barbs or projections 104a' can be similar in shape to the corresponding barb 104a", and can extend from the filamentary element 103a on a side (e.g., about 180 degrees) opposite to the corresponding barb 104a" and in a direction opposite to the corresponding barb 104a". Examples of barbs that can be used herein, such as barbs or projections 104a, 104b, can be described in more detail in U.S. Publication No. 2014 / 0081321, which is incorporated herein by reference in its entirety. According to the examples herein, barbs or projections such as 104a, 104b can be formed by any suitable method, such as a composite tooth profile stamped from a preformed material in a manner more described in detail in U.S. Patent Publication No. 2007 / 0257395 and U.S. Patent No. 7,850,894 (both of which are incorporated herein by reference in their entirety).
[0029] The first suture line segment 102a and the second suture line segment 102b may include the same or different suture line configurations. For example, the first suture line segment 102a may include a filament 103a and a barb or projection 104a with different characteristics such as barb size, filament size, material type, barb type, filament type, etc. to form a first suture line configuration. In addition, in an example, the second suture line segment 102b may include a filament 103b and a barb or projection 104b with different characteristics such as barb size, filament size, material type, barb type, filament type, etc. to form a second suture line configuration. In one example, the first suture line configuration and the second suture line configuration may be identical, that is, the first filament 103a and the second filament 103b and barbs or projections 104a, 104b may have the same size, material, type, etc. In addition, in examples, the first suture configuration and the second suture configuration may be different, that is, the first filamentary element 103a and the second filamentary element 103b and / or the barbs or protrusions 104a, 104b may have different sizes, materials, types, etc. For example, the first suture configuration may include a filamentary element 103a and a barb or protrusion 104a having a specific or selected size and / or material (e.g., a 3-0 symmetrical PDS barbed suture), but it may be undyed, and the second suture configuration may include a filamentary element 103b and a barb or protrusion 104b having the same size or material (e.g., a 3-0 symmetrical PDS barbed suture), but it may be dyed. In such examples, the wound closure device or suture may have suture segments of different colors to make the suture or wound closure device chain or segment appropriately visible in a bloody (e.g., the segment may be a dyed material so that it is visible therein) and a non-bloody (e.g., the segment may be an undyed material) surgical area. The examples herein may also include other combinations of sizes, materials, types, etc. (eg, as described herein).
[0030] In one example, the first suture segment 102a may include a first needle or insertion device 101a at its corresponding first proximal end 109a and the second suture segment 102b may include a second needle or insertion device 101b at its corresponding second proximal end 109b. The first needle or insertion device 101a and the second needle or insertion device 101b may be any suitable needle or insertion device configured to pass through tissue. In addition, the first needle or insertion device 101a and the second needle or insertion device 101b may be made of any suitable material such as steel, Ethalloy, etc., may be any suitable shape and size such as straight, curved, etc., and / or may have any other suitable characteristics including tapered cuts, tapered points, blunt heads, etc., so that the first needle or insertion device 101a and the second needle or insertion device 101b can be inserted and can pass through tissue so that the first suture segment 102a and the second suture segment 102b can pass through and approach tissue as described herein. In an example, the first needle or insertion device 101a and the second needle or insertion device 101b may be the same. For example, the first needle or insertion device 101a and the second needle or insertion device 101b may have the same material, shape, size, etc. (i.e., they may have the same properties as each other). In another example, the first needle or insertion device 101a and the second needle or insertion device 101b may be different. For example, the first needle or insertion device 101a and the second needle or insertion device 101b may have different materials, shapes, sizes, etc. (i.e., they may have one or more properties that are different from each other).
[0031] As shown, the first suture segment 102a may include a first distal end 106a and the second suture segment may include a second distal end 106b. The first distal end 106a and the second distal end 106b may have fixed tabs or stop elements 108a and 108b attached to them or formed from them, respectively. The first fixed tab 108a and the second fixed tab 108b can be joined together to form a transition zone 107 (e.g., connecting segment) between the first suture segment 102a and the second suture segment 102b using various methods such as lamination as described herein. Therefore, in the examples herein, the fixed tabs or stop elements can provide enough surface area to laminate the two fixed tab surfaces together using RF energy or other ways of joining different materials to produce a bidirectional chain. In addition, in the examples herein, the transition zone or connecting segment 107 can be a transition point between a suture segment and another suture segment (e.g., a transition point between two sutures as described herein). In addition, according to one or more examples, the transition region or connecting segment 107 and each corresponding fixing tab or stop element can provide a tactile indicator to the user of the wound closure device that each leg can be properly placed in the tissue. After lamination, in an example, a portion of the connecting segment or transition region 107 can also be trimmed or stamped out to reduce the size of the transition region or connecting segment or change the shape of the transition region or connecting segment.
[0032] Figure 3 For example, before forming a connecting segment (eg, transition zone 107), Figure 1-Figure 2 108a, 108b of the wound closure device 100. As shown, in an example, the stop elements 108a, 108b may include a leading edge defined by a leading edge thickness t and a leading edge width w, and also have a length l along the elongated axis of the suture. In an example, the stop elements 108a, 108b may have the same shape, size, etc. (e.g., the same t, w, and l). In addition, the stop elements 108a, 108b may have different shapes, sizes, etc. (e.g., the same Figure 9-14 , as shown in the stop elements 308a, 308b). In some examples, one of the first suture segment 102a and the second suture segment 102b may include a stop element, while the other suture segment may not include a stop element. In an example, the stop element described herein may have a thickness (e.g., t) of about 0.010" to 0.025", a width (e.g., w) of about 0.095" to 0.120", and a length (e.g., l) of about 0.095" to about 0.200". According to one example, the length of the stop element 308a (e.g., about 0.095") may be shorter than the length (e.g., about 0.200") of other stop elements such as the stop elements 108a, 108b, 208b, 308c, 408a, 508a, 608a, 708a, 708b, 808a, etc.
[0033] Figure 4-6B The diagram shows, for example, after forming the connecting section or transition zone 107 (for example, after laminating the stop elements 108a, 108b together). Figure 1-Figure 2, a top view, a cross-sectional view, a perspective view, and a side view of a wound closure device of the present invention. As shown, the first side 120a of the first stop element 108a can be joined with the first side 122a of the second stop element 108b to form a transition zone or connecting segment 107. In an example, the first side 120a can be directly laminated to the first side 122a to form the transition zone or connecting segment 107. Thus, in an example, at least a portion of the stop element 308a can be laminated (e.g., directly laminated) to at least a portion of the stop element 308b. In such an example, no other materials may be used to form the transition zone or connecting segment 107 during the lamination process, and as shown, for example, each of the suture segments or legs 102a, 102b can have its own integral end effector (e.g., the first stop element 108a and the second stop element 108b) before lamination. According to one or more examples herein, in order to laminate the first sides 120a, 122a together, RF energy may be applied to each of the sides 120a, 122a of the tabs or stop elements 108a, 108b, and then the two sides to which the RF energy has been applied may be joined together to form the transition region or connecting segment 107. According to another example, the sides (e.g., 120a, 122a) may be laminated together by applying thermal energy (e.g., using infrared and laser technology and / or energy), mechanical energy (e.g., using vibration and ultrasonic technology and / or energy), etc.
[0034] In order to laminate the stop elements (e.g., 108a, 108b) together as described herein, the sides of the stop elements (e.g., they may be made of an insulating material such as PDS) may be dielectrically heated using RF lamination and / or welding. RF lamination and / or welding to form a connecting segment or transition zone (e.g., 107) as described herein may include dielectrically heating a non-conductive or electrically insulating material such as PDS (e.g., from which the stop elements may be made). According to an example, one or more polymer molecules of these dielectric materials include a portion of the molecule that may have a slight positive charge, while the opposite portion of the molecule may have a slight negative charge. When placed in an electric field, these polar molecules may orient themselves so that their positive poles face the negative pole of the applied electric field and their negative poles face the positive pole of the applied electric field. When electrical power is applied, the electrical power may change the electric field on the plate at a frequency of 13 MHz / second to 100 MHz / second. For dielectric materials such as PDS, this change in the electric field can cause electrons to be alternately pulled within the dielectric field and molecular friction to generate heat to laminate the materials (e.g., the first side of the stop element such as 120a of 108a, 122a of 108b) together. Therefore, according to the examples herein, in order to laminate the stop elements together to form a connection segment or transition zone, power or energy can be applied to the stop element (e.g., the first parameter) for a specific amount of time or duration (e.g., the second parameter) and at a specific pressure (e.g., the third parameter).
[0035] According to the examples herein, laminating suture segments (e.g., 102a, 102b) (also referred to as legs or chains) together can enable the overall length of the device to be greater than the tool limitations that may normally allow due to the tool being set to a maximum length of a single chain. For example, the equipment and tools may limit the length of the segments or chains that can be achieved for barbed sutures. By using the lamination processes or methods described herein, the overall length of a suture device or wound closure device can be increased. For example, by joining segments or chains together as shown, the overall length of a suture device or wound closure device can be up to twice the length of a single segment or chain without having to invest in equipment or tools to produce an integrally formed suture or wound closure device of the same or similar length or features.
[0036] Figure 7 Another example of a wound closure device 200 and a connecting segment 207 thereof according to an example of the present invention is shown. Figure 7 As shown (for example, similar to Figure 1-Figure 2 ), the wound closure device 200 may include a first suture segment 202a and a second suture segment 202b, and a connecting segment or transition segment 207 therebetween. The first suture segment 202a and the second suture segment 202b may include a first filamentary element 203a and a second filamentary element 203b according to the examples herein. As shown, the first filamentary element 203a and the second filamentary element 203b may have different sizes (e.g., a No. 3-0 suture may be connected or laminated to a No. 1 suture). For example, the first filamentary element 203a may have a diameter or width c1, and the second filamentary element 203b may have a diameter or width c2. In an example, the diameter c2 may be larger than the diameter c1 as shown.
[0037] As described herein, the first suture segment 202a and the second suture segment 202b can be comprised of any suitable surgical suture material (ie, absorbable and non-absorbable polymeric materials, metals, or ceramic materials). Figure 7 As shown, in one example, the first suture segment 202a may include a plurality of barbs or protrusions 204a extending outwardly from the filamentary element 203a. In addition, as shown in the example, the second suture segment 102b may include a plurality of barbs or protrusions 204b extending outwardly from the filamentary element 203b. As described herein, the barbs or protrusions may be used to increase the fixing strength of the suture and / or eliminate the need for knotting. In addition, in Figure 7In the example shown, the barbs or protrusions 204a, 204b can be symmetrical. For example, one of the barbs or protrusions 204a' can be similar in shape to the corresponding barb 204a", and can extend from the filamentary element 203a on a side (e.g., about 180 degrees) opposite to the corresponding barb 204a" and in a direction opposite to the corresponding barb 204a". According to the examples herein, the barbs or protrusions can be formed by any suitable method, such as a composite tooth profile stamped from a preformed material and / or any other suitable method as described herein.
[0038] The first suture line segment 202a and the second suture line segment 202b may comprise identical or different suture line configurations.For example, as mentioned above, the first suture line segment 202a may comprise a filament element 203a with different characteristics such as smaller filament size (for example, smaller cross section, width or diameter) to form the first suture line configuration.In addition, in an example, the second suture line segment 202b may comprise a filament element 203b with different characteristics such as larger filament size (for example, larger cross section, width or diameter) to form the second suture line configuration.Other characteristics of each suture line segment also may be identical or different, such as color as described herein or dye, barb size, suture line type, material, pin and their characteristics etc.
[0039] In one example, the first suture segment 202a may include a first needle or insertion device (not shown) at its respective first proximal end, and the second suture segment 202b may include a second needle or insertion device (not shown) at its respective second proximal end (e.g., Figure 1 101a and the second needle 101b are shown in the example). The first needle or insertion device and the second needle or insertion device can be any suitable needle or insertion device configured to pass through the tissue. In addition, the first needle or insertion device and the second needle or insertion device can be made of any suitable material such as steel, Ethalloy, etc., can be any suitable shape and size such as straight, curved, etc., and / or can have any other suitable characteristics including a tapered cut, a tapered point, a blunt head, etc., so that the first needle or insertion device and the second needle or insertion device can be inserted and can pass through the tissue so that the first suture segment 202a and the second suture segment 202b can pass through and approach the tissue as described herein. In an example, the first needle or insertion device and the second needle or insertion device may be the same. For example, the first needle or insertion device and the second needle or insertion device may have the same material, shape, size, etc. (that is, they may have the same characteristics as each other). In another example, the first needle or insertion device and the second needle or insertion device may be different. For example, the first needle or insertion device and the second needle or insertion device may have different materials, shapes, sizes, etc. (that is, they may have one or more characteristics different from each other).
[0040] As shown, the first suture segment 202a may include a first distal end 206a and the second suture segment 202b may include a second distal end 206b. The first distal end 206a and the second distal end 206b may have fixing tabs or stop elements 208a and 208b attached to or formed from them, respectively. The first fixing tab 208a and the second fixing tab 208b may be joined together using various methods as described herein, such as lamination, to form a transition zone 207 (e.g., a connecting segment) between the first suture segment 202a and the second suture segment 202b. Therefore, in the examples herein, the fixing tabs or stop elements may provide sufficient surface area to laminate the two fixing tab surfaces together using RF energy or other methods of joining different materials to produce a bidirectional chain. In addition, in the examples (e.g., as Figure 8-13B As described above), additional tabs may be used to form a transition zone or connecting segment 207. In examples herein, the transition zone or connecting segment 207 may be a transition point between one suture segment and another suture segment (e.g., a transition point between two sutures as described herein). In addition, according to one or more examples, the transition zone or connecting segment 207 and each corresponding fixing tab or stop element may provide a tactile indicator to a user of the wound closure device that each leg may be properly placed in the tissue. After lamination, in examples, a portion of the connecting segment or transition zone 207 may also be trimmed or stamped out to reduce the size of the transition zone or connecting segment or to change the shape of the transition zone or connecting segment.
[0041] Figure 8 Another example of a wound closure device 300 and a connecting segment 307 thereof according to an example of the present invention is shown. Figure 8 As shown (for example, similar to Figure 1-Figure 2 ), the wound closure device 300 may include a first suture segment 302a and a second suture segment 302b, and a connecting segment or transition segment 307 therebetween. In an example, the wound closure device 300 may be a bidirectional barbed suture for multilayer tissue closure, which may include one suture leg or segment (e.g., 302a) and another suture leg or segment (e.g., 302b) that are engaged with each other, wherein the one suture leg or segment is made of PDS material, has an anchor geometry of appropriate size and a needle for fascia closure, and the other suture leg or segment is made of MONOCRYL material, has an anchor geometry of appropriate size in the opposite direction and a needle suitable for subcutaneous tissue or substratum corneum tissue. As described herein, the first suture segment 302a and the second suture segment 302b may be made of other suitable surgical suture materials (i.e., absorbable and non-absorbable polymer materials, metals or ceramic materials).
[0042] The first suture segment 302a and the second suture segment 302b may also include a first filamentary element 303a and a second filamentary element 303b according to the examples herein. Figure 8 As shown, in one example, the first suture segment 302a may include a plurality of barbs or protrusions 304a extending outwardly from the filamentary element 303a. In addition, as shown in the example, the second suture segment 302b may include a plurality of barbs or protrusions 304b extending outwardly from the filamentary element 303b. As described herein, the barbs or protrusions may be used to increase the fixing strength of the suture and / or eliminate the need for knotting, and each segment or segment (e.g., 302a, 302b) may include a plurality of barbs or protrusions 304b extending outwardly from the filamentary element 303b. Figure 8 Different barbs as shown or the same barbs (e.g., as described herein and as Figure 1 and Figure 7 ). The barbs or protrusions 204a, 204b may be symmetrical. For example, one of the barbs or protrusions 304a' may be similar in shape to the corresponding barb 304a", and may extend from the filamentary element 303a on a side (e.g., about 180 degrees) opposite to the corresponding barb 304a" and in a direction opposite to the corresponding barb 304a". According to the examples herein, the barbs or protrusions may be formed by any suitable method, such as a composite tooth profile stamped from a preformed material and / or any other suitable method as described herein.
[0043] The first suture line segment 302a and the second suture line segment 302b may include the same or different suture line configurations.For example, as mentioned above, the first suture line segment 302a may include material such as MONOCRYL material, wherein barb has the first geometric shape and / or size as shown in the figure, thereby forming the first suture line configuration.In addition, in an example, the second suture line segment 302b may include material such as PDS different from the first suture line segment 302a, wherein barb has the second geometric shape and / or as shown in the figure, thereby forming the second suture line configuration.Other characteristics of each suture line segment also may be the same or different, such as filament size as described herein, color or dye, suture type, pin and their characteristics etc.
[0044] In one example, the first suture segment 302a may include a first needle or insertion device (not shown) at its respective first proximal end, and the second suture segment 302b may include a second needle or insertion device (not shown) at its respective second proximal end (e.g., Figure 1101a and the second needle 101b are shown in the example). The first needle or insertion device and the second needle or insertion device can be any suitable needle or insertion device configured to pass through the tissue. In addition, the first needle or insertion device and the second needle or insertion device can be made of any suitable material such as steel, Ethalloy, etc., can be any suitable shape and size such as straight, curved, etc., and / or can have any other suitable characteristics including tapered cuts, tapered points, blunt heads, etc., so that the first needle or insertion device and the second needle or insertion device can be inserted and can pass through the tissue so that the first suture segment 302a and the second suture segment 302b can pass through and approach the tissue as described herein. In an example, the first needle or insertion device and the second needle or insertion device may be the same. For example, the first needle or insertion device and the second needle or insertion device may have the same material, shape, size, etc. (that is, they may have the same characteristics as each other). In another example, the first needle or insertion device and the second needle or insertion device may be different. For example, the first needle or insertion device and the second needle or insertion device may have different materials, shapes, sizes, etc. (that is, they may have one or more characteristics different from each other).
[0045] As shown, the first suture segment 302a may include a first distal end 306a and the second suture segment 202b may include a second distal end 306b. The first distal end 306a and the second distal end 306b may have fixing tabs or stop elements 308a and 308b attached to or formed from them, respectively. The first fixing tab 308a and the second fixing tab 308b may be joined together using various methods such as lamination as described herein to form a transition zone 307 (e.g., a connecting segment) between the first suture segment 302a and the second suture segment 302b. Therefore, in the examples herein, the fixing tabs or stop elements may provide sufficient surface area to laminate the two fixing tab surfaces together using RF energy or other methods of joining different materials to produce a bidirectional chain. In addition, in embodiments such as Figure 8-13B In the example shown, additional tabs can be used to form a transition zone or connecting segment 307. In the examples herein, the transition zone or connecting segment 307 can be a transition point between one suture segment and another suture segment (e.g., a transition point between two sutures as described herein). In addition, according to one or more examples, the transition zone or connecting segment 307 and each corresponding fixing tab or stop element can provide a tactile indicator to the user of the wound closure device that each leg can be properly placed in the tissue. After lamination, in examples, a portion of the connecting segment or transition zone 307 can also be trimmed or stamped out to reduce the size of the transition zone or connecting segment or change the shape of the transition zone or connecting segment.
[0046] Figure 9-11 For example, before forming the connecting segment (eg, or transition zone 307) Figure 8Exploded view of the stop element and / or tab of the wound closure device 300. As shown in the figure, in the example, the stop element 308a can be generally rounded rectangular in shape (e.g., Fig.10 The stop element 308a, 308b may be generally rectangular in shape and may include a leading edge defined by a leading edge thickness t1 and a leading edge width w1, and may also have a length l1 along the elongated axis of the suture. Additionally, the stop element 308b may be generally rectangular in shape and may include a leading edge defined by a leading edge thickness t1' and a leading edge width w1', and may also have a length l1' along the elongated or longitudinal axis of the suture. Thus, in the example shown, the stop elements 308a, 308b may have different shapes and / or sizes.
[0047] Furthermore, according to the example, Fig. 9 Another stop element 303c (e.g., a third stop element) shown that is not attached to the first filament 303a and the second filament 303b or is not formed integrally with them can be used to form the connecting segment 307 as described herein. As shown, the stop element 308c can be generally rectangular in shape and can include a leading edge defined by a leading edge thickness t1" and a leading edge width w1", and also has a length l1" along the elongated or longitudinal axis of the suture. According to the example shown, the stop element 308c can be the same as and similar in size to the stop element 302b.
[0048] Figure 12-13B 308a, 308b, 308c are shown, for example, after forming the connecting section or transition zone 307 (for example, after laminating the stop elements 308a, 308b, 308c together). Figure 8-Figure 111 and 10. A top view and a cross-sectional view of a wound closure device of FIG. 10. As shown, the first side 320a of the first stop element 308a can be joined with the first side 322a of the second stop element 308b and the second side 320b of the first stop element 308a can be joined with the first side 324a of the stop element 308c to form a transition region or connecting segment 307. In an example, the first side 320a can be directly laminated to the first side 322a and the second side 320b can be directly laminated to the first side 324a to form the transition region or connecting segment 307. In addition, at least a portion of the first side 322a can be laminated to the first side 324a as shown. Therefore, in an example, at least a portion of the stop element 308a can be laminated to at least a portion of the stop elements 308b and 308c, and / or a portion of the stop elements 308b and 308c can be laminated to each other (e.g., directly laminated). In such examples, no other materials may be used to form the transition region or connecting segment 307 during the lamination process, and as shown, each of the suture segments or legs 102a, 102b may have its own integral end effector (e.g., first stop element 108a and second stop element 108b), for example, which may be stacked with end effector 308c prior to lamination. According to one or more examples herein, to laminate the first sides 320a, 322a together, laminate the second side 320b and the first side 324a together, and / or laminate the first sides 322a, 324a together, RF energy may be applied to each of the sides 320a, 320b, 322a, 324a of the tabs or stop elements 308a, 308b, 308c, and then the sides to which RF energy has been applied may be joined together as described herein (e.g., as described above) to form the transition region or connecting segment 307.
[0049] According to the examples herein, laminating suture segments (e.g., 302a, 302b) (also referred to as legs or chains) together can enable the overall length of the device to be greater than the tool limitations that may normally allow due to the tool being set to a maximum length of a single chain. For example, the equipment and tools may limit the length of the segments or chains that can be achieved for barbed sutures. By using the lamination processes or methods described herein, the overall length of a suture device or wound closure device can be increased. For example, by joining segments or chains together as shown, the overall length of a suture device or wound closure device can be up to twice the length of a single segment or chain without having to invest in equipment or tools to produce an integrally formed suture or wound closure device of the same or similar length or features.
[0050] Fig.14 Another example of a wound closure device 400 and a connecting segment 407 thereof according to an example of the present invention is shown. Fig.14As shown, the wound closure device 400 may include a first suture segment 402a and a second suture segment 402b, and a connecting segment or transition segment 407 therebetween. The first suture segment 402a and the second suture segment 402b may include a first filamentary element 403a and a second filamentary element 403b according to the examples herein. As shown, the first filamentary element 403a and the second filamentary element 403b may have different sizes (e.g., a No. 0 suture may be connected or laminated to a No. 3-0 suture).
[0051] As described herein, the first suture segment 402a and the second suture segment 402b can be made of any suitable surgical suture material (i.e., absorbable and non-absorbable polymer materials, metals, or ceramic materials). In an example, the first suture segment 402a and the second suture segment 402b can be made of the same material, such as PDS. In other examples, the first suture segment and the second suture segment can be made of different materials.
[0052] like Fig.14 As shown, in one example, the first suture segment 402a may include a plurality of barbs or protrusions 404a extending outwardly from the filamentary element 403a. In addition, as shown in the example, the second suture segment 402b may include a plurality of barbs or protrusions 404b extending outwardly from the filamentary element 403b. As described herein, the barbs or protrusions may be used to increase the fixing strength of the suture and / or eliminate the need for knotting.
[0053] In the example, Fig.14 As shown, the barb or protrusion 404a can be symmetrical. For example, the barb or protrusion 404a' can be similar in shape to the corresponding barb 404a", and can extend from the filamentary element 403a on the side opposite to the corresponding barb 404a" (e.g., about 180 degrees) and in the opposite direction to the corresponding barb 404a". According to the examples herein, the barb or protrusion 404a can be formed by any suitable method, such as a composite tooth shape stamped from a preformed material and / or any other suitable method as described herein.
[0054] In addition, in an example, the barb or protrusion 404b can be asymmetric or spiral. For example, the barb or protrusion 404b can be formed in an asymmetric pattern such as a spiral pattern around or in the filament 403b, so that the barb 404b' can be inserted into or formed on the filament 403b asymmetrically (or spirally) relative to the adjacent barb 404b". In an example, the asymmetric pattern can be a spiral pattern, so that the barbs including barbs 404b' and 404b" are spirally inserted or formed on the filament 403b. The barb or protrusion, such as the barb or protrusion 404b, can be inserted or formed with any other asymmetric pattern. Examples of barbs that can be used herein, such as barbs or protrusions 404b, can be described in more detail in U.S. Patent No. 8,721,681 and U.S. Patent No. 8,721,664, both of which are incorporated herein by reference in their entirety. According to the examples herein, barbs or protrusions such as 404b may be formed by any suitable method, such as being cut, etched, injection molded, laser cut or formed, etc., such as using the exemplary methods described in more detail in U.S. Patent No. 6,848,152, which is incorporated herein by reference in its entirety.
[0055] The first suture line segment 402a and the second suture line segment 402b may comprise different suture line configurations. For example, as mentioned above, the first suture line segment 402a may comprise a barb 404a with different characteristics such as symmetrical barbs, thereby forming the first suture line configuration. In addition, in an example, the second suture line segment 402b may comprise a barb 404b with different characteristics such as asymmetric or spiral barbs, thereby forming the second suture line configuration. Other characteristics of each suture line segment may also be identical or different, such as color or dye as described herein, filament size or characteristic, barb size, suture line type, material, pin and their characteristics etc.
[0056] In one example, the first suture segment 402a may include a first needle or insertion device (not shown) at its respective first proximal end, and the second suture segment 402b may include a second needle or insertion device (not shown) at its respective second proximal end (e.g., Figure 1101a and the second needle 101b in the example shown). The first needle or insertion device and the second needle or insertion device can be any suitable needle or insertion device configured to pass through the tissue. In addition, the first needle or insertion device and the second needle or insertion device can be made of any suitable material such as steel, Ethalloy, etc., can be any suitable shape and size such as straight, curved, etc., and / or can have any other suitable characteristics including a tapered cut, a tapered point, a blunt head, etc., so that the first needle or insertion device and the second needle or insertion device can be inserted and can pass through the tissue so that the first suture segment 402a and the second suture segment 402b can pass through and approach the tissue as described herein. In an example, the first needle or insertion device and the second needle or insertion device may be the same. For example, the first needle or insertion device and the second needle or insertion device may have the same material, shape, size, etc. (that is, they may have the same characteristics as each other). In another example, the first needle or insertion device and the second needle or insertion device may be different. For example, the first needle or insertion device and the second needle or insertion device may have different materials, shapes, sizes, etc. (that is, they may have one or more characteristics different from each other).
[0057] As shown, the first suture segment 402a may include a first distal end 406a and the second suture segment 402b may include a second distal end 406b. The first distal ends 406a may have a fixing tab or stop element 408a attached to or formed from them. The first fixing tab 408a may be joined together with the distal end 406b of the second suture segment and an additional tab (not shown) using various methods as described herein, such as lamination, to form a transition region 407 (e.g., a connecting segment). For example, in an example, a stacking pattern (e.g., similar to the embodiment of the present invention) is formed by laminating the first stop element 408a to the distal end 406b of the second suture segment and the additional tab. Figure 8-13B ), additional tabs may be used to form a transition zone or connecting segment 407. Thus, in examples herein, a fixing tab or stop element may provide sufficient surface area to laminate the first suture segment 402a and the second suture segment 402b together using RF energy or other means of joining different materials to produce a bidirectional chain. In examples herein, the transition zone or connecting segment 407 may be a transition point between one suture segment and another suture segment (e.g., a transition point between two sutures as described herein). In addition, according to one or more examples, the transition zone or connecting segment 407 and each corresponding fixing tab or stop element may provide a tactile indicator to the user of the wound closure device indicating that each leg may be properly placed in the tissue. After lamination, in an example, a portion of the connecting segment or transition zone 407 may also be trimmed or stamped out to reduce the size of the transition zone or connecting segment or change the shape of the transition zone or connecting segment.
[0058] Fig.15Another example of a wound closure device 500 and a connecting segment 507 thereof according to an example of the present invention is shown. Fig.15 As shown, the wound closure device 500 may include a first suture segment 502a and a second suture segment 502b, and a connecting segment or transition segment 507 therebetween. The first suture segment 502a and the second suture segment 502b may include a first filamentary element 503a and a second filamentary element 503b according to the examples herein. As shown, the first filamentary element 503a and the second filamentary element 503b may have different sizes (e.g., a No. 0 suture may be connected or laminated to a No. 3-0 suture) and may have different colors (e.g., dyed and undyed).
[0059] As described herein, the first suture segment 502a and the second suture segment 502b can be composed of any suitable surgical suture material (i.e., absorbable and non-absorbable polymer materials, metals, or ceramic materials). In examples, the first suture segment and the second suture segment can be composed of different materials such as PDS and MONOCRYL (e.g., the first suture segment 502a can be composed of PDS and the second suture segment 502b can be composed of MONOCRYL). In other examples, the first suture segment 502a and the second suture segment 502b can be composed of the same material.
[0060] like Fig.15 As shown, in one example, the first suture segment 502a may include a plurality of barbs or projections 504a extending outwardly from the filamentary element 503a. As described herein, the barbs or projections may be used to increase the fixing strength of the suture and / or eliminate the need for knotting. In addition, as shown in the example, the second suture segment 502b may include a suture without barbs such as a monofilament suture.
[0061] In the example, Fig.15 As shown, the barb or protrusion 504a can be symmetrical. For example, the barb or protrusion 504a' can be similar in shape to the corresponding barb 504a", and can extend from the filamentary element 203a on the side opposite to the corresponding barb 504a" (e.g., about 180 degrees) and in the opposite direction to the corresponding barb 504a". According to the examples herein, the barb or protrusion 504a can be formed by any suitable method, such as a composite tooth profile stamped from a preformed material and / or any other suitable method as described herein.
[0062] The first suture line segment 502a and the second suture line segment 502b may include different suture line configurations. For example, as described above, the first suture line segment 502a may include barbs 404a with different characteristics such as symmetrical barbs to form a first suture line configuration, which may be dyed and may have a filament of a first size. In addition, in an example, the second suture line segment 502b may be a monofilament suture, may be undyed, and may have a filament of a second size that may be different from the first size. Other characteristics of each suture line segment may also be the same or different as described herein.
[0063] In one example, the first suture segment 502a can include a first needle or insertion device (not shown) at its respective first proximal end, and the second suture segment 502b can include a second needle or insertion device (not shown) at its respective second proximal end (e.g., Figure 1 101a and the second needle 101b in the example shown). The first needle or insertion device and the second needle or insertion device can be any suitable needle or insertion device configured to pass through the tissue. In addition, the first needle or insertion device and the second needle or insertion device can be made of any suitable material such as steel, Ethalloy, etc., can be any suitable shape and size such as straight, curved, etc., and / or can have any other suitable characteristics including tapered cuts, tapered points, blunt heads, etc., so that the first needle or insertion device and the second needle or insertion device can be inserted and can pass through the tissue so that the first suture segment 502a and the second suture segment 502b can pass through and approach the tissue as described herein. In an example, the first needle or insertion device and the second needle or insertion device may be the same. For example, the first needle or insertion device and the second needle or insertion device may have the same material, shape, size, etc. (that is, they may have the same characteristics as each other). In another example, the first needle or insertion device and the second needle or insertion device may be different. For example, the first needle or insertion device and the second needle or insertion device may have different materials, shapes, sizes, etc. (that is, they may have one or more characteristics different from each other).
[0064] As shown, the first suture segment 502a may include a first distal end 506a and the second suture segment 502b may include a second distal end 506b. The first distal ends 506a may have fixed tabs or stop elements 508a attached to or formed from them. The first fixed tabs or stop elements 508a may be joined together with the distal end 506b of the second suture segment and additional tabs or stop elements (not shown) using various methods as described herein, such as lamination, to form a transition zone 507 (e.g., a connecting segment). For example, in an example, a stacking pattern (e.g., similar to the embodiment of the present invention) is formed by laminating the first stop element 508a to the distal end 506b of the second suture segment 502b and the additional tabs. Figure 8-13B), additional tabs may be used to form a transition zone or connecting segment 507. Thus, in examples herein, a fixing tab or stop element may provide sufficient surface area to laminate the first suture segment 502a and the second suture segment 502b together using RF energy or other means of joining different materials to produce a bidirectional chain. In examples herein, a transition zone or connecting segment 507 may be a transition point between one suture segment and another suture segment (e.g., a transition point between two sutures as described herein). In addition, according to one or more examples, the transition zone or connecting segment 507 and each corresponding fixing tab or stop element may provide a tactile indicator to a user of the wound closure device indicating that each leg may be properly placed in the tissue. After lamination, in an example, a portion of the connecting segment or transition zone 507 may also be trimmed or stamped out to reduce the size of the transition zone or connecting segment or change the shape of the transition zone or connecting segment.
[0065] Fig.16 Another example of a wound closure device 600 and its connecting section 607 according to an example of the present invention is shown. Fig.16 As shown, the wound closure device 600 may include a first suture segment 602a and a second suture segment 602b, and a connecting segment or transition segment 607 therebetween. The first suture segment 602a and the second suture segment 602b may include a first filamentary element 603a and a second filamentary element 603b according to the examples herein. As shown, the first filamentary element 603a and the second filamentary element 603b may have different sizes (e.g., a No. 0 suture may be connected or laminated to a No. 2-0 suture).
[0066] As described herein, the first suture segment 602a and the second suture segment 602b can be composed of any suitable surgical suture material (i.e., absorbable and non-absorbable polymer materials, metals, or ceramic materials). In examples, the first suture segment and the second suture segment can be composed of different materials such as PDS and VICRYL (e.g., the first suture segment 602a can be composed of PDS and the second suture segment 602b can be composed of VICRYL). In other examples, the first suture segment 602a and the second suture segment 602b can be composed of the same material.
[0067] like Fig.16 As shown, in one example, the first suture segment 602a may include a plurality of barbs or projections 604a extending outwardly from the filamentary element 603a. As described herein, the barbs or projections may be used to increase the fixing strength of the suture and / or eliminate the need for knotting. In addition, as shown in the example, the second suture segment 602b may include a suture without barbs such as a multifilament suture.
[0068] In the example, Fig.16As shown, the barb or protrusion 504a can be symmetrical. For example, the barb or protrusion 604a' can be similar in shape to the corresponding barb 604a", and can extend from the filamentary element 603a on the side opposite to the corresponding barb 604a" (e.g., about 180 degrees) and in the opposite direction to the corresponding barb 604a". According to the examples herein, the barb or protrusion 604a can be formed by any suitable method, such as a composite tooth shape stamped from a preformed material and / or any other suitable method as described herein.
[0069] The first suture line segment 602a and the second suture line segment 602b may include different suture line configurations. For example, as described above, the first suture line segment 602a may include barbs 604a with different characteristics such as symmetrical barbs to form a first suture line configuration, and may have a filament of a first size. In addition, in an example, the second suture line segment 602b may be a multifilament suture and may have a filament of a second size that may be different from the first size. Other characteristics of each suture line segment may also be the same or different as described herein.
[0070] In one example, the first suture segment 602a can include a first needle or insertion device (not shown) at its respective first proximal end, and the second suture segment 602b can include a second needle or insertion device (not shown) at its respective second proximal end (e.g., Figure 1 101a and the second needle 101b in the example shown). The first needle or insertion device and the second needle or insertion device can be any suitable needle or insertion device configured to pass through the tissue. In addition, the first needle or insertion device and the second needle or insertion device can be made of any suitable material such as steel, Ethalloy, etc., can be any suitable shape and size such as straight, curved, etc., and / or can have any other suitable characteristics including tapered incisions, tapered points, blunt heads, etc., so that the first needle or insertion device and the second needle or insertion device can be inserted and can pass through the tissue so that the first suture segment 602a and the second suture segment 602b can pass through and approach the tissue as described herein. In an example, the first needle or insertion device and the second needle or insertion device may be the same. For example, the first needle or insertion device and the second needle or insertion device may have the same material, shape, size, etc. (that is, they may have the same characteristics as each other). In another example, the first needle or insertion device and the second needle or insertion device may be different. For example, the first needle or insertion device and the second needle or insertion device may have different materials, shapes, sizes, etc. (that is, they may have one or more characteristics different from each other).
[0071] As shown, the first suture segment 602a may include a first distal end 606a and the second suture segment 602b may include a second distal end 606b. The first distal ends 606a may have a fixing tab or stop element 608a attached to or formed from them. The first fixing tab or stop element 608a may be joined together with the distal end 606b of the second suture segment and an additional tab or stop element (not shown) using various methods as described herein, such as lamination, to form a transition region 607 (e.g., a connecting segment). For example, in an example, a stacking pattern (e.g., similar to the embodiment of the present invention) is formed by laminating the first stop element 608a to the distal end 606b of the second suture segment 602b and the additional tab. Figure 8-13B ), additional tabs may be used to form a transition zone or connecting segment 607. Thus, in examples herein, a fixing tab or stop element may provide sufficient surface area to laminate the first suture segment 602a and the second suture segment 602b together using RF energy or other means of joining different materials to produce a bidirectional chain. In examples herein, a transition zone or connecting segment 607 may be a transition point between one suture segment and another suture segment (e.g., a transition point between two sutures as described herein). Additionally, according to one or more examples, the transition zone or connecting segment 607 and each corresponding fixing tab or stop element may provide a tactile indicator to a user of the wound closure device indicating that each leg may be properly placed in the tissue. After lamination, in an example, a portion of the connecting segment or transition zone 607 may also be trimmed or stamped out to reduce the size of the transition zone or connecting segment or to change the shape of the transition zone or connecting segment.
[0072] Fig.17 Another example of a wound closure device 700 and a connecting segment 707 thereof according to an example herein is shown. In an example, the wound closure device 700 may have one or more of the other exemplary features or characteristics of the wound closure devices described herein. For example, Fig.17 As shown, the wound closure device 700 may include a first suture segment 702a and a second suture segment 702b, and a connecting segment or transition segment 707 therebetween. The first suture segment 702a and the second suture segment 702b may include a first filamentary element 703a and a second filamentary element 703b according to the examples herein. As shown, the first filamentary element 703a and the second filamentary element 703b may have different lengths (e.g., the first filamentary element 703a may be longer than the second filamentary element 703b).
[0073] As described herein, the first suture segment 702a and the second suture segment 702b can be composed of any suitable surgical suture material (i.e., absorbable and non-absorbable polymer materials, metals, or ceramic materials). In examples, the first suture segment and the second suture segment can be composed of different materials such as PDS and VICRYL (e.g., the first suture segment 702a can be composed of PDS and the second suture segment 702b can be composed of VICRYL). In other examples, the first suture segment 702a and the second suture segment 702b can be composed of the same material.
[0074] like Fig.17 As shown, in one example, the first suture segment 702a may include a plurality of barbs or protrusions 704a extending outwardly from the filamentary element 403a. In addition, as shown in the example, the second suture segment 702b may include a plurality of barbs or protrusions 404b extending outwardly from the filamentary element 703b. As described herein, the barbs or protrusions may be used to increase the fixing strength of the suture and / or eliminate the need for knotting.
[0075] In the example, Fig.17 As shown, the barbs or projections 704a, 704b can be symmetrical. For example, the barbs or projections 704a, 704b can be similar in shape to the corresponding barbs and can extend from the filamentary elements 703a, 703b on a side opposite to the corresponding barbs (e.g., about 180 degrees) and in a direction opposite to the corresponding barbs. According to examples herein, the barbs or projections 704a, 704b can be formed by any suitable method, such as a composite tooth profile stamped from a preformed material and / or any other suitable method as described herein.
[0076] In addition, in an example, barbs or projections 704a, 704b can be asymmetric or spiral (not shown). For example, barbs or projections 704a, 704b can be formed around the filament or therein with an asymmetric pattern such as a spiral pattern, so that the barbs can be inserted into the filament asymmetrically (or spirally) relative to adjacent barbs or formed thereon. In an example, the asymmetric pattern can be a spiral pattern, so that the barbs are inserted or formed on the filament spirally. Barbs or projections such as barbs or projections can be inserted or formed with any other asymmetric pattern. Examples of barbs that can be used herein such as barbs or projections 404b can be described in more detail in U.S. Patent No. 8,721,681 and U.S. Patent No. 8,721,664, both of which are incorporated herein by reference in their entirety. According to examples herein, the barbs or protrusions may be formed by any suitable method, such as being cut, etched, injection molded, laser cut or formed, etc., such as using the exemplary methods described in more detail in U.S. Patent No. 6,848,152, which is incorporated herein by reference in its entirety.
[0077] In another example, one or more of the first suture segment 702a or the second suture segment 702b may include a monofilament or multifilament suture as described herein having different lengths, properties, etc. Thus, the suture segments 702a, 702b may include barbed, unbarbed, and / or any other suture types and properties.
[0078] For example, the first suture line segment 702a and the second suture line segment 702b may include different suture configurations. For example, as described above, the first suture line segment 702a may include a first length to form a first suture configuration. In addition, in an example, the second suture line segment 702b may have a second length to form a second suture configuration. Other characteristics of each suture line segment may also be the same or different, such as color or dye as described herein, filament size or characteristic, barb size, suture type, material, pin and their characteristics etc.
[0079] In one example, the first suture segment 702a may include a first needle or insertion device 701a at its corresponding first proximal end and the second suture segment 702b may include a second needle or insertion device 701b at its corresponding second proximal end. The first needle or insertion device 701a and the second needle or insertion device 701b may be any suitable needle or insertion device configured to pass through tissue. In addition, the first needle or insertion device 701a and the second needle or insertion device 701b may be made of any suitable material such as steel, Ethalloy, etc., may be any suitable shape and size such as straight, curved, etc., and / or may have any other suitable characteristics including tapered incisions, tapered points, blunt heads, etc., so that the first needle or insertion device 701a and the second needle or insertion device 701b may be inserted and may pass through tissue so that the first suture segment 702a and the second suture segment 702b can pass through and approach tissue as described herein. In an example, the first needle or insertion device and the second needle or insertion device may be identical. For example, the first needle or insertion device 701a and the second needle or insertion device 701b may have the same material, shape, size, etc. (i.e., they may have the same properties as each other). In another example, the first needle or insertion device and the second needle or insertion device may be different. For example, the first needle or insertion device 701a and the second needle or insertion device 701b may have different materials, shapes, sizes, etc. (i.e., they may have one or more properties that are different from each other).
[0080] As shown, the first suture segment 702a may include a first distal end 706a and the second suture segment 702b may include a second distal end 706b. The first distal end 706a and the second distal end 706b may have a first fixing tab or stop element 708a and a second fixing tab or stop element (not shown) attached to or formed from them, respectively. The first fixing tab and the second fixing tab may be joined together using various methods as described herein, such as lamination, to form a transition zone 707 (e.g., a connecting segment) between the first suture segment 702a and the second suture segment 702b. Therefore, in the examples herein, the fixing tabs or stop elements may provide sufficient surface area to laminate the two fixing tab surfaces together using RF energy or other methods of joining different materials to produce a bidirectional chain. Additionally, in the examples (e.g., as Figure 8-13B As described above), additional tabs may be used to form a transition zone or connecting segment 707. In examples herein, the transition zone or connecting segment 707 may be a transition point between one suture segment and another suture segment (e.g., a transition point between two sutures as described herein). In addition, according to one or more examples, the transition zone or connecting segment 707 and each corresponding fixing tab or stop element may provide a tactile indicator to a user of the wound closure device that each leg may be properly placed in the tissue. After lamination, in examples, a portion of the connecting segment or transition zone 707 may also be trimmed or stamped out to reduce the size of the transition zone or connecting segment or to change the shape of the transition zone or connecting segment.
[0081] Fig.18 Another example of a wound closure device 800 and a connecting segment 807 thereof according to an example herein is shown. In an example, the wound closure device 800 may have one or more of the other exemplary features or characteristics of the wound closure devices described herein. For example, Fig.18 As shown, the wound closure device 800 may include a first suture segment 802a, a second suture segment 802b, and a third suture segment 802c, and a connecting segment or transition segment 807 therebetween. In an example, as shown by the dashed line, the wound closure device 800 may also include additional suture segments so that the wound closure device 800 may have suitable characteristics, etc., to close a wound.
[0082] The first suture segment 802a, the second suture segment 802b and the third suture segment 802c may include corresponding filamentous elements according to examples herein. As described herein, the first suture segment 802a, the second suture segment 802b and the third suture segment 802c may be made of any suitable surgical suture material (i.e., absorbable and non-absorbable polymer materials, metals or ceramic materials). In an example, the first suture segment 802a, the second suture segment 802b and the third suture segment 802c may be made of different materials such as PDS and VICRYL (e.g., the first suture segment 802a may be made of PDS and the second suture segment 802b and the third suture segment may be made of VICRYL and / or any other combination thereof). In other examples, the first suture segment 802a, the second suture segment 802b and the third suture segment 802c may be made of the same material.
[0083] like Fig.18 As shown, in one example, the first suture segment 802a, the second suture segment 802b and the third suture segment 802c may include a plurality of barbs or projections extending outwardly from the filamentary element. As described herein, barbs or projections can be used to increase the fixing strength of suture and / or eliminate the need for knotting. As described herein, barbs or projections can be symmetrical. In addition, in an example, barbs or projections can be asymmetric or spiral (not shown) as described herein. In another example, one or more of the first suture segment 802a, the second suture segment 802b and the third suture segment 802c may include monofilament or multifilament sutures with different lengths, characteristics, etc. as described herein. Therefore, the first suture segment 802a, the second suture segment 802b and the third suture segment 802c may include barbs, no barbs and / or any other suture type and characteristics.
[0084] For example, the first suture segment 802a, the second suture segment 802b and the third suture segment 802c may include different suture configurations. For example, as described above, the first suture segment 802a may include a first set of characteristics or features to form a first suture configuration. In addition, in an example, the second suture segment 802b may include a second set of characteristics or features to form a second suture configuration. In addition, the third suture segment 803c may include a third set of characteristics or features to form a third suture configuration. One or more configurations in these configurations may be the same and / or different. In an example, the feature or characteristics of each suture segment may include one or more of the following as described herein, which may be the same or different: length, color or dye, filament size or characteristics, barb size, suture type, material, needle and their characteristics, etc.
[0085] In one example, the first suture segment 802a, the second suture segment 802b, and the third suture segment 802c may include a needle or insertion device (not shown) at their respective proximal ends. The first needle or insertion device and the second needle or insertion device (e.g., similar to 101a, 101b) may be any suitable needle or insertion device configured to pass through tissue. In addition, the needle or insertion device may be made of any suitable material such as steel, Ethalloy, etc., may be any suitable shape and size such as straight, curved, etc., and / or may have any other suitable characteristics including a tapered incision, a tapered point, a blunt head, etc., so that the needle or insertion device can be inserted and can pass through the tissue so that the first suture segment 802a, the second suture segment 802b, and the third suture segment 802c can pass through and approach the tissue as described herein. In an example, the needle or insertion device may be the same. For example, the needle or insertion device may have the same material, shape, size, etc. (i.e., they may have the same characteristics as each other). In another example, the needle or insertion device may be different. For example, the needles or insertion devices may have different materials, shapes, sizes, etc. (ie, they may have one or more properties that differ from each other).
[0086] As described herein, in one or more examples, the first suture segment 802a, the second suture segment 802b, and the third suture segment 802c may include corresponding distal ends. The distal ends of the suture segments may respectively have a fixing tab or stop element attached to or formed from the distal end as described herein. The fixing tabs may be joined together using various methods as described herein, such as lamination, to form a transition zone 807 (e.g., a connecting segment) between the first suture segment 802a, the second suture segment 802b, and the third suture segment 802c. Therefore, in the examples herein, the fixing tabs or stop elements may provide sufficient surface area to laminate the fixing tab surfaces together using RF energy or other methods of joining different materials to produce a bidirectional chain. In addition, in the examples (e.g., as Figure 8-13B As described above), additional tabs may be used to form a transition zone or connecting segment 807. In examples herein, the transition zone or connecting segment 807 may be a transition point between one suture segment and another suture segment (e.g., a transition point between two sutures as described herein). In addition, according to one or more examples, the transition zone or connecting segment 807 and each corresponding fixing tab or stop element may provide a tactile indicator to a user of the wound closure device that each leg may be properly placed in the tissue. After lamination, in examples, a portion of the connecting segment or transition zone 807 may also be trimmed or stamped out to reduce the size of the transition zone or connecting segment or to change the shape of the transition zone or connecting segment.
[0087] Various aspects of the wound closure devices and subject matter described herein may be set forth in the following example sets, which may be independent of or combined with other example sets.
[0088] Example set 1.
[0089] Embodiment 1 - A wound closure device may be provided. The wound closure device includes: a first suture segment having a first suture configuration; a second suture segment having a second suture configuration, the second suture segment being different from the first suture segment; and a connecting segment configured to provide a transition from the first suture segment to the second suture segment.
[0090] Embodiment 2 - The wound closure device according to embodiment 1, wherein the first suture configuration includes a first plurality of barbs having a first barb size, the first plurality of barbs extending from a first filamentary element having a first filament size.
[0091] Embodiment 3 - The wound closure device according to embodiment 1 and / or 2, wherein the second suture configuration comprises a second plurality of barbs having a second barb size, the second plurality of barbs extending from a second filamentary element having a second filament size.
[0092] Embodiment 4 - The wound closure device according to embodiment 3, wherein the first barb size and the second barb size are different.
[0093] Embodiment 5 - The wound closure device according to embodiment 3, wherein the first filament size and the second filament size are the same.
[0094] Embodiment 6 - The wound closure device according to one or more of embodiments 2-5, wherein the first filament size and the second filament size are different.
[0095] Embodiment 7 - The wound closure device of one or more of Embodiments 3-6, wherein the first plurality of barbs have a first shape and the second plurality of barbs have a second shape, wherein the first shape and the second shape are different.
[0096] Example 8 - The wound closure device according to one or more of Examples 1-7, wherein the first suture segment has a first proximal end and a first distal end, the first distal end having a first stop element integrally formed from the first distal end, and the second suture segment has a second proximal end and a second distal end, the second distal end having a second stop element integrally formed from the second distal end, and wherein the connecting segment includes at least a portion of the first stop element laminated to at least a portion of the second stop element.
[0097] Example 9 - The wound closure device according to Example 8 also includes a third stop element separated from the first suture segment and the second suture segment and the first stop element and the second stop element, wherein the connecting segment includes at least a portion of the third stop element laminated to at least a portion of the first stop element and the second stop element.
[0098] Embodiment 10 - The wound closure device of one or more of Embodiments 3-9, wherein the first plurality of barbs comprises symmetrical barbs and the second plurality of barbs comprises helical barbs.
[0099] Embodiment 11 - The wound closure device of one or more of Embodiments 1-10, wherein the first suture segment comprises a first polymer material and the second suture segment comprises a second polymer material.
[0100] Embodiment 12 - The wound closure device according to Embodiment 11, wherein the first polymer material and the second polymer material are the same.
[0101] Embodiment 13 - The wound closure device according to Embodiment 11, wherein the first polymer material and the second polymer material are different.
[0102] Embodiment 14 - The wound closure device according to Embodiment 11, wherein the first polymer material and the second polymer material are non-polar materials configured to be plasma treated to produce a polar substrate prior to forming the connecting segment.
[0103] Embodiment 15 - The wound closure device according to one or more of embodiments 1-14, wherein the second suture configuration comprises a second filamentary element having a second filament size.
[0104] Embodiment 16 - The wound closure device according to embodiment 15, wherein the first filament size and the second filament size are the same.
[0105] Embodiment 17 - The wound closure device according to embodiment 15, wherein the first filament size and the second filament size are different.
[0106] Example 18 - The wound closure device according to Example 15, wherein the second filamentary element comprises a monofilament.
[0107] Example 19 - The wound closure device according to Example 15, wherein the second filamentary element comprises multiple filaments.
[0108] Embodiment 20 - The wound closure device according to one or more of embodiments 1-19, wherein the first suture configuration has a first color and the second suture configuration has a second color, and wherein the first color and the second color are different from each other.
[0109] Example 21 - The wound closure device according to one or more of Examples 1-20, wherein the first suture segment includes a first filamentary element having a first length and the second suture segment includes a second filamentary element having a second length, wherein the first length and the second length are different.
[0110] Example set 2.
[0111] Embodiment 1 - A wound closure device may be provided. The wound closure device includes: a first suture segment, the first suture segment including a first filamentary element and a first plurality of barbs extending from the first filamentary element, the first suture segment having a first proximal end and a first distal end, the first proximal end having a needle attached to the first proximal end and the first distal end having a first stop element integrally formed from the first distal end, the first suture segment having a first suture configuration; a second suture segment, the second suture segment including a second filamentary element and a second plurality of barbs extending from the second filamentary element, the second suture segment having a second proximal end and a second distal end, the second proximal end having a needle attached to the second proximal end and the second distal end having a stop element integrally formed from the second distal end, the second suture segment having a second suture configuration, the second suture segment being different from the first suture segment; and a connecting segment configured to join the first suture segment and the second suture segment, the connecting segment including at least a portion of the first stop element laminated to at least a portion of the second stop element.
[0112] Example 2 - The wound closure device according to Example 1 also includes a third stop element separated from the first suture segment and the second suture segment and the first stop element and the second stop element, wherein the connecting segment includes at least a portion of the third stop element laminated to at least a portion of the first stop element and the second stop element.
[0113] Embodiment 3 - The wound closure device according to one or more of embodiments 1 and / or 2, wherein the first suture configuration comprises the first plurality of barbs having a first barb size.
[0114] Embodiment 4 - The wound closure device according to Embodiment 3, wherein the second suture configuration comprises the second plurality of barbs having a second barb size.
[0115] Embodiment 5 - The wound closure device according to one or more of embodiments 3 and / or 4, wherein the first barb size and the second barb size are different.
[0116] Embodiment 6 - The wound closure device according to one or more of embodiments 2-5, wherein the first filament size and the second filament size are the same.
[0117] Embodiment 7 - The wound closure device according to one or more of embodiments 2-5, wherein the first filament size and the second filament size are different.
[0118] Embodiment 8 - The wound closure device according to one or more of embodiments 2-7, wherein the first suture configuration comprises the first plurality of barbs being symmetrical and the second suture configuration comprises the second plurality of barbs being helical.
[0119] Embodiment 9 - The wound closure device according to one or more of embodiments 1-8, wherein the first suture configuration has a first color and the second suture configuration has a second color, and wherein the first color and the second color are different from each other.
[0120] Example set 3.
[0121] Embodiment 1 - A wound closure device may be provided. The wound closure device includes: a first suture segment, the first suture segment including a first filamentary element and a first plurality of barbs, the first suture segment having a first proximal end and a first distal end, the first proximal end having a needle attached to the first proximal end and the first distal end having a first stop element integrally formed from the first distal end; a second suture segment, the second suture segment including a second filamentary element, the second suture segment having a second proximal end and a second distal end, the second proximal end having a needle attached to the second proximal end; a second stop element, the second stop element being separate from the first suture segment and the second suture segment; and a connecting segment, the connecting segment being configured to join the first suture segment and the second suture segment, the connecting segment including at least a portion of the first stop element laminated to at least a portion of the second stop element, wherein at least a portion of the second distal end of the suture configuration is laminated between the portion of the first stop element and the portion of the second stop element.
[0122] Embodiment 2 - The wound closure device according to embodiment 1, wherein the first suture configuration includes the first filamentary element having a first filament size and the second suture configuration includes the second filamentary element having a second filament size.
[0123] Embodiment 3 - The wound closure device according to embodiment 2, wherein the first filament size and the second filament size are the same.
[0124] Embodiment 4 - The wound closure device according to embodiment 2, wherein the first filament size and the second filament size are different.
[0125] Embodiment 5 - The wound closure device according to one or more of embodiments 1-4, wherein the second suture configuration includes the second filamentary element being a monofilament.
[0126] Embodiment 6 - The wound closure device according to one or more of embodiments 1-4, wherein the second suture configuration includes the second filamentary element being multifilament.
[0127] Embodiment 7 - The wound closure device according to one or more of embodiments 1-6, wherein the first suture configuration has a first color and the second suture configuration has a second color, and wherein the first color and the second color are different from each other.
[0128] Example set 3.
[0129] Embodiment 1 - A wound closure device may be provided. The wound closure device includes: a first suture segment, the first suture segment having a first suture configuration; a second suture segment, the second suture segment having a second suture configuration, the second suture segment being different from the first suture segment; a third suture segment, the third suture segment having a third suture configuration, the third suture segment being different from at least one of the first suture segment and the second suture segment; and a connecting segment, the connecting segment being configured to provide a transition from the first suture segment to the second suture segment.
[0130] Embodiment 2 - The wound closure device according to embodiment 1, wherein the first suture configuration includes a first plurality of barbs having a first barb size, the first plurality of barbs extending from a first filamentary element having a first filament size.
[0131] Embodiment 3 - The wound closure device according to embodiment 1 and / or 2, wherein the second suture configuration comprises a second plurality of barbs having a second barb size, the second plurality of barbs extending from a second filamentary element having a second filament size.
[0132] Embodiment 4 - The wound closure device of Embodiments 1-3, wherein the second suture configuration comprises a third plurality of barbs having a third barb size, the third plurality of barbs extending from a third filamentary element having a third filament size.
[0133] Embodiment 5 - The wound closure device according to Embodiment 4, wherein at least one of the first barb size, the second barb size, and the third filament size is different.
[0134] Embodiment 6 - The wound closure device according to embodiment 4, wherein the first filament size, the second filament size and the third filament size are the same.
[0135] Embodiment 7 - The wound closure device according to one or more of embodiments 2-6, wherein the first filament size, the second filament size and the third filament size are different.
[0136] Example 8 - The wound closure device according to one or more of Examples 2-7, wherein the first plurality of barbs have a first shape, the second plurality of barbs have a second shape, and the third plurality of barbs have a third shape, wherein at least one of the first shape, the second shape and the third shape are different.
[0137] Example 9 - The wound closure device according to one or more of Examples 2-8, wherein the first suture segment has a first proximal end and a first distal end, the first distal end has a first stop element integrally formed from the first distal end, the second suture segment has a second proximal end and a second distal end, the second distal end has a second stop element integrally formed from the second distal end, and the third suture segment has a third proximal end and a third distal end, the third distal end has a third stop element integrally formed from the third distal end, and wherein the connecting segment includes at least a portion of the first stop element laminated to at least a portion of the second stop element and at least a portion of the second stop element laminated to at least a portion of the third stop element.
[0138] Example 10 - The wound closure device according to Example 9 also includes a fourth stop element, which is separated from the first suture segment, the second suture segment and the third suture segment and the first stop element, the second stop element and the third stop element, wherein the connecting segment includes at least a portion of the fourth stop element laminated to at least a portion of at least one of the first stop element and the third stop element.
[0139] Example 11 - The wound closure device according to one or more of Examples 2-10, wherein at least one of the first plurality of barbs, the second plurality of barbs, and the third plurality of barbs comprises symmetrical barbs and at least one of the first plurality of barbs, the second plurality of barbs, or the third plurality of barbs comprises spiral barbs.
[0140] Embodiment 12 - The wound closure device according to one or more of embodiments 1-11, wherein the first suture segment comprises a first polymer material, the second suture segment comprises a second polymer material, and the third suture segment comprises a third polymer material.
[0141] Embodiment 13 - The wound closure device of Embodiment 12, wherein the first polymeric material, the second polymeric material and the third polymeric material are the same.
[0142] Embodiment 14 - The wound closure device of Embodiment 12, wherein at least one of the first polymeric material, the second polymeric material, and the third polymeric material are different.
[0143] Embodiment 15 - The wound closure device according to Embodiment 12, wherein at least one of the first polymer material, the second polymer material and the third polymer material is a non-polar material configured to be plasma treated to produce a polar substrate prior to forming the connecting segment.
[0144] Example 16 - The wound closure device of one or more of Examples 1-3, wherein the third suture configuration comprises a third filamentary element having a third filament size.
[0145] Example 17 - The wound closure device according to Example 16, wherein the first filament size, the second filament size and the third filament size are the same.
[0146] Embodiment 18 - The wound closure device according to Embodiment 16, wherein at least one of the first filament size, the second filament size and the third filament size is different.
[0147] Embodiment 19 - The wound closure device according to one or more of embodiments 16-18, wherein the third filamentary element comprises a monofilament.
[0148] Embodiment 20 - The wound closure device according to one or more of embodiments 16-18, wherein the third filamentary element comprises multiple filaments.
[0149] Example 21 - The wound closure device according to one or more of Examples 1-20, wherein the first suture configuration has a first color, the second suture configuration has a second color, and the third suture configuration has a third color, wherein at least one of the first color, the second color, and the third color is different from the other colors.
[0150] Example 22 - The wound closure device according to one or more of Examples 1-21, wherein the first suture segment includes a first filamentary element having a first length, the second suture segment includes a second filamentary element having a second length, and the third suture segment includes a third filamentary element having a third length, wherein at least one of the first length, the second length and the third length is different from the other lengths.
[0151] It should be understood that any type of instrument described herein may also include various other features in addition to or as an alternative to those described above. By way of example only, any of the instruments described herein may also include one or more of the various characteristic structures disclosed in any of the various references incorporated herein by reference. It should also be understood that the teachings herein may be easily applied to any instrument described in any other reference cited herein, so that the teachings herein may be easily combined with the teachings in any reference cited herein in a variety of ways. In addition, those of ordinary skill in the art will recognize that the various teachings herein may be easily applied to electrosurgical instruments, suturing instruments, and other types of surgical instruments. Other types of instruments that may be combined with the teachings herein will be apparent to those of ordinary skill in the art.
[0152] It should be understood that any patent, patent publication, or other public material, whether in whole or in part, allegedly incorporated herein by reference is incorporated herein only to the extent that the incorporated material does not conflict with existing definitions, statements, or other public materials described in the present disclosure. Therefore, and to the extent necessary, the disclosure explicitly listed herein supersedes any conflicting material incorporated herein by reference. Any material or portion thereof allegedly incorporated herein but conflicting with existing definitions, statements, or other public materials listed herein will be incorporated only to the extent that there is no conflict between the incorporated material and the existing public materials.
[0153] The above-described device versions may be used in conventional medical treatments and surgeries performed by medical professionals, as well as robotic-assisted medical treatments and surgeries. By way of example only, the various teachings herein may be readily incorporated into a robotic surgical system, such as the DAVINCI® by Intuitive Surgical, Inc. (Sunnyvale, California). TM Similarly, one of ordinary skill in the art will recognize that the various teachings herein may be readily combined with the various teachings of U.S. Patent No. 6,783,524, entitled “Robotic Surgical Tool with Ultrasound Cauterizing and Cutting Instrument,” issued on August 31, 2004, the disclosure of which is incorporated herein by reference.
[0154] The versions described above can be designed to be discarded after a single use, or they can be designed to be used multiple times. In either case or both, these patterns can be repaired for reuse after at least one use. Repair can include any combination of the following steps: disassembly of the device, then cleaning or replacing specific parts and subsequently reassembling. Specifically, some types of devices can be disassembled, and any number of specific parts or parts of the device can be selectively replaced or removed in any combination. When cleaning and / or replacing specific parts, some types of the device can be reassembled at a repair facility or reassembled by the user before surgery is about to be performed for subsequent use. Those skilled in the art will appreciate that the repair of the device can be disassembled, cleaned / replaced, and reassembled using a variety of techniques. The use of such technology and the resulting repair device are all within the scope of the present application.
[0155] By way of example only, the types described herein may be sterilized before and / or after surgery. In one sterilization technique, the device is placed in a closed and sealed container such as a plastic bag or a TYVEK bag. The container and device may then be placed in a field of radiation that can penetrate the container, such as gamma radiation, x-rays, or high-energy electrons. The radiation may kill bacteria on the device and in the container. The sterilized device may then be stored in a sterile container for later use. The device may also be sterilized using any other technique known in the art, including but not limited to beta or gamma radiation, ethylene oxide, or steam.
[0156] Various embodiments of the present invention have been shown and described, and further improvements of the methods and systems described herein may be achieved by appropriate modifications by those of ordinary skill in the art without departing from the scope of the present invention. Several such possible modifications have been mentioned, and other modifications will be apparent to those of skill in the art. For example, the embodiments, embodiments, geometries, materials, dimensions, ratios, steps, etc. discussed above are illustrative and not required. Therefore, the scope of the present invention should be considered in light of the following claims, and should be understood not to be limited to the details of the structure and operation shown and described in the specification and drawings.
Claims
1. A wound closure device, comprising: a first suture segment having a first suture configuration, wherein the first suture segment has a first proximal end and a first distal end, the first distal end having a first stop element integrally formed therefrom; a second suture segment having a second suture configuration, the second suture segment being different from the first suture segment, wherein the second suture segment has a second proximal end and a second distal end, the second distal end having a second stop element integrally formed therefrom; and A connecting segment is configured to provide a transition from the first suture segment to the second suture segment, wherein the connecting segment includes at least a portion of the first retaining element laminated to at least a portion of the second retaining element.
2. The wound closure device of claim 1, wherein the first suture configuration comprises a first plurality of barbs having a first barb size, the first plurality of barbs extending from a first filamentary element having a first filament size.
3. The wound closure device of claim 2, wherein the second suture configuration comprises a second plurality of barbs having a second barb size, the second plurality of barbs extending from a second filamentary element having a second filament size.
4. The wound closure device of claim 3, wherein the first barb size and the second barb size are different.
5. The wound closure device of claim 3, wherein the first filament size and the second filament size are the same.
6. The wound closure device of claim 3, wherein the first filament size and the second filament size are different.
7. The wound closure device of claim 3, wherein the first plurality of barbs have a first shape and the second plurality of barbs have a second shape, wherein the first shape and the second shape are different.
8. The wound closure device of claim 3, further comprising a third stop element separate from the first suture segment and the second suture segment and the first stop element and the second stop element, wherein the connecting segment comprises at least a portion of the third stop element laminated to at least a portion of the first stop element and the second stop element.
9. The wound closure device of claim 3, wherein the first plurality of barbs comprises symmetrical barbs and the second plurality of barbs comprises helical barbs.
10. The wound closure device of claim 3, wherein the first suture segment comprises a first polymer material and the second suture segment comprises a second polymer material.
11. The wound closure device of claim 10, wherein the first polymer material and the second polymer material are the same.
12. The wound closure device of claim 10, wherein the first polymeric material and the second polymeric material are different.
13. The wound closure device of claim 10, wherein the first polymer material and the second polymer material are non-polar materials configured to be plasma treated to produce a polar substrate prior to forming the connecting segment.
14. The wound closure device of claim 2, wherein the second suture configuration comprises a second filamentary element having a second filament size.
15. The wound closure device of claim 14, wherein the first filament size and the second filament size are the same.
16. The wound closure device of claim 14, wherein the first filament size and the second filament size are different.
17. The wound closure device of claim 14, wherein the second filamentary element comprises a monofilament.
18. The wound closure device of claim 14, wherein the second filamentary element comprises multiple filaments.
19. The wound closure device of claim 1, wherein the first suture configuration has a first color and the second suture configuration has a second color, and wherein the first color and the second color are different from each other.
20. The wound closure device of claim 1, wherein the first suture segment comprises a first filamentary element having a first length and the second suture segment comprises a second filamentary element having a second length, wherein the first length and the second length are different.
21. A wound closure device, comprising: a first suture segment, the first suture segment comprising a first filamentary element and a first plurality of barbs extending from the first filamentary element, the first suture segment having a first proximal end and a first distal end, the first proximal end having a needle attached to the first proximal end and the first distal end having a first stop element integrally formed from the first distal end, the first suture segment having a first suture configuration; a second suture segment, the second suture segment comprising a second filamentary element and a second plurality of barbs extending from the second filamentary element, the second suture segment having a second proximal end and a second distal end, the second proximal end having a needle attached to the second proximal end and the second distal end having a second stop element integrally formed from the second distal end, the second suture segment having a second suture configuration, the second suture segment being different from the first suture segment; and A connecting segment is configured to join the first suture segment and the second suture segment, the connecting segment comprising at least a portion of the first retaining element laminated to at least a portion of the second retaining element.
22. The wound closure device of claim 21, further comprising a third stop element separate from the first suture segment and the second suture segment and the first stop element and the second stop element, wherein the connecting segment comprises at least a portion of the third stop element laminated to at least a portion of the first stop element and the second stop element.
23. The wound closure device of claim 21, wherein the first suture configuration comprises the first plurality of barbs having a first barb size, the first plurality of barbs extending from a first filamentary element having a first filament size.
24. The wound closure device of claim 23, wherein the second suture configuration comprises the second plurality of barbs having a second barb size, the second plurality of barbs extending from a second filamentary element having a second filament size.
25. The wound closure device of claim 24, wherein the first barb size and the second barb size are different.
26. The wound closure device of claim 24, wherein the first filament size and the second filament size are the same.
27. The wound closure device of claim 24, wherein the first filament size and the second filament size are different.
28. The wound closure device of claim 21, wherein the first suture configuration comprises the first plurality of barbs being symmetrical and the second suture configuration comprises the second plurality of barbs being helical.
29. The wound closure device of claim 21, wherein the first suture configuration has a first color and the second suture configuration has a second color, and wherein the first color and the second color are different from each other.
30. A wound closure device, comprising: a first suture segment, the first suture segment comprising a first filamentary element and a first plurality of barbs, the first suture segment having a first proximal end and a first distal end, the first proximal end having a needle attached to the first proximal end and the first distal end having a first stop element integrally formed from the first distal end, the first suture segment having a first suture configuration; a second suture segment, the second suture segment comprising a second filamentary element, the second suture segment having a second proximal end and a second distal end, the second proximal end having a needle attached to the second proximal end, the second suture segment having a second suture configuration; a second stop element that is decoupled from the first suture segment and the second suture segment; and and a connecting segment configured to join the first suture segment and the second suture segment, the connecting segment comprising at least a portion of the first stop element laminated to at least a portion of the second stop element, wherein at least a portion of the second distal end of the second suture configuration is laminated between the portion of the first stop element and the portion of the second stop element.
31. The wound closure device of claim 30, wherein the first suture configuration comprises the first filamentary element having a first filament size and the second suture configuration comprises the second filamentary element having a second filament size.
32. The wound closure device of claim 31 , wherein the first filament size and the second filament size are the same.
33. The wound closure device of claim 31 , wherein the first filament size and the second filament size are different.
34. The wound closure device of claim 30, wherein the second suture configuration comprises the second filamentary element being a monofilament.
35. The wound closure device of claim 30, wherein the second suture configuration comprises the second filamentary element being multifilament.
36. The wound closure device of claim 30, wherein the first suture configuration has a first color and the second suture configuration has a second color, and wherein the first color and the second color are different from each other.
37. A wound closure device, comprising: a first suture segment having a first suture configuration, wherein the first suture segment has a first proximal end and a first distal end, the first distal end having a first stop element integrally formed therefrom; a second suture segment having a second suture configuration, the second suture segment being different from the first suture segment, wherein the second suture segment has a second proximal end and a second distal end, the second distal end having a second stop element integrally formed therefrom; a third suture segment having a third suture configuration, the third suture segment being different from at least one of the first suture segment and the second suture segment, wherein the third suture segment has a third proximal end and a third distal end, the third distal end having a third stop element integrally formed therefrom; and A connecting segment configured to provide a transition from the first suture segment to the second suture segment, wherein the connecting segment includes at least a portion of the first stop element laminated to at least a portion of the second stop element and at least a portion of the second stop element laminated to at least a portion of the third stop element.
38. The wound closure device of claim 37, wherein the first suture configuration comprises a first plurality of barbs having a first barb size, the first plurality of barbs extending from a first filamentary element having a first filament size.
39. The wound closure device of claim 38, wherein the second suture configuration comprises a second plurality of barbs having a second barb size, the second plurality of barbs extending from a second filamentary element having a second filament size.
40. The wound closure device of claim 39, wherein the third suture configuration comprises a third plurality of barbs having a third barb size extending from a third filamentary element having a third filament size.
41. The wound closure device of claim 40, wherein at least one of the first barb size, the second barb size, and the third barb size are different.
42. The wound closure device of claim 40, wherein the first filament size, the second filament size, and the third filament size are the same.
43. The wound closure device of claim 40, wherein the first filament size, the second filament size, and the third filament size are different.
44. The wound closure device of claim 40, wherein the first plurality of barbs have a first shape, the second plurality of barbs have a second shape, and the third plurality of barbs have a third shape, wherein at least one of the first shape, the second shape, and the third shape are different.
45. The wound closure device according to claim 40 further includes a fourth stop element, which is separated from the first suture segment, the second suture segment and the third suture segment and the first stop element, the second stop element and the third stop element, wherein the connecting segment includes at least a portion of the fourth stop element laminated to at least a portion of at least one of the first stop element and the third stop element.
46. The wound closure device of claim 40, wherein at least one of the first plurality of barbs, the second plurality of barbs, and the third plurality of barbs comprises symmetrical barbs and at least one of the first plurality of barbs, the second plurality of barbs, or the third plurality of barbs comprises helical barbs.
47. The wound closure device of claim 40, wherein the first suture segment comprises a first polymer material, the second suture segment comprises a second polymer material, and the third suture segment comprises a third polymer material.
48. The wound closure device of claim 47, wherein the first polymeric material, the second polymeric material, and the third polymeric material are the same.
49. The wound closure device of claim 47, wherein at least one of the first polymeric material, the second polymeric material, and the third polymeric material are different.
50. The wound closure device of claim 47, wherein at least one of the first polymeric material, the second polymeric material, and the third polymeric material is a non-polar material configured to be plasma treated to produce a polar substrate prior to forming the connecting segment.
51. The wound closure device of claim 39, wherein the third suture configuration comprises a third filamentary element having a third filament size.
52. The wound closure device of claim 51, wherein the first filament size, the second filament size, and the third filament size are the same.
53. The wound closure device of claim 51 , wherein at least one of the first filament size, the second filament size, and the third filament size are different.
54. The wound closure device of claim 51, wherein the third filamentary element comprises a monofilament.
55. The wound closure device of claim 51, wherein the third filamentary element comprises multiple filaments.
56. The wound closure device of claim 37, wherein the first suture configuration has a first color, the second suture configuration has a second color, and the third suture configuration has a third color, wherein at least one of the first color, the second color, and the third color is different from the other colors.
57. A wound closure device according to claim 37, wherein the first suture segment includes a first filamentary element having a first length, the second suture segment includes a second filamentary element having a second length, and the third suture segment includes a third filamentary element having a third length, wherein at least one of the first length, the second length, and the third length is different from the other lengths.
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