JP2018526130A - Improved end effector for wound closure devices - Google Patents

Abstract

A suturing device comprising an improved weld anchoring device at the distal end to provide improved retention strength during and after implantation of sutures in tissue. The weld fixing device can be a composite fixing tab comprising a first layer and a second layer welded to the first layer.

Description

  The present invention relates generally to the field of medical devices, and more particularly to barbed suturing devices having improved end effectors.

  Many wounds and surgical incisions are closed using surgical sutures or some other surgical closure device. Self-holding sutures, also known as barbed sutures, are well known and attract attention for a variety of medical applications. Typically, a self-holding suture is a series of retainers (also referred to as “barbs” or “protrusions”) that extend outward from the suture to increase the holding strength of the suture and / or eliminate the need for a knot. And is used interchangeably herein).

  Certain types of sutures and barbed sutures have an end effector at the distal end of the suture that provides a “stop” at the end that prevents the suture from being completely pulled out of the tissue. At the same time, it is also known that the holding strength of the suture is increased, and a knot is not required for fixing the suture. Examples of the end effector include an anchor, a knot, a tab, and a loop. According to the conventional idea, the greater the surface area of the stop in the direction perpendicular to the suture insertion direction, the higher the holding strength that can be achieved. However, thick or other large end effectors are practically limited in size, however, as they may not be tolerated in surgical procedures and / or may be undesirable because they are palpable. One suitable end effector is found in US Patent Application Publication No. 2013/0085525.

  Although this end effector is effective, the present invention seeks to provide an improved end effector that not only provides increased stopping and holding forces, but also demonstrates tolerance in surgical procedures. .

  In one embodiment, the present invention provides an elongated suture body having a proximal end and a distal end, the body extending along a central axis, a weld or adhesive securing tab attached to the distal end, A composite suturing device comprising: a composite securing tab having a top surface and a bottom surface, the first comprising a thickness therebetween, a length extending parallel to the central axis, and a width extending perpendicular to the central axis. And a second layer having a top surface and a bottom surface, a thickness between them, a length extending parallel to the central axis, and a width extending perpendicular to the central axis. The composite suturing device includes a lower surface welded to the upper surface of the first layer.

  The present invention also includes a method of using such a suturing device.

  In another embodiment, the present invention includes a method of forming a suturing device having a welded or adhesive securing tab, the method comprising forming the suturing device from a preform ribbon having a desired thickness configuration. The suturing device comprises a proximal end and a distal end with a body extending along a central axis, a securing tab, the securing tab including an upper surface and a lower surface, and including a length, a width and a thickness Adding an end attachment to the upper surface of the securing tab, the end attachment being formed from the same preform ribbon as the suturing device, the end attachment having a length and width substantially similar to the securing tab; And welding the securing tab and the end attachment together to form a composite securing tab.

1 shows a prior art suturing device having a rectangular end effector. FIG. 2 is a side view of the end effector of the suture of FIG. 1 when viewed along a central axis. FIG. 1 is a top view of a suturing device including an end welded form of an end effector and a separate end attachment. FIG. FIG. 3B is a side view of the suturing device of FIG. 3A with the end attachment and end effector positioned adjacent to each other. 3B is a top view of the suturing device of FIG. 3B after welding the end attachment and end effector together. FIG. 3D is a side view of the welded suturing device of FIG. 3C. FIG. FIG. 3 is a top view of a suturing device including an end-effector in an unwelded form and a separate end attachment in a vertical orientation. FIG. 4B is a top view of the suturing device of FIG. 4A after welding the end effector and the end attachment together. FIG. 4B is a side view of the suturing device of FIG. 4B. 1 is a top view of a suturing device including an end-effector in an unwelded form and two separate end attachments, each in a parallel orientation. FIG. FIG. 5B is a top view of the suturing device of FIG. 5A after the end effector and end attachment are welded together. FIG. 5B is a side view of the suturing device of FIG. 5B. FIG. 6 is a top view of a suturing device including an end effector in an unwelded form and separate end attachments each in a vertical orientation. FIG. 6B is a top view of the suturing device of FIG. 6A after the end effector and end attachment are welded together. FIG. 6B is a side view of the suturing device of FIG. 6B. FIG. 6 is a top view of a suturing device including an end welded form of an end effector and a separate foldable end attachment. FIG. 7B is a top view of the suturing device of FIG. 7A after welding the end effector and the foldable end attachment together. FIG. 7B is a side view of the suturing device of FIG. 7B. FIG. 6 is a top view of a suturing device including an end effector in an unwelded form and a separate foldable end attachment with a central opening. FIG. 8B is a top view of the suturing device of FIG. 8A after the end effector and end attachment are welded together. FIG. 8B is a side view of the suturing device of FIG. 8B. FIG. 3 is a top view of a suturing device including a foldable end effector in an unwelded form. FIG. 9B is a top view of the suturing device of FIG. 9A after the end effector is folded and welded. FIG. 9B is a side view of the suturing device of FIG. 9B. 1 is a top view of a suturing device including an elongate foldable end effector in an unwelded form. FIG. FIG. 10B is a top view of the suturing device of FIG. 10A after the end effector is folded and welded. FIG. 10B is a side view of the suturing device of FIG. 10B. FIG. 10 is a top view of a suturing device including a foldable end effector having a distal prong in an unwelded form. FIG. 11B is a top view of the suturing device of FIG. 11A after the end effector is folded and welded. FIG. 11B is a side view of the suturing device of FIG. 11B. 2 is a graph of the shear strength of various weld forms. Figure 6 is a plot of the starting strength of various end effector configurations in porcine fascia. FIG. 6 is a correlation plot of starting strength versus shear strength for multiple end effector configurations.

  The present invention provides a wound closure device having a filamentary body having a proximal end and a distal end, and a stop element at the distal end of the filamentous body, the device being a self-holding suture. May be. The suture may be formed by any suitable method, but preferably is preformed in the manner described in further detail in US Patent Application Publication No. 2007/0257395, which is hereby incorporated by reference in its entirety. A composite profile stamped from a ribbon or strip material. In some embodiments, the stop element may be substantially flat and may have a rectangular or square-like shape, or in other embodiments may have a more oval or circular shape. As used herein, the term “stop element” refers to a device at the rear end (or distal) of a suture and may also be referred to as an “anchor” or “end effector”. One type of end effector that may be useful in the present invention includes those described in US Patent Application Publication No. 2013/0085525, the entire contents of which are hereby incorporated by reference. While the aforementioned end effectors are useful, the present invention provides an improved end effector that provides enhanced stopping and holding forces while avoiding intolerance and other problems during and after surgical procedures. It is something to try.

  FIG. 1 shows a prior art suturing device 100 comprising an end effector 108 located at the distal end (106) of an elongate suture body 102 in the form of a tab (also referred to as a “fixation tab”). The suture body 102 has a central longitudinal axis between its distal end and the opposite proximal end (not visible), where the proximal end is the insertion end and a tissue piercing feature such as a needle. May comprise a part. For self-holding sutures, the body 102 may include a plurality of retainers 104, and the retainers 104 are disposed along the suture body 102, for example, symmetrically, in any arrangement including a helix, or in a random orientation. Can be done.

  As can be seen, the end effector 108 is generally rectangular in length and width and comprises a leading edge 110 defined by a leading edge thickness (t), a leading edge width (w), and has a length (l). Also have. As used herein and as can be seen from this figure, the length of the end effector is parallel to the central longitudinal axis of the suture body 102. The width of the end effector 108 is substantially perpendicular to the central long axis of the filamentous element. In the device as seen in FIG. 1, the suturing device 100 may be formed from a single preform or ribbon of suitable material, where the device 100 is die cut or stamped into the desired shape. Or it is stamped with a different shape. In such an embodiment, the suture body 102 and the end effector 108 are stamped from the same preform and are thus a single unitary structure.

  As used herein in connection with each of the components, and throughout this application, the term “proximal” shall refer to the end inserted into the tissue of the suturing device, while the term “distal”. Refers to the end opposite the insertion end of the suturing device. In the suturing device of FIG. 1, the distal end includes an end effector 108 and the insertion end (not shown) may be the farthest end along the suture body 102 opposite the end effector 108. . An end effector as described herein may also have a proximal end and a distal end, where the proximal end of the end effector is attached to the suture body 102 by the end effector. Position (eg, suture body distal end 106), and the distal end of the end effector is the opposite edge along its length of the end effector. The terms “distal” and “proximal” may generally refer to these ends of the suturing device and / or the ends of the end effectors described herein.

  Known sutures having an end effector as in FIG. 1 are typically stamped or molded from a single sheet material so that the end effector thickness configuration is the same as the suture body itself. It is. That is, since the device is stamped from a single piece, the thickness configuration of the end effector 108 does not differ from the thickness configuration of the suture body 102. That is, the thickness of the suture body 102 is substantially the same as the thickness 110 of the end effector 108. In some embodiments, the central portion of the suture body (102) may have a different thickness than the retainer 104, and this variation in thickness is similar along the length and width of the end effector 108. obtain. Thus, end effector 108 can be seen in FIG. 2 and can have a thickness configuration that varies along its width, as described below. Suitable end effectors need not be rectangular, but may be circular, oval, square, or other forms. In some embodiments, the thickness (t) of the end effector of FIG. 1 may be about 203-635 micrometers (about 8-25 mils) and the width (w) is about 1778-3048 micrometers ( About 70-120 mils) and length (l) may be about 990-5080 micrometers (about 39-200 mils). The length to width ratio of the stop element may be at least 1.5.

  The prior art device as seen in FIG. 1 can be provided with a pattern or other preform form on the body of the end effector 108, thereby leading to the end effector along the length of the suture body 102. The same pattern or preform form can be present. For example, in FIG. 1, the thickness along the central axis of the suture body 102 is thicker at several points compared to the area adjacent to the central axis, such as the retainer 104, and the change in thickness is the end effector. It is consistent along the length of 108.

By way of example, a conventional end effector is formed from a single sheet material having a thickness of about 152-635 micrometers (about 6-25 mils), typically 101-305 micrometers (4-12 mils). The thickness may be maximized along the central axis of the suturing device (ie, along the central axis of the suture body 102) and / or at the first and / or second outer edges, The thickness is minimized at a position between the first and / or second outer edge. FIG. 2 shows an enlarged view of the end effector of FIG. 1 when viewed along its length (ie, visible in width and thickness). As can be seen, in this embodiment, the end effector central region 122 extends along the central axis of the suture body 102 and the end effector also includes a first outer region 120, a second outer region 120, a second intermediate region 124 having a first intermediate region 124, and similarly the thickness _{t 2} having a thickness _{t 2} also includes. The thickness of each outer region 120 need not be the same, and the thickness of the intermediate region 124 need not be the same. The cross-sectional thickness configuration of the end effector 108 may be different from that shown, for example, the thickness may be substantially the same across the entire width of the end effector 108, if desired.

  Increasing the size of the end effector can increase the retention strength of the end effector. However, there are practical and clinical limitations regarding the size and mass that can be implanted. For example, if the device is too small, it can provide low strength, but if it is too large, it is undesirable because it can leave a large mass in the implant. In addition, large masses can sometimes be difficult in terms of manufacturing and providing reasonable structure. The present invention makes it possible to improve the holding strength while avoiding such restrictions. Specifically, the present invention provides a welded end effector, wherein the overall mass of the welded end effector is about the mass of the unmodified tab end effector as seen in FIGS. 1.1 to 3.0 times, more specifically about 1.5 to about 2.0 times. However, the welded end effector thickness only increases about 1.1 to less than 2 times the thickness of the unmodified tab end effector as seen in FIGS. In a preferred embodiment, the increase in mass (compared to the unmodified tab end effector) is greater than the increase in thickness compared to the same unmodified tab end effector. Although the cross-section of the unwelded tab as seen in FIG. 2 has an irregular contour shape, the welded tab may have a substantially rectangular cross-sectional shape. In some embodiments, the welded tabs may have different shapes, which can be formed by a shaped die having any desired shape. This will be further described below.

  The device 100 can be made of an absorbent or non-absorbable polymer, metal or ceramic material. In yet another embodiment, the device comprises a co-polymerization of polydioxanone, polyglactin, polyglycolic acid, glycolide and / or lactide and / or caprolactone, including combinations and / or copolymers of absorbent and non-absorbable materials. Polymers, polyoxaesters, polygrecaprone, polypropylene, polyethylene, polyvinylidene fluoride (PVDF), hexafluoropropylene, vinylidene fluoride / hexafluoropropylene copolymer, polyesters, polyethylene terephthalate, polybutylene terephthalate, glycol modified polyethylene Terephthalate, polytetrafluoroethylene, fluoropolymer, thermoplastic elastomer, ionomer, ethylene / methacrylic acid copolymer, polyamides, polytetramethylene oxide, polystyrene Emissions, polybutadiene, absorbable and non-absorbable homopolymer made of polybutylene or the like, a random copolymer, is made of a polymer material selected from the block copolymer or the group consisting of a blend.

  As can be seen in FIG. 3A, the present invention includes a suturing device 200 having an elongated suture body 202 and a plurality of retainers 204, the suture body having a proximal end (insertion end) 206 and a distal end 208. Defined by The device 200 comprises an end effector 210 attached to the distal end 208 that may be similar to that of FIG. As can be seen, the end effector 210 of FIG. 3A includes a form that varies in thickness over width (w), which may have the thickness form seen in FIG. Of course, the end effector 210 may have a consistent thickness across its width if desired. The suturing device 200 may be formed by stamping or stamping the device from a single preform or ribbon material so that the suture body 202 and the end effector 210 are formed in one piece and the same material It is certain to include.

  The present invention seeks to improve the end effector 210 in a variety of ways that take the suturing device 200 and increase its mass and retention strength while at the same time avoiding the difficulties associated with increasing the size of the end effector. . 3-11 show various configurations suitable for accomplishing this purpose. The composite device includes a suture having an end effector as described above with components that are welded or bonded to the end effector. In some embodiments, the end effector is welded with two or more end attachments. The final device is a composite end effector (also referred to as a weld fixation tab or composite fixation tab) and these pieces are welded together as described below. Composite fixation tabs can refer to “welded” or “glued” fixation tabs that are welded together (ie, by applying energy) or chemically It should be understood that various components can be included that can be bonded together, such as by applying mechanical bonding or other known bonding techniques. Thus, the composite securing tab may be bonded by chemical means or welded by applying energy.

  Composite fastening tabs have been shown to provide statistically significant increases in maximum load, elongation, and energy at break when compared to fastening tabs alone in a metal jig tensile test. Importantly, however, this composite locking tab does not increase the mass of the end effector to an undesirable level and does not introduce foreign material into the device.

  3A-3D illustrate one form of using a single parallel weld attachment. FIG. 3A shows the suture body 200 described above and a separate end attachment 250 having a profile similar to the end effector 210 of the suture 200. As pointed out above, the device can be formed by cutting or stamping sutures and end effectors from the same precursor material, referred to as a preform or ribbon. Specifically, the end attachment 250 has the same thickness form and the same width as the end effector 210. The lengths can be different or the same. In the embodiment seen in FIG. 3A, the thickness of both the end effector 210 and the end attachment 250 is such that the central region 212, the first outer region 214, the second outer region 216, the first intermediate region 218, and the second Have separate thicknesses along the middle region 220. The thickness of the central region 212 may be the same as or different from the first outer region 214 and the second outer region 216. The first outer region 214 may have the same thickness as the second outer region 216 or a different thickness. The end attachment 250 in this embodiment must have a thickness profile that is substantially similar to the end effector 210 along its width.

  As can be seen in FIG. 3B, one surface of the end attachment 250 is placed on one surface of the end effector 210, and the width and length of each is substantially aligned with one another. It may be useful to use a method of maintaining these components in alignment with each other, such as mechanical retention devices and / or adhesives or chemical fixation. Maintaining the component may be temporary, preventing the two components from moving relative to each other until the welding is complete. In some embodiments, multiple components may be held together in the die both before and during the welding procedure. The die may be an RF die, including polymer parts and / or metal parts.

  Cutting or stamping the end attachment 250 from the same starting ribbon as the suture itself is particularly useful because it ensures that the width and thickness profile is substantially the same as the end effector 210. In addition, if the end attachment 250 is formed from the same ribbon as the suture 200 itself, the final composite material is made from the same material used to form the suture, particularly from the same batch of polymer material. Can be.

  Once end effector 210 and end attachment 250 are attached and held together, it is desirable to weld these parts together to form the device as seen in FIG. 3C, where the resulting composite locking tab 270 is A fixed composite device. In some embodiments, it is useful that the welding process results in a composite securing tab 270 having a substantially flat surface, which surface is defined by a length l and a width w. In some embodiments, the resulting composite securing tab 270 may have a thickness profile similar to the end effector 210 and end attachment 250 prior to welding. A view of the securing tab 270 from the side (and thus the thickness of the weld tab 270 is shown) can be seen in FIG. 3D. As can be seen, the thickness of the composite securing tab 270 is only slightly greater than the thickness of the suture body 202. The thickness of the composite securing tab 270 can be varied as required. Composite securing tab 270 may have a substantially rectangular cross-section, or may be any other desired shape depending on the shape of the die used. The side and distal end of the composite securing tab 270 may have a substantially flat surface, or there may be a seam where the end effector 210 and the end attachment 250 are bonded together.

  The weld tab 270 may be manufactured by welding or otherwise attaching the end effector 210 and the end attachment 250 to each other in any suitable manner. For example, the devices may be attached to each other by welding with a high frequency generator. Other energy sources may be used to weld the devices together, including ultrasonic welding or thermal welding. Adding additional material to the tab using a high frequency welder increases the tensile strength of the final composite securing tab by 50-100%, indicating that the overall volume increase is negligible. ing. The welding process can inevitably increase the mass of the tab as more material is added to the device, while making the profile of the fixed tab uniform and only increases about 25-50% of the original thickness. Provides a uniform thickness. Alternatively, the tab may be attached using chemical bonding.

  With proper die design and proper machine parameters, the rest of the device remains unaffected, particularly the core of the suture body 102 and the portion of the suture just before the end effector (eg, the distal end 208). Energy can be applied to the end effector 210. While the suture core retains its original strength and properties, the resulting weld fixation device can have a unique configuration that enhances its shear stress resistance. Unlike other common forms of welding (heat, ultrasound, solvent), high frequency energy can be heated from the inside to the outside rather than from the outside to the inside of the device. This is an advantage because the polymer on the surface of the separate part can begin to melt and form a weld that minimizes the remaining orientational strain in the tab. Although using RF energy improves results, other energy sources are contemplated and may be useful in certain embodiments. For example, welding using thermal energy is possible, and parts may be fused together. This may be useful in some cases, but in other cases high frequency energy may be more desirable.

  Using the same material and the same dimensions, including the same thickness form, greatly increases the strength of the resulting weld end effector, but does not increase the variation. The weld tab has a greater mass than the original end effector, for example, if one end attachment is used, it has approximately twice the mass of the original design. However, the resulting composite securing tab 270 has a length and width substantially similar to the original end effector 210, with only a maximum thickness increase of about 10% to about 25%. Thus, the relatively small increase in thickness and the maintenance of other dimensional sizes, both the original end effector 210 and the end attachment 250 are made of the same preform material, so that each is pre-welded. This is due to the fact that it is certain to have a surface structure with a similar contour. In addition to increasing the strength of the resulting composite securing tab 270, it has been shown that the securing tab data can be normalized by adding additional mass to the securing device. Since the nominal fixed tab strength value does not follow any known distribution, manufacturing control becomes more difficult. When the end effector 210 is welded to the end attachment 250, the weak portion of the tab is sufficiently enhanced and the device strength can be modeled in several distributions including a normal distribution.

  In addition to minimal volume increase, the method of adding additional material to the device also minimizes the additional surface area added to the device. For example, adding a single additional layer to the end effector only increases the surface area of the device by about 0.3%. It is worth noting that this change in surface area is minimal because the surface area greatly affects the rate at which the additive or coating can diffuse into the polymer article. By essentially maintaining the surface area of the final composite securing tab 270 after welding, it is believed that additive or coating dose requirements can be maintained from before the welding of the securing device to after welding. Similar surface area also means that the number of additional bacterial colonization sites or tissue reaction sites in vivo is reduced.

  The above weld tab design seen in FIG. 3 uses a single end attachment 250 attached to the end effector 210 in a parallel arrangement. That is, the molecular alignment in each is matched, and the thickness morphology in each is also matched. This parallel alignment makes it possible to take advantage of the original end effector 210 and preform orientation that existed prior to welding, however, multiple arrangements that increase the strength and performance of the tab in various ways. And orientation is possible. For example, by configuring the preform in a parallel orientation, the orientation within a given range across the width of the preform can be increased because more orientation will be added on it. FIG. 5 shows an arrangement using a double parallel configuration, in which two or more end attachments are attached to the end effector, and each attachment is attached in a parallel arrangement. As seen in FIG. 5A, the suture includes a preform end effector, and a first end attachment 250 and a second end attachment 250 are provided. The first and second end attachments 250 are attached to the end effector 210, and the end effector 210 is sandwiched between each end attachment 250, or the end attachments 250 are directly adjacent to each other, and the end effector 210 is the two of them. One end attachment 250 or the other. 5B and 5C show a welded configuration (top and side views, respectively), with a welded fixation device 280 located at the distal end 208 of the suturing device 200. FIG.

  Another possible configuration is a vertical orientation as shown in FIG. 4, which uses the same mass of material as in FIG. 3, but the end attachment 300 has an alignment of the material in the end attachment 300 compared to the end effector 210. And is cut so as to rotate about 90 degrees. End attachment 300 still has approximately the same dimensional size and shape (eg, approximately the same width, length, and / or thickness) as end effector 210, but the molecular alignment in the attachment is different. In addition, the change in the thickness of the end effector 210 may be along its width, as seen in FIG. 2, while the change in the thickness of the end attachment 300 is as seen in FIG. 4A. , Along its length. These two parts can be aligned and welded as described above, and the resulting composite securing tab 310 can be seen in FIGS. 4B and 4C. Accordingly, the composite fixing tab 310 includes a first side surface in which the molecular orientation is arranged in the first direction, and a second side surface in which the molecular orientation is arranged in the vertical direction. Since the orientation of the original end effector 210 and the end attachment 300 is vertical, it is ensured that cracks or tears are less likely to propagate along the length or width of the composite fixing tab 310, and so forth. Strength and stability can be increased. Such cracks or tears are more likely to be blocked by vertically aligned molecules.

  In another vertical arrangement seen in FIG. 6, the original suture 200 with the preform end effector 210 is formed as described above, and the additional end attachment 350 is cut. However, in this embodiment, the end attachment is cut into multiple pieces (350 each). Each end attachment piece 350 may be independently parallel to the end effector 210 or may be perpendicular to the end effector 210. In the embodiment seen in FIG. 6A, four end attachment pieces 350 are formed, each about half the length of the original end effector 210 and having approximately the same width as the end effector 210. Thereby, each piece 350 can be placed and welded at a desired position on the end effector 210. Here, two end attachment pieces 350 are welded to the upper surface of the end effector 210, and two end attachment pieces 350 are welded to the lower surface of the end effector 210. It may be desirable to attach each end attachment piece 350 to the end effector 210 in a vertical arrangement, or to attach each end attachment piece 350 in a parallel arrangement to the end effector 210, or a combination thereof. Each end attachment piece 350 is attached to the end effector 210 as described above and similarly subjected to welding as described above. The resulting composite securing tab 360 can be seen in FIGS. 6B and 6C.

  As can be seen in the various embodiments of FIGS. 3-6, the additional material to be welded to the end effector (210) can be formed, aligned and ultimately welded in a number of ways. When the parts are welded together, the resulting composite securing tab is hard and firm and the original part does not easily separate. As noted above, in any of the above embodiments, the resulting composite securing tab may have a substantially flat surface, or may have a thickness variation as required. FIGS. 3 and 4 illustrate a method of making a composite fixation tab by adding only one end attachment, while FIGS. 5 and 6 add all the various layers and parts to provide the desired composite fixation tab. It can be formed. Each embodiment provides a different strength profile, ease of use and formation, and increased stiffness. Any of the embodiments found in these figures can be used depending on the final composite fastening tab desired.

  When using only one end attachment, if the end attachment is approximately equal to the size and shape of the end effector, the resulting composite securing tab has approximately twice the mass of the original end effector prior to welding. In embodiments that use two end attachments, if each end attachment is approximately equal to the size and shape of the end effector, the resulting composite securing tab has a mass that is approximately three times that of the original end effector prior to welding. The composite may be in a generally sandwich arrangement, where the first end attachment is placed on the top surface of the end effector and the second end attachment is placed on the bottom surface of the end effector.

  An alternative method of forming a triple mass composite locking tab that does not incorporate an end effector and two separate end attachments (or more end attachments) can be seen in FIGS. 7A-7C. In this embodiment, a suturing device 200 comprising an end effector 210 is prepared as described above to form a separate end attachment 400, where the end attachment 400 is approximately twice the length of the end effector 210 and the end effector 210 The attachment 400 can be folded along a line parallel to the width of the device. The device can include a folding region 405 as seen in FIG. 7A. The folded end attachment 400 can be placed over the distal end of the end effector 210, held in place, and finally welded in place, as seen in FIGS. 7B and 7C. A composite securing tab 410 is formed. The composite securing tab 410 includes a welded folded area 415, which is the same area as the folded area 405 after welding is complete. Desirably, the foldable end attachment 400 is sized and shaped such that after folding, the length and width of the folded device is approximately equal to the length and width of the end effector 210. The resulting composite securing tab 410 has a mass about three times that of the original end effector 210.

  Another embodiment for preparing a composite fixation tab of about three times the mass can be seen in FIGS. 8A-8C. Again, the original suture 200 with the end effector 210 is prepared, and a separate foldable end attachment 450 is also preferably prepared from the same material and the same preform as the suture 200. The foldable end attachment 450 uses a folded end attachment substantially similar to that seen in FIG. 7, where the foldable end attachment 450 comprises a foldable region 455 along its width. In this embodiment, a portion of the material has been removed from the center of the end attachment 450 (seen as region 460). When the central portion is removed in region 460, a foldable end attachment 450 can be inserted over the proximal end 206 of the suture 200 and slid along the length of the suture body 202, where it can be folded. The end attachment 450 is aligned with the end effector 210. It may be desirable or necessary to twist or rotate the foldable end attachment 450 before or while moving it along the suture body 202. When the end attachment 450 reaches the end effector 210, it can be positioned to fold around the proximal end of the end effector 210. This device can be welded to form a composite locking tab 470 as seen in FIGS. 8B and 8C. In this embodiment, the resulting composite fixation tab 470 includes a welded fold region 475 disposed at the proximal end of the composite fixation tab 470. As in FIG. 7, welded fold region 475 is in approximately the same position as fold region 460, but is welded. This configuration helps by further protecting the securing tab 470 at its proximal end.

  In the various embodiments described above, separate one or more parts (ie, end attachments) are added to the end effector 210 and welded in place. An alternative to adding additional material to the end effector is to change the end effector geometry slightly during its initial formation, i.e. when it is stamped or stamped, or the resulting composite locking tab This is due to the provision of a device that is shorter in length than the original end effector 210.

  For example, FIGS. 9A-9C show a device comprising a suture body 202 having an end effector 500. In this embodiment, the length of the end effector (measured from proximal end 510 to distal end 515) is approximately twice the desired length of the final desired weld end effector and is foldable. It can be folded along a folding region 505 that extends along the width of the end effector 500. In this embodiment, the foldable end effector 500 is folded in half so that the proximal end 510 is generally flush with the distal end 515 prior to welding. The folded end effector is then welded in place to form a weld fixture 520 (FIG. 9B). A side view of this embodiment can be seen in FIG. 9C. This method has the advantage of avoiding the use of additional materials or the addition of any additional parts that may differ from the material of the end effector 500. In addition, this method avoids the need to attach separate pieces to each other. This also maintains that the final composite securing tab 520 has a desired length equal to the original tab described above. In addition, the final weld fixture 520 has the same device mass as it was originally formed.

  In some embodiments as seen in FIGS. 10A-10C, the end effector 550 is elongate in length compared to a conventional device (as in FIG. 1) and along a fold region 555 that extends across its width. And can be folded. In this embodiment, when the end effector 550 is folded so that its proximal end 560 is substantially flush with the distal end 565, the resulting length of the welded end effector 570 is longer than the embodiment of FIG. According to this embodiment, the thickness can be increased and the rigidity of the welding fixing device 570 can be increased, but the length is longer than that in FIG. 9.

  In another embodiment seen in FIGS. 11A-11C, an end effector with a bi-fold design with prongs can be prepared. In this embodiment, the end effector 600 is elongated in length, with the first fold region 605 extending along its width and the second fold region 610 extending along its width in a different region. There are first and second prongs 615 at the distal end. The length of the first region (defined by the proximal end of the end effector 600 to the first fold region 605) is the length of the second region (the first fold region and the second fold region 610). Defined as the length between). The length of the prong (defined as the length between the second folded region 610 and the distal end of the end effector 600) may be approximately equal to the length of the first region and the second region.

  In the embodiment of FIGS. 11A-11C, as described in more detail above, the length of the end effector 600 is about three times the length of the final desired weld fixture and The end effector is first stamped or stamped. In this embodiment, there is an elongated region removed from one third of the most distal end of the end effector 600 along a substantially central length, forming first and second prongs 615. The amount of material removed to form the prongs 615 can vary, but it must be sufficient to allow the suture body 202 to pass through the void between the prongs 615. This extended prong shape allows the end effector to be folded once (in the first fold region 605) and then again in the second fold region 610, where the prong 615 causes the suture body 202 to fold. It can pass over the proximal end of the end effector 600 (seen in FIG. 11A). The device can then be welded in place to form a weld fixture 620 as seen in FIG. 11B (side profile seen in FIG. 11C). This design has the same advantages as folding on the front side with respect to the configuration seen in FIGS. 8A-8C, ie the front face of the end effector 600 is enclosed and is more resistant to cracking.

  Each of the foregoing configurations and methods has a higher stability and effectiveness than the original stamped end effector, but the final thickness, width or length of the resulting welded end effector does not increase significantly. Provides a composite securing tab. In some embodiments, as described above, the mass can be doubled (eg, when using one end attachment) or tripled (eg, when using two end attachments), but the end effector The thickness of is only increased from about 10% to about 70%, or from about 25% to about 50%, depending on the number of end attachments and the size / shape / form of one or more end attachments. Furthermore, due to the welding process, a composite fastening tab having a smooth surface of substantially similar thickness along the width of the final weld fastening device and which may have smooth edges and / or corners. Can bring. Further, in some embodiments, the molecular alignment or physical alignment of the end effector and the one or more end attachments may be misaligned or configured vertically so that a plurality of molecules can be Alignment can be provided. This can increase the strength of the device.

  In any of the foregoing forms, the resulting end effector welding is desirably accomplished with a die of a suitable size and shape to provide the desired level of fixation and the resulting shape. In particular, the size of the die used should be such that the various parts fit snugly within the weld space and thus allow energy to be applied equally to each of the surfaces of the composite device. The energy applied must be sufficient to fuse the various attachments to the original end effector, but not so high that the various components are melted until their molecular orientation is substantially changed. When the part melts to an undesired level, the resulting weld end effector is less strong than desired. As a result of the added energy, one or more attachments and the original end effector fuse together, creating a visible seam surrounding the weld end effector. The fusion of parts must be sufficient to withstand the level of energy added during normal surgical use without causing destruction or separation.

  In use, the proximal end of the suturing device with the composite securing tab is inserted into the tissue, and eventually the suture is substantially passed through the tissue and near the composite securing tab on the outer surface of the tissue into which the device is implanted. The top end abuts. The weld tab is in contact with the tissue surface, preventing further withdrawal of the suture from the tissue. This keeps the suture in place and allows the user to continue suturing the tissue in the desired area of the body. When the suture includes a plurality of retainers along its body as described above, these tissue retainers serve to hold the suture in place in various regions of the tissue into which the suturing device is inserted. The combination of the composite securing tab and the plurality of retainers helps to prevent the suture from being pulled too proximally while at the same time preventing or limiting the device from coming off in the distal direction.

  The resulting composite fixation tab provides a stronger and more secure stop at the distal end of the suturing device, while manufacturing difficulties and post-implantation difficulties (such as when a device with too much mass remaining is used). Avoid problems such as. Furthermore, the resulting fixation device may have a smoother and / or more uniform surface, allowing for easy use and healing.

  The present invention includes a tissue suturing method using a suture provided with a welding fixation device. The suture may comprise a plurality of retainers along at least a portion of the body, where the retainers may be disposed symmetrically along the suture body or spiral around the suture body. Or it may be randomly placed around the suture body. Any of the above weld anchors can be used as a weld anchor at the distal end of the suture. The proximal end of the suture body must be equipped with an insertion means such as a needle or other point to penetrate tissue. In use, a user such as a physician or other clinician inserts the proximal end of the suturing device into a desired location in the tissue and at least partially pulls the suture body through the tissue. The suture body retainer allows the suture to be pulled proximally but restricts or otherwise restricts the movement of the suture in the reverse direction (distal direction). The proximal end of the suture is pulled through the tissue and eventually the proximal end of the fixation device abuts the tissue into which the suture has been inserted. At this point, the suture body is restricted from further pulling in the proximal direction, and the presence of the suture body retainer now holds the distal end of the suture in place at the insertion site. Either before or after the fixation device abuts the first region of tissue, the insertion end of the suture body may be inserted through the second region of tissue. The second region of tissue can be, for example, on the wound side opposite the first tissue region. The user can continue to insert the proximal end of the suturing device into as many tissue regions as necessary to achieve wound closure.

  In an alternative embodiment, a bi-directional suturing device having a central weld tab may be provided, which includes two sutures having an unmodified tab (as in FIGS. 1-2) at the distal end. . In this embodiment, the first suture unmodified tab is rotated 180 degrees relative to the second suture unmodified tab, and the distal end of the first tab is proximal to the second tab. It is almost flush with the edge. The first and second tabs can then be welded together, such as by high frequency welding or other energy applications. The resulting structure thus includes a first suture with a proximal end facing away from the proximal end of the second suture. There is a central weld tab between the two proximal ends. If desired, additional mass may be provided to the central weld tab using an end attachment as described in any of FIGS.

  A suture having a weld fixation device may be housed in a suitable package, such as a suture holder. Desirably, the suture is held in place in the package in such a manner that the suture does not become entangled upon removal of the suture. It may be desirable to wrap the suture around one or more posts or other retaining means within the suture package. The package allows the user to pull the suture proximally out of the suture package without grasping the proximal end of the suture (which may include a needle) and holding or tangling the suture Must. The suture may have a coating of antimicrobial material contained thereon, which coating may be provided by any means including dipping, spraying, vapor deposition, and the like. Two or more sutures may be contained in the package, or one suture may be contained in one package. The package can be hermetically sealed to protect the suture and maintain the sterility of the suture.

Example 1-Tabletop Instron Test Tensile testing of each suture was performed with a tabletop Instron test with a custom metal jig, and the custom metal test jig was the size and shape for the suture and / or composite end effector. . This test is more commonly referred to as the shear strength test, and for this example it is considered a fixed tab shear strength test because it measures the shear strength of the fixed tab being tested. Each anchor tab was tested for shear strength by loading each individual suture into a custom metal test fixture. Each test piece was introduced into the slit of the jig top plate so that the fixing tab was in direct contact with the lower surface of the top plate and the free end of the suture was available on the upper surface side of the top plate. The free end of the suture was grasped by the upper Instron gripper under light tension (sufficient to keep the suture taut) at a gauge length of 2.54 centimeters (1 inch). The suture was aligned with the center of the gripper so that it was perpendicular to the jig and not skewed. Each specimen was pulled at 30 cm / min (12 inches / min) until the securing tabs were broken.

  A suture was formed according to the design of FIG. 1 and a stamped end effector that was not manipulated after formation was taken as a control (“nominal”). The control suture was a size 1 suture and was punched from the PDS preform material (the in-process raw material used to make the suture). The tab end effector has a length of about 5080 micrometers (about 200 mils), a width of about 2413 micrometers (about 95 mils), and a thickness of about 495 to 546 micrometers (about 19.5 to 21.5 mils). And had the contour profile seen in FIGS. In addition, a second suture was formed in the same configuration, except that a single parallel end attachment (described above and seen as in FIGS. 3C-3D) was welded to the end effector by high frequency welding. This single parallel end attachment was formed by cutting a substantially rectangular shape from the same PDS preform material used to form the control and second sutures. This rectangular end attachment was welded to the existing securing tab of the second suture. The cut rectangular attachment has a length of about 5080 micrometers (about 200 mils), a width of about 2413-2540 micrometers (about 95-100 mils), and a thickness of about 495-546 micrometers (about 19.5). 21.5 mil). This end attachment had the same profile thickness profile as the unmodified tab, and when the attachment and tab were finally welded, at that point, the welded end effector had a more rectangular cross-sectional configuration. Each anchor tab was tested for shear strength by loading each individual suture into a custom metal test fixture. Each test piece was introduced into the slit of the jig top plate so that the fixing tab was in direct contact with the lower surface of the top plate and the free end of the suture was available on the upper surface side of the top plate.

  The free end of the suture was grasped by the upper Instron gripper under light tension (sufficient to keep the suture taut) at a gauge length of 2.54 centimeters (1 inch). The suture was aligned with the center of the gripper so that it was perpendicular to the jig and not skewed. Each specimen was pulled at 30 cm / min (12 inches / min) until the securing tabs were broken.

  Table I shows the performance differences between nominal (not welded, stamped) tabs and high frequency welded tabs (parallel arrangement) for the same lot of material. In addition to an increase in mean intensity, the lower limit of the population is significantly increased, which is interpreted as a decrease in the coefficient of variation. Less device variability is interpreted as leading to high product consistency across the surgeon's hands.

  FIG. 12 shows the tensile strength tested with a metal fixture when comparing a nominally tabbed device (not welded) with various embodiments of the present invention. Samples of the present invention were prepared from the same lot of material as the nominal comparison device, one formed as a parallel laminate, one formed as a double parallel laminate (FIGS. 5B-5C), and one folded. It was formed as an attachment (FIGS. 7B to 7C).

  For these three designs, the% increase in average strength relative to the nominal (non-welded) anchorage is 88% for the single parallel laminated end attachment, 132% for the double parallel laminated end attachment, and folds around the back (rear) Folding) was 149% for the end attachment.

Example 2-Pig origin strength test The origin strength is a test different from the shear strength test described in Example 1. For the initial strength test, the suturing device is inserted through porcine fascia tissue, the proximal end of the fixation tab abuts the tissue, and the free end of the suture is loaded into the Instron and pulled until it breaks.

  A comparative (nominal) suture was formed according to the design of FIG. 1 and as described in Example 1 and had a punched end effector that was not welded after formation. The second suture (“Invention 1”) was formed of the same material and size, but a single parallel end attachment (as in FIGS. 3C-3D) was welded to the end effector by high frequency welding (this configuration was implemented). Explained as in Example 1). The third suture ("Invention 2") was formed of the same material and size, but with two substantially identical parallel end attachments, one on the tab end effector and one on the tab end Welded the tab under the effector. The end attachment and tab were aligned so that they were substantially flush with each other and each was welded simultaneously to the end effector by high frequency welding. This configuration is referred to as a double parallel stack design (as in FIGS. 5B-5C).

  The starting strength test measures the strength of the fixation device when implanted in the porcine midline fascia. Each specimen is prepared by first inserting the proximal end of the suture near the apex on both sides of the incision and pulling the suture through the fascia until the proximal end of the fixation tab abuts the porcine fascia tissue. did. Place the tissue specimen in a raised jig to expose the incision area for visual observation and apply a load to the proximal end of the suture until the tester records device or tissue failure. (Load perpendicular to the fixed tissue plane) was made possible. This set up simulates the surgeon pulling and “raising” the proximal end of the suture after the device has begun into the tissue. As shown in FIG. 13, the fixation device of the present invention resulted in an increase in starting strength compared to the nominal fixation device. A single parallel end attachment resulted in an increase of about 50% compared to the nominal tab, while a double parallel end attachment resulted in an increase of about 70% compared to the nominal fixed tab.

FIG. 14 shows the origin strength (y-axis) in pig fascia and the shear strength of the fixation device using a metal jig (x-axis) for the nominal fixation device, single parallel end attachment configuration, and double parallel end attachment configuration. The correlation plot of is shown. An R ² value of 0.9989 is obtained from a linear fit of the data points, indicating a strong correlation between these two test methods.

Embodiment
(1) A composite suturing device,
(A) an elongated suture body having a proximal end and a distal end, the body extending along a central axis;
(B) a composite securing tab attached to the distal end, wherein the composite securing tab comprises:
(I) a first layer having an upper surface and a lower surface, comprising a thickness between them, a length extending parallel to the central axis, and a width extending perpendicular to the central axis;
(Ii) a second layer having an upper surface and a lower surface, and having a thickness between them, a length extending parallel to the central axis, and a width extending perpendicular to the central axis;
The composite suturing device, wherein the lower surface of the second layer is welded to the upper surface of the first layer.
(2) The composite suturing device according to embodiment 1, wherein the layers have substantially the same width and length.
(3) The composite suturing device according to embodiment 1 or 2, wherein the layers are made of the same material.
(4) The composite suturing device according to any one of embodiments 1 to 3, wherein the suture body and the first layer are profile punched from a preform ribbon.
(5) The composite suturing device according to embodiment 4, wherein the second layer is made of the same preform ribbon as the suture body.

(6) The composite suturing device according to any one of embodiments 1 to 5, wherein the first layer has a certain thickness form, and the thickness form includes a thicker region in the central axis.
(7) The composite suturing device according to embodiment 6, wherein the thickness configuration of the first layer includes thicker regions on the first and second side portions.
(8) The composite suturing device according to embodiment 7, wherein the second layer has a thickness configuration substantially the same as that of the first layer.
(9) The composite according to any of embodiments 1-8, wherein the suture body has a plurality of retainers along the length, each of the retainers having a pointed tip towards the distal end. Suture device.
(10) Embodiments 1 to 1 further including a third layer having an upper surface and a lower surface, the third layer having a thickness therebetween, a length extending in parallel with the central axis, and a width extending perpendicular to the central axis. The composite suturing device according to any one of 9.

(11) The composite suturing device according to embodiment 10, wherein the third layer is welded to the lower surface of the first layer.
(12) The composite suturing device according to embodiment 10, wherein the second layer and the third layer are separate pieces.
(13) The composite suturing device according to embodiment 10, wherein the second layer and the third layer are attached to each other by folding an elongated element.
(14) The composite suturing device according to any one of embodiments 1 to 13, wherein the first layer and the second layer have a vertical molecular alignment.
15. The composite according to any of embodiments 1-14, wherein the thickness of the composite securing tab is about 1.1 to about 2.0 times the thickness of the first layer before welding. Suture device.

(16) A method for producing the composite device according to any one of Embodiments 1 to 15, wherein the first layer and the second layer are placed in communication with each other, the first layer and the Applying sufficient energy to the layer to weld the second layer to each other.
(17) A method of forming a suturing device having a composite securing tab comprising:
a. Forming a suturing device from a preform ribbon having a desired thickness configuration, the suturing device comprising a proximal end and a distal end with a body extending along a central axis, and a securing tab. The fixing tab includes an upper surface and a lower surface and has a length, a width, and a thickness;
b. Adding an end attachment to the upper surface of the securing tab, wherein the end attachment is formed from the same preform ribbon as the suturing device, and the end attachment has a length and width substantially similar to the securing tab; Process,
c. Welding the fixation tab and the end attachment together to form a composite fixation tab.
18. The method of embodiment 17, further comprising adding a second end attachment to the bottom surface of the securing tab and welding the second end attachment to the securing tab.
(19) The method according to embodiment 17 or 18, wherein the end attachment is formed by folding a distal end of the fixing tab to form a laminated form of the fixing tab and the end attachment.
(20) The method according to any of embodiments 17-19, wherein the anchoring tab and the end attachment have a vertical molecular alignment.

21. The method of any one of embodiments 17-20, wherein the thickness of the composite securing tab is about 1.1 to about 2.0 times the thickness of the first layer before welding. .

Claims (21)

A compound suturing device,
(A) an elongated suture body having a proximal end and a distal end, the body extending along a central axis;
(B) a composite securing tab attached to the distal end, wherein the composite securing tab comprises:
(I) a first layer having an upper surface and a lower surface, comprising a thickness between them, a length extending parallel to the central axis, and a width extending perpendicular to the central axis;
(Ii) a second layer having an upper surface and a lower surface, and having a thickness between them, a length extending parallel to the central axis, and a width extending perpendicular to the central axis;
The composite suturing device, wherein the lower surface of the second layer is welded to the upper surface of the first layer.   The composite suturing device of claim 1, wherein the layers have substantially the same width and length as each other.   The composite suturing device according to claim 1 or 2, wherein the layers are made of the same material.   The composite suturing device according to any one of claims 1 to 3, wherein the suture body and the first layer are stamped out of a preform ribbon.   The composite suturing device according to claim 4, wherein the second layer is made from the same preform ribbon as the suture body.   The composite suturing device according to any one of claims 1 to 5, wherein the first layer has a thickness configuration, and the thickness configuration includes a thicker region in the central axis.   The composite suturing device according to claim 6, wherein the thickness configuration of the first layer includes thicker regions at the first and second sides.   8. The composite suturing device of claim 7, wherein the second layer has a thickness configuration substantially similar to the first layer.   The composite suture according to any one of the preceding claims, wherein the suture body has a plurality of retainers along its length, each of the retainers having a point toward the distal end. apparatus.   10. A third layer according to any of claims 1 to 9, further comprising a third layer having an upper surface and a lower surface, and comprising a thickness therebetween, a length extending parallel to the central axis, and a width extending perpendicular to the central axis. The composite suturing device according to claim 1.   The composite suturing device according to claim 10, wherein the third layer is welded to the lower surface of the first layer.   The composite suturing device according to claim 10, wherein the second layer and the third layer are separate pieces.   The composite suturing device of claim 10, wherein the second layer and the third layer are attached to each other by folding an elongated element.   The composite suturing device according to any one of claims 1 to 13, wherein the first layer and the second layer have a vertical molecular alignment.   15. The composite suture of any one of the preceding claims, wherein the thickness of the composite securing tab is about 1.1 to about 2.0 times the thickness of the first layer before welding. apparatus.   16. A method of manufacturing a composite device according to any one of claims 1 to 15, wherein the first layer and the second layer are placed in communication with each other, the first layer and the first layer Applying sufficient energy to the layers to weld the two layers together. A method of forming a suturing device having a composite securing tab comprising:
a. Forming a suturing device from a preform ribbon having a desired thickness configuration, the suturing device comprising a proximal end and a distal end with a body extending along a central axis, and a securing tab. The fixing tab includes an upper surface and a lower surface and has a length, a width, and a thickness;
b. Adding an end attachment to the upper surface of the securing tab, wherein the end attachment is formed from the same preform ribbon as the suturing device, and the end attachment has a length and width substantially similar to the securing tab; Process,
c. Welding the fixation tab and the end attachment together to form a composite fixation tab.   The method of claim 17, further comprising adding a second end attachment to the lower surface of the securing tab and welding the second end attachment to the securing tab.   The method according to claim 17 or 18, wherein the end attachment is formed by folding a distal end of the fixation tab to form a laminated form of the fixation tab and the end attachment.   20. The method of any one of claims 17-19, wherein the securing tab and end attachment have a vertical molecular alignment.   21. The method of any one of claims 17-20, wherein the thickness of the composite securing tab is about 1.1 to about 2.0 times the thickness of the first layer before welding.

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