magnetic suture

Abstract

The magnetic suture has a ferrule with a tapered section where a knotted suture is placed and secured with adhesive, and a straight section where a magnet is placed. The magnetic suture can be manufactured and assembled by tying a knot in the suture, threading the suture through the tapered section, and applying adhesive. The structure and method provide a magnetic suture, resulting in increased manufacturing tolerances and reduced failure rates, thereby increasing the speed and reliability of manufacturing or assembly of magnetic suture assemblies and reducing wasted components and time.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Application No. 62 / 895,564, filed September 4, 2019, which is incorporated herein by reference in its entirety.

[0002] The present disclosure relates to magnetic sutures. More particularly, the present disclosure relates to sutures having a magnet at one end (magnetic tip). Such magnetic sutures are described, for example, in U.S. Patent No. 10,245,021, issued April 2, 2019, entitled "MAGNETIC U-STITCH DEVICE," which is incorporated herein by reference in its entirety. (「’021」) The present invention can be used with a magnetic U-suture device such as that described in the above patent. [Background technology]

[0003] As described in the '021 patent, a suture having a magnetic tip is inserted into a patient's body cavity through a hypodermic needle (and then withdrawn by a magnetic probe of opposite polarity). In some embodiments, the suture and magnetic tip are advanced through a cannula into the hypodermic needle, with the magnet at the magnetic tip having a diameter larger than the inner diameter of the cannula. Thus, the force of inserting the cannula into the hypodermic needle is transferred to the magnet and, therefore, to the suture, which is also within the hypodermic needle. In other words, inserting a suture having a magnetic tip can exert a force on the magnetic tip away from the suture itself.

[0004] As seen in FIG. 1 , according to current designs of magnetic sutures, magnetic suture 100 includes a small cylindrical magnet 102, a thin, tubular stainless steel sleeve (hereafter referred to as a "ferrule") 104, a suture 106 with a knot 108 at one end, and room-temperature-curing adhesive 110 to hold the suture 106 or knot 108, magnet 102, and ferrule 104 together. Ferrule 104 may be a laser-cut stainless steel hypodermic tube with consistent inner and outer diameters. Magnet 102 is flush with the end of ferrule 104 at one end, and adhesive 110 secures suture 106 or knot 108, magnet 102, and ferrule 104 together at the other end.

[0005] With this in mind, some magnetic suture designs may suffer from failure during use and testing, with the magnet becoming dislodged from the suture upon even a small amount of tug (e.g., during insertion as described above). Furthermore, manufacturing and assembly techniques for attaching magnets to the ends of sutures may suffer from several deficiencies. For example, manufacturing tolerances may be small, making mass assembly and manufacturing difficult. Also, errors in the alignment of the magnet relative to the suture may affect the function of the suturing device. For example, an eccentric or angled magnet may not fit within a hypodermic needle and / or may not be able to advance through the needle. Summary of the Invention

[0006] According to one example of the present disclosure, the magnetic suture has a small opening at the end of the tapered region; straight a ferrule having a large opening at an end of a region, a small opening at an end of the ferrule opposite the large opening, the ferrule having an inner diameter that tapers at least partially toward the small opening; a suture extending from the small opening; and straight and a magnet located within the region.

[0007] In various embodiments of the above example, the suture has a knot and the knot is positioned in the tapered region between the magnet and the small opening, and the magnetic suture further comprises an adhesive in the tapered region between the magnet and the small opening. straight The inner diameter of the region is substantially constant and is substantially equal to the outer diameter of the magnet. The inner diameter of the smaller opening is substantially equal to the diameter of the suture and / or the magnet extends from the larger opening.

[0008] According to another example of the present disclosure, a method includes tying a knot in a suture at a first end of the suture, passing a knotless second end of the suture through a small opening in the ferrule such that the knot is inside the ferrule, applying adhesive to the inside of the ferrule, and inserting a magnet into a large opening in the ferrule, the small opening being at an end opposite the large opening of the ferrule, and the knot being between the magnet and the small opening.

[0009] In various instances of the above embodiments, the method further includes severing a portion of the remaining strand of suture beyond the knot at the first end before threading the knot-free second end of the suture through the small opening in the ferrule. Threading the suture is performed with a vacuum tool. Threading the suture involves using a vacuum tool to pick up the ferrule and threading the suture through the small opening in the ferrule. from Added R vacuum By ferrule against Center and use a vacuum tool to ensure the knot is inside the ferrule. While The method includes passing the knot-free second end of the suture through a small opening in the ferrule and applying suction. The method includes removing excess adhesive that leaks from the small opening in the ferrule. Removal The small opening of the ferrule opens into the tapered region of the ferrule, and the large opening of the ferrule opens into the tapered region of the ferrule. straight The suture extends through the small opening and the magnet is at least partially straight Within the region and / or the magnet extends from the large opening. [Brief explanation of the drawings]

[0010] [Figure 1]1A-1C show an exemplary suture with a magnetic tip according to existing designs. [Figure 2] 1A-1C illustrate an exemplary suture having a magnetic tip in accordance with the present disclosure. [Figure 3] 10A-10C illustrate a method for manufacturing a suture having a magnetic tip in accordance with the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0011] The magnetic suture and method of manufacture according to the present disclosure overcomes the above-mentioned deficiencies, thereby increasing the speed and reliability of magnetic suture assembly while reducing component and time waste.

[0012] As can be seen in FIG. 2, the magnetic suture 200 of the present disclosure includes: straight contiguous with region 214 or straight The ferrule 204 has a tapered region 212 adjacent to a region 216. In particular, the ferrule 204 has at least one tapered region (also referred to herein as a "transition region") 212 where the inner diameter decreases (variably or continuously) toward a smaller opening 216 and opens into the smaller opening, and a tapered region (also referred to herein as a "transition region") 212 where the inner diameter decreases (variably or continuously) toward a larger opening 218. And preferably Approximately constant inner diameter With do straight The tapered region 212 includes a small opening 216 and a small opening 218. straight It may taper between regions 214 for only a portion of its length, but may taper continuously or to a variable extent throughout region 212. Preferably, minor opening 216 is slightly larger than or approximately equal to the outer diameter of suture 206. straight Region 214 has an inner diameter that is slightly larger than or approximately equal to the outer diameter of the cylindrical magnet 202 therein. The ferrule 204 does not need to extend the length of the magnet, and therefore the large opening 218 does not need to be flush with the end of the magnet 202. In other words, the magnet 202 may extend from the large opening 218.

[0013] straightAt the other end of region 214 (opposite large opening 218), ferrule 204 has a natural "stop" or shoulder 220 where the inner diameter of ferrule 204 begins to transition or decrease in transition region 212. Because the inner diameter of ferrule 204 is smaller than the outer diameter of magnet 202, magnet 202 cannot be inserted past shoulder 220 into transition region 212 of ferrule 204. The shoulder is naturally formed by the shape of ferrule 204, but the ferrule does not move beyond the shoulder 220. straight A physical stop (such as a shelf) extending perpendicularly to the side of region 214 may also be included.

[0014] Additionally, the suture 206 has a knot 208, and the knot 208 is located within a transition region 212 of the ferrule 204. The ferrule 204, suture 206, and magnet 202 may be held together within the transition region 212 via adhesive 210.

[0015] With this configuration, the tapered ferrule 204 forms a mechanical stop for the suture knot 208 at the small opening 216, allowing the magnet 202 and adhesive 210 to press against the knot 208 and contain excess suture 206 within the ferrule 204. This reduces the risk of the suture unraveling when pulled. Additionally, the knot 208 and ferrule 204 form a natural mechanical bond as a fail-safe in the event that the adhesive 210 fails.

[0016] Additionally, tapered region 212 of ferrule 204 helps ensure that the suture remains straight and centered relative to ferrule 204 and magnet 202, thus preventing the crooked assembly described above. Because the position of suture 206 is guided by the shape of tapered region 212 of ferrule 204 and the position of magnet 202 therein, tapered region 212 of ferrule 204 also allows for movement of suture 206 during curing of adhesive 210. In other words, suture knot 208 is sandwiched between magnet 202 and small opening 216 of ferrule 204, enhancing the bond strength between the elements of magnetic suture 200 and helping to ensure proper positioning of knot 208 and suture 206 within transition region 212 during adhesive curing.

[0017] The magnetic suture 200 of Figure 2 can be manufactured and assembled according to the method shown in Figure 3. As can be seen, the method begins with tying a knot near one end of the suture (300). Next, the small remaining strand of suture beyond the knot is cut (302) so as not to damage the knot itself. It is not necessary to cut as close to the knot as possible. Thus, the magnetic suture can be manufactured to greater tolerances than the current design, minimizing any potential damage to the knot from the cut.

[0018] After the knot is formed, Conclusion Seamless of sutures The end is threaded from the larger opening side of the ferrule through the smaller opening of the ferrule (304). The suture knot is too large to fit through the smaller opening of the ferrule, so the suture is threaded through the smaller opening. (threaded) mosquito others In the way From a small opening pulled (pulled through) , machine In some embodiments, this can be achieved using a vacuum tool. For example, the tapered end of the ferrule Because the shoulder is formed ) true At the end of the empty tool Ferrule Pick it up , the suture against the ferrule It can be centered, The suture knot Within the tapered area The suture is placed in the knot so that it can be pulled out by vacuum.Seamless of sutures The end is pulled through a small opening in the ferrule by an applied vacuum. from suction and take it out The use of a vacuum reduces the dependency on the steady hand and sharp eye of the assembler. degree can be reduced.

[0019] Following threading of the suture, a drop of adhesive is applied to the interior of the ferrule (306). This drop does not need to be placed deep inside the ferrule, as in some current technologies. Furthermore, because a magnet is placed inside the ferrule after the adhesive is applied (see below), the total amount of adhesive can be applied in a single (relatively large) drop, which can be placed anywhere inside the ferrule, rather than as used in some existing designs. This allows for the use of a more viscous adhesive, as the adhesive is spread by the application of the magnet rather than by its viscosity and gravity. Furthermore, any excess adhesive that seeps out of the small opening in the ferrule can be wiped away (see below), allowing for greater tolerance in the amount of adhesive applied. All of this simplifies and facilitates the manufacturing and assembly process.

[0020] A magnet (in the correct polar orientation) is then inserted as far as possible into the large opening of the ferrule until it hits a natural stop or shoulder inside the ferrule 308. By inserting the magnet after the adhesive has been applied, the magnet acts as a piston to force the adhesive all the way inside the ferrule and around the knot and magnet, helping to ensure proper adhesive coverage.

[0021] Finally, any adhesive that leaks through the small opening in the ferrule can be wiped off the ferrule (310).

[0022] A quality check of the magnetic suture described above can be performed simply by pulling on the suture at one end and the magnet at the other end to ensure they are securely attached to the ferrule. For the reasons stated above, this process will not damage the final assembly.

Claims

1. 1. A magnetic suture, comprising: a ferrule having a small opening at the end of a tapered region and a large opening at the end of a straight region, the small opening being at one end of the ferrule and the large opening being at the other end of the ferrule, the tapered region having an inner diameter that tapers toward the small opening but remains constant at the end of the small opening; a suture extending from the small opening, the suture having a diameter approximately equal to the inner diameter at the small opening; a magnet at least partially within the straight region; Including, a shoulder is formed at the end of the straight region of the ferrule opposite the large opening, and the inner diameter of the tapered region begins to decrease from the shoulder, preventing the magnet from passing over the shoulder and entering the tapered region; the suture has a knot, the knot being too large to pass through the small opening, the knot being located within the tapered region between the magnet and the small opening, the small opening forming a mechanical stop for the knot at the end of the tapered region; A magnetic suture, wherein an adhesive is contained within the tapered region between the magnet and the small opening.

2. The magnetic suture of claim 1 , wherein the inner diameter of the straight region is substantially constant and substantially equal to the outer diameter of the magnet.

3. The magnetic suture of claim 1 , wherein the magnet extends from the large opening in the straight region.

4. 1. A method comprising: tying a knot in the suture at a first end of the suture; threading a second end of the knotless suture through a small opening in the ferrule while the knot is inside the ferrule; applying an adhesive to the interior of the ferrule; Inserting a magnet into the large opening of the ferrule; Including, the small opening is at an end of the ferrule opposite the large opening; the knot is between the magnet and the small opening; the small opening being slightly larger than or approximately equal to the outer diameter of the suture; method.

5. and further comprising cutting a portion of the remaining strand of the suture beyond the knot at the first end prior to threading the knotless second end of the suture through the small opening in the ferrule. The method of claim 4.

6. The method of claim 4 , wherein the threading of the suture is performed with a vacuum tool.

7. passing the suture, using a vacuum tool to pick up the ferrule and center the suture relative to the ferrule by applying vacuum from the vacuum tool; using the vacuum tool to suck the second end of the knotless suture through the small opening in the ferrule while the knot remains inside the ferrule; The method of claim 4, comprising:

8. further comprising removing excess adhesive leaking from the small opening in the ferrule. The method of claim 4.

9. the small opening in the ferrule opens into a tapered region of the ferrule; the large opening of the ferrule opens into a straight region of the ferrule; the suture extends from the small opening; the magnet is at least partially within the straight region; The method of claim 4.

10. The method of claim 4 , wherein the magnet extends from the large opening.

11. 2. The magnetic suture of claim 1, wherein an adhesive is contained within the tapered region between the magnet and the small opening, and the knot and ferrule of the suture form a fail-safe natural mechanical bond to the magnet even if the adhesive fails.

12. 10. The magnetic suture of claim 1, wherein the ferrule accommodates excess suture within the tapered region to reduce the risk of the suture coming undone under tension when the suture is pulled through the small opening.

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