Device and method for securing an implant to tissue

Abstract

A device for attaching an implant to a tissue. The device including a first strand having two opposing ends forming two adjustable and lockable loops and at least one second strand that is slidably connected to a first loop of the two adjustable and lockable loops.

Description

[0001] DEVICE AND METHOD FOR SECURING AN IMPLANT TO TISSUE

[0002] RELATED APPLICATION / S

[0003] This application claims the benefit of priority of U.S. Provisional Patent Application No. 63 / 511,694, filed on July 3, 2023, the contents of which are incorporated herein by reference in their entirety.

[0004] BACKGROUND

[0005] The present invention relates to a device and to a method of using same for securing an implant to a tissue. Embodiments of the present invention relate to securement of a prosthetic device to a valve annulus using a knotless suture approach.

[0006] Surgical sutures are used in a variety of surgical repair procedures from simple wound closure to repair of muscles, connective tissue and even hard tissue. Sutures are typically secured using knots or suture-locking devices. Knot tying is labor-intensive and may significantly increase the overall time of a surgical procedure. In addition, in some surgical procedures the existence of the knot itself (or a knot-locking device) may be disadvantageous. For example, in mitral valve replacement procedures, a sewing ring surrounds the new valve and is used to sew the valve in place within the valve annulus. A typical procedure can utilize numerous knots or suture-locking devices that can adversely affect the profile of the ring.

[0007] Self-locking sutures (e.g., barbed sutures) overcome the above limitations, however, such sutures can be prone to failure as the required holding strength needed for a particular procedure increases.

[0008] Thus, it would be desirable to provide a suture having an increased holding strength and / or reduces or eliminates the need for knot tying.

[0009] SUMMARY

[0010] According to one aspect of the present invention there is provided a device for attaching an implant to a tissue comprising a first strand having two opposing ends forming two adjustable and lockable loops and at least one second strand being slidably connected to a first loop of the two adjustable and lockable loops.

[0011] According to embodiments of the present invention the device further comprises a needle attached to the at least one second strand.

[0012] According to embodiments of the present invention the needle is also attached to one of the two opposing ends of the first strand. According to embodiments of the present invention the two adjustable and lockable loops are formed by threading each of the two opposing ends through a splice section formed in the first strand.

[0013] According to embodiments of the present invention at least one second strand is slidably connected to the first loop of the two adjustable and lockable loops through a braided cuff.

[0014] According to embodiments of the present invention the device further comprises an additional second strand being slidably connected to a second loop of the two adjustable and lockable loops.

[0015] According to another aspect of the present invention there is provided method of attaching an implant to a tissue comprising passing through tissue and the implant a needle attached to a first and second strand having two opposing ends forming two adjustable and lockable loops; and at least one second strand being slidably connected through a braided cuff to a first loop of the two adjustable and lockable loops; and pulling each of the two opposing ends to thereby tighten the two adjustable and lockable loops and force the braided cuff against a surface of the implant and lock the implant against the tissue.

[0016] According to embodiments of the present invention the implant is an annular ring and the tissue is a valve annulus.

[0017] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Although methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention, suitable methods and materials are described below. In case of conflict, the patent specification, including definitions, will control. In addition, the materials, methods, and examples are illustrative only and not intended to be limiting.

[0018] BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

[0019] The invention is herein described, by way of example only, with reference to the accompanying drawings. With specific reference now to the drawings in detail, it is stressed that the particulars shown are by way of example and for purposes of illustrative discussion of the preferred embodiments of the present invention only, and are presented in the cause of providing what is believed to be the most useful and readily understood description of the principles and conceptual aspects of the invention. In this regard, no attempt is made to show structural details of the invention in more detail than is necessary for a fundamental understanding of the invention, the description taken with the drawings making apparent to those skilled in the art how the several forms of the invention may be embodied in practice.

[0020] In the drawings:

[0021] FIG. 1 schematically illustrates one embodiment of the present device.

[0022] FIG. 2 illustrates the spliced section of the device of Figure 1.

[0023] FIG. 3 illustrates a needle attached to the tightening and braided strands of the device of Figure 1.

[0024] FIGs. 4, 5, 6 7 and 8 illustrate an annular tissue and an annuloplasty ring attachment procedure using the device of Figure 1 fitted with two opposing needles.

[0025] FIG. 9 schematically illustrates another embodiment of the present device.

[0026] FIG. 10 illustrates use of a pledget with the present device in securing a prosthetic valve.

[0027] FIG. 11 illustrates a device that includes a finger hold resulting from a bifurcated or split strand.

[0028] FIG. 12 illustrates the ring secured to the valve annulus showing the ‘button’ end pairs of the device.

[0029] DETAILED DESCRIPTION

[0030] The present invention is of a device which can be used to secure an implant to a tissue. Specifically, the present invention can be used to secure a prosthetic ring (e.g., annuloplasty or artificial valve) to a valve annulus using a suture-based device that can be secured without use of knots or anchors.

[0031] The principles and operation of the present invention may be better understood with reference to the drawings and accompanying descriptions.

[0032] Before explaining at least one embodiment of the invention in detail, it is to be understood that the invention is not limited in its application to the details of construction and the arrangement of the components set forth in the following description or illustrated in the drawings. The invention is capable of other embodiments or of being practiced or carried out in various ways. Also, it is to be understood that the phraseology and terminology employed herein is for the purpose of description and should not be regarded as limiting.

[0033] Securing an implant to a tissue using sutures is a well-established and trusted approach and is commonly used in both open and minimally invasive surgical procedures. Suture tying using knots is a labor-intensive procedure (especially in minimally invasive surgery) that can significantly increase the overall time of surgery. In addition, in some surgical procedures the existence of knots or a knot cascade may be disadvantageous. While suture locking devices can substantially reduce the time of surgery, the presence of a hard locking device in the tissue or on the implant can be disadvantageous.

[0034] In order to overcome these aforementioned limitations of suture knots or locking devices, the present inventor has devised a strand-based device that can be used to lock an implant to a tissue without the need for knots or suture locking devices.

[0035] Thus, according to one aspect of the present invention there is provided a device for securing an implant to a tissue. The tissue can be soft or hard tissue and the implant can be of any stitched type. Examples of implants and tissue include, but are not limited to prosthetic devices (e.g., annuloplasty rings and prosthetic valves) to the annulus (respectively), ventricular Assist Devices (VAD) and Pacemakers.

[0036] The device of the present invention includes at least two interconnected strands. The first strand (also referred to herein as the tightening strand) includes a spliced section in the middle of the strand, through which the two opposing ends of the first strand are threaded to form two opposing loops that are adjustable and lockable. The second strand (also referred to herein as the braided strand) includes a braided cuff (a “cuff’ as used herein describes a region at which the second strand is spliced / looped / threaded at the loop of the first strand); various embodiments of a cuff are described hereinunder.

[0037] The device can optionally include one or more needles (e.g., 2 needles) each attached to an end of the device. The needle can be attached to the free ends of the first and second strands. In a two-needle configuration, each needle is attached to free ends of the first and second strands on opposing sides.

[0038] The free ends of the first and second strands can be delivered through a tissue (and implant) by the needle(s). When securing an annuloplasty (prosthetic) ring to a valve annulus, each end of the device is fitted with a needle, and each needle is delivered through a tissue and punctures through the annuloplasty ring such that the free ends of the two second strands and the two free ends (for adjusting the opposing loops) of the first strand are positioned outside the tissue and ring and the spliced section of the first strand is positioned within the tissue.

[0039] As long as the two ends are attached to the needle, they pull the “cuff’ and the adjustable loop. While the needles are still attached, the ring is “parachuted” down to come into contact with the annulus tissue. This delivers the cuff and adjustable loop through the ring, positioning them above the ring. The needle can then be removed freeing the two ends of the first and second strands. Pulling the free ends (of the tightening strand) locks the device against the ring and secures it to the tissue. One embodiment of the present device which is referred to herein as device 10 is shown in Figures 1-3, 9 and 11. Figures 4-8 and 12 illustrate use of device 10 in securing an annuloplasty ring to a valve annulus while Figure 10 illustrates use of device 10 in securing a prosthetic valve to annulus tissue.

[0040] As is shown in Figure 1, device 10 includes a first strand 12 that includes a spliced section 14 through which opposing free ends 16 and 16’ are threaded to form opposing loops 18 and 18’ (Trans configuration in which free end 16 resides opposite loop 18). Strand 12 can be fabricated from any typical braided suture material (e.g., polyester, UHMWPE, etc.), either tubular or ribbon (as long as the center spliced section is hollow and tubular), the total length of strand 12 can be about 50-100 cm (can vary according to the procedure). The thickness of strand 12 can be any (in cardiology 1-0 to 4-0 is typical), the spliced section can be 5-20 mm long.

[0041] Spliced section 14 is configured for allowing adjustment and locking of loops 18 and 18’ (e.g., whoopie sling) and is fabricated so as to apply a frictional force on a strand spliced therethrough. Approaches for fabricating spliced section 14 are well known in the art.

[0042] Device 10 also includes one or two second strands 20 and 20’ (one shown in Figure 1) each fabricated from a braided (or a woven ribbon) suture (e.g., polyester, UHMWPE, etc.) that can be formed as a tube or a ribbon (if a sleeve cuff is to be formed, at least that section needs to be tubular, if the button cuff is a threaded section, see Figure 9, elements 22’: 25, then this whole strand can be either a flat braid or a woven ribbon). The total length of strand 12 can be about 50-100 cm (can vary according to the procedure), the thickness of strand 12 is typically 1-0 to 4- 0. Each including a braided cuff 22 and 22’ (cuff 22 / 22’ generates the (button / pledget) anchor described hereinunder). Braided cuff 22 (and 22’) is fitted around or threaded through loop 18 (and 18’) of strand 12.

[0043] Free end 24 of strand 20 and free end 16 of strand 12 can be attached to needle 26 (Figure 3). Free end 24’ of strand 20’ and free end 16’ of strand 12 can be attached to needle 26’ (not specifically shown).

[0044] Figure 9 illustrates a variation of device 10 in which loops 18 and 18’ are created by free ends 16 and 16’ that reside on the same side of the loops (CIS configuration). In such a configuration free end 16 controls loop 18 and free end 16’ controls loop 18’ Such a configuration is enables by looping the ends of strand 12 through a junction 27 at splice section 14 such that ends 16 and 16’ exit splice section 14 opposite the direction in which they entered.

[0045] Figure 9 also illustrates variations of cuff 22 and cuff 22’. Cuff 22 is formed as a tube 23 with strand 12 being looped through and out of the tube. Such a configuration of cuff 22 is advantageous since first, it makes the compressed “cuff’ into a bulbous shape “button” rather than an omega shape, therefore assists the trimming off the excessive strands flush, leaving a smaller yet “button” on the prosthetic ring; second, it allows for a lower profile device, smoothing the passage through tissue and prosthetic ring.

[0046] Cuff 22’ forms a ribbon 25 that snakes in an out by strand 12. Such a configuration of cuff 22’ is advantageous since it does not require the splicing of the second strand, simplifying fabrication. It allows the second strand to be made of a woven or flat braid ribbon and may reduce friction at tightening, as the threaded ribbon slides along strand 18.

[0047] The various configurations of device 10 described herein can also include a guide sleeve 41 (Figure 7) constructed by strand 20, allowing passage through of strand 12. Such a guide sleeve 41 enables strands 12 and 20 to move relative to each other when strand 12 is pulled for tightening (under minimal friction) but prevents strand 20 from dropping onto the surgical field when needle 26 is detached from free end 16 and strand 20, keeping the two strands coupled, assisting the handling and trimming. In another configuration (Figure 6), the two strands are coupled (assisting the handling and trimming) by threading strand 20 in and out of strand 12.

[0048] As is mentioned hereinabove, device 10 and variations thereof can be used to secure any implant to any soft or hard tissue. The following exemplifies use of device 10 in an annuloplasty procedure.

[0049] Device 10 can be used in an open or minimally invasive procedure. The site of ring securement can be accessed through the vasculature (using a dedicated catheter) or exposed using open or semi-open approach. Needles 26 and 26’ are delivered through a tissue 30 (e.g., annular tissue) and through an implant 32 (e.g., prosthetic ring 32) such that spliced section 14 resides within tissue 30 and free ends 24 and 24’ and 16 and 16’ are positioned outside implant 32 (Figure 4).

[0050] The above is repeated for as many times as necessary (depending on the diameter of ring 32 (or surgeon preferences). The ring is then parachuted (pushed down) against the annular tissue, this extends loop 18 and 18’ and attached cuff 22 and 22’ outside implant 32.

[0051] Needles 26 and 26’ can then be removed (Figure 5) and free (cut) ends (16 / 16’) of strand 12 (Figure 6) can then be pulled (by grasping free ends 16 / 16’ or by placing a finger through fingerhold 33, Figure 11) to reduce the size of loops 18 / 18’, and slide cuffs 22 / 22’ toward ring 32. The use of fingerhold 33 is advantageous since it enables a surgeon to easily hold (under tension) the free ends 16 / 16’ of device 10 using index fingers and to evenly pull free ends 16 / 16’ to controllably slide cuffs 22 / 22’ towards ring 32 such that the ring evenly contacts and compresses against the annular tissue. Once cuffs 22 / 22’ contact ring 32, they compress against it (since they cannot pass through the ring) and expand in diameter to form a button, omega or bulbous -like shape (button 40). Additional pulling of free ends of strand 12 tightens ring 32 against the tissue and tensions loops 18 / 18’ and spliced section 14. Such tightening is converted to a compression force of spliced section 14 on strand 12, self-locking loops 18 / 18’. Further tightening of strand 12 increases the tension force between cuffs 22 / 22’ (now forming button 40, Figure 7), ring 32 and the annular tissue.

[0052] Once ring 32 is secured to tissue 30 free ends 24, 24’ 16 and 16’ are trimmed close to button 40 and removed (Figures 8 and 12).

[0053] Device 10 can also be used for securing a prosthetic valve to annular tissue. In such procedures, splice section 14 of device 10 is somewhat out of the tissue and is looped through a pledget 31 that serves as an anchor against the tissue surface (Figure 10). This enables device 10 to carry the loads necessary for securing a prosthetic valve during operation.

[0054] As used herein the term “about” refers to ± 10 %.

[0055] It is appreciated that certain features of the invention, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention, which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable subcombination.

[0056] Although the invention has been described in conjunction with specific embodiments thereof, it is evident that many alternatives, modifications and variations will be apparent to those skilled in the art. Accordingly, it is intended to embrace all such alternatives, modifications and variations that fall within the spirit and broad scope of the appended claims. All publications, patents and patent applications mentioned in this specification are herein incorporated in their entirety by reference into the specification, to the same extent as if each individual publication, patent or patent application was specifically and individually indicated to be incorporated herein by reference. In addition, citation or identification of any reference in this application shall not be construed as an admission that such reference is available as prior art to the present invention.

[0057] In addition, any priority document(s) of this application is / are hereby incorporated herein by reference in its / their entirety.

Claims

WHAT IS CLAIMED IS:

1. A device for attaching an implant to a tissue comprising a first strand having two opposing ends forming two adjustable and lockable loops and at least one second strand being slidably connected to a first loop of said two adjustable and lockable loops.

2. The device of claim 1, further comprising a needle attached to said at least one second strand.

3. The device of claim 2, wherein said needle is also attached to one of said two opposing ends of said first strand.

4. The device of claim 1, wherein said two adjustable and lockable loops are formed by threading each of said two opposing ends through a splice section formed in said first strand.

5. The device of claim 1, wherein said at least one second strand is slidably connected to said first loop of said two adjustable and lockable loops through a braided cuff.

6. The device of claim 1, further comprising an additional second strand being slidably connected to a second loop of said two adjustable and lockable loops.

7. A method of attaching an implant to a tissue comprising:(a) passing through tissue and the implant a needle attached to:(i) a first strand having two opposing ends forming two adjustable and lockable loops; and(ii) at least one second strand being slidably connected through a braided cuff to a first loop of said two adjustable and lockable loops;(b) pulling each of said two opposing ends to thereby tighten said two adjustable and lockable loops and force said braided cuff against a surface of the implant and lock the implant against the tissue.

8. The method of claim 7, wherein the implant is an annular ring and said tissue is a valve annulus.

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