ADJUSTABLE ANCHOR SYSTEMS

专利摘要:
adjustable anchor systems and methods. the present invention relates to an adjustable anchor system that provides tissue fixation to the bone and includes an anchor with a retractable suture loop attached to it and a tissue suture connected to the retractable suture loop. after the tissue suture is loaded into the tissue and the anchor is implanted in the bone, the retractable loop is closed to tension the tissue suture.
公开号:BR112013018333B1
申请号:R112013018333-0
申请日:2011-12-23
公开日:2020-10-06
发明作者:Joseph Hernandez；Mehmet Ziya Sengun；Gerome Miller；Gregory R. Whittaker；Gary B. Mcalister
申请人:Depuy Mitek, Llc；
IPC主号:

专利说明:

BACKGROUND OF THE INVENTION
[0001] This order is partly a continuation of the US Order serial number (12 / 977,146) filed on December 23, 2010, the entire contents of which are hereby incorporated by reference. 1. Field of the invention
[0002] The invention relates to a system and method for attaching tissue to bone and, more particularly, to adjustable tissue tensioning, which eliminates the need for knots. 2. Description of the related technique
[0003] A common injury, especially among athletes, is the complete or partial detachment of tendons, ligaments or other soft tissues, from the bone. Tissue separation can occur during a fall, overexertion or for a number of other reasons. Often, surgical intervention is necessary, particularly when the tissue is completely separated from its associated bone. Currently available devices for fixing tissue include screws, staples, suture anchors and tacks. An example of a cannula suture anchor is provided in US patent application publication 2008/0147063 filed by Cauldwell et al.
[0004] There are several suture implant systems that are said to be "without a knot", that is, they do not require a surgeon to make a knot during surgery. Many of these systems control the tension on the tissue through the depth at which an anchor is placed in the bone. U.S. Patent Nos. 5,782,864 and 7,381,213 issued to Lizardi disclose certain types of suture anchors that capture a fixed length suture loop. Knotless anchor assemblies with adjustable loop that use an anchor element inserted into a sleeve are described by Thal in US Patent Nos. 5,569,306 and 6,045,574 and in US Patent Application Publication No. 2009/0138042.
[0005] Suture anchor systems with sliding knots for repairing broken or damaged tissue, especially for meniscus repair, are disclosed in US Patent 7,390,332 to Selvitelli et al. and are used in the OmniSpan ™ meniscus repair system commercially available from DePuy Mitek Inc., 325 Paramount Drive, Raynham, Massachusetts 02767, USA. Other suture anchor systems with sliding knots and blocking knots for tissue repair include US Patent 6,767,037 issued to Wenstrom, Jr.
[0006] Therefore, it is desirable to adjust the tension of a tissue after an anchor has been attached to the bone, without the need for a surgeon to tie knots, specifically during arthroscopic procedures. SUMMARY OF THE INVENTION
[0007] A suture anchor system according to the present invention comprises a suture anchor, a retractable suture loop attached to the anchor and a fabric suture attached to the retractable suture loop.
[0008] In one aspect of the invention, the fabric suture is passed through the retractable loop. The fabric suture can be formed from a separate suture piece other than the retractable loop or the same suture that forms the retractable loop. In one aspect of the invention, the fabric suture has a characteristic selected from the list of: materials, construction, size and coatings that differ from the corresponding characteristic of the retractable loop. For example, the fabric suture can be adapted to be delicate for the fabric and the retractable loop could be formed from a suture that slides more easily, that has greater resistance, fits well in a knot or other feature that is not so important for suturing tissue. Preferably, the retractable suture loop has a lower coefficient of friction than that of tissue suture.
[0009] Preferably, the retractable suture loop comprises a sliding knot, through which a portion of the suture loop can be pulled to retract. Preferably, the sliding knot comprises a fixed tail and a posterior branch. In the aspect of the invention, the tissue suture comprises the fixed tail.
[00010] Preferably, a fastener on the anchor passes through the retractable suture loop to secure the retractable loop to the anchor.
[00011] Preferably, the anchor has a central axial cannulation and the retractable loop comprises a sliding knot that has a posterior branch extending from the sliding knot, with a tension on the posterior branch closing the loop, and the loop retractable and the posterior branch extend proximally out of the cannulation. Preferably, a column on the anchor passes through the retractable loop to secure the retractable loop to the anchor. In one aspect of the invention, the sliding knot is disposed distally from the column. Then, preferably, the posterior branch passes around a retention surface adjacent to the point at which the column passes through the retractable loop and then passes proximally outside the cannulation. In such a configuration, the sliding node is arranged close to the column. In another aspect of the invention, the tissue suture comprises the fixed tail.
[00012] Preferably, protuberances are provided around the suture anchor for engagement with the bone. Preferably, the anchor has an elongated cylindrical shape whereby it is received fixedly within a hole drilled in the bone. Also preferably, the suture anchor, retractable loop and tissue suture are sterile and packed in a bacteria-proof wrapper, also preferably with instructions for use in fixing soft tissues to the bone, as described here.
[00013] In one aspect of the invention, a suture receiver is provided at the suture anchor to receive the tissue suture. The suture receiver may comprise a eyelet at a distal end of the suture anchor. The eyelet can be formed of overlapping arms to allow the suture to be loaded into the eyelet between the arms. Alternatively, the eyelet is formed of a side wall that has a funnel-shaped slit to allow the suture to be loaded into the eyelet through the slit. The suture receiver may comprise a notch at the distal end of the anchor, the notch being separated from the retractable loop so that the tissue suture in the notch is not in a position bordering any moving part of the retractable loop. The suture receiver helps guide the suture of tissue along an exterior of the suture anchor as it is implanted in the bone to trap the tissue suture between the anchor and the bone.
[00014] In one aspect of the invention, the anchor has a central axial cannulation and a suture claw is received through the cannulation, to facilitate the passage of the tissue suture through the cannulation after it is loaded into a soft tissue. The suture claw preferably comprises an elongated body that passes through the cannulation with a suture capture mechanism distal to the suture anchor. The suture capture mechanism can be a loop of flexible material, through which the tissue suture can pass.
[00015] A method according to the present invention describes the attachment of soft tissue to a bone. The method comprises the steps of: passing a tissue suture through a portion of soft tissue; implant the suture anchor in the bone; and closing a retractable suture loop that is attached to the anchor and connected to the tissue suture and thus tensioning the tissue suture. Preferably, the looseness in the tissue suture is removed prior to the step of implanting the suture anchor in the bone.
[00016] In one aspect of the invention, the method comprises the step of capturing a first portion of the tissue suture between the suture anchor and the bone. A second portion of the tissue suture, in a position adjacent to the first portion of the tissue suture, can pass through an axial cannulation through the suture anchor prior to implantation of the anchor in the bone. This helps to align the tissue suture along the suture anchor as it is implanted to better secure the tissue suture. The second portion can be passed through the cannulation by means of a suture claw passed through the cannulation by loading the second portion into a suture capture mechanism of the suture claw located distally from the anchor and then by pulling the claw. suture, including the suture capture mechanism, proximally through cannulation. Preferably, when the suture is trapped between the suture anchor and the bone, the soft tissue is arranged in the tissue suture between the first portion and the point where the tissue suture connects to the retractable loop.
[00017] In one aspect of the invention, the tissue suture is engaged with a distal end of the suture anchor prior to implantation of the anchor in the bone. Preferably, the tissue suture is loaded into a loop located at the distal end of the anchor.
[00018] Preferably, the retractable loop is restricted by a column fixed to the suture anchor and passing through the retractable loop. Preferably, the retractable loop comprises a sliding loop that has a loop portion, a sliding knot that closes the loop portion and a posterior branch extending out of the sliding knot and thus the step of closing the retractable loop comprises applying tension to the posterior branch. In one aspect of the invention, the anchor comprises a central axial cannulation with the loop portion and the posterior branch extending proximally outward, the step of retracting the loop pulling the loop distally into the cannulation.
[00019] In one aspect of the invention, the tissue suture extends from the soft tissue like a loop that interconnects with the retractable loop and, thus, the step of retracting the retractable loop tensions the loop of the tissue suture.
[00020] In one aspect of the invention, the anchor comprises a central axial cannulation with a fixed tail of the sliding knot and the posterior branch extending proximally outward, the fixed tail passing through the soft tissue to become the suture of fabric. BRIEF DESCRIPTION OF THE DRAWINGS
[00021] The preferred embodiments of the invention are explained in more detail with reference to the following drawings.
[00022] Figure 1 is a perspective view of an adjustable anchor system according to the present invention that has a closed loop and an adjustable filament loop;
[00023] Figures 1A, 2 and 3 are seen in schematic cross section of alternative anchor systems according to the present invention;
[00024] Figure 4 is a schematic view of a closed loop after it has been pulled through a portion of tissue to be attached to the bone, which can pull a portion of the adjustable loop with it through the tissue;
[00025] Figure 5 illustrates an anchor being passed through the fixed loop and being directed to a hole formed in the bone;
[00026] Figure 6 shows the anchor attached to the bone with tension to be applied to the posterior branch;
[00027] Figure 7 illustrates the tissue in a desired position under final tension after the posterior branch has been trimmed;
[00028] Figure 8 shows an alternative technique to that illustrated in Figures 6 and 7, in which the anchor engages the closed loop instead of passing through it;
[00029] Figures 8A to 8C show still other modalities in which the closed loop is long enough to extend from the anchor to and through the fabric, as shown in an enlarged view in Figure 8B, and another less preferred modality in which the closed loop has been eliminated and the adjustable loop passes completely through the fabric, as shown in Figure 8C;
[00030] Figure 9 is a top plan view of a Tennessee sliding knot for use with the suture anchor systems in accordance with the present invention;
[00031] Figure 10 is an anterior elevation and cross-sectional view of another embodiment of a suture anchor system according to the present invention;
[00032] Figure 11A is a perspective view of the suture anchor body of the suture anchor system of Figure 10;
[00033] Figure 11B is a top plan view of the body of the suture anchor in Figure 11 A;
[00034] Figure 11C is a side elevation view of the body of the suture anchor in Figure 11 A;
[00035] Figure 12 is a front elevation and cross-sectional view of another embodiment of a suture anchor system according to the present invention;
[00036] Figures 13A to 13H are seen in anterior elevation and in cross section of a method of using the suture anchor system of Figure 12;
[00037] Figure 14 is a front elevation and cross-sectional view of another embodiment of a suture anchor system according to the present invention, having a distal eye;
[00038] Figures 15A to 15E are seen in anterior elevation and in cross section of a method of using the suture anchor system of Figure 14;
[00039] Figure 16A is an anterior elevation and cross-sectional view of another embodiment of a suture anchor system according to the present invention, which has a distal eye and has a funnel-shaped opening in the eye. the loading of the suture in the eye;
[00040] Figure 16B is an anterior elevation and cross-sectional view of another embodiment of a suture anchor system in accordance with the present invention, which has a distal eye comprising overlapping arms for loading the suture in the eye;
[00041] Figure 16C is a front elevation and cross-sectional view of an additional embodiment of a suture anchor system according to the present invention that has a bifurcated distal tip to receive the suture;
[00042] Figure 17 is an anterior elevation and cross-sectional view of an additional embodiment of a suture anchor system according to the present invention in which the sliding knot is proximal to the point of attachment of the loop to the anchor; and
[00043] Figures 18A to 18H are seen in anterior elevation and in cross section of a method of using the suture anchor system of Figure 17. DETAILED DESCRIPTION OF CURRENTLY PREFERENTIAL MODALITIES
[00044] This invention can be accomplished by an adjustable anchor system for attaching tissue to the bone, which includes an anchor that has at least one passage extending from a proximal end towards a distal end. The passage defines a constraint, such as a restricted opening or an occlusion element. The anchor has at least one bone engaging element disposed between the proximal and distal ends. The system further includes a first material, such as a first suture, formed as a closed loop, preferably with a fixed length, and capable of being placed through a portion of the tissue, and a second filament that has an end end, a posterior branch and a sliding knot tied between the terminal end and the posterior branch to establish an elongated loop with adjustable length that extends beyond the proximal end of the anchor and captures the closed loop of the first material. The second filament knot is restricted by the restricted opening or by the occlusion element when tension is applied, as desired, to the posterior branch to shorten the elongated loop and pull the fabric towards the anchor until the desired tension is reached.
[00045] The adjustable anchor system 10, Figure 1, has a suture anchor 12, a closed loop with fixed length 14 of a first material, and a second filament 16 having an end end 18, a posterior branch 20, a sliding semi-curved half-knot 22, and an adjustable loop 24 with loop branches 26 and 28. In one construction, suture anchor 12 is similar to the cannula suture anchor presented by Cauldwell et al. in U.S. Patent Application No. 2008/0147063, incorporated herein by reference. In anchor systems according to the present invention, however, it is not necessary to have a column-like suture engaging element or other occlusion element over which one or more sutures or suture edges pass to serve as a restriction on proximal movement ; in many constructions, it is sufficient to have a restricted opening 46 to prevent the removal of node 22 as discussed in more detail below, particularly in relation to Figures 1A to 3.
[00046] The suture anchor 12 has a proximal end 30 and a distal end 32 with opposite distal arms 34 and 36, defining a cutout 38 between them. The passage 40 is an internal lumen that extends from the proximal end 30 to the distal cutout 38. Although the knot 22 is shown extending beyond the cutout 38 in Figure 1, for purposes of illustration, the knot 22 is preferably seated against the restricted opening 46 between the arms 34 and 36, or otherwise held at the distal end 32 by a cavity or other element, during the insertion of the anchor system 10 in a patient to minimize the interference of the knot 22 in the engagement element to the bone 42, or other outer surface of anchor 12, and the bone to which suture anchor 12 is attached.
[00047] One or more engagement elements to the bone 42, such as the helical thread illustrated in Figure 1 or other engagement mechanisms such as teeth, ridges, or other protuberances, are formed outside the anchor 12 to improve the attachment to the bone. In a construction, the suture anchor rotates to attach to the bone at its proximal end, to minimize detachment. In several constructions, a hole is formed in the bone before the anchor is inserted; in other constructions, a suture anchor is inserted directly into the bone.
[00048] One or more passages or channels can be formed on the outside of the suture anchor, as the channel 44 illustrated in dashed line in Figure 1, which crosses the engagement element to the bone 42. Other configurations are illustrated in Figures 1A, 2 and 3 for the adjustable anchor systems 10a, 10b and 10c, respectively, according to the present invention, the former having fixed length loops 14a, 14b, 14c and the latter having adjustable length filaments 16a, 16b, 16c , respectively. Anchor 12a, Figure 1A, defines an inner lumen 40a and an outer passage 50 extending from the distal end to the proximal end of anchor 12a. Sliding knot 22a, formed in the second filament 16a, is seated against the restricted opening 46a, the adjustable loop 24a extends through the passage 40a to capture the closed loop 14a, and the posterior branch 20a is within the outer channel 50 in this construction.
[00049] It is a matter of preference of the surgeon that an end end, such as end end 18a, Figure 1A, is kept long enough to rest against the outside of at least one bone engaging member 42a for be captured against the bone during insertion, or be trimmed to a shorter length. Different examples of terminal end length are provided in Figures 6 to 8 below. In addition, a constraint such as the restricted opening 46a can be defined, at least in part, by engaging with the bone when anchor 12a is attached to the bone to prevent node 22a from moving with the posterior branch 20a when tension is applied to the posterior branch 20a, as described in more detail below for procedures for using an anchor system according to the present invention.
[00050] The anchor system 10b, Figure 2, has at least three external passages or channels 52, 54 and 56 without any internal passages in this construction. The node 22b is held at the distal end of anchor 12b by occlusion 51 defined, at least in part, by the distal surface of anchor 12b, while branches 26b, 28b of loop 24b are located within passages 52, 54 and the posterior branch 20b of the second filament 16b is located within the passage 56. As described above, the occlusion 51 can be defined, in part, by engaging the anchor 12b with the bone after fixation.
[00051] The anchor system 10c, Figure 3, has an internal passage 40c through which the posterior branch 20c extends from a restricted opening 46c that secures node 22c. External passages 58, 60 carry branches 26c, 28c of adjustable loop 16c. Although anchors 12a, 12b and 12c are shown without arms that extend distally in these constructions, in other constructions one or more of these distal extensions or other protuberances are provided, in the same way as in some constructions by Cauldwell et al. mentioned above or US patent 7,381,213 filed by Lizardi, also incorporated herein, by way of reference. In still other constructions, a cavity, a cup or a cylindrical or otherwise circumferential countersink element is provided at the distal end of the anchor to tighten the knot 22 during insertion and fixation.
[00052] In preferred constructions, loop 14, also called a first filament, and the second filament 16 are formed by one or more types of sutures. Acceptable diameters for the second filament 16 include size 0 or size 2 suture, such as Orthocord ™ suture commercially available from DePuy Mitek, while equal or larger diameters, such as size 2 to size 5 suture are preferred for loop 14, such as Ethibond ™ suture available from Ethicon. The Orthocord ™ suture has approximately fifty-five to sixty-five percent poly-dioxanone, which is bioabsorbable, and the remaining percentage consists of high molecular weight polyethylene, while the Ethibond ™ suture is primarily a high-strength polyester. In some constructions, specifically for shoulder repair procedures, loop 14 has a fixed length of approximately 2.54 cm (one inch) while adjustable loop 24 has a length of at least 45.72 cm (eighteen inches). The amount and type of bioabsorbable material, if any, used in the first or second filament is primarily a matter of preference for the surgeon for the particular surgical procedure to be performed.
[00053] Although the same type of suture can be used for loop 14 and filament 16, a suture that has a lower abrasive property on its surface is preferred for the first material that forms closed loop 14. The most abrasive property Low can be achieved by a larger diameter, a softer composition, a softer ribbon, pleat or yarn pattern, or a combination of these characteristics. In some constructions, the suture material for the closed loop 14 is tied with a fixed knot to form the fixed length loop 14. In other constructions, the loop 14 is shaped or otherwise formed as a ring of material.
[00054] Sliding knot 22 has been described as a semi-curved half-knot in some constructions, but other suitable knots will be readily apparent to those skilled in the suturing technique after reviewing the present invention. The term "slide" for use in the present invention encompasses sliding nodes that can be tied, and sliding nodes. Various types of suitable nodes are described in the Arthroscopic Knot Tying Manual (2005) available from DePuy Mitek, and in US patent 6,767,037 by Wenstrom, Jr.
[00055] A procedure according to the present invention for using a cannula anchor system similar to that shown in Figure 1 is illustrated in Figures 4 to 7 to attach tissue 68 to bone 80. The reference numerals used to describe the system shown for this procedure correspond to the numerals used for system 10, Figure 1, for the purposes of simplicity and clarity, although several other types of anchors with different filament branch arrangements, as illustrated in other Figures, can also be used in a different way similar. An initial suture 70, Figure 4, having a needle 72 as its distal end is passed through tissue 68 to pull at least closed loop 14 at least partially through tissue 68. Alternatively, a suture-passing instrument is inserted through the tissue 68 to hold closed loop 14 and pull it through fabric 68. The extent to which the elongated adjustable loop 24 is pulled through fabric 68, and if an anchor passes through or engages closed loop 14 or adjustable loop 24, are described in more detail below with respect to Figures 8-8C.
[00056] In this procedure, a hole 82, Figure 4, is formed through the compact layer 84 in the spongy layer 86 of the bone 80 at the desired repair site. Anchor 12, in Figure 5, passes through a closed loop opening 89, as indicated by arrows 90, and is attached to the bone as shown in Figure 6. Preferably, the posterior branch 20 is extracted from closed loop 14 after anchor 12 passes through opening 89 in closed loop 14, Figure 5, so that the rear branch 20 can directly pull one of the branches of the adjustable loop through node 22 without being constrained by closed loop 14. The end end 18 is trapped between bone 86 and a portion of the distal end 32 of anchor 12 in this construction, and the sliding knot 22 is held by a restricted opening in the inner lumen 40. Alternatively, the terminal end 18 is of sufficient length to extend proximally along the exterior of anchor 12 passing through a plurality of engagement elements with bone 42, as shown in dashed line as length 18d, or is a shorter length 18e, as shown in Figure 8.
[00057] After fixing the anchor 12, Figure 6, proximal tension is applied to the posterior branch 20, as indicated by the arrow 92. While the posterior branch 20 is moved proximally, the adjustable loop 24 slides readily through the closed loop 14, as branches 26 and 28 are shortened. The fabric 68 is thus pulled towards the anchor 12 until the desired final position, under a desired tension, is obtained, as shown in Figure 7. The closed loop 14 engages the elongated loop 24 in a first and a second points 96 and 98.
[00058] Other systems and methods according to the present invention are shown in Figures 8 to 8C as alternatives to the final configuration shown in Figure 7. The end end 18e, of Figure 8, is intentionally short, so that it is not trapped between anchor 12 and bone 80. In this construction, the end end 18e remains within the perforation of bone 82 and is not placed under any tension.
[00059] Rather than requiring an opening 89, Figure 5, in closed loop 14 to be larger than the circumference of anchor 12, so that anchor 12 can pass completely through closed loop 14, in other constructions, the distal end 32 it engages a portion of the closed loop 14, as shown in Figure 8. The filament can be engaged as shown in Figures 11 and 12 of US Patent No. 7,381,213, by Lizardi. However, a benefit obtained by the present invention is that additional tensioning of the fabric 68 is possible after fixing the anchor by pulling the posterior branch of the adjustable loop. Another benefit of the present invention is that the anchor insertion agent (or insert) and related triggering instruments are removed prior to final tensioning and positioning of the tissue to be repaired to provide enhanced visual and tactile feedback to the surgeon.
[00060] Other filament arrangements are illustrated in Figures 8A to 8C. Anchor 12, Figure 8A, engages the portion of filament 118 that passes through fabric 68 to emerge from the other proximal side in the circled region indicated at 100. In the construction shown in Figure 8B for this circled region 100, adjustable loop 124 passes through of a portion of closed loop 114. In other words, the same branches of the filament form portions 114 and 118 of a single closed loop of fixed length. This arrangement is preferred because the branches of the adjustable loop 124 are able to slide over the closed loop filament in place 116 without passing through the fabric while the adjustable loop 124 is reduced in size.
[00061] In contrast, the branches of the adjustable portion 124 pass through the fabric 68 in Figure 8C, which represents an alternative configuration for Figure 8A, and the adjustable branches emerge to form the portion 118 which is engaged by the distal end 32 of the anchor. 12. In other words, no closed loop is used in the configuration represented by Figure 8C. However, the elimination of the fixed-length loop is less desirable because the adjustable loop can tend to stick on itself and can stick to or cause damage to the soft tissue through which it passes. The adjustable loop may have a tendency to cling to itself, even if the anchor has already passed completely through the adjustable loop. Additionally, the adjustability of the portion 118, Figure 8C, can still be barred by a fit with the bone, unless the branches of the portion 118 are correctly aligned in channels or in other external passages along the anchor 12.
[00062] A suture 200 for use with anchors in accordance with the present invention may use a Tennessee 202 sliding knot (Figure 9) in place of the knot of half of the blind line 22. It comprises a loop 204, the posterior branch 206 and the terminal end 208. Terminal end 208 passes over, and then behind, the rear branch 206, then over loop 204, and then finally, behind the rear branch 206 and back out.
[00063] Figures 10 and 11A to 11C illustrate an additional embodiment of a suture anchor 210 according to the present invention. It comprises a body 212 that has a proximal end 214 and a distal end 216 with an axial lumen 218 that passes through the proximal end 214. Distal end 216 is split with a saddle 220 between two distal sides 222. An opening 224 passes axially through the saddle 220. The annular barbed flanges 225 around the body 212 provide better fixation.
[00064] Suture 200 with Tennessee 202 sliding knot is positioned at anchor 210 with knot 202 distal from opening 224 in a pocket 227 created on sides 222, a fixed tail 226 of loop 204 that passes proximally to knot 202 through the opening 224 and an adjustable tail 228 of loop 204 surrounding saddle 220 to meet node 202. Loop 204 extends proximally out of lumen 218. Posterior branch 206 extends proximally around the opposite side of saddle 220 from the tail adjustable 228 and also extends proximally out of lumen 218. Anchor 210 can be used in a similar way to the above mentioned modalities.
[00065] Figures 12 and 13A to 13G illustrate an alternative procedure for use with suture anchors in accordance with the present invention. An anchor system 230 comprises suture anchor 210 with suture 200 equipped as shown in Figure 10 and with a flexible thread suture capture device 232 that has a suture capture loop 234 (such as the Chia Percpasser, available with to DePuy Mitek, Inc. of Raynham, MA) passed through lumen 218 with suture capture loop 234 distal to anchor body 212. A separate length of tissue suture 236 is passed through loop 204.
[00066] Typically, anchor system 230 is used arthroscopically through a cannula that could pass through the patient's skin 238 to tissue 240 and bone 242, where the repair should be performed, but is not illustrated here for further emphasis the tightening and movement of sutures 200 and 236, and suture anchor 210. First, a hole in bone 244 is created adjacent to tissue 240 (Figure 13A). The tissue suture 236 passes through the tissue 240 (for example, the rotator cuff tendon) and is pulled out of the cannula (not shown) to stay out of the skin 238 (Figure 13B) where it can pass through the capture loop suture 234 (Figure 13C). A suture drawer to pass the suture through the tissue, such as the EXPRESSEW flexible suture drawer, available from DePuy Mitek, Inc. of Raynham, MA, USA, can be used for this purpose. The suture capture device 232 is pulled proximally out of the lumen 218, the tissue suture 236 passing through the lumen 218 (Figure 13D). Suture anchor 210 is then passed under the cannula (not shown) to bone hole 244. The distal end of suture anchor 216 is placed in hole 244 and the looseness is then removed from the suture of tissue 236 (Figure 13E). Anchor 210 is then pushed into the orifice of bone 244, thereby locking the tissue suture 236 between anchor 210 and bone 242 (Figure 13F). Preferably, anchor 210 is inserted and pushed into bone hole 244 by means of a cannulated insert 248 with the posterior branch 206 located within a cannulation 250 through insert 248. After anchor 210 is pushed into the hole from bone 244, insert 248 is preferably removed (Figure 13G), and then the posterior branch 206 is pulled to retract loop 204 and tension tissue 236 (Figure 13H).
[00067] The combination of retractable loop 204 with tissue suture 236 provides great advantage for retraction of loop 204 during repair tensioning. Loop 204 slides over tissue suture 236 instead of sliding through the tissue itself, which makes it easier to tension the repair, since the friction coefficient between loop 204 and tissue suture 236 will be less than that if loop 204 is sliding through the fabric itself, and this minimizes any effects on the fabric.
[00068] Although it is shown with a single anchor 210, a typical fabric repair can involve a row of anchors or multiple rows of anchors. Anchor 210 and other modalities are, for example, useful for double-row repairs of the rotator cuff in which a first central row of anchors is placed under the cuff with the suture extending through the cuff and up to a second lateral row of anchors. located near the edge of the clamp. The suture that extends through the cuff from the central row could replace tissue suture 236 and be captured by anchors 210, in which case the suture capture device could preferably be placed through lumen 218, as in Figure 10, and then back through loop 204 so that the suture would pass from the central anchors in place of the tissue suture 236. To facilitate loading such a tissue suture loop, the retractable loop could be provided with a loop closed, like loop 14, with the anchor being passed through it and through the fabric suture loop, so that the retractable loop moves against the closed loop as it retracts.
[00069] Figure 14 illustrates an additional embodiment of an anchor system 250 in accordance with the present invention. It comprises a suture anchor 252 with a suture 200 and a tissue suture 254. Anchor 252 comprises a structure 256 that has a distal end 258 and a proximal end 260. An axial lumen 262 enters from the proximal end 260 and has there a restriction 264. The barbed flanges 266 surround the structure 256. A ring 268 is provided at the distal end 258. Suture 200 is located at the anchor with node 202 distal from restriction 264 and loop 204 and the posterior branch 206 passing proximally through restriction 264 and out of lumen 262. Restriction 264 restricts node 202.
[00070] Figures 15A to 15E illustrate a procedure for the anchor system 250 and, as in the previous representations, the instrumentation and the arthroscopic cannula have been omitted for the sake of clarity. An orifice 270 is formed in a bone 272 under the patient's skin 274 in a position adjacent to tissue 276 (Figure 15A). The tissue suture 254 is passed through the tissue (Figure 15B) and passed through eye 268 (Figure 15C). A suture capture device 232 (not shown in Figures 15A to 15E) could be used through eye 268 to facilitate loading suture 254 through it. Anchor 252 is placed in hole 270 of the bone, looseness is removed from tissue suture 254, and then the anchor is inserted into hole 270 of the bone to lock the tissue suture between anchor 252 and bone 272, in preferably on two sides of anchor 252. The tension applied to the posterior branch 206 retracts loop 204 and tensions the fabric suture 254.
[00071] Figures 16A to 16C illustrate variations of the suture anchor system 250. Similar parts on anchors 252a, 252b and 252c have similar part numbers for anchor 250, with the exception of their subscripts. Anchor 252a (Figure 16A) has an eyelet 280 that has a funnel-shaped entry slot 282 to load fabric suture 254a into the eyelet and then inhibit its passage back out of slot 282. The anchor 252b (Figure 16B) has an eyelet 284 formed by overlapping arms 286 that create a tortuous path 288 into eyelet 284 for the tissue suture 254b. Anchor 252c (Figure 16C) has a fork-shaped tip 290 formed of teeth 292 that project distally between which tissue suture 254c can be captured.
[00072] Figures 17 and 18A to 18Ha illustrate an additional embodiment of an anchor suture system 300 according to the present invention. It comprises a suture anchor 302 which has an elongated cylindrical shape with an axial cannulation 304 and an inner saddle 306 for suture. The ring-shaped flanges 308 surround the anchor 302 to improve its attachment to the bone. A suture 310 comprises a sliding knot 312 that forms a retractable loop 314 around the saddle of suture 306 with a long fixed tail 316 and the retractable tail 318. A suture driver 320 comprises a flexible thread 322 received through cannulation 304 and ending in a distal suture capture loop 324 away from anchor 302.
[00073] To use the suture anchor system 300, a bone hole 326 is formed in a bone 328 below the patient's skin 330 and in a position adjacent to the soft tissue 332, such as a tendon (Figure 18A) which is to be attached to the bone 328 with the suture anchor system 300. The fixed tail 316 passes through the soft tissue 332 and returns outside the skin 330 (Figure 18B). As in the descriptions of the previous procedure, the procedure is preferably performed arthroscopically and the associated arthroscopy equipment and the anchor insert are not shown in the Figures for clarity in illustrating the operation of the 300 suture anchor system. The fixed tail 316 is loaded into the suture capture loop 324 (Figure 18C) and the suture driver 320 is removed proximally through cannulation 304 to load the fixed tail 316 through cannulation 304 (Figure 18D). The suture anchor 302 is then placed inside the bone hole opening 326 and the looseness is removed from the fixed tail 316 (Figure 18E). When suture anchor 302 is pushed into the hole of bone 326, it traps the fixed tail 316 between anchor 302 and bone 328 (Figure 18F). When the retractable tail is pulled 318, retractable knot 312 retracts loop 304 and moves downward towards the saddle of suture 306, thereby pulling the fixed tail 316 and therefore the soft tissue 332 towards anchor 302 ( Figure 18G). The retractable tail 318 and the fixed tail 316 can then be trimmed to complete the procedure (Figure 18H). The resulting knot is very strong, since the tension between the fixed tail 316 at the point where it leaves the knot 312 and the loop 314 tightens the knot and such tension is provided by the load between the soft tissue 332 and the saddle of the suture 306 , thereby providing strong fixation.
[00074] The new suture anchors of the present invention can be produced from a number of suitable materials, including a metallic material, a non-biodegradable polymer, a biodegradable polymer or a composite of a biodegradable polymer or copolymer and a bioceramic. The term biodegradable, for use in the present invention, means materials that degrade in the body and are then absorbed or excreted by the body. The term bioceramics, as defined here, means ceramic and glass materials that are compatible with body tissues. Bioceramics are preferably biodegradable.
[00075] The metallic materials that can be used to manufacture the anchors of the present invention include stainless steel, titanium, nickel and titanium alloys, or other biocompatible metallic materials.
[00076] Non-biodegradable materials that can be used to manufacture the anchors of the present invention include polyethylene, polypropylene, (PEEK) (polyether ether ketone) or other biocompatible non-absorbable polymers.
[00077] Biodegradable polymers that can be used to manufacture the anchors used in the present invention include biodegradable polymers selected from the group consisting of aliphatic polyesters, poly-orthoesters, polyanhydrides, polycarbonates, polyurethanes, polyamides and polyalkylene oxides . Preferably, the biodegradable polymers are aliphatic polyester polymers and copolymers, and mixtures thereof. Aliphatic polyesters are typically synthesized in a ring opening polymerization. Suitable monomers include, but are not limited to, lactic acid, lactide (including L-, D-, meso and D, L mixtures), glycolic acid, epsilon-caprolactone, p-dioxanone (1,4-dioxan-2- ona), trimethylene carbonate (1,3-dioxan-2-one), delta-valerolactone, and combinations thereof.
[00078] Bioceramics that can be used in the composite anchors of the present invention include ceramics comprising mono, di, tri, alpha-tri, beta-tri, and calcium tetraphosphate, apatite hydroxide, calcium sulfates, calcium oxides, carbonates calcium, calcium phosphate and magnesium. It is particularly preferable to use a calcium beta-triphosphate. In addition to bioceramics, bio-glass can also be used in composite threads. Bioglasses can include glass and phosphate bioglasses.
[00079] Suitable biocompatible synthetic polymers can include polymers selected from the group consisting of aliphatic polyesters, poly (amino acids), copoly (ether-esters), polyalkylene oxalates, polyamides, tyrosine-derived polycarbonates, poly (iminocarbonates), polyesters , polyoxaesters, polyamidoesters, polyoxaesters containing amine groups, poly (anhydrides), polyphosphazenes, polyurethanes, poly (urethane ether), poly (urethane ester), poly (propylene fumarate), poly (hydroxy alkanoate) and mixtures thereof.
[00080] In accordance with the purposes of this invention, aliphatic polyesters include, but are not limited to, lactide homopolymers and copolymers (which include lactic acid, D-, L- and mesolactide); glycolide (including glycolic acid); ε-caprolactone; p-dioxanone (1,4-dioxan-2-one); trimethylene carbonate (1,3-dioxan-2-one); alkyl derivatives of trimethylene carbonate; delta-valerolactone; beta-butyrolactone; gamma-buty lactone; epsilon - decalactone; hydroxy-butyrate; hydroxy-valerate; 1,4-dioxepan-2-one (including its 1,5,8,12-tetra-oxa-cyclo-tetradecan-7,14-dione dimer); 1,5-dioxepan-2-one; 6,6-dimethyl-1,4-dioxan-2-one; 2,5-dicheto-morpholine; pivalolactone; alpha., alpha.-diethyl-propiolactone; ethylene carbonate; ethylene oxalate; 3-methyl-1,4-dioxane-2,5-dione; 3,3-diethyl-1,4-dioxan-2,5-diona-; 6,6-dimethyl-dioxepan-2-one; 6,8-dioxabicycloctane-7-one and mixtures of polymers thereof. Additional examples of polymers or mixtures of polymers include, as a non-limiting example, a poly-dioxanone, a poly (hydroxy-butyrate) -cohydroxy-valerate, polyortocarbonate, a polyamine carbonate, and a polymethylene carbonate. The aliphatic polyesters used in the present invention can be homopolymers or copolymers (random, block, segmented, tapered, graft, triblock, etc.) that have a linear, branched or star structure. For the purpose of this invention, poly (iminocarbonates) are understood to include polymers as described by Kemnitzer and Kohn, in the Handbook of Biodegradable Polymers, edited by Domb, et. al., Hardwood Academic Press, pp. 251-272 (1997). For the purpose of this invention, copoli (ether-esters) are understood to include the copolyester-ethers described in the Journal of Biomaterials Research, Vol. 22, pp. 993-1009, 1988 by Cohn and Younes, and in Polymer Preprints (ACS Division of Polymer Chemistry), Vol. 30 (1), page 498, 1989 by Cohn (for example, PEO / PLA). Polyalkylene oxalates, for the purpose of this invention, include those described in U.S. patents 4,208,511, 4,141,087, 4,130,639, 4,140,678, 4,105,034 and 4,205,399. Polyphosphazenes, polymers based on mixed co-, ter- and higher-order monomers made from L-lactide, D, L-lactide, lactic acid, glycolide, glycolic acid, para-dioxanone, trimethylene carbonate and E -caprolactone, such as those described by Allcock in The Encyclopedia of Polymer Science, Vol. 13, pages 31 to 41, Wiley Intersciences, John Wiley & Sons, 1988 and by Vandorpe, et al in the Handbook of Biodegradable Polymers, edited by Domb, et al., Hardwood Academic Press, pages 161-182 (1997). Polyanhydrides include derivatives of diacids of the form HOOC - C.sub.6H.sub.4 - O - (- CH.sub.2) .sub.m - O - C.sub.6H .sub.4 - COOH, in which m is an integer in the range 2 to 8, and copolymers of these with alpha-omega aliphatic diacids of up to 12 carbons. Polyoxa esters, polyoxamides and polyoxaesters containing amines and / or starch groups are described in one or more of the following US Patent Nos: 5,464,929, 5,595,751, 5,597,579, 5,607,687, 5,618,552, 5,620. 698, 5,645,850, 5,648,088, 5,698,213, 5,700,583 and 5,859,150. Poliortoesters include those described by Heller in the Handbook of Biodegradable Polymers, edited by Domb, et al, Hardwood Academic Press, pages 99-118 (1997).
[00081] Thus, although fundamental innovative characteristics of the invention have been shown, described and indicated, as applied to a preferred modality of the same, it will be understood that various omissions, substitutions and changes in the shape and details of the illustrated devices, and in their operation, can be done by those skilled in the art without deviating from the spirit and scope of the invention. For example, it is expressly provided that all combinations of those elements and / or steps that perform substantially the same function, in substantially the same way, will achieve the same results within the scope of the invention. Substitutions of elements from one modality described to another are also completely foreseen and contemplated. It must also be understood that the drawings are not necessarily drawn to scale, and are merely of a conceptual nature. It is the intention, therefore, that the invention is limited only as indicated by the scope of the appended claims.
[00082] Each granted patent, pending patent application, publication, newspaper article, book or any other reference cited in the present invention is incorporated by reference in its entirety.

权利要求:
Claims (16)
[0001]
1. Adjustable suture anchor system (10.10a-c) for fixing tissue to bone, characterized by the fact that it comprises: a suture anchor (12.12a-c) having at least one passage (40.40a-c ) extending from a proximal end towards a distal end, the passage including a restraint (46.46a-c) and the anchor having at least one bone engaging element (42.42a) disposed between the proximal and distal ends ; a first material formed as a closed loop (14,14a-c) and capable of being placed through a portion of the fabric; a second filament (16.16a-c) having an end end, a posterior branch (20.20a-c) and a slip knot (22.22a-c) tied between the end end and the posterior branch to establish an elongated loop with adjustable length that extends beyond the proximal end of the anchor and captures the closed loop of the first material; and the knot (22,22a-c) of the second filament (16,16a-c) is contained by the constraint (46,46a-c) when tension is applied to the posterior branch to shorten the elongated loop to attract the fabric towards to the anchor.
[0002]
2. Suture anchor system, according to claim 1, characterized by the fact that the first material is a first filament (14,14a-c).
[0003]
3. Suture anchor system, according to claim 2, characterized by the fact that the closed loop of the first filament is shorter than the elongated loop of the second filament (16,16a-c).
[0004]
4. Suture anchor system according to claim 2, characterized by the fact that the first filament has a diameter at least as large as that of the second filament.
[0005]
5. Suture anchor system according to claim 2, characterized by the fact that the first filament is formed to have less abrasive properties on its surface than that of the second filament.
[0006]
6. Suture anchor system, according to claim 1, characterized by the fact that the first material is formed from a first suture and the second filament is formed from a second suture.
[0007]
7. Suture anchor system according to claim 6, characterized by the fact that the first suture has a different composition than the second suture.
[0008]
8. Suture anchor system according to claim 1, characterized by the fact that the sliding knot (22,22a-c) is a semi-curved half-knot.
[0009]
9. Suture anchor system, according to claim 1, characterized by the fact that the passage (40, 40a, 56) is defined by at least one internal lumen in the anchor.
[0010]
10. Suture anchor system according to claim 1, characterized by the fact that the restriction is defined at least in part by the engagement with the bone when the anchor is attached to the bone. The sliding knot is disposed distally from the column.
[0011]
11. Suture anchor system, according to claim 1, characterized by the fact that the passage (44) extends along an external surface of the anchor that crosses the engagement element to the bone, and the engagement element to the Each bone defines at least one channel as part of the passage.
[0012]
12. Suture anchor system, according to claim 1, characterized by the fact that; the constraint is a restricted opening (46.46a-c) defined by the passage; the first material is a first filament (14,14a-c) formed as a closed loop with an opening greater than an anchor circumference; the elongated loop is initially larger in length than the closed loop of the first filament; and the knot (22,22a-c) of the second filament is contained by the restricted opening when the proximal tension is applied to the posterior branch after fixation of the anchor in the bone.
[0013]
13. Suture anchor system according to claim 12, characterized by the fact that the first filament is formed from a first suture and the second filament is formed from a second suture.
[0014]
14. Suture anchor system according to claim 13, characterized in that it comprises the first suture has a different composition than the second suture.
[0015]
15. Suture anchor system according to claim 13, characterized by the fact that the sliding knot is a half-curved half-knot.
[0016]
16. Suture anchor system according to claim 12, characterized by the fact that the passage is defined by at least one internal lumen in the anchor.

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EP2468194A3|2012-11-14|

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法律状态:
2018-12-18| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|

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2020-07-28| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|

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2020-10-06| B16A| Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 23/12/2011, OBSERVADAS AS CONDICOES LEGAIS. |

优先权:

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申请号 | 申请日 | 专利标题

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US12/977,146|US8821543B2|2010-12-23|2010-12-23|Adjustable anchor systems and methods|

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US12/977,146|2010-12-23|

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PCT/US2011/067119|WO2012088496A2|2010-12-23|2011-12-23|Adjustable anchor systems and methods|

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