Integrally-formed weft-knitted rotator cuff patch with full-suture anchor and preparation of integrally-formed weft-knitted rotator cuff patch

Abstract

The invention belongs to the technical field of weft-knitted rotator cuff patches, and relates to an integrally-formed weft-knitted rotator cuff patch with a full-stitch anchor and preparation of the integrally-formed weft-knitted rotator cuff patch with the full-stitch anchor, and the whole rotator cuff patch is of a sheet-shaped structure formed by weft knitting of yarn and stitches; the whole body formed by yarns in the rotator cuff patch is divided into a patch main body area, a patch forking and extending area and a nail body area which are sequentially arranged in the longitudinal direction, a sewing thread is only located in the nail body area and does not participate in knitting and looping, at least one sewing thread is arranged in each nail body area, and the nail body area and the sewing thread in the nail body area form a full-sewing-thread anchor nail. During preparation, a computerized flat knitting machine is adopted for production, firstly, yarn is adopted for knitting a patch main body area, then a knitting area is gradually narrowed down, a patch forking and extending area is formed in the process, finally, yarn is adopted for knitting a nail body area, a sewing thread is introduced into the knitting area in a weft insertion mode, and then the sewing thread is taken out of the knitting area in the weft insertion mode. The rotator cuff patch has the characteristics of high mechanical strength, uniform stress distribution, high fixing strength and the like.

Description

Technical Field

[0001] The invention belongs to the technical field of weft-knitted rotator cuff patches and relates to an integrally formed weft-knitted rotator cuff patch with self-contained suture anchors. Background Art

[0002] Rotator cuff injury, a common shoulder disease that severely impacts patients' quality of life, has long been a research focus in clinical medicine and biomaterials science. Its pathogenesis is complex, involving the tearing or degeneration of the shoulder's peripheral tendons (such as the supraspinatus and infraspinatus muscles), a process closely related to factors such as long-term overuse, traumatic impact, and tissue aging due to aging. In daily life and exercise, the shoulder joint is frequently subjected to a variety of complex stresses. When these stresses exceed the tolerance limit of the rotator cuff tendons, microscopic damage is induced. As the damage gradually accumulates, it eventually leads to tendon tears, which in turn causes a series of functional disorders such as shoulder pain and limited mobility, seriously interfering with the patient's normal life and work.

[0003] From an anatomical perspective, the tendon-bone junction of a normal rotator cuff has a unique and exquisite four-layer gradient structure, which consists of tendon, fibrocartilage, mineralized cartilage, and bone from the tendon end to the bone end. This structure is not a simple stack of tissues, but an optimized structure that has been formed in the long process of biological evolution to adapt to the mechanical environment of the shoulder joint. During the mechanical transmission process, this gradient structure can effectively achieve a smooth transition and dispersion of force, evenly distribute concentrated stress, thereby significantly reducing local stress concentration and greatly reducing the risk of rotator cuff tears. It is the key structural basis for maintaining the stability and integrity of the rotator cuff. Numerous biomechanical studies have shown that this unique structure is closely linked to the normal biomechanical function of the rotator cuff, and any factor that destroys the integrity of this structure may lead to rotator cuff dysfunction.

[0004] In the clinical treatment of rotator cuff injuries, simple suture repair can often achieve relatively satisfactory results for patients with smaller tears or better tissue quality. However, for patients with huge tears or poor tissue quality, simple suture repair is difficult to restore the normal tendon-bone connection structure, and the risk of re-tear after surgery is extremely high. According to clinical statistics, the incidence of re-tear after simple suture repair in such patients is high, which seriously affects the patient's rehabilitation effect and quality of life. Against this background, rotator cuff patches have emerged as an important auxiliary repair method. By bridging the defect area, rotator cuff patches can enhance the mechanical strength of the tendon, provide additional support and protection for the rotator cuff, effectively reduce the incidence of postoperative re-tear, and improve the success rate of repair. In recent years, with the rapid development of materials science and biomedical engineering, the research and development and application of rotator cuff patches have made significant progress. More and more new patch materials and designs have emerged, bringing new hope for the repair of rotator cuff injuries.

[0005] Although existing rotator cuff patches have achieved certain results in clinical applications, there are still many problems that need to be solved. From the perspective of mechanical properties, existing patches generally have the problem of insufficient mechanical strength. During the healing period of the rotator cuff, the shoulder joint needs to bear a certain load, and existing patches are often unable to withstand this high-load stress and are prone to structural failure. Studies have shown that most patch failures occur at the tendon-bone junction, which is subjected to stress concentration of up to 100~150MPa, far higher than the tolerance limit of 50~100MPa of the tendon itself. If the mechanical strength of the patch is insufficient, the patch is easily cut repeatedly by the sutures at the tendon-bone suture interface, resulting in damage to the structural integrity, and ultimately causing patch rupture and tendon re-tear.

[0006] Furthermore, uneven stress distribution is a significant drawback of existing patches. Irrational structural design prevents the patch from evenly distributing stress when subjected to force, leading to severe localized stress concentration and further increasing the risk of patch rupture and repair failure.

[0007] In terms of fixation strength, rotator cuff patch surgery currently mostly uses suture anchors for fixation. Commonly used anchors include metal anchors, absorbable anchors, and full-suture anchors. Full-suture anchors are woven from ultra-high molecular weight polyethylene fibers (UHMWPE). There is no need to pre-drill a large bone tunnel during implantation. Fixation is achieved by the expansion of the nail body within the bone. They have the advantages of avoiding interference from metal artifacts, reducing bone loss, and flexible operation. However, due to the high stress characteristics of the tendon-bone connection interface, no matter what type of anchor is used, the problem of suture cutting and damage to the patch and tendon stump remains prominent. The continuous traction force generated by postoperative shoulder joint movement and the high pressure at the suture contact site can easily lead to cutting and tearing of the patch material or tendon tissue at the suture interface, becoming a key mechanical factor for postoperative re-tear and repair failure.

[0008] Although the relevant patent technology has provided ideas for the improvement of rotator cuff patches to a certain extent, it also has limitations. For example, patent CN202110099938.3 discloses a pin-type soft tissue repair patch, which consists of a sheet-like part connected to a double-columnar part. The double-columnar part can be directly inserted into the bone tunnel to enhance the grip of the patch and the bone, replace sutures for suturing and fixing at the tendon-bone junction, avoid suture cutting damage, and improve the bonding strength between the patch and the bone tissue, which has significant advantages in the fixation method. However, the patch is made by electrospinning, and it is speculated that its overall strength is weak and it is difficult to meet the high load requirements of the rotator cuff healing period. At the same time, the sheet-like part is an electrospun fiber felt, and the double-columnar part is rolled up from a sheet-like electrospun composite material coated with artificial bone induction material. There is a difference in stiffness between the two, and there is no stress buffer zone between the sheet-like part and the double-columnar part. The connection is prone to stress concentration, which leads to patch rupture. In addition, the double-columnar part does not deform after being implanted in the bone tunnel, and the actual fixation strength does not reach the level of full suture anchors, which may affect the stability of the patch in the bone and increase the risk of patch displacement or falling off.

[0009] In summary, existing rotator cuff patches have significant deficiencies in mechanical strength, stress distribution, and fixation strength, making them difficult to meet the stringent clinical requirements for rotator cuff repair. Therefore, the development of new artificial rotator cuff patches is of great practical significance and urgency. These new patches should possess high mechanical strength, uniform stress distribution, and high fixation strength to better adapt to the complex mechanical environment of the shoulder joint, improve the success rate of rotator cuff repair, and enhance patients' quality of life. Summary of the Invention

[0010] The purpose of the present invention is to solve the problems existing in the prior art and to provide an integrally formed weft-knitted rotator cuff patch with self-contained suture anchors.

[0011] In order to achieve the above object, the technical solution adopted by the present invention is as follows:

[0012] An integrally formed weft-knitted rotator cuff patch with self-contained suture anchors, wherein the rotator cuff patch is a sheet-like structure formed by weft-knitting yarns and sutures;

[0013] The yarn structure of the rotator cuff patch is divided into a patch main body region, a patch bifurcated extension region, and a nail body region arranged in sequence along the longitudinal direction. The number of the patch main body region is 1, the number of the patch bifurcated extension regions is n and they are arranged in sequence along the transverse direction, and the number of the nail body regions is n and they are arranged in sequence along the transverse direction, and n ≥ 2;

[0014] The end of the patch bifurcation extension region connected to the patch main body region is marked as end A, and the end connected to the nail body region is marked as end B. The size of the patch bifurcation extension region gradually decreases from end A to end B.

[0015] The n nail body regions are connected to the n patch bifurcation extension regions in a one-to-one correspondence;

[0016] The suture is only located in the nail body area and does not participate in knitting. There is at least one suture in each nail body area. The n nail body areas and the sutures therein constitute n full suture anchors.

[0017] The main area of ​​the patch and the bifurcated extension area of ​​the patch are used to bridge the torn tendon, and the full suture anchor is used to anchor the bone tunnel.

[0018] The rotator cuff patch of the present invention has high mechanical strength because the entire patch is formed by weft knitting yarns and sutures.

[0019] The stress distribution of the rotator cuff patch of the present invention is uniform. On the one hand, because the connection between the patch main body area and the nail body area is designed as a gradually narrowing patch bifurcation extension area, the stress mutation of the traditional right-angle connection can be avoided, and there is a better stress dispersion effect, which makes the rotator cuff patch less likely to curl up and has a better fit with the rotator cuff interface; on the other hand, because the rotator cuff patch is formed by coils strung together, the elastic hinge network formed can dissipate stress in multiple directions.

[0020] The rotator cuff patch of the present invention has high fixation strength. During use, the nail body area is implanted, folded, and then inserted into the bone tunnel. When the two free ends of the same suture are pulled synchronously in the same direction, the nail body area penetrated by the suture expands within the bone tunnel, enlarging the cancellous bone tunnel while maintaining the size of the cortical bone hole. This ensures that the nail body area is anchored within the bone tunnel (below the cortical bone and within the cancellous bone), fully utilizing the high fixation strength of the full-suture anchor. In addition, the suture contained in the full-suture anchor can also be used to sew other edges of the patch.

[0021] As the preferred technical solution:

[0022] As described above, the one-piece weft-knitted rotator cuff patch with built-in suture anchors has a weft-knitted double-sided structure, in which the coils are composed of one or more of loops, tucks, and floats.

[0023] As described above, the one-piece weft-knitted rotator cuff patch with built-in suture anchors has a main area of ​​the patch that is rectangular in shape, with a longitudinal length of 30 to 50 mm and a transverse length of 20 to 40 mm.

[0024] As described above, the one-piece weft-knitted rotator cuff patch with self-contained suture anchors has a rectangular shape in the nail body area, a longitudinal length of 5 to 22 mm, and a transverse length of 4 to 20 mm.

[0025] As described above, the one-piece weft-knitted rotator cuff patch with built-in suture anchors has a longitudinal length of 5 to 10 mm in the bifurcated extension area and a maximum transverse length of 8 to 18 mm.

[0026] The above-mentioned integrally formed weft-knitted rotator cuff patch with self-contained suture anchors, wherein the yarn is a medical polymer yarn with a linear density of 75 to 500 D, and the medical polymer material includes but is not limited to: one or more of polyethylene terephthalate (PET), polypropylene (PP), polyethylene (PE), polytetrafluoroethylene (PTFE), polyglycolic acid (PGA), polylactic acid (PLA), polylactic-co-glycolic acid (PGLA), polyglycolic acid-polycaprolactone copolymer (PGCL), polydioxanone (PPDO), polycaprolactone (PCL), poly-L-lactide (PLLA), polyglycolide-caprolactone (PGCL), polydioxanone (PHA) and polytrimethylene carbonate (PTMC);

[0027] The suture was made of ultra-high molecular weight polyethylene (UHMWPE) braided wire with a diameter of 0.3-0.6 mm.

[0028] As described above, in an integrally formed weft-knitted rotator cuff patch with built-in suture anchors (referred to as integrally formed weft-knitted rotator cuff patch A with built-in suture anchors), the minimum transverse length of the patch bifurcation extension area is less than or equal to the transverse length of the nail body area, the longitudinal length of the nail body area is greater than the transverse length, the suture penetrates the nail body area longitudinally and alternately emerges on the two surfaces of the nail body area, the suture forms at least two penetration sites in each nail body area, and the distance between two adjacent penetration sites is 2 to 6 mm.

[0029] As described above, in an integrally formed weft-knitted rotator cuff patch with built-in suture anchors (referred to as integrally formed weft-knitted rotator cuff patch B with built-in suture anchors), the minimum transverse length of the patch bifurcated extension area is smaller than the transverse length of the nail body area, the longitudinal length of the nail body area is smaller than the transverse length, the suture penetrates the nail body area in the transverse direction and alternately emerges on the two surfaces of the nail body area, the suture forms at least two penetration sites in each nail body area, and the distance between two adjacent penetration sites is 2 to 6 mm.

[0030] The present invention also provides a method for preparing the above-mentioned one-piece weft-knitted rotator cuff patch A with self-contained full suture anchors, which is produced using a computerized flat knitting machine. First, yarn is used to weave the main body area of ​​the patch, and then the knitting area is gradually narrowed. In this process, a forked extension area of ​​the patch is formed, and finally, yarn is used to weave the nail body area. In this process, the suture is first introduced into the knitting area in the form of weft insertion, and then penetrated into the nail body area through a needle turning action. Then, the yarn guide with the suture is swung in the middle of the nail body area. At each penetration point, the suture is transferred from one surface of the nail body area to another surface through a needle turning action. After the nail body area is knitted, the suture is brought out of the knitting area in the form of weft insertion, and n full suture anchors are knitted simultaneously.

[0031] As the preferred technical solution:

[0032] According to the method described above, the yarn guide swings in the middle of the nail body area within a range of 1 to 5 stitches.

[0033] The present invention also provides a method for preparing the above-mentioned one-piece weft-knitted rotator cuff patch B with full suture anchors, which is produced using a computer flat knitting machine. First, yarn is used to knit the main body area of ​​the patch, and then the knitting area is gradually narrowed to form a patch bifurcation extension area in the process. Finally, yarn is used to knit the nail body area. In this process, the nail body area is first knitted to half of its longitudinal length, and the row knitted to half of the longitudinal length is recorded as knitting row M. Then, the nail body area is divided into m equal parts in the transverse direction, where m≥5. The coils of each part are all turned to the front needle bed or the rear needle bed in the knitting row M, and the coils of two adjacent parts are turned to different needle beds. Then, the suture is introduced into the knitting area in the form of weft insertion, and the knitting of the nail body area for one row is continued. Then, the suture is brought out of the knitting area in the form of weft insertion, and then the knitting of the nail body area is continued to its complete longitudinal length. Then, the coils of the nail body area are unhooked in the form of flat needle narrowing, and n full suture anchors are knitted in sequence.

[0034] Beneficial effects:

[0035] (1) The one-piece weft-knitted rotator cuff patch with built-in suture anchors of the present invention has high mechanical strength, uniform stress distribution, and high fixing strength. It can effectively reduce the cutting damage of sutures to the patch and the tendon at the tendon-bone junction. The size can be flexibly customized according to the needs of rotator cuff repair surgery without the need for subsequent cutting and threading. The unique bifurcated extension area design of the patch can disperse the stress at the tendon-bone junction, reduce the risk of loose fiber inflammation and manual uncertainty, and can improve the repair effect and reduce the re-tear rate.

[0036] (2) The present invention provides a method for preparing an integrally formed weft-knitted rotator cuff patch with a built-in suture anchor. The integrated weaving of the patch and the suture anchor is achieved through the knitting weft knitting one-line full-form technology. During the knitting process, a whole of "patch main body area - patch bifurcation extension area - nail body area + suture" is formed. The nail body area can be directly anchored into the bone tunnel of the humeral head. The nail body area can be expanded and fixed by tightening the suture. BRIEF DESCRIPTION OF THE DRAWINGS

[0037] Figure 1 This is a front view of an integrally formed weft-knitted rotator cuff patch with self-contained suture anchors according to Example 1 of the present invention;

[0038] Figure 2 This is a schematic cross-sectional view of an integrally formed weft-knitted rotator cuff patch with self-contained suture anchors according to Example 1 of the present invention;

[0039] Figure 3Schematic diagram of the full-suture anchor portion of an integrally formed weft-knitted rotator cuff patch with built-in full-suture anchors according to Example 1 of the present invention;

[0040] Figure 4 This is a computerized flat knitting diagram of the patch bifurcation extension area of ​​an integrally formed weft-knitted rotator cuff patch with self-contained suture anchors according to Example 1 of the present invention; wherein B is the front needle bed and F is the rear needle bed;

[0041] Figure 5 This is a computerized flat knitting diagram of a portion of a fully sutured anchor of an integrally formed weft-knitted rotator cuff patch with built-in suture anchors according to Example 1 of the present invention; wherein B is the front needle bed, F is the rear needle bed, and Y^ is a yarn guide elevation mark;

[0042] Figure 6 This is a schematic diagram of an integrally formed weft-knitted rotator cuff patch with self-contained suture anchors according to Example 1 of the present invention, wherein the sutures are relaxed, the nail body area is folded in half and then curled into a rod shape, and then implanted into a bone tunnel;

[0043] Figure 7 This is a schematic diagram of an integrally formed weft-knitted rotator cuff patch with self-contained suture anchors according to Example 1 of the present invention, in which the suture is tightened, the nail body area contracts and expands, and is anchored in the bone tunnel;

[0044] Figure 8 This is a schematic diagram of the use of an integrally formed weft-knitted rotator cuff patch with self-contained suture anchors in human rotator cuff repair according to Example 1 of the present invention;

[0045] Figure 9 This is a tensile performance curve of an integrally formed weft-knitted rotator cuff patch with self-contained suture anchors according to Example 1 of the present invention;

[0046] Figure 10 This is a front view of an integrally formed weft-knitted rotator cuff patch with self-contained suture anchors according to Example 2 of the present invention;

[0047] Figure 11 Schematic diagram of the full-suture anchor portion of an integrally formed weft-knitted rotator cuff patch with built-in full-suture anchors according to Example 2 of the present invention;

[0048] Figure 12 The figure shows the comparison of the fixing strength of Example 1, Example 2, Comparative Example 1 and Comparative Example 2 of the present invention;

[0049] Figure 13 This is a front view of an integrally formed weft-knitted rotator cuff patch with self-contained suture anchors according to Example 3 of the present invention;

[0050] Among them, 1-rotator cuff patch, 2-patch main body area, 3-patch bifurcation extension area, 4-nail body area, 5-suture, 5.1-ultra-high molecular weight polyethylene braided wire I, 5.2-ultra-high molecular weight polyethylene braided wire II. DETAILED DESCRIPTION

[0051] Below in conjunction with specific embodiment, further set forth the present invention.Should be understood that these embodiments are only used to illustrate the present invention and are not used in limiting the scope of the present invention.In addition, should be understood that after reading the content taught by the present invention, those skilled in the art can make various changes or modifications to the present invention, and these equivalent forms fall equally within the scope limited by the appended claims of the application.

[0052] The test methods involved in the performance indicators in the embodiments and comparative examples of the present invention are as follows:

[0053] (1) Breaking strength and elongation: Refer to the standard GB / T 3923.1-2013 "Tensile properties of textile fabrics - Part 1: Determination of breaking strength and elongation (strip method)" and based on the actual size of the rotator cuff patch. During the test, a clamping distance of 35 mm was used and the specimen was stretched to break at a speed of 50 mm / min. The strength and elongation at break were recorded. Each experiment was repeated five times and the average value was used as the final result.

[0054] (2) Fixation strength: Since structural failure of rotator cuff patches often occurs at the tendon-bone junction, the fixation strength of the rotator cuff patch with its own suture anchor and the rotator cuff patch with a conventional structure at the tendon-bone junction was tested and compared.

[0055] For the self-contained full-suture anchor rotator cuff patch in the embodiment of the present invention, since the tendon-bone junction is directly anchored into the bone tunnel with the self-contained anchor, the "fixation strength" test method described in the standard YY / T 1867-2023 "Sports Medicine Implant Device with Wire Anchor" is referred to: a two-phase polyurethane material of pcf20 and pcf40 produced by Pacific Research Laboratories, Inc. of the United States is used to simulate artificial bone, and the full-suture anchor carried by the patch is anchored into the tunnel of the artificial bone material. A tensile force is applied to the suture at a speed of 50 mm / min until the nail body area is pulled out or failure occurs. The maximum force measured in this process is the fixation strength of the self-contained full-suture anchor rotator cuff patch. Each experiment is repeated five times and the average value is taken as the final result;

[0056] For the ordinary structure rotator cuff patch in the comparative example, since the tendon-bone connection is fixed by suture, the "suture strength" test method described in the standard YY / T 1814-2022 "Surgical Implant Synthetic Non-absorbable Patch Hernia Repair Patch" is referred to: use a suture thread to pass through the patch 5 mm away from the edge at one end of the patch and sew it into a semi-circle. The suture is pulled out at a speed of 50 mm / min. The pulling force that pulls the suture out of the patch or damages the patch is the fixation strength of the patch at the tendon-bone connection. Each experiment is repeated five times and the average value is taken as the final result.

[0057] The sources of some of the substances of the present invention are as follows:

[0058] PET yarn: The manufacturer is Jiangsu Hengli Chemical Fiber Co., Ltd., and the specification is 200D / 48f.

[0059] Ultra-high molecular weight polyethylene braided wire: The manufacturer is Dongguan Shunli New Materials Co., Ltd., with diameters of 0.4 mm, 0.5 mm or 0.6 mm.

[0060] PLA yarn: specification is 200D / 36f.

[0061] PE yarn: The manufacturer is Zhejiang Qianxilong Special Fiber Co., Ltd., and the specification is 100D / 36f.

[0062] Example 1

[0063] An integrally formed weft-knitted rotator cuff patch with self-sutured anchors, such as Figures 1 and 2 As shown, the rotator cuff patch 1 as a whole is a sheet structure formed by weft knitting yarns and sutures; the tissue structure of the rotator cuff patch 1 is a weft knitted double-sided tissue;

[0064] The yarn is 3 PET filaments with a specification of 200D / 48f; the suture is ultra-high molecular weight polyethylene braided wire with a diameter of 0.5mm;

[0065] The yarn structure of the rotator cuff patch is divided into a patch main body region 2, a patch bifurcated extension region 3 and a nail body region 4 arranged in sequence along the longitudinal direction, wherein the patch main body region 2, the patch bifurcated extension region 3 and the nail body region 4 are all double rib structures;

[0066] The number of the patch main body area 2 is 1, and the shape of the patch main body area 2 is rectangular, with a longitudinal length of 35 mm and a transverse length of 25 mm; the transverse density is 42 columns / 50 mm, and the longitudinal density is 72 rows / 50 mm;

[0067] The number of patch bifurcation extension regions 3 is 2 and they are arranged sequentially in the transverse direction. The longitudinal length of the patch bifurcation extension region 3 is 8 mm, the maximum transverse length is 12 mm, and the minimum transverse length is equal to the transverse length of the nail body region 4. The transverse density is 44 columns / 50 mm and the longitudinal density is 63 rows / 50 mm.

[0068] The number of nail body regions 4 is 2 and they are arranged in sequence in the transverse direction; the shape of the nail body region is rectangular, with a longitudinal length of 19 mm and a transverse length of 7 mm; the transverse density is 45 columns / 50 mm and the longitudinal density is 68 rows / 50 mm;

[0069] The end of the patch bifurcation extension region 3 connected to the patch main body region 2 is marked as end A, and the end connected to the nail body region is marked as end B. The size of the patch bifurcation extension region gradually decreases from end A to end B.

[0070] The two nail body areas are connected to the two patch bifurcation extension areas in a one-to-one correspondence;

[0071] like Figure 3 As shown, the suture 5 is only located in the nail body area 4 and does not participate in the knitting loop. There is a suture 5 in each nail body area 4, and the two nail body areas 4 and the sutures 5 therein respectively form two full suture anchors;

[0072] The suture 5 penetrates the nail body region 4 in the longitudinal direction and appears alternately on the two surfaces of the nail body region 4; the suture 5 forms 6 penetration sites in each nail body region, and the distance between two adjacent penetration sites is 3 mm.

[0073] like Figure 12 As shown in FIG, the one-piece weft-knitted rotator cuff patch with full suture anchors is implanted in a biphasic polyurethane block with a fixation strength of 605.5 N; Figure 9 As shown in FIG, the breaking strength of the patch main body area of ​​the one-piece weft-knitted rotator cuff patch with full suture anchors is 1705.9 N, and the breaking elongation is 91.2%.

[0074] The above-mentioned method for preparing the one-piece weft-knitted rotator cuff patch with built-in suture anchors is produced using a STOLLADF530-32W computerized flat knitting machine (Karl Mayer, Germany) with a machine gauge of E7.2. The specific steps are as follows:

[0075] (1) threading the yarn;

[0076] On a computerized flat knitting machine, yarns are respectively passed through two yarn guides, namely a first yarn and a second yarn, and the sewing thread is then passed through another yarn guide; with the front needle bed direction of the flat knitting machine as the front and the rear needle bed direction as the rear, the tracks of the three yarn guides are arranged in the following order from front to rear: first yarn, sewing thread, and second yarn;

[0077] (2) Weaving: The patch main body area, patch bifurcation extension area, and nail body area are knitted continuously in sequence on a knitting computer flat knitting machine. The knitting methods for different parts of the rotator cuff patch are as follows:

[0078] ① The main area of ​​the patch;

[0079] The first yarn is knitted into an interlocking rib structure on the front and back needle beds. The knitting area width is 26 needles, the loop length NP=10.3, and the fabric stretch value WM=1.5.

[0080] ② Patch bifurcation extension area;

[0081] like Figure 4 As shown, the first yarn is knitted, and an interlocking rib structure is knitted on the front and rear needle beds. The knitting area is gradually narrowed by a blind narrowing method, and a patch bifurcation extension area is formed in this process. Each time, the left and right edges of each patch bifurcation extension area are narrowed by one stitch, and this process is repeated three times, so that the width of the knitting area becomes 14 stitches, the loop length NP = 11.0, and the fabric stretch value WM = 1.5.

[0082] ③ Nail body area, the knitting area width of each nail body area is 7 stitches, the coil length NP=10.3, the fabric stretch value WM=1.2, and the suture is introduced during the knitting process of the nail body area. The specific knitting steps of each nail body area are as follows (such as Figure 5 shown):

[0083] (a) knitting two rows of double rib with the first yarn, and then pausing knitting of the first yarn;

[0084] (b) The thread guide is moved in a low position by itself in a weft insertion mode, the weft presser foot is activated, and the thread is introduced to the center of the knitting area. Then, the "weft / automatic transfer" action is performed. A rear bed loop in the center of the knitting area is interlaced with a front bed loop at the same needle position via a transfer needle, and the thread is pressed between the loop and the previous row of front bed loops, thereby achieving a preliminary slidable connection of the thread on the nail body area.

[0085] (c) The first yarn is knitted in an interlocking pattern on the front and back needle beds, with only the front bed loop being knitted at the center needle of the knitting area. During this process, the thread guide is always in the high position and oscillates within the center needle of the knitting area. This process is repeated for four rows, so that the stitch is on the back of the knitted nail body area.

[0086] (d) The thread guide is kept in a high position and swung within the range of 1 needle in the knitting area. The first yarn is knitted temporarily, and the front bed loop is turned over to the back bed at the same needle position at the 1 needle in the middle of the knitting area. Then the second yarn is knitted, and the double rib structure is knitted on the front and back needle beds. Only the back bed loop is knitted at the 1 needle in the middle of the knitting area. This process is repeated for 4 rows so that the suture is located on the front side of the knitted nail body area.

[0087] Repeating operations (c) to (d) once will form a penetration site for the suture on the nail body area. Repeating multiple times will allow the suture to alternately appear on the front and back sides of the nail body area. After the nail body area is knitted, the suture is brought out of the knitting area in the form of weft insertion, and two full suture anchors are knitted simultaneously.

[0088] like Figure 6 The figure shows a schematic diagram of an integrally formed weft-knitted rotator cuff patch with self-contained suture anchors implanted into a bone tunnel in accordance with Example 1 of the present invention. When the suture is relaxed, the nail body area is folded in half and then curled into a rod shape, so that the lower end of the patch can be directly implanted into the bone tunnel.

[0089] like Figure 7 The figure shows a schematic diagram of an integrally formed weft-knitted rotator cuff patch with self-contained suture anchors anchored in a bone tunnel according to Example 1 of the present invention. When the suture is tightened, the nail body area contracts and expands, and the lower end of the patch can be firmly anchored in the bone tunnel, and the lower end of the patch does not need to be sutured.

[0090] like Figure 8 The figure shows a schematic diagram of the use of an integrally formed weft-knitted rotator cuff patch with self-contained suture anchors in embodiment 1 of the present invention in human rotator cuff repair surgery. This surgical method can repair huge rotator cuff tears.

[0091] Example 2

[0092] An integrally formed weft-knitted rotator cuff patch with self-sutured anchors, such as Figure 10 As shown, the rotator cuff patch 1 is a sheet-like structure formed by weft knitting yarns and sutures; the tissue structure of the rotator cuff patch is a weft knitted double-sided tissue;

[0093] The yarn is 2 PET yarns with a specification of 200D / 48f; the suture is ultra-high molecular weight polyethylene braided wire with a diameter of 0.5mm;

[0094] The yarn structure of the rotator cuff patch is divided into a patch main body region 2, a patch bifurcated extension region 3 and a nail body region 4 arranged in sequence along the longitudinal direction, wherein the patch main body region 2, the patch bifurcated extension region 3 and the nail body region 4 are all double rib structures;

[0095] The number of the patch main body area 2 is 1, and the shape of the patch main body area 2 is rectangular, with a longitudinal length of 35 mm and a transverse length of 25 mm; the transverse density is 55 columns / 50 mm, and the longitudinal density is 75 rows / 50 mm;

[0096] The number of patch bifurcation extension regions 3 is 2 and they are arranged sequentially in the transverse direction. The longitudinal length of the patch bifurcation extension region 3 is 8 mm, the maximum transverse length is 12 mm, and the minimum transverse length is 5 mm. The transverse density is 56 columns / 50 mm, and the longitudinal density is 77 rows / 50 mm.

[0097] The number of nail body regions 4 is 2 and they are arranged in sequence in the transverse direction; the shape of the nail body region is rectangular, with a longitudinal length of 6 mm and a transverse length of 17 mm; the transverse density is 50 columns / 50 mm and the longitudinal density is 70 rows / 50 mm;

[0098] The end of the patch bifurcation extension region 3 connected to the patch main body region 2 is marked as end A, and the end connected to the nail body region is marked as end B. The size of the patch bifurcation extension region gradually decreases from end A to end B.

[0099] The two nail body areas are connected to the two patch bifurcation extension areas in a one-to-one correspondence;

[0100] like Figure 11 As shown, the suture 5 is only located in the nail body area 4 and does not participate in the knitting loop. There is a suture 5 in each nail body area 4, and the two nail body areas 4 and the sutures 5 therein respectively form two full suture anchors;

[0101] The suture 5 penetrates the nail body area 4 in the transverse direction and appears alternately on the two surfaces of the nail body area 4; the suture 5 forms 6 penetration sites in each nail body area, and the distance between two adjacent penetration sites is 3 mm.

[0102] like Figure 12 As shown in the figure, the full-suture anchor of the one-piece weft-knitted rotator cuff patch with its own full-suture anchor is implanted in a two-phase polyurethane block, with a fixation strength of 589.7 N; the breaking strength of the patch main area of ​​the one-piece weft-knitted rotator cuff patch with its own full-suture anchor is 1124.6 N, and the elongation at break is 87.2%.

[0103] The above-mentioned one-piece weft-knitted rotator cuff patch with built-in suture anchors is produced using a STOLLCMS 530ki W computerized flat knitting machine (Karl Mayer, Germany) with a machine gauge of E10.2. The specific steps are as follows:

[0104] (1) threading the yarn;

[0105] On a computerized flat knitting machine, the yarns are respectively passed through two yarn guides, namely the first yarn and the second yarn, and the sewing thread is then passed through another yarn guide;

[0106] (2) Weaving: The patch main body area, patch bifurcation extension area, and nail body area are knitted continuously in sequence on a knitting computer flat knitting machine. The knitting methods for different parts of the rotator cuff patch are as follows:

[0107] ① The main area of ​​the patch;

[0108] The first yarn is knitted into an interlocking rib structure on the front and rear needle beds. The knitting area is 36 stitches wide, the loop length NP = 10.5, and the fabric stretch value WM = 1.0.

[0109] ② Patch bifurcation extension area;

[0110] The first yarn is knitted into an interlocking rib structure on the front and rear needle beds. The knitting area is gradually narrowed by blind narrowing, forming a patch bifurcation extension area in the process. Each time, the left and right edges of each patch bifurcation extension area are narrowed by one stitch, and this process is repeated six times, so that the total width of the knitting area becomes 12 stitches, the loop length NP = 11.0, and the fabric stretch value WM = 1.0.

[0111] ③ In the nail body area, two full-suture anchors are knitted in sequence. First, one of the full-suture anchors is knitted with the first yarn. After the stitches are flattened and the loops are cast off, the other full-suture anchor is knitted with the second yarn. The knitting area width of each nail body area is 21 stitches, the loop length NP=10.5, and the fabric stretch value WM=1.0. Sutures are introduced during the knitting process of the nail body area. The specific knitting steps for each nail body area are as follows:

[0112] (a) The first yarn is knitted in an interlocking rib pattern from one of the bifurcated extension areas of the patch to half the longitudinal length of the nail body. The row knitted to half the longitudinal length is recorded as knitting row M. The nail body area is divided into 7 equal parts along the length direction. The stitches in the 1st, 3rd, 5th, and 7th parts from the left are all transferred to the front needle bed in knitting row M. The stitches in the 2nd, 4th, and 6th parts from the left are all transferred to the back needle bed in knitting row M.

[0113] (b) introducing the stitches into the woven area in the form of weft insertion;

[0114] (c) the first yarn is continued to be knitted into an interlock stitch for one row, and the stitches are led out of the knitting area in the form of weft insertion;

[0115] (d) the first yarn continues to be knitted into an interlocking rib structure until the nail body region reaches the total longitudinal length;

[0116] (e) After the nail body area is knitted, the knitted area is unstitched by flat-closing the stitches;

[0117] Repeat steps (a) to (e) once more using the second yarn to form two full suture anchors.

[0118] Comparative Example 1

[0119] An integrally formed weft-knitted rotator cuff patch, having the same patch body area as the integrally formed weft-knitted rotator cuff patch with self-contained suture anchors as in Example 1, but without other areas.

[0120] like Figure 12 As shown in the figure, two UHMWPE sutures with a diameter of 0.5 mm were inserted under the one-piece weft-knitted rotator cuff patch, and the fixing strength was 347.88 N.

[0121] Comparing Comparative Example 1, Example 1 and Example 2, it can be found that the fixing strength of Comparative Example 1 is significantly reduced. This is because if the lower end of the patch is directly sutured with sutures, it is equivalent to the sutures locally cutting the patch. The lower end of the patch is prone to local rupture at the cut, which leads to overall failure.

[0122] Comparative Example 2

[0123] An integrally formed weft-knitted rotator cuff patch is basically the same as Example 1, except that the yarn-formed rotator cuff patch is divided into a patch main body area and a nail body area arranged in sequence along the longitudinal direction, i.e., the patch bifurcation extension area is omitted.

[0124] like Figure 12 As shown in the figure, the one-piece weft-knitted rotator cuff patch has a full suture anchor implanted in a two-phase polyurethane block, with a fixation strength of 370 N; the one-piece weft-knitted rotator cuff patch has a breaking strength of 982 N and an elongation at break of 87.1%.

[0125] The method for preparing the above-mentioned integrally formed weft-knitted rotator cuff patch is basically the same as that in Example 1, except that the process of weaving the bifurcated extension area of ​​the patch in step (2) is omitted.

[0126] Comparing Comparative Example 2, Example 1 and Example 2, it can be found that the fixing strength of Comparative Example 2 is significantly reduced. This is because the patch body area and the nail body area are directly connected, and a right angle is formed at the width change point, which is prone to stress concentration and leads to a decrease in fixing strength.

[0127] Example 3

[0128] An integrally formed weft-knitted rotator cuff patch with self-sutured anchors, such as Figure 13 As shown, the rotator cuff patch 1 is a sheet-like structure formed by weft knitting yarns and sutures; the tissue structure of the rotator cuff patch is a weft knitted double-sided tissue;

[0129] The yarn is 3 PET filaments with a specification of 200D / 48f; the suture is ultra-high molecular weight polyethylene braided wire with a diameter of 0.3mm;

[0130] The yarn structure of the rotator cuff patch is divided into a patch main body region 2, a patch bifurcated extension region 3 and a nail body region 4 arranged in sequence along the longitudinal direction, wherein the patch main body region 2, the patch bifurcated extension region 3 and the nail body region 4 are all double rib structures;

[0131] The number of the patch main body area 2 is 1, and the shape of the patch main body area 2 is rectangular, with a longitudinal length of 35 mm and a transverse length of 25 mm; the transverse density is 43 columns / 50 mm, and the longitudinal density is 71 rows / 50 mm;

[0132] The number of patch bifurcated extension regions 3 is 2 and they are arranged sequentially in the transverse direction. The longitudinal length of the patch bifurcated extension region 3 is 8 mm, the maximum transverse length is 12 mm, and the minimum transverse length is equal to the transverse length of the nail body region 4. The transverse density is 43 columns / 50 mm and the longitudinal density is 65 rows / 50 mm.

[0133] The number of nail body regions 4 is 2 and they are arranged in sequence in the transverse direction; the shape of the nail body region 4 is rectangular, with a longitudinal length of 9 mm and a transverse length of 7 mm; the transverse density is 45 columns / 50 mm and the longitudinal density is 68 rows / 50 mm;

[0134] The end of the patch bifurcated extension region 3 connected to the patch main body region 2 is marked as end A, and the end connected to the nail body region 4 is marked as end B. The size of the patch bifurcated extension region 3 gradually decreases from end A to end B.

[0135] The two nail body regions 4 are connected to the two patch bifurcation extension regions 3 in a one-to-one correspondence;

[0136] The sutures 5 are only located in the nail body area 4 and do not participate in the knitting. Each nail body area 4 contains two sutures 5, namely, ultra-high molecular weight polyethylene braided thread I 5.1 and ultra-high molecular weight polyethylene braided thread II 5.2. The two nail body areas 4 and the sutures 5 therein respectively form two full suture anchors.

[0137] The suture 5 penetrates the nail body area 4 in the longitudinal direction and appears alternately on the two surfaces of the nail body area 4; the suture 5 forms 6 penetration sites in each nail body area 4, and the distance between two adjacent penetration sites is 3 mm.

[0138] The one-piece weft-knitted rotator cuff patch with built-in full-suture anchors has a fixation strength of 714.2 N, with the full-suture anchors implanted in a dual-phase polyurethane block. The breaking strength of the main patch area of ​​the one-piece weft-knitted rotator cuff patch with built-in full-suture anchors is 1687.0 N, and the elongation at break is 75.8%.

[0139] The above-mentioned method for preparing the one-piece weft-knitted rotator cuff patch with built-in suture anchors is produced using a STOLLADF530-32W computerized flat knitting machine (Karl Mayer, Germany) with a machine gauge of E7.2. The specific steps are as follows:

[0140] (1) threading the yarn;

[0141] On a computerized flat knitting machine, yarns are respectively passed through two yarn guides, namely a first yarn and a second yarn, and the sewing thread is then passed through another yarn guide; with the front needle bed direction of the flat knitting machine as the front and the rear needle bed direction as the rear, the tracks of the three yarn guides are arranged in the following order from front to rear: first yarn, sewing thread, and second yarn;

[0142] (2) Weaving: The patch main body area, patch bifurcation extension area, and nail body area are knitted continuously in sequence on a knitting computer flat knitting machine. The knitting methods for different parts of the rotator cuff patch are as follows:

[0143] ① The main area of ​​the patch;

[0144] The first yarn is knitted into an interlocking rib structure on the front and back needle beds. The knitting area width is 26 needles, the loop length NP=10.3, and the fabric stretch value WM=1.5.

[0145] ② Patch bifurcation extension area;

[0146] The first yarn is knitted into an interlocking rib structure on the front and back needle beds. The knitting area is gradually narrowed by blind narrowing, forming a patch bifurcation extension area in the process. Each time, the left and right edges of each patch bifurcation extension area are narrowed by one stitch, and this process is repeated three times, so that the knitting area width becomes 14 stitches, the loop length NP = 11.0, and the fabric stretch value WM = 1.5.

[0147] ③ Nail body area: the knitting area width of each nail body area is 7 stitches, the coil length NP=10.3, the fabric stretch value WM=1.2, and the suture is introduced during the knitting process of the nail body area. The specific knitting steps for each nail body area are as follows:

[0148] (a) knitting two rows of double rib with the first yarn, and then pausing knitting of the first yarn;

[0149] (b) The thread guide is moved in a low position by itself in a weft insertion mode, the weft presser foot is activated, and the thread is introduced to the center of the knitting area. Then, the "weft / automatic transfer" action is performed. A rear bed loop in the center of the knitting area is interlaced with a front bed loop at the same needle position via a transfer needle, and the thread is pressed between the loop and the previous row of front bed loops, thereby achieving a preliminary slidable connection of the thread on the nail body area.

[0150] (c) The first yarn is knitted in an interlocking pattern on the front and back needle beds, with only the front bed loop being knitted at the center needle of the knitting area. During this process, the thread guide is always in the high position and oscillates within the center needle of the knitting area. This process is repeated for four rows, so that the stitch is on the back of the knitted nail body area.

[0151] (d) The thread guide is kept in a high position and swung within the range of one needle in the middle of the knitting area. The first yarn is knitted temporarily, and the front bed loop is turned over to the back bed at the same needle position at one needle in the middle of the knitting area. Then the second yarn is knitted, and the double rib structure is knitted on the front and back needle beds. Only the back bed loop is knitted at one needle in the middle of the knitting area. This process is repeated for four rows so that the suture is located on the front side of the knitted nail body area.

[0152] Repeating operations (c) to (d) once will form a penetration site for the suture on the nail body area. Repeating multiple times will allow the suture to alternately appear on the front and back sides of the nail body area. After the nail body area is knitted, the suture is brought out of the knitting area in the form of weft insertion, and two full suture anchors are knitted simultaneously.

[0153] Example 4

[0154] An integrally formed weft-knitted rotator cuff patch with self-contained suture anchors, wherein the rotator cuff patch is a sheet-like structure formed by weft knitting yarn and suture; the weave structure of the rotator cuff patch is a weft-knitted double-sided weave;

[0155] The yarn is composed of two 200D / 48f PET yarns and one weft inlay yarn; the weft inlay yarn is a single 200D / 36f PLA yarn; the suture is an ultra-high molecular weight polyethylene braided wire with a diameter of 0.5 mm;

[0156] The yarn structure of the rotator cuff patch is divided into a patch main body area, a patch bifurcated extension area and a nail body area arranged in sequence along the longitudinal direction, wherein the patch main body area and the patch bifurcated extension area are double rib weft inlay structures, and the nail body area is double rib weft inlay structures;

[0157] The number of patch main body areas is 1, and the shape of the patch main body area is rectangular, with a longitudinal length of 30 mm and a transverse length of 20 mm; the transverse density is 50 columns / 50 mm, and the longitudinal density is 81 rows / 50 mm;

[0158] The number of patch bifurcation extension regions is 2 and they are arranged in sequence along the transverse direction. The longitudinal length of the patch bifurcation extension region is 8 mm, the maximum transverse length is 10 mm, and the minimum transverse length is 5 mm. The transverse density is 47 columns / 50 mm, and the longitudinal density is 72 rows / 50 mm.

[0159] The number of nail body regions is 2 and they are arranged in sequence in the horizontal direction. The shape of the nail body region is rectangular, with a vertical length of 15 mm and a horizontal length of 6.5 mm. The horizontal density is 50 columns / 50 mm and the vertical density is 80 rows / 50 mm.

[0160] The end of the patch bifurcation extension region connected to the patch main body region is marked as end A, and the end connected to the nail body region is marked as end B. The size of the patch bifurcation extension region gradually decreases from end A to end B.

[0161] The two nail body areas are connected to the two patch bifurcation extension areas in a one-to-one correspondence;

[0162] The suture is only located in the nail body area and does not participate in the knitting loop. There is one suture in each nail body area, and the two nail body areas and the sutures therein constitute two full suture anchors;

[0163] The suture penetrates the nail body area longitudinally and appears alternately on the two surfaces of the nail body area; the suture forms four penetration sites in each nail body area, and the distance between two adjacent penetration sites is 3 mm.

[0164] The one-piece weft-knitted rotator cuff patch with full suture anchors has a fixation strength of 579.3 N, with the full suture anchors implanted in a two-phase polyurethane block. The breaking strength of the main patch area of ​​the one-piece weft-knitted rotator cuff patch with full suture anchors is 1309.7 N, and the elongation at break is 69.8%.

[0165] The above-mentioned method for preparing the one-piece weft-knitted rotator cuff patch with self-contained suture anchors is produced using a STOLLADF530-32W computerized flat knitting machine (Karl Mayer, Germany) with a machine gauge of E8.2. The specific steps are as follows:

[0166] (1) threading the yarn;

[0167] On a computerized flat knitting machine, yarns are respectively passed through two yarn guides, namely a first yarn and a second yarn, and the stitching yarn and the inlay yarn are respectively passed through two other yarn guides; with the front needle bed direction of the flat knitting machine as the front and the rear needle bed direction as the rear, the tracks of the three yarn guides are arranged in the following order from front to rear: first yarn, stitching yarn, second yarn, and inlay yarn;

[0168] (2) Weaving: The patch main body area, patch bifurcation extension area, and nail body area are knitted continuously in sequence on a knitting computer flat knitting machine. The knitting methods for different parts of the rotator cuff patch are as follows:

[0169] ① The main area of ​​the patch;

[0170] The first yarn and the weft inlay yarn are knitted in a loop on the front and rear needle beds to form an interlocking weft inlay structure. The weaving area width is 26 needles, the loop length NP=10.3, and the fabric draft value WM=1.5.

[0171] ② Patch bifurcation extension area;

[0172] The first yarn and the weft inlay yarn are knitted in a loop on the front and rear needle beds to form an interlock weft inlay. The knitting area is gradually narrowed by a blind narrowing method, forming a patch bifurcation extension area in this process. Each time, the left and right edges of each patch bifurcation extension area are narrowed by one stitch, and this process is repeated three times, so that the knitting area width becomes 14 stitches, the loop length NP = 11.0, and the fabric stretch value WM = 1.5.

[0173] ③ Nail body area: the knitting area width of each nail body area is 7 stitches, the coil length NP=10.3, the fabric stretch value WM=1.1, and the suture is introduced during the knitting process of the nail body area. The specific knitting steps for each nail body area are as follows:

[0174] (a) knitting two rows of double rib with the first yarn, and then pausing knitting of the first yarn;

[0175] (b) The thread guide is moved in a low position by itself in a weft insertion mode, the weft presser foot is activated, and the thread is introduced to the center of the knitting area. Then, the "weft / automatic transfer" action is performed. A rear bed loop in the center of the knitting area is interlaced with a front bed loop at the same needle position via a transfer needle, and the thread is pressed between the loop and the previous row of front bed loops, thereby achieving a preliminary slidable connection of the thread on the nail body area.

[0176] (c) The first yarn is knitted in an interlocking pattern on the front and back needle beds, with only the front bed loop being knitted at the center needle of the knitting area. During this process, the thread guide is always in the high position and oscillates within the center needle of the knitting area. This process is repeated for four rows, so that the stitch is on the back of the knitted nail body area.

[0177] (d) The thread guide is kept in a high position and swung within the range of one needle in the middle of the knitting area. The first yarn is knitted temporarily, and the front bed loop is turned over to the back bed at the same needle position at one needle in the middle of the knitting area. Then the second yarn is knitted, and the double rib structure is knitted on the front and back needle beds. Only the back bed loop is knitted at one needle in the middle of the knitting area. This process is repeated for four rows so that the suture is located on the front side of the knitted nail body area.

[0178] Repeating operations (c) to (d) once will form a penetration site for the suture on the nail body area. Repeating multiple times will allow the suture to alternately appear on the front and back sides of the nail body area. After the nail body area is knitted, the suture is brought out of the knitting area in the form of weft insertion, and two full suture anchors are knitted simultaneously.

[0179] Example 5

[0180] An integrally formed weft-knitted rotator cuff patch with self-contained suture anchors, wherein the rotator cuff patch is a sheet-like structure formed by weft knitting yarn and suture; the weave structure of the rotator cuff patch is a weft-knitted double-sided weave;

[0181] The yarn is 4 PE yarns, each with a specification of 100D / 36f; the suture is ultra-high molecular weight polyethylene braided wire with a diameter of 0.4 mm;

[0182] The yarn structure of the rotator cuff patch is divided into a patch main body area, a patch bifurcated extension area and a nail body area arranged in sequence along the longitudinal direction, wherein the patch main body area, the patch bifurcated extension area and the nail body area are all 1+1 rib structure;

[0183] The number of patch main body areas is 1, and the shape of the patch main body area is rectangular, with a longitudinal length of 35 mm and a transverse length of 30 mm; the transverse density is 44 columns / 50 mm, and the longitudinal density is 75 rows / 50 mm;

[0184] The number of patch bifurcation extension regions is 3 and they are arranged in sequence along the transverse direction. The longitudinal length of the patch bifurcation extension region is 8 mm, the maximum transverse length is 10 mm, and the minimum transverse length is 5 mm. The transverse density is 41 columns / 50 mm, and the longitudinal density is 59 rows / 50 mm.

[0185] The number of nail body regions is 3 and they are arranged in sequence in the horizontal direction. The shape of the nail body region is rectangular, with a vertical length of 15 mm and a horizontal length of 6.5 mm. The horizontal density is 49 columns / 50 mm and the vertical density is 70 rows / 50 mm.

[0186] The end of the patch bifurcation extension region connected to the patch main body region is marked as end A, and the end connected to the nail body region is marked as end B. The size of the patch bifurcation extension region gradually decreases from end A to end B.

[0187] The three nail body areas are connected to the three patch bifurcation extension areas one by one;

[0188] The suture is only located in the nail body area and does not participate in knitting. There is one suture in each nail body area, and the three nail body areas and the sutures therein constitute three full suture anchors;

[0189] The suture penetrates the nail body area longitudinally and appears alternately on the two surfaces of the nail body area; the suture forms 6 penetration sites in each nail body area, and the distance between two adjacent penetration sites is 2 mm.

[0190] The one-piece weft-knitted rotator cuff patch with full suture anchors has a fixation strength of 854.6 N, with the full suture anchors implanted in a dual-phase polyurethane block. The breaking strength of the main patch area of ​​the one-piece weft-knitted rotator cuff patch with full suture anchors is 877 N, and the elongation at break is 89.9%.

[0191] The above-mentioned method for preparing the one-piece weft-knitted rotator cuff patch with self-contained suture anchors is produced using a STOLLADF530-32W computerized flat knitting machine (Karl Mayer, Germany) with a machine gauge of E8.2. The specific steps are as follows:

[0192] (1) threading the yarn;

[0193] On a computerized flat knitting machine, yarns are respectively passed through two yarn guides, namely a first yarn and a second yarn, and the sewing thread is then passed through another yarn guide; with the front needle bed direction of the flat knitting machine as the front and the rear needle bed direction as the rear, the tracks of the three yarn guides are arranged in the following order from front to rear: first yarn, sewing thread, and second yarn;

[0194] (2) Weaving: The patch main body area, patch bifurcation extension area, and nail body area are knitted continuously in sequence on a knitting computer flat knitting machine. The knitting methods for different parts of the rotator cuff patch are as follows:

[0195] ① The main area of ​​the patch;

[0196] The first yarn is knitted into a 1+1 rib structure on the front and back needle beds. The knitting area width is 33 needles, the loop length NP=10.3, and the fabric stretch value WM=1.6.

[0197] ② Patch bifurcation extension area;

[0198] The first yarn is knitted in a 1+1 rib pattern on the front and back needle beds. The knitting area is gradually narrowed by narrowing the stitches, forming a patch bifurcation extension area. Each time, the left and right edges of each patch bifurcation extension area are shifted by 2 stitches, and narrowed by 1 stitch. This process is repeated 3 times, so that the knitting area width becomes 15 stitches, the loop length NP = 11.0, and the fabric stretch value WM = 1.6.

[0199] ③ Nail body area: The knitting area width of each nail body area is 5 stitches, the coil length NP=11, the fabric stretch value WM=1.0, and the suture is introduced during the knitting process of the nail body area. The specific knitting steps for each nail body area are as follows:

[0200] (a) knitting two rows of double rib with the first yarn, and then pausing knitting of the first yarn;

[0201] (b) The thread guide is moved in a low position by itself in a weft insertion mode, the weft presser foot is activated, and the thread is introduced to the center of the knitting area. Then, the "weft / automatic transfer" action is performed. A rear bed loop in the center of the knitting area is interlaced with a front bed loop at the same needle position via a transfer needle, and the thread is pressed between the loop and the previous row of front bed loops, thereby achieving a preliminary slidable connection of the thread on the nail body area.

[0202] (c) The first yarn is knitted in a 1+1 rib pattern on the front and back needle beds, with only the front bed loop knitted on the center needle of the knitting area. During this process, the thread guide is always in the high position and oscillates within the range of 4 needles in the center of the knitting area. This process is repeated for 4 rows, so that the stitch is on the back of the knitted nail body area.

[0203] (d) The thread guide is kept in a high position and swung within the range of one needle in the middle of the knitting area. The first yarn is knitted temporarily, and the front bed loop is turned over to the back bed at the same needle position at one needle in the middle of the knitting area. Then the second yarn is knitted, and a 1+1 rib structure is knitted on the front and back needle beds. Only the back bed loop is knitted at one needle in the middle of the knitting area. This is repeated for four rows so that the suture is located on the front side of the knitted nail body area.

[0204] Repeating operations (c) to (d) once will form a penetration site for the suture on the nail body area. Repeating multiple times will allow the suture to alternately appear on the front and back sides of the nail body area. After the nail body area is knitted, the suture is brought out of the knitting area in the form of weft insertion, and three full suture anchors are knitted simultaneously.

[0205] Example 6

[0206] An integrally formed weft-knitted rotator cuff patch with self-contained suture anchors, wherein the rotator cuff patch is a sheet-like structure formed by weft knitting yarn and suture; the weave structure of the rotator cuff patch is a weft-knitted double-sided weave;

[0207] The yarn is 4 PE yarns, each with a specification of 100D / 36f; the suture is ultra-high molecular weight polyethylene braided wire with a diameter of 0.3 mm;

[0208] The yarn structure of the rotator cuff patch is divided into a patch main body area, a patch bifurcated extension area and a nail body area arranged in sequence along the longitudinal direction, wherein the patch main body area, the patch bifurcated extension area and the nail body area are all 1+1 rib structure;

[0209] The number of patch main body areas is 1, and the shape of the patch main body area is rectangular, with a longitudinal length of 35 mm and a transverse length of 35 mm; the transverse density is 41 columns / 50 mm, and the longitudinal density is 76 rows / 50 mm;

[0210] The number of patch bifurcated extension regions is 4 and they are arranged in sequence along the transverse direction. The longitudinal length of the patch bifurcated extension region is 8 mm, the maximum transverse length is 8 mm, and the minimum transverse length is equal to the transverse length of the nail body region. The transverse density is 40 columns / 50 mm and the longitudinal density is 58 rows / 50 mm.

[0211] The number of nail body regions is 4 and they are arranged in sequence along the horizontal direction. The shape of the nail body region is rectangular, with a vertical length of 18 mm and a horizontal length of 5 mm. The horizontal density is 47 columns / 50 mm and the vertical density is 72 rows / 50 mm.

[0212] The end of the patch bifurcation extension region connected to the patch main body region is marked as end A, and the end connected to the nail body region is marked as end B. The size of the patch bifurcation extension region gradually decreases from end A to end B.

[0213] The four nail body areas are connected to the four patch bifurcation extension areas one by one;

[0214] The suture is only located in the nail body area and does not participate in knitting. There is one suture in each nail body area, and the four nail body areas and the sutures therein constitute four full suture anchors;

[0215] The suture penetrates the nail body area longitudinally and appears alternately on the two surfaces of the nail body area; the suture forms four penetration sites in each nail body area, and the distance between two adjacent penetration sites is 4 mm.

[0216] The one-piece weft-knitted rotator cuff patch with full suture anchors has a fixation strength of 870.2 N, with the full suture anchors implanted in the duplex polyurethane block. The breaking strength of the main patch area of ​​the one-piece weft-knitted rotator cuff patch with full suture anchors is 891.5 N, and the elongation at break is 77.8%.

[0217] The above-mentioned method for preparing the one-piece weft-knitted rotator cuff patch with self-contained suture anchors is produced using a STOLLADF530-32W computerized flat knitting machine (Karl Mayer, Germany) with a machine gauge of E8.2. The specific steps are as follows:

[0218] (1) threading the yarn;

[0219] On a computerized flat knitting machine, yarns are respectively passed through two yarn guides, namely a first yarn and a second yarn, and the sewing thread is then passed through another yarn guide; with the front needle bed direction of the flat knitting machine as the front and the rear needle bed direction as the rear, the tracks of the three yarn guides are arranged in the following order from front to rear: first yarn, sewing thread, and second yarn;

[0220] (2) Weaving: The patch main body area, patch bifurcation extension area, and nail body area are knitted continuously in sequence on a knitting computer flat knitting machine. The knitting methods for different parts of the rotator cuff patch are as follows:

[0221] ① The main area of ​​the patch;

[0222] The first yarn is knitted into a 1+1 rib structure on the front and back needle beds. The knitting area width is 44 needles, the loop length NP=10.3, and the fabric stretch value WM=1.7.

[0223] ② Patch bifurcation extension area;

[0224] The first yarn is knitted in a 1+1 rib pattern on the front and back needle beds. The knitting area is gradually narrowed by blind narrowing, forming a patch bifurcation extension area. Each patch bifurcation extension area is narrowed by one stitch on each left and right edge three times, so that the knitting area width becomes 20 stitches, the loop length NP = 11.0, and the fabric stretch value WM = 1.7.

[0225] ③ Nail body area: the knitting area width of each nail body area is 5 stitches, the coil length NP=10.3, the fabric stretch value WM=1.0, and the suture is introduced during the knitting process of the nail body area. The specific knitting steps for each nail body area are as follows:

[0226] (a) knitting two rows of double rib with the first yarn, and then pausing knitting of the first yarn;

[0227] (b) The suture yarn guide is moved in a low position by itself in a pad yarn introduction mode, the weft presser foot is activated, and the suture is introduced to the center of the knitting area. Then, the "weft / automatic transfer" action is performed. A rear bed loop in the center of the knitting area is interlaced with the front bed loop at the same needle position through the transfer needle, and the suture is pressed between the loop and the previous row of front bed loops, thereby achieving a preliminary slidable connection of the suture on the nail body area.

[0228] (c) The first yarn is knitted in a 1+1 rib pattern on the front and back needle beds, with only the front bed loop knitted on the center stitch. The thread guide is always in the high position and oscillates within the center stitch area. This process is repeated for four rows, so that the stitch is on the back of the knitted nail area.

[0229] (d) The thread guide is kept in a high position and swung within the range of one needle in the middle of the knitting area. The first yarn is knitted temporarily, and the front bed loop is turned over to the back bed at the same needle position at one needle in the middle of the knitting area. Then the second yarn is knitted, and a 1+1 rib structure is knitted on the front and back needle beds. Only the back bed loop is knitted at one needle in the middle of the knitting area. This is repeated for four rows so that the suture is located on the front side of the knitted nail body area.

[0230] Repeating operations (c) to (d) once will form a penetration site for the suture on the nail body area. Repeating multiple times will allow the suture to alternately appear on the front and back sides of the nail body area. After the nail body area is knitted, the suture is brought out of the knitting area in the form of weft insertion, and four full suture anchors are knitted simultaneously.

Claims

1. An integrally formed weft-knitted rotator cuff patch with self-contained suture anchors, characterized in that: The rotator cuff patch is a sheet-like structure formed by weft knitting yarns and sutures. The yarn structure of the rotator cuff patch is divided into a patch main body region, a patch bifurcated extension region, and a nail body region arranged in sequence along the longitudinal direction. The number of the patch main body region is 1, the number of the patch bifurcated extension regions is n and they are arranged in sequence along the transverse direction, and the number of the nail body regions is n and they are arranged in sequence along the transverse direction, and n ≥ 2; The end of the patch bifurcation extension region connected to the patch main body region is marked as end A, and the end connected to the nail body region is marked as end B. The size of the patch bifurcation extension region gradually decreases from end A to end B. The n nail body regions are connected to the n patch bifurcation extension regions in a one-to-one correspondence; The suture is only located in the nail body area and does not participate in knitting. There is at least one suture in each nail body area, and n nail body areas and the sutures therein constitute n full suture anchors.

2. The one-piece weft-knitted rotator cuff patch with self-contained suture anchors according to claim 1, characterized in that: The tissue structure of the rotator cuff patch is a weft-knitted double-sided tissue, in which the coils are composed of one or more combinations of loops, tucks, and floats.

3. The one-piece weft-knitted rotator cuff patch with self-contained suture anchors according to claim 1, characterized in that: The main area of ​​the patch is rectangular in shape, with a longitudinal length of 30-50 mm and a transverse length of 20-40 mm.

4. The one-piece weft-knitted rotator cuff patch with self-contained suture anchors according to claim 1, characterized in that: The shape of the nail body area is rectangular, with a longitudinal length of 5~22 mm and a transverse length of 4~20 mm.

5. The one-piece weft-knitted rotator cuff patch with self-contained suture anchors according to claim 1, characterized in that: The longitudinal length of the patch bifurcation extension area is 5-10 mm, and the maximum transverse length is 8-18 mm.

6. The one-piece weft-knitted rotator cuff patch with self-contained suture anchors according to claim 1, characterized in that: The yarn is made of medical polymer material with a linear density of 75~500 D; The suture is ultra-high molecular weight polyethylene braided wire with a diameter of 0.3-0.6 mm.

7. The integrally formed weft-knitted rotator cuff patch with self-contained suture anchors according to any one of claims 1 to 6, characterized in that: The minimum transverse length of the patch bifurcation extension area is less than or equal to the transverse length of the nail body area, the longitudinal length of the nail body area is greater than the transverse length, and the suture penetrates the nail body area longitudinally and alternately appears on the two surfaces of the nail body area.

8. The integrally formed weft-knitted rotator cuff patch with self-contained suture anchors according to any one of claims 1 to 6, characterized in that: The minimum transverse length of the patch bifurcation extension area is smaller than the transverse length of the nail body area, the longitudinal length of the nail body area is smaller than the transverse length, and the suture penetrates the nail body area in the transverse direction and alternately appears on the two surfaces of the nail body area.

9. A method for preparing the integrally formed weft-knitted rotator cuff patch with self-contained suture anchors as claimed in claim 7, characterized in that: It is produced using a computerized flat knitting machine. First, yarn is used to weave the main body area of ​​the patch, and then the needle is gradually narrowed to narrow the weaving area. In this process, a bifurcated extension area of ​​the patch is formed. Finally, yarn is used to weave the nail body area. In this process, the suture is first introduced into the weaving area in the form of weft insertion, and then penetrated into the nail body area through the needle transfer action. Then, the yarn guide with the suture is swung in the middle of the nail body area. At each penetration point, the suture is transferred from one surface of the nail body area to another through the needle transfer action. After the nail body area is knitted, the suture is brought out of the knitting area in the form of weft insertion, and n full suture anchor nails are knitted simultaneously.

10. A method for preparing the integrally formed weft-knitted rotator cuff patch with self-contained suture anchors as claimed in claim 8, characterized in that: It is produced using a computerized flat knitting machine. First, yarn is used to knit the main body area of ​​the patch, and then the knitting area is gradually narrowed. In this process, a patch bifurcation extension area is formed, and finally yarn is used to knit the nail body area. In this process, the nail body area is first knitted to half of its longitudinal length, and the row knitted to half of the longitudinal length is recorded as knitting row M. Then the nail body area is divided into m equal parts in the transverse direction, m ≥ 5, and the coils of each part are all turned to the front needle bed or the rear needle bed in the knitting row M, and the coils of two adjacent parts are turned to different needle beds, and then the suture is introduced into the knitting area in the form of weft insertion, and the nail body area is continued to be knitted for one row, and then the suture is brought out of the knitting area in the form of weft insertion, and then the nail body area is continued to be knitted to its complete longitudinal length, and then the coils of the nail body area are unhooked in the form of flat needle narrowing, and n full suture anchors are knitted in sequence.

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