An integrally formed weft-knitted self-sutured rotator cuff patch and method of making the same

Abstract

The present application belongs to the technical field of weft-knitted shoulder sleeve patch, and relates to an integrally formed weft-knitted shoulder sleeve patch with full-suture anchor and preparation thereof. The shoulder sleeve patch as a whole is formed into a sheet structure by weft-knitting of yarn and suture. The whole formed by the yarn in the shoulder sleeve 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. The suture is only located in the nail body area and does not participate in the knitting loop. There is at least one suture in each nail body area. The nail body area and the suture therein form a full-suture anchor. During preparation, a computerized flat knitting machine is used. First, the yarn is used to knit the patch main body area. Then, the stitches are gradually collected and the knitting area is narrowed. In this process, the patch bifurcated extension area is formed. Finally, the yarn is used to knit the nail body area. The suture is introduced into the knitting area in the form of weft insertion. Then, the suture is taken out of the knitting area in the form of weft insertion. The shoulder sleeve patch has the characteristics of high mechanical strength, uniform stress distribution and high fixation strength.

Description

TECHNICAL FIELD

[0001] The application belongs to the technical field of weft-knitted shoulder sleeve patch, and relates to an integrally formed weft-knitted shoulder sleeve patch with full suture anchors. BACKGROUND

[0002] Shoulder sleeve injury, as a very common shoulder joint disease that seriously affects the quality of life of patients, has always been the focus of research in the fields of clinical medicine and biomaterial science. Its pathogenesis is complex, involving the tearing or degeneration of shoulder peritendinous muscles such as supraspinatus and infraspinatus muscles. This process is closely related to factors such as long-term overuse, traumatic impact, and tissue aging caused by age growth. In daily life and sports, the shoulder joint frequently bears various complex stresses. When these stresses exceed the bearing limit of the shoulder sleeve muscle tendon, microscopic damage occurs, and with the gradual accumulation of damage, the muscle tendon eventually tears, causing a series of functional disorders such as shoulder pain and limited movement, seriously interfering with the normal life and work of patients.

[0003] From the perspective of anatomy, the tendon-bone junction of a normal shoulder sleeve has a unique and delicate four-layer gradient structure, which is muscle tendon, fibrocartilage, mineralized cartilage, and bone from the muscle tendon end to the bone end. This structure is not simply a stack of tissues, but an optimized structure formed in the long process of biological evolution to adapt to the mechanical environment of the shoulder joint. In the process of mechanical transmission, this gradient structure can effectively achieve smooth transition and dispersion of force, uniformly distribute concentrated stress, and thus significantly reduce the risk of shoulder sleeve tear, which is the key structural basis for maintaining the stability and integrity of the shoulder sleeve. Numerous biomechanical studies have shown that this unique structure is closely related to the normal biomechanical function of the shoulder sleeve, and any factor that damages the integrity of this structure can cause abnormal function of the shoulder sleeve.

[0004] In the clinical treatment of shoulder sleeve injury, for patients with small tears or good tissue quality, simple suture repair can often achieve satisfactory results. However, for patients with large tears or poor tissue quality, simple suture is difficult to restore the normal tendon-bone connection structure, and the risk of postoperative re-tear is extremely high. According to clinical statistics, the re-tear rate of such patients after simple suture repair is high, which seriously affects the rehabilitation effect and quality of life of patients. Against this background, shoulder sleeve patch as an important auxiliary repair method emerged as the times require. Shoulder sleeve patch can enhance the mechanical strength of the muscle tendon by bridging the defect area, providing additional support and protection for the shoulder sleeve, effectively reducing the incidence of postoperative re-tear, and improving the success rate of repair. In recent years, with the rapid development of material science and biomedical engineering, the research and application of shoulder sleeve patch have made significant progress, and more and more new patch materials and designs have emerged, bringing new hope for the repair of shoulder sleeve injury.

[0005] Although the existing rotator cuff patch has achieved certain success in clinical application, there are still many problems to be solved. From the aspect of mechanical properties, the existing patch generally has the problem of insufficient mechanical strength. During the healing period of the rotator cuff, the shoulder joint needs to bear a certain load, and the existing patch often cannot withstand such high load stress, and is prone to structural failure. Studies have shown that most patch failures occur at the tendon-bone junction, which bears a stress concentration of up to 100-150 MPa, much higher than the tolerance limit of the tendon body of 50-100 MPa. If the mechanical strength of the patch is insufficient, at the tendon-bone suture interface, the patch is easily cut by the suture repeatedly, leading to the destruction of the structural integrity, and eventually causing the patch to rupture and the tendon to re-tear.

[0006] In addition, uneven stress distribution is also an important defect of the existing patch. Unreasonable structural design makes the patch unable to evenly disperse stress when under stress, and the local stress concentration phenomenon is serious, further increasing the risk of patch rupture and repair failure.

[0007] In terms of fixation strength, the current rotator cuff patch surgery mostly uses suture anchor fixation, and the commonly used anchor includes metal anchor, absorbable anchor and all-suture anchor. The all-suture anchor is woven from ultra-high molecular weight polyethylene fiber (UHMWPE), and does not need to pre-drill a large bone tunnel when implanted, and is fixed by expanding the pin body in the bone, which has the advantages of avoiding metal artifact interference, reducing bone loss, and flexible operation. However, based on the high stress characteristics of the tendon-bone connection interface, regardless of the type of anchor used, the problem of suture cutting damage to the patch and tendon stump remains prominent. The continuous pulling force generated by the postoperative shoulder joint movement and the high pressure at the suture contact site easily lead to the cutting and tearing of the patch material or tendon tissue at the suture interface, which becomes a key mechanical factor for postoperative re-tear and repair failure.

[0008] Although the related patent technologies provide ideas for the improvement of the rotator cuff patch to some extent, there are still limitations. For example, the patent CN202110099938.3 discloses a plug-in soft tissue repair patch, which is composed of a sheet-shaped part and double columnar parts. The double columnar parts can be directly inserted into the bone tunnel to enhance the holding force of the patch on the bone, replace suture fixation at the tendon-bone junction, avoid suture cutting damage, and improve the bonding strength of the patch and the bone tissue, which has a significant advantage in the fixation method. However, the patch is made of electrospinning, and it is speculated that the overall strength is weak, which is difficult to meet the high load demand during the healing period of the rotator cuff. At the same time, the sheet-shaped part is an electrospun fiber felt, and the double columnar part is rolled from a sheet-shaped 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-shaped part and the double columnar part, and the connection is prone to stress concentration, leading to the rupture of the patch. In addition, the double columnar part does not deform after being implanted into the bone tunnel, and the actual fixation strength does not reach the level of full suture anchor, which may affect the stability of the patch in the bone and increase the risk of displacement or shedding of the patch.

[0009] In summary, the existing rotator cuff patch has obvious deficiencies in mechanical strength, stress distribution, and fixation strength, and it is difficult to meet the strict requirements of clinical rotator cuff injury repair. Therefore, it is of great practical significance and urgency to develop a new type of artificial rotator cuff patch. The new patch should have high mechanical strength, uniform stress distribution, and high fixation strength, etc. to better adapt to the complex mechanical environment of the shoulder joint, improve the success rate of rotator cuff injury repair, and improve the quality of life of patients. SUMMARY

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

[0011] To achieve the above-mentioned purpose, the technical solutions adopted by the present application are as follows:

[0012] An integrally formed weft-knitted rotator cuff patch with full suture anchor, the whole rotator cuff patch is formed into a sheet-shaped structure by weft knitting of yarn and suture;

[0013] The whole part of the yarn in 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, the number of the patch main body area is 1, the number of the patch bifurcated extension area is n and arranged in sequence along the transverse direction, the number of the nail body area is n and arranged in sequence along the transverse direction, n≥2;

[0014] One end of the patch bifurcated extension area connected with the patch main body area is marked as end A, and the other end connected with the nail body area is marked as end B, the patch bifurcated extension area gradually shrinks in size from end A to end B;

[0015] n nail body regions are respectively connected with n patch bifurcated extension regions one-to-one;

[0016] The suture is only located in the nail body region and does not participate in the loop knitting, and at least one suture is arranged in each nail body region, and n nail body regions and the sutures therein form n full-suture anchors;

[0017] The patch main body region and the patch bifurcated extension region are used for bridging the torn tendon, and the full-suture anchor is used for anchoring the bone tunnel.

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

[0019] The stress distribution of the shoulder rotator cuff patch is uniform, on the one hand, because the connection between the patch main body region and the nail body region is designed as a gradually narrowing patch bifurcated extension region, stress mutation of the traditional right-angle connection can be avoided, and the shoulder rotator cuff patch has good stress dispersion effect and is not easy to be warped, and the interface adhesion of the shoulder rotator cuff patch is better; on the other hand, because the shoulder rotator cuff patch is formed by interlocking loops, an elastic hinge network is formed to dissipate stress in multiple directions.

[0020] The shoulder rotator cuff patch has high fixing strength, when the nail body region is implanted into the folded and curled state and inserted into the bone tunnel, and two free ends of the same suture are pulled in the same direction at the same time, the nail body region penetrated by the suture expands in the bone tunnel, the cancellous bone tunnel is expanded, and the size of the cortical bone hole remains unchanged, so that the nail body region is anchored in the bone tunnel (below the cortical bone and inside the cancellous bone), and the advantages of high fixing strength of the full-suture anchor are fully utilized. In addition, the suture in the full-suture anchor can also be used for suturing other edges of the patch.

[0021] As a preferred technical solution:

[0022] The shoulder rotator cuff patch with an integrated full-suture anchor is weft-knitted, and the structure of the shoulder rotator cuff patch is weft-knitted double-face structure, and the loops therein are formed by one or more combinations of looping, tucking and floating.

[0023] The shoulder rotator cuff patch with an integrated full-suture anchor is weft-knitted, and the structure of the shoulder rotator cuff patch is weft-knitted double-face structure, and the loops therein are formed by one or more combinations of looping, tucking and floating.

[0024] The shoulder rotator cuff patch with an integrated full-suture anchor is weft-knitted, and the structure of the shoulder rotator cuff patch is weft-knitted double-face structure, and the loops therein are formed by one or more combinations of looping, tucking and floating.

[0025] The shoulder rotator cuff patch with an integrated full-suture anchor is weft-knitted, and the structure of the shoulder rotator cuff patch is weft-knitted double-face structure, and the loops therein are formed by one or more combinations of looping, tucking and floating.

[0026] The one-piece weft-knitted self-suture anchor shoulder rotator cuff patch as described above is made of medical polymer yarns with linear density of 75-500 D, and the medical polymer yarns include but are not limited to one or more of polyethylene terephthalate (PET), polypropylene (PP), polyethylene (PE), polytetrafluoroethylene (PTFE), polyglycolic acid (PGA), polylactic acid (PLA), polyglycolic acid-lactic acid (PGLA), polyglycolic acid-polycaprolactone copolymer (PGCL), poly-p-dioxanone (PPDO), polycaprolactone (PCL), poly-L-lactide (PLLA), polyglycolide-caprolactone (PGCL), polydioxanone (PHA) and polytrimethylene carbonate (PTMC).

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

[0028] The one-piece weft-knitted self-suture anchor shoulder rotator cuff patch (denoted as one-piece weft-knitted self-suture anchor shoulder rotator cuff patch A) as described above has a minimum transverse length of the patch bifurcated extension area less than or equal to the transverse length of the nail body area, a longitudinal length of the nail body area greater than the transverse length, the suture penetrating the nail body area along the longitudinal direction and alternately appearing on the two surfaces of the nail body area, the suture forming at least two penetration points in each nail body area, and the distance between the two adjacent penetration points being 2-6 mm.

[0029] The one-piece weft-knitted self-suture anchor shoulder rotator cuff patch (denoted as one-piece weft-knitted self-suture anchor shoulder rotator cuff patch B) as described above has a minimum transverse length of the patch bifurcated extension area less than the transverse length of the nail body area, a longitudinal length of the nail body area less than the transverse length, the suture penetrating the nail body area along the transverse direction and alternately appearing on the two surfaces of the nail body area, the suture forming at least two penetration points in each nail body area, and the distance between the two adjacent penetration points being 2-6 mm.

[0030] The present application also provides a method for preparing the one-piece weft-knitted self-suture anchor shoulder rotator cuff patch A as described above, which is produced by using a computerized flat knitting machine. First, the yarns are used to knit the main body area of the patch, then the knitting area is gradually narrowed by needle withdrawal, during which the patch bifurcated extension area is formed, and finally the yarns are used to knit the nail body area, during which the suture is introduced into the knitting area in the form of a weft, penetrates the nail body area by a needle turning action, and then the guide wire with the suture is swung in the middle of the nail body area, the suture is transferred from one surface to the other surface of the nail body area by a needle turning action at each penetration point, and finally the suture is taken out of the knitting area in the form of a weft after the nail body area is knitted, and n self-suture anchors are knitted at the same time.

[0031] As a preferred technical solution:

[0032] The method as described above, the range of the oscillation of the thread guide in the middle of the nail body region is 1-5 needles.

[0033] The application also provides a method for preparing the integrally formed weft-knitted self-suture-anchor-nail shoulder-sleeve patch B as described above, which is produced by using a computerized flat knitting machine, first knits the patch main body region with yarn, then gradually narrows the knitting region by needle reduction, in the process, the patch bifurcated extension region is formed, finally knits the nail body region with yarn, in the process, first knits the nail body region to half of its longitudinal length, records the row of knitting to half of the longitudinal length as knitting row M, then equally divides the nail body region into m parts along the transverse direction, m>=5, flips all the loops of each part to the front needle bed or the back needle bed at knitting row M, and flips the loops of adjacent two parts to different needle beds, then introduces the suture in the form of weft insertion into the knitting region, continues to knit the nail body region by one row, then takes out the suture from the knitting region in the form of weft insertion, then continues to knit the nail body region to its full longitudinal length, then de-loops the loops of the nail body region in the form of flat needle reduction, and knits n self-suture-anchor-nails in sequence.

[0034] Advantages:

[0035] (1) The integrally formed weft-knitted self-suture-anchor-nail shoulder-sleeve patch has high mechanical strength, uniform stress distribution and high fixing strength, can effectively reduce the cutting damage of the suture to the patch and the tendon-bone connection tendon, can be flexibly customized in size according to the requirements of shoulder sleeve repair surgery, does not need subsequent cutting and threading, and the unique patch bifurcated extension region design can disperse the stress at the tendon-bone connection, reduce the risk of inflammatory risk and artificial uncertainty, and can improve the repair effect and reduce the re-tear rate.

[0036] (2) The preparation method of the integrally formed weft-knitted self-suture-anchor-nail shoulder-sleeve patch realizes the integrated weaving of the patch and the self-suture-anchor-nail by using the weft-knitted one-line full-forming technology, forms the whole of "patch main body region-patch bifurcated extension region-nail body region+suture" during the knitting process, the nail body region can be directly anchored into the bone tunnel of the humeral head, and the suture tensioning can realize the expansion fixation of the nail body region. BRIEF DESCRIPTION OF DRAWINGS

[0037] Figure 1 It is a front view of the integrally formed weft-knitted self-suture-anchor-nail shoulder-sleeve patch of embodiment 1 of the application;

[0038] Figure 2 It is a cross-sectional view of the integrally formed weft-knitted self-suture-anchor-nail shoulder-sleeve patch of embodiment 1 of the application;

[0039] Figure 3A schematic diagram of the full suture anchor portion of a one-piece weft-knitted self-anchoring suture anchor shoulder rotator cuff patch of embodiment 1 of the present invention;

[0040] Figure 4 A computerized flat knitting machine knitting diagram of the patch bifurcated extension region of a one-piece weft-knitted self-anchoring suture anchor shoulder rotator cuff patch of embodiment 1 of the present invention; where B is the front needle bed and F is the back needle bed;

[0041] Figure 5 A computerized flat knitting machine knitting diagram of the full suture anchor portion of a one-piece weft-knitted self-anchoring suture anchor shoulder rotator cuff patch of embodiment 1 of the present invention; where B is the front needle bed and F is the back needle bed, and Y^ is the yarn carrier lift indicator;

[0042] Figure 6 A schematic diagram of the full suture anchor portion of a one-piece weft-knitted self-anchoring suture anchor shoulder rotator cuff patch of embodiment 1 of the present invention; where B is the front needle bed and F is the back needle bed, and Y^ is the yarn carrier lift indicator;

[0043] Figure 7 A schematic diagram of the full suture anchor portion of a one-piece weft-knitted self-anchoring suture anchor shoulder rotator cuff patch of embodiment 1 of the present invention; where B is the front needle bed and F is the back needle bed, and Y^ is the yarn carrier lift indicator;

[0044] Figure 8 A schematic diagram of the full suture anchor portion of a one-piece weft-knitted self-anchoring suture anchor shoulder rotator cuff patch of embodiment 1 of the present invention; where B is the front needle bed and F is the back needle bed, and Y^ is the yarn carrier lift indicator;

[0045] Figure 9 A schematic diagram of the full suture anchor portion of a one-piece weft-knitted self-anchoring suture anchor shoulder rotator cuff patch of embodiment 1 of the present invention; where B is the front needle bed and F is the back needle bed, and Y^ is the yarn carrier lift indicator;

[0046] Figure 10 A schematic diagram of the full suture anchor portion of a one-piece weft-knitted self-anchoring suture anchor shoulder rotator cuff patch of embodiment 1 of the present invention; where B is the front needle bed and F is the back needle bed, and Y^ is the yarn carrier lift indicator;

[0047] Figure 11 A schematic diagram of the full suture anchor portion of a one-piece weft-knitted self-anchoring suture anchor shoulder rotator cuff patch of embodiment 1 of the present invention; where B is the front needle bed and F is the back needle bed, and Y^ is the yarn carrier lift indicator;

[0048] Figure 12 A schematic diagram of the full suture anchor portion of a one-piece weft-knitted self-anchoring suture anchor shoulder rotator cuff patch of embodiment 1 of the present invention; where B is the front needle bed and F is the back needle bed, and Y^ is the yarn carrier lift indicator;

[0049] Figure 13 A schematic diagram of the full suture anchor portion of a one-piece weft-knitted self-anchoring suture anchor shoulder rotator cuff patch of embodiment 1 of the present invention; where B is the front needle bed and F is the back needle bed, and Y^ is the yarn carrier lift indicator;

[0050] Wherein, 1-shoulder sleeve patch, 2-patch main body area, 3-patch bifurcated 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] The application will be further described below in connection with specific embodiments. It should be understood that these embodiments are only used to illustrate the application and not used to limit the scope of the application. Furthermore, it should be understood that after reading the content taught by the application, those skilled in the art can make various modifications or changes to the application, and these equivalent forms also fall within the scope of the appended claims.

[0052] The performance indicators in the examples and comparative examples of the application involve the following test methods:

[0053] (1) Breaking strength and elongation at break: refer to the standard GB / T 3923.1-2013 "Textiles-Determination of tensile resistance of fabrics-Part 1: Breaking force and elongation at break (strip method)", and according to the actual size of the shoulder sleeve patch, the clamping distance is 35 mm during testing, and the sample is stretched to break at a speed of 50 mm / min, and the strength and elongation at break are recorded. Each experiment is repeated five times and the average value is taken as the final result.

[0054] (2) Fixing strength: since structural failure of the shoulder sleeve patch often occurs at the tendon-bone junction, the fixing strength of the self-contained full-suture anchor shoulder sleeve patch in the application and the ordinary structure shoulder sleeve patch at the tendon-bone junction is compared.

[0055] For the self-contained full-suture anchor shoulder sleeve patch in the examples of the application, since the tendon-bone junction is directly anchored into the bone tunnel by the self-contained anchor, refer to the "fixing strength" test method described in the standard YY / T 1867-2023 "Sports Medicine Implant Devices-Threaded Anchors": use the bi-phasic polyurethane material pcf20 and pcf40 produced by the Pacific Research Laboratories Company to simulate artificial bone, anchor the full-suture anchor carried by the patch into the tunnel of the artificial bone material, and apply a pulling force to the suture at a speed of 50 mm / min until the nail body area is pulled out or fails. The maximum force measured during this process is the fixing strength of the self-contained full-suture anchor shoulder sleeve patch, and 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 junction is fixed by suturing, the "suture strength" test method described in the standard YY / T 1814-2022 "Surgical implants - Synthetic non-absorbable patches - Hernia repair patches" is referred to: a suture is passed through the patch at a distance of 5 mm from the edge at one end of the patch, and is sutured into a half ring. The suture is pulled out at a speed of 50 mm / min, and the pulling force at which the suture is pulled out of the patch or the patch is damaged is the fixing strength of the patch at the tendon-bone junction. Each experiment is repeated five times, and the average value is taken as the final result.

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

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

[0059] Ultrahigh molecular weight polyethylene braided wire: the manufacturer is Dongguan Shunli New Material Co., Ltd., and the diameter is 0.4 mm, 0.5 mm or 0.6 mm.

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

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

[0062] Example 1

[0063] A one-piece weft-knitted rotator cuff patch with full-suture anchor, as shown in Figures 1-2 The whole rotator cuff patch 1 is a patch-shaped structure formed by weft-knitting of yarns and sutures; the structure of the rotator cuff patch 1 is weft-knitted double-sided structure.

[0064] The yarns are 3 PET filaments with a specification of 200D / 48f; the sutures are ultrahigh molecular weight polyethylene braided wires with a diameter of 0.5 mm.

[0065] The whole formed by the yarns in the rotator cuff patch is divided into a patch main body area 2, a patch bifurcation extension area 3 and a nail body area 4 arranged in sequence along the longitudinal direction, wherein the patch main body area 2, the patch bifurcation extension area 3 and the nail body area 4 are all double-r 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 areas 3 is 2 and they are arranged sequentially in the transverse direction. The longitudinal length of patch bifurcation extension area 3 is 8 mm, the maximum transverse length is 12 mm, and the minimum transverse length is equal to the transverse length of nail body area 4. The transverse density is 44 columns / 50 mm, and the longitudinal density is 63 rows / 50 mm.

[0068] There are 2 nail body areas 4, which are arranged sequentially in the horizontal direction; the shape of the nail body area is rectangular, with a vertical length of 19 mm and a horizontal length of 7 mm; the horizontal density is 45 columns / 50 mm and the vertical density is 68 rows / 50 mm.

[0069] The end of the patch bifurcation extension area 3 that connects to the patch body area 2 is denoted as end A, and the end that connects to the nail body area is denoted as end B. The size of the patch bifurcation extension area gradually decreases from end A to end B.

[0070] The two nail areas are connected one-to-one with the two branching extension areas of the patch;

[0071] like Figure 3 As shown, the thread 5 is only located in the nail body area 4 and does not participate in the knitting loop. There is one thread 5 in each nail body area 4. The two nail body areas 4 and the thread 5 therein constitute two fully sewn anchors respectively.

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

[0073] like Figure 12 As shown, the fully stitched anchors of the one-piece weft-knitted shoulder and sleeve patch with integrated full-stitch anchors are embedded in the duplex polyurethane block, with a fixing strength of 605.5 N; Figure 9 As shown, the breaking strength of the main area of ​​the one-piece weft-knitted shoulder and sleeve patch with full-seam anchors is 1705.9 N, and the breaking elongation is 91.2%.

[0074] The above-mentioned method for preparing a one-piece weft-knitted shoulder and sleeve patch with built-in full-seam anchors was carried out using a STOLLADF530-32W computerized flat knitting machine (Karl Mayer, Germany), machine number E7.2. The specific steps are as follows:

[0075] (1) To thread a gauze;

[0076] On a computerized flat knitting machine, the yarn is threaded through two yarn guides, namely the first yarn and the second yarn, and then the sewing thread is threaded 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 back, the order of the tracks of the above three yarn guides from front to back is: first yarn, sewing thread, second yarn.

[0077] (2) weaving, sequentially and continuously knitting the patch main body area, the patch diverging extension area, the nail body area on the computerized flat knitting machine, and the knitting methods of different parts of the shoulder sleeve patch are as follows:

[0078] ① patch main body area;

[0079] The first yarn participates in knitting, and double rib stitches are knitted on the front and back needle beds, the knitting area width is 26 needles, the loop length NP = 10.3, and the fabric pulling value WM = 1.5;

[0080] ② patch diverging extension area;

[0081] As shown in Figure 4 , the first yarn participates in knitting, and double rib stitches are knitted on the front and back needle beds, and the knitting area is gradually narrowed by means of hidden needle collection, and the patch diverging extension area is formed in this process; each time, the left and right edges of each patch diverging extension area are collected by 1 needle, and the knitting area width is changed to 14 needles by collecting 3 times, the loop length NP = 11.0, and the fabric pulling value WM = 1.5;

[0082] ③ nail body area, the knitting area width of each nail body area is 7 needles, the loop length NP = 10.3, and the fabric pulling value WM = 1.2, and the sewing thread is introduced in the process of knitting the nail body area, and the specific knitting steps of each nail body area are as follows (as shown in Figure 5 ):

[0083] (a) the first yarn knits 2 rows of double rib, and then the first yarn pauses knitting;

[0084] (b) by enabling the sewing thread guide to be low-positioned and self-walked in the way of weft yarn introduction, enabling the weft thread presser, introducing the sewing thread to the middle of the knitting area, and then performing the "weft / automatic needle turning" action, a back bed loop in the middle of the knitting area is entangled with the front bed loop at the same needle position through needle turning, and the sewing thread is pressed between the loop and the previous front bed loop, realizing the initial slidable connection of the sewing thread on the nail body area;

[0085] (c) the first yarn participates in knitting, and double rib stitches are knitted on the front and back needle beds, and only front bed loops are knitted at 1 needle in the middle of the knitting area, and in this process, the sewing thread guide is always in the high position and swings within the range of 1 needle in the middle of the knitting area, and this process is repeated for 4 rows, so that the sewing thread is located on the reverse side of the knitted nail body area;

[0086] (d) The thread guide is kept in a high position and swings within the range of 1 needle in the knitting area. The first yarn stops knitting and the front bed loop is flipped to the back bed at the same needle position at the 1 needle in the middle of the knitting area. Then the second yarn participates in knitting and double rib is knitted in circles 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 is repeated for 4 rows so that the thread is on the front side of the knitted nail body area.

[0087] Each repetition of steps (c) to (d) creates a point where the suture passes through the nail body area. Repeating this process multiple times allows the suture to alternately appear on the front and back sides of the nail body area. Once the nail body area is woven, the suture is brought out of the weaving area as a weft insert, and two fully sutured anchors are woven simultaneously.

[0088] like Figure 6 The diagram shown is a schematic of an integrally formed weft-knitted shoulder sleeve patch with built-in full-stitch anchors implanted into a bone tunnel according to Embodiment 1 of the present invention. In the suture loose state, the anchor area is folded in half and then rolled 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 diagram shown is a schematic of an integrally formed weft-knitted shoulder sleeve patch with built-in full-stitch anchors, as described in Embodiment 1 of the present invention, anchored in a bone tunnel. When the sutures are tightened, the anchor area contracts and expands, and the lower end of the patch can be firmly anchored in the bone tunnel without the need for suturing.

[0090] like Figure 8 The diagram shown illustrates the use of an integrally formed weft-knitted rotator cuff patch with built-in full-stitch anchors in human rotator cuff repair surgery according to Embodiment 1 of the present invention. This surgical method can repair large rotator cuff tears.

[0091] Example 2

[0092] A one-piece, weft-knitted shoulder and sleeve patch with fully sewn anchors, such as... Figure 10 As shown, the shoulder and sleeve patch 1 is a sheet-like structure formed by weft knitting of yarn and seam thread; the structure of the shoulder and sleeve patch is a double-sided weft knitted structure.

[0093] The yarn consists of two PET filaments with a specification of 200D / 48f; the stitching is made of ultra-high molecular weight polyethylene braided thread with a diameter of 0.5mm.

[0094] The entire structure of the shoulder and sleeve patch, composed of yarn, is divided into three parts: the main patch area 2, the patch bifurcation extension area 3, and the pin area 4, which are arranged longitudinally. The main patch area 2, the patch bifurcation extension area 3, and the pin area 4 are all double rib knit.

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

[0096] The number of the patch bifurcated extension area 3 is 2 and arranged in sequence along the transverse direction, the longitudinal length of the patch bifurcated extension area 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 the staple body area 4 is 2 and arranged in sequence along the transverse direction; the shape of the staple body area is rectangular, the longitudinal length is 6 mm, and the transverse length is 17 mm; the transverse density is 50 columns / 50 mm, and the longitudinal density is 70 rows / 50 mm;

[0098] One end of the patch bifurcated extension area 3 connected with the patch main area 2 is recorded as end A, and the other end connected with the staple body area is recorded as end B, and the size of the patch bifurcated extension area gradually decreases from end A to end B;

[0099] The two staple body areas are respectively connected with the two patch bifurcated extension areas one by one;

[0100] As shown in the figure, Figure 11 The suture 5 is only located in the staple body area 4 and does not participate in the loop knitting, and there is one suture 5 in each staple body area 4, and the two staple body areas 4 and the suture 5 in each of them form two full-suture anchor nails;

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

[0102] As shown in the figure, Figure 12 The full-suture anchor nail of the integrally formed weft-knitted self-contained full-suture anchor nail shoulder and shoulder blade patch is implanted in a two-phase polyurethane block, and the fixation strength is 589.7 N; the breaking strength of the patch main area of the integrally formed weft-knitted self-contained full-suture anchor nail shoulder and shoulder blade patch is 1124.6 N, and the breaking elongation is 87.2%.

[0103] The preparation method of the above-mentioned one integrally formed weft-knitted self-contained full-suture anchor nail shoulder and shoulder blade patch adopts an STOLL CMS 530ki W knitting computer machine (Karl Mayer, Germany) with a gauge of E10.2, and the specific steps are as follows:

[0104] (1) threading;

[0105] Thread the yarns into two guides on the knitting computer machine respectively as the first yarn and the second yarn, and then thread the suture into another guide.

[0106] (2) weaving, sequentially and continuously knitting the patch main body area, the patch divergent extension area, the nail body area on the computerized flat knitting machine, and the knitting methods of different parts of the shoulder sleeve patch are as follows:

[0107] ① the patch main body area;

[0108] The first yarn participates in knitting, and interloop double rib knits are knitted on the front and back needle beds, the knitting area width is 36 needles, the loop length NP = 10.5, and the fabric draw value WM = 1.0;

[0109] ② the patch divergent extension area;

[0110] The first yarn participates in knitting, and interloop double rib knits are knitted on the front and back needle beds, the knitting area width is 36 needles, the loop length NP = 10.5, and the fabric draw value WM = 1.0;

[0111] ③ the nail body area, two full suture anchor nails are knitted in turn, one full suture anchor nail is knitted by the first yarn first, and then the other full suture anchor nail is knitted by the second yarn after the interloop double rib knits are knitted by flat knitting; the knitting area width of each nail body area is 21 needles, the loop length NP = 10.5, and the fabric draw value WM = 1.0; the suture is introduced during the knitting of the nail body area, and the specific knitting steps of each nail body area are as follows:

[0112] (a) the first yarn continues to knit the interloop double rib knits in the patch divergent extension area, and when the length of the nail body area is half, the row of knitting to the half length of the nail body area is recorded as the knitting row M, the nail body area is equally divided into 7 parts along the length direction, and the loops in the left 1st, 3rd, 5th and 7th parts are all transferred to the front needle bed at the knitting row M, and the loops in the left 2nd, 4th and 6th parts are all transferred to the back needle bed at the knitting row M;

[0113] (b) the suture is introduced into the knitting area in the form of weft;

[0114] (c) the first yarn continues to knit the interloop double rib knits for 1 row, and the suture is introduced out of the knitting area in the form of weft;

[0115] (d) the first yarn continues to knit the interloop double rib knits until the nail body area reaches the total length;

[0116] (e) after the knitting of the nail body area is completed, the knitting area is transferred out by flat knitting;

[0117] Then, the second yarn is used to repeat the operations (a)~(e) once, that is, two full suture anchor nails are formed.

[0118] Comparative Example 1

[0119] A one-piece weft-knitted shoulder-sleeve patch, which is the same as the patch main body region of the one-piece weft-knitted shoulder-sleeve patch with full-suture anchor of Example 1, without other regions.

[0120] As shown in Figure 12 , two UHMWPE sutures with a diameter of 0.5 mm were respectively inserted into the lower part of the one-piece weft-knitted shoulder-sleeve patch, and the fixation strength was 347.88 N.

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

[0122] Comparative Example 2

[0123] A one-piece weft-knitted shoulder-sleeve patch, which is basically the same as Example 1, except that the whole yarn in the shoulder-sleeve patch is divided into a patch main body region and a nail body region arranged in sequence along the longitudinal direction, i.e. the patch bifurcation extension region is omitted.

[0124] As shown in Figure 12 , the full-suture anchor of the one-piece weft-knitted shoulder-sleeve patch is implanted into a biphasic polyurethane block, and the fixation strength is 370 N; the breaking strength of the patch main body region of the one-piece weft-knitted shoulder-sleeve patch is 982 N, and the breaking elongation is 87.1%

[0125] The preparation method of the above one-piece weft-knitted shoulder-sleeve patch is basically the same as Example 1, except that the process of step (2) weaving the patch bifurcation extension region is omitted.

[0126] Comparing Comparative Example 2, Example 1 and Example 2, it can be found that the fixation strength of Comparative Example 2 decreased significantly, because the patch main body region and the nail body region are directly connected, a right angle is formed at the width change, and stress concentration occurs at this place, which leads to the decrease of the fixation strength.

[0127] Example 3

[0128] A one-piece weft-knitted shoulder-sleeve patch with full-suture anchor, as shown in Figure 13 , the shoulder-sleeve patch 1 is a sheet structure formed by weft-knitting of yarns and sutures; the shoulder-sleeve patch has a weft-knitted double-sided structure.

[0129] The yarns are 3 PET filaments with a specification of 200D / 48f; the sutures are ultra-high molecular weight polyethylene braided wires with a diameter of 0.3 mm;

[0130] The whole of the yarns in the rotator cuff patch is divided into a patch main body area 2, a patch bifurcated extension area 3 and a nail body area 4 arranged in sequence along the longitudinal direction, wherein the patch main body area 2, the patch bifurcated extension area 3 and the nail body area 4 are all double-rifling structures;

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

[0132] The number of the patch bifurcated extension area 3 is 2 and arranged in sequence along the transverse direction, the longitudinal length of the patch bifurcated extension area 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 area 4; the transverse density is 43 columns / 50 mm, and the longitudinal density is 65 rows / 50 mm;

[0133] The number of the nail body area 4 is 2 and arranged in sequence along the transverse direction; the shape of the nail body area 4 is rectangular, the longitudinal length is 9 mm, and the transverse length is 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 area 3 connected with the patch main body area 2 is recorded as end A, and the end connected with the nail body area 4 is recorded as end B, and the size of the patch bifurcated extension area 3 gradually shrinks from end A to end B;

[0135] The two nail body areas 4 are respectively connected with the two patch bifurcated extension areas 3 one by one;

[0136] The suture 5 is only located in the nail body area 4 and does not participate in the loop knitting, and each nail body area 4 has two suture 5, namely, the ultra-high molecular weight polyethylene braided wire I 5.1 and the ultra-high molecular weight polyethylene braided wire II 5.2, and the two nail body areas 4 respectively form two full-suture anchors with the suture 5 therein;

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

[0138] The full-suture anchor of the one-piece weft-knitted self-full-suture-anchor rotator cuff patch is implanted into a two-phase polyurethane block, and the fixation strength is 714.2 N; the breaking strength of the patch main body area of the one-piece weft-knitted self-full-suture-anchor rotator cuff patch is 1687.0 N, and the breaking elongation is 75.8%.

[0139] The preparation method of the above-mentioned integrally-formed weft-knitted self-contained full-suture anchor shoulder sleeve patch is produced by using a STOLL ADF 530-32W computerized flat knitting machine (KARL MAIER, Germany) with a gauge of E7.2, and the specific steps are as follows:

[0140] (1) threading;

[0141] The yarns are threaded into two guides on the computerized flat knitting machine respectively as the first yarn and the second yarn, and the suture is threaded into another guide; taking the front needle bed direction of the flat knitting machine as the front and the back needle bed direction as the back, the order of the tracks of the above-mentioned three guides from front to back is: the first yarn, the suture, and the second yarn;

[0142] (2) knitting, the main body area, the patch bifurcation extension area, and the nail body area of the shoulder sleeve patch are continuously knitted in sequence on the computerized flat knitting machine, and the knitting methods of different parts of the shoulder sleeve patch are as follows:

[0143] ① the main body area of the patch;

[0144] The first yarn is involved in knitting, and double-rabbit stitch is formed on the front and back needle beds, the width of the knitting area is 26 needles, the loop length NP=10.3, and the fabric draw value WM=1.5;

[0145] ② the patch bifurcation extension area;

[0146] The first yarn is involved in knitting, and double-rabbit stitch is formed on the front and back needle beds, and the knitting area is gradually narrowed by means of hidden needle collection, and the patch bifurcation extension area is formed in this process; the left and right edges of each patch bifurcation extension area are collected by 1 needle each time, and the width of the knitting area is changed to 14 needles by being collected for 3 times, the loop length NP=11.0, and the fabric draw value WM=1.5;

[0147] ③ the nail body area, the width of the knitting area of each nail body area is 7 needles, the loop length NP=10.3, and the fabric draw value WM=1.2, and the suture is introduced during the knitting of the nail body area, and the specific knitting steps of each nail body area are as follows:

[0148] (a) the first yarn knits 2 rows of double-rabbit stitch, and then the first yarn pauses knitting;

[0149] (b) the suture guide is introduced to the middle of the knitting area by means of low-position self-walking with weft insertion and enabling the weft presser, and then the action of “weft / automatic tuck” is performed, a back bed loop in the middle of the knitting area is entangled with the front bed loop at the same needle position by tucking, and the suture is pressed between the loop and the previous front bed loop, realizing the preliminary slidable connection of the suture on the nail body area;

[0150] (c) the first yarn is engaged in knitting, double rib stitch is knitted on the front and back needle beds, only the front bed loop is knitted at the middle 1 needle of the knitting area, the thread guide is kept at the high position and swings within the range of the middle 1 needle of the knitting area, and the process is repeated for 4 rows so that the thread is on the reverse side of the knitted peg area;

[0151] (d) the thread guide is kept at the high position and swings within the range of the middle 1 needle of the knitting area, the first yarn is suspended from knitting, the front bed loop is turned to the back bed of the same needle at the middle 1 needle of the knitting area, and then the second yarn is engaged in knitting, double rib stitch is knitted on the front and back needle beds, only the back bed loop is knitted at the middle 1 needle of the knitting area, and the process is repeated for 4 rows so that the thread is on the front side of the knitted peg area;

[0152] Each time the operations (c)~(d) are repeated once, one through point of the thread on the peg area is formed, and multiple repetitions can realize the thread appearing alternately on the front and reverse sides of the peg area; after the knitting of the peg area is completed, the thread is taken out of the knitting area in the form of a weft, and two full-thread anchors are knitted at the same time.

[0153] Embodiment 4

[0154] An integrally formed weft-knitted shoulder sleeve patch with full-thread anchors, the shoulder sleeve patch is in the form of a sheet structure formed by weft-knitting of yarns and threads; the shoulder sleeve patch has a weft-knitted double-sided structure;

[0155] The yarns are composed of 2 PET filaments with a fineness of 200D / 48f and 1 weft yarn; the weft yarn is a PLA yarn with a fineness of 200D / 36f; the thread is an ultra-high molecular weight polyethylene knitting thread with a diameter of 0.5 mm;

[0156] The yarns in the shoulder sleeve patch are divided into a patch main body area, a patch bifurcated extension area and a peg area arranged in sequence along the longitudinal direction, wherein the patch main body area and the patch bifurcated extension area are double rib weft-knitted structures, and the peg area is a double rib structure;

[0157] The patch main body area is in the form of a rectangle 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 patch bifurcated extension area is in the form of a rectangle with a longitudinal length of 8 mm and a maximum transverse length of 10 mm and a minimum transverse length of 5 mm; the transverse density is 47 columns / 50 mm, and the longitudinal density is 72 rows / 50 mm;

[0159] The number of the nail body regions is 2 and arranged in sequence along the transverse direction; the shape of the nail body region is rectangular, the longitudinal length is 15 mm, and the transverse length is 6.5 mm; the transverse density is 50 columns / 50 mm, and the longitudinal density is 80 rows / 50 mm;

[0160] The end of the patch bifurcated extension region connected with the patch main body region is recorded as end A, and the end connected with the nail body region is recorded as end B, and the patch bifurcated extension region gradually shrinks in size from end A to end B;

[0161] 2 nail body regions are respectively connected with 2 patch bifurcated extension regions one by one;

[0162] The suture is only located in the nail body region and does not participate in the loop knitting, and there is one suture in each nail body region, and the 2 nail body regions and the suture therein form 2 full suture anchors;

[0163] The suture penetrates the nail body region along the longitudinal direction and alternately appears on the two surfaces of the nail body region; the suture forms 4 penetration points in each nail body region, and the distance between adjacent two penetration points is 3 mm.

[0164] The full suture anchor of the integrally formed weft-knitted self-full-suture-anchor-attached shoulder and humeral patch is implanted into a two-phase polyurethane block, and the fixation strength is 579.3 N; the breaking strength of the patch main body region of the integrally formed weft-knitted self-full-suture-anchor-attached shoulder and humeral patch is 1309.7 N, and the breaking elongation is 69.8%.

[0165] The preparation method of the above-mentioned integrally formed weft-knitted self-full-suture-anchor-attached shoulder and humeral patch adopts a STOLL ADF 530-32W knitting computer machine (KARL MAIER, Germany), the machine number is E8.2, and the specific steps are as follows:

[0166] (1) threading;

[0167] Thread the yarns into 2 guides on the knitting computer machine respectively, which are the first yarn and the second yarn, and then thread the suture and the weft yarn into the other 2 guides; taking the front needle bed direction of the machine as front and the back needle bed direction as back, the order of the tracks of the above-mentioned 3 guides from front to back is: the first yarn, the suture, the second yarn, and the weft yarn;

[0168] (2) weaving, continuously knitting the patch main body region, the patch bifurcated extension region, and the nail body region on the knitting computer machine in sequence, and the knitting methods of different parts of the shoulder and humeral patch are as follows:

[0169] ① the patch main body region;

[0170] The first yarn and the weft yarn are engaged in knitting, and interlock stitches are knitted on the front and back needle beds to form a double-rubber weft-knitted structure. The width of the knitting area is 26 stitches, the stitch length NP = 10.3, and the fabric pull value WM = 1.5;

[0171] ② patch bifurcation extension area;

[0172] The first yarn and the weft yarn are engaged in knitting, and interlock stitches are knitted on the front and back needle beds to form a double-rubber weft-knitted structure. The width of the knitting area is 26 stitches, the stitch length NP = 10.3, and the fabric pull value WM = 1.5;

[0173] ③ nail body area, the width of the knitting area of each nail body area is 7 stitches, the stitch length NP = 10.3, and the fabric pull value WM = 1.1. During the knitting of the nail body area, the suture is introduced. The specific knitting steps of each nail body area are as follows:

[0174] (a) The first yarn knits 2 rows of double-rubber, and then the first yarn is paused for knitting;

[0175] (b) The suture is introduced to the middle of the knitting area by enabling the suture guide to run low in the weft yarn introduction mode and enabling the weft needle presser, and then the "weft / automatic needle turning" action is performed. A back bed stitch in the middle of the knitting area is intertwined with a front bed stitch at the same needle position through needle turning, and the suture is pressed between the stitch and the previous front bed stitch, realizing the initial slidable connection of the suture on the nail body area;

[0176] (c) The first yarn is engaged in knitting, and interlock stitches are knitted on the front and back needle beds to form a double-rubber structure. Only front bed stitches are knitted at 1 needle in the middle of the knitting area. During this process, the suture guide is always in the high position and swings within the range of 1 needle in the middle of the knitting area. This is repeated for 4 rows, so that the suture is located on the reverse side of the knitted nail body area;

[0177] (d) The suture guide remains in the high position and swings within the range of 1 needle in the middle of the knitting area. The first yarn is paused for knitting, and the front bed stitch at 1 needle in the middle of the knitting area is turned to the back bed at the same needle position. Then the second yarn is engaged in knitting, and interlock stitches are knitted on the front and back needle beds to form a double-rubber structure. Only back bed stitches are knitted at 1 needle in the middle of the knitting area. This is repeated for 4 rows, so that the suture is located on the front side of the knitted nail body area;

[0178] Each time the operations (c)~(d) are repeated once, one through point of the suture on the nail body area is formed, and multiple repetitions can realize the front and back of the suture on the nail body area to appear alternately; after the nail body area is knitted, the suture is taken out of the knitting area in the form of weft, and two full-suture anchors are knitted at the same time.

[0179] Embodiment 5

[0180] An integrally formed weft-knitted shoulder sleeve patch with full-suture anchors, the shoulder sleeve patch is formed into a sheet structure by weft-knitting of yarns and sutures; the shoulder sleeve patch has a weft-knitted double-sided structure;

[0181] The yarns are 4 PE filaments, each having a specification of 100D / 36f; the sutures are ultra-high molecular weight polyethylene knitting lines, each having a diameter of 0.4 mm;

[0182] The yarns in the shoulder sleeve patch are divided into a patch main body area, a patch bifurcation extension area and a nail body area arranged in sequence along the longitudinal direction, wherein the patch main body area, the patch bifurcation extension area and the nail body area are all 1+1 rib structures;

[0183] The patch main body area has a number of 1 and a rectangular shape, 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 patch bifurcation extension area has a number of 3 and is arranged in sequence along the transverse direction, a longitudinal length of 8 mm, a maximum transverse length of 10 mm and a minimum transverse length of 5 mm; the transverse density is 41 columns / 50 mm, and the longitudinal density is 59 rows / 50 mm;

[0185] The nail body area has a number of 3 and is arranged in sequence along the transverse direction; the nail body area has a rectangular shape, a longitudinal length of 15 mm and a transverse length of 6.5 mm; the transverse density is 49 columns / 50 mm, and the longitudinal density is 70 rows / 50 mm;

[0186] The end of the patch bifurcation extension area connected with the patch main body area is marked as end A, and the end connected with the nail body area is marked as end B; the patch bifurcation extension area gradually shrinks in size from end A to end B;

[0187] The three nail body areas are connected with 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 into a loop; there is one suture in each nail body area, and the three nail body areas and the sutures therein form three full-suture anchors;

[0189] The suture thread penetrates the nail body region in the longitudinal direction and alternately appears on the two surfaces of the nail body region; the suture thread forms 6 penetration points in each nail body region, and the distance between two adjacent penetration points is 2 mm.

[0190] The integral woven self-full suture anchor shoulder sleeve patch is implanted in a full suture anchor two-phase polyurethane block, and the fixing strength is 854.6 N; the patch main body region of the integral woven self-full suture anchor shoulder sleeve patch has a breaking strength of 877 N and a breaking elongation of 89.9%.

[0191] The preparation method of the above-mentioned integral woven self-full suture anchor shoulder sleeve patch is produced by using a STOLL ADF 530-32W needle-knitting computerized flat machine (Karl Mayer, Germany) with a gauge of E8.2, and the specific steps are as follows:

[0192] (1) threading;

[0193] The yarns are respectively threaded into two guides on the needle-knitting computerized flat machine, which are the first yarn and the second yarn, and the suture thread is threaded into another guide; taking the front needle bed direction of the flat machine as the front and the back needle bed direction as the back, the order of the tracks of the above-mentioned three guides from front to back is: the first yarn, the suture thread, and the second yarn;

[0194] (2) weaving, the patch main body region, the patch bifurcation extension region, and the nail body region are continuously knitted in sequence on the needle-knitting computerized flat machine, and the knitting methods of different parts of the shoulder sleeve patch are as follows:

[0195] ① the patch main body region;

[0196] The first yarn participates in knitting, and 1+1 rib structure is knitted in loops on the front and back needle beds, the knitting area width is 33 needles, the loop length NP=10.3, and the fabric draw value WM=1.6;

[0197] ② the patch bifurcation extension region;

[0198] The first yarn participates in knitting, and 1+1 rib structure is knitted in loops on the front and back needle beds, and the knitting area is gradually knitted by narrowing the knitting area through the clear take-up needle method, and the patch bifurcation extension region is formed in this process; each patch bifurcation extension region moves 2 loops and takes up 1 needle on the left and right edges, and the knitting area width is changed to 15 needles by taking up 3 times, the loop length NP=11.0, and the fabric draw value WM=1.6;

[0199] ③ the nail body region, the knitting area width of each nail body region is 5 needles, the loop length NP=11, and the fabric draw value WM=1.0, and the suture thread is introduced during the knitting of the nail body region, and the specific knitting steps of each nail body region are as follows:

[0200] (a) the first yarn weaves 2 rows of double rib, then the first yarn pauses weaving;

[0201] (b) by making the thread guide low self-walking in the way of weft insertion, enabling the weft presser foot, introducing the thread to the middle of the weaving area, then performing the "weft / automatic needle turning" action, a back bed loop in the middle of the weaving area is entangled with the front bed loop of the same needle position through needle turning, and the thread is pressed between the loop and the last row of front bed loops, realizing the initial slidable connection of the thread on the shank area;

[0202] (c) the first yarn participates in weaving, weaving 1+1 rib structure on the front and back needle beds, only weaving front bed loops at 1 needle in the middle of the weaving area, and the thread guide is always in the high position and swings within the range of 4 needles in the middle of the weaving area, repeating the weaving of 4 rows, so that the thread is located on the reverse side of the woven shank area;

[0203] (d) the thread guide remains in the high position and swings within the range of 1 needle in the middle of the weaving area, the first yarn pauses weaving, and the front bed loop is turned to the back bed of the same needle position at 1 needle in the middle of the weaving area, then the second yarn participates in weaving, weaving 1+1 rib structure on the front and back needle beds, only weaving back bed loops at 1 needle in the middle of the weaving area, repeating the weaving of 4 rows, so that the thread is located on the front side of the woven shank area;

[0204] Each time the (c)~(d) operation is repeated once, a through point of the thread on the shank area is formed, and multiple repetitions can realize the alternating appearance of the thread on the front and back sides of the shank area; after the shank area is woven, the thread is taken out of the weaving area in the form of weft insertion, and 3 full-thread anchors are woven at the same time.

[0205] Example 6

[0206] An integrally formed weft-knitted shoulder sleeve patch with full-thread anchors, the shoulder sleeve patch is a sheet structure formed by weft-knitting yarns and threads; the structure of the shoulder sleeve patch is weft-knitted double-sided structure;

[0207] The yarns are 4 PE filaments, each with a specification of 100D / 36f; the thread is an ultra-high molecular weight polyethylene knitting thread with a diameter of 0.3 mm;

[0208] The whole formed by the yarns in the shoulder sleeve patch is divided into a patch main body area, a patch bifurcated extension area and a shank area arranged in sequence along the longitudinal direction, wherein the patch main body area, the patch bifurcated extension area and the shank area are all 1+1 rib structures;

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

[0210] The number of patch bifurcation extension regions is 4 and arranged in sequence along the transverse direction, the longitudinal length of the patch bifurcation 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 arranged in sequence along the transverse direction; the shape of the nail body region is rectangular, the longitudinal length is 18 mm, and the transverse length is 5 mm; the transverse density is 47 columns / 50 mm, and the longitudinal density is 72 rows / 50 mm;

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

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

[0214] The suture is only located in the nail body region and does not participate in the loop knitting, and there is one suture in each nail body region, and the four nail body regions and the sutures therein form four full-suture anchor nails;

[0215] The suture penetrates the nail body region along the longitudinal direction and alternately appears on the two surfaces of the nail body region; the suture forms four penetration points in each nail body region, and the distance between the two adjacent penetration points is 4 mm.

[0216] The full-suture anchor nail of the integrally formed weft-knitted self-contained full-suture anchor nail shoulder and shoulder blade patch is implanted into a biphasic polyurethane block, and the fixation strength is 870.2 N; the breaking strength of the patch body region of the integrally formed weft-knitted self-contained full-suture anchor nail shoulder and shoulder blade patch is 891.5 N, and the breaking elongation is 77.8%.

[0217] The preparation method of the above-mentioned integrally formed weft-knitted self-contained full-suture anchor nail shoulder and shoulder blade patch adopts a STOLL ADF 530-32W needle-knitting computerized flat knitting machine (Karl Mayer, Germany), the machine number is E8.2, and the specific steps are as follows:

[0218] (1) threading;

[0219] The yarns are respectively threaded into two guides on a computerized flat knitting machine, which are respectively the first yarn and the second yarn, and the sewing thread is threaded into another guide; taking the front needle bed direction of the flat knitting machine as front and the back needle bed direction as back, the order of the tracks of the above three guides from front to back is: the first yarn, the sewing thread, and the second yarn;

[0220] (2) Weaving, sequentially and continuously knitting the patch main body area, the patch bifurcation extension area, and the nail body area on the computerized flat knitting machine, and the knitting methods of different parts of the shoulder sleeve patch are respectively:

[0221] ① The patch main body area;

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

[0223] ② The patch bifurcation extension area;

[0224] The first yarn participates in knitting, and 1+1 rib structure is knitted on the front and back needle beds, and the knitting area is gradually narrowed by means of hidden needle collection, and the patch bifurcation extension area is formed in this process; each time, 1 needle is collected on the left and right edges of each patch bifurcation extension area, and the knitting area width is changed to 20 needles after being collected for 3 times, the loop length NP=11.0, and the fabric draw value WM=1.7;

[0225] ③ The nail body area, the knitting area width of each nail body area is 5 needles, the loop length NP=10.3, and the fabric draw value WM=1.0, and the sewing thread is introduced during the knitting of the nail body area, and the specific knitting steps of each nail body area are as follows:

[0226] (a) The first yarn knits 2 rows of double rib, and then the first yarn pauses knitting;

[0227] (b) The sewing thread guide is introduced to the middle of the knitting area by means of low-position self-walking with padding yarn introduction and enabling the weft presser foot, and then the “weft / automatic needle turning” action is performed, one back bed loop in the middle of the knitting area is turned over with the front bed loop at the same needle position, and the sewing thread is pressed between the loop and the previous front bed loop, realizing the preliminary slidable connection of the sewing thread on the nail body area;

[0228] (c) The first yarn participates in knitting, and 1+1 rib structure is knitted on the front and back needle beds, and only the front bed loop is knitted at 1 needle in the middle of the knitting area, and in this process, the sewing thread guide is always in the high position and swings within the range of 5 needles in the middle of the knitting area, and this process is repeated for 4 rows, so that the sewing thread is located on the reverse side of the knitted nail body area;

[0229] (d) the suture guide is kept in the high position and oscillated within the range of 1 needle in the middle of the knitting area, the first yarn is suspended from knitting, the front bed loop is turned to the back bed of the same needle position at 1 needle in the middle of the knitting area, then the second yarn participates in knitting, 1+1 rib stitch is knitted in loops on the front and back needle beds, only the back bed loop is knitted at 1 needle in the middle of the knitting area, and the knitting is repeated for 4 rows so that the suture is located on the front of the knitted nail body area;

[0230] Each repetition of operations (c)~(d) 1 time can form one through point of the suture on the nail body area, and multiple repetitions can realize the alternate appearance of the suture on the front and back of the nail body area; after the nail body area is knitted, the suture is taken out of the knitting area in the form of a weft, and 4 full-suture anchors are knitted at the same time.

Claims

1. An integrally formed, weft-knitted, self- full suture-anchoring rotator-cuff patch, characterized by, The shoulder muscle patch is a sheet structure formed by weft knitting of yarn and suture thread; The whole of the yarn in the shoulder muscle patch is divided into a patch main body area, a patch bifurcation extension area and a nail body area arranged in sequence along the longitudinal direction, the number of the patch main body area is 1, the number of the patch bifurcation extension area is n and arranged in sequence along the transverse direction, the number of the nail body area is n and arranged in sequence along the transverse direction, and n≥2; One end of the patch bifurcation extension area connected with the patch main body area is marked as end A, and the other end connected with the nail body area is marked as end B, and the patch bifurcation extension area gradually shrinks in size from end A to end B; The n nail body areas are connected with the n patch bifurcation extension areas one by one; The suture thread is only located in the nail body area and does not participate in the knitting, and there is at least one suture thread in each nail body area, and the n nail body areas and the suture threads therein form n full-suture-thread anchors.

2. An integrally formed, weft knitted, self-sutured rotator cuff patch according to claim 1, wherein, The shoulder muscle patch has a weft-knitted double-sided structure, and the loops therein are formed by one or more combinations of looping, purling and floating.

3. An integrally formed, weft knitted, self-sutured rotator cuff patch according to claim 1, wherein, The patch main body area has a rectangular shape, a longitudinal length of 30-50 mm and a transverse length of 20-40 mm.

4. An integrally formed, weft knitted, self-sutured rotator cuff patch according to claim 1, wherein, The nail body area has a rectangular shape, a longitudinal length of 5-22 mm and a transverse length of 4-20 mm.

5. An integrally formed, weft knitted, self-sutured rotator cuff patch according to claim 1, wherein, The patch bifurcation extension area has a longitudinal length of 5-10 mm and a maximum transverse length of 8-18 mm.

6. An integrally formed, weft knitted, self-sutured rotator cuff patch according to claim 1, wherein, The yarn is a medical polymer material yarn with a linear density of 75-500 D. The suture thread is an ultra-high molecular weight polyethylene braided thread with a diameter of 0.3-0.6 mm.

7. A one-piece integrally formed, weft knitted, self-sutured rotator cuff patch 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 thread penetrates the nail body area along the longitudinal direction and alternately appears on the two surfaces of the nail body area.

8. A one-piece integrally formed, weft knitted, self-sutured rotator cuff patch 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 the transverse length of the nail body area, the longitudinal length of the nail body area is less than the transverse length, and the suture thread penetrates the nail body area along the transverse direction and alternately appears on the two surfaces of the nail body area.

9. A method of making a unitary, weft-knitted, full-suture-anchored rotator cuff patch according to claim 7, wherein, The computerized flat knitting machine is used for production, the yarn is first used to knit the patch main body area, then the knitting area is gradually narrowed by needle collection, the patch bifurcation extension area is formed in this process, the yarn is then used to knit the nail body area, the suture thread is introduced into the knitting area in the form of a weft thread in this process, the suture thread is penetrated into the nail body area through the needle turning action, the guide for the suture thread is then swung in the middle of the nail body area, the suture thread is transferred from one surface to the other surface of the nail body area through the needle turning action at each penetration point, and the suture thread is taken out of the knitting area in the form of a weft thread after the knitting of the nail body area is completed, and the n full-suture-thread anchors are knitted simultaneously.

10. A method of making a unitary, weft-knitted, self-anchoring rotator cuff patch according to claim 8, wherein, The computerized flat knitting machine is used to produce the suture anchor, which comprises a suture patch main area, a suture patch bifurcated extension area and a suture body area. Firstly, the suture patch main area is knitted by using yarns, then the knitted area is gradually narrowed by using the needle reduction, in the process, the suture patch bifurcated extension area is formed, finally, the suture body area is knitted by using yarns, in the process, the suture body area is knitted to half of its longitudinal length, the row of knitting to half of its longitudinal length is recorded as knitting row M, then the suture body area is equally divided into m parts along the transverse direction, m≥5, the loops of each part are all transferred to the front needle bed or the back needle bed at the knitting row M, the loops of adjacent two parts are transferred to different needle beds, then the suture thread is introduced into the knitting area in the form of weft, the suture body area is continuously knitted for one row, then the suture thread is taken out of the knitting area, subsequently, the suture body area is continuously knitted to its full longitudinal length, then the loops of the suture body area are cast off in the form of flat needle, and n full-suture thread anchors are knitted in sequence.

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