Dual Function Anchor System

Abstract

The present invention provides a surgical anchor comprising a screw and a coil, the coil having a conical shape wound around a screw shaft with a first end of the coil tapered and having a ring circumference smaller than that of the screw head and engaged with the base of the screw head, and a second end of the coil flared with a larger ring circumference and positioned along the screw shaft. TIFF2023536558000002.tif87170

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of priority to U.S. Provisional Patent Application No. 63 / 034,895, filed June 4, 2020, the contents of which are incorporated herein by reference in their entirety. [Background technology]

[0002] Background of the Invention Movement of the human body requires complex communication between structural components such as muscles, tendons, bones, and vascular structures, as well as electrical pulses that control muscles to create movement. Over time, the body ages, which can result in wear and tear on muscles, tendons, and bones. A relatively common injury involves the complete or partial separation of ligaments, tendons, or other soft tissues from their associated human bone. Complete or partial separation of ligaments, tendons, and other soft tissues is a relatively common site in athletes and typically results from excessive stress being placed on such tissues. Of course, separation or detachment of soft tissue from human bone can similarly occur as a result of accidents such as falls, overexertion during work-related activities, overexertion during physical activity, or several different situations involving human activity.

[0003] In many cases, partial avulsion injuries do not heal spontaneously and, despite treatment using conservative management techniques and procedures, cause chronic pain and / or ongoing discomfort to the patient. Such injuries are typically repaired through open surgery because it is difficult to adequately fixate the tissue and ensure healing otherwise. Therefore, several surgical procedures have been devised to reattach such avulsed or separated tissue. Furthermore, surgical techniques have advanced to the point where severely damaged ligaments and / or tendons can be surgically replaced.

[0004] One such technique involves reattaching detached or separated tissue using "traditional" attachment devices such as metal staples, suture buttons, and cancellous bone screws. These "traditional" devices have also been used in connection with the attachment of ligaments or tendons harvested from other parts of the body and used to replace or repair severely damaged tissue. However, not surprisingly, "traditional" repair methods have not been uniformly successful. For example, the rigid attachment of ligaments and tendons using "traditional" attachment devices such as staples, screws, and sutures cannot be maintained when subjected to extreme tensile loads.

[0005] Given the risk of comorbidities and infections, as well as the potential for failure of "traditional" devices, developing novel devices capable of achieving functional reattachment of soft tissue to bone using a minimally invasive approach following the principles of conservative management is of great interest and in the public health interest. To optimally heal this type of injury minimally invasively, specialized systems containing components for use in vivo and ex vivo are required. Biocompatibility and mechanical performance are important aspects of the implantable components in such systems, and a given implantation site involves distinct considerations regarding both biocompatibility and mechanical performance.

[0006] For fixation within bone tissue, a rigid, high-strength material is required to effectively position the device within the bone. This includes generating sufficient torque to penetrate the bone as well as possessing sufficient strength to establish and maintain fixation for the desired period of time, in this case, at least six months. For soft tissue fixation, a ductile material is required to effectively position the device within the soft tissue and guide it into the bone anchor. This involves maintaining adequate strength while temporarily deforming under the forces exerted in connection with positioning. The ability to accomplish these functions is determined by the component composition. Parameters such as elastic modulus, tensile strength, shear strength, and flexural strength guide the selection of suitable materials for each component. Summary of the Invention

[0007] In certain aspects, the present invention provides a surgical anchor comprising a screw and a coil, the coil having a conical shape wound around a screw shaft with a first end of the coil tapered and having a ring circumference smaller than the ring circumference of the screw head and engaged to the base of the screw head, and a second end of the coil flared with a larger ring circumference and positioned along the screw shaft.

[0008] In certain aspects, the present invention provides a surgical system comprising: a needle having an opening of sufficient diameter to receive a surgical anchor having a screw and a coil; and a stylet tool insertable into the opening to insert the anchor and capable of engaging and turning the screw, wherein the screw has a shaft with threads and a head, the head having a bottom surface, and the coil has a conical shape wound around the shaft with a first end of the coil tapered and having a ring circumference smaller than the ring circumference of the screw head and engaged with the bottom of the screw head, and a second end of the coil flared with a larger ring circumference and positioned along the screw shaft.

[0009] In some embodiments, the screws or coils described herein comprise one or more materials selected from poly(L-lactic acid), poly(DL-lactic acid), poly(lactic-co-glycolic acid), poly(p-dioxanone), poly(propylene fumarate), copolymers of poly(L-lactic acid and poly(lactic-co-glycolic acid), magnesium-based alloys including Mg—Zn, Mg-6Zn, Mg—Zn—Ca, Mg—Ca—Sr, and MgYREZr, and iron-based alloys including Fe—Mn.

[0010] In some embodiments, the screws or coils described herein comprise a polymer and / or coating on the metal, wherein the polymer or coating comprises one or more materials as set forth in claim 9.

[0011] In some embodiments, the screws or coils described herein comprise a ceramic material comprising calcium phosphate, tricalcium phosphate, and hydroxyapatite in a particle-reinforced polymer matrix, and a coating comprising a ceramic material comprising calcium phosphate, tricalcium phosphate, and hydroxyapatite.

[0012] In some embodiments, the screws described herein have shape memory properties. In some embodiments, the screws or coils described herein are non-absorbable.

[0013] In certain aspects, the present invention provides a method for repairing soft tissue when it has dissected from bone, comprising inserting a surgical anchor into soft tissue that has been detached from the bone, the system comprising: an opening for inserting a surgical anchor having a screw and a coil; and a stylet tool insertable into the opening for inserting the anchor and capable of engaging and turning the screw to advance the screw into the bone, the screw comprising a shaft with a thread, a head with a bottom surface, and a coil, the coil having a conical shape with a first end of the coil tapered and having a ring circumference smaller than the ring circumference of the screw head and engaged with the bottom of the screw head, and a second end of the coil flared with a larger ring circumference and positioned along the screw shaft.

[0014] In some aspects, the present invention provides a surgical anchor comprising a screw and a coil, the screw comprising a head, a threaded shaft, and a collar, the collar having a cross-sectional area greater than the cross-sectional areas of the shaft and head. In some embodiments, the screw comprises a collar having threads in the same direction as the threads of the screw shaft. In some embodiments, the anchor comprises a coil having one or more of the following shapes: a conical shape, where a first end of the coil is tapered and has a ring circumference smaller than the ring circumference of the screw head and is engaged with the collar, and a second end of the coil is flared with a larger ring circumference and positioned along the screw shaft; and a cylindrical shape, where a first end of the coil is engaged with the collar and the second end of the coil is wound around the screw shaft with the first end of the coil being positioned along the screw shaft.

[0015] In certain aspects, the present invention provides a method of repairing soft tissue when dissected from bone, comprising inserting a surgical anchor into soft tissue detached from the bone, the system comprising: an aperture for inserting a surgical anchor comprising a screw and a coil; and a stylet tool insertable into the aperture for inserting the anchor and capable of engaging and turning the screw to advance the screw into the bone, the screw comprising a head, a threaded shaft, and a collar, the collar having a cross-sectional area greater than the cross-sectional areas of the shaft and head. In some embodiments, the screw comprises a collar having threads in the same direction as the threads of the screw shaft. In some embodiments, the anchor comprises a coil having one or more of the following shapes: a conical shape, where a first end of the coil is tapered and has a ring circumference smaller than the ring circumference of the screw head and is engaged with a collar, and a second end of the coil is flared with a larger ring circumference and is positioned along the screw shaft, and is wound around the screw shaft; and a cylindrical shape, where the first end of the coil is engaged with a collar and the second end of the coil is wound around the screw shaft, and is positioned along the screw shaft.

[0016] In some aspects, the invention provides a surgical anchor comprising a screw and a coil, the screw comprising a head, the head having a base, a shaft having threads, the shaft comprising a section having a larger cross-sectional area than the remainder of the shaft, such that the shaft tapers from this section both toward and away from the head.

[0017] In some embodiments, the anchor includes a coil having one or more of the following shapes: a conical shape, in which a first end of the coil is tapered and has a ring circumference smaller than the ring circumference of the screw head and is engaged with a bottom surface of the screw head, and a second end of the coil is flared with a larger ring circumference and positioned along the screw shaft, and is wound around the screw shaft; and a cylindrical shape, in which a first end of the coil is engaged with a bottom surface of the screw head and a second end of the coil is positioned along the screw shaft, and is wound around the screw shaft.

[0018] In certain aspects, the present invention relates to a method for repairing soft tissue when dissected from a bone, comprising inserting a surgical anchor into soft tissue that has been detached from the bone, the system comprising: an opening for inserting a surgical anchor having a screw and a coil; and a stylet tool insertable into the opening for inserting the anchor and capable of engaging and turning the screw to advance the screw into the bone, the screw having a head with a base surface and a shaft having threads, the shaft including a section having a larger cross-sectional area than the remainder of the shaft such that the shaft tapers from this section in both directions toward and away from the head, wherein the coil is positioned between the screw head and the section with the larger cross-sectional area.

[0019] In some embodiments, the method includes a coil having one or more of the following shapes: a conical shape, where a first end of the coil is tapered and has a ring circumference smaller than the ring circumference of the screw head and is engaged with a collar, and a second end of the coil is flared with a larger ring circumference and positioned along the screw shaft, and is wound around the screw shaft, with the first end of the coil engaged with a collar and the second end of the coil positioned along the screw shaft; and a cylindrical shape, where the first end of the coil is wound around the screw shaft, with the first end of the coil engaged with a collar and the second end of the coil positioned along the screw shaft.

[0020] In a particular aspect, the present invention relates to the use of a dual-action surgical system for fixing soft tissue to bone, the surgical system comprising an applicator having a needle and an opening for inserting a surgical anchor, the surgical anchor comprising a screw having a shaft with a thread and a coil; the coil wound around the screw shaft comprising a coil end and a second coil end defined to engage at least one surface of the screw; and engaging the end of the shaft and the second coil end with the soft tissue.

[0021] In certain aspects, the present invention provides a surgical anchor comprising a fastener and an external inverting coil coupled to a proximal end of the fastener. In some embodiments, the fastener is a screw comprising a distal thread and a reamer proximal to the distal thread, the screw being a capitate screw, the screw comprising an annular recess proximal to the reamer, the recess adapted and configured to receive a portion of the external inverting coil. In some embodiments, the screw includes a head having an outer diameter equal to or less than the outer diameter of the reamer.

[0022] In certain aspects, the present invention provides a surgical anchor comprising a screw having a distal thread, a proximal head, and a coil coupled to the screw proximal to the distal thread, wherein the screw can freely rotate within the coil in either rotational direction without driving the coil or the diameter of the coil expanding distally.

[0023] In certain aspects, the present invention provides a method of repairing soft tissue when dissected from bone, comprising driving a surgical anchor through the soft tissue and into the bone until at least a portion of the coil presses against and expands the soft tissue proximal to the head of the screw. [The present invention 1001] 1. A surgical anchor comprising a screw and a coil, the coil comprising: a conical shape wound around the screw shaft with a first end of the coil tapered and having a ring circumference smaller than that of the screw head and engaged with the bottom of the screw head, and a second end of the coil flared with a larger ring circumference and positioned along the screw shaft; 10. The surgical anchor according to claim 9, further comprising: [The present invention 1002] a needle having an opening of sufficient diameter to receive a surgical anchor having a screw and a coil; a stylet tool that is insertable into the opening for inserting the anchor and that can engage with and turn the screw; 1. A surgical system comprising: the screw having a threaded shaft and a head, the head having a bottom surface, and the coil comprising: a conical shape wound around the screw shaft with a first end of the coil tapered and having a ring circumference smaller than that of the screw head and engaged with the bottom of the screw head, and a second end of the coil flared with a larger ring circumference and positioned along the screw shaft; The surgical system comprising: [The present invention 1003] The screw or coil of invention 1001 or 1002, comprising one or more materials selected from poly(L-lactic acid), poly(DL-lactic acid), poly(lactic-co-glycolic acid), poly(p-dioxanone), poly(propylene fumarate), copolymers of poly(L-lactic acid and poly(lactic-co-glycolic acid), magnesium-based alloys including Mg—Zn, Mg-6Zn, Mg—Zn—Ca, Mg—Ca—Sr, and MgYREZr, and iron-based alloys including Fe—Mn. [The present invention 1004] The screw or coil of invention 1001 or 1002, comprising a polymer and / or coating on metal, said polymer or coating comprising one or more materials of invention 1009. [The present invention 1005] a ceramic material including calcium phosphate, tricalcium phosphate, and hydroxyapatite in a particle-reinforced polymer matrix; a coating comprising a ceramic material including calcium phosphate, tricalcium phosphate, and hydroxyapatite; The screw or coil of any one of 1001 to 1004 of the present invention, comprising: [The present invention 1006] A coil according to any one of 1001 to 1005 of the present invention, having shape memory properties. [The present invention 1007] The screw or coil of any one of 1001 to 1006 of the present invention, which is non-absorbable. [The present invention 1008] 1. A method of repairing soft tissue when dissociated from bone, comprising inserting a surgical anchor into soft tissue that has been detached from bone, the system comprising: an opening for inserting a surgical anchor comprising a screw and a coil; a stylet tool insertable into the opening for inserting the anchor and capable of engaging and turning the screw to advance the screw into the bone; the screw comprises a shaft having a thread, a head having a bottom surface, and a coil, the coil comprising: a conical shape wound around the screw shaft with a first end of the coil tapered and having a ring circumference smaller than that of the screw head and engaged with the bottom of the screw head, and a second end of the coil flared with a larger ring circumference and positioned along the screw shaft; The method comprising: [The present invention 1009] 1. A surgical anchor comprising a screw and a coil, wherein the screw comprises a head, a threaded shaft, and a collar, the collar having a cross-sectional area greater than the cross-sectional areas of the shaft and the head. [The present invention 1010] The screw of the present invention 1009, comprising a collar having threads in the same direction as the threads of the screw shaft. [The present invention 1011] a conical shape wound around the screw shaft with a first end of the coil tapered and having a ring circumference smaller than that of the screw head and engaged with the collar, and a second end of the coil flared and having a larger ring circumference and positioned along the screw shaft; a cylindrical shape, wherein a first end of the coil is engaged with the collar and a second end of the coil is wound around the threaded shaft with the second end of the coil positioned along the threaded shaft; The anchor of the present invention 1009 or 1010, comprising a coil having one or more selected from the following: [The present invention 1012] 1. A method of repairing soft tissue when dissociated from bone, comprising inserting a surgical anchor into soft tissue that has been detached from bone, the system comprising: an opening for inserting a surgical anchor comprising a screw and a coil; a stylet tool insertable into the opening for inserting the anchor and capable of engaging and turning the screw to advance the screw into the bone; wherein the screw comprises a head, a threaded shaft, and a collar, the collar having a cross-sectional area greater than the cross-sectional areas of the shaft and the head. [The present invention 1013] 1012. The method of claim 1012, wherein the screw comprises a collar having threads in the same direction as the threads of the screw shaft. [The present invention 1014] a conical shape wound around the screw shaft with a first end of the coil tapered and having a ring circumference smaller than that of the screw head and engaged with the collar, and a second end of the coil flared and having a larger ring circumference and positioned along the screw shaft; a cylindrical shape, wherein a first end of the coil is engaged with the collar and a second end of the coil is wound around the threaded shaft with the second end of the coil positioned along the threaded shaft; The method of any one of claims 1012 to 1013, further comprising a coil having one or more selected from the group consisting of: [The present invention 1015] 1. A surgical anchor comprising a screw and a coil, wherein the screw comprises a head, the head having a base, a shaft having threads, the shaft comprising a section having a larger cross-sectional area than a remainder of the shaft, whereby the shaft tapers from the section in both directions toward and away from the head. [The present invention 1016] a conical shape wound around the screw shaft with a first end of the coil tapered and having a ring circumference smaller than the ring circumference of the screw head and engaged with a bottom surface of the screw head, and a second end of the coil flared with a larger ring circumference and positioned along the screw shaft; a cylindrical shape, wherein a first end of the coil is engaged with a bottom surface of the screw head and a second end of the coil is positioned along the screw shaft and wound around the screw shaft; The anchor of the present invention 1015, comprising a coil having one or more selected from the following: [The present invention 1017] 1. A method of repairing soft tissue when dissociated from bone, comprising inserting a surgical anchor into soft tissue that has been detached from bone, the system comprising: an opening for inserting a surgical anchor comprising a screw and a coil; a stylet tool insertable into the opening for inserting the anchor and capable of engaging and turning the screw to advance the screw into the bone; wherein the screw comprises a head having a base surface and a shaft having threads, the shaft including a section having a larger cross-sectional area than the remainder of the shaft such that the shaft tapers from the section in both directions toward and away from the head, and wherein the coil is positioned between the screw head and the section with the larger cross-sectional area. [The present invention 1018] a conical shape wound around the screw shaft with a first end of the coil tapered and having a ring circumference smaller than that of the screw head and engaged with the collar, and a second end of the coil flared and having a larger ring circumference and positioned along the screw shaft; a cylindrical shape, wherein a first end of the coil is engaged with the collar and a second end of the coil is wound around the threaded shaft with the second end of the coil positioned along the threaded shaft; The method of the present invention 1017, comprising a coil having one or more selected from the following: [The present invention 1019] 1. Use of a dual-action surgical system for fixing soft tissue to bone, the surgical system comprising: an applicator having a needle and an opening for inserting a surgical anchor, the surgical anchor comprising a screw having a shaft with a thread and a coil; the coil wound around the screw shaft comprising a coil end and a second coil end defined to engage at least one surface of the screw; and engaging the end of the shaft and the second coil end with soft tissue. [The present invention 1020] a fastener; an external inverting coil coupled to the proximal end of the fastener; A surgical anchor comprising: [The present invention 1021] The fastener is a distal thread; Reaming the distal thread proximally A screw comprising: The screw is a headless screw, the screw includes an annular recess proximal to the reamer, the recess adapted and configured to receive a portion of the outer inverting coil. The surgical anchor of the present invention 1020. [The present invention 1022] 1021. A surgical anchor according to claim 1021, wherein the screw has a head having an outer diameter equal to or less than the outer diameter of the reamer. [The present invention 1023] a distal thread; a proximal head; a coil coupled to the screw proximal to the distal thread; equipped with a screw 1. A surgical anchor comprising: the screw is free to rotate within the coil in either direction of rotation without driving the coil; or the diameter of the coil expands distally; The surgical anchor. [The present invention 1024] 1. A method of repairing soft tissue when dissociated from bone, comprising: Driving the surgical anchor of any one of claims 1020 to 1023 through the soft tissue and into the bone until at least a portion of the coil is pressed against and spread against the soft tissue proximal to the head of the screw. The method comprising: [Brief explanation of the drawings]

[0024] [Figure 1] 1 illustrates a needle inserted adjacent to soft tissue separated from bone. [Figure 2] 1 illustrates a needle inserted into soft tissue. [Figure 3] Figures 3A-3C illustrate details of an embodiment of a screw with a wound conical coil, Figure 3B illustrates a top view of a screw with a wound conical coil showing concentric circles, and Figure 4C illustrates a screw with an inverted wound conical coil. [Figure 4] Figures 4A and 4B illustrate a screw with a wound conical coil deployed through a needle into soft tissue. Figure 6A illustrates the use of a screw driver through the interior of the needle. Figure 6B illustrates the top surface of the screw head (here shaped like an inverted pyramid) with an inlet for the screw driver. [Figure 5] 10 illustrates the advancement of a screw into bone to secure the soft tissue to the bone. [Figure 6] 1 illustrates the screw advanced with the coil deployed and inverted, compressing the soft tissue against the bone. [Figure 7] 10 illustrates the screw advanced with the coil deployed and inverted, compressing the soft tissue against the bone and leaving a superficially depressed area. [Figure 8]Figures 8A and 8B illustrate alternative screw designs. Figure 8A illustrates a screw with a larger diameter collar relative to the screw hub and shaft and wound coils from a position starting below the collar. Figure 10B illustrates a screw with a core region in the shaft that is larger in diameter compared to the rest of the shaft and wound coils from a position below the screw head and above the wide core of the shaft. [Figure 9] 9A-9C illustrate the insertion of the alternative screw design of FIG. 8B. FIG. 9A illustrates advancing the screw into bone to secure the soft tissue to the bone. FIG. 9B illustrates the advanced screw with the coil deployed and everted, and the large screw shaft forming a trailing chamber in the bone. FIG. 9C illustrates the advanced screw with the coil deployed and everted, compressing the soft tissue against the bone, leaving a depressed area on the surface, and the tissue drawn into the bone defect created by the large screw. [Figure 10] 1 illustrates a headless screw design according to an embodiment of the present invention. [Figure 11] FIG. 11A illustrates an exemplary coil design according to an embodiment of the present invention having closed top and bottom ends. FIG. 11B illustrates an exemplary spring washer screw as contemplated herein. A three-view of the screw is shown in the left panel of FIG. 11B. The spring washer screw includes a symmetrical self-tapping feature. A close-up of the head of the screw illustrates the engagement of the spring washer with the screw. The spring washer screw embodiment also includes a chisel tip. [Figure 12] Illustrates decomposition treatment options for partial tendon tears. [Figure 13] Illustrated is an MRI image of the lower back showing a partial subsurface tear of the gluteus medius tendon (GMM) at the greater trochanter (GT). [Figure 14] Illustrated is an image of the hip abductor anatomy illustrating a gluteus medius split injury. [Figure 15] 1 illustrates a diagram of an exemplary percutaneous fastener placement at a lesion site between tendon and bone. [Figure 16] 1 illustrates an image of an exemplary coil loaded onto a screw. [Figure 17] 1A-1C illustrate exemplary force profile diagrams of a standard suture anchor (left) and a tendon fastener, in accordance with embodiments of the present invention. [Figure 18] 1 illustrates an exemplary fastener prototype placed in a synthetic model, according to an embodiment of the present invention. [Figure 19] 19A and 19B illustrate MRI images of a partial gluteus medius tear on a cadaver. Figure 19A illustrates the partial tear highlighted by an arrow. Figure 19B illustrates a fastener according to the present invention in a partial tear on a cadaver. DETAILED DESCRIPTION OF THE INVENTION

[0025] Detailed Description of the Drawings Soft tissue injuries can be particularly debilitating for both young and old alike. Male and female athletes commonly face weakened adductor muscles and abdominal tears, where tendons or muscles become separated from bone. To repair these injuries, unproven platelet-rich plasma is utilized. Other options include open surgery, which has long recovery times.

[0026] For elderly patients (e.g., age 65 and older), age-related injuries include the risk of hip fractures associated with gluteal tendon tears. These common injuries result in weakness of the gluteal muscles, leading to pelvic sagging, tilt, and a gluteus medius paretic gait. Ultimately, these weaknesses lead to debilitation and an increased risk of falls. Hip fractures occur in approximately 250,000 people annually in the United States, posing a significant risk of disability and death.

[0027] Available surgical procedures are inadequate due to long recovery times and increased risk of secondary infection or other disease progression for certain patients. Therefore, new approaches are needed to repair soft tissue that has become detached from bone. Embodiments herein describe anchor systems including screws and coils suitable for engaging soft tissue and bone.

[0028] 1 illustrates soft tissue 3, typically muscle or tendon, detached from bone 2. The detached space 4 is the injury that will be repaired by the surgical tools described herein. In a healthy scenario, the soft tissue 3 is attached to the bone 2. The presence of the detached space 4 is an injury, where the soft tissue 3 is separated from the bone 2.

[0029] 1 further illustrates the needle entering the tissue space. The needle 1 is inserted into the tissue surrounding the injury under normal insertion protocols. This can be completed manually or with imaging guidance by other means known to those skilled in the art. An opening 5 in the needle is defined to allow for deployment of a tool for insertion of a device screw, as illustrated in further figures.

[0030] 2 illustrates further advancement of needle 1 into soft tissue 3, with the tip of needle 1 inserted into soft tissue 3. For deployment, the needle may also be adjacent to the soft tissue, allowing the tip of the screw or coil to penetrate the soft tissue first, allowing deployment of the anchor as described herein.

[0031] 3A, 3B, and 3C illustrate orthopedic anchors used to attach soft tissue 3 to bone 2 of FIGS. 1 and 2, with FIG. 3A illustrating a screw 6 with a coil 10 wound therearound. While a screw 6 is the fastener most likely to be utilized in surgery (e.g., given its holding power and ease of driving and removal), embodiments of the present invention may be applied to other fasteners, such as nails, pins, rivets, bolts, etc.

[0032] The orthopedic anchor 6 includes a head 7 and a shaft 8 having threads 9. The bottom surface of the head 7 engages a coil 10 having a tapered end 11 and a flared end 12. The coil 12 is wrapped around the shaft 8, with the tapered end positioned at the bottom surface of the head 7 and the flared end positioned at the distal end of the screw 6. In certain embodiments, the screw 6 may include a self-tapping region 13. In some embodiments, the screw is a self-drilling screw. That is, in some embodiments, a self-drilling screw does not require a pilot hole to be pre-drilled. FIG. 3B illustrates the top surface of the anchor of FIG. 3A, looking down from the top surface. From this view, the coil 10 can appear as tightly packed concentric circles. FIG. 3C illustrates the anchor of FIGS. 3A and 3B with the coil 10 inverted (as may occur after being driven through soft tissue 3 and into bone 2). In this configuration, the tapered end 11 of the coil 10 engages the upper portion of the screw 6 and directly contacts the screw head 7 illustrated in FIG. 3A.

[0033] The screws herein may have a variety of dimensions that can be selected to achieve desired biomechanical performance. For example, the screws may have lengths of about 5 mm to about 15 mm, about 8 mm to about 12 mm, about 10 mm, etc.

[0034] The coil 10 and / or screw 6 may be fabricated from a bioabsorbable material, such that the respective components can be absorbed into the body after a predetermined amount of time. However, it may be preferable to fabricate the respective components from a non-bioabsorbable but simply biocompatible material for permanent positioning within the body. Alternatively, it may be desirable for certain components to be bioabsorbable and others nonabsorbable; for example, the coil may be bioabsorbable while the screw is nonabsorbable. Any combination of absorbable or nonabsorbable components may be used as desired.

[0035] The surgical screw 6 preferably has properties that allow it to penetrate bone and secure itself within the bone tissue. Therefore, the screw 6 is preferably rigid to allow such penetration. If the screw is to be retained within the body, the screw is preferably made of poly(ether ether ketone) or another polymer, stainless steel (316L) or titanium, or another metal or alloy with similar bending strength, pull-out strength, and rigidity. Exemplary magnesium-based alloys include Mg—Ca—Sr, Mg—Zn, Mg-6Nz, Mg—Zn—Ca, MGYREZr, etc. Iron-based alloys include Fe—Mn, etc.

[0036] In certain embodiments, the screw itself is bioabsorbable, thus degrading in the body and being replaced by tissue ingrowth. However, to ensure that the mechanical properties of the screw are maintained long enough to allow for healing of the injury, the mechanical properties may be maintained for at least three months, preferably at least six months, before degradation begins. Ultimately, complete degradation of the FDA-approved biomaterial and replacement by tissue ingrowth of the material is desired. Suitable materials include, but are not limited to, certain polymers such as PLLA, PLDLA (e.g., 70:30, 80:20 L / L), PLGA (e.g., 50:50 L / L), PLLA-PLGA block copolymers, poly(paradioxanone) (PPD), and poly(propylene fumarate) (PPF).

[0037] In certain embodiments, the screw may be manufactured from a composite material with a coating polymer or metal bulk material or a ceramic-reinforced polymer matrix. In certain cases, the coating / filler material may include CaP, tricalcium phosphate, hydroxyapatite (HA), and similar materials known for their biocompatibility and use in the human body.

[0038] The coil material may also have independent properties that assist in allowing the coil to effectively grip the soft tissue and affix it to adjacent bone tissue. In particular, the coil may have shape memory that limits its overall deformation upon deployment. This ensures that the coil is not simply deformed, but instead maintains sufficient stiffness and shape to grip into the soft tissue to allow contact between the tissue and bone for reattachment of the soft tissue.

[0039] The coil material may be made of a variety of polymers or metals, allowing for both permanent and bioabsorbable production. The material preferably has physical properties similar to those of nitinol or platinum in bending strength, pull-out strength, and stiffness.

[0040] If the coil is bioabsorbable, like the screws described above, the material can maintain its mechanical properties for at least three months, and preferably at least six months, allowing for healing of the injury before degradation sets in. However, the material can completely degrade and be replaced by tissue ingrowth over time.

[0041] Suitable materials may include PLLA, PVA, PEG, PLA, poly(caprolactone) (PCL, ε-PCL), PLLA-PLGA, PEG-PCL, chitosan (e.g., dinipin crosslinked), or other materials with similar biocompatibility and bioabsorbability profiles. If the material is to be retained, metal alloys (e.g., spring steel), composite materials, and combinations thereof, including the same materials as the screws (discussed above), are suitable.

[0042] 3A and 3B positioned inside a needle 1 that engages a tool 14 to turn the screw 6. The screw 6 remains partially within the needle opening 5, with only a portion of the coil 10 and shaft 8 protruding from the opening 5. The flared end 12 of the coil is forced into the soft tissue 3, and FIG. 4B illustrates the top surface of the screw head 7, including an inlet means 15 for turning the screw 6. While a pyramidal shaped inlet is shown, certain embodiments may include alternative shapes, such as, for example, a hexagonal shape. Other suitable drives include slot, cross, cruciform, Phillips, Frearson, French recess, JIS B 1012, Mortorq, Pozidriv PV, Supadriv PZ, Torq-set, Phillips / slotted, external polygon, square, pentagon, hexagon, 12-point, internal polygon, triangular, Robertson, hexagon (Allen), double square, triple square, 12-spline flange, double hexagon, Torx, Torx Plus, Polydrive, 3-point, triple point, triple groove, triple wing, Bristol, Quadrex, Pentalobe, spanner (pig nose), and the like.

[0043] The screw 6 can have a variety of head shapes, including pan, button, dome, round, mushroom, truss, countersunk, flat, oval, ride, bugle, cheese, fillister, or flange. In some embodiments, the head includes a flange that is substantially perpendicular to the shaft of the screw 6.

[0044] In some embodiments, the head diameter of the screw 6 is sized to hold the coil 10, which can be wound around the shaft of the screw 6. To facilitate reversal of the coil 10 during driving, the head diameter may be relatively small relative to the major diameter of the thread. For example, the screw head may have a diameter that is 110% to 100%, 100% to 90%, etc., of the major diameter of the thread. The screw diameter (e.g., thread, shaft, and / or head) can include about 1 mm to about 1.5 mm, about 1.5 mm to about 2 mm, about 2 mm to about 2.5 mm, about 2.5 mm to about 3 mm, about 3 mm to about 3.5 mm, about 3.5 mm to about 4 mm, about 4 mm to about 4.5 mm, about 4.5 mm to about 5 mm, about 5 mm to about 5.5 mm, about 5.5 mm to about 6 mm, about 6 mm to about 6.5 mm, about 6.5 mm to about 7 mm, about 7 mm to about 7.5 mm, about 7.5 mm to about 8 mm, about 8 mm to about 8.5 mm, about 8.5 mm to about 9 mm, about 9 mm to about 9.5 mm, about 9.5 mm to about 10 mm, and any and all increments therebetween.

[0045] In some embodiments, the screw 6 is a headless screw, in which case the coil 10 can engage the screw 6 and rotate in a driving direction. The coil 10 can have a pitch opposite to the thread of the screw, so that the distal end of the coil rotates on the surface of the soft tissue 3 but does not penetrate the soft tissue 3. Pierced10 illustrates a headless screw 1006 including an annular recess 1035 adapted and configured to receive a coil 1010. The screw 1006 can optionally rotate within the coil 1010. The coil can be between about 0.05 mm and about 0.1 mm, about 0.1 mm and about 0.15 mm, about 0.15 mm and about 0.2 mm, about 0.2 mm and about 0.25 mm, about 0.25 mm and about 0.3 mm, about 0.3 mm and about 0.35 mm, about 0.35 mm and about 0.4 mm, about 0.4 mm and about 0.45 mm, about 0.45 mm and about 0.5 mm, about 0.5 mm and about 0.55 mm, about 0.5 mm and about 0.65 mm, about 0.65 mm and about 0.75 mm, about 0.75 mm and about 0.85 mm, about 0.85 mm and about 0.95 mm, about 0.9 ... Wire thicknesses may include from 0.55 mm to about 0.6 mm, from about 0.6 mm to about 0.65 mm, from about 0.65 mm to about 0.7 mm, from about 0.7 mm to about 0.75 mm, from about 0.75 mm to about 0.8 mm, from about 0.8 mm to about 0.85 mm, from about 0.85 mm to about 0.9 mm, from about 0.9 mm to about 0.95 mm, from about 0.95 mm to about 1 mm, and any and all increments therebetween. On another scale, in some embodiments, the wire has a gauge number ranging from about 18 g to about 20 g, about 20 g to about 22 g, about 22 g to about 24 g, about 24 g to about 26 g, about 26 g to about 28 g, about 28 g to about 30 g, about 30 g to about 32 g, about 32 g to about 34 g, about 34 g to about 36 g, about 36 g to about 28 g, about 28 g to about 29 g, about 29 g to about 30 g, about 30 g to about 31 g, about 31 g to about 32 g, about 32 g to about 34 g, about 34 g to about 36 g, about 36 g to about 38 g, about 38 g to about 40 g, about 40 g to about 42 g, and any and all increments therebetween.

[0046] 5 illustrates anchor insertion. As the screw 6 is rotated by the tool 14, the screw shaft 8 traverses the soft tissue 3 and enters the bone 4, and the flared end 12 of the coil 10 presses into the soft tissue 3. This is visualized by the coil 10 having fewer windings tightly wound around the shaft 8, with the outer windings extending widely into or over the soft tissue. The anchor, including the screw and coil, can have an outer diameter such that when the coil is wound around the screw, the anchor is sized to fit within, for example, a 10 g delivery cannula. In some embodiments, the anchor is sized to fit within an 8g cannula, as well as 8g to 10g cannulas, 10g to 12g cannulas, 12g to 14g cannulas, 14g to 16g cannulas, 16g to 18g cannulas, 18g to 20g cannulas, 20g to 22g cannulas, 22g to 24g cannulas, and any and all increments therebetween. Inserting the coil into the needle allows the coil to deform inwardly and longitudinally before radially expanding so that its end emerges from the distal end of the needle.

[0047] The coil may have a shape memory that returns it to its previously formed shape after emerging from the distal end of the needle. For example, the coil may have a resting length and diameter. For example, the coil may have a length of about 5 mm to about 15 mm, about 8 mm to about 12 mm, about 10 mm, etc. In some embodiments, the coil may have a length that is shorter than the screw (e.g., terminating proximal to the distal end of the screw when engaged with the screw).

[0048] The coil diameter (e.g., outer diameter and proximal or distal end) can be about 1 mm to about 1.5 mm, about 1.5 mm to about 2 mm, about 2 mm to about 2.5 mm, about 2.5 mm to about 3 mm, about 3 mm to about 3.5 mm, about 3.5 mm to about 4 mm, about 4 mm to about 4.5 mm, about 4.5 mm to about 5 mm, about 5 mm to about 5.5 mm, about 5.5 mm to about 6 mm, about 6 mm to about 6.5 mm, about 6.5 mm to about 7 mm, about 7 mm to about 7.5 mm, about 7.5 mm to about 8 mm, about 8 mm to about 8.5 mm, about 8.5 mm to about 9 mm, about 9 mm to about 9.5 mm, about 9.5 mm to about 10 mm, and any and all increments therebetween. In some embodiments, the outer diameter of the distal end of the coil is 2.5 mm, which can fit into a 10G or 11G needle without deformation.

[0049] By turning the screw 6 using the tool 14, the threads 9 of the screw shaft engage the bone 2, and simultaneously, pressure is applied from the bottom of the screw head 7 to the tapered end 11 of the coil 10, thereby compressing the coil 10 during advancement of the screw 6 into the bone 2. As the screw 30 advances into the bone 2, the separated space 4 of Figures 1, 2 and 4A is eliminated. Comparing Figures 4A and 5 shows that the separated space 4 is eliminated.

[0050] FIG. 6 illustrates further insertion of the anchor. As the screw 6 is advanced further into the bone 2 by the tool 14, the flared end 12 of the coil 10 maintains its position outside the outer surface 15 of the soft tissue 3. Meanwhile, the tapered end 11 of the coil 10 maintains its position under the screw head, causing the coil 10 to invert as shown in FIG. 3C. The soft tissue 3 is further pressed against the bone 2, creating a recessed area 16 surrounding the coil 10. This allows the soft tissue 3 to heal and reattach to the bone 2 surface. It may be advantageous to add a compound or therapeutic agent to the surgical site to enhance the healing process. Additionally, it may be advantageous to coat various components, the coil, and / or the screw or washer, with a therapeutic agent to enhance the healing process.

[0051] FIG. 7 illustrates the deployed anchor.

[0052] The screw shaft 8 is fully embedded in the bone 2. The coil 10 maintains an inverted orientation as the tapered end 11 is held under the screw head 7 while the flared end 12 remains outside the surface 15 of the soft tissue 3. An area of ​​recess 16 serves as an insertion site and is formed into the shape of a funnel by fastening the screw head 7 against the soft tissue 3 and pressing the soft tissue 3 against the bone 2. Contact between the two tissues allows the healing process to occur, where the soft tissue 3 typically attaches to the bone 2.

[0053] Figures 8A and 8B illustrate further embodiments of an orthopedic anchor. Figure 8A illustrates a screw 17, like Figure 3A, including a head 18 with an inlet 19, a shaft 20 with threads 21, and a coil 22. However, this embodiment includes a collar 23 with a larger cross-sectional area than the shaft 20 and head 18. The collar 23 includes threads 24 oriented in the same direction as the threads 21 on the shaft 20. Figure 8B illustrates a screw 25, like Figure 3A, including an inlet 27, a shaft 28 with threads 29, and a head 26 with a coil 30. However, in this embodiment, the shaft 28 includes a section with a larger cross-sectional area 31 than the remainder of the shaft 28 and the head 26, such that the shaft tapers in both directions from this section 31 toward the head 26 and the screw tip 32, forming a candle shape for the shaft 28. The coil 30 is positioned between the screw head 26 and the section with the larger cross-sectional area 31.

[0054] 9A, 9B, and 9C illustrate the deployment of the anchor with screw 25 shown in FIG. 8B. FIG. 9A illustrates the insertion of the anchor with screw 25 into soft tissue 3 and bone 2 using the needle 1 and tool 14 shown in FIG. 5 for an anchor with screw 6, and FIG. 9B illustrates the further insertion of the anchor with screw 25 into soft tissue 3 and bone 2 using the needle 1 and tool 14 shown in FIG. 6 for an anchor with screw 6. As the screw 25 advances further into bone 2, a region of bone clearance 33 is formed in bone 2 as a result of the wider region 31 of the screw shaft 28. FIG. 9C illustrates the deployed anchor with screw 25 shown for the anchor in FIG. 7. However, in this case, a portion of the soft tissue 34 surrounding the coil 30 is drawn into the region of clearance 33, allowing the soft tissue 3 to heal and reattach to the bone 2 surface. It may be advantageous to add certain compounds or therapeutic agents to the surgical site to enhance the healing process. Additionally, it may be advantageous to coat various components, coils, and / or screws or washers with certain therapeutic agents to enhance the healing process.

[0055] Specific bone or vascular stimulators can be utilized to stimulate healing at the surgical site, and indeed these may be coated onto the screws and / or coils, or a combination thereof, or injected into the surgical area, or applied to the surgical area through a needle during the surgical procedure.

[0056] A further embodiment describes the use of a dual function anchor system to drive soft tissue having an embedded coil into contact with bone by engaging dislocated soft tissue, engaging the soft tissue with the coil, and driving a screw into the bone. The dual function anchor system includes a surgical screw having a threaded shaft and a coil; the coil is wound around the screw shaft; the coil has a coil end defined to engage a bottom surface of the screw head; and engages the shaft end and coil into the soft tissue.

[0057] 11A illustrates an additional embodiment of a coil having one end that engages the threads of an anchoring system and the other end having a closed configuration. A "closed" configuration includes, but is not limited to, coils in which the ends of the coil are adjacent helical curves. Directly below, distal side The coil may include a configuration in which the coil aligns with the surface of the adjacent helical curve, with the end contacting the adjacent helical curve with or without fastening. In some embodiments, the end of the coil has a tapered edge such that when the end contacts the adjacent helical curve, the end is flush with the surface of the adjacent helical curve. When the anchor is advanced, the closed end of the coil does not engage soft tissue, while the screw engages bone. In some embodiments, the coil according to this embodiment acts as a spring washer that compresses as the screw is driven into bone.

[0058] In certain preferred embodiments and methods of treatment, it may be desirable to drive a dual-function anchor system including a screw and a coil into the patient's tissue, and the apertures in the dual-function anchor system may further be utilized to inject certain bone or vascular healing compositions into the surgical site either before or after engaging the tissue.

[0059] Thus, the treatment method may include the method described above, further comprising the step of injecting a therapeutic agent, such as a bone or vascular healing composition, into the wound site. The additional therapeutic agent may include an antibiotic. In certain embodiments, the coil or screw may be coated with a therapeutic agent, including a bone or vascular healing composition or an antibiotic. Those skilled in the art will recognize these compounds and their appropriate dosages for administration. For example, a non-limiting list of antibiotics may include clindamycin, trimethoprim / sulfamethoxazole, doxycycline, vancomycin, linezolid, daptomycin, metronidazole, or a combination thereof. [Example]

[0060] Example 1 Musculoskeletal (MSK) injuries affect 20% of the general population and up to 55% of those over 60 years of age. Partial tendon tears are a very common type of musculoskeletal injury, affecting over 31 million people annually in the United States, although countless cases remain unreported. When the attachment to bone is damaged, a lesion forms, causing pain and significant loss of strength. Because surgery is only indicated for tears greater than half-thickness, the severity of the tear determines the recommended treatment. This leaves nearly 90% of the large general patient population presenting with tendon tears underserved by the current paradigm, as conservative treatment is strongly preferred over surgical intervention. This is illustrated in the breakdown of treatment approaches shown (Figure 12), with corresponding options for each approach also illustrated. Under conservative management, none of the existing treatments, including injectable bioactive agents, have been proven to restore full function faster than the natural healing process. Surgical intervention typically results in better outcomes but is costly, time-consuming, and carries a higher risk of complications. Physicians are reluctant to operate on partial tears, especially when treating elderly patients. This represents a significant gap in the current paradigm: there are no intermediate procedures that offer the benefits of surgery using a minimally invasive approach.

[0061] The importance of this unmet need is illustrated by the prevalence of partial tendon tears around the body. This is estimated at approximately 31 million cases in the United States, with a usable market including partial tears with clean margins and no tendon retraction or comminuted tearing. This represents approximately 3 million cases involving the rotator cuff, gluteus medius, hip adductor muscles, epicondyles, and patella. These are candidates for new modes of minimally invasive repair. For example, orthopedic surgeons have recently shown interest in repairing the gluteus medius tendon, thereby reducing gait deficits. Gait disorders associated with gluteus medius tendon tears and muscle atrophy have been identified as a significant cause of falls in elderly patients. However, elderly patients are often poor surgical candidates due to comorbidities (i.e., cardiac, pulmonary, or renal disease) that make general anesthesia risky in this population and leave the majority of cases untreated. In a study of 185 randomly selected MRI examinations of the pelvis divided into 10-year age groups, partial tears of the gluteus medius tendon were observed in 31.8% of the 50-59 age group, 46.3% of the 60-69 age group, and 61.7% of patients aged 70 years or older. An inexpensive, readily available non-surgical method for gluteus tendon repair could significantly impact the quality of life of elderly patients and reduce the risk of falls and related injuries.

[0062] Tendon reattachment This paper presents a solution that allows percutaneous reattachment of a partially torn gluteus medius tendon insertion to the greater trochanter without a surgical procedure requiring general anesthesia. This technique involves placing an implant at the tendon insertion site (footprint) through a partial tear. The implant consists of two functional parts: a self-drilling screw and a tissue capture coil. The coil is securely attached to the neck of the screw adjacent to the hub. The coil winding is cone-shaped with an increasing circumference along its path. The screw and coil construct fits into a 10-gauge delivery cannula. Partial-thickness tendon tears are identified by imaging with either MRI (Figure 13) or ultrasound. Patient selection tests, including steroid injection into the bursa adjacent to the tendon, can be performed; if pain temporarily improves, tendon repair is more likely to reduce the patient's symptoms. One key feature that makes partial-thickness tears suitable is that the tendon remains in its normal position along the footprint of its origin on the iliac crest of the femur at the greater trochanter (Figure 14). An initial study using de-identified patient data found that 100% of tears were clearly defined at initial presentation with hip pain (i.e., not comminuted), and all subsequently progressed to full-thickness tears due to muscle atrophy within 2-4 years. Massive tissue loss and impaired healing due to atrophy inhibit both mechanical fixation and biological repair. The reinforcement technique of the present invention for partially torn tendons may limit full-thickness tear progression and muscle atrophy in patients who are painful and lack atrophy early in the disease course, making them potential treatment candidates.

[0063] Using ultrasound guidance, a common interventional radiology tool that allows real-time visualization of implant placement, the laceration is identified, the needle path is planned, and the skin is marked. The insertion tool is envisioned, with the implant-loaded delivery cannula positioned at the laceration site (Figure 15). The system is passed percutaneously to the bone target using an integrated stylet applicator compatible with the screw hub. The outer needle sheath is retracted to expose the device for implantation. The core is then advanced and rotated clockwise, driving the anchor into the bone. Multiple implants can be placed to add reinforcement to the insertion site. The implant is rotated clockwise and advanced into the bone. As the screw enters the bone, the coil captures the overlying tendon and pulls it along the screw, against and into the bone. The coil acts as an expandable washer, like a funnel that holds the tendon surface.

[0064] Adhesion Technology The fastener of the present invention is based on establishing the ability to effectively tack partial-thickness tears, particularly painful partial-thickness tears that are not yet surgical candidates but do not respond to conservative management techniques. While such repairs are not as strong as standard suture anchors, they are likely superior to existing needle-based procedures for partial-thickness tears. Because the proposed technique achieves functional repair, it falls within the realm of surgery for reimbursement purposes, but can be performed in a physician's office or imaging suite. By utilizing the internal space of a percutaneous needle to house a device that can mechanically achieve tissue fixation, our concept represents an innovative approach for the treatment of painful partial-thickness tendon tears. The tendon fastener implant design of the present invention includes a standard clockwise-threaded bone screw with an attached conical compression spring, as depicted (Figure 16).

[0065] This changes the force profile of the fixation compared to a conventional suture anchor, which is diagrammed (Figure 17). Suture anchors act to pin the tendon to the bone, with a concentration of force (arrows) along a single plane of the suture. There is also a single contact point, the suture junction and the anchor eyelet. These combined create a weakening of the implant, which is exacerbated by techniques that introduce knots along the suture. Conversely, the fastener of the present invention, as a result of its multiple contact points within the tendon tissue, enjoys a distribution of force (arrows) along a wider area, with no eyelet to act as a failure point. By also drawing the tendon into the bone, the fastener of the present invention provides increased fixation strength and failure resistance.

[0066] Results and Conclusions In benchtop testing using a synthetic bone and tendon tissue model, it was observed that upon anchor insertion, the coil inverted slightly over the screw head, creating a funnel-and-swirl effect (Figure 18). Data was collected using human cadaver hips. Each gluteus medius tendon was examined. One had a clean, partial tear, clearly visible on MRI image capture (Figure 19A), and was selected for use as a model case. A labeled wooden skewer was placed on the greater trochanter specimen to localize the insertion. A repeat MRI indicated which skewer best localized the gluteus medius insertion site. The surface was marked with a permanent marker, and a cutdown was made along the skewer. The tensor fasciae latae muscle was incised at the iliac crest. Vertical incisions were made laterally to expose the greater trochanter and gluteus medius insertions. The target site was then implanted with an exemplary percutaneous fastener of the present invention using a retractor and hex driver. The fixation was demonstrated on MRI (Figure 19B), with the tendon funneling into the bone insertion site at the greater trochanter. Two other cadavers were partially torn and used in comparative testing with the self-drilling device described herein and the Arthrex pre-drilled suture anchor. Pull-out failure was typically measured in the same direction as the force exerted on the hip using a tension meter. Failure tests were performed on the specimens by tensioning the repair construct along its longitudinal axis. A tension meter (maximum 200 N, 0.01 N scale) was affixed to the platform, which set the measured peak force. A metal wire was sewn into the muscle above the tendon insertion of the specimen and connected to the tension meter via a hook. Increasing manual tension was applied parallel to the tendon orientation until failure. The peak value at the point of failure was captured and compared across the cadaveric specimens. The fastener of the present invention exhibited a failure strength measured at 155.0 N, 92.5% of which was achieved with the suture anchor measured at 167.6 N. This demonstrates that tendon fixation can be successfully achieved using the fastener of the present invention.

[0067] equivalent While preferred embodiments of the present invention have been described using specific terminology, it is to be understood that such description is for purposes of example only and that changes and modifications can be made without departing from the spirit or scope of the following claims.

[0068] Incorporation by Reference The entire contents of all patents, published patent applications, and other references cited herein are expressly incorporated herein by reference in their entirety.

Claims

1. 1. A surgical anchor comprising a screw and a coil, The coil is a first end of the coil that is tapered and has a ring circumference that is smaller than a ring circumference of the screw head and is engaged with a bottom of the screw head; a second end of the coil that is flared and has a ring circumference greater than the ring circumference of the first end of the coil and is positioned along a threaded shaft; a conical shape wound around the screw shaft; 10. The surgical anchor according to claim 9, further comprising:

2. The surgical anchor of claim 1 , wherein the coil does not penetrate soft tissue.

3. A surgical anchor as described in claim 2, wherein the second end of the coil has a closed configuration aligned distally directly below the adjacent spiral curve so that the second end of the coil contacts the adjacent spiral curve.

4. The surgical anchor of claim 1 , wherein the coil has an opposite pitch to the threads of the screw.

5. The surgical anchor of claim 1 , wherein the screw rotates within the coil.

6. The surgical anchor of claim 1 , wherein a distal end of the coil is coplanar with an adjacent helical curve of the coil.

7. A surgical anchor comprising a screw and a coil, the screw is a headless screw comprising a distal thread, a reamer proximal to the distal thread, an annular recess proximal to the reamer, and a proximal end, the outer diameter of the proximal end being equal to or less than the outer diameter of the reamer; The coil is a first end of the coil that is tapered and has a ring circumference that is smaller than a ring circumference of the proximal end of the grub screw and is engaged with the annular recess of the grub screw; a second end of the coil that is flared and has a ring circumference greater than the ring circumference of the first end of the coil and is positioned along a threaded shaft; a conical shape wound around the screw shaft; 10. The surgical anchor according to claim 9, further comprising:

8. a needle having an opening of sufficient diameter to receive a surgical anchor having a screw and a coil; a stylet tool that is insertable into the opening for inserting the anchor and that can engage with and turn the screw; 1. A surgical system comprising: the screw having a threaded shaft and a head, the head having a bottom surface, and the coil comprising: a conical shape wound around the screw shaft with a first end of the coil tapered and having a ring circumference smaller than the ring circumference of the screw head and engaged with the bottom of the screw head, and a second end of the coil flared and having a ring circumference larger than the ring circumference of the first end of the coil and positioned along the screw shaft; The surgical system comprising:

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