Bifunctional anchor system

Abstract

A surgical anchor includes a screw and a coil; the coil has a conical shape, wrapped around a screw shaft, wherein a first end of the coil is tapered and has a ring circumference that is smaller than a ring circumference of a head of the screw, and is joined to a bottom of the screw head, and a second end of the coil is flared with a larger ring circumference and is positioned along the screw shaft.

Description

[0001] Related Applications Cross Reference To

[0002] 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

[0003] Movement of the human body requires complex communication between structural components, i.e., muscles, tendons, bones, and vasculature, and electrical impulses that control the muscles to produce movement. Over time, physical aging can occur, i.e., wear and tear and damage to muscles, tendons, and bones. Relatively common injuries involve the complete or partial separation of a human bone from the ligaments, tendons, or other soft tissue associated therewith. Complete or partial separation of ligaments, tendons, and other soft tissue is relatively common among athletes and is typically caused by the application of excessive stress to such tissue. Of course, separation or detachment of soft tissue from a human bone can also occur as a result of an accident, such as a fall, during work-related activities, during physical activity, or overexertion in several different situations involving human activity.

[0004] In many cases, injuries that are partially detached do not heal naturally despite treatment with methods using conservative management techniques and procedures, resulting in chronic pain and / or persistent discomfort for the patient. Such injuries are often repaired with open surgery, otherwise it is difficult to properly secure the tissue and ensure recovery. Thus, many surgical procedures have been designed for reattaching such detached or separated tissue. In addition, surgical techniques have advanced such that severely damaged ligaments and / or tendons can now be replaced through surgery.

[0005] One such technique involves the use of “traditional” attachment devices, such as metal sutures, button sutures, and cancellous bone screws, to reattach detached or separated tissue. These “traditional” devices have also been used for attachment of ligaments or tendons harvested from other parts of the human body and for replacement or repair of severely damaged tissue. However, it should be appreciated that “traditional” repair methods are not uniformly successful. For example, when extreme tensile loads are applied to rigid attachments of ligaments and tendons using “traditional” attachment devices, such as sutures, screws, and suture, the rigid attachments cannot be maintained.

[0006] In view of the risks of comorbidities and infections and the possibility of failure of “traditional” devices, there is great interest and public health benefit in developing new devices that enable functional reattachment of soft tissue to bone using minimally invasive methods after conservative management principles. To optimally heal such injuries in a minimally invasive manner, a specialized system comprising components for use in vivo and ex vivo is needed. Biocompatibility and mechanical performance are key aspects of implantable components in such systems, and given implantation sites have different considerations related to both biocompatibility and mechanical performance.

[0007] For anchoring in bone tissue, a rigid high strength material is required to effectively position the device into the bone tissue. This includes generating sufficient torque to penetrate the bone tissue and having sufficient strength to establish and maintain fixation over the required time period, in this case at least 6 months. For fixation in soft tissue, a ductile material is required to effectively position the device into the soft tissue for guidance into the bone anchor. This includes temporary deformation under forces associated with positioning while maintaining appropriate strength. The ability to achieve these functions is determined by the composition of the assembly. Parameters such as modulus of elasticity, tensile strength, shear strength, flexural strength, etc. will influence the selection of appropriate materials for the respective assembly. SUMMARY

[0008] In certain aspects, the present invention provides a surgical anchor comprising a screw and a coil; the coil having a conical shape wrapped around a screw shaft, wherein a first end of the coil is tapered and has a ring circumference that is smaller than a ring circumference of a head of the screw and is joined to a bottom of the head of the screw, and a second end of the coil is flared with a larger ring circumference and is positioned along the screw shaft.

[0009] In certain aspects, the present invention provides a surgical system comprising a needle comprising an aperture of sufficient diameter for receiving a surgical anchor comprising a screw and a coil; a probe tool insertable into the aperture for inserting the anchor and capable of engaging and turning the screw; the screw comprising a shaft having threads and a head, the head having a bottom surface, and the coil having a conical shape wrapped around a screw shaft, wherein a first end of the coil is tapered and has a ring circumference that is smaller than a ring circumference of a head of the screw and is joined to a bottom of the head of the screw, and a second end of the coil is flared with a larger ring circumference and is positioned along the screw shaft.

[0010] In some embodiments, the screw or coil described herein comprises one or more materials selected from the group consisting of poly(L-lactic acid), poly(D-L-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 comprising Mg-Zn, Mg-6Zn, Mg-Zn-Ca, Mg-Ca-Sr, and MgYREZr, and iron-based alloys comprising Fe-Mn.

[0011] In some embodiments, the screw or coil described herein comprises a polymer and / or coating on a metal, wherein the polymer or coating comprises one or more materials according to claim 9.

[0012] In some embodiments, the screws or coils described herein include ceramic materials including calcium phosphate, tricalcium phosphate, and hydroxyapatite in a particulate reinforced polymer matrix, and coatings including ceramic materials including calcium phosphate, tricalcium phosphate, and hydroxyapatite.

[0013] In some embodiments, the screws described herein have shape memory properties. In some embodiments, the screws or coils described herein are non-absorbable.

[0014] In certain aspects, the present invention provides a method of repairing soft tissue when it has been detached from bone, comprising: inserting a surgical anchor into soft tissue that has been detached from bone, the system comprising an orifice for inserting a surgical anchor comprising a screw and a coil, and a probe tool insertable into the orifice for inserting the anchor and capable of engaging and turning the screw to cause it to enter the bone; the screw comprising a shaft having threads and a head, the head having a bottom surface, and a coil; the coil having a conical shape wrapped around the screw shaft, wherein a first end of the coil is tapered and has a ring circumference that is smaller than a ring circumference of the screw head and is engaged to the bottom of the screw head, and a second end of the coil is flared with a larger ring circumference and is positioned along the screw shaft.

[0015] In certain aspects, the present invention provides a surgical anchor comprising a screw and a coil, the screw comprising a head, a shaft having threads, and a collar having a cross-sectional area that is larger than the cross-sectional area of the shaft and the head. In some embodiments, the screw includes a collar having threads in the same direction as the threads of the screw shaft. In some embodiments, the anchor includes a coil having one or more selected from the group consisting of: a conical shape wrapped around the screw shaft, wherein a first end of the coil is tapered and has a ring circumference that is smaller than a ring circumference of the screw head and is engaged to the collar, and a second end of the coil is flared with a larger ring circumference and is positioned along the screw shaft; and a cylindrical shape wrapped around the screw shaft, wherein the first end of the coil is engaged to the collar, and the second end of the coil is positioned along the screw shaft.

[0016] In certain aspects, the present invention provides a method of repairing soft tissue when it has been detached from bone, comprising: inserting a surgical anchor into soft tissue that has been detached from bone, the system comprising an orifice for inserting a surgical anchor comprising a screw and a coil, and a probe tool insertable into the orifice for inserting the anchor and capable of engaging and turning the screw to cause it to enter the bone; the screw comprising a head, a shaft having threads, and a collar, the collar having a cross-sectional area that is larger than the cross-sectional area of the shaft and the 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 selected from: a conical shape wrapped around the screw shaft, wherein a first end of the coil tapers and has a ring circumference that is smaller than the ring circumference of the screw head, and is engaged to the collar, and a second end of the coil flares with a larger ring circumference and is positioned along the screw shaft; and, a cylindrical shape wrapped around the screw shaft, wherein the first end of the coil is engaged to the collar, and the second end of the coil is positioned along the screw shaft.

[0017] In certain aspects, the present invention provides a surgical anchor comprising a screw and a coil, the screw comprising a head and a shaft having threads, the head having a bottom surface, the shaft comprising a section having a larger cross-sectional area than the rest of the shaft, such that the shaft tapers from the section in both directions towards and away from the head.

[0018] In some embodiments, the anchor comprises a coil having one or more selected from:

[0019] a conical shape wrapped around the screw shaft, wherein a first end of the coil tapers and has a ring circumference that is smaller than the ring circumference of the screw head, and is engaged to the bottom surface of the screw head, and a second end of the coil flares with a larger ring circumference and is positioned along the screw shaft; and, a cylindrical shape wrapped around the screw shaft, wherein the first end of the coil is engaged to the bottom surface of the screw head, and the second end of the coil is positioned along the screw shaft.

[0020] In certain aspects, the present invention relates to a method of repairing soft tissue when it has been detached from bone, comprising: inserting a surgical anchor into soft tissue that has been detached from bone, the system comprising an aperture for inserting a surgical anchor comprising a screw and a loop, and a probe tool insertable into the aperture for inserting the anchor and capable of engaging and turning the screw to cause it to enter the bone; the screw comprising a head and a shaft having threads, the head having a bottom surface, the shaft comprising a section having a larger cross-sectional area than the rest of the shaft, such that the shaft tapers in both directions away from the section, wherein the loop is positioned between the screw head and the section having the larger cross-sectional area.

[0021] In some embodiments, the method comprises the loop having one or more of:

[0022] a conical shape wrapped around the screw shaft, wherein a first end of the loop tapers and has a ring circumference that is smaller than a ring circumference of the screw head, and is engaged to the collar, and a second end of the loop flares with a larger ring circumference and is positioned along the screw shaft; a cylindrical shape wrapped around the screw shaft, wherein the first end of the loop is engaged to the collar, and the second end of the loop is positioned along the screw shaft.

[0023] In certain aspects, the present invention relates to a use of a dual action surgical system for fixing soft tissue to bone, the surgical system comprising an applicator having a needle and an aperture for inserting a surgical anchor, the surgical anchor comprising a screw and a loop, the screw comprising a shaft having threads; the loop wrapped around the screw shaft comprises a loop end and a second loop end, the loop end defined as engaging at least one surface of the screw; engaging an end of the shaft and the second loop end to soft tissue.

[0024] In certain aspects, the present invention provides a surgical anchor having: a fastener; and an external reversible loop coupled to a proximal end of the fastener. In some embodiments, the fastener is a screw having: a distal thread; and a reamer proximate the distal thread, wherein the screw is a headless screw; and the screw includes an annular recess proximate the reamer, the recess adapted and configured to receive a portion of the external reversible loop. In some embodiments, the screw includes a head having an outer diameter equal to or smaller than an outer diameter of the reamer.

[0025] In certain aspects, the present invention provides a surgical anchor comprising: a screw comprising: a distal thread; and a proximal head; and a coil coupled to the screw proximate the distal thread; wherein: the screw can freely rotate within the coil in either rotational direction without driving the coil; or the coil expands distally in diameter.

[0026] In certain aspects, the present invention provides a method of repairing soft tissue upon disassociation of the soft tissue from bone, the method comprising: driving a surgical anchor as described herein through the soft tissue and into the bone until at least a portion of the coil abuts the soft tissue proximate the head of the screw. BRIEF DESCRIPTION OF DRAWINGS

[0027] Figure 1 Depiction of a needle inserted proximate soft tissue separated from bone.

[0028] Figure 2 Depiction of a needle inserted into soft tissue.

[0029] Figures 3A-3C Depiction of details of an embodiment of a screw with a wrapped conical coil. Figure 3B Depiction of a top view of a screw with a wrapped conical coil showing concentric rings. Figure 3C Depiction of a screw with a wrapped conical coil that is inverted.

[0030] Figure 4A And 4B Depiction of a screw in which a wrapped conical coil is deployed into soft tissue through a needle. Figure 4A Depiction of use of a screwdriver through a needle interior. Figure 4B Depiction of a top surface of a screw head that includes an entry for a screwdriver, here in the shape of an inverted cone.

[0031] Figure 5 Depiction of a screw being advanced into bone to secure soft tissue to bone.

[0032] Figure 6 Depiction of an advanced screw in which a coil is deployed and inverted and soft tissue is compressed to bone.

[0033] Figure 7 Depiction of an advanced screw in which a coil is deployed and inverted and soft tissue is compressed to bone, leaving a recessed area at the surface.

[0034] Figure 8A And 8B Depiction of an alternative screw design. Figure 8A Depiction of a screw with a collar having a larger diameter relative to the screw hub and shaft and a coil wrapped from a position below the collar. Figure 8BDepiction of a screw with a core region having a larger diameter in the shaft relative to the rest of the shaft and a coil wound from a location below the screw head and above the widened core of the shaft.

[0035] Figures 9A-9C Depiction of an alternative design screw insertion. Figure 8B Depiction of an alternative design screw insertion. Figure 9A Depiction of a screw being advanced into bone to secure soft tissue to bone; Figure 9B Depiction of an advanced screw with the coil deployed and inverted and the large screw shaft creating a trailing chamber in the bone. Figure 9C Depiction of an advanced screw with the coil deployed and inverted and soft tissue compressed to the bone leaving a concave area at the surface and the tissue pulled into the bone defect created by the large screw.

[0036] Figure 10 Depiction of a headless screw design according to embodiments of the invention.

[0037] Figure 11A Depiction of an exemplary coil design according to embodiments of the invention with a closed top end and a bottom end. Figure 11B Depiction of an exemplary spring washer screw as contemplated herein. Figure 11B Depiction of a three view of a screw in the left image. The spring washer screw contains symmetrical self-tapping features. An enlarged view of the head of the screw depicts the spring washer engagement with the screw. Embodiments of the spring washer screw also contain a chisel tip.

[0038] Figure 12 Depiction of a diagram showing a partial tendon tear with a split treatment option.

[0039] Figure 13 Depiction of an MRI image of a hip showing a partial sub-surface tear of the gluteus medius tendon (GMM) at the greater trochanter (GT).

[0040] Figure 14 Depiction of an image of the hip abductor anatomy showing a partial tear of the gluteus medius.

[0041] Figure 15 Depiction of a diagram showing an exemplary percutaneous fastener placed at the site of a lesion between the tendon and the bone.

[0042] Figure 16 Depiction of an image of an exemplary coil loaded onto a screw.

[0043] Figure 17 Depiction of an exemplary force distribution diagram for a standard suture anchor (left) and a tendon fastener according to embodiments of the invention.

[0044] Figure 18 Depiction of an exemplary fastener prototype according to embodiments of the invention placed in a synthetic model.

[0045] Figure 19A and 19B MRI image depicting partial gluteus medius tear on cadaver. Figure 19A Depicting partial tear highlighted by arrows. Figure 19B Depicting fastener according to the invention in partial tear in cadaver. DETAILED DESCRIPTION

[0046] Soft tissue injuries can particularly debilitate both young and old people. Male and female athletes often face debilitating abductor and abdominal tears, where the tendon or muscle is detached from the bone. To repair these injuries, platelet-rich plasma has been used, but results have not been proven. Other options include open surgery, but these face long recovery times.

[0047] For older patients (e.g., patients over 65 years old), age-related injuries include the risk of hip fractures associated with gluteal tendon tears. These common injuries result in weak gluteal muscles and cause the pelvis to sag, tilt, and result in a Trendelenburg gait. Ultimately, these weaknesses result in debilitation and increase the risk of falling. In the United States, hip fractures occur nearly 250,000 times per year and result in significant disability and risk of death.

[0048] Available surgeries are inadequate because they have large recovery times and, for some patients, increase the risk of secondary infection or other disease progression. Therefore, new strategies are needed to repair soft tissue detached from bone. In this document, embodiments describe an anchor system including a screw and a loop suitable for joining soft tissue and bone.

[0049] Figure 1 Depicting soft tissue 3, which is typically a muscle or tendon detached from bone 2. Detached space 4 is the injury corrected by the surgical tools described herein. In a healthy context, soft tissue 3 is attached to bone 2. The presence of detached space 4 is an injury, where soft tissue 3 is separated from bone 2.

[0050] Figure 1 Further depicting needle into tissue space. Needle 1 is inserted into tissue surrounding the injury according to normal insertion protocols. This can be done by imaging guidance, manually, or by other means known to those of ordinary skill in the art. Needle hole 5 is defined to allow deployment of tools for inserting device screw, as depicted by additional figures.

[0051] Figure 2depicts further advancement of the needle 1 into the soft tissue 3, with the tip of the needle 1 inserted into the soft tissue 3. For deployment, the needle can also be adjacent to the soft tissue, allowing the tip of the screw or coil to penetrate the soft tissue first, and allowing the anchor to be deployed as described herein.

[0052] Figure 3A , 3B and 3C depict an orthopedic anchor for attaching soft tissue 3 to Figure 1 and 2 bone 2; Figure 3A depicts the screw 6, with the coil 10 wrapped around it. Although the screw 6 is the fastener most likely to be used in surgery (e.g., given the holding power of a screw and ease of driving and removal), embodiments of the present invention can be applied to other fasteners, such as nails, pins, rivets, bolts, etc.

[0053] The orthopedic anchor 6 includes a head 7 and a shaft 8 having threads 9. The bottom face of the head 7 engages the coil 10, which includes 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 site of the bottom face of the head 7, and the flared end positioned at the distal end of the screw 6. In certain embodiments, the screw 6 can include a self-tapping region 13. In some embodiments, the screw is a self-drilling screw. That is, in some embodiments, the self-drilling screw does not require a pre-drilled pilot hole. Figure 3B depicts a top view of the anchor of Figure 3A from above, looking down. From this view, the coil 10 can appear as a tightly packed series of concentric circles. Figure 3C depicts the anchor of Figure 3A and 3B with the coil 10 inverted (as it would look after being driven through the soft tissue 3 and into the bone 2). In this configuration, the tapered end 11 of the coil 10 engages the top portion of the screw 6, directly contacting the screw head 7 as depicted in Figure 3A .

[0054] The screw herein can have various dimensions that can be selected to achieve desired biomechanical properties. For example, the screw can have a length of between about 5 mm and about 15 mm, between about 8 mm and about 12 mm, about 10 mm, etc.

[0055] The coil 10 and / or the screw 6 can be made of a bioabsorbable material, such that after a predetermined amount of time, each component can be absorbed into the body. However, it can also be appropriate for each component to be made of a non-bioabsorbable material, but simply a biocompatible material, for permanent positioning in the body. Alternatively, it can be advisable for certain components to be bioabsorbable, while others are not, e.g., the coil can be bioabsorbed, but the screw can be non-absorbable. Any combination of absorbable or non-absorbable can be utilized as desired.

[0056] The surgical screw 6 preferably has properties that allow it to penetrate bone and anchor within the bone tissue. Thus, the screw 6 is preferably rigid to achieve such penetration. In the case where the screw is maintained in the body, the screw is preferably poly(ether ether ketone) or another polymer, stainless steel (316L) or titanium, or another metal or alloy having similar flexural strength, pullout strength, and stiffness. Exemplary magnesium-based alloys include Mg-Ca-Sr, Mg-Zn, Mg-6Nz, Mg-Zn-Ca, MGYREZr, etc. Iron-based alloys include Fe-Mn, etc.

[0057] In certain embodiments, the screw itself is bioabsorbable and thus degrades and is replaced with ingrown tissue in the body. However, to ensure that the mechanical properties of the screw are maintained for a sufficient duration to achieve healing of the injury, the mechanical properties can be maintained for at least 3 months, and preferably at least 6 months, before degradation begins. Ultimately, a fully degradable FDA-approved biomaterial is needed and the material is replaced with ingrown tissue. 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(p-dioxanone) (PPD); poly(propylene fumarate) (PPF); etc.

[0058] In certain embodiments, the screw can be made of a composite having a coated polymer or metal bulk material or a ceramic specifically reinforced polymer matrix. In certain cases, the coating / filler material can include CaP; tricalcium phosphate; hydroxyapatite (HA); and similar materials known to be biocompatible and used in the human body.

[0059] The coil material can also have independent properties that help enable the coil to effectively grasp soft tissue and attach the soft tissue to adjacent bone tissue. In particular, the coil can have shape memory that limits its overall deformation during deployment. This ensures that the coil is not simply deformed, but maintains sufficient rigidity and shape to grasp into the soft tissue to achieve contact between the tissue and the bone for reattachment of the soft tissue.

[0060] The coil material can be manufactured from various polymers or metals, enabling permanent production and also bioabsorbable production. The material preferably has physical properties similar to Nitinol or platinum in terms of flexural strength, pullout strength, and stiffness.

[0061] In the case where the coil is bioabsorbable, as in the case of the screw described above, the material can have mechanical properties that are maintained for at least 3 months, and preferably at least 6 months, to achieve healing of the injury before degradation begins. However, the material can be fully degradable and replaced with ingrown tissue after a set amount of time.

[0062] Suitable materials can include PLLA:PVA, PEG, PLA, poly(caprolactone) (PCL, ε-PCL), PLLA-PLGA, PEG-PCL, chitosan (e.g., genipin cross-linked), or other materials with similar characteristics for biocompatibility and bioabsorbability. In the event the material is maintained, metal alloys (e.g., spring steel), composites, and combinations thereof, including the same materials as the screw (detailed above), are suitable.

[0063] Figure 4A depicts the anchor positioned inside the needle 1 in engagement with the tool 14 to turn the screw 6. Figure 3A and 3B depicts the anchor positioned inside the needle 1 in engagement with the tool 14 to turn the screw 6. Figure 4B depicts the top surface of the screw head 7, which includes the entry device 15 for turning the screw 6. A tapered entry is shown, and certain embodiments can include alternative shapes, such as a hexagon. Other suitable drivers include a slot, a cross, a cruciform, Phillips, Frearson, French recess, JIS B 1012, Mortorq, Pozidriv PV, Supadriv PZ, Torq-set, Phillips / slot, external polygon, square, pentagonal, hexagonal, 12-point, internal polygon, triangular, Robertson, hexalobular (Allen), double square, triple square, 12-point socket flange, double hex, Torx, Torx Plus, Polydrive, tri-wing, tri-point, tri-slot, tri-wing, Bristol, Quadex, Pentalove, spanner (pig nose), etc.

[0064] The screw 6 can have various head geometries, including a disc, button, dome, round, mushroom, truss, countersunk, flat, oval, convex, bell, cheese, recessed, or flanged. In some embodiments, the head includes a flange substantially perpendicular to the axis of the screw 6.

[0065] In some embodiments, the head diameter of the screw 6 is sized to hold the coil 10, which can be wrapped around the shaft of the screw 6. To facilitate inversion of the coil 10 during driving, the head diameter can be relatively small relative to the major diameter of the threads. For example, the screw head can have a diameter that is between 110% and 100%, between 100% and 90%, etc. relative to the major diameter of the threads. The screw diameter (e.g., threads, 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.

[0066] In some embodiments, the screw 6 is a headless screw, in which case the coil 10 can be engaged with the screw 6 and rotated in the driving direction. The coil 10 can have a pitch opposite to the threads of the screw, such that the distal end of the coil rotates on the surface of the soft tissue 3, but does not pierce the soft tissue 3. Figure 10A headless screw 1006 is depicted containing 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 have a wire thickness of from about 0.05 mm to about 0.1 mm, from about 0.1 mm to about 0.15 mm, from about 0.15 mm to about 0.2 mm, from about 0.2 mm to about 0.25 mm, from about 0.25 mm to about 0.3 mm, from about 0.3 mm to about 0.35 mm, from about 0.35 mm to about 0.4 mm, from about 0.4 mm to about 0.45 mm, from about 0.45 mm to about 0.5 mm, from about 0.5 mm to about 0.55 mm, from about 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. By another measure, in some embodiments, the wire has a gauge number in the range of from about 18 g to about 20 g, from about 20 g to about 22 g, from about 22 g to about 24 g, from about 24 g to about 26 g, from about 26 g to about 28 g, from about 28 g to about 30 g, from about 30 g to about 32 g, from about 32 g to about 34 g, from about 34 g to about 36 g, from about 36 g to about 28 g, from about 28 g to about 29 g, from about 29 g to about 30 g, from about 30 g to about 31 g, from about 31 g to about 32 g, from about 32 g to about 34 g, from about 34 g to about 36 g, from about 36 g to about 38 g, from about 38 g to about 40 g, from about 40 g to about 42 g, and any and all increments therebetween.

[0067] Figure 5 Insertion of the anchor is depicted. As the screw 6 is turned 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 can be visualized by the coil 10 having fewer windings tightly wound around the shaft 8 and the outer windings more widely flared into or over the soft tissue. As the coil is wound around the screw, the anchor, including the screw and the coil, can have an outer diameter such that 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 8 g cannula, and any and all increments therebetween, an 8 g to 10 g cannula, a 10 g to 12 g cannula, a 12 g to 14 g cannula, a 14 g to 16 g cannula, a 16 g to 18 g cannula, a 18 g to 20 g cannula, a 20 g to 22 g cannula, a 22 g to 24 g cannula. The coil can deform inwardly and longitudinally as it is inserted into the needle, then expand radially as the end is exposed from the distal end of the needle.

[0068] The coil can have shape memory to return to a previously formed shape after emerging from the distal end as needed. For example, the coil can have a resting length and diameter. For example, the coil can have a length of between about 5 mm and about 15 mm, between about 8 mm and about 12 mm, about 10 mm, etc. In some embodiments, the coil can have a length that is less than the screw (e.g., terminates at the proximal end of the screw when engaged with the screw).

[0069] The coil diameter (e.g., outer diameter and proximal or distal end) 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. In some embodiments, the outer diameter of the distal end of the coil is 2.5 mm, which will fit within a 10G or 11G needle without deformation.

[0070] By turning the screw 6 using the tool 14, the threads of the screw shaft 9 engage with the bone 2 and, at the same time, the tapered end 11 of the coil 10 is pressed from the underside of the screw head 7, so that the coil 10 is compressed during the advancement of the screw 6 into the bone 2. As the screw 30 advances into the bone 2, the disengagement space 4 of Figure 1 , 2 and 4A is removed. Figure 4A A comparison between Figure 5 shows the disengagement space 4 removed.

[0071] Figure 6 Further insertion of the anchor is depicted. As the screw 6 is further advanced 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. At the same time, the tapered end 11 of the coil 10 maintains its position under the screw head, so that the coil 10 becomes inverted, as shown in Figure 3C Further insertion of the anchor is depicted. As the screw 6 is further advanced 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. At the same time, the tapered end 11 of the coil 10 maintains its position under the screw head, so that the coil 10 becomes inverted, as shown in

[0072] Figure 7 Deployment of the anchor is depicted.

[0073] The screw shaft 8 is fully embedded into the bone 2. When the tapered end 11 remains below the screw head 7, the coil 10 maintains an inverted orientation, while the flared end 12 remains outside the surface 15 of the soft tissue 3. By tightening the screw head 7 on the soft tissue 3, a funnel-shaped recess area 16 is formed, pressing the soft tissue 3 against the bone 2 as an insertion site. The contact between the two tissues allows the healing process to occur, in which the soft tissue 3 is typically attached to the bone 2.

[0074] Figure 8A and 8B Further embodiments of an orthopedic anchor are depicted. Figure 8A A screw 17 is depicted, which is similar to Figure 3A , comprising a head 18 including an entry port 19, a shaft 20 having threads 21, and a coil 22. However, this embodiment includes a collar 23 having a cross-sectional area that is larger than that of the shaft 20 and head 18. The collar 23 includes threads 24 that are oriented in the same direction as the threads 21 of the shaft 20. Figure 8B A screw 25 is depicted, which is similar to Figure 3A , comprising a head 26 including an entry port 27, a shaft 28 having threads 29, and a coil 30. However, in this embodiment, the shaft 28 includes a section 31 having a larger cross-sectional area than the rest of the shaft 28 and head 26, such that the shaft tapers from this section 31 in both directions toward the head 26 and a screw tip 32 to form a candlelight shape of the shaft 28. The coil 30 is positioned between the screw head 26 and the section 31 having the larger cross-sectional area.

[0075] Figure 9A , 9B and 9C depict deployment of an anchor including Figure 8B the screw 25 depicted in Figure 9A depicts use of an anchor including the screw 25 using Figure 5 the needle 1 and tool 14 depicted in for an anchor including the screw 6; Figure 9B depicts use of an anchor including the screw 25 using Figure 6 the needle 1 and tool 14 depicted in for an anchor including the screw 6 are further inserted into the soft tissue 3 and bone 2. As the screw 25 is further advanced into the bone 2, a bone displacement area 33 is formed in the bone 2 due to the widened region 31 of the screw shaft 28. Figure 9C depicts an anchor including the screw 25 as depicted in Figure 7The deployed anchor of Figure 25 depicts the screw 25 of the anchor. However, in this case, a portion of the soft tissue 34 surrounding the coil 30 is pulled into the displace region 33. This further allows the soft tissue 3 to heal and reattach to the surface of the bone 2. It can be advantageous to add certain compounds or therapeutic agents to the surgical site to enhance the healing process. In addition, it can be advantageous to coat various components, coils, and / or screws or washers with certain therapeutic agents to enhance the healing process.

[0076] Certain bone or vascular stimulating agents can be utilized to stimulate healing at the surgical site. In fact, these can be coated onto the screw and / or coil or combination thereof, or injected into or applied to the surgical area by needle during the surgical procedure.

[0077] Additional embodiments describe using a dual function anchor system to engage displaced soft tissue, engage the soft tissue with a coil, and drive the soft tissue with the embedded coil to contact the bone by driving a screw into the bone. The dual function anchor system includes a surgical screw including a shaft having threads; a coil wrapped around the screw shaft; the coil including a coil end defined to engage a bottom surface of a screw head of the screw; the end of the shaft and the coil end are engaged to the soft tissue.

[0078] Figure 11A Additional embodiments depict a coil with one end engaged with a screw of an anchor system and the other end having a closed configuration. The "closed" configuration can include, but is not limited to, a configuration in which the end of the coil is aligned distally under the adjacent spiral curve such that the end contacts the adjacent spiral curve with or without a fastener. In some embodiments, the end of the coil has a tapered edge such that when the end contacts the adjacent spiral curve, the end is flush with the surface of the adjacent spiral curve. When the anchor is advanced, the screw engages the bone while the closed end of the coil does not engage the soft tissue. In some embodiments, the coil according to this embodiment performs compression as a spring washer when the screw is driven into the bone.

[0079] In certain preferred embodiments and methods of treatment, it can be appropriate to drive a dual function anchor system including a screw and a coil into the tissue of a patient. Prior to or after engaging the tissue, certain bone or vascular healing compositions can be further injected into the surgical site utilizing the aperture of the dual function anchor system.

[0080] Therefore, treatment methods may include the methods described above, further comprising the step of injecting a therapeutic agent, such as a bone or blood vessel healing composition, into the wound site. Additional therapeutic agents may contain antibiotics. In some embodiments, coils or screws may be coated with a therapeutic agent comprising a bone or blood vessel healing composition or an antibiotic. Those skilled in the art will recognize these compounds and their appropriate dosages. For example, a non-limiting list of antibiotics may include clindamycin, trimethoprim / sulfamethoxazole, doxycycline, vancomycin, linezolid, daptomycin, metronidazole, or combinations thereof.

[0081] Experimental Examples

[0082] Example 1

[0083] Musculoskeletal (MSK) injuries affect 20% of the general population and up to 55% of those over 60 years of age. Partial tendon tears are an extremely common type of musculoskeletal injury, and due to countless unreported cases, we estimate there are over 31 million cases annually in the United States. The lesion forms as damage to the bone attachment, resulting in pain and a significant decrease in strength. The severity of the tear determines the recommended treatment, as surgery is only suitable for tears exceeding half the thickness of the bone. This leaves nearly 90% of the large general patient population experiencing tendon tears undertreated in the current paradigm, as conservative treatment is preferred over surgical intervention. This is explained in the breakdown of the treatment methods shown (…). Figure 12 The diagram illustrates this, along with corresponding options for each method. Under conservative management, existing activities, including injectable bioactive agents, have not been shown to restore full functionality faster than the natural healing process. Surgical interventions generally produce better results but are costly, time-intensive, and carry a higher risk of complications. Physicians are reluctant to operate on partial tears, especially when treating elderly patients. This highlights a significant gap in the current paradigm where no intermediate procedure exists to provide the benefits of surgery using minimally invasive methods.

[0084] The prevalence of partial tendon insertions around the body underscores the importance of this unmet need. It is estimated to be approximately 31 million in the United States, a market that can be served by partial tears with clean margins, as well as tendons that do not retract or tear. This amounts to approximately 3 million cases involving the rotator cuff, gluteus medius, hip abductors, epicondyle, and patella. These are candidates for a new modality of minimally invasive repair. For example, there has been recent interest in repairing the gluteus medius tendon in orthopedic surgery, thereby reducing gait deficits. Gait impairment associated with gluteus medius tendon tears and muscle atrophy has been identified as a significant cause of falls in elderly patients. However, elderly patients are often poor surgical candidates due to comorbidities (i.e., heart, lung, or kidney disease) that make general anesthesia risky in this population and leave most cases untreated. In a study of 185 randomly selected pelvic MRI exams divided into 10-year age groups, partial tears of the gluteus medius tendon were observed in 31.8% in the 50-59 age category, 46.3% in the 60-69 age group, and 61.7% in patients 70 and older. An inexpensive, readily available non-surgical method for tendon repair can have a significant impact on the quality of life for elderly patients and reduce the risk of falls and associated injuries.

[0085] Tendon reattachment

[0086] A solution is provided herein that can percutaneously reattach a partially torn gluteus medius tendon insert to the greater trochanter without the need for surgery requiring general anesthesia. This technique involves placing an implant through the partial tear into the tendon insertion site (occupying space). The implant is composed of two functional parts: a self-drilling screw and a tissue capturing coil. The coil is tightly bound to the neck of the screw adjacent to the hub. The coil winding has an increasing circumference along its progression in a conical configuration. The screw and coil construct fits within a 10 gauge delivery sheath. Partial thickness tendon tears are confirmed by MRI Figure 13 ) or ultrasound imaging. A test can be performed for patient selection, including steroid injection into the bursa adjacent to the tendon; if the pain is temporarily relieved, it indicates a higher likelihood that tendon repair will alleviate the patient's symptoms. An important feature of treatable partial thickness tears is that the tendon remains in its normal position along its original occupying space at the iliac crest of the femur at the greater trochanter Figure 14 ). In an initial study using unconfirmed patient data, it has been determined that 100% of the tears were clearly defined at the initial presentation of hip pain (i.e., not torn) and all of the tears subsequently progressed to full thickness tears followed by muscle atrophy within 2-4 years. The loss of tissue volume and healing defects caused by atrophy impede both mechanical fixation and biological repair. The augmentation technique of the present invention for partially torn tendons will stop the progression to full tear and muscle atrophy, with patients who are in pain and without atrophy in the early stages of their disease process as candidates for treatment.

[0087] Surgical procedures are performed using ultrasound guidance, a common interventional radiology modality that allows real-time visualization of implant placement, confirmation of a tear; planning of needle trajectory, and marking of the skin. Envision an insertion tool ( Figure 15 ) where a delivery sheath loaded with an implant is positioned at the site of a tear. The system is delivered percutaneously to the bony target using an integrated probe applicator compatible with the screw hub. The outer needle sheath is retracted, exposing the device for implantation. The core is then advanced and turned clockwise, causing the anchor to enter the bone. Multiple implants can be placed to augment 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, pulling it toward and into the bone along with the screw. The coil acts as an expandable grommet, similar to a funnel that grips the tendon surface.

[0088] Attachment techniques

[0089] The fastener according to the present invention is based on the ability to effectively pin a partial thickness tear - particularly those painful partial tears that have not become surgical candidates but have not responded to conservative management techniques. While such a repair can not be as strong as a standard suture anchor, it can be superior to existing needle-based surgical procedures for partial thickness tears. Since the proposed technique accomplishes a functional repair, this falls into the realm of surgery for medical 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 capable of mechanically effecting tissue fixation, our concept represents an innovative approach for treating painful partial tendon tears. The tendon fastener implant design of the present invention includes a bone screw with a standard clockwise thread, and an attached conical compression spring, as shown in Figure 16 ).

[0090] This changes the force distribution relative to fixation compared to a traditional suture anchor, as shown in Figure 17 ). The suture anchor is used to pin the tendon to the bone, and there is a concentration of force along a single plane of the suture (arrow). There is also a single point of contact, the junction of the suture with the anchor eyelet. These together create a weak point in the implant, which is exacerbated by the technique of introducing a knot along the suture. In contrast, the fastener of the present invention enjoys a distribution of force along a wider area (arrow) due to its multiple points of contact within the tendon tissue, and the fastener does not have an eyelet acting as a point of failure. In the case where the tendon is also pulled into the bone, the fastener of the present invention provides increased strength of fixation and resistance to failure.

[0091] Results and conclusions

[0092] In bench testing using synthetic bone and tendon tissue models, it was observed that the coil became slightly inverted over the screw head upon insertion of the anchor, creating a funnel and a cyclone separator-like effect Figure 18 Human cadaver hips were used to collect data. The middle gluteal muscle tendon of each cadaver was examined. One was a clean partial tear that was clearly visible on MRI image capture Figure 19A ) and was chosen to be used as a model case. Marked wooden dowels were placed into the sample at the greater trochanter to locate insertion. An MRI was repeated and showed which dowel was best located at the middle gluteal insertion site. The surface was marked with permanent markers and a cut was made along the dowel. The tensor fascia lata muscle was incised at the iliac crest. The vertical incision was reflected to each side, exposing the greater trochanter and middle gluteal insertion. The exemplary percutaneous fastener of the present invention was implanted into the target site using a retractor and hex driver. Fixation was shown on MRI Figure 19B ) with the tendon confluence to the bone insertion site at the greater trochanter.

[0093] Two additional cadaver portions were partially torn and used for comparative studies with the self-drilling device described herein and the Arthrex pre-drilled suture anchor. Pull-out failure was measured in the same direction as the force typically applied on the hip using a dynamometer. Failure testing was performed on the sample by tensioning the repair construct longitudinally. A dynamometer set to measure peak force (max 200 N, 0.01 N scale) was attached to a platform. A metal suture was sewn into the muscle over the tendon insertion on the sample and connected to the dynamometer via a hook. Increasing manual tension was applied parallel to the tendon orientation until failure. The peak at the point of failure was captured for the cadaver samples and compared. The fastener of the present invention exhibited a failure strength measured at 155.0 N, which was 92.5% of the failure strength measured for the suture anchor at 167.6 N. This indicates that the fastener of the present invention can be used to successfully achieve tendon fixation.

[0094] Equivalent arrangements

[0095] While the preferred embodiments of the application have been described using specific terms, such description is for illustrative purposes only, and it is to be understood that changes and variations can be made without departing from the spirit or scope of the following claims.

[0096] Incorporated by reference

[0097] The entire contents of all patents, published patent applications and other references cited herein are hereby expressly incorporated by reference in their entireties.

Claims

1. A surgical anchor, comprising: fastener; as well as An external reversible coil, coupled to the proximal end of the fastener, wherein the external reversible coil comprises: The first end of the fastener is connected to the proximal end; as well as The second end has a closed configuration such that the second end is aligned toward the distal end below the adjacent spiral curve, such that the second end contacts the adjacent spiral curve.

2. The surgical anchor according to claim 1, wherein the fastener is a screw, the screw comprising: Distant thread; as well as A reamer, which is located near the distal thread, in: The screw is a headless screw; and The screw includes an annular recess near the expander, the recess being adapted and configured to receive a portion of the external reversible coil.

3. The surgical anchor according to claim 1, wherein the fastener is a screw, the screw comprising: Distant thread; as well as A reamer, which is located near the distal thread, in: The screw includes a head, the outer diameter of which is equal to or smaller than the outer diameter of the reamer.

4. A surgical instrument comprising: The surgical anchor as described in claim 1; The needle includes an orifice of sufficient diameter for receiving the surgical anchor. as well as Tools, said tools being adapted and configured to: Insert into the orifice to insert the surgical anchor; and Engage and rotate the surgical anchor.

5. A surgical anchor comprising: Screw, the screw comprising: Distal thread; and Proximal head; and A coil, the coil being connected to the screw near the distal thread; in: The screw is capable of rotating freely within the coil in any rotational direction without driving the coil; or The diameter of the coil extends to the distal end; The coil includes: Connected to the first end of the screw; and The second end has a closed configuration such that the second end is aligned toward the distal end below the adjacent spiral curve, such that the second end contacts the adjacent spiral curve.

6. A surgical anchor comprising a screw and a coil; the coil having a conical shape and wound around a screw axis, wherein a first end of the coil tapers and has a circumference smaller than that of the screw head and is engaged to the bottom of the screw head, and a second end of the coil is flared with a larger circumference and positioned along the screw axis, wherein the second end of the coil is distally aligned under an adjacent helical curve such that the second end contacts the adjacent helical curve.

7. A surgical system comprising a needle including an orifice of sufficient diameter for receiving a surgical anchor comprising a screw and a coil; a probe tool insertable into the orifice for inserting the anchor and capable of engaging and rotating the screw; the screw including a threaded shaft and a head having a bottom surface, and the coil having a conical shape wound around the screw shaft, wherein a first end of the coil tapers and has a circumference smaller than that of the screw head and engages at the bottom of the screw head, and a second end of the coil is flared with a larger circumference and positioned along the screw shaft, wherein the second end of the coil is distally aligned below an adjacent helical curve such that the second end contacts the adjacent helical curve.

8. A surgical anchor comprising a screw and a coil, the screw including a head, a collar, and a threaded shaft, the collar having a cross-sectional area larger than the cross-sectional area of ​​the shaft and the head; The coil includes: It is connected to the first end of the screw; as well as The second end has a closed configuration such that the second end is aligned distally in the direction of the adjacent spiral curve, such that the second end contacts the adjacent spiral curve.

9. The surgical anchor of claim 8, wherein the screw includes a collar having threads in the same direction as the threads of the screw shaft.

10. A surgical anchor comprising a screw and a coil, the screw including a head and a threaded shaft, the head having a bottom surface, the shaft including a section having a cross-sectional area larger than the rest of the shaft, such that the shaft tapers from the section in both directions toward and away from the head; The coil includes: It is connected to the first end of the screw; as well as The second end has a closed configuration such that the second end is aligned toward the distal end below the adjacent spiral curve, such that the second end contacts the adjacent spiral curve.

11. The anchor of claim 10, comprising a coil having one of the following: A conical shape, wound around a screw axis, wherein a first end of the coil tapers and has a circumference smaller than that of the screw head, and engages with the bottom surface of the screw head, and a second end of the coil flares out with a larger circumference and is positioned along the screw axis; and, The coil has a cylindrical shape and is wound around the screw shaft, wherein the first end of the coil is engaged with the bottom surface of the screw head, and the second end of the coil is positioned along the screw shaft.

12. The surgical anchor of claim 10, wherein the coil does not puncture soft tissue.

13. The surgical anchor of claim 10, wherein the coil has a pitch opposite to the thread of the screw.

14. The surgical anchor of claim 10, wherein the screw rotates within the coil.

15. The surgical anchor of claim 10, wherein the distal end of the coil is flush with the adjacent helical curve of the coil.

16. The surgical anchor of claim 10, wherein the screw engages and rotates such that the bottom of the screw head engages the first end of the coil and the second end of the coil is pressed against the surface of soft tissue.

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