WO2001006933A2 - Suture anchor - Google Patents

Suture anchor Download PDF

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Publication number
WO2001006933A2
WO2001006933A2 PCT/US2000/020293 US0020293W WO0106933A2 WO 2001006933 A2 WO2001006933 A2 WO 2001006933A2 US 0020293 W US0020293 W US 0020293W WO 0106933 A2 WO0106933 A2 WO 0106933A2
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WO
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Patent type
Prior art keywords
suture
suture spear
spear
ofthe
according
Prior art date
Application number
PCT/US2000/020293
Other languages
French (fr)
Other versions
WO2001006933A3 (en )
Inventor
John R. Bianchi
Kevin C. Carter
Tom Sander
C. Randal Mills
Russell S. Donda
Randal Spencer
Michael Esch
Andy Bernhardt
Daniel R. Lee
Ilsa Webeck
Original Assignee
Regeneration Technologies, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, E.G. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/08Muscles; Tendons; Ligaments
    • A61F2/0811Fixation devices for tendons or ligaments
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/84Fasteners therefor or fasteners being internal fixation devices
    • A61B17/86Threaded wires, pins or screws; Nuts therefor
    • A61B17/8625Shanks, i.e. parts contacting bone tissue
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/84Fasteners therefor or fasteners being internal fixation devices
    • A61B17/86Threaded wires, pins or screws; Nuts therefor
    • A61B17/864Threaded wires, pins or screws; Nuts therefor hollow, e.g. with socket or cannulated
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0409Instruments for applying suture anchors
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0412Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors having anchoring barbs or pins extending outwardly from suture anchor body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0414Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors having a suture-receiving opening, e.g. lateral opening
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0427Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors having anchoring barbs or pins extending outwardly from the anchor body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/044Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors with a threaded shaft, e.g. screws
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, E.G. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/08Muscles; Tendons; Ligaments
    • A61F2/0805Implements for inserting tendons or ligaments
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, E.G. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/08Muscles; Tendons; Ligaments
    • A61F2/0811Fixation devices for tendons or ligaments
    • A61F2002/0876Position of anchor in respect to the bone
    • A61F2002/0888Anchor in or on a blind hole or on the bone surface without formation of a tunnel
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, E.G. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/28Bones
    • A61F2002/2835Bone graft implants for filling a bony defect or an endoprosthesis cavity
    • A61F2002/2839Bone plugs or bone graft dowels
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, E.G. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2002/30001Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30003Material related properties of the prosthesis or of a coating on the prosthesis
    • A61F2002/30004The prosthesis made from materials having different values of a given property at different locations within the same prosthesis
    • A61F2002/30059The prosthesis made from materials having different values of a given property at different locations within the same prosthesis differing in bone mineralization, e.g. made from both mineralized and demineralized adjacent parts

Abstract

A substantially cylindrical or wedge-shaped cortical bone implant (10) wherein one end of the cylinder (30) or wedge tapers to a sharp point (21) and which comprises one or more through-channel(s) (40) for receipt of suture(s), is disclosed for fixation of tissues to bone or other tissues of sufficient strength to provide solid fixation of tissue to which the implant is affixed (10). The implant (10) optionally has a circumferential, longitudinal or angled barbs to enhance structural and retention characteristics of the implant. Certain embodiments of the invention include portions of the implant in a partially or fully demineralized state, such that added flexibility is imparted to the demineralized or partially demineralized segment. Additionally, embodiments of this invention optionally include threaded portions (410), fluted portions or slotted portions (610), depending on the desired implantation means and retention characteristics. The implant is optimally configured for a single step impaction implantation, although other forms of implantation are also contemplated.

Description

TITLE OF THE INVENTION SUTURE SPEAR

REFERENCES TO RELATED APPLICATIONS

This application is a continuation-in-part to prior pending application Serial No. 09/360,584, filed on July 26, 1999.

FIELD OF THE INVENTION

This invention relates to a new implant made from bone for securing sutures and tissues to bone, to devices for implantation ofthe suture spear, and to methods of making and use thereof.

BACKGROUND OF THE INVENTION

In the field of orthopedics, a wide variety of devices have been developed to assist in the fixation of tissues to bone, frequently through provision of means for fixing sutures to bone. See, for example, U.S. Patent Nos. 4,409,974; 4,632,100; 4,712,550; 5,037,422; 5,141,520; 5,156,616; 5,372,604; 5,403,348; 5,496,348; 5,500,001; 5,522,846; 5,527,342; 5,527,343; 5,534,012; 5,549,630; 5,569,305; 5,571,139; 5,584,862; 5,645,589; 5,683,418; 5,690,649; 5,713,921; 5,715,942; 5,718,717; 5,720,765; 5,720,766; 5,725,557; 5,733,306; 5,743,914. In general, the fixation devices known in the art are metallic, plastic or resorbable synthetic devices which require additional insertion devices and frequently pre-drilling of cavities for receipt ofthe fixation devices. Fixation devices made from metal, due to the differences between bone and metal, may work themselves loose or create other problems which require surgical removal ofthe device. In addition, for devices known in the art where pre-drilling is required, the surgical time for installation is frequently unacceptably prolonged. Accordingly, there remain needs in the art for new fixation devices or implants which overcome limitations in the existing devices. The present invention provides a suture spear made from cortical bone which is inserted directly into bone, without the need for pre- drilling, and because the suture spear itself is made from bone, the spear is incorporated into the recipient bone over time, eliminating the need for subsequent surgical removal of a foreign, metallic or plastic body.

BRIEF DESCRIPTION OF THE DRAWINGS

Figure 1A shows a side view of a first embodiment ofthe suture spear of this invention.

Figure IB shows a side view of a first embodiment ofthe suture spear of this invention with a suture inserted through a suture canal formed in said suture spear.

Figure 2 A shows a side view of a second embodiment ofthe suture spear of this invention.

Figure 2B shows a side view of a second embodiment ofthe suture spear of this invention with a suture inserted through a suture canal formed in said suture spear.

Figure 3 A shows a side view of a third embodiment ofthe suture spear of this invention.

Figure 3B shows a side view of a third embodiment ofthe suture spear of this invention with a suture inserted through a suture canal formed in said suture spear.

Figure 4A shows a side view of a fourth embodiment ofthe suture spear of this invention.

Figure 4B shows a side view of a fourth embodiment ofthe suture spear of this invention with a suture inserted through a suture canal formed in said suture spear.

Figure 5 A shows a side view of a fifth embodiment ofthe suture spear of this invention.

Figure 5B shows a side view of a fifth embodiment ofthe suture spear of this invention with a suture inserted through a suture canal formed in said suture spear.

Figure 6 A shows a side view of a sixth embodiment ofthe suture spear of this invention.

Figure 6B shows a side view of a sixth embodiment ofthe suture spear of this invention with a suture inserted through a suture canal formed in said suture spear.

Figure 7 A shows a side view of a seventh embodiment ofthe suture spear of this invention. Figure 7B shows a side view of a seventh embodiment ofthe suture spear of this invention with a suture inserted through a suture canal formed in said suture spear.

Figure 8 A shows a side view of an eighth embodiment ofthe suture spear of this invention.

Figure 8B shows a side view of an eighth embodiment ofthe suture spear of this invention with a suture inserted through a suture canal formed in said suture spear.

Figure 9A shows a side view of a first embodiment of an insertion device for implantation ofthe suture spear of this invention.

Figure 9B shows the insertion device with a suture spear loaded therein.

Figure 9C shows a side view of a further embodiment ofthe implant insertion device of this invention with an embodiment ofthe suture spear of this invention loaded therein.

Figure 10A shows a side view of a further embodiment ofthe suture spear of this invention comprising a flange for tacking tissue to bone.

Figure 10B shows a cross sectional view ofthe suture spear having a flange after having been impacted into recipient bone.

Figure 11A shows a schematic view of one embodiment ofthe suture spear of this invention.

Figure 1 IB shows a rear view ofthe suture spear, looking from the rear conical body toward the pointed head portion ofthe spear.

Figure 1 IC shows a side view ofthe suture spear of this invention showing a forward suture canal and specific dimensions for the spear.

Figure 1 ID shows a side view, rotated ninety degrees from the view shown in figure 11C, with additional specific dimensions ofthe suture spear.

Figure 12A shows a perspective view of a further embodiment ofthe suture spear of this invention having a rounded tip and an inscribed groove, rather than or in addition to a through canal.

Figure 12B shows a cross-sectional side view ofthe suture spear shown in figure

12A along line A-A in figure 12C.

Figure 12C shows an external side view with optional dimensions in millimeters for one embodiment ofthe suture spear shown in figure 12 A.

Figure 12D shows an end-on frontal view ofthe rounded tip of the suture spear shown in figure 12 A. Figure 12E shows a cross-sectional view along line B-B shown in figure 12C viewed toward the rear.

Figure 12F shows an end-on rear view ofthe insertion hole and rear end ofthe suture spear shown in figure 12 A.

Figure 13 A shows an external side view of one embodiment of an insertion device for the suture spear shown in figure 12 A.

Figure 13B shows a cross-sectional side view ofthe insertion device shown in figure 13 A along section line A-A.

Figure 14 shows the suture spear of figure 12A mounted on the tip ofthe insertion device of figure 13 A, with a suture mounted thereon and a retainer sleeve mounted on the shaft ofthe insertion device.

Figure 15 shows impact curves with and without spring damper in inserter.

SUMMARY OF THE INVENTION

A substantially cylindrical or wedge-shaped cortical bone implant wherein one end ofthe cylinder or wedge tapers to a sharp point and which comprises one or more through-channel(s) for receipt of suture(s), is disclosed for fixation of tissues to bone or other tissues of sufficient strength to provide solid fixation of tissue to which the implant is affixed. The implant optionally has a circumferential, longitudinal, spiral or angled barbs to enhance structural and retention characteristics ofthe implant. Certain embodiments ofthe invention include portions ofthe implant in a partially or fully demineralized state, such that added flexibility and fracture resistance is imparted to the demineralized or partially demineralized segment. Additionally, embodiments of this invention optionally include threaded portions, fluted portions or slotted portions, depending on the desired implantation means and retention characteristics. The implant is optimally configured for a single step impaction implantation, although other forms of implantation are also contemplated.

Accordingly, it is one object of this invention to provide an improved suture anchor made from cortical bone. A further object of this invention is to provide a suture spear made from bone comprising a conical, trocar, wedge-shaped or other sharp point configuration which may be directly impacted into recipient bone.

A further object of this invention is to provide a suture anchor which may be inserted in a single step, without the need for a separate tapping or cortex puncture step.

A further object of this invention is to provide a suture anchor made from bone comprising a point having a thread, for turning the anchor into recipient bone.

Another object of this invention is to provide a suture spear comprising segments of bone that are partially or completely demineralized.

Another object of this invention is to provide a suture anchor which exhibits strong compressive properties of cortical bone.

Another object of this invention is to provide a suture spear which remodels into host bone for long-term fixation of sutures, which does not typically occur with synthetic or metallic implant suture anchors.

A further object of this invention is to provide a suture spear to which one or a plurality of suture lines may be attached.

A further object of this invention is to provide an improved method for attaching tissues, such as ligaments or tendons, or any other tissue, to bone.

Further objects and advantages of this invention will be appreciated from a review of the complete disclosure and claims appended hereto. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

It will be understood that the term "suture" as used herein refers to any commonly used thread, suture, or other type of string or tissue material that can be used to fix a suture spear or anchor to other tissue.

The term "skirt" and "barb" may be used synonymously, except that the term "skirt" is generally applied to a continuous circumferential feature, while the term "barb" is generally intended to mean a skirt that is in some way discontinuous. A substantially cylindrical or wedge-shaped cortical bone implant wherein one end ofthe cylinder or wedge tapers to a sharp point and which comprises one or more through-channel(s) for receipt of suture(s), is disclosed for fixation of tissues to bone or other tissues of sufficient strength to provide solid fixation of tissue to which the implant is affixed. The implant optionally has circumferential, longitudinal or angled barbs or skirts, to enhance structural and retention characteristics ofthe implant. Certain embodiments ofthe invention include portions ofthe implant in a partially or fully demineralized state, such that added flexibility is imparted to the demineralized or partially demineralized segment. Additionally, embodiments of this invention optionally include threaded portions, fluted portions or slotted portions, depending on the desired implantation means and retention characteristics. In some embodiments ofthe invention, the implant is shown with a suture receiving canal running transversely through the long axis ofthe implant, with the canal passing through a forward or rearward skirt, to form barbs on the cylindrical portion ofthe implant. It will be appreciated that the canal may be situated behind a skirt or barb, and that the forward point ofthe implant may be situated behind a cylindrical portion ofthe implant in the form of a skirt, rather than being a continuous, tapered point.

In one embodiment of this invention, because ofthe elastic properties ofthe bone from which the suture spear of this invention is formed, it is not necessary for any portion ofthe implant to be demineralized. The implant is fashioned from a selected piece of cortical bone and simply hammered into place, piercing the cortex of bone into which it is to be implanted, thereby fixing in place any tissue attached to the suture spear. Alternatively, to add flexibility to the implant, or to alter the physical and biological properties ofthe implant, portions thereof may be slightly or fully demineralized. In one embodiment, a trailing extension is provided on the suture spear, which is demineralized to form a flexible "tail" to which tissue may be directly sutured, without the need to bury suture. The demineralized strip, flap or tail provides a flexible portion ofthe implant with increased area for reattaching tendons, ligaments or other tissue to bone. Furthermore, while in one embodiment ofthe invention, the head ofthe suture spear is unthreaded, various embodiments ofthe implant include a head which is slotted, fluted, or threaded, including a standard helical thread and variations thereof. In one specific embodiment, the head is threaded in such a way as to exhibit alternating first and second helical threads running substantially parallel with each other along the head ofthe suture spear. In a variant of this specific embodiment, the first and second threads exhibit diameters substantially different from each other, thereby exhibiting a high-low thread configuration. In yet a further embodiment, the suture spear may comprise a plurality of helical threads, each exhibiting different diameters. In yet a further embodiment, the implant exhibits parallel but out-of-phase threads. It will be appreciated that, while the following disclosure provides specific views in various figures showing one feature ofthe invention for purposes of simplicity and clarity, in fact combinations ofthe diagrammed features may be included in additional embodiments ofthe invention, without departing from the scope and intent ofthe present disclosure. Thus, while one figure shows a threaded head on an implant having only one retention means, and a second figure shows an implant having two sets of retention means, this disclosure should be interpreted to include an embodiment wherein a threaded head and two retention means are included in a single implant embodiment.

One unique aspect ofthe suture spear ofthe present invention is that it is made from bone of sufficient strength to permit a single-step impaction implant procedure to be achieved. In addition, host bone/tissue attaches to the implant of this invention, which remodels over time to recipient bone, thereby providing long-term suture attachment and thereby minimizing or eliminating the chance for anchor loosening or pull-out, a problem that may occur with synthetic or metal suture anchors known in the art.

Referring now to the figures, there is provided in figure 1 a first embodiment 10 of the implant of this invention, showing a substantially conical head portion 20 and a substantially cylindrical body portion 30, which is integrally connected with said conical head portion 20. In this embodiment, the substantially conical head portion extends for a forward bone penetrating tip 21 to a wider diameter portion 22, referred to herein as a skirt, which upon seating ofthe implant of this invention inside a recipient bone, provides a substantial resistive effect through retention by the inside surface ofthe recipient bone against the retention surface 23 of said head portion 20. Through said conical head portion 20 and said substantially cylindrical body portion 30 is a transverse canal 40, through which a suture 50 is loaded. Finally, the implant 10 has an impaction end portion 60 which is substantially flat, for loading into any appropriate loading means, (see figure 9 for one example of an implant driver which may be used according to this invention), or for direct impaction with a mallet. In order to protect the suture as the implant 10 is driven into bone via the head portion 20 and impaction at the impaction end portion 60, the implant 10 is preferably provided with a channel 41 in which the suture 50 may lodged. Those skilled in the art will appreciate that the conical head 20 as represented in figure 1 may be designed to have different shapes than a cone. Thus, for example, a wedge-shaped head (which would appear similar from a side view to the appearance ofthe conical head shown in figure 1) could be used. Other variations and modifications ofthe head design portion 20 as may be suggested by the instant disclosure and which provide sufficient strength to permit the cortical bone implant to penetrate into an implant bone site upon impaction ofthe implant 10 against the surface ofthe recipient bone come within the scope of this invention and the claims appended hereto.

Upon impaction against a recipient bone, the bone implant shown in figure 1 has sufficient inherent flexibility that the skirt portion 22 penetrates into bone, without cracking, to permit efficient penetration ofthe suture spear 10 into the recipient bone. However, in order to enhance the survivability ofthe implant, in some circumstances, it is desirable to demineralize or partially demineralize portions of the implant 10. Prime among the portions ofthe implant to be demineralized or partially demineralized to enhance flexibility are the skirt portion, 22, or just the peripheral edges thereof, and a portion ofthe head 24 referred to herein as the hinge. Demineralization or partial demineralization of bone is a procedure that is well known in the art. Accordingly, the implant 10 or specific portions thereof are exposed to acid leaching of minerals, using, for example, one normal hydrochloric acid or the like for sufficient time to leach out a sufficient percentage of minerals to increase the implant portion's elasticity. Care should be taken, however, not to demineralize the implant to such an extent that upon impaction into a recipient bone site, the suture spear is so flexible that it may become loosened from its site of implantation. Typically, leaching of between about one to twenty-five percent ofthe mineral from a particular site on the implant is sufficient to confer desired properties of elasticity such that fracture ofthe implant upon impaction is minimized, while at the same time retaining sufficient implant rigidity to ensure a secure impaction ofthe implant into host bone.

The implant shown in figure 1 is preferably machined from a dowel of cortical bone, either obtained as autograft, allograft or xenograft. The bone is desirably cleaned of extraneous debris, proteins and any potentially pathogenic organisms. This is achieved by treatment with ethanol, peroxide, sonication, vapor phase sterilants, irradiation and the like. It will be appreciated that it is preferred for the donor ofthe implant bone from which the implant of this invention is machined should be healthy and free of any known diseases. Where human cadaveric bone is used, it is typically possible to obtain information through family members of the deceased as to the health or otherwise ofthe donor. Known screening methods, including PCR, antibody testing, ELIZA assays and the like may all be employed to rule out pathologic contamination ofthe donor bone tissue. Any method known in the art for sterilization of implants may be utilized, so long as the structural integrity ofthe implant is not compromised. The conical, wedge- shaped, trocar or other sharp or pointed head portion 20 is machined using a lathe, a computer numerically controlled (CNC) lathe, mill, or both, or like machining devices, as is the cylindrical portion 30. The suture canal 40 is drilled through the implant while the channel 41 is machined using the equivalent of a carpenter's lathe. Preferably, the entire suture spear is fashioned from a single piece of bone, although the implant may also be fashioned from, for example, a cylindrical portion which is inserted into a pointed forward section, either by way of a threaded segment on the cylindrical portion, by means of a male- female fit, or any other method of fixation. We have also discovered that it is preferable to machine a piece of bone such that the long axis ofthe suture spear corresponds with the long axis ofthe bone from which the suture spear is machined. In this way, the grain ofthe resulting implant runs with the length ofthe implant, which, we have found, confers significant strength advantages in the suture spear implant that results. This is particularly true when the suture spear, after machining, is freeze- dried, by lyophilization, sublimation or the like. Freeze-drying ofthe machined suture spear is a preferred method for preservation and storage ofthe suture spear.

In figure 2 there is represented a second embodiment 100 of this invention, similar portions ofthe implant are assigned reference numerals identical to those assigned in figure 1. In this embodiment ofthe invention, a second canal, 45, is provided for accepting a second suture strand 55. This embodiment would be preferred in situations where angular implant fixation to bone is required, or where added security is required, as where a ligament or tendon is being attached to bone under tension or where it is anticipated that the ligament or tendon will experience severe pull-out loads. Preferably, the first canal 40 and, if present, the second canal 45 are configured such that if desired one or more sutures may be passed therethrough. This is facilitated when the canal is oval in shape. It is also desirable for the canal to have radiused edges, such that chaffing and possible cutting of suture strands is minimized. Preferably, the long axis ofthe oval matches the long axis ofthe suture spear, such that the grain ofthe bone goes with the long axis ofthe oval for strength considerations.

In a further embodiment 200 of this invention, shown in figure 3, the implant of this invention is provided with a barb as an additional retention means 210 in the form of a discontinuous skirt with a channel 220 to permit the tails ofthe suture 50 to be held in close proximity to the implant 200 when it is being inserted into recipient bone. The channel also facilitates suture slide to aid the surgeon in tying off of suture ends and to facilitate proper placement of desired suture lengths. In this embodiment ofthe invention, the retention means 210 is formed during the machining process, such that a piece of bone of an initial diameter greater than the greatest diameter ofthe head portion 20 and said additional retention means 210 is machined to form the tapered head 20 and additional retention means 210, such as on a lathe. In yet a further embodiment 300 of this invention, shown in figure 4, the implant is identical to that shown in figure 3, except that a second canal 45 is provided, to permit fixation of a second suture thread.

In figure 5, a further embodiment ofthe implant of this invention 400 is shown, with a thread 410 inscribed onto the external surface ofthe head portion 20. In this embodiment, the rear end of said implant 60' is modified to permit a means for providing torque, such that said threaded head portion 20 may be threaded into an implant site, rather than being impacted into an implant site. The rear end 60' may be modified to include a slot, such as for torque application by a flat-head driver means; it may be recessed, for torque application by a hexagon shaped driver means, or the like. The rear end 60' may further be shaped in such a form, such as a square, to permit purchase by a driver means bearing a mating shape to impart torque thereto.

In figure 6, there is shown yet a further embodiment ofthe implant of this invention, wherein the head portion 20 has inscribed on the external surface thereof two substantially parallel threads 510 and 520, wherein said threads have different diameters, such that two planes are defined in the external surface of said head portion 20, namely and external plane 511, and an internal plane, 512.

In figure 7, there is shown a further embodiment 600 ofthe implant of this invention, wherein the head portion 20 ofthe implant has formed thereon a fluting or slotted arrangement 610, such that the head 20 ofthe implant truly resembles a spear, having a plurality of ridges 620 and valleys. Viewed end-on in figure 7C, this configuration appears to have a clover-leaf structure, with the substantially cylindrical rear portion 30 of the implant being visible as a circle. In yet a further embodiment, the implant head comprises a gradually curving thread pattern which is sufficiently shallow in curvature that the thread does not impede impaction of the implant into recipient bone, but which, upon impaction, imparts a slight rotation to the implant. This is achieved where the shallow helical thread substantially runs along the long axis ofthe front end ofthe suture spear. In another variation, a feature is included on one side but not the other ofthe forward end ofthe suture spear such that upon insertion, the feature bites into bone, causing the suture spear to cant, and become lodged in recipient bone at an angle offset from a perpendicular entry direction.

In figure 8, there is shown an embodiment ofthe implant 700 wherein an end portion 710 ofthe implant has been substantially demineralized, such that said end portion ofthe implant is flexible, and accommodates a plurality of suture fixation holes 720. The presence of these holes, which are pre-formed, may facilitate the elimination ofthe canal 40 in this embodiment ofthe implant. For implantation, this embodiment ofthe implant is fitted into an implantation device which may be impacted by transferring the impact to the rear surface 23 ofthe head ofthe implant (see figure 9), and thereafter, the flexible end portion 710 is withdrawn from the insertion device and is sutured to the tissue for fixation to bone. The sutures may be installed either prior to or subsequent to impaction ofthe implant, depending on the length ofthe flexible end portion extension 710.

It will be appreciated that the implant suture spear according to this invention may be implanted into a recipient in need thereof by any appropriate means. For example, a device for implanting a cortical bone suture spear preferably comprises: an impact handle connected to a shaft bearing a means for receiving a cortical bone suture spear therein at the end ofthe shaft opposite the impact handle. The shaft into which the implant is received is either slidably mounted within an external tubular housing, or is a single piece into which the implant is loaded. Where there is an internal and an external shaft, it is preferred for the internal shaft to be unitary with the impact handle, and for the internal shaft and the external shaft to be adjustably mounted. In this fashion, upon impaction ofthe impact handle with a cortical bone suture spear mounted within the receiving means, and abutted against a recipient's bone, the cortical bone suture spear is impacted into the recipient's bone. With reference to figures 9A-9C, specific embodiments of such a device are disclosed.

In figure 9 A, there is provided one embodiment of an insertion device 800 for impaction into recipient bone ofthe implant according to this invention. An implant receiving port 810 comprises a cavity 820 formed by the tines 821, 822, 823 of a collett assembly into which the substantially cylindrical rear end 30 ofthe implant is fitted. The receiving port 810 is formed at the distal end of a slidable shaft 830 which fits inside a housing 840. At the proximal end ofthe shaft 830 is an impaction handle 850 which is struck with a hammer or like impaction means, causing the shaft 830 to advance, impacting the suture spear into recipient bone at least the full length ofthe suture spear, and up to a stop 845 on the housing 840. In order to secure a loaded suture spear in the implant receiving port 810, the cavity 820 is reduced in size by threading the handle 850 on threads 855 which mate between the outer shaft 840 and the inner shaft 830. Turning the handle in a first direction, which may be clockwise or counter-clockwise, causes the inner shaft 830 to retract into the outer shaft 840, causing the tines 821, 822, 823 ofthe collett assembly to be forced together, around the base 30 ofthe implant. After impaction, the rear end 30 ofthe implant is released by turning the handle 850 the opposite direction, thereby allowing the tines 821, 822, 823 ofthe collett assembly to emerge from the outer shaft 840. A similar result may be achieved by other means, such as, for example, a simple two position stop system, wherein, in a first stop position, the inner shaft is fully extended, and the tines 821, 822, 823 ofthe collett assembly extend from the end ofthe outer shaft 840 for implant loading or release after impaction, while in a second retention position, the tines 821, 822, 823 ofthe collett assembly are drawn into the outer shaft 840, which results in secure grip on the based 30 ofthe implant. It will be appreciated that the diameter ofthe outer shaft 840 ofthe insertion device 800 should be sufficiently small to facilitate navigation ofthe suture spear loaded into the implant receiving port to a desired location, even in an arthroscopic or laproscopic procedure. In figure 9B, the implant apparatus is shown with a suture spear mounted therein, in readiness for impaction implantation. In figure 9C, an alternate embodiment ofthe loading device 800 is shown wherein the implant receiving port is simply a pair of tines 860, between which an implant is located. The tine ends 861 abut the rear surface 23 ofthe implant, such that upon impaction, the implant is driven into recipient bone. This embodiment ofthe loading device 800 is preferred for implantation of embodiments of this invention, such as that shown in figure 8, since the flexible implant portion 710 is simply situated between the tines 861. It will be appreciated that the tines ofthe implant loading device 800 may form a complete circle around the implant end portion 30, thereby maximizing protection of that portion ofthe implant during implantation thereof.

In figure 10, there is shown a further embodiment 900 ofthe implant of this invention wherein a flange 910 is included as the base ofthe implant. The flange 910 or rear surface 23 ofthe point 20 may further comprise barbs 920. In this embodiment ofthe implant, a piece of soft tissue 940 may be interposed between the implant point 20 and recipient bone 930 upon implantation. As the implant penetrates the soft tissue 940, the flange 910 forms a retention means for the penetrated tissue, essentially tacking the tissue to recipient bone 930 into which the implant 900 is impacted. The barbs 920, if present, assist in gripping ofthe soft tissue by the implant. In yet a further embodiment, the flange 910 may be demineralized at the terminal ends thereof, providing an additional or exclusive site for suture fixation. Tissue 950 is affixed to the suture spear 900 and bone 930, into which the suture spear is impacted, by means of sutures.

In figure 11 A, there is shown a schematic view of one embodiment ofthe suture spear of this invention. In figure 1 IB, there is shown a rear view ofthe suture spear, viewed from the rear ofthe suture spear cylindrical body toward the pointed head. Specific dimensions in millimeters are provided as suggestive of acceptable or preferred dimensions and tolerances, although it will be appreciated that this invention is not limited to these specifics. In figure 1 IC, there is shown a side view of this embodiment of the sutures spear, again with specific tolerances and dimensions shown in millimeters, as exemplary written description of this embodiment ofthe invention. In figure 1 ID, there is shown a side view of this embodiment ofthe suture spear, rotated ninety degrees as compared with the view shown in figure 1 IC, with further specific dimensions shown as suggestive and to complete the written description of this implant. The point 1000 may have a 0.125 maximum point radius, or it may have a 0.5 mm maximum blunt end. It will be appreciated that for all of these dimensions and tolerances, some variations may be permitted, for various embodiments of this invention, without departing from the essential features of this invention.

Suture spears prepared according to the foregoing disclosure have been implanted into humerus by direct impaction without the need for tapping or threading ofthe recipient humerus. We have found, surprisingly, that the suture spears thus implanted have a pull-out strength which is at least equivalent to the strength of number two suture. Accordingly, based on these tests, we anticipate the suture spear of this invention to be fully functional clinically, since the pull-out strength ofthe spears is at least as great as the failure load of commonly used sutures. Where the suture spear of this invention is to be implanted into particularly dense cortical bone, as in, for example, the glenoid rim, it is preferred to use an awl to puncture a hole into which the suture spear may subsequently be impacted. Alternatively, a tapped hole may be created in the recipient bone, and a threaded embodiment ofthe suture spear carefully torqued into the tapped hole. Surprisingly, we have found that the pull out strength and insertion survival of cortical bone suture spears of this invention is greater when the suture spear is impacted into recipient bone, as opposed to threaded insertion ofthe suture spear.

In view ofthe foregoing disclosure, it will be appreciated that this invention disclosure is directed to a cortical bone suture spear, which preferably comprises a pointed head portion, a substantially cylindrical body portion, and a first canal for receiving a suture therethrough. It will be appreciated that a substantially cylindrical portion includes perfectly cylindrical body portions, body portions that are not perfectly cylindrical and body portions having, for example, multiple faces, as in an hexagonal, octagonal or like geometric shape. It is also conceivable that the body portion would be triangular in cross section, and such variation should not be considered to be outside the scope ofthe instant disclosure. In one embodiment, the head portion is substantially conical. In certain embodiments, the cylindrical body portion comprises a second canal for receiving a second suture therethrough. Preferably, for strength considerations, where a second suture canal is present, the second canal is substantially oriented at ninety degrees to the orientation ofthe first canal. Furthermore, in some embodiments of this invention, it is preferred for the cylindrical body portion to comprise, in addition to the head portion having a diameter greater than that ofthe cylindrical portion, an additional retention means in the form of a barb of cortical bone. The maximum diameter ofthe barb and ofthe conical head may be the same or different. Thus, the head maximum diameter may be greater or smaller than that ofthe barb.

In certain embodiments ofthe suture spear of this invention, it is preferred for the pointed head portion to have an external feature inscribed therein in the form of a helical screw thread. In this event, it is preferred for the body portion to include a means for applying torque for insertion ofthe helical screw thread, although in certain preferred embodiments, where a relatively gradual helical thread is inscribed into the head portion, the suture spear bearing such an external feature is impact driven into recipient bone with great success, enhanced pull-out strength, and reduced insertion resistance, at least in part due to the ability to form sharp edges to such threads, thereby reducing frictional drag upon insertion ofthe suture spear bearing this feature. In one embodiment, the pointed head portion has external features inscribed therein in the form of a first thread and a second thread, wherein the first and second threads are substantially parallel, but wherein the first thread has a different diameter than the second thread at any specific point along the pointed head portion.

In some embodiments ofthe suture spear of this invention, a portion thereof is preferably partially or completely demineralized. In one such embodiment, the conical suture spear head portion is partially demineralized at the largest diameter circumference of conical head portion. In another such embodiment, the substantially conical suture spear head portion is partially demineralized to form a hinge portion between adjacent sides ofthe conical head portion.

In practice, we have found that the suture spear of this invention is preferably between about 5 and about 20 mm long. Most preferably, the suture spear is between about 8 and about 15 mm long. In addition, the suture spear conical head portion preferably tapers to a point from a maximum diameter of between about 1 mm to about 10 mm, and most preferably, from a maximum diameter of between about 2.5 mm to about 7 mm, or 3 mm to about 5 mm.

It will further be appreciated, in light ofthe foregoing disclosure, that this invention comprises a method of fixing tissue to bone which comprises suturing such tissue to a cortical bone suture spear. This method is useful in such procedures as repair of rotator cuff injuries in the shoulder, reattachment of tissue at the rim ofthe glenoid socket, repair of slap lesions, Bankhardt procedures, in ACL or other ligament repair, or any other medical procedure in which it is desirable to attach or re-attach tissue to bone. The invention further comprises a method of making a suture spear which comprises harvesting a segment of cortical bone, machining the cortical bone to form said suture spear comprising a pointed head portion, a cylindrical body portion, and a first canal for receiving a suture therethrough. Machining of an additional retention barb, additional suture canals, threads and other features as disclosed and suggested herein also come within the scope of this invention and the claims appended hereto.

In yet a further embodiment of this invention, a suture spear having a rounded head is prepared from cortical bone on a CNC lathe or the like, preferably having a fourth floating axis for a ball and end mill. This embodiment ofthe suture spear may have one or more through canals for receiving one or more suture threads. Alternatively, in an embodiment shown in Figure 12 A, which shows a perspective view of a further embodiment ofthe suture spear of this invention having a rounded tip and an inscribed groove, rather than or in addition to a through canal. In Figure 12 A, the suture spear 1200 has a rounded head portion 1210, a collar portion 1220, and a rear portion 1230. Inscribed into the suture spear 1200 is a suture groove 1240 which starts at one side ofthe rear portion 1230 and proceeds anteriorly toward and over the rounded head portion 1210 and down an opposite side of suture spear 1200 toward the rear portion 1230. The depth and width of the suture groove 1240 is preferably maintained at a constant level sufficient to accommodate a suture within the groove along the rear portion 1230, the collar portion 1220 and the rounded head portion 1210, except that, as shown in figure 12C below, preferably, at the very apex ofthe head 1210, the suture is retained in a slightly deeper notch 1241.

Figure 12B shows a cross-sectional side view ofthe suture spear shown in figure 12A along line A-A in figure 12C. Like parts are numbered as in figure 12 A, but also shown in cross-section is a partial cannulation 1250 for insertion ofthe tip of a suture-spear insertion device. Also shown is the solid, preferably flush rear surface 1231 ofthe rear end 1230 ofthe suture spear 1200 which abuts the end of the insertion device upon application ofthe suture spear onto the inserter.

Figure 12C shows an external side view with optional dimensions in millimeters for one embodiment ofthe suture spear shown in figure 12 A. It will be understood that these dimensions are suggestive only and that variations and modifications of these dimensions may be required, depending on the suture- anchoring operation required and the nature ofthe implant site. For clarity, parts of this view are not labeled as in figures 12A and 12B, except that at the very apex ofthe head 1210, the suture is retained in a slightly deeper notch 1241. Also shown in this view is a slight narrowing 1242 ofthe suture groove 1240 right at the apex ofthe rounded head 1210, due to leaving a slight lip of bone 1242 on either side ofthe groove. This slight lip 1242 on either side ofthe suture groove 1240 assists in retention and loading ofthe suture onto the spear, which preferably is already mounted on an inserter.

Figure 12D shows an end-on frontal view ofthe rounded tip ofthe suture spear shown in figure 12 A. This view emphasizes features ofthe head 1210 of the suture spear 1200, including the groove 1240, the depression 1241, and the narrowing 1242 in the suture groove at the apex ofthe head 1210. Figure 12E shows a cross-sectional view along line B-B shown in figure 12C viewed toward the rear. This view emphasizes the features ofthe collar 1220, including the presence ofthe central partial cannulation 1250, and the suture groove 1240. As can also be seen from this view, the collar has a narrower diameter 1221 as compared to the diameter 1232 ofthe rear end 1230. In this manner, as the suture spear 1200 is caused to penetrate into a recipient's bone, upon passage ofthe head portion 1210 through the cortex ofthe recipient's bone, the rear end 1230 may act as a stop to prevent further penetration, and the cortex ofthe recipient's bone "springs-back" and retains the suture spear 1200 at the collar region 1220. Alternatively, the suture spear may be completely buried in the recipient's bone, and the narrower collar region 1220 facilitates traversal of the broader rear end 1230, which upon penetration into the cortex ofthe recipient's bone, acts as a stop to extrusion ofthe anchor via the flush rear surface 1231 abutting the inside surface ofthe patient's cortical bone.

Figure 12F shows an end-on rear view ofthe insertion hole and rear end ofthe suture spear shown in figure 12A. Emphasized in this view is the rear end 1230 of the suture spear, showing the flush rear surface 1231 ofthe rear end 1230, the instrument attachment hole 1250, and the suture groove, 1240.

In a further embodiment ofthe suture spear 1200 of this invention, the suture spear may have a second suture groove 1240' inscribed at a location spaced apart on the body ofthe suture spear 1200 such that the groove 1240 and the groove 1240' intersect at right angles on the head 1210 ofthe suture spear 1200. In addition, the suture spear may comprise one or more through canals. Such modifications may be employed for procedures requiring multiple suture lines. In addition, it will be appreciated that the suture grooves 1240 and 1240', if present, accommodate required movement and sliding ofthe suture by the surgeon within the groove, thus facilitating formation of required knots and the like at the distal end ofthe suture. Figure 13 A shows an external side view of one embodiment of an insertion device 1300 for the suture spear shown in figure 12A. As can be seen, the inserter 1300 has a front tip 1310 for insertion into the partial cannulation 1250 in the rear end 1230 ofthe suture spear 1200. The diameter of the tip 1310 should be precisely matched to the diameter ofthe partial cannulation 1250 so that a tight fit between the inserter 1300 and suture spear 1200 occurs upon installation ofthe suture spear on the inserter. To provide maximal strength to the inserter, the shaft 1305 ofthe instrument comprises sections 1320 and 1330 of increasing diameters. Naturally, those skilled in the art will appreciate based on this disclosure that modifications on this arrangement may be made without destroying the operative principles ofthe device. At the distal end ofthe inserter, there is provided a handle 1340 which has a distal end 1341. In one embodiment, the distal end 1341 ofthe handle 1340 is a flush surface which may be impacted with a mallet, hammer or like impeller means. In this manner, a suture spear 1200 loaded on the tip 1310 ofthe inserter 1300 may be induced to perforate the cortical surface of a recipient's bone. Since a suture loaded on the suture spear 1200 is protected within the suture groove 1240 the insertion ofthe suture spear firmly seats the suture within the recipient's bone, as disclosed for other embodiments ofthe suture spear disclosed herein.

Figure 13B shows a cross-sectional side view ofthe insertion device 1300 shown in figure 13A along section line A-A. In this embodiment ofthe insertion device 1300', within the handle 1340', there is disposed a means for cushioning, integrating or otherwise averaging an impact applied to surface 1341'. In the embodiment diagrammed in figure 13B, there is provided a dampening means in the form of a spring 1342, which rides at the head of a piston 1343 attached to the head 1344 ofthe shaft 1305. The piston 1343 slidably rides within a cylindrical housing which forms the handle 1340'. Upon impaction ofthe surface 1341', the impact energy is absorbed by the spring 1342 which then conveys the energy to the piston 1343 to drive in a significantly more smooth fashion the penetration of the suture spear 1200 into a recipient's bone. (See figure 15). In an alternative to this embodiment, the insertion device 1300 is a push impactor, with a mechanism such as is known in the art for such a device, such that upon application of a steady force to the handle 1340, a compressive force is stored within the handle and at a pre-determined load, is released, to deliver a known, metered force to the shaft 1305 ofthe inserter 1300. In yet a further embodiment, the inserter comprises both a damping spring 1342 and means for providing a push impactor. In this fashion, use of a hammer, mallet or the like is not required, as the surgeon or other operator ofthe inserter applies force to the handle 1340 and at a predetermined load, the inserter fires, causing advancement ofthe shaft 1305. However, in this embodiment, the damping spring 1342 averages out the metered force over time to provide for smooth insertion ofthe suture spear 1200. To minimize the force required for the suture spear 1200 to penetrate a recipient's bone, preferably an implant hole is first drilled, fashioned with an awl, spike or the like. Preferably, the hole has a diameter smaller than the largest diameter of the head 1210 ofthe suture spear 1200. In this fashion, upon penetration ofthe suture spear into the recipient's bone, a tight fit occurs without splitting the recipient's bone. In addition, traversal ofthe rear end 1230 ofthe suture spear 1200 into the recipient's bone is ensured to create a firm fixation ofthe suture spear in the implant site.

Figure 14 shows the suture spear 1200 of figure 12A mounted on the tip 1310 of the insertion device 1300 of figure 13A, with a suture 1400 mounted thereon and a retainer sleeve 1410 mounted on the shaft ofthe insertion device, over the suture. As can be seen, the suture 1400 is placed within the groove 1240 ofthe suture spear 1200 and is retained within the tip 1210 ofthe suture spear, inside a preferred depression 1241, if present. The retainer sleeve 1410 is preferably mounted over the suture spear 1200 and the suture 1400 mounted on the tip 1310 ofthe inserter 1300. The suture 1400 is thus maintained in a taught condition as shown by suture outline 1400', and held by the surgeon holding the handle 1340. Subsequent to insertion ofthe suture spear 1200 into the implant site, the suture is allowed to slide free from the retainer sleeve 1410 and the inserter 1300 is removed from the suture spear. A further optional feature ofthe retainer sleeve, which may be made from clear, sterile plastic, metal or any other sterile material, is the positioning ofthe proximal end 1415 ofthe retainer sleeve 1410 such that upon impaction of the inserter device 1300, the proximal end 1415 ofthe retainer sleeve 1410 acts as a stop against the surface ofthe recipient's bone, to prevent excess penetration ofthe suture spear 1200 or the inserter 1300.

Having generally described this invention with respect to the method of making and using the suture spear of this invention, including the best mode thereof, the scope of legal protection in which exclusive rights is claimed herein is defined by the claims, and equivalents thereof, which are appended hereto.

EXAMPLES:

EXAMPLE 1

Insertional loading and test results of RTI Grooved internal drive suture spear Forty-two suture spears from from three different donors were manufactured to the specifications as described in Figure 12 A. The anchors were lyophilzed and tested for insertion and pullout in the glenoid rim and rotator cuff locations. SpiderWire with 601bs of tensile strength was utilized instead of metallic cable for pullout testing. Table 1 and 2 describe the results from all ofthe tests. Results - Rotator Cuff

All anchors were successfully inserted in the rotator cuff location. However, one ofthe anchors failed during insertion. This unsuccessful insertion attempt was attributed to the instability ofthe femur while impact loads were being applied. In order to insert an anchor in the simulated rotator cuff location in a pig femur. It required an average of 22 hits (Range: 7-49) between 52 — 1000+ lbf of impact on the inserter. All anchors recorded pullout loads above 112.5N. However, three anchors were noted to pullout below 112.5N. All three of these anchors were in the same pig femur which upon closer examination revealed poor quality low density cancellous bone. Two ofthe anchors were reinstalled in a different location and recorded pullout loads well above 112.5N. Excluding the data points below 112.5N, the average pullout loads were 174N (Range 116-225N, n=17). Many ofthe anchors failed by pullout and appeared intact, however several were observed after pullout to have broken midshaft. In addition, failure also occurred by the spiderwire failing at the knot or untieing. This occurred well above 112.5N. Results - Glenoid Rim

All anchors were successfully inserted in the glenoid rim location. However, three ofthe anchors failed and this was attributed to the fact that the pig femur was not secure in the vice in which it was being held. The unsuccessful insertion attempt was attributed to the instability ofthe femur while impact loads were being applied. In order to insert an anchor in the simulated glenoid rim location in a pig femur. It required an average of 23 hits (Range: 7-57) between 52 — 1000+ lbf of impact on the inserter. The average pullout loads was 189N (Range 133- 282N, n=18). Many ofthe anchors failed by pullout and appeared intact, however several were observed after pullout to have broken midshaft. In addition, failure also occurred by the spiderwire failing at the knot or untieing. This occurred well above 112.5N. Conclusion: The anchors in the current design meet the acceptance criteria.

EXAMPLE 2

Biomechanical Evaluation of a Novel Allograft Suture Anchor

The use of allograft bone has significantly expanded over the past few years as a direct result ofthe development of precision processing technologies. For example, precision machined allograft dowels, interference screws, and pins have recently been introduced into the surgical community. Other potential applications are as a suture anchor, which secures a suture line into a bony substrate. However, in order for these implants to be widely accepted, they must be convenient for the user, successfully withstand insertion loading, and have high resistance to pullout.

Freeze-drying is a common and convenient method for storage of allografts. However, this process makes bone brittle and could impart unacceptable consequences on products that are maintained in such a state. If these mechanisms are understood, products may be properly designed in order to overcome these deficiencies.

The objectives of this study are to describe a novel allograft suture anchor composed entirely of freeze-dried cortical bone, as well as to present our results on the biomechancs of insertion and its resistance to pullout. MATERIALS AND METHODS

Cortical bone from three donors was procured, machined into 35 suture anchors and lyopholized. Specimens from each donor were randomly chosen and placed into two different insertion sites: a glenoid rim location and rotator cuff location. SpiderWire™ (Johnson Worldwide Associates, Inc; Stuartevant, WI) with a tensile strength of 240N was utilized in lieu of #2 suture (USP tensile strength 70N) so that the failure would occur by anchor pullout rather than suture breakage. The porcine femoral head, which is representative of a 50 year old male, was used for the implantation ofthe suture anchors. The intact femoral head represented the glenoid rim location while a trough cut into the femoral head, which removed the cortical bone surface, represented the rotator cuff location. An awl created a 3.0mm hole for insertion ofthe anchor. The suture anchor was inserted into the site with specially designed instruments and a surgical mallet. The mallet was equipped with a lOOOlbf-impact load cell (PCB Piezotronics Depey, NY) which was attached to an oscilloscope to record the maximum impact load and the number of hits to insert the anchor approximately 3mm below the surface ofthe insertion site.

Pullout loads were determined on the MTS Bionix 858 servohydrauhc mechanical test apparatus. The porcine femur was pinned underneath a plate and the Spiderwire™ looped around a hook and pulled parallel to the tunnel. Load applied at the rate of 12.5mm/sec and the maximum load and type of failure recorded. These methodologies were adapted from descriptions in the literature.

RESULTS AND DISCUSSION

All suture anchors were successfully implanted into the rotator cuff (n=17) and glenoid rim (n=l 8) locations. Insertion requirements for the rotator cuff and glenoid rim locations were an average of 22 hits (range: 7-49) and 23 hits (range: 7-57) respectively with the impact loads between 52 - 1,000+ lbf. The pullout loads were 174N (range: 116-225N) and 189N (range: 133 - 282N) for the rotator cuff and glenoid rim location respectively. CONCLUSIONS

Allograft suture anchors may be designed with sufficient strength to exceed insertional loading requirements as well as provide pullout resistance comparable to synthetic anchors and well above the USP strength of #2 suture.

Claims

WHAT IS CLAIMED IS:
1. A cortical bone suture spear.
2. The suture spear according to claim 1 comprising a pointed head portion, a substantially cylindrical body portion, and a first canal for receiving at least one suture therethrough.
3. The suture spear according to claim 2 wherein said head portion is substantially conical, trocar shaped, or wedge shaped
4. The suture spear according to claim 3 wherein said cylindrical body portion comprises a second canal for receiving a second suture therethrough.
5. The suture spear according to claim 4 wherein said second canal is substantially oriented at ninety degrees to the orientation of said first canal.
6. The suture spear according to claim 2 wherein said cylindrical body portion comprises, in addition to said head portion, an additional retention means in the form of a barb of cortical bone.
7. The suture spear according to claim 2 wherein said pointed head portion is substantially conical.
8. The suture spear according to claim 7 wherein said pointed head portion, said cylindrical portion or both, has an external feature inscribed therein in the form of a helical screw thread, and wherein said body portion has a means for applying torque for insertion of said helical screw thread or impaction insertion thereof.
9. The suture spear according to claim 7 wherein said pointed head portion has external features inscribed therein in the form of a first thread and a second thread, wherein said first and said second threads are substantially parallel, but wherein said first thread has a different diameter than said second thread at any specific point along said pointed head portion, and wherein said body portion has a means for applying torque or impaction for insertion of said helical screw thread.
10. The suture spear according to claim 7 wherein said pointed head portion has external features inscribed therein in the form of a first thread and a second thread, wherein said first and said second threads are substantially parallel, but out of phase with each other by approximately one half turn, and wherein the axes about which said first thread and said second thread translate are on either side ofthe central axis ofthe suture spear.
11. The suture spear according to claim 2 wherein a portion thereof is partially or completely demineralized.
12. The suture spear according to claim 3 wherein a portion of said substantially conical suture spear head portion is partially demineralized at the largest diameter circumference of said conical head portion.
13. The suture spear according to claim 3 wherein a portion of said substantially conical suture spear head portion is partially demineralized to form a hinge portion between adjacent sides of said conical head portion.
14. The suture spear according to claim 2 wherein said suture spear is between about 5 and about 20 mm long.
15. The suture spear according to claim 14 wherein said suture spear is between about 8 and about 15 mm long.
16. The suture spear according to claim 2 wherein said suture spear conical head portion tapers to a point from a maximum diameter of between about 1 mm to about 10 mm.
17. The suture spear according to claim 16 wherein said suture spear conical head portion tapers to a point from a maximum diameter of between about 2.5 mm to about 7 mm or about 3 mm to about 5 mm.
18. The suture spear according to claim 1 wherein the longitudinal axis of said suture spear corresponds to the longitudinal axis of a source bone from which said suture spear is machined.
19. The suture spear according to claim 1 wherein said suture spear is freeze- dried.
20. The suture spear according to claim 10 wherein said partially or completely demineralized portion of said suture spear has suture holes formed therein for threading of sutures therethrough.
21. The suture spear according to claim 2 wherein said cylindrical body portion terminates in a flange.
22. The suture spear according to claim 21 wherein said flange comprises a barb.
23. The suture spear according to claim 2 wherein said first canal is substantially oval in shape.
24. The suture spear according to claim 4 wherein said second canal is substantially oval in shape.
25. The suture spear according to claim 1 wherein said suture spear comprises at least one suture-receiving canal running therethrough wherein said at least one suture-receiving canal has a trailing edge facing away from the pointed end of the suture spear which tapers to the full diameter of a cylindrical portion ofthe suture spear, thus forming a channel within which a suture strand slidably rides and is protected against fraying by bone upon insertion.
26. The suture spear according to claim 23 wherein the long axis ofthe oval canal corresponds with the long axis ofthe suture spear.
27. A method of fixing tissue to bone which comprises suturing said tissue to a cortical bone suture spear.
28. The method according to claim 27 wherein said suture spear comprises a pointed head portion, a substantially cylindrical body portion, and a first canal for receiving a suture therethrough.
29. The method according to claim 28 wherein said cylindrical body portion comprises a terminal end away from said pointed head portion which is partially or completely demineralized and through which sutures are threaded.
30. The method according to claim 29 wherein said cylindrical body portion comprises a terminal end away from said pointed head portion in the form of a flange, which grips tissue through which said pointed head portion passes while being implanted into recipient bone.
31. A method of making a suture spear which comprises harvesting a segment of cortical bone, machining the cortical bone to form said suture spear comprising a pointed head portion, a substantially cylindrical body portion, and a first canal for receiving a suture therethrough.
32. A device for implanting a cortical bone suture spear which comprises an impact handle connected to a shaft bearing a means for receiving a cortical bone suture spear therein at the end of said shaft opposite said impact handle, wherein said shaft is slidably mounted within an external tubular housing to which said impact handle is adjustably mounted, such that upon impaction of said impact handle with a cortical bone suture spear mounted within said receiving means, and abutted against a recipient's bone, said cortical bone suture spear is impacted into said recipient's bone.
33. The suture spear according to claim 1 having a rounded head.
34. The suture spear according to claim 33 prepared from cortical bone on a CNC lathe.
35. The suture spear according to claim 1 comprising a rounded head portion, collar portion, a rear portion and a groove inscribed in said suture spear.
36. The suture spear according to claim 35 wherein said groove starts at one side of said rear portion and proceeds anteriorly toward and over said rounded head portion and down another side of said suture spear.
37. The suture spear according to claim 35 wherein said groove is of a depth and width to accommodate a suture.
38. The suture spear according to claim 37 wherein said groove is deeper at the rounded head portion than other portions of said suture spear.
39. The suture spear according to claim 38 wherein said groove is naπower at the apex of said rounded head portion than at other locations along said groove.
40. The suture spear according to claim 1 wherein said suture spear is partially or fully cannulated.
41. The suture spear according to claim 1 wherein said collar portion is smaller in diameter than the rear portion or rounded head portion, or both.
42. The suture spear according to claim 1 wherein said suture spear comprises one or more through channels.
43. A device for inserting a suture spear into a recipient's bone comprising a shaft having a first end and a second end; a tip for engaging said suture spear, said tip being in rigid attachment to said first end of said shaft; and a handle, said handle being attached to said second end of said shaft.
44. The device of claim 43 wherein said suture spear is partially or fully cannulated and said tip is inserted into said cannulation.
45. The device of claim 43 wherein said handle comprises a housing that encloses a slideable piston, said piston comprising a first end that is in contact with a dampening means and a second end that is attached to said second end of said shaft.
46. The device of claim 43, wherein said handle comprises a means for providing a push impactor, such that a upon application of steady a force to said handle, a compressive force is stored within the handle and, at a predetermined load, is released to deliver a known, returned force to said shaft.
47. A method of fixing an object to bone comprising inserting into said bone a suture spear held in contact with one or more sutures, and attaching said suture to said object.
48. The method of claim 47 wherein said object is tissue.
49. The method of claim 47 further comprising forming an implant hole in said bone for receiving said suture spear, whereby damage to the surrounding bone at the insertion site is decreased.
PCT/US2000/020293 1999-07-26 2000-07-26 Suture anchor WO2001006933A3 (en)

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US09/360,584 1999-07-26
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EP2581046A1 (en) * 2011-10-16 2013-04-17 Rold Orlando Da Anchor for fixing tissue in bone
US8894684B2 (en) 2012-05-07 2014-11-25 Medos International Sàrl Systems, devices, and methods for securing tissue using a suture having one or more protrusions
US9060763B2 (en) 2012-05-07 2015-06-23 Medos International Sàrl Systems, devices, and methods for securing tissue
US9060764B2 (en) 2012-05-07 2015-06-23 Medos International Sàrl Systems, devices, and methods for securing tissue
US9095331B2 (en) 2010-12-23 2015-08-04 Medos International Sàrl Adjustable anchor systems and methods
US9179908B2 (en) 2010-11-23 2015-11-10 Medos International Sàrl Surgical filament snare assemblies
US9192373B2 (en) 2012-12-27 2015-11-24 Medos International Sàrl Surgical constructs and methods for securing tissue
US9345567B2 (en) 2012-05-07 2016-05-24 Medos International Sàrl Systems, devices, and methods for securing tissue using snare assemblies and soft anchors
US9532778B2 (en) 2010-11-23 2017-01-03 Medos International Sàrl Surgical filament snare assemblies
US9737293B2 (en) 2013-03-15 2017-08-22 Medos International Sàrl Surgical constructs with collapsing suture loop and methods for securing tissue
US9763655B2 (en) 2012-09-20 2017-09-19 Medos International Sarl Systems, devices, and methods for securing tissue using hard anchors
US9872678B2 (en) 2012-03-30 2018-01-23 Medos International Sarl Surgical filament assemblies

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WO2008090252A1 (en) * 2007-01-25 2008-07-31 Guillen Garcia Pedro Surgical instrument for suturing the skeletal muscle system and surgical technique using same
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US9198653B2 (en) 2010-11-23 2015-12-01 Medos International Sàrl Surgical filament snare assemblies
US9179908B2 (en) 2010-11-23 2015-11-10 Medos International Sàrl Surgical filament snare assemblies
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US9833229B2 (en) 2010-12-23 2017-12-05 Medos International Sàrl Adjustable anchor systems and methods
CN102525583A (en) * 2010-12-23 2012-07-04 德普伊米特克公司 Adjustable anchor system
US9095331B2 (en) 2010-12-23 2015-08-04 Medos International Sàrl Adjustable anchor systems and methods
US8974495B2 (en) 2010-12-23 2015-03-10 Medos International Sàrl Adjustable anchor systems and methods
EP2581046A1 (en) * 2011-10-16 2013-04-17 Rold Orlando Da Anchor for fixing tissue in bone
US9872678B2 (en) 2012-03-30 2018-01-23 Medos International Sarl Surgical filament assemblies
US9060763B2 (en) 2012-05-07 2015-06-23 Medos International Sàrl Systems, devices, and methods for securing tissue
US9345567B2 (en) 2012-05-07 2016-05-24 Medos International Sàrl Systems, devices, and methods for securing tissue using snare assemblies and soft anchors
US8894684B2 (en) 2012-05-07 2014-11-25 Medos International Sàrl Systems, devices, and methods for securing tissue using a suture having one or more protrusions
US9060764B2 (en) 2012-05-07 2015-06-23 Medos International Sàrl Systems, devices, and methods for securing tissue
US9034013B2 (en) 2012-05-07 2015-05-19 Medos International Sàrl Systems, devices, and methods for securing tissue using a suture having one or more protrusions
US9757116B2 (en) 2012-05-07 2017-09-12 Medos International Sárl Systems, devices, and methods for securing tissue
US9795373B2 (en) 2012-05-07 2017-10-24 Medos International Sàrl Systems, devices, and methods for securing tissue using a suture having one or more protrusions
US9763655B2 (en) 2012-09-20 2017-09-19 Medos International Sarl Systems, devices, and methods for securing tissue using hard anchors
US9192373B2 (en) 2012-12-27 2015-11-24 Medos International Sàrl Surgical constructs and methods for securing tissue
US9271716B2 (en) 2012-12-27 2016-03-01 Medos International Sàrl Surgical constructs and methods for securing tissue
US9737293B2 (en) 2013-03-15 2017-08-22 Medos International Sàrl Surgical constructs with collapsing suture loop and methods for securing tissue

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