(12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT)
`
` CORRECTED VERSION
`
`(19) World Intellectual Property Organization
`International Bureau
`
`(43) International Publication Date
`25 April 2002 (25.04.2002)
`
`
`
`PCT
`
`(10) International Publication Number
`WO 02/032345 A3
`
`(51) International Patent Classificati0n7:
`
`A61F 2/08
`
`(21) International Application Number:
`
`PCT/US01/31693
`
`(22) International Filing Date: 10 October 2001 (10.10.2001)
`
`(72) Inventors; and
`JACOBS, Daniel
`(75) Inventors/Applicants (for US only):
`[US/US]; 4289 Brianwood, Palo Alto, CA 94306 (US).
`WEI, Michael [US/US]; 177 N. El Camino Real, No. 18,
`San Mateo, CA 94401 (US).
`
`(25) Filing Language:
`
`(26) Publication Language:
`
`English
`
`English
`
`(30) Priority Data:
`09/691,652
`
`17 October 2000 (17.10.2000)
`
`US
`
`(63) Related by continuation (CON) or continuation-in-part
`(CIP) to earlier application:
`US
`Filed on
`
`09/691,652 (CIP)
`17 October 2000 (17.10.2000)
`
`(74) Agents: HAN, Johney, U. et al.; Morrison & Foerster LLP,
`755 Page Mill Road, Palo Alto, CA 94304—1018 (US).
`
`(81) Designated States (national): AE, AG, AL, AM, AT, AU,
`AZ, BA, BB, BG, BR, BY, BZ, CA, CH, CN, CO, CR, CU,
`CZ, DE, DK, DM, DZ, EC, EE, ES, FI, GB, GD, GE, GH,
`GM, HR, HU, ID, IL, IN, IS, JP, KE, KG, KP, KR, KZ, LC,
`LK, LR, LS, LT, LU, LV, MA, MD, MG, MK, MN, MW,
`MX, MZ, NO, NZ, PH, PL, PT, R0, RU, SD, SE, SG, SI,
`SK, SL, TJ, TM, TR, TT, TZ, UA, UG, US, UZ, VN, YU,
`ZA, ZW.
`
`(71) Applicant 0’or all designated States except US): COAPT
`SYSTEMS, INC. [US/US]; 261 Hamilton Avenue, Suite
`413, Palo Alto, CA 94301 (US).
`
`(84) Designated States (regional): ARIPO patent (GH, GM,
`KE, LS, MW, MZ, SD, SL, SZ, TZ, UG, ZW), Eurasian
`patent (AM, AZ, BY, KG, KZ, MD, RU, TJ, TM), European
`
`[Continued on next page]
`
`(54) Title: INTRAOSSEOUS SOFT TISSUE—TO—BONE ANCHOR
`
`
`
`02/032345A3
`
`(57) Abstract: This is a surgical device. More particularly, it is an intraosseous anchor for securing soft tissue, such as a tendon or
`ligament, to a cavity formed in a bone. The device itself preferably is formed in such a way that the soft tissue is pressed against the
`bone by the device to accelerate growth by the soft tissue and attachment to the bone. The device preferably utilizes anchor barbas
`O on its exterior to grasp the soft tissue under conditions of improved distribution of tension and with a minimal disruption of the
`soft tissue—bone interface and the allied nutrient supplies. the anchor and soft tissue may be treated with osteogenic growth factors.
`Various processes of using the device are also shown.
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`|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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`patent (AT, BE, CH, CY, DE, DK, Es, FT, FR, GB, GR, IE,
`IT, LU, MC, NL, PT, SE, TR), OAPI patent (BF, BJ, CF,
`CG, CI, CM, GA, GN, GQ, GW, ML, MR, NE, SN, TD,
`TG).
`
`Published:
`
`7 with international search report
`
`(48) Date of publication of this corrected version:
`21 August 2003
`
`(15) Information about Correction:
`see PCT Gazette No. 34/2003 of 21 August 2003, Section II
`
`(88) Date of publication of the international search report:
`6 September 2002
`
`For two-letter codes and other abbreviations, refer to the ”Guid-
`ance Notes on Codes andAbbreviations " appearing at the begin-
`ning ofeach regular issue ofthe PCT Gazette.
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`INTRAOSSEOUS SOFT TISSUE-TO-BONE ANCHOR
`
`FIELD OF THE INVENTION
`
`This invention is in the field of surgery. More particularly, it relates to an
`
`intraosseous anchor for securing soft tissue, such as a tendon or ligament, to a cavity
`
`formed in a bone. The device itself preferably is formed in such a way that the soft tissue
`
`is pressed against the bone by the device to accelerate growth by the soft tissue and
`
`attachment to the bone. The device preferably utilizes anchor barbs on its exterior to
`
`grasp the soft tissue under conditions of improved distribution of tension and with a
`
`minimal disruption of the soft tissue-bone interface and the allied nutrient supplies. The
`
`invention also includes combinations of the device with the soft tissue graft and various
`
`growth factors. Processes of using the inventive device are also a portion of the
`
`invention.
`
`DESCRIPTION OF RELATED ART
`
`There are a variety of orthopedic surgery procedures which sometimes require the
`
`attachment or reattachment of soft tissue flexible members to a bone. One such common
`
`procedure is the replacement of an anterior cruciate ligament graft in the knee. The ends
`
`of such grafts are typically attached within bone tunnels drilled into the respective bones.
`
`The attachment is then completed by use of a compression or interference—fit screws or
`
`the like.
`
`Typical of such devices used to press one end of a flexible member against the
`
`interior wall of a bone cavity include US. Patent Number 6,123,711, to Winters, US.
`
`Patent 5,454,811, to Hubner; US. Patent 5,425,767, to Steininger et a1. ; and US. Patent
`
`10
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`15
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`20
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`25
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`5,062,843, to Mahony.
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`No cited references show the devices nor the procedures described herein.
`
`SUMMARY OF THE INVENTION
`
`As noted below, this invention relates to an intra-osseous soft tissue-to-bone
`
`anchor for contacting soft tissue with an opening in a bone. The device is made up of a
`longitudinal fixture having a distal and a proximal end and an exterior surface. The
`
`proximal end preferably has an opening (generally integral with the exterior surface cavity
`
`discussed just below) for passage of the soft tissue graft proximally of the device. The
`
`distal end preferably is configured for entry into that bone opening. The exterior surface
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`preferably has at least one external cavity containing anchor barbs to graspingly accept the
`
`soft tissue and they are sized and oriented to press the soft tissue within the bone opening
`
`10
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`against the bone wall. The exterior surface is also adapted for anchoring the anchor in the
`
`opening.
`
`The exterior surface cavity preferably is longitudinal along the body of the device.
`
`There may be more than one cavity. Desirably, at least one diametric passageway extends
`
`between or among the various multiple exterior cavities for passage of soft tissue.
`
`15
`
`The distal end generally is adapted for entering the bone opening by, e.g.,
`
`chamfering the end or providing a distal end opening.
`
`., The exterior surface may be adapted for anchoring in the bone opening via
`
`placement of, e. g., one or more circumferential ridges or knob-like protuberances on the
`
`exterior surface or by use of movable protuberances perhaps which are movable and rotate
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`20
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`into the exterior surface from the interior.
`
`The exterior surface itself is generally cylindrical (allowing, of course for the
`
`exterior cavities). The surface may be threaded or have a cut from one end to the other
`
`allowing a snap fit into a generally cylindrical shape from a generally spiral shape. The
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`interior surface may include soft tissue barbs. The anchor may be of a shape which is
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`25
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`notched to provide a “splay” at the proximal end and provide tension against the bone
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`interior wall. The device may be formed in two parts: a saddle part making up a portion
`
`of the exterior surface and having an inner surface and a rail part which slides into the
`
`saddle part and forms the external cavities.
`
`The exterior surface may be a folded “V” having a distal fold, an exterior wall,
`
`and an opening through said exterior wall near the fold or it may also be a generally
`
`rectangular sheet having at least one passageway between the proximal end and the distal
`
`end for passage of soft tissue between the proximal and distal end, perhaps having
`
`exterior protuberances and soft tissue barbs in the passageway.
`
`x
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`Additionally, the anchor structure may have extendable spring wings or arms
`
`which extend into the softer bone areas beneath the cortical plate. The proximal end may
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`10
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`be made up of multiple longitudinal spring arms splayed at (or making up) the proximal
`end.
`i
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`The inventive anchor is preferably made of at least on biodegradable polymer or
`copolymer, such as polyglycolide, polylactide, poly-a—caprolactone, polydiaxanone,
`
`polyglyconate, polylactide-co-glycolide, their mixtures, alloys, and random and block
`
`copolymers.
`
`15
`
`The various devices may further be a combination of the soft tissue graft and an
`
`osteogenic growth factor.
`
`Another variation of the inventive device is a spiral intra—osseous soft tissue-to-
`
`bone anchor made up of a spirally wound sheet having a longitudinal axis, an interior
`
`surface for graspingly accepting a soft tissue, e. g., a tendon and ligament, along that axis
`
`20
`
`when the spirally wound sheet is collapsed around the soft tissue. The exterior surface is
`
`adapted, by integral or formed grooving or by radial protruberances to anchor to the bone
`
`opening. The spirally wound sheet may be foraminous or not. The interior surface may
`
`be grooved or have anchor barbs to grasp and hold the soft tissue graft in the anchor.
`
`The materials of construction for this variation are the same as those mentioned
`
`above. Similarly this variation may include the soft tissue graft and an osteogenic growth
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`25
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`factor.
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`BRIEF DESCRIPTION OF THE DRAWINGS
`
`Figures 1A, 1B, 1C show respectively perspective and cross-sectional views of
`
`one variation of the inventive anchor device having external cavities for pressing soft
`
`tissue against the surface of a bone cavity.
`
`Figure 2A shows another variation of the inventive device which uses a spring ,
`
`pressure to maintain placement of the device within the bone cavity.
`
`Figure 2B shows steps of installing the device of Figure 2A in a bone cavity.
`
`Figure 3 shows another variation of the inventive anchor device.
`
`Figures 4A and 4B show respectively a side view and end views of the variations
`
`of the inventive anchor device in which the barbs mechanically expand from the interior
`
`of the device into the bone.
`
`Figure 4C shows manner in which the device may be molded in a single piece and
`
`assembled.
`
`Figure 4D shows the introduction of drive pin into the device of Figures 4A, 4B,
`
`and 4C to mechanically expand the barbs.
`
`Figures 5A, 5B, and 5C show, respectively, perspective and end views of the
`
`device made according to the invention.
`
`Figure 6A shows a perspective View of a two-piece variation ofthe inventive
`
`anchor device.
`
`Figure 6B shows an in View of the assembled Figure 6A device.
`Figures 7A and 7B show, respectively, side and end views of a variation ofthe
`
`device having exterior soft tissue cavities and exterior spring catches for anchoring the
`
`device within the bone.
`
`Figures 8A and 8B show, respectively, side and end views of a bone anchor made
`
`according to the invention having no interior cavities.
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`10
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`15
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`Figures 9A and 9B Show, respectively, side and end views of a screw-like device
`
`having exterior soft tissue cavities.
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`Figures 10A and 10B show, respectively, side and end views of a snap-fit spiral
`
`realm device for pressing soft tissue into bone cavity.
`
`Figures 11A and 11B show, respectively, side and end views of a snap-fit device
`
`in which both the interior and exterior of the device are equipped with barbs to hold soft
`
`tissue in place.
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`10
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`15
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`Figures 12A and 12B show, respectively, cross-sectional and end views of a
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`conical device having soft tissue barbs on the interior.
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`Figures 13A, 13B, 13C, and 13D show respectively a top View, side View, end
`
`view, and a view as-installed in a slot—shaped cavity in a bone.
`
`Figures 14A and 14B show respectively top views and side views of a device
`
`made according to the invention having exterior and interior cavities equipped with soft
`
`tissue barbs for retaining soft tissue in the device. This variation is also installed in a slot—
`
`shaped cavity in a bone.
`
`Figures 15A and 15B show respectively a perspective View and as—installed, cross-
`
`sectional view of a device made according to the invention. This variation is a
`
`foraminous device which utilizes a groove on the interior to grasp the soft tissue and a
`
`groove on the exterior to secure the assembly to the bone.
`
`fl
`
`Figure 16 shows a variation of the device shown in Figures 15A and 15B having
`
`interior tissue-grasping tines and exterior protuberances for securing the device to the
`
`20
`
`bone.
`
`Figure 17 shows a variation of the device depicted in Figures 15A and 15B which
`
`is not foraminous.
`
`‘ Figure 18 shows a variation of the device shown in Figure 15A having alternative
`
`for grasping the bone and the soft tissue.
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`Figures 19A, 19B, and 19C show, respectively, a perspective View, a cross-
`
`sectional View, and as—installed view of device which grasps soft tissue using an interior
`
`, spring-like member.
`
`Figures 20A, 20B, and 20C show, respectively, a perspective View, side view
`
`,
`
`(during installation), and a side View (after installation) of variation of the invention
`
`device which snap—fits into a bone cavity.
`
`Figures 21A, 21B, and 21C show, respectively, side view of variation of the
`
`inventive device during installation, after installation, and a side, cross-sectional View
`
`after installation.
`
`DESCRIPTION OF THE INVENTION
`
`10
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`15
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`As noted elsewhere, this invention is an intraosseous anchor for securely attaching
`
`‘ soft tissue such as a tendon or ligament to a cavity specifically produced by surgeon for
`
`holding the inventive device. Preferably, although not necessarily as will be shown
`
`below, the device is fashioned in such a way that it holds the soft tissue against the
`
`interior surface of the bone cavity. Further, it is highly desirable that the inventive device
`
`and the soft tissue be installed in a single step. Generally, or at least preferably, the
`
`devices will entail external or internal cavities which are situated in such a way that the
`
`l device will grasp the soft tissue using some type of soft tissue attachment points.
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`20
`
`Generally, we will refer to those attachment points as “tines” or “prongs”. These tines
`
`will refer both to points which are either sharp, i.e., able to separate tissue at chosen use,
`
`or blunt, i.e., not able to separate tissue in that use. The attachment points may also be
`
`referred to as “barbs” when those points have retaining point positioned in several of the :
`
`figures discussed below.
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`The shape of the soft tissue points or barbs may be varied depending upon the size
`
`and type of tissue requiring grasping. Various tines or barbs may canted or erect. Various
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`shapes include those approximating thorns, arrowheads, hooks, nails, sharpened pencils,
`
`or the like. The attachment points may be canted in a selected direction or may be radial
`
`in direction. They may be barbed, double barbed, or the like, all as desired. Further
`
`information relating to these barbs or tines may be found in US. Patent Application Serial
`
`No. 09/574,603 May 19, 2000, (attorney docket No. 23569-20001.00), the entirety of
`
`which is incorporated by reference.
`
`We prefer to use biodegradable polymers as materials of construction in our
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`10
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`devices. Polymers synthesized from monomers comprising esters, anhydrides, ortho
`
`esters, and amides are suitable for use as biodegradable materials. Specific examples of a!
`
`biodegradable polymers are polyglycolide, polylactide, poly-oc—caprolactone,
`
`polydioxanone, polyglyconate, copolymers of polylactide and polyglycolide, and the
`
`15
`
`block and random copolymers of these polymers. Copolymers of glycolic, lactic, and
`
`other oc-hydroxy acids are highly desirable. Although we prefer to use a single polymer or
`
`copolymer in a specific device, generally for ease of construction by molding, the
`
`invention is not so limited. Of course, an example of the inventive device may be made
`
`of two or moretypes of polymers or copolymers, or of differing molecular weights of the
`
`same polymer or copolymer. For instance, the backing material might be produced from a
`
`more flexible polymer and the points or tines from a stiffer material. These polymers
`
`have been safely used in suture materials, stents, drug delivery devices, orthopedic
`
`fixation devices, and intestinal anastomotic rings.
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`By “soft tissue” herein is normally meant tendons or ligaments. This is so simply
`
`because the body readily grows natural connections between these types of soft tissue and
`
`bone. In some instances, muscle fibers may be included.
`
`In any event, the soft tissue may be autologous material, allograft material,
`
`xenograft, and organic or inorganic material, and mixtures or engineering constructs of
`
`the materials. For instance, suitable ligament xenografts are described in US. Patent No.
`
`‘ 6,110,206, to Stone, and tissue-engineered tendons and ligaments are shown in US.
`
`Patent No. 6,023,727, to Vacanti et a1. Harvested or donor soft tissue is an obvious
`
`choice for the soft tissue described herein.
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`10
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`As noted above, each of the devices described herein as of the type is installed as a
`
`combination of the inventive device and the soft tissue graft. This invention includes
`
`combinations of the soft tissue graft and the inventive anchor.
`
`Finally, the invention includes independent combinations of the inventive anchor,
`
`15
`
`soft tissue, and certain growth factors. Bone healing is an intricate biologic process in
`
`which the home’s structural integrity is restored through the regeneration of bone. Recent
`
`' orthopedic literature has focused on proteins that enhance bone formation, thus increasing
`
`the "osteoinductive" potential. Specific proteins called growth factors have been shown
`
`to play a role in osteoinduction. These include bone morphogenetic protein (BMP),
`
`transforming growth factor beta (TGFB), platelet derived growth factor (PDGF), ,
`
`fibroblast growth factor (FGF) and insulin-like growth factor (ILGF). Of these, BMP has
`
`proven to be the most potent osteoinductive agent in laboratory animals by Cook (CORR
`
`310: 1994), Gerhart (CORR 293: 1993), and Yasko (JBJS 74: 1992). Indeed, studies are
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`20
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`25
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`now beginning on human subjects (Boden, AAOS abstract, Anaheim 1999).
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`BMP's are growth factors that can be made in large quantities with current
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`recombinant gene technology. Absorbable polymers have been shown to be good carriers
`
`for BMP and promote new bone formation in vitro (Boyan, J Biomed Mater Res, July
`
`1 999).
`
`The noted growth factors may be introduced variously onto the surface of the
`
`anchors, into the interior of the inventive anchors, or to the soft tissue graft, particularly
`
`the soft tissue graft portion that is introduced into the cavity formed within the bone.
`
`EXTERNALLY PLACED CAVITY SOFT TISSUE-TO—BONE ANCHORS
`
`Figures 1A shows the firstvariation of inventive anchor (100). Anchor (100) has
`
`a distal end (102), a proximal end (104), and an exterior surface which has at least one
`
`cavity (106) with soft tissue barbs (108). As may be seen from Figure 1C, the exterior
`
`cavity ( 106) may be repeated, e.g., (110), on other parts of the device (100). The exterior
`
`cavities (106), (110) are sized in such a way that the barbs (108) press into the soft tissue
`
`and in turn, the back walls of the cavities (106), (110) press the soft tissue against the
`
`bony wall into which device (100) is placed. It is common in these types of orthopedic
`
`procedures to drill a hole of a specific size into the bone suitable for accepting the device.
`
`The device is introduced via simple pressure or by impact. Also found in Figure 1A is a
`
`transverse passageway (112) which passes (as shown in Figure 1B) from exterior cavity
`
`(106) to exterior cavity (110). The soft tissue, as should be apparent, is usually long and
`
`passes along one of the exterior cavities (106), (110) through passageway (112) and
`
`returns towards proximal end (104) via the remaining exterior cavity (106), (110). The
`
`shaft of the longitudinal fixture forming the anchor (100) may also have a variety of
`
`protuberances (114) placed along the shaft.
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`The distal end (102) of device (100) is adapted for entering the cavity formed in
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`the bone. Such adaptation may include chamfering, e.g., via the chamfer (116) as shown
`
`in Figure 1A and, perhaps with the distal passageway (118) also shown in Figure 1A.
`
`Distal passageway (118) may be generally for pressure release of fluids during
`introduction ofthe device (100) into the chosen or crafted bone cavity. It also allows
`
`nutrient passage to the soft tissue during its traverse through passageway (112).
`
`Figure 2A shows another variation of the inventive device (130). This variation of
`
`the invention relies, in addition to the exterior protuberances or barbs (132) upon an
`
`included spring action between the halves (134), (136) of the device. The slot (138)
`
`between halves (134), (136) allows such a spring action as is shown in Figure 2B. In any
`
`. event, the proximal end (140) of the device includes an opening (142) which is a portion
`
`of the exterior cavity (144). Second cavity (146) is also found in the variation (130)
`
`shown in Figure 2A.
`
`Figure 2B shows the steps of introducing the device shown in Figure 2A into a
`
`cavity (148) in bone (150).
`
`As shown in step 1 of Figure 2B, the inventive device (130) has a certain amount
`
`of “splay”. This splay provides (depending on the composition of the material, of course)
`
`some definite amount of overall springiness which is used to secure the device (130) in
`the hole (148) when as shown in step 2. The pathway of soft tissue (152) through the
`
`device is also shown in step one of Figure 2B. The soft tissues wends its way through
`
`passageway (154), through slot (138), through passageway (156), along the partial
`
`longitudinal cavity (146), and back through passageway (158) into slot ( 138). In this way,
`
`the soft tissue is held both in the external cavity (142) through which it protrudes out of
`
`the bone through opening (144) and along passageway (146). It is within the scope of the
`
`invention that soft tissue barbs be found in each of exterior cavities (144) and (146).
`
`Further, the shorter exterior cavity (146) may be extended to the proximal end of the
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`device (130) if so desired.
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`Figure 3 shows another variation of the inventive anchor (160), again utilizing a
`
`slot (162) which provides springiness between the halves (164), (166) of device (160). In
`
`this instance, the external protuberance is (168) are ridges which are generally
`
`circumferential around non-cavity portions of the exterior surface of the device (160).
`
`This variation (160) similarly has soft tissue barbs (170) and a cross passageway (172).
`
`The opposite face of the device (160) shown in Figure 3 may or may not have an exterior
`
`cavity as is shown in the view of Figure 3. The distal portion of the device is also
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`adapted, perhaps by a chamfer (176) and a distal passageway (178) to allow introduction
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`of the device (160) into a chosen bone opening. It should be apparent that the opening
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`(178) is placed there to prevent “pressure 100 ” during installation and passage of
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`nutrients to the soft tissue in passageway (172), but it should be noted nonnally it would
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`pass all the way into and intersect into passageway ( 172). It need not, however, do so.
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`Figure 4A shows a variation (180) of the device in which the radial protuberance
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`is (182) mechanically deployed using a pin (184) (as shown in Figure 4D) after the device
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`(180) and its attendant soft tissue are placed in the crafted hole in the boneface. As is the
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`case with the variations discussed above, this variation (180) may include a cross
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`passageway (184), one or more exterior cavities (186) With soft tissue barbs (188). The
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`distal end (190) may also include a chamfer (192) and a longitudinal, distal passageway
`(184). The moveable bone barbs or protuberances (182) are considered a portion of the
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`external surface of this device.
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`Figure 4B shows an end View of a device (180) displaying the moveable radial
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`protuberances (182) and, in this case, two external cavities (186). As noted above,
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`although two external cavities (186) are shown here, the number of external cavities may
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`only be a single one or may be a multiplicity, e. g., two, three, four or more. The seam
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`(188) allowing the device to be molded in a single piece is seen.
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`Figure 4C shows device (180) in an “as molded” condition. By careful design,
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`this device may be molded in a single piece. The rotating barbs (182) are hinged so that
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`as they rotate towards the exterior device upon the impetus of pin (184) as shown in
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`Figure 4D, they dig into the interior of the crafted bone hole and secure device (180) in
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`place.
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`Figure 5A shows another variation of the inventive device (190) having four
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`spring arms, two spring arms (192), (194) having exterior cavities (196) for soft tissue
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`passage. Similarly, the other two spring arms (198) and (200) include protuberances
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`(202) for engagement with the interior of the bone hole. Again, the exterior cavities (196)
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`include soft tissue barbs (204).
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`Figure 5B shows the splay of the various spring arms (198), (200) (with
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`protuberances (202)) and spring arms (192), (194) with external cavities ( 196).
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`Figure 5 C shows device (190) after installation in a bone hole (Without soft tissue
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`or, indeed, the bone) to show how the various spring arms are pulled together when
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`installed in a hole in the bone.
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`Figure 6A shows a two part device (210) made up of a saddle section (212) and a
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`rail portion (214). As a side note, although each of these devices allows relatively easy
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`adjustment of the length of the soft tissue to be used with the inventive anchor, this
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`variation may be the easiest to use. The saddle portion (212) may include the external
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`protuberances (216) as are described elsewhere and a distal end (218) having a chamfer
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`220 and an optional distal passageway (222) (not seen in Figure 6A). In any event, the
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`saddle portion (212) includes slots (224) to allow engaging keys (226) to slide down to
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`engagement notches (228) to secure locking between rail portion (214) and saddle portion
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`(212).
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`In this variation, the as assembled includes one or more cavities (228) having at
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`least one proximal opening to allow passage of the included soft tissue proximally of the
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`device. Again, the external cavities (228) preferably having soft tissue barbs (230)
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`included therein.
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`Figure 6B shows an end View of the assembled device having rail portion (214)
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`Within saddle section (212). The external protuberances (216) for holding the device
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`(210) within the bone cavity is also shown. The slot (218) as shown in Figure 6A is also
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`seen in Figure 6B.
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`Figure 7A shows a side View of a variation of the device (250) having two
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`separate methods of providing springing to the device (250). Particularly, the device has
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`extensions (252) which are preferably made of spring metal such as a biocompatible
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`stainless steel, or preferably nickel-titanium, material, such as nitinol. These wings (252)
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`preferably are spaced in such a way that When they extend after installation, they are in the
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`“marrow” portion of the bone below the cortical plate. Indeed it is preferred that Wings
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`(252) expand and are held against the lower side of the cortical plate. Additionally, the
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`proximal end (254) of the device (250) may be splayed about the slot (256) in the manner
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`shown in several of the variations described above. This allows a secure fixation of
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`device (250) within a hole in a bone. This variation shown in Figure 7A and as shown in
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`Figure 7B similarly has one exterior cavity (258) preferably with soft tissue barbs (260) as
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`has been noted above.
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`Variation (250) includes as a portion of its at least one exterior cavity (258), a
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`proximal opening to allow soft tissue to extend proximally of the device (250). Also, as
`sh6wn in Figure 7B, the interior ofthe device (250) may be equipped with soft tissue
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`barbs 264 for additional fixation of the soft tissue included with this device.
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`Figures 8A and 8B show respectively side and top views of a device (266) much
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`as is shown in Figures 7A and 7B but without an interior cavity for grasping a soft tissue.
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`Instead, in this instance, the soft tissue passes down one exterior cavity (268), preferably
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`having included soft tissue barbs (270) for grasping the soft tissue. The graft then passes
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`through a diametric passageway (273) into the opposite exterior cavity (275) where it
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`preferably is held in place by more tissue barbs. This variation of the inventive anchor
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`(266) clearly places a substantial length of soft tissue graft against the wall of the bone
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`hole. Additionally, the device (266) has a V-shaped slot (277) providing a bit of “splay” at
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`the proximal end. As was the case with the device shown in Figures 7A and 7B, the
`device includes lower spring arms (272) which preferably are situated below the cortical
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`plate when the device is installed.
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`Figures 9A and 9B show still another variation of the invention (290) including
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`screw threads (292) which, in conjunction with upper slot (294) may be used to twist the
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`device (290) into a hole (threaded or not) in a bone.
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`This device (290) includes one or more longitudinal exterior cavities for grasping
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`the soft tissue. The proximal end of device (290) includes holes (298) at the end of one or
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`more exterior cavities (296) to allow the soft tissue to proceed from anchor (290)
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`proximally to another site. The distal end (300). is also adapted to enter the chosen bone
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`hole. It may be modified to include a thread cutting portion at that distal end (300).
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`Figure 10A shows a side View of a device (3 00), that as shown in Figure 10B and
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`10C, snaps into a generally cylindrical shape after introduction into the bone hole. The
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`installed form is generally a cylinder but contains one or more external cavities for
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`passage of the soft tissue. The external protuberances (304) and soft tissue barbs (306)
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`are shown in this variation. Again, the device is carefully sized in relation to the chosen
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`diameter of the hole, so that there is a tight fit when it progresses from the unsnapped
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`‘ shape as shown in Figure 10B toithevsnapped shape—asshown fiilly installed in Figure
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`1 0C.
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`Figures 11A and 11B show a variation of the device shown in Figures 10A, 10B,
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`and 10C. In this instance, the radial protuberances (310) on the device (312) are of a
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`different form in that they are teeth or blocks rather than being ridges as shown in Figure
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`10C. Furthermore, the interior (314) of the device includes soft tissue barbs (316) to
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`allow further grasping attachment of the soft tissue device. Again, the device shown in
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`Figure 11B is inserted loosely into the bone hole and snapped into shape as shown in
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`Figure 10C after the device and its attendant soft tissue are properly positioned.
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`OTHER SOFT TIS SUE—TO-BONE ANCHORS
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`In this section are described a number of interosseous soft tissue-to-bone anchors
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`in which the anchors themselves may or may not have external cavities for pressing the
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`soft tissue against the bone hole provided for their introduction.
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`Figure 12A shows one such variation (320). In this variation, the proximal end
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`(322) is smaller than the distal end (324). The soft tissue is preferably simply knotted in
`the device and installed in th