(19)
(11)EP 3 019 090 B1

(12)EUROPEAN PATENT SPECIFICATION

(45)Mention of the grant of the patent:
06.05.2020 Bulletin 2020/19

(21)Application number: 14713335.9

(22)Date of filing:  06.03.2014
(51)Int. Cl.: 
A61B 17/04  (2006.01)
(86)International application number:
PCT/US2014/021302
(87)International publication number:
WO 2015/005951 (15.01.2015 Gazette  2015/02)

(54)

DISTAL TIP TWO PIECE EXTERNAL EXPANSION ANCHOR

ZWEITEILIGER EXTERNE SPREIZANKER MIT DISTALER SPITZE

ANCRAGE D'EXPANSION EXTERNE À DEUX COMPOSANTS À POINTE DISTALE


(84)Designated Contracting States:
AL AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HR HU IE IS IT LI LT LU LV MC MK MT NL NO PL PT RO RS SE SI SK SM TR

(30)Priority: 10.07.2013 US 201361844674 P

(43)Date of publication of application:
18.05.2016 Bulletin 2016/20

(73)Proprietor: Smith & Nephew, Inc.
Andover, MA 01810 (US)

(72)Inventors:
  • LUNN, Richard M.
    Kingston, Massachusetts 02364 (US)
  • YOUNG, Timothy
    Natick, Massachusetts 01760 (US)
  • KOSKI, Matthew Edwin
    Westford, Massachusetts 02760 (US)
  • SLUSARZ, John
    Hopedale, Massachusetts 01747 (US)
  • DUHAMEL, Paul R.
    Groton, Massachusetts 01450 (US)
  • FAN, Wei Li
    Boston, Massachusetts 02116 (US)
  • ASTORINO, Steven
    Norfolk, Massachusetts 02056 (US)

(74)Representative: Smith & Nephew 
Group Legal Department PO Box 81 101 Hessle Road
Hull HU3 2BN
Hull HU3 2BN (GB)


(56)References cited: : 
WO-A1-98/38938
US-A1- 2013 158 597
US-A1- 2009 149 883
  
      
    Note: Within nine months from the publication of the mention of the grant of the European patent, any person may give notice to the European Patent Office of opposition to the European patent granted. Notice of opposition shall be filed in a written reasoned statement. It shall not be deemed to have been filed until the opposition fee has been paid. (Art. 99(1) European Patent Convention).


    Description

    BACKGROUND



    [0001] Surgeons use a variety of suture anchors to conduct soft tissue repair procedures. For these procedures, one or more sutures called "repair" sutures are attached to a suture anchor, which is or will be fixed to bone. The repair sutures are used to tie soft tissue down to the bone. There are many challenges to joining a repair suture to a suture anchor.

    [0002] One kind of suture anchor used in soft tissue repair procedures is secured into/within bone through an interference fit with a pre-drilled bone hole. Maximum interference fit is desirable because it results in higher bone fixation strength and less chance of the anchor pulling out of bone. The issue arises, however, when attempting to obtain the maximum interference fit with small diameter anchors (e.g., on the order of 1mm- 3mm).

    [0003] As anchors decrease in diameter without height change, their column strength also decreases. Lower column strength makes it more difficult to insert small diameter anchors into bone, especially when the bone is dense. In short, because small diameter anchors are less structurally sound and require greater force to insert them, there is an increased risk of small diameter anchors failing when inserting them.

    [0004] Another kind of suture anchor used in soft tissue repair is an expanding suture anchor. Expanding the suture anchor inside a bone hole creates a radial force of expansion. This force presses against of the walls of the bone hole and secures the anchor to the bone. One of the problems with the expanding anchor is that once expanded, there is no way of knowing that the expansion of the anchor has been retained with surrounding pressure from the bone hole pressing back in on the radial force of expansion.

    [0005] US2013/0158597 describes methods and devices for anchoring suture to bone. A suture anchor is provided that includes a proximal component, a distal component, and an intermediate component positioned between the distal component and the proximal component. The proximal and distal components can each be configured to move independent of one another and to move relative to the intermediate component. In this way, the proximal, intermediate, and distal components of the suture anchor can be configured to cooperate with one another to prevent removal of the suture anchor from a bone hole in which the suture anchor is disposed and to lock a suture relative to the suture anchor and to the bone hole.

    [0006] WO98/38938 describes anchoring devices and methods for coupling an object, such as a suture or soft tissue, to bone. A bone anchor (4) is placed into compression fit with a predrilled bone hole by pulling an insertion stem (2) at least partially into an anchoring element (4). In its non-expanded state, the anchoring element (4) is slidably mounted on the proximal end (9) of the insertion stem (2). As the insertion stem (2) is pulled through a channel in the anchoring element (4), it causes the walls of the anchoring element (4) to expand outwardly, to engage the bone hole walls in a pressure or compression fit.

    [0007] US2009/0149883 describes an anchor device and system for coupling soft tissue to ossesous tissue which includes a stopper member that supports a loop of suture material. A fixing member includes features that allow it to be rigidly coupled to surrounding bone and thus hold the stopper member in a cavity within the bone. The loop of suture material, in turn, supports a second suture device, which is coupled to, and thus retains, the soft tissue. In certain embodiments, the stopper member includes a mechanical linkage for coupling it to the fixing member, and surface features that resist withdrawal of the fixing member from the bone.

    SUMMARY



    [0008] The invention is defined in the appended claims. Described herein are examples of a suture anchor for soft tissue repair that address the foregoing shortcomings and others as well. In one aspect, at least one example described herein provides a suture anchor. The suture anchor includes a cannulated non-expandable body comprising a distal end having a first portion and a second portion, a proximal end configured to engage a suture anchor insertion instrument, and a plurality of projections extending, radially, from an outer surface extending between the distal end and proximal end. The plurality of projections are configured to compress into bone. The suture anchor also includes an expandable cap defining a cavity configured to engage the distal end of the cannulated non-expandable body. The cavity has a diameter larger than the first portion and smaller than the second portion that allows the expandable cap to expand radially outward and compress into the bone during engagement of the distal end of the cannulated non-expandable body and the expandable cap. The suture anchor also includes a suture extending from the cavity of the expandable cap and slidably received within the cannulation of the non-expandable body. The non-expandable body and the expandable cap each comprise complementary engagement features configured to mechanically engage with each other to lock the non-expandable body and the cap together and to inhibit the expandable cap from returning to an unexpected state. The expandable cap further comprises a terminal surface adjacent the cavity defining a first aperture, a second aperture, and a bridge separating the first aperture and the second aperture. The suture extends around the bridge, and a first free end and a second free of the suture are routed through the first aperture and second aperture, respectively, and through the through hole toward the proximal end of the cannulated non-expandable body. The first free end and the second free may be coupled together.

    [0009] In another example, the suture anchor may further include one or more of the following, alone or in any combination. In some examples of the suture anchor, the distal end is a truncated conical section having a first diameter and a second diameter larger than the first diameter. In some examples of the suture anchor, the first portion of the distal end does not engage a surface of the cavity and the second portion of the distal end engages the surface of the cavity.

    [0010] The proximal end may include a protrusion or recess configured to engage a complementary recess or protrusion, respectively, of a suture anchor insertion instrument. The plurality of projections may comprise a plurality of annular ribs, wings, or a combination of annular ribs and wings.

    [0011] The cavity may have a shape complementary to the distal end of the cannulated non-expandable body. In some examples of the suture anchor, the suture comprises an eyelet extending from the expandable cap.

    [0012] The expandable cap comprises a distal end and a proximal end, and may further comprise at least one expansion slot formed in the proximal end of the expandable cap. In one example, the at least one expansion slot is aligned with the axis of the cannulated non-expandable body.

    [0013] The distal end of the cannulated non-expandable body may further comprise a locking insert tab and the expandable cap may further comprise a holding insert tab configured to engage the locking insert tab. When the locking insert tab and holding insert tab are engaged, the expandable cap and the cannulated non-expandable body are locked together. In some examples, the distal end of the cannulated non-expandable body may comprise an annular protrusion and the expandable cap may comprise an annular groove configured to engage the annular protrusion. When the annular groove and annular protrusion are engaged, the expandable cap and the cannulated non-expandable body are locked together.

    [0014] Other examples of the suture anchor further include a post extending, axially, from the cavity of the expandable cap. The cannulation of the non-expandable body is configured to receive the post and align the non-expandable body and the expandable cap.

    [0015] Some examples of the suture anchor include at least one protrusion formed on the outer surface of the cannulated non-expandable body at the distal end. In these examples, the at least one expansion slot is configured to receive the at least one protrusion and align the cannulated non-expandable body and the expandable cap.

    [0016] The cannulated non-expandable body may be made from a first material and the expandable cap may be made from a second material more flexible than the first material. The cannulated non-expandable body may have a diameter between 1mm and 3mm. The cannulated non-expandable body may comprises a material selected from a formulation of poly(lactic-co-glycolic) acid (PLGA), β-Tricalcium phosphate (B-TCP) and calcium sulfate, poly-L-lactic acid - hydroxyapatite (PLLA-HA), polyether ether ketone (PEEK) or variants thereof.

    [0017] In another aspect, at least one example described herein provides a procedure for soft tissue repair. The procedure includes providing any example of the suture anchor described herein. The procedure also includes inserting the suture anchor into a hole prepared in bone. The procedure also includes expanding the expandable cap by applying a force aligned with a longitudinal axis extending between distal end and proximal end of a cannulated non-expandable body of the suture anchor. The procedure also includes tying soft tissue down to the bone using a repair suture coupled to the suture. Expanding the expandable cap may include pulling the expandable cap over the distal end of the cannulated non-expandable body using the suture. Alternatively, expanding the expandable cap may include pushing the distal end of the cannulated non-expandable body into the cavity of the expandable cap using a suture anchor insertion instrument. In yet another example, expanding the expandable cap may include a combination of pulling the expandable cap over the distal end of the cannulated non-expandable body using the suture and pushing the distal end of the cannulated non-expandable body into the cavity of the expandable cap using the suture anchor insertion instrument. The procedure also includes drilling the hole into the bone.

    BRIEF DESCRIPTION OF THE DRAWINGS



    [0018] The accompanying drawings, which are incorporated in and form a part of the specification, illustrate examples of the present disclosure and together with the written description serve to explain the principles, characteristics, and features of the disclosure. In the drawings:

    FIGS. 1A-1C are side views on a suture anchor with a non-expandable body and an expandable cap being inserted into bone.

    FIG. 2 is a sectional view of an example of the non-expandable body.

    FIG. 3 is a sectional view of an example of the expandable cap.

    FIG. 4A is a sectional view of an example of the suture anchor.

    FIG. 4B is a side view of an example of the suture anchor.

    FIGS. 5A-D are views of an expandable suture anchor with a snap over cap.


    DESCRIPTION



    [0019] In the following detailed description of the illustrated examples, reference is made to accompanying drawings, which form a part thereof, and within which are shown by way of illustration, specific examples, by which the subject matter can be practiced. It is to be understood that other examples can be utilized and structural changes can be made without departing from the scope of the disclosure.

    [0020] The particulars shown herein are by way of example and for purposes of illustrative discussion of the examples only and are presented in the case of providing what is believed to be the most useful and readily understood description of the principles and conceptual aspects of the disclosure. In this regard, no attempt is made to show structural details of the subject matter in more detail than is necessary for the fundamental understanding of the disclosure, the description taken with the drawings making apparent to those skilled in that how the several forms of the present disclosure can be embodied in practice. Further, like reference numbers and designations in the various drawings indicate like elements.

    [0021] FIGS. 1A-1C, show an example suture anchor 100 including a non-expandable body 105 and expandable cap 110. The suture anchor 100, in an undeployed state, is at an end of a suture anchor insertion instrument (shown in phantom outline). A surgeon uses the instrument to insert the suture anchor 100, distal end first, into the bone hole. The surgeon then pushes on or hits (shown as an insertion force) the instrument to push the suture anchor 100 into the bone hole. The suture anchor 100 moves into the hole until the desired insertion depth is reached. The desired insertion depth may be controlled, for example, by a positive stop feature between a drill guide and the driver, or when a mark on the driver matches up with a respective line on a drill guide. The surgeon continues to push on the instrument to push the non-expandable body 105 into the expandable cap 110. That is, the proximal portion of the suture anchor 100 is protracted against the distal portion. This action expands the expandable cap 110 outward, radially, into the bone hole and secures the suture anchor 100, now in the deployed state, in the bone hole. In the deployed state, the distal portion of the suture anchor 100 has a larger outer diameter than the proximal portion of the suture anchor 100.

    [0022] In another mode of operation, the surgeon pulls on a suture attached to the expandable cap 110, which is routed through a cannulation (or through hole) running the length of the non-expandable body 105, to pull the expandable cap 110 onto the body 105. That is, the distal portion of the suture anchor 100 is retracted against the proximal portion. In turn, the expandable cap 110 expands outward, radially, into the bone hole and secures the suture anchor 100 in the bone hole. In yet another mode of operation, the surgeon does a combination of pushing the non-expandable body 105 into the expandable cap 110 and pulling the expandable cap 110 onto the non-expandable body 105 to expand the expandable cap 110 into the bone hole and secure the suture anchor 100 in the bone hole.

    [0023] FIG. 2 shows an example of the cannulated non-expandable body 105 (or simply referred to as non-expandable body) having a proximal end 115, distal end 120, and longitudinal axis 135 extending between the proximal and distal ends 115, 120. A convenient example of the non-expandable body 105 has a diameter between 1mm and 3mm. At the proximal end 115, the non-expandable body 105 includes a protrusion 125 that mates with a complementary recess in a suture anchor insertion instrument and couples the suture anchor 100 to the instrument. Other means for coupling include, for example, a spline and a corresponding socket.

    [0024] Between the proximal and distal ends 115, 120, the non-expandable body 105 includes a plurality of annular ribs. The annular ribs 130 contribute to the overall fixation strength of the suture anchor 100. The expandable cap 110 enhances or augments the fixation strength provided by the annular ribs 130. The annular ribs 130 are formed circumferentially around the non-expandable body 105. The geometry of the ribs 130 is selected based on the ability to be inserted into a bone hole and the ability to be retained in a bone hole. Other means for retaining the suture anchor 100 into a bone hole include, for example, ribs that are discontinuous and a plurality of wings.

    [0025] At the distal end 120, the non-expandable body 105 includes a ramp 140 that engages and expands the expandable cap 110. (Described in more detail below.) The ramp 140 is formed at angle to the longitudinal axis 125 of the non-expandable body 105. As shown, the angle is between 20° and 45° angle. Other angles between 0° and 90° selected based on a variety of factors including manufacturability are also contemplated. For example, as shown, the geometry of the ramp 140 is substantially similar to that of the annular ribs 130. The ramp 140 has a diameter called an "engagement diameter" 140. The engagement diameter is the dimension of the ramp 140 at which the non-expandable body 105 engages the expandable cap 110 and causes the expandable cap 110 to expand outward, radially, into a bone hole. The size of the engagement diameter may be selected based on a specific degree of expansion (e.g., 30%-40% increase over the original size of the expandable cap 110.

    [0026] Along the longitudinal axis 125, the non-expandable body 105 includes a cannulation 145 running the length of the non-expandable body 105 between the proximal and distal ends 115, 120 of the non-expandable body 105. The cannulation 145 is sized to receive a suture or a suture doubled over on itself so as to form an eyelet 190 at one end. In some examples of the non-expandable body 105, the cannulation 145 slidably receives suture(s). That is, the sutures can slide through the cannulation 145. As described in greater detail below, the cannulation 145 receives at least a portion of the suture and shelters that portion from damage from the environment.

    [0027] FIG. 3 shows an example of the expandable cap 110 configured to receive the distal end 120 of the non-expandable body 105. The expandable cap 110 includes a proximal end 150, distal end 155, and cavity 160 formed by the expandable cap 110. The cavity 160 has an opening 165 at the proximal end 150 of the expandable cap 110. In some examples, the diameter of the opening 165 is larger than the engagement diameter 140 of the non-expandable body 105 and tolerates an amount of misalignment between the non-expandable body 105 and expandable cap 110.

    [0028] The cavity 160 further has a surface 170 and at least one diameter, called a "receiving diameter" 175 that is the same as or smaller than the engagement diameter 140 of the non-expandable body 105. At the receiving diameter175 of the cavity 160, the non-expandable body 105 and expandable cap 110 are engaged. The ramp 140 and surface 170 are in contact with one another. This engagement expands the expandable cap 110 outward, radially.

    [0029] As shown, the surface 170 of the cavity 160 is an inverse geometry of the ramp 140 of the non-expandable body 105. The diameters of the cavity 160 are increasingly smaller than the engagement diameter 140 toward the distal end 155 of the expandable cap 110. Further engagement of the non-expandable body 105 and expandable cap 110 (either by pushing the non-expandable body 105 into the expandable cap 110, pulling the expandable cap 110 onto the non-expandable body 105, or a combination of both) pushes the ramp 140 against the surface 170 and expands the expandable cap 110 in an outward radial direction.

    [0030] As shown, the expandable cap 110 has the shape of a truncated cone. Other geometries are possible. For example, the expandable cap 110 may be pointed enabling a surgeon to lift or otherwise manipulate soft tissue intraoperatively.

    [0031] The expandable cap 110 further includes an expansion slot 180 contributing to the expandability of the expandable cap 110. The expansion slot 180 is formed in the expandable cap 110 and aligned with the longitudinal axis 125 of the non-expandable body 105. In some examples, the expansion slot 180 is at an angle to the longitudinal axis 125 of the non-expandable body 105. The expansion slot 180 extends from the proximal end 150 of the expandable cap 110 towards the distal end 155 of the expandable cap 110.

    [0032] Another example of the expandable cap 110 has an inner surface, outer surface and wall formed from the inner surface and outer surface. The expandable cap 110 further includes an expansion slot 180 formed in the wall and aligned with the longitudinal axis 125 of the non-expandable body 105. The expansion slot 180 extends from the proximal end 150 of the expandable cap 110 towards the distal end 155 of the expandable cap 110.

    [0033] Each expansion slot 180 defines a flexible wall section. The expandable cap 110 has an expanded state defined by the distal movement of the non-expandable body 105 into the expandable cap 110 and radial outward movement of the flexible wall section. The expandable cap 110 in the expanded state compresses into bone.

    [0034] FIGS. 4A and 4B show a suture 185 projecting from the cavity 160 of the expandable cap 110 and forming an eyelet 190 at one end. The eyelet 190 receives the repair suture and allows the repair suture to slide, freely. The ability for the repair suture suture to slide, referred to as "suture slide," is beneficial because it allows the surgeon to tie knots in the repair suture and secure the soft tissue to bone. Suture slide further allows the surgeon to position and reposition the soft tissue readily. In a typical application, the suture anchor 100 with suture 185 and repair suture are preloaded onto a suture anchor insertion instrument (e.g., as part of a surgical system) ready for a surgeon to use. The surgeon drills a hole in bone, inserts the suture anchor 100 into the hole, deploys the suture anchor 100, and then uses the repair suture to tie the soft tissue down to the correct anatomical position.

    [0035] The suture 185 may be coupled to the expandable cap 110 (e.g., with an adhesive) or formed integral with the expandable cap 110 (e.g., over molded). Another example of the expandable cap 110 includes a through-hole through which the suture 185 forming the eyelet 190 is passed. A knot or mechanical knot tied at the other end the suture 185, opposite the eyelet 190, inhibits the suture 185 from being pulled through the expandable cap 110 when tensioned. Yet another example of the expandable cap 110 includes a bridge around which the suture 185 forming the eyelet 190 is passed. A knot or mechanical knot is tied at the proximal end of the anchor.

    [0036] The cannulation 145 of the non-expandable body 105 is configured to slidably receive the suture 185 and eyelet 190 (suture/eyelet). As shown in FIG. 4A, the cannulation 145 receives the entire portion of the suture/eyelet. This arrangement is particularly beneficial because it protects the suture/eyelet from the surgical site environment. For example, the interface or junction between the suture/eyelet and repair suture is located inside the non-expandable body 105 and, thus, shielded from sharp edges of a bone hole.

    [0037] FIG. 4B shows another arrangement in which a portion of the suture/eyelet is received by the cannulation 145 leaving a remaining portion exposed. The exposed portion of the suture/eyelet provides unobstructed access to the eyelet 190 during an operation. As such, this arrangement advantageously enables a surgeon to intraoperatively slide a repair suture (s) through the eyelet 190.

    [0038] Another example arrangement has the suture/eyelet received within the cannulation 145, completely, when the suture anchor 100 is in its undeployed state. When the suture anchor 100 is in its deployed state (e.g., the non-expandable body 105 is pushed into the expandable cap 110 or vice versa, and the expandable cap 110 is expanded) a portion of the suture/eyelet is exposed.

    [0039] The foregoing examples of the non-expandable body 105 and expandable cap 110 are made of the same material (e.g., polyether ether ketone or PEEK). Other examples of the non-expandable body 105 and expandable cap 110 are made from different materials. In these examples, the non-expandable body 105 is formed of a material less flexible (more stiff) then the one forming the expandable cap 110. One such example includes the non-expandable body 105 made from a bioabsorbable material and the expendable cap made from more flexible PEEK.

    [0040] Examples of the suture anchor 100 can provide one or more of the following advantages. One advantage is improving the chance of insertion success because interference fit upon insertion is lower. Another advantage is increasing fixation strength through increased interference fit at the distal tip (after distal expansion). High fixation strength is obtained after the suture anchor is fully seated into a bone hole.

    [0041] FIGS. 5A-5D show a suture anchor 200 with retention features. The suture anchor 200 is similar to the suture anchor 100 of FIGS. 2, 3, 4A, and 4B having a non-expendable body 205 and an expendable cap 210. The suture anchor 200, however, differs from the suture anchor 100 with the addition of retention futures, described in more detail below. In operation, owing to the geometry of the non-expendable body 205 and expendable cap 210 (described in greater detail below) the expendable cap 210 expands radially in response to an axial insertion force that brings the non-expendable body 205 and expendable cap 210 together. Complementary retention features 230 on the non-expendable body 205 and expendable cap 210 mechanically engage one another, locking the non-expendable body 205 and expendable cap 210 together. In the locked state shown in FIG. 5B, the retention features 230 inhibit the expendable cap 210 from returning or "relaxing" back into its unexpended state. Advantageously, this maintains the interference fit that provides fixation of the suture anchor 200 in a bone hole.

    [0042] With reference to FIG. 5A, the non-expendable body 205 includes a distal end 220 similar to the distal end 120 described above with reference to FIG. 2. In a convenient example of the suture anchor 200, the retention features 230 include at least one locking insert tab 230a formed on a surface 235 of the distal end 220. The expendable cap 210 includes at least one holding insert tab 230b configured to engage the locking insert tab 230a on the non-expendable body 205. The locking insert tab 230a includes an incline surface 230a-1 extending away from the surface 235 of the distal end 220 in the proximal direction. The inclined surface 230a-1 facilities the expendable cap 210 fitting over the distal end 220 of the non-expendable body 205. The locking insert tab 230a terminates at a shoulder 230a-2 having a proximal facing surface 230a-3. As more clearly shown in FIG. 5C, the proximal facing surface 230a-3 abuts a distal facing surface 230b-1 of the holding insert tab 230b and acts as a stop.

    [0043] It should be readily apparent that other means and configurations for retaining the non-expendable body 205 and expendable cap 210 are within the contemplation of this disclosure. For example, the placement of the locking insert tab 230a on the non-expendable body 205 and the holding insert tab 230b in the expendable cap 210 described above may be switched. Other examples of the retention features 230 include an annular protrusion formed around the distal end 220 and complementary annular groove formed in the cap 210, or vice versus.

    [0044] With reference to FIG. 5D, the distal end 220 includes a first portion 220a and second portion 220b that is proximal to the first portion 220a. The expendable cap 210 has a cavity 260. The cavity 260 has a diameter larger than the first portion 220a and smaller than the second portion 220b. In the example shown, a substantial portion (e.g., 60% to 90%) of the cavity 260 has a constant diameter of "d." Other examples of the cavity 260 may have geometry similar to the cavity 160 described above with reference to FIG. 2.

    [0045] In some situations, as the non-expendable body 205 and expendable cap 210 are brought together, initially, the first portion 220a of the distal end does not contact the surface of the cavity 260. In an off-axis situation, in which the non-expendable body 205 and expendable cap 210 are not aligned with one another other (e.g., the longitudinal axis of each does not coincide with the other), the first portion 220a contacts a portion of the surface. In both situations, bringing the non-expendable body 205 and expendable cap 210 further together brings the second portion 220b and surface into contact with each other and centers the expendable cap 210 with respect to the non-expendable body 205. Advantageously, this arrangement corrects for any initial misalignment between the non-expendable body 205 and expendable cap 210.

    [0046] The expendable cap 210 includes a terminal surface adjacent 265 to the cavity 260. In a convenient example, the terminal surface 265 defines a first aperture 270a and second aperture 270b. A bridge 275 separates the first aperture 270a and second aperture 270b. A suture 285 extends around the bridge 275 and through a cannulation 245 in the non-expendable body 205. This example is advantageous because it allows the suture to be passed distally through one aperture and proximally through the other aperture; negating the need for a knot.

    [0047] Another example of the expendable cap 210 includes an axial hole that is coaxial with the cannulation 245 of the non-expendable body 205. A suture is threaded through the hole of the expendable cap 210. The suture has a distal knot that inhibits the suture from being pulled through the non-expendable body 205. Yet example of the expendable cap 210 is formed, integrally, with a suture. A knot at the distal end 220 of the suture is overmolded with the expendable cap 210.

    [0048] The suture anchor 200 includes an optional expansion slot 280 that assists in the expansion of the expendable cap 210. A convenient example of the expansion slot 280 is similar to the expansion slot 180 described above with reference to FIG. 3. In another example, the expansion slot 280 cooperates with an optional side boss 290 for aligning the expendable cap 210 and non-expendable body 205. For example, the optional side boss 290 is inserted into the expansion slot 280. Advantageously, this inhibits the non-expendable body 205 from rotating about the expendable cap 210 and maintains the preferred orientation between the two.

    [0049] Some examples of the suture anchors 100 and 200 are small-diameter anchors or "microanchors" having diameters on the order of 1mm to 3mm. Other examples include larger diameter anchors for use in different parts of the body. Examples of the suture anchors 100 and 200 may be completely or a portions thereof (e.g., the body) made from a formulation of poly(lactic-co-glycolic) acid (PLGA), β-Tricalcium phosphate (B-TCP) and calcium sulfate, poly-L-lactic acid - hydroxyapatite (PLLA-HA), polyether ether ketone (PEEK) or variants thereof. Biocomposite examples of suture anchors 100, 200, 400, 500, and 600 made from a combination of PLGA, β-TCP, and calcium sulfate are absorbable by the body, which is beneficial to natural healing. An example formulation of PLGA, B-TCP, and calcium sulfate is described in U.S. Patent No. 8,545,866. Other commonly used material for implants are also contemplated by this disclosure.

    [0050] It is noted that the foregoing examples have been provided merely for the purpose of explanation and are in no way to be construed as limiting of the present invention. While the present invention has been described with reference to examples, it is understood that the words, which have been used herein, are words of description and illustration, rather than words of limitation. Changes may be made, within the purview of the appended claims, as presently stated and as amended, without departing from the scope of the present invention in its aspects. Although the present invention has been described herein with reference to particular means, materials and examples, the present invention is not intended to be limited to the particulars disclosed herein; rather, the present invention extends to all functionally equivalent structures, methods and uses, such as are within the scope of the appended claims


    Claims

    1. A suture anchor comprising:

    a cannulated non-expandable body (105) comprising:

    a distal end (120) having a first portion and a second portion;

    a proximal end (115) configured to engage a suture anchor insertion instrument;

    a plurality of projections (130) extending, radially, from an outer surface extending between the distal end and proximal end, the plurality of projections configured to compress into bone;

    an expandable cap (110) defining a cavity configured to engage the distal end of the cannulated
    non-expandable body, the cavity having a diameter larger than the first portion and smaller than the second portion that allows the expandable cap to expand radially outward and compress into the bone during engagement of the distal end of the cannulated nonexpandable body and the expandable cap; and
    a suture (185) extending from the cavity of the expandable cap and slidably received within the cannulation of the non-expandable body; wherein the non-expandable body and the expandable cap each comprise complementary engagement features configured to mechanically engage with each other to lock the non-expandable body and the cap together and to inhibit the expandable cap from returning to an unexpanded state,

    wherein the expandable cap further comprises a terminal surface adjacent the cavity defining a first aperture, a second aperture, and a bridge separating the first aperture and the second aperture; and

    wherein the suture extends around the bridge, and a first free end and a second free end of the suture are routed through the first aperture and second aperture, respectively, and through the cannulation of the non-expandable body toward the proximal end of the cannulated non-expandable body.


     
    2. The suture anchor of claim 1 wherein the distal end is a truncated conical section comprising a first diameter and a second diameter larger than the first diameter.
     
    3. The suture anchor of claim 1 wherein the first portion of the distal end does not engage a surface of the cavity; and the wherein the second portion of the distal end engages the surface of the cavity.
     
    4. The suture anchor of any one of claims 1 to 3 wherein the proximal end comprises one of a protrusion or recess configured to engage a complementary recess or protrusion, respectively, of a suture anchor insertion instrument.
     
    5. The suture anchor of any one of the preceding claims wherein the plurality of projections comprise a plurality of annular ribs, wings, or a combination of annular ribs and wings.
     
    6. The suture anchor of claim 1 wherein the cavity has a shape complementary to the distal end of the cannulated non-expandable body.
     
    7. The suture anchor of any one of the preceding claims wherein the suture comprises an eyelet extending from the expandable cap.
     
    8. The suture anchor of any one of the preceding claims, wherein the first free end and the second free are coupled together.
     
    9. The suture anchor of any one of the preceding claims wherein the expandable cap comprises a distal end and a proximal end; and
    further comprises at least one expansion slot formed in the proximal end of the expandable cap.
     
    10. The suture anchor of any one of claims 1 to 9 wherein the distal end of the cannulated non-expandable body comprises a locking insert tab and the expandable cap comprises a holding insert tab configured to engage the locking insert tab such that when the locking insert tab and holding insert tab are engaged, the expandable cap and the cannulated non-expandable body are locked together.
     
    11. The suture anchor of any one of claims 1 to 9 wherein to provide the complementary engagement features the distal end of the cannulated non-expandable body comprises an annular protrusion and
    wherein the expandable cap comprises an annular groove configured to engage the annular protrusion such that when the annular groove and annular protrusion are engaged, the expandable cap and the cannulated non-expandable body are locked together.
     
    12. The suture anchor of any one of the preceding claims further comprising a post extending, axially, from the cavity of the expandable cap; and
    wherein the cannulation is configured to receive the post and align the nonexpandable body and the expandable cap.
     
    13. The suture anchor of claim 9 further comprising at least one protrusion formed on the outer surface of the cannulated non-expandable body at the distal end; and
    wherein the at least one expansion slot is configured to receive the at least one protrusion and align the cannulated non-expandable body and the expandable cap.
     
    14. The suture anchor of any one of the preceding claims wherein the cannulated nonexpandable body is made from a first material; and
    wherein the expandable cap is made from a second material more flexible than the first material.
     
    15. The suture anchor of any one of the preceding claims wherein the non-expendable body comprises a material selected from a formulation ofpoly(lactic-co-glycolic) acid (PLGA), Tricalcium phosphate (β-TCP) and calcium sulfate, poly-L-lactic acid - hydroxyapatite (PLLA-HA), polyether ether ketone (PEEK) or variants thereof.
     


    Ansprüche

    1. Ein Fadenanker, beinhaltend:

    einen kanülierten nicht-expandierbaren Körper (105), beinhaltend:

    ein distales Ende (120) mit einem ersten Abschnitt und einem zweiten Abschnitt;

    ein proximales Ende (115), konfiguriert, um in ein Fadenanker-Einsetzinstrument einzugreifen;

    eine Vielzahl von Vorsprüngen (130), die sich radial von einer Außenoberfläche, die sich zwischen dem distalen Ende und proximalen Ende erstreckt, erstrecken, wobei die Vielzahl von Vorsprüngen konfiguriert ist, um in Knochen hinein zu komprimieren;

    eine expandierbare Kappe (110), die einen Hohlraum definiert, konfiguriert, um in das distale Ende des kanülierten nicht-expandierbaren Körpers einzugreifen, wobei der Hohlraum einen Durchmesser, größer als der erste Abschnitt und kleiner als der zweite Abschnitt, aufweist, der der expandierbaren Kappe erlaubt, sich während des Eingreifens des distalen Endes des kanülierten nicht-expandierbaren Körpers und der expandierbaren Kappe radial nach außen zu expandieren und in den Knochen hinein zu komprimieren; und

    einen Faden (185), der sich von dem Hohlraum der expandierbaren Kappe erstreckt und gleitbar innerhalb der Kanülierung des nicht-expandierbaren Körpers aufgenommen ist; wobei der nicht-expandierbare Körper und die expandierbare Kappe beide komplementäre Eingriffsmerkmale beinhalten, konfiguriert, um mechanisch miteinander einzugreifen, um den nicht-expandierbaren Körper und die Kappe miteinander zu verriegeln und die expandierbare Kappe vom Zurückkehren in einen unexpandierten Zustand zu inhibieren,

    wobei die expandierbare Kappe ferner eine dem Hohlraum benachbarte terminale Oberfläche beinhaltet, die eine erste Apertur, eine zweite Apertur und eine Brücke, die die erste Apertur und die zweite Apertur trennt, definiert; und

    wobei der Faden sich um die Brücke herum erstreckt und ein erstes freies Ende und ein zweites freies Ende des Fadens jeweils durch die erste Apertur und zweite Apertur und durch die Kanülierung des nicht-expandierbaren Körpers in Richtung des proximalen Endes des kanülierten nicht-expandierbaren Körpers geleitet werden.


     
    2. Fadenanker gemäß Anspruch 1, wobei das distale Ende ein trunkierter konischer Bereich ist, beinhaltend einen ersten Durchmesser und einen zweiten Durchmesser, größer als der erste Durchmesser.
     
    3. Fadenanker gemäß Anspruch 1, wobei der erste Abschnitt des distalen Endes nicht in eine Oberfläche des Hohlraums eingreift; und wobei der zweite Abschnitt des distalen Endes in die Oberfläche des Hohlraums eingreift.
     
    4. Fadenanker gemäß einem der Ansprüche 1 bis 3, wobei das proximale Ende eines von einem Fortsatz oder einer Aussparung beinhaltet, die konfiguriert sind, um jeweils in eine(n) komplementäre(n) Aussparung oder Fortsatz eines Fadenanker-Einsetzinstruments einzugreifen.
     
    5. Fadenanker gemäß einem der vorhergehenden Ansprüche, wobei die Vielzahl von Vorsprüngen eine Vielzahl von ringförmigen Rippen, Flügeln oder eine Kombination von ringförmigen Rippen und Flügeln beinhaltet.
     
    6. Fadenanker gemäß Anspruch 1, wobei der Hohlraum eine zu dem distalen Ende des kanülierten nicht-expandierbaren Körpers komplementäre Form aufweist.
     
    7. Fadenanker gemäß einem der vorhergehenden Ansprüche, wobei der Faden eine Öse beinhaltet, die sich von der expandierbaren Kappe erstreckt.
     
    8. Fadenanker gemäß einem der vorhergehenden Ansprüche, wobei das erste freie Ende und das zweite freie miteinander verbunden sind.
     
    9. Fadenanker gemäß einem der vorhergehenden Ansprüche, wobei die expandierbare Kappe ein distales Ende und ein proximales Ende beinhaltet; und
    ferner mindestens einen in dem proximalen Ende der expandierbaren Kappe gebildeten Expansionsschlitz beinhaltet.
     
    10. Fadenanker gemäß einem der Ansprüche 1 bis 9, wobei das distale Ende des kanülierten nicht-expandierbaren Körpers eine verriegelnde Einsatzlasche beinhaltet und die expandierbare Kappe eine haltende Einsatzlasche beinhaltet, konfiguriert, um in die verriegelnde Einsatzlasche so einzugreifen, dass, wenn die verriegelnde Einsatzlasche und haltende Einsatzlasche in Eingriff gebracht werden, die expandierbare Kappe und der kanülierte nicht-expandierbare Körper miteinander verriegelt werden.
     
    11. Fadenanker gemäß einem der Ansprüche 1 bis 9, wobei, um die komplementären Eingriffsmerkmale bereitzustellen, das distale Ende des kanülierten nicht-expandierbaren Körpers einen ringförmigen Fortsatz beinhaltet und
    wobei die expandierbare Kappe eine ringförmige Rille beinhaltet, konfiguriert, um in den ringförmigen Fortsatz einzugreifen, sodass, wenn die ringförmige Rille und der ringförmige Vorsprung in Eingriff gebracht werden, die expandierbare Kappe und der kanülierte nicht-expandierbare Körper miteinander verriegelt werden.
     
    12. Fadenanker gemäß einem der vorhergehenden Ansprüche, ferner beinhaltend einen sich axial aus dem Hohlraum der expandierbaren Kappe erstreckenden Pfahl; und wobei die Kanülierung konfiguriert ist, um den Pfahl aufzunehmen und den nicht-expandierbaren Körper und die expandierbare Kappe auszurichten.
     
    13. Fadenanker gemäß Anspruch 9, ferner beinhaltend mindestens einen an dem distalen Ende auf der Außenoberfläche des kanülierten nicht-expandierbaren Körpers gebildeten Fortsatz; und
    wobei der mindestens eine Expansionsschlitz konfiguriert ist, um mindestens einen Fortsatz aufzunehmen und den kanülierten nicht-expandierbaren Körper und die expandierbare Kappe auszurichten.
     
    14. Fadenanker gemäß einem der vorhergehenden Ansprüche, wobei der kanülierte nicht-expandierbare Körper aus einem ersten Material hergestellt ist; und
    wobei die expandierbare Kappe aus einem zweiten Material, flexibler als das erste Material, hergestellt ist.
     
    15. Fadenanker gemäß einem der vorhergehenden Ansprüche, wobei der nicht-expandierbare Körper ein Material beinhaltet, ausgewählt aus einer Formulierung von Polylactid-co-Glycolid (PLGA), Tricalciumphosphat (β-TCP) und Calciumsulfat, Poly-L-Milchsäure-Hydroxyapatit (PLLA-HA), Polyetheretherketon (PEEK) oder Varianten davon.
     


    Revendications

    1. Une ancre de fil de suture comprenant :

    un corps non dilatable canulé (105) comprenant :

    une extrémité distale (120) ayant une première portion et une deuxième portion ;

    une extrémité proximale (115) configurée pour se mettre en prise avec un instrument d'insertion d'ancre de fil de suture ;

    une pluralité de saillies (130) s'étendant, radialement, depuis une surface externe s'étendant entre l'extrémité distale et l'extrémité proximale, la pluralité de saillies étant configurées pour se comprimer à l'intérieur d'un os ;

    un capuchon dilatable (110) définissant une cavité configurée pour se mettre en prise avec l'extrémité distale du corps non dilatable canulé, la cavité ayant un diamètre plus grand que la première portion et plus petit que la deuxième portion qui permet au capuchon dilatable de se dilater radialement vers l'extérieur et de se comprimer à l'intérieur de l'os pendant que l'extrémité distale du corps non dilatable canulé et le capuchon dilatable sont mis en prise ; et

    un fil de suture (185) s'étendant depuis la cavité du capuchon dilatable et reçu de façon à pouvoir glisser au sein de la canule du corps non dilatable ; dans laquelle le corps non dilatable et le capuchon dilatable comprennent chacun des éléments de mise en prise complémentaires configurés pour se mettre en prise mécaniquement les uns avec les autres afin de verrouiller le corps non dilatable et le capuchon ensemble et d'empêcher le capuchon dilatable de revenir à un état non dilaté,

    dans laquelle le capuchon dilatable comprend en sus une surface terminale adjacente à la cavité définissant une première ouverture, une deuxième ouverture, et un pont séparant la première ouverture et la deuxième ouverture ; et

    dans laquelle le fil de suture s'étend autour du pont, et une première extrémité libre et une deuxième extrémité libre du fil de suture sont amenées à passer par la première ouverture et la deuxième ouverture, respectivement, et par la canule du corps non dilatable en direction de l'extrémité proximale du corps non dilatable canulé.


     
    2. L'ancre de fil de suture de la revendication 1 dans laquelle l'extrémité distale est une section tronconique comprenant un premier diamètre et un deuxième diamètre plus grand que le premier diamètre.
     
    3. L'ancre de fil de suture de la revendication 1 dans laquelle la première portion de l'extrémité distale ne se met pas en prise avec une surface de la cavité ; et dans laquelle la deuxième portion de l'extrémité distale se met en prise avec la surface de la cavité.
     
    4. L'ancre de fil de suture de n'importe laquelle des revendications 1 à 3 dans laquelle l'extrémité proximale comprend soit une protubérance, soit un renfoncement configuré(e) pour se mettre en prise avec un renfoncement ou une protubérance complémentaire, respectivement, d'un instrument d'insertion d'ancre de fil de suture.
     
    5. L'ancre de fil de suture de n'importe laquelle des revendications précédentes dans laquelle la pluralité de saillies comprennent une pluralité de nervures annulaires, d'ailettes, ou une combinaison de nervures annulaires et d'ailettes.
     
    6. L'ancre de fil de suture de la revendication 1 dans laquelle la cavité a une conformation complémentaire de l'extrémité distale du corps non dilatable canulé.
     
    7. L'ancre de fil de suture de n'importe laquelle des revendications précédentes dans laquelle le fil de suture comprend un œillet s'étendant depuis le capuchon dilatable.
     
    8. L'ancre de fil de suture de n'importe laquelle des revendications précédentes, dans laquelle la première extrémité libre et la deuxième libre sont accouplées ensemble.
     
    9. L'ancre de fil de suture de n'importe laquelle des revendications précédentes dans laquelle le capuchon dilatable comprend une extrémité distale et une extrémité proximale ; et
    comprend en sus au moins une fente de dilatation formée dans l'extrémité proximale du capuchon dilatable.
     
    10. L'ancre de fil de suture de n'importe laquelle des revendications 1 à 9 dans laquelle l'extrémité distale du corps non dilatable canulé comprend une patte de verrouillage à insérer et le capuchon dilatable comprend une patte de retenue à insérer configurée pour se mettre en prise avec la patte de verrouillage à insérer de telle sorte que quand la patte de verrouillage à insérer et la patte de retenue à insérer sont mises en prise, le capuchon dilatable et le corps non dilatable canulé sont verrouillés ensemble.
     
    11. L'ancre de fil de suture de n'importe laquelle des revendications 1 à 9 dans laquelle afin de fournir les éléments de mise en prise complémentaires, l'extrémité distale du corps non dilatable canulé comprend une protubérance annulaire et
    dans laquelle le capuchon dilatable comprend une rainure annulaire configurée pour se mettre en prise avec la protubérance annulaire de telle sorte que quand la rainure annulaire et la protubérance annulaire sont mises en prise, le capuchon dilatable et le corps non dilatable canulé sont verrouillés ensemble.
     
    12. L'ancre de fil de suture de n'importe laquelle des revendications précédentes comprenant en sus un tenon s'étendant, axialement, depuis la cavité du capuchon dilatable ; et
    dans laquelle la canule est configurée pour recevoir le tenon et aligner le corps non dilatable et le capuchon dilatable.
     
    13. L'ancre de fil de suture de la revendication 9 comprenant en sus au moins une protubérance formée sur la surface externe du corps non dilatable canulé au niveau de l'extrémité distale ; et
    dans laquelle l'au moins une fente de dilatation est configurée pour recevoir l'au moins une protubérance et aligner le corps non dilatable canulé et le capuchon dilatable.
     
    14. L'ancre de fil de suture de n'importe laquelle des revendications précédentes dans laquelle le corps non dilatable canulé est fabriqué à partir d'un premier matériau ; et dans laquelle le capuchon dilatable est fabriqué à partir d'un deuxième matériau plus souple que le premier matériau.
     
    15. L'ancre de fil de suture de n'importe laquelle des revendications précédentes dans laquelle le corps non dilatable comprend un matériau sélectionné à partir d'une formulation d'acide poly(lactique-co-glycolique) (PLGA), de phosphate de tricalcium (β-TCP) et sulfate de calcium, d'acide poly-L-lactique-hydroxyapatite (PLLA-HA), de poly(étheréthercétone) (PEEK) ou de variantes de ceux-ci.
     




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    REFERENCES CITED IN THE DESCRIPTION



    This list of references cited by the applicant is for the reader's convenience only. It does not form part of the European patent document. Even though great care has been taken in compiling the references, errors or omissions cannot be excluded and the EPO disclaims all liability in this regard.

    Patent documents cited in the description