US20180289366A1 - Staples for generating and applying compression within a body - Google Patents
Staples for generating and applying compression within a body Download PDFInfo
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- US20180289366A1 US20180289366A1 US16/003,636 US201816003636A US2018289366A1 US 20180289366 A1 US20180289366 A1 US 20180289366A1 US 201816003636 A US201816003636 A US 201816003636A US 2018289366 A1 US2018289366 A1 US 2018289366A1
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- staple
- bridge
- delivery device
- hinge region
- legs
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/064—Surgical staples, i.e. penetrating the tissue
- A61B17/0642—Surgical staples, i.e. penetrating the tissue for bones, e.g. for osteosynthesis or connecting tendon to bone
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
- A61B17/0682—Surgical staplers, e.g. containing multiple staples or clamps for applying U-shaped staples or clamps, e.g. without a forming anvil
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/72—Intramedullary pins, nails or other devices
- A61B17/7233—Intramedullary pins, nails or other devices with special means of locking the nail to the bone
- A61B17/7258—Intramedullary pins, nails or other devices with special means of locking the nail to the bone with laterally expanding parts, e.g. for gripping the bone
- A61B17/7266—Intramedullary pins, nails or other devices with special means of locking the nail to the bone with laterally expanding parts, e.g. for gripping the bone with fingers moving radially outwardly
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/72—Intramedullary pins, nails or other devices
- A61B17/7291—Intramedullary pins, nails or other devices for small bones, e.g. in the foot, ankle, hand or wrist
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00831—Material properties
- A61B2017/00867—Material properties shape memory effect
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00831—Material properties
- A61B2017/00867—Material properties shape memory effect
- A61B2017/00871—Material properties shape memory effect polymeric
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00831—Material properties
- A61B2017/00946—Material properties malleable
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/064—Surgical staples, i.e. penetrating the tissue
- A61B2017/0641—Surgical staples, i.e. penetrating the tissue having at least three legs as part of one single body
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/064—Surgical staples, i.e. penetrating the tissue
- A61B2017/0645—Surgical staples, i.e. penetrating the tissue being elastically deformed for insertion
Definitions
- the present invention relates to staples for generating, applying, and maintaining compression to a site in a human or animal body in order to facilitate healing of diseased or damaged tissue.
- the invention finds particular utility in the field of orthopedics and specifically for reducing fractures and maintaining compression between bone fragments, and/or for reducing openings and maintaining compression between bone segments in osteotomies, and/or for inducing fusion across the bones of a joint in an arthrodesis. While the invention has application throughout the body, its utility will be illustrated herein in the context of the repair of fractured or displaced bone tissue, such as during an Akin Osteotomy of the foot or an Isolated Lunocapitate Arthrodesis of the hand/wrist.
- Staples are formed from a plurality of legs (typically two legs, although sometimes more) connected together by a bridge. Staples are typically manufactured from stainless steel alloys, titanium alloys or Nitinol, a shape memory alloy. The legs of the staples are inserted into pre-drilled holes on either side of the fracture line, with the bridge of the staple spanning the fracture line.
- the staple comprises a malleable bridge with two elastic legs
- the staple can be inserted into the fracture site prior to bending the bridge.
- the bridge can be bent after implantation using a tamp-like device of the sort known in the art.
- the present invention provides a novel fixation device which is able to bring bone fragments into close proximity with each other, generate a compressive load across a fracture line and maintain that compressive load across the fracture line while healing occurs.
- the present invention comprises the provision and use of a novel staple which is manufactured from a shape memory material (e.g., a material capable of exhibiting superelasticity and/or a temperature-induced shape change).
- the shape memory material may comprise a metal alloy (e.g., Nitinol) or a polymer (e.g., appropriately processed PEEK).
- the novel staple may be manufactured from another suitable material, e.g., stainless steel, titanium, etc.
- the staple is designed to reduce fractures and generate and maintain compression across a fracture line between the bone fragments to aid in fracture healing. Note that in the preferred form of the invention, the staple is designed to generate and maintain compression between both the cortical bone and the cancellous bone of the bone fragments so as to promote effective healing.
- the staple comprises an elastic bridge and two elastic legs.
- the bridge and the legs meet at a pair of curved hinge regions which are also elastic.
- the hinge regions comprise holes that run through the full thickness of the hinge regions and are used to mate the staple to a delivery device.
- the legs of the staple are oriented inwardly with an angle of less than 90° (relative to the bridge) and the bridge of the staple is bowed upward.
- the bridge of the staple can be reversibly bent and the legs of the staple can be reversibly pivoted (e.g., by bending at the elastic hinge regions) so that the bridge is more linear and the legs are substantially perpendicular to the longitudinal axis of the bridge.
- a delivery device that mates with the holes in the staple's hinge region may be used to strain the staple, or the delivery device may act as a constraint, with the staple being strained while not loaded on the delivery device and then loaded onto the delivery device in the strained state.
- the constrained staple can then be inserted into the prepared fracture site (e.g., by positioning the staple's legs into pre-drilled holes on either side of the fracture line) and the staple can be released from the delivery device. Since the delivery device engages the staple at the holes in the hinge region, the staple can be fully seated during implantation (i.e., the bottom of the bridge can sit on the surface of the bone) and does not need to be tamped in order to fully seat the staple. Releasing the staple from the delivery device allows the bridge and legs of the staple to attempt to return to their original unrestrained state, thereby generating and maintaining a compressive load while healing occurs.
- apparatus for generating, applying and maintaining compression to a site in a human or animal body, the apparatus comprising: a staple comprising: a bridge configured to be elastically bendable; a first leg connected to the bridge by a first hinge region configured to be elastically bendable; and a second leg connected to the bridge by a second hinge region configured to be elastically bendable; wherein the first hinge region comprises a first hole configured to mate with a first element of a delivery device and the second hinge region comprises a second hole configured to mate with a second element of a delivery device; and wherein the first and second legs are angled toward one another when they are in an unstrained state; whereby, when the staple is mounted to a delivery device so that the first hole of the first hinge region mates with a first element of a delivery device and the second hole of the second hinge region mates with a second element of a delivery device, and when the delivery device applies a force to the bridge of the staple so as to reconfigure the bridge of the staple
- a method for generating, applying and maintaining compression to a site in a human or animal body comprising: providing a staple comprising: a bridge configured to be elastically bendable; a first leg connected to the bridge by a first hinge region configured to be elastically bendable; and a second leg connected to the bridge by a second hinge region configured to be elastically bendable; wherein the first hinge region comprises a first hole configured to mate with a first element of a delivery device and the second hinge region comprises a second hole configured to mate with a second element of a delivery device; and wherein the first and second legs are angled toward one another when they are in an unstrained state; providing a delivery device comprising: a first element sized to be received in the first hole of the first hinge region of the staple; a second element sized to be received in the second hole of the second hinge region of the staple; and a plunger adapted to apply a force to the bridge of the staple so as to reconfigure the bridge of the
- a staple comprising: a bridge configured to be elastically bendable; a first leg connected to the bridge by a first hinge region configured to be elastically bendable; and a second leg connected to the bridge by a second hinge region configured to be elastically bendable; wherein the first hinge region comprises a first hole and the second hinge region comprises a second hole; and wherein the bridge has a non-linear configuration when it is in an unstrained state, and wherein the first and second legs are angled toward one another when they are in an unstrained state.
- apparatus for securing tissue to a site in a human or animal body comprising: a staple comprising: a bridge configured to be elastically bendable; a first leg connected to the bridge by a first hinge region configured to be elastically bendable; and a second leg connected to the bridge by a second hinge region configured to be elastically bendable; wherein the first hinge region comprises a first hole and the second hinge region comprises a second hole; and wherein the bridge has a non-linear configuration when it is in an unstrained state, and wherein the first and second legs are angled toward one another when they are in an unstrained state; and at least one suture extending through (i) at least one of the first hole and the second hole, and (ii) the tissue to be secured to the site in a human or animal body.
- a staple comprising: a bridge configured to be plastically deformable; a first leg connected to the bridge by a first hinge region configured to be elastically bendable; and a second leg connected to the bridge by a second hinge region configured to be elastically bendable; wherein the first hinge region comprises a first hole and the second hinge region comprises a second hole; and wherein the bridge has a non-linear configuration when it is in an unstrained state, and wherein the first and second legs are angled toward one another when they are in an unstrained state.
- a staple comprising: a bridge configured to be elastic; a first leg connected to the bridge by a first hinge region configured to be elastically bendable; and a second leg connected to the bridge by a second hinge region configured to be elastically bendable; wherein the first hinge region comprises a first hole and the second hinge region comprises a second hole; and wherein the first and second legs are angled toward one another when they are in an unstrained state.
- FIG. 1 is a schematic view of a novel staple formed in accordance with the present invention, wherein the staple comprises a bridge which is capable of being elastically bent and legs which are capable of being elastically pivoted about elastic hinge regions, and further wherein the staple is shown in its unstrained condition;
- FIG. 2 is a schematic view of the novel staple shown in FIG. 1 , wherein the bridge of the staple has been elastically bent (i.e., made to be more linear) and the legs of the staple have been elastically pivoted outwards (e.g., by bending at the elastic hinge regions) so as to be perpendicular to the bridge;
- FIG. 3 is a schematic view showing how the elastically bent staple of FIG. 2 will have its legs “kick inward” when the strain on the staple is removed;
- FIGS. 4, 4A, 4B, 5, 6, 6A and 6B are schematic views showing a novel delivery device which may be used with the novel staple shown in FIG. 1 to strain and constrain the staple (e.g., with the staple legs perpendicular to the staple bridge);
- FIGS. 7 and 8 are schematic views showing the delivery device of FIGS. 4, 4A, 4B, 5, 6, 6A and 6B being used with the novel staple shown in FIG. 1 to elastically bend the bridge of the staple and elastically pivot the legs of the staple (e.g., by bending at the elastic hinge regions);
- FIGS. 9 and 10 are schematic views showing how the novel staple of FIG. 1 may be used to generate and maintain compression between bone fragments so as to aid in fracture healing;
- FIGS. 11-13 are schematic views showing another novel staple formed in accordance with the present invention, wherein the novel staple comprises a bridge which is capable of being elastically bent and legs which are capable of being elastically pivoted about elastic hinge regions—the novel staple of FIGS. 11-13 has a concave bridge specifically engineered to match the anatomy of the fracture site (e.g., an Akin Osteotomy site), where FIG. 11 shows the staple in its unstrained condition, FIG. 12 shows the staple strained with its bridge elastically bent (i.e., made to be more concave) and its legs pivoted outwards (e.g., by bending at the elastic hinge regions) so as to be perpendicular to the bridge, and FIG. 13 is a schematic view showing how the elastically bent staple of FIG. 12 will have its legs “kick inward” when the strain on the staple is removed;
- the novel staple comprises a bridge which is capable of being elastically bent and legs which are capable of being elastically pivoted about elastic hinge regions
- FIGS. 14-16 are schematic views showing still another novel staple formed in accordance with the present invention, wherein the novel staple comprises a sloped bridge which is capable of being elastically bent and legs which are capable of being elastically pivoted about elastic hinge regions—the novel staple of this design has a slanted bridge specifically engineered to match the anatomy of the fracture site (e.g., an Akin Osteotomy site), where FIG. 14 shows the staple in its unstrained condition, FIG. 15 shows the staple strained with its bridge elastically bent (i.e., made to be more sloped) and its legs pivoted outwards (e.g., by bending at the elastic hinge regions) so as to be parallel with each other, and FIG. 16 is a schematic view showing how the elastically bent staple of FIG. 15 will have its legs “kick inward” when the strain on the staple is removed;
- the novel staple comprises a sloped bridge which is capable of being elastically bent and legs which are capable of being elastically pivoted about elastic hinge regions
- the novel staple of this design has a
- FIGS. 17-19 are schematic views showing yet another novel staple formed in accordance with the present invention, wherein the novel staple comprises a bridge which is capable of being elastically bent and legs which are capable of being elastically pivoted about elastic hinge regions—the staple of this design has a stepped bridge specifically engineered to match the anatomy of the fracture site (e.g., sliding calcaneal osteotomies, calcaneocuboid fusions, Lapidus procedures, etc.), where FIG. 17 shows the staple in its unstrained condition, FIG. 18 shows the staple strained with its bridge elastically bent (i.e., made to be more linear) and its legs pivoted outwards (e.g., by bending at elastic hinge regions) so as to be perpendicular to the bridge, and FIG. 19 is a schematic view showing how the elastically bent staple of FIG. 18 will have its legs “kick inward” when the strain on the staple is removed;
- the novel staple comprises a bridge which is capable of being elastically bent and legs which are capable of being elastically
- FIGS. 20-22 are schematic views showing another novel staple formed in accordance with the present invention, wherein the staple comprises a malleable bridge which is capable of being plastically bent (i.e., to take a set) and legs which are capable of being elastically pivoted about elastic hinge regions—
- FIG. 20 shows the staple in its unstrained condition
- FIG. 21 shows the staple strained with its malleable bridge plastically bent (i.e., made to take a set so as to be concave to match the fracture site anatomy) and its legs pivoted outwards (e.g., by bending at elastic hinge regions) so as to be perpendicular to the bridge
- FIG. 22 is a schematic view showing how the elastically bent staple of FIG. 21 will have its legs “kick inward” when the strain on the staple is removed;
- FIG. 23 shows how the holes at the hinge region of the staple may be used by the surgeon to attach sutures for tying down tissue (e.g., ligaments, tendons, etc.).
- tissue e.g., ligaments, tendons, etc.
- FIG. 1 there is shown a novel staple 5 which is able to bring bone fragments into close proximity with each other, generate a compressive load across the fracture line, and maintain a compressive load across the fracture line while healing occurs.
- Staple 5 can be fully seated against the bone fragments without needing to be tamped after being released from the delivery device.
- Novel staple 5 is preferably manufactured from a shape memory material (e.g., a material capable of exhibiting superelasticity and/or a temperature-induced shape change).
- the shape memory material may comprise a metal alloy (e.g., Nitinol) or a polymer (e.g., appropriately processed PEEK).
- staple 5 may be manufactured from another suitable material, e.g., stainless steel, titanium, etc.
- Staple 5 is designed to reduce fractures and generate and maintain compression between bone fragments (e.g., across a fracture line) so as to aid in fracture healing.
- Staple 5 comprises an elastic bridge 10 and two elastic legs 15 . Bridge 10 and legs 15 meet at a pair of curved hinge regions 20 which are also elastic. Hinge regions 20 have holes 25 passing therethrough.
- Holes 25 may be round or may have other configurations consistent with the present invention.
- Legs 15 may have barbed teeth 30 to help the legs of the staple grip the bone after implantation into the bone and prevent the legs of the staple from working their way back out of the bone.
- bridge 10 In its unrestrained state, bridge 10 is bowed upwardly in the manner shown in FIG. 1 .
- legs 15 of staple 5 In the unrestrained state, legs 15 of staple 5 are elastically pivoted inwardly at elastic hinge regions 20 with an angle of less than 90° (relative to bridge 10 ).
- legs 15 extend at an angle of about 65° to the longitudinal axis of bridge 10 when in their unrestrained state.
- bridge 10 of staple 5 Prior to implantation, bridge 10 of staple 5 can be reversibly bent (i.e., bent to nearly linear) and legs 15 of staple 5 can be reversibly pivoted at elastic hinge regions 20 (e.g., by bending at the elastic hinge regions 20 ) to a position substantially perpendicular to bridge 10 ( FIG. 2 ) so as to allow for insertion of the legs of the staple into a prepared fracture site, with the bridge of the staple spanning across the fracture line (see below). Note that where staple 5 is formed out of Nitinol, elastic deformations of up to approximately 8% are achievable.
- a delivery device can be used to elastically bend bridge 10 and pivot legs 15 at elastic hinge regions 20 (e.g., by bending at the elastic regions 20 ), constrain and hold the staple in its strained state prior to implantation, and then insert the staple into the prepared fracture site.
- Delivery device 35 which may be used to selectively bend bridge 10 and to selectively pivot legs 15 of staple 5 at elastic hinge regions 20 (e.g., by bending at the elastic hinge regions 20 ).
- Delivery device 35 comprises a body 40 having an internal threaded region 45 ( FIG. 6 ) configured to mate with threaded screw 50 .
- Threaded screw 50 has a handle 55 mounted to its proximal end.
- Advancing threaded screw 50 into body 40 causes the distal end of threaded screw 50 to push against the proximal end of a plunger 60 .
- the distal end of plunger 60 engages elastic bridge 10 of staple 5 .
- plunger 60 is moved distally (i.e., by moving threaded screw 50 distally by rotating handle 55 )
- the distal end of plunger 60 engages elastic bridge 10 of stable 5 and elastically bends elastic bridge 10 into a more linear configuration.
- Staple 5 is releasably mounted to delivery device 35 by a pair of pins 65 which are mounted to two arms 70 which are each pivotally mounted to body 40 of delivery device 35 by a pivot pin 75 .
- Pins 65 are received within holes 25 formed in staple 5 .
- staple 5 is configured so that the force that is generated as staple 5 reconfigures (i.e., as bridge 10 and legs 15 attempt to return back to their original disposition) is less than the “tear through” force of the bone receiving legs 15 , i.e., staple 5 is specifically engineered so as to not “tear through” the bone tissue when staple 5 attempts to return to its original, unbiased shape.
- the compressive forces generated by staple 5 as staple 5 attempts to reconfigure i.e., as bridge 10 contracts and as elastic legs 15 of staple 5 attempt to pivot inboard toward one another about elastic hinge regions 20 ) can be controlled by modulating the material properties of staple 5 and/or the geometry of staple 5 .
- the percentage of cold work in the shape memory material forming staple 5 affects the compressive force that is generated by the reconfiguring staple 5 . As the percentage of cold work increases, the compression force that is generated decreases.
- staple 5 has between about 15% and about 55% cold work in order to control the recovery force (i.e., the compressive force generated by bridge 10 and legs 15 as staple 5 reconfigures) of staple 5 ; however, if desired, other degrees of cold work may be used, and/or the material comprising staple 5 may not be cold worked at all.
- another material property that affects the compression force generated by staple 5 as the staple reconfigures is the temperature differential between the body that staple 5 will be implanted into (assumed to be approximately 37° C., which is the temperature of a human body) and the austenite finish temperature of the shape memory material forming staple 5 .
- a smaller temperature differential between the two will result in staple 5 generating a smaller compressive load as staple 5 reconfigures; conversely, a larger temperature differential between the two will result in staple 5 generating a larger compressive load as staple 5 reconfigures.
- the shape memory material that staple 5 is made out of should, preferably, have an austenite finish temperature of greater than about ⁇ 10° C., resulting in a temperature differential of about 47° C. when the staple is implanted (assuming that the staple is implanted in a human body).
- staple geometry also affects the compression forces generated as staple 5 reconfigures. More particularly, the cross-sectional areas of elastic bridge 10 , elastic hinges 20 and elastic legs 15 affect the compression forces generated by the reconfiguring staple 5 . As the cross-sectional areas increase, the compression forces that the reconfiguring staple 5 generates also increase.
- Elastic legs 15 of staple 5 are critical for transmitting the compression force to the bone without “tearing through” the bone.
- the height, width, and length of the staple legs, and the geometry of the staple legs, are all significant factors relating to the staple's ability to not “tear through” the bone.
- Elastic legs 15 having greater surface area are better able to distribute the compression force and thus resist “tearing through” the bone.
- FIG. 9 shows how staple 5 may be used to reduce a fracture and generate and maintain compression between bone fragments 80 and 85 .
- the fracture 90 which is to be fused is first re-approximated and reduced.
- a drill guide (not shown) of the sort well known in the art is used to drill two holes 95 the correct distance apart to accommodate the legs 15 of staple 5 .
- Staple 5 is mounted to pins 65 of delivery device 35 , and delivery device 35 is used to bend bridge 10 and straighten legs 15 of staple 5 in the manner discussed above (i.e., by turning handle 55 to advance plunger 60 which is used to bend bridge 10 and pivot legs 15 at elastic hinge regions 20 ). While still mounted to pins 65 of delivery device 35 , legs 15 of staple 5 are placed into the pre-drilled holes 95 .
- Staple 5 is then released from pins 65 of delivery device 35 , i.e., by turning handle 55 in the opposite (e.g., counter-clockwise) direction and sliding staple 5 off of pins 65 .
- This allows the bent bridge 10 and pivoted legs 15 of staple 5 to attempt to return (reconfigure) to their un-bent configuration, thereby applying compression across fracture 90 .
- staple 105 is designed to generate and maintain compression between both the cortical bone and the cancellous bone of the bone fragments so as to promote effective healing.
- bridge 10 elastic hinges 20 and the proximal (i.e., bridge-side) portions of legs 15 typically engage cortical bone, the pivoting nature of the reconfiguring distal portions of legs 15 will help apply enhanced compressive forces to the cancellous bone (i.e., the interior bone) of the bone fragments.
- staple 5 is mounted to delivery device 35 via pins 65 being inserted into holes 25 , staple 5 can be fully inserted into pre-drilled holes 95 with bridge 10 in direct contact with bone fragments 80 and 85 . Tamping is not needed in order to fully seat staple 5 ( FIG. 10 ).
- staple 5 can be used to attach soft tissue to bone (e.g., to attach a rotator cuff to bone).
- delivery device 35 it can be desirable to modify delivery device 35 so as to ensure that legs 15 cannot be pivoted at hinge regions 20 beyond 90 degrees (relative to the longitudinal axis of bridge 10 ) when legs 15 of staple 5 are pivoted outboard. In other circumstances, it may be desirable for delivery device 35 to allow legs 15 of staple 5 to be pivoted outboard less than, or greater than, 90 degrees to allow insertion into slightly mispositioned (or angled) drill holes 95 .
- delivery device 35 can also be used to remove staple 5 from the bone. More particularly, delivery device 35 can be used to re-engage staple 5 at the holes 25 (i.e., by inserting pins 65 of delivery device 35 into holes 25 of staple 5 ) in the hinge regions 20 of staple 5 .
- Turning handle 55 e.g., clockwise
- plunger 60 causes plunger 60 to bend staple bridge 10 and to reconfigure staple 5 such that bridge 10 is substantially perpendicular to staple legs 15 . Staple 5 can then be removed from the bone by pulling the staple out perpendicular to the bone.
- staple delivery device 35 allows the surgeon to “sense” how much compression staple 5 will exert on the bone when it is released from delivery device 35 and attempts to reconfigure. More particularly, as the surgeon turns handle 55 to straighten bridge 10 and open staple legs 15 (e.g., by turning handle 55 clockwise), handle 55 requires greater levels of torque as staple 5 is opened (i.e, as bridge 10 is pushed down and legs 15 are pivoted outboard), thereby providing a degree of tactile feedback to the surgeon. The torque that the surgeon applies to handle 55 is proportional to the compression that staple 5 will exert on the bone as the staple reconfigures.
- delivery device 35 also allows the surgeon to ascertain and control how much compression staple 5 will exert when the staple is released from delivery device 35 .
- delivery device 35 also allows the surgeon to control the rate at which staple 5 loads the bone as the staple is removed from delivery device 35 . More particularly, turning handle 55 of delivery device 35 counterclockwise releases the downward (i.e., distal) force that plunger 60 exerts on bridge 10 of staple 5 . This allows staple 5 to attempt to recover (i.e., reconfigure) to its original shape and apply compression across the fracture site. It may be desirable to allow the surgeon to be able to control this “release rate” so that the bone is not damaged as staple 5 reconfigures and so that staple 5 remains in the desired location.
- staple 5 and delivery device 35 are provided in the form of a sterilized kit.
- Staple 5 may be “pre-loaded” (i.e, mounted) onto delivery device 35 (i.e., with pins 65 of delivery device 35 extending through holes 25 of staple 5 ).
- Staple 5 may be mounted on delivery device 35 in an unconstrained or a constrained state.
- the kit may include additional instruments to aid in the implantation of the staple (e.g., k-wire, drill bit, staple size guide, etc.).
- the compressive force generated by staples of the present invention formed out of Nitinol with greater than 20% cold work are able to generate 50 to 100 Newtons of force depending on the staple dimensions. This is more than twice the compression force able to be generated by conventional staples of a similar size.
- staple bridge 10 may be formed so as to have a different configuration.
- the constraint on bridge 10 and hinges 20 is removed, whereupon staple 5 attempts to return (i.e., reconfigure) to its original un-restrained state ( FIG.
- a staple 5 having a concave bridge 10 for the treatment of fractures where the anatomy is “hour-glass” shaped (e.g., in an Akin Osteotomy).
- a staple 5 having a bridge 10 formed with a sloped geometry ( FIG. 14 ).
- legs 15 can be elastically pivoted so as to be parallel to one another ( FIG. 15 ).
- staple 5 attempts to return to its original un-restrained state ( FIG. 16 ), thereby generating a compressive load and maintaining that compressive load while healing occurs.
- staple 5 having this configuration for the treatment of fractures where the anatomy is non-linear (e.g., at the metaphyseal flares).
- staple 5 may also be desirable to provide staple 5 with bridge 10 having a stepped geometry ( FIG. 17 ).
- bridge segments 10 a and 10 b are parallel to each other ( FIG. 18 ).
- staple 5 attempts to return (i.e., reconfigure) to its original un-restrained state ( FIG. 19 ), thereby generating a compressive load across the fracture line and maintaining that compressive load across the fracture line while healing occurs.
- staple 5 having this configuration for the treatment of fractures where the anatomy is uneven (i.e., sliding calcaneal osteotomies, calcaneocuboid fusions, Lapidus procedures, etc.).
- a staple 5 having a malleable bridge 10 which is plastically deformable so as to be able to take a set ( FIG. 20 ).
- delivery device 35 can be used to deform/shape staple bridge 10 .
- a staple of this configuration has a force applied to its bridge 10 so that staple legs 15 are pivoted so as to be parallel to each other, malleable bridge 10 is plastically deformed so as to take a set ( FIG. 21 ).
- a staple of this configuration may be beneficial for the treatment of fractures where the anatomy is uneven (e.g., in an Akin Osteotomy).
- holes 25 are primarily used for releasably mounting staple 5 to delivery device 35 (i.e., via pins 65 ), holes 25 also may be used after implantation to aid the surgeon with tying ligaments and/or tendons directly down to the bone ( FIG. 23 ). Typically, a surgeon would use a suture anchor, bone tunnel or other method/device known in the art to re-secure a ligament and/or tendon to the bone. It should be appreciated that the staple of the present invention provides the surgeon with holes 25 which may be used to tie ligaments and/or tendons directly to the bone. This allows the surgeon to avoid having to use an additional implant or perform an additional procedure to achieve the same outcome.
- novel staple 5 and novel delivery device 35 are discussed in the context of rejoining a broken bone.
- novel staple 5 and novel delivery device 35 may be used to promote joinder of substantially any two (or more) bone segments, e.g., they may be used to reduce openings and maintain compression between bone segments in osteotomies, or they may be used for inducing fusion across the bones of a joint in an arthrodesis, etc.
Abstract
Apparatus for generating, applying and maintaining compression to a site in a human or animal body, the apparatus comprising: a staple comprising: a bridge configured to be elastically bendable; a first leg connected to the bridge by a first hinge region configured to be elastically bendable; and a second leg connected to the bridge by a second hinge region configured to be elastically bendable; wherein the first hinge region comprises a first hole configured to mate with a first element of a delivery device and the second hinge region comprises a second hole configured to mate with a second element of a delivery device; and wherein the first and second legs are angled toward one another when they are in an unstrained state; whereby, when the staple is mounted to a delivery device so that the first hole of the first hinge region mates with a first element of a delivery device and the second hole of the second hinge region mates with a second element of a delivery device, and when the delivery device applies a force to the bridge of the staple so as to reconfigure the bridge of the staple, the first and second legs are pivoted away from one another toward a parallel disposition.
Description
- This patent application:
- (i) is a continuation of pending prior U.S. patent application Ser. No. 15/079,770 filed on Mar. 24, 2016 by MX Orthopedics, Corp. and Daniel Morgan et al. for STAPLES FOR GENERATING AND APPLYING COMPRESSION WITHIN A BODY (Attorney's docket No. 67486-025PUS4).
- (ii) is a continuation-in-part of pending prior U.S. patent application Ser. No. 14/540,351, filed Nov. 13, 2014 by MX Orthopedics, Corp. and Matthew Palmer et al. for STAPLES FOR GENERATING AND APPLYING COMPRESSION WITHIN A BODY (Attorney's Docket No. FONTE-52);
- (iii) claims benefit of pending prior U.S. Provisional Patent Application Ser. No. 62/137,496, filed Mar. 24, 2015 by MX Orthopedics, Corp. and Daniel Morgan et al. for STAPLES THAT DO NOT NEED TO BE TAMPED TO BE FULLY SEATED FOR GENERATING AND APPLYING COMPRESSION WITHIN A BODY (Attorney's Docket No. FONTE-55 PROV);
- (iv) claims benefit of pending prior U.S. Provisional Patent Application Ser. No. 62/137,570, filed Mar. 24, 2015 by MX Orthopedics, Corp. and Daniel Morgan et al. for STAPLES THAT DO NOT NEED TO BE TAMPED TO BE FULLY SEATED FOR GENERATING AND APPLYING COMPRESSION WITHIN A BODY (Attorney's Docket No. FONTE-56 PROV); and
- (v) claims benefit of pending prior U.S. Provisional Patent Application Ser. No. 62/238,472, filed Oct. 7, 2015 by MX Orthopedics, Corp. and Matthew Palmer et al. for DEVICES FOR CONTROLLING THE UNLOADING OF SUPERELASTIC AND SHAPE MEMORY ORTHOPEDIC IMPLANTS (Attorney's Docket No. FONTE-69 PROV).
- The five (5) above-identified patent applications are hereby incorporated herein by reference.
- The present invention relates to staples for generating, applying, and maintaining compression to a site in a human or animal body in order to facilitate healing of diseased or damaged tissue. The invention finds particular utility in the field of orthopedics and specifically for reducing fractures and maintaining compression between bone fragments, and/or for reducing openings and maintaining compression between bone segments in osteotomies, and/or for inducing fusion across the bones of a joint in an arthrodesis. While the invention has application throughout the body, its utility will be illustrated herein in the context of the repair of fractured or displaced bone tissue, such as during an Akin Osteotomy of the foot or an Isolated Lunocapitate Arthrodesis of the hand/wrist.
- In the field of orthopedic surgery it is common to rejoin broken bones. The success of the surgical procedure often depends on the ability to re-approximate the bone fragments, the amount of compression achieved between the bone fragments, and the ability to sustain that compression over a period of time. If the surgeon is unable to bring the bone fragments into close contact, a gap will exist between the bone fragments and the bone tissue will need to fill that gap before complete healing can take place. Furthermore, gaps between bone fragments that are too large allow motion to occur between the bone fragments, disrupting the healing tissue and thus slowing the healing process. Optimal healing requires that the bone fragments be in close contact with each other, and for a compressive load to be applied and maintained between the bone fragments. Compressive strain between bone fragments has been found to accelerate the healing process in accordance with Wolf's Law.
- Broken bones can be rejoined using staples. Staples are formed from a plurality of legs (typically two legs, although sometimes more) connected together by a bridge. Staples are typically manufactured from stainless steel alloys, titanium alloys or Nitinol, a shape memory alloy. The legs of the staples are inserted into pre-drilled holes on either side of the fracture line, with the bridge of the staple spanning the fracture line.
- Existing staples need to be impacted so as to make the bottom of the staple bridge sit flush with the bone surface following implantation of the staple legs into the pre-drilled holes. This is because current staples and their associated delivery devices are typically designed to grip the staples under the bridge of the staple. After the staple has been deployed from the delivery device, there is a gap between the bottom of the bridge and the top surface of the bone. A tamp is typically used to fully seat the staple bridge against the bone surface. Thus, an additional step (i.e., the tamping step) is required. In addition, the action of tamping can cause the bone fragments to move out of position, impairing healing.
- Furthermore, current staple systems do not allow the surgeon to control the amount of compression that the staple will exert when it is released from the delivery device. While the shape memory and superelastic properties allow Nitinol staples to pull together the opposing bone fragments, the recovery forces and recoverable strain generated by these staples may be too great and may result in the staples “tearing through” the bone tissue and thus not providing a means to generate and maintain compression between the bone fragments.
- Additionally, current staple systems do not allow the surgeon to control the rate at which the staple loads the bone when it is removed from the delivery device. Current delivery devices load the bone nearly instantaneously. This may result in a large force impulse as the staple's legs rapidly undergo shape recovery. This force impulse may damage the bone and result in impaired healing.
- Current staple systems also do not allow the surgeon to control the extent to which the staple's legs are opened. This can make it particularly difficult to implant the staple into the pre-drilled holes if the holes were drilled slightly out of position. More particularly, if the pre-drilled holes are slightly too close together or slightly too far apart, it may be difficult to fit the staple legs into the holes and may result in impaired healing.
- Finally, current staple systems do not allow for the staple to be easily removed following implantation. Since the staples are tamped flush with the bone surface, there is no easy way for surgeons to grip and remove current staples. It is very time-consuming for surgeons to pry out deployed staples and it is difficult to cut deployed staples for removal. In addition, these actions may damage the underlying bone, thus impairing healing and may result in the patient needing to be under anesthesia for a longer period of time.
- Thus there exists a significant clinical need for a new staple and a new associated delivery device to implant the staple flush with the bone surface without the need for tamping to fully seat the staple. Additionally, there is a significant clinical need for a staple system that allows the surgeon to control the amount of compression the staple will generate across the fracture line after the staple has been implanted into bone, to control the rate at which the staple loads the bone, to allow the surgeon to adjust opening the staple legs for proper alignment with pre-drilled holes, and to allow the staple to be easily removed from the bone if desired.
- Additionally, it is possible that where the staple comprises a malleable bridge with two elastic legs, the staple can be inserted into the fracture site prior to bending the bridge. The bridge can be bent after implantation using a tamp-like device of the sort known in the art.
- The present invention provides a novel fixation device which is able to bring bone fragments into close proximity with each other, generate a compressive load across a fracture line and maintain that compressive load across the fracture line while healing occurs.
- Among other things, the present invention comprises the provision and use of a novel staple which is manufactured from a shape memory material (e.g., a material capable of exhibiting superelasticity and/or a temperature-induced shape change). The shape memory material may comprise a metal alloy (e.g., Nitinol) or a polymer (e.g., appropriately processed PEEK). Alternatively, the novel staple may be manufactured from another suitable material, e.g., stainless steel, titanium, etc. The staple is designed to reduce fractures and generate and maintain compression across a fracture line between the bone fragments to aid in fracture healing. Note that in the preferred form of the invention, the staple is designed to generate and maintain compression between both the cortical bone and the cancellous bone of the bone fragments so as to promote effective healing.
- In one form of the invention, the staple comprises an elastic bridge and two elastic legs. The bridge and the legs meet at a pair of curved hinge regions which are also elastic. The hinge regions comprise holes that run through the full thickness of the hinge regions and are used to mate the staple to a delivery device. In the unrestrained state, the legs of the staple are oriented inwardly with an angle of less than 90° (relative to the bridge) and the bridge of the staple is bowed upward. Prior to implantation, the bridge of the staple can be reversibly bent and the legs of the staple can be reversibly pivoted (e.g., by bending at the elastic hinge regions) so that the bridge is more linear and the legs are substantially perpendicular to the longitudinal axis of the bridge. This allows for insertion of the staple into a prepared fracture site. A delivery device that mates with the holes in the staple's hinge region may be used to strain the staple, or the delivery device may act as a constraint, with the staple being strained while not loaded on the delivery device and then loaded onto the delivery device in the strained state. The constrained staple can then be inserted into the prepared fracture site (e.g., by positioning the staple's legs into pre-drilled holes on either side of the fracture line) and the staple can be released from the delivery device. Since the delivery device engages the staple at the holes in the hinge region, the staple can be fully seated during implantation (i.e., the bottom of the bridge can sit on the surface of the bone) and does not need to be tamped in order to fully seat the staple. Releasing the staple from the delivery device allows the bridge and legs of the staple to attempt to return to their original unrestrained state, thereby generating and maintaining a compressive load while healing occurs.
- In one preferred form of the invention, there is provided apparatus for generating, applying and maintaining compression to a site in a human or animal body, the apparatus comprising: a staple comprising: a bridge configured to be elastically bendable; a first leg connected to the bridge by a first hinge region configured to be elastically bendable; and a second leg connected to the bridge by a second hinge region configured to be elastically bendable; wherein the first hinge region comprises a first hole configured to mate with a first element of a delivery device and the second hinge region comprises a second hole configured to mate with a second element of a delivery device; and wherein the first and second legs are angled toward one another when they are in an unstrained state; whereby, when the staple is mounted to a delivery device so that the first hole of the first hinge region mates with a first element of a delivery device and the second hole of the second hinge region mates with a second element of a delivery device, and when the delivery device applies a force to the bridge of the staple so as to reconfigure the bridge of the staple, the first and second legs are pivoted away from one another toward a parallel disposition.
- In another preferred form of the invention, there is provided a method for generating, applying and maintaining compression to a site in a human or animal body, the method comprising: providing a staple comprising: a bridge configured to be elastically bendable; a first leg connected to the bridge by a first hinge region configured to be elastically bendable; and a second leg connected to the bridge by a second hinge region configured to be elastically bendable; wherein the first hinge region comprises a first hole configured to mate with a first element of a delivery device and the second hinge region comprises a second hole configured to mate with a second element of a delivery device; and wherein the first and second legs are angled toward one another when they are in an unstrained state; providing a delivery device comprising: a first element sized to be received in the first hole of the first hinge region of the staple; a second element sized to be received in the second hole of the second hinge region of the staple; and a plunger adapted to apply a force to the bridge of the staple so as to reconfigure the bridge of the staple; mounting the staple to the delivery device so that the first hole of the first hinge region mates with the first element of the delivery device and the second hole of the second hinge region mates with the second element of the delivery device; applying a force to the bridge of the staple with the plunger of the delivery device so as to reconfigure the bridge of the staple such that the first and second legs are pivoted away from one another toward a parallel disposition; inserting the staple into a site in a human or animal body; withdrawing the plunger of the delivery device from the bridge of the staple so as to cause the staple to apply compression to the site in a human or animal body as the staple reconfigures; and releasing the staple from the delivery device.
- In another preferred form of the invention, there is provided a staple comprising: a bridge configured to be elastically bendable; a first leg connected to the bridge by a first hinge region configured to be elastically bendable; and a second leg connected to the bridge by a second hinge region configured to be elastically bendable; wherein the first hinge region comprises a first hole and the second hinge region comprises a second hole; and wherein the bridge has a non-linear configuration when it is in an unstrained state, and wherein the first and second legs are angled toward one another when they are in an unstrained state.
- In another preferred form of the invention, there is provided apparatus for securing tissue to a site in a human or animal body, the apparatus comprising: a staple comprising: a bridge configured to be elastically bendable; a first leg connected to the bridge by a first hinge region configured to be elastically bendable; and a second leg connected to the bridge by a second hinge region configured to be elastically bendable; wherein the first hinge region comprises a first hole and the second hinge region comprises a second hole; and wherein the bridge has a non-linear configuration when it is in an unstrained state, and wherein the first and second legs are angled toward one another when they are in an unstrained state; and at least one suture extending through (i) at least one of the first hole and the second hole, and (ii) the tissue to be secured to the site in a human or animal body.
- In another preferred form of the invention, there is provided a staple comprising: a bridge configured to be plastically deformable; a first leg connected to the bridge by a first hinge region configured to be elastically bendable; and a second leg connected to the bridge by a second hinge region configured to be elastically bendable; wherein the first hinge region comprises a first hole and the second hinge region comprises a second hole; and wherein the bridge has a non-linear configuration when it is in an unstrained state, and wherein the first and second legs are angled toward one another when they are in an unstrained state.
- In another preferred form of the invention, there is provided a staple comprising: a bridge configured to be elastic; a first leg connected to the bridge by a first hinge region configured to be elastically bendable; and a second leg connected to the bridge by a second hinge region configured to be elastically bendable; wherein the first hinge region comprises a first hole and the second hinge region comprises a second hole; and wherein the first and second legs are angled toward one another when they are in an unstrained state.
- These and other objects and features of the present invention will be more fully disclosed or rendered obvious by the following detailed description of the preferred embodiments of the invention, which is to be considered together with the accompanying drawings wherein like numbers refer to like parts, and further wherein:
-
FIG. 1 is a schematic view of a novel staple formed in accordance with the present invention, wherein the staple comprises a bridge which is capable of being elastically bent and legs which are capable of being elastically pivoted about elastic hinge regions, and further wherein the staple is shown in its unstrained condition; -
FIG. 2 is a schematic view of the novel staple shown inFIG. 1 , wherein the bridge of the staple has been elastically bent (i.e., made to be more linear) and the legs of the staple have been elastically pivoted outwards (e.g., by bending at the elastic hinge regions) so as to be perpendicular to the bridge; -
FIG. 3 is a schematic view showing how the elastically bent staple ofFIG. 2 will have its legs “kick inward” when the strain on the staple is removed; -
FIGS. 4, 4A, 4B, 5, 6, 6A and 6B are schematic views showing a novel delivery device which may be used with the novel staple shown inFIG. 1 to strain and constrain the staple (e.g., with the staple legs perpendicular to the staple bridge); -
FIGS. 7 and 8 are schematic views showing the delivery device ofFIGS. 4, 4A, 4B, 5, 6, 6A and 6B being used with the novel staple shown inFIG. 1 to elastically bend the bridge of the staple and elastically pivot the legs of the staple (e.g., by bending at the elastic hinge regions); -
FIGS. 9 and 10 are schematic views showing how the novel staple ofFIG. 1 may be used to generate and maintain compression between bone fragments so as to aid in fracture healing; -
FIGS. 11-13 are schematic views showing another novel staple formed in accordance with the present invention, wherein the novel staple comprises a bridge which is capable of being elastically bent and legs which are capable of being elastically pivoted about elastic hinge regions—the novel staple ofFIGS. 11-13 has a concave bridge specifically engineered to match the anatomy of the fracture site (e.g., an Akin Osteotomy site), whereFIG. 11 shows the staple in its unstrained condition,FIG. 12 shows the staple strained with its bridge elastically bent (i.e., made to be more concave) and its legs pivoted outwards (e.g., by bending at the elastic hinge regions) so as to be perpendicular to the bridge, andFIG. 13 is a schematic view showing how the elastically bent staple ofFIG. 12 will have its legs “kick inward” when the strain on the staple is removed; -
FIGS. 14-16 are schematic views showing still another novel staple formed in accordance with the present invention, wherein the novel staple comprises a sloped bridge which is capable of being elastically bent and legs which are capable of being elastically pivoted about elastic hinge regions—the novel staple of this design has a slanted bridge specifically engineered to match the anatomy of the fracture site (e.g., an Akin Osteotomy site), whereFIG. 14 shows the staple in its unstrained condition,FIG. 15 shows the staple strained with its bridge elastically bent (i.e., made to be more sloped) and its legs pivoted outwards (e.g., by bending at the elastic hinge regions) so as to be parallel with each other, andFIG. 16 is a schematic view showing how the elastically bent staple ofFIG. 15 will have its legs “kick inward” when the strain on the staple is removed; -
FIGS. 17-19 are schematic views showing yet another novel staple formed in accordance with the present invention, wherein the novel staple comprises a bridge which is capable of being elastically bent and legs which are capable of being elastically pivoted about elastic hinge regions—the staple of this design has a stepped bridge specifically engineered to match the anatomy of the fracture site (e.g., sliding calcaneal osteotomies, calcaneocuboid fusions, Lapidus procedures, etc.), whereFIG. 17 shows the staple in its unstrained condition,FIG. 18 shows the staple strained with its bridge elastically bent (i.e., made to be more linear) and its legs pivoted outwards (e.g., by bending at elastic hinge regions) so as to be perpendicular to the bridge, andFIG. 19 is a schematic view showing how the elastically bent staple ofFIG. 18 will have its legs “kick inward” when the strain on the staple is removed; -
FIGS. 20-22 are schematic views showing another novel staple formed in accordance with the present invention, wherein the staple comprises a malleable bridge which is capable of being plastically bent (i.e., to take a set) and legs which are capable of being elastically pivoted about elastic hinge regions—FIG. 20 shows the staple in its unstrained condition,FIG. 21 shows the staple strained with its malleable bridge plastically bent (i.e., made to take a set so as to be concave to match the fracture site anatomy) and its legs pivoted outwards (e.g., by bending at elastic hinge regions) so as to be perpendicular to the bridge, andFIG. 22 is a schematic view showing how the elastically bent staple ofFIG. 21 will have its legs “kick inward” when the strain on the staple is removed; and -
FIG. 23 shows how the holes at the hinge region of the staple may be used by the surgeon to attach sutures for tying down tissue (e.g., ligaments, tendons, etc.). - Looking first at
FIG. 1 , there is shown anovel staple 5 which is able to bring bone fragments into close proximity with each other, generate a compressive load across the fracture line, and maintain a compressive load across the fracture line while healing occurs. Staple 5 can be fully seated against the bone fragments without needing to be tamped after being released from the delivery device. -
Novel staple 5 is preferably manufactured from a shape memory material (e.g., a material capable of exhibiting superelasticity and/or a temperature-induced shape change). The shape memory material may comprise a metal alloy (e.g., Nitinol) or a polymer (e.g., appropriately processed PEEK). Alternatively,staple 5 may be manufactured from another suitable material, e.g., stainless steel, titanium, etc.Staple 5 is designed to reduce fractures and generate and maintain compression between bone fragments (e.g., across a fracture line) so as to aid in fracture healing.Staple 5 comprises anelastic bridge 10 and twoelastic legs 15.Bridge 10 andlegs 15 meet at a pair ofcurved hinge regions 20 which are also elastic.Hinge regions 20 haveholes 25 passing therethrough.Holes 25 may be round or may have other configurations consistent with the present invention.Legs 15 may havebarbed teeth 30 to help the legs of the staple grip the bone after implantation into the bone and prevent the legs of the staple from working their way back out of the bone. In its unrestrained state,bridge 10 is bowed upwardly in the manner shown inFIG. 1 . In the unrestrained state,legs 15 ofstaple 5 are elastically pivoted inwardly atelastic hinge regions 20 with an angle of less than 90° (relative to bridge 10). By way of example but not limitation, in one preferred form of the invention,legs 15 extend at an angle of about 65° to the longitudinal axis ofbridge 10 when in their unrestrained state. - Prior to implantation,
bridge 10 ofstaple 5 can be reversibly bent (i.e., bent to nearly linear) andlegs 15 ofstaple 5 can be reversibly pivoted at elastic hinge regions 20 (e.g., by bending at the elastic hinge regions 20) to a position substantially perpendicular to bridge 10 (FIG. 2 ) so as to allow for insertion of the legs of the staple into a prepared fracture site, with the bridge of the staple spanning across the fracture line (see below). Note that wherestaple 5 is formed out of Nitinol, elastic deformations of up to approximately 8% are achievable. A delivery device (see below) can be used to elastically bendbridge 10 and pivotlegs 15 at elastic hinge regions 20 (e.g., by bending at the elastic regions 20), constrain and hold the staple in its strained state prior to implantation, and then insert the staple into the prepared fracture site. - Upon insertion of the
strained staple 5 into the prepared fracture site, the constraint onbridge 10 andlegs 15 is removed, whereuponstaple 5 attempts to return to its original un-restrained state (FIG. 3 ), thereby generating a compressive load across the fracture line and maintaining that compressive load across the fracture line while healing occurs. - Looking next at
FIGS. 4, 4A, 4B, 5, 6, 6A, 6B, 7 and 8 , there is shown anovel delivery device 35 which may be used to selectively bendbridge 10 and to selectively pivotlegs 15 ofstaple 5 at elastic hinge regions 20 (e.g., by bending at the elastic hinge regions 20).Delivery device 35 comprises abody 40 having an internal threaded region 45 (FIG. 6 ) configured to mate with threadedscrew 50. Threadedscrew 50 has ahandle 55 mounted to its proximal end. Advancing threadedscrew 50 into body 40 (e.g., by selectively rotatinghandle 55 so as to selectively rotate threadedscrew 50 such that the threads of threadedscrew 50 engage internal threaded region 45) causes the distal end of threadedscrew 50 to push against the proximal end of aplunger 60. The distal end ofplunger 60 engageselastic bridge 10 ofstaple 5. Whenplunger 60 is moved distally (i.e., by moving threadedscrew 50 distally by rotating handle 55), the distal end ofplunger 60 engageselastic bridge 10 of stable 5 and elastically bendselastic bridge 10 into a more linear configuration.Staple 5 is releasably mounted todelivery device 35 by a pair ofpins 65 which are mounted to twoarms 70 which are each pivotally mounted tobody 40 ofdelivery device 35 by apivot pin 75.Pins 65 are received withinholes 25 formed instaple 5. Whenplunger 60 is moved distally againstelastic bridge 10 ofstaple 5, the deforming (i.e., straightening)bridge 10 ofstaple 5 causesarms 70 ofdelivery device 35 to pivot outwardly, withelastic hinge regions 20 ofstaple 5 bending aboutpins 65 so as to pivotstaple legs 15 outwardly. - More particularly, and looking now at
FIGS. 7 and 8 , whenstaple 5 is mounted topins 65 of delivery device 35 (i.e., withpins 65 being received withinholes 25 of staple 5) and handle 55 is rotated so as to advance threadedscrew 50 distally,plunger 60 is also advanced distally, whereby to push againstelastic bridge 10, causingelastic bridge 10 to bend and become more linear, and causingarms 70 ofdelivery device 35 to articulate (i.e., pivot) outwardly. As this occurs,elastic hinge regions 20 ofstaple 5 bend aboutpins 65, causingelastic legs 15 to be pivoted aboutelastic hinge regions 20 so as to be oriented generally perpendicular to elastic bridge 10 (FIG. 8 ). - Note that
staple 5 is configured so that the force that is generated asstaple 5 reconfigures (i.e., asbridge 10 andlegs 15 attempt to return back to their original disposition) is less than the “tear through” force of thebone receiving legs 15, i.e.,staple 5 is specifically engineered so as to not “tear through” the bone tissue when staple 5 attempts to return to its original, unbiased shape. The compressive forces generated bystaple 5 asstaple 5 attempts to reconfigure (i.e., asbridge 10 contracts and aselastic legs 15 ofstaple 5 attempt to pivot inboard toward one another about elastic hinge regions 20) can be controlled by modulating the material properties ofstaple 5 and/or the geometry ofstaple 5. - By way of example but not limitation, the percentage of cold work in the shape memory
material forming staple 5 affects the compressive force that is generated by the reconfiguringstaple 5. As the percentage of cold work increases, the compression force that is generated decreases. In one preferred form of the present invention,staple 5 has between about 15% and about 55% cold work in order to control the recovery force (i.e., the compressive force generated bybridge 10 andlegs 15 asstaple 5 reconfigures) ofstaple 5; however, if desired, other degrees of cold work may be used, and/or thematerial comprising staple 5 may not be cold worked at all. - By way of further example but not limitation, another material property that affects the compression force generated by
staple 5 as the staple reconfigures is the temperature differential between the body thatstaple 5 will be implanted into (assumed to be approximately 37° C., which is the temperature of a human body) and the austenite finish temperature of the shape memorymaterial forming staple 5. A smaller temperature differential between the two will result instaple 5 generating a smaller compressive load asstaple 5 reconfigures; conversely, a larger temperature differential between the two will result instaple 5 generating a larger compressive load asstaple 5 reconfigures. The shape memory material thatstaple 5 is made out of should, preferably, have an austenite finish temperature of greater than about −10° C., resulting in a temperature differential of about 47° C. when the staple is implanted (assuming that the staple is implanted in a human body). - By way of further example but not limitation, staple geometry also affects the compression forces generated as
staple 5 reconfigures. More particularly, the cross-sectional areas ofelastic bridge 10, elastic hinges 20 andelastic legs 15 affect the compression forces generated by the reconfiguringstaple 5. As the cross-sectional areas increase, the compression forces that the reconfiguringstaple 5 generates also increase. -
Elastic legs 15 ofstaple 5 are critical for transmitting the compression force to the bone without “tearing through” the bone. The height, width, and length of the staple legs, and the geometry of the staple legs, are all significant factors relating to the staple's ability to not “tear through” the bone.Elastic legs 15 having greater surface area are better able to distribute the compression force and thus resist “tearing through” the bone. -
FIG. 9 shows how staple 5 may be used to reduce a fracture and generate and maintain compression between bone fragments 80 and 85. - More particularly, the
fracture 90 which is to be fused is first re-approximated and reduced. A drill guide (not shown) of the sort well known in the art is used to drill twoholes 95 the correct distance apart to accommodate thelegs 15 ofstaple 5.Staple 5 is mounted topins 65 ofdelivery device 35, anddelivery device 35 is used to bendbridge 10 and straightenlegs 15 ofstaple 5 in the manner discussed above (i.e., by turninghandle 55 to advanceplunger 60 which is used to bendbridge 10 and pivotlegs 15 at elastic hinge regions 20). While still mounted topins 65 ofdelivery device 35,legs 15 ofstaple 5 are placed into the pre-drilled holes 95.Staple 5 is then released frompins 65 ofdelivery device 35, i.e., by turninghandle 55 in the opposite (e.g., counter-clockwise) direction and slidingstaple 5 off ofpins 65. This allows thebent bridge 10 and pivotedlegs 15 ofstaple 5 to attempt to return (reconfigure) to their un-bent configuration, thereby applying compression acrossfracture 90. - Note that in the preferred form of the invention, staple 105 is designed to generate and maintain compression between both the cortical bone and the cancellous bone of the bone fragments so as to promote effective healing. In this respect note also that, while
bridge 10, elastic hinges 20 and the proximal (i.e., bridge-side) portions oflegs 15 typically engage cortical bone, the pivoting nature of the reconfiguring distal portions oflegs 15 will help apply enhanced compressive forces to the cancellous bone (i.e., the interior bone) of the bone fragments. - Significantly, it should be appreciated that since
staple 5 is mounted todelivery device 35 viapins 65 being inserted intoholes 25,staple 5 can be fully inserted intopre-drilled holes 95 withbridge 10 in direct contact withbone fragments FIG. 10 ). - It should also be appreciated that, if desired,
staple 5 can be used to attach soft tissue to bone (e.g., to attach a rotator cuff to bone). - In some circumstances it can be desirable to modify
delivery device 35 so as to ensure thatlegs 15 cannot be pivoted athinge regions 20 beyond 90 degrees (relative to the longitudinal axis of bridge 10) whenlegs 15 ofstaple 5 are pivoted outboard. In other circumstances, it may be desirable fordelivery device 35 to allowlegs 15 ofstaple 5 to be pivoted outboard less than, or greater than, 90 degrees to allow insertion into slightly mispositioned (or angled) drill holes 95. - It should be appreciated that following implantation, if desired,
delivery device 35 can also be used to removestaple 5 from the bone. More particularly,delivery device 35 can be used to re-engagestaple 5 at the holes 25 (i.e., by insertingpins 65 ofdelivery device 35 intoholes 25 of staple 5) in thehinge regions 20 ofstaple 5. Turning handle 55 (e.g., clockwise) causesplunger 60 to bendstaple bridge 10 and to reconfigurestaple 5 such thatbridge 10 is substantially perpendicular tostaple legs 15. Staple 5 can then be removed from the bone by pulling the staple out perpendicular to the bone. - Additionally,
staple delivery device 35 allows the surgeon to “sense” howmuch compression staple 5 will exert on the bone when it is released fromdelivery device 35 and attempts to reconfigure. More particularly, as the surgeon turns handle 55 to straightenbridge 10 and open staple legs 15 (e.g., by turninghandle 55 clockwise), handle 55 requires greater levels of torque asstaple 5 is opened (i.e, asbridge 10 is pushed down andlegs 15 are pivoted outboard), thereby providing a degree of tactile feedback to the surgeon. The torque that the surgeon applies to handle 55 is proportional to the compression thatstaple 5 will exert on the bone as the staple reconfigures. - Thus
delivery device 35 also allows the surgeon to ascertain and control howmuch compression staple 5 will exert when the staple is released fromdelivery device 35. The greater the degree to whichbridge 10 is straightened andlegs 15 ofstaple 5 are opened (i.e., pivoted outboard), the morecompressive force staple 5 will exert on the bone when it is released fromdelivery device 35. - Additionally,
delivery device 35 also allows the surgeon to control the rate at whichstaple 5 loads the bone as the staple is removed fromdelivery device 35. More particularly, turninghandle 55 ofdelivery device 35 counterclockwise releases the downward (i.e., distal) force that plunger 60 exerts onbridge 10 ofstaple 5. This allows staple 5 to attempt to recover (i.e., reconfigure) to its original shape and apply compression across the fracture site. It may be desirable to allow the surgeon to be able to control this “release rate” so that the bone is not damaged asstaple 5 reconfigures and so thatstaple 5 remains in the desired location. - In one preferred form of the invention,
staple 5 anddelivery device 35 are provided in the form of a sterilized kit. Staple 5 may be “pre-loaded” (i.e, mounted) onto delivery device 35 (i.e., withpins 65 ofdelivery device 35 extending throughholes 25 of staple 5). Staple 5 may be mounted ondelivery device 35 in an unconstrained or a constrained state. The kit may include additional instruments to aid in the implantation of the staple (e.g., k-wire, drill bit, staple size guide, etc.). - The compressive force generated by staples of the present invention formed out of Nitinol with greater than 20% cold work are able to generate 50 to 100 Newtons of force depending on the staple dimensions. This is more than twice the compression force able to be generated by conventional staples of a similar size.
- Looking now at
FIGS. 11-19 it should be appreciated thatstaple bridge 10 may be formed so as to have a different configuration. By way of example but not limitation, it may be beneficial forstaple bridge 10 to have a concave geometry (FIGS. 11-13 ), such that whenbridge 10 ofstaple 5 is reversibly bent (i.e., so thatlegs 15 are pivoted so that they are parallel to each other),bridge 10 can bend downwardly, i.e., so as to become more concave (FIG. 12 ). Upon insertion of thestrained staple 5 across the prepared fracture site, the constraint onbridge 10 and hinges 20 is removed, whereuponstaple 5 attempts to return (i.e., reconfigure) to its original un-restrained state (FIG. 13 ), thereby generating a compressive load across the fracture line and maintaining that compressive load across the fracture line while healing occurs. By way of example but not limitation, it may be beneficial to provide astaple 5 having aconcave bridge 10 for the treatment of fractures where the anatomy is “hour-glass” shaped (e.g., in an Akin Osteotomy). - It may also be desirable to provide a
staple 5 having abridge 10 formed with a sloped geometry (FIG. 14 ). In this form of the invention,legs 15 can be elastically pivoted so as to be parallel to one another (FIG. 15 ). Upon insertion of thestrained staple 5 into the prepared fracture site, the constraint onbridge 10 and hinges 20 is removed, whereuponstaple 5 attempts to return to its original un-restrained state (FIG. 16 ), thereby generating a compressive load and maintaining that compressive load while healing occurs. It may be desirable to providestaple 5 having this configuration for the treatment of fractures where the anatomy is non-linear (e.g., at the metaphyseal flares). - It may also be desirable to provide
staple 5 withbridge 10 having a stepped geometry (FIG. 17 ). In this form of the invention, whenstaple 5 is reversibly strained (i.e., so thatlegs 15 are pivoted outboard so as to be parallel to each other),bridge segments FIG. 18 ). Upon insertion of thestrained staple 5 into the prepared fracture site, the constraint onbridge 10 and hinges 20 is removed, whereuponstaple 5 attempts to return (i.e., reconfigure) to its original un-restrained state (FIG. 19 ), thereby generating a compressive load across the fracture line and maintaining that compressive load across the fracture line while healing occurs. It may be desirable to provide astaple 5 having this configuration for the treatment of fractures where the anatomy is uneven (i.e., sliding calcaneal osteotomies, calcaneocuboid fusions, Lapidus procedures, etc.). - It may also be desirable to provide a
staple 5 having amalleable bridge 10 which is plastically deformable so as to be able to take a set (FIG. 20 ). This allows the surgeon to shapestaple bridge 10 in order to conform to the anatomy of the patient. With this form of the invention,delivery device 35 can be used to deform/shape staple bridge 10. When a staple of this configuration has a force applied to itsbridge 10 so thatstaple legs 15 are pivoted so as to be parallel to each other,malleable bridge 10 is plastically deformed so as to take a set (FIG. 21 ). The morestaple legs 15 are opened (i.e., pivoted outboard), the morestaple bridge 10 is plastically deformed. Upon insertion of thestrained staple 5 into the prepared fracture site, elastic hinges 20 attempt to returnstaple legs 15 to their original un-restrained state whilestaple bridge 10 remains deformed (FIG. 22 ), thereby generating a compressive load and maintaining that compressive load across the fracture line while healing occurs. A staple of this configuration may be beneficial for the treatment of fractures where the anatomy is uneven (e.g., in an Akin Osteotomy). - While
holes 25 are primarily used for releasably mountingstaple 5 to delivery device 35 (i.e., via pins 65), holes 25 also may be used after implantation to aid the surgeon with tying ligaments and/or tendons directly down to the bone (FIG. 23 ). Typically, a surgeon would use a suture anchor, bone tunnel or other method/device known in the art to re-secure a ligament and/or tendon to the bone. It should be appreciated that the staple of the present invention provides the surgeon withholes 25 which may be used to tie ligaments and/or tendons directly to the bone. This allows the surgeon to avoid having to use an additional implant or perform an additional procedure to achieve the same outcome. - In the foregoing disclosure,
novel staple 5 andnovel delivery device 35 are discussed in the context of rejoining a broken bone. However, it should be appreciated thatnovel staple 5 andnovel delivery device 35 may be used to promote joinder of substantially any two (or more) bone segments, e.g., they may be used to reduce openings and maintain compression between bone segments in osteotomies, or they may be used for inducing fusion across the bones of a joint in an arthrodesis, etc. - It should be understood that many additional changes in the details, materials, steps and arrangements of parts, which have been herein described and illustrated in order to explain the nature of the present invention, may be made by those skilled in the art while still remaining within the principles and scope of the invention.
Claims (20)
1. Apparatus for generating, applying and maintaining compression to a site in a human or animal body, the apparatus comprising:
a staple comprising:
a bridge configured to be elastically bendable;
a first leg connected to the bridge by a first hinge region configured to be elastically bendable; and
a second leg connected to the bridge by a second hinge region configured to be elastically bendable;
wherein the first hinge region comprises a first hole configured to mate with a first element of a delivery device and the second hinge region comprises a second hole configured to mate with a second element of a delivery device; and
wherein the first and second legs are angled toward one another when they are in an unstrained state;
whereby, when the staple is mounted to a delivery device so that the first hole of the first hinge region mates with a first element of a delivery device and the second hole of the second hinge region mates with a second element of a delivery device, and when the delivery device applies a force to the bridge of the staple so as to reconfigure the bridge of the staple, the first and second legs are pivoted away from one another toward a parallel disposition.
2. Apparatus according to claim 1 wherein the bridge has a non-linear configuration when it is in an unstrained state, and further wherein when a delivery device applies a force to the bridge of a staple, the bridge is reconfigured from a non-linear configuration toward a linear configuration.
3. Apparatus according to claim 2 wherein the staple comprises a shape memory material.
4. Apparatus according to claim 3 wherein the shape memory material comprises Nitinol.
5. Apparatus according to claim 2 wherein the bridge has a curved configuration when the bridge is in an unstrained state.
6. Apparatus according to claim 5 wherein the bridge is curved away from the first and second legs when the bridge is in an unstrained state.
7. Apparatus according to claim 2 wherein the bridge has a stepped configuration when the bridge is in an unstrained state.
8. Apparatus according to claim 2 wherein the staple comprises more than two legs.
9. Apparatus according to claim 2 further comprising a delivery device, the delivery device comprising:
a first element sized to be received in the first hole of the first hinge region of the staple;
a second element sized to be received in the second hole of the second hinge region of the staple; and
a plunger adapted to apply a force to the bridge of the staple so as to reconfigure the bridge of the staple from a non-linear configuration toward a linear configuration.
10. Apparatus according to claim 9 wherein the delivery device comprises a body, the first element is mounted to a first arm which is pivotally connected to the body, the second element is mounted to a second arm which is pivotally connected to the body, and the plunger is movably mounted to the body.
11. Apparatus according to claim 9 wherein the plunger is movably mounted to the body so as to allow the user to control the amount of force applied to the bridge of the staple.
12. Apparatus according to claim 9 wherein the staple and the delivery device are packaged as a sterilized kit.
13. A method for generating, applying and maintaining compression to a site in a human or animal body, the method comprising:
providing a staple comprising:
a bridge configured to be elastically bendable;
a first leg connected to the bridge by a first hinge region configured to be elastically bendable; and
a second leg connected to the bridge by a second hinge region configured to be elastically bendable;
wherein the first hinge region comprises a first hole configured to mate with a first element of a delivery device and the second hinge region comprises a second hole configured to mate with a second element of a delivery device; and
wherein the first and second legs are angled toward one another when they are in an unstrained state;
providing a delivery device comprising:
a first element sized to be received in the first hole of the first hinge region of the staple;
a second element sized to be received in the second hole of the second hinge region of the staple; and
a plunger adapted to apply a force to the bridge of the staple so as to reconfigure the bridge of the staple;
mounting the staple to the delivery device so that the first hole of the first hinge region mates with the first element of the delivery device and the second hole of the second hinge region mates with the second element of the delivery device;
applying a force to the bridge of the staple with the plunger of the delivery device so as to reconfigure the bridge of the staple such that the first and second legs are pivoted away from one another toward a parallel disposition;
inserting the staple into a site in a human or animal body;
withdrawing the plunger of the delivery device from the bridge of the staple so as to cause the staple to apply compression to the site in a human or animal body as the staple reconfigures; and
releasing the staple from the delivery device.
14. A method according to claim 13 wherein the bridge has a non-linear configuration when it is in an unstrained state, and further wherein when the delivery device applies a force to the bridge of a staple, the bridge is reconfigured from a non-linear configuration toward a linear configuration.
15. A method according to claim 14 wherein the staple comprises a shape memory material.
16. A method according to claim 15 wherein the shape memory material comprises Nitinol.
17. A method according to claim 14 wherein the bridge has a curved configuration when the bridge is in an unstrained state.
18. A method according to claim 14 wherein the bridge is curved away from the first and second legs when the bridge is in an unstrained state.
19. A method according to claim 14 wherein the bridge has a stepped configuration when the bridge is in an unstrained state.
20. A method according to claim 14 wherein the staple comprises more than two legs.
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US20150133940A1 (en) | 2015-05-14 |
EP3068312A4 (en) | 2017-07-26 |
EP3068312A1 (en) | 2016-09-21 |
EP3068325A1 (en) | 2016-09-21 |
EP3563776A2 (en) | 2019-11-06 |
CN106413606A (en) | 2017-02-15 |
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CN106413575A (en) | 2017-02-15 |
US9861357B2 (en) | 2018-01-09 |
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WO2015073642A1 (en) | 2015-05-21 |
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CN106413575B (en) | 2020-09-01 |
EP3563776A3 (en) | 2020-08-05 |
US20170311946A1 (en) | 2017-11-02 |
EP3068325A4 (en) | 2017-08-30 |
US10610218B2 (en) | 2020-04-07 |
US10064619B2 (en) | 2018-09-04 |
CN106413606B (en) | 2020-03-13 |
WO2015073728A1 (en) | 2015-05-21 |
EP3068325B1 (en) | 2021-09-15 |
US20170311948A1 (en) | 2017-11-02 |
US20180344316A1 (en) | 2018-12-06 |
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