Thoracic plate implants and methods of use

An implant for a human rib can include an elongate body, a plurality of bores, and a placement tool interface. The elongate body can include a first portion including a flat outer face where the elongate body can be curved along a plane perpendicular to the flat outer face. The second portion can extend from the first portion to form a curved outer face. The plurality of bores can extend through the flat outer face of the first portion and into the second portion. The bores can extend partially into the curved outer face of the second portion. The placement tool interface can extend into the body.

BACKGROUND

Implants are common in the medical field for strengthening bones of patients. In some cases, implants can be attachable to bones that are broken. For example, when patients have cracked and broken (fractured) ribs, surgeons sometimes install a plate to maintain rib alignment to promote proper healing. The plate can be secured to the rib on both sides of the fracture to maintain proper alignment of the rib during healing. The plate can be secured to the rib using fasteners. In some cases, the plate and fasteners can be removed from the patient after the fracture has healed.

OVERVIEW

In some cases of fractured ribs where a plate is required to promote proper healing, it may be desired to install the plate on the posterior portion of the rib for reduced palpability and increased comfort. In these cases, it is common to install the plate from the opposite side of the thoracic cavity. For example, a rib that is fractured at a ventral portion may be accessed from a posterior side of the patient. While this placement of an implant has many relative benefits, a procedure to place an implant as such can present several difficulties. For example, aligning the rib plate on the fractured rib and maintaining alignment for creation of bores in the rib and for fastening the plate to the rib can be a difficult process.

The present inventors have recognized, among other things, that a suture can be connected to the plate and pulled through a bore in the rib to align the plate to the rib for fastening, thereby improving the alignment and fastening process. The inventors have also recognized that a rib plate secured to the posterior portion of the fractured rib can include a curved anterior portion to reduce aggravation of adjacent tissues, where a template can be used in some examples to create bores for fastening the (posterior) rib plate from an anterior side of the rib. The rib plate can further include an interface for temporary connection to a placement tool, where the tool can be used to position the implant during drilling and fastening operations.

To further illustrate the apparatuses and systems disclosed herein, the following non-limiting examples are provided:

Example 1 is an implant for a human rib, the implant comprising: an elongate body comprising: a first portion including a flat outer face, the elongate body curved along a plane perpendicular to the flat outer face; and a second portion extending from the first portion to form a curved outer face; a plurality of bores extending through the flat outer face of the first portion and into the second portion; and a placement tool interface extending into the body.

In Example 2, the subject matter of Example 1 optionally includes wherein the placement tool interface comprises: a first bore extending into the second portion, the first bore configured to receive a placement tool.

In Example 3, the subject matter of Example 2 optionally includes wherein the placement tool interface comprises: a second bore coaxial with the first bore and configured to receive the placement tool.

In Example 4, the subject matter of Example 3 optionally includes wherein the first bore and second bore terminate in the second portion prior to intersecting.

In Example 5, the subject matter of any one or more of Examples 1-4 optionally include wherein the second portion comprises a notch in the curved face, configured to allow the elongate body to be bent at the notch.

In Example 6, the subject matter of Example 5 optionally includes wherein notch is located at the placement tool interface.

In Example 7, the subject matter of any one or more of Examples 1-6 optionally include wherein the flat outer face and the curved outer face form a half-capsule shape.

In Example 8, the subject matter of any one or more of Examples 1-7 optionally include wherein the body is curved to engage an interior rib surface.

In Example 9, the subject matter of any one or more of Examples 1-8 optionally include wherein the flat outer face comprises: a protrusion extendable into the human rib, the protrusion configured to limit movement of the flat outer face relative to the human rib when extended into the human rib.

Example 10 is an implant assembly for securing an implant to a human rib, the implant assembly comprising: an implant securable a human rib, the implant comprising: an elongate body comprising: a first portion and a second portion opposite the first portion; an implant bore extending through the first portion and partially into the second portion; and a placement tool interface extending into the body; a placement tool comprising: a handle; an arm extending from the handle; and a retaining pin extending from a distal portion of the arm, the retaining pin engageable with the placement tool interface to form a pivotable engagement therewith; and a fastener comprising: a proximal threaded portion securable to the rib; and a distal threaded portion extending distally from the proximal threaded portion, the distal threaded portion threadably securable to the implant bore.

In Example 11, the subject matter of Example 10 optionally includes the assembly further comprising: a lag screw configured to pass through a rib bore without threadably engaging the rib bore and including a lag distal threaded portion threadably securable to a second bore of the implant.

In Example 12, the subject matter of any one or more of Examples 10-11 optionally include wherein the fastener further comprises: a head comprising a tool interface, the head including a head diameter; and a body extending distally from the head, the body comprising: the proximal threaded portion that extends distally from the head, the proximal threaded portion comprising: a proximal minor diameter that is larger than the head diameter; and a proximal major diameter; and the distal threaded portion that extends distally from the proximal threaded portion, the distal threaded portion comprising: a distal major diameter of a size equal to or smaller than the proximal minor diameter.

In Example 13, the subject matter of Example 12 optionally includes wherein the distal threaded portion further comprises: a locking thread adjacent the proximal threaded portion, the locking thread configured to lockably engage one of the implant bore including a first thread type.

In Example 14, the subject matter of Example 13 optionally includes wherein the placement tool further comprises: a second arm flexibly coupled to a distal portion of the elongate handle, the first and second arms extending distally from the elongate handle, the first and second arms movable between a first position and a second position.

In Example 15, the subject matter of Example 14 optionally includes wherein the placement tool further comprises: a second retaining pin extending from a distal portion of the second arm towards the first arm such that the first retaining pin is spaced away from the second retaining pin, the second retaining pin coaxial with the first retaining pin when the first and second arms are in a first position, the first retaining pin and second retaining pin spaced further apart when the first and second arms are in a second position.

In Example 16, the subject matter of Example 15 optionally includes wherein the placement tool interface further comprises: a first pin bore extending into the second portion, the first bore configured to receive the first retaining pin; and a second pin bore coaxial with the first pin bore and configured to receive the second retaining pin.

In Example 17, the subject matter of Example 16 optionally includes wherein the first pin bore and second pin bore terminate in the second portion prior to intersecting.

In Example 18, the subject matter of any one or more of Examples 10-17 optionally include wherein: the first portion includes a flat outer face, the elongate body curved along a plane perpendicular to the flat outer face; and the second portion extends from the first portion to form a curved outer face.

In Example 19, the subject matter of Example 18 optionally includes wherein the implant further comprises: a plurality of bores extending through the flat outer face and partially into the second portion, each of the plurality of bores capable of receiving the fastener.

In Example 20, the subject matter of any one or more of Examples 18-19 optionally include the second portion further comprising: a notch in the curved outer face located at the placement tool interface and configured to allow the elongate body to be bent at the notch.

Example 21 is a fastener for securing an implant to human bone, the fastener comprising: a head comprising a tool interface, the head including a head diameter; a body extending distally from the head, the body comprising: a proximal threaded portion extending distally from the head, the proximal threaded portion comprising: a proximal minor diameter that is larger than the head diameter; and a proximal major diameter; and a distal threaded portion extending distally from the proximal threaded portion, the distal threaded portion comprising: a distal major diameter of a size equal to or smaller than the proximal minor diameter.

In Example 22, the subject matter of Example 21 optionally includes the distal threaded portion further comprising thread configured to interface with a threaded bore and the proximal threaded portion further comprising thread configured to interface with bone.

In Example 23, the subject matter of any one or more of Examples 21-22 optionally include the distal threaded portion further comprising: a locking thread adjacent the proximal threaded portion, the locking thread configured to lockably engage an implant bore.

In Example 24, the subject matter of any one or more of Examples 21-23 optionally include wherein the proximal threaded portion includes self-tapping threads.

Example 25 is a placement tool for placing and securing an implant to human bone, the placement tool comprising: an elongate handle; first and second arms flexibly coupled to a distal portion of the elongate handle, the first and second arms extending distally from the elongate handle, the first and second arms movable between a first position and a second position; a first retaining pin extending from a distal portion of the first arm towards the second arm; and a second retaining pin extending from a distal portion of the second arm towards the first arm such that the first retaining pin is spaced away from the second retaining pin, the second retaining pin coaxial with the first retaining pin when the first and second arms are in the first position, the first retaining pin and second retaining pin spaced further apart when the first and second arms are in the second position.

In Example 26, the subject matter of Example 25 optionally includes a coupler engageable with the retaining pins and including a set of jaws coupleable to a recessed portion of a plate.

In Example 27, the subject matter of any one or more of Examples 25-26 optionally include wherein the first arm and the second arm are biased to the first position.

In Example 28, the subject matter of any one or more of Examples 25-27 optionally include wherein the first retaining pin and second retaining pin are configured to form a pivotable engagement with a placement tool interface of an implant when the arms are in the first position.

Example 29 is a method of securing an implant to human bone, the method comprising: creating a bore proximate a break in the human bone; passing a suture through first and second bores of an implant; passing the suture through the bore of the human bone; pulling the implant to an anterior portion of the human bone using the sutures; passing a fastener through a third bore of the implant; threading the fastener into the human bone with a distal thread of the fastener; and threading the fastener into the third bore of the implant with a proximal thread of the fastener.

In Example 30, the subject matter of Example 29 optionally includes removing the suture from the implant.

Example 31 is a method of securing an implant to human bone, the method comprising: attaching a drill guide to a placement tool; pivoting the drill guide to substantially align with arms of the placement tool; inserting the drill guide and the placement tool into a thoracic opening; pivoting the drill guide to align with a posterior portion of a rib; guiding a drill bit into position using a drill guide bore; drilling a rib bore using the drill guide bore as a guide; removing the drill guide and the placement tool from the thoracic opening; attaching the placement tool to an implant; pivoting the implant to substantially align with arms of the placement tool; inserting the implant and the placement tool into a thoracic opening; and threading the fastener into a bore of the implant with a distal thread of the fastener.

In Example 32, the subject matter of Example 31 optionally includes detaching the placement tool from the implant; and removing the placement tool from the thoracic opening.

In Example 33, the subject matter of any one or more of Examples 31-32 optionally include continuing drilling through skin adjacent the rib bore.

In Example 34, the implant, assembly, or method of any one of or any combination of Examples 1-34 is optionally configured such that all elements or options recited are available to use or select from.

These and other examples and features of the present apparatuses and systems will be set forth in part in the following Detailed Description. This Overview is intended to provide non-limiting examples of the present subject matter and it is not intended to provide an exclusive or exhaustive explanation. The Detailed Description below is included to provide further information about the present apparatuses and methods.

DETAILED DESCRIPTION

The present application relates to devices and systems for orthopedic implant procedures. For example, the present application discloses a rib implant system configured to secure to a rib or ribs of a patient. The description below discusses rib implants primarily configured to engage an interior portion of a rib referred to as a posterior portion of the rib throughout the description. In some embodiments, these implants can be alternatively configured to engage the outer or anterior portion of a rib. Details are discussed further below.

FIG. 1shows an isometric view of implant assembly100and rib50of a patient, in accordance with an example of the present disclosure. Rib50can include rib bore52. Implant assembly100can include implant102, fastener104, driver106, and suture108. Implant102can include implant bores110A-110N. Fastener104can include distal threaded portion111and proximal threaded portion113.FIG. 1also shows orientation indicators Anterior and Posterior.

Implant102can be a rigid or semi-rigid member comprised of materials such as plastics, metals, composites, and the like. In some examples, implant102can be comprised of biocompatible metals and alloys such as stainless steel, titanium, and cobalt chromium. Implant102can include bores110A-110N, which can be spaced apart, equally in some examples, along a length of a body of implant102. Each of bores110a-110ncan be threaded to receive proximal threaded portion113of fastener104.

Fasteners104can be rigid fasteners comprised of materials such as plastics, metals, composites, and the like. In some examples, fasteners104can be composed of biocompatible metals and alloys such as stainless steel, titanium, and cobalt chromium. Fasteners104can include proximal threaded portion113configured to secure to bores110A-110N of implant102and distal threaded portion111configured to secure to bone (as discussed in more detail further below).

Driver106can be a driver such as a screw driver, configured to transfer a torque from a handle down a shaft and to the head of fastener104. Driver106can include a fastener interface, such as standard, cross-recess, hex, and the like. Sutures108can be medical sutures composed of absorbable or non-absorbable materials such as nylon, polyester, polypropylene, polyamide, silk, steel, metallic strands, polyglactin, polyglycolic acid, catgut, poliglecaprone, polydioxanone, combinations thereof, and the like.

In some patients, rib50may be fractured due to trauma. In these cases, rib plate102can be secured to rib50to maintain alignment of the rib during the healing process. However, alignment of implant102with rib50can be difficult. In these cases, suture108can be passed through two or more of implant bores110A-110N. As shown inFIG. 1, suture108can be passed through bores110C and110D. Suture108can then be passed through bone bore52to an anterior side of rib50. In other examples, suture108can be pre-mounted to implant102prior to the insertion of implant102into the thoracic space. Suture108can be pulled tight from an anterior side of rib50, drawing implant102against a posterior side of rib50. Holding suture108tight can hold implant102in place against rib50while bores are created in rib50using implant102as a template. Sutures108can be held tight until fasteners (such as fastener104) are driven into the bores of rib50and have secured implant102to rib50. After fasteners104have secured implant102to rib50, sutures108can be left in place (if absorbable) or can be removed, and holes110C and110D (that were used for suture) can receive fasteners therethrough to further secure implant102to rib50.

FIG. 2shows an isometric view of implant assembly200and rib50of a patient, in accordance with an example of the present disclosure. Rib50can include rib bore52. Implant assembly200can include implant202and suture208. Implant202can include implant bores210A-210N.FIG. 2also shows orientation indicators Anterior and Posterior.

Implant assembly200can be similar to implant assembly100described above with respect toFIG. 1, except that implant assembly100can include suture208, which can include line212and knot-up214. Line212and knot-up214can be composed of materials described above with reference to sutures108.

In operation of some examples, suture208can be passed through bore210C. Suture208can then be passed through bone bore52to an anterior side of rib50. Ends of suture208can be pulled tight causing knot-up214to change shape, creating a knot or dense portion of material that has a size larger than bore210C such that knot-up214cannot pass through bore210C. Suture208can then be pulled at an anterior side of rib50, drawing implant202against a posterior side of rib50. Holding suture208tight can hold implant in place so that bores can be created in rib50and so that fasteners (such as fastener104ofFIG. 1) can be driven into the bores of the rib and secured to implant202. Suture208can provide the benefit of only passing through a single bore, allowing that bore, such as bore210C to be aligned with bore52of rib50. This can reduce the number or size of required rib bores.

FIG. 3shows an isometric view of implant300, in accordance with an example of the present disclosure. Implant300can include body301, tool interface306, and bores310A-310N. Body301can include portion302and curved portion304. Portion302can be flat in cross-section and rounded or curved along its length, as shown inFIG. 3. Edges of body301can be tapered and smooth to prevent soft tissue irritation.

Body301can be a rigid or semi-rigid member comprised of materials such as plastics, metals, composites, and the like. In some examples, body301can be comprised of biocompatible metals and alloys such as stainless steel, titanium, and cobalt chromium. Portion302of body301can include flat outer face308. Curved portion304can extend from portion302to form curved outer face309. In some examples, curved portion304can have a smooth exterior with rounded corners to limit friction between second portion304and surrounding tissue, limiting discomfort and reducing a possibility of puncturing or abrading of internal organs. In some examples, flat face308of portion302can have an abrasive surface configured to prevent movement of implant300relative to a rib. In other examples, flat face308of portion302can have a smooth surface configured to allow movement of implant300relative to a rib when, for example, a rib is likely to move during the healing process.

Bores310A-310N can be threaded bores, in some examples, extending through flat outer face308of first portion302and into second portion304. Tool interface306can be a bore or bores extending into body301. In some examples, tool interface306can be a bore, slot, aperture, or other opening configured to receive a notch or protrusion of a tool. In some examples, tool interface306can have a round geometric shape, but can have other shapes in other examples. In some examples, tool interface306can be a single bore extending entirely through implant300configured to receive one or more portions of a tool. In other examples, tool interface306can be multiple bores, each configured to receive a portion of a tool. Operation of implant300is described with respect toFIGS. 5-9 and 13-19below.

FIG. 4Ashows an isometric view of placement tool400, in accordance with an example of the present disclosure. Placement tool400can include handle420and arms422.FIG. 4Aalso shows orientation indicators Proximal and Distal.

Handle420and arms422A and422B can be rigid or semi-rigid members comprised of materials such as plastics, metals, composites, combinations thereof, and the like. Handle420can have a profile shaped for ergonomics and traction, in some examples. Arms422A and422B can extend from a distal portion of handle420generally parallel to each other. Arm422A can include pin424A (or retaining pin/first retaining pin) and arm422B can include pin424B (or second retaining pin). In some examples, pin424A can extend from an inner surface of arm422A generally perpendicular to arm422A and toward arm422B and pin424B. Similarly, pin424B can extend from an inner surface of arm422B generally perpendicular to arm422B and toward arm422A and pin424A. In some examples, pins424A and424B can be coaxial when arms422A and422B are parallel. In some other examples, arms422can include only one pin. Similarly, tool400can include only one arm422and one pin424. In these examples, pin424can be relatively longer to extend entirely through a tool interface, in some examples.

In some examples, arms422A and422B can be cantilevered from handle420, such that arms422A and422B can flexibly move toward and away from each other, allowing pins424A and424B to move toward and away from each other. Because arms422and body420can be comprised of rigid and semi-rigid materials, arms422can be attached to body420such that flexing of arms422at handle420allowing for relative movement of arms422can be within an elastic region of the materials of handle420and arms422allowing arms422to return to a parallel position when a force causing relative displacement of arms422is removed. Because arms422A and422B are parallel, they can create a low visibility profile, increasing visibility of a fracture site. Operation of placement tool400is described with respect to theFIGS. 5-9 and 13-19below.

FIG. 4Bshows an isometric view of placement tool500, in accordance with an example of the present disclosure. Placement tool500can be similar to placement tool400, except that handle520of placement tool500can include finger holes518A and518B, locking interface526and pivot joint528. Finger hole518A can be coupled to arm522A and finger hole518B can be coupled to arm522B.FIG. 4Balso shows orientation indicators Proximal and Distal.

Arms522A and522B can be pivotably coupled at pivot joint528such that finger holes518A and518A can be operated in a scissor-like fashion to open and close arms522A and522B so that pins524A and524B can engage an implant. Locking device526can be a feature extending between arms522A and522B allowing for automatic locking and manual release of the arms522A and522B relative to each other, similar to the operation of Kelly forceps, in some examples.

FIG. 5shows an isometric view of an implant assembly600in a first configuration, in accordance with an example of the present disclosure.FIG. 6shows an isometric view of implant assembly600in another configuration, in accordance with an example of the present disclosure.FIGS. 5 and 6are discussed below concurrently.

Implant602can be similar to implant300described above with respect toFIG. 3and placement tool604can be similar to either of placement tools400ofFIG. 4A or 500ofFIG. 4B, except thatFIG. 5more clearly shows how implant602can be curved such that flat portion605and curved portion607can form a half-capsule shape of implant602. In some examples, implant602can be curved along a plane formed by the Y and Z axes, substantially perpendicular to the flat face of flat portion605. The curvature can be matched to patient-specific anatomy, in some examples. In other examples, the curvature can be matched to average curvature of ribs. In other examples, the curvature can be matched to average ribs of a specific anatomic location, such as true, floating, or false ribs. Further, the curvature can be matched to average ribs of a specific anatomic location, such as an anterior portion, a posterior portion, or a medial portion.

FIGS. 5 and 6also illustrate how implant602and placement tool604can operate together, in some examples. As shown inFIG. 5, pins624A and624B can be inserted into tool interface606. Once pins624A and624B are inserted into tool interface606, implant602can be pivoted about pins624aand624band therefore relative to arms622A and622B such that implant602can rotate entirely (360 degrees) between arms622A and622B. In some examples, placement tool604can include a stop to limit rotation past, for example, 190 degrees of rotation.

In one example, as shown inFIG. 5, implant602can be substantially perpendicular to arms622A and622B. Implant602can then be pivoted to be substantially parallel to (or in alignment with) arms622A and622B, as shown inFIG. 6. This can allow implant assembly600to be inserted into a relatively small incision.

For example, in the example shown inFIG. 6, implant602and arms622A and622B can be in alignment and can be inserted into thoracic opening54. Once implant602and placement tool604have been fully inserted into a thoracic cavity, implant602can then be pivoted again such that implant602is substantially perpendicular to arms622A and622B (or any position in between parallel and perpendicular) to allow for securing of implant602to a rib, as discussed further below.

FIG. 7shows an elevation view of implant assembly700, in accordance with an example of the present disclosure. Implant assembly700can include implant702, first placement tool704, and second placement tool706. First placement tool704can include arms722A and722B, each of which can include pins724A and724B. Second placement tool706can include arms723A and723B, each of which can include pins725A and725B.

In this example, multiple placement tools can be connected to implant702to place implant702within a thoracic cavity. Use of multiple placement tools, such as first placement tool704and second placement tool706, can provide additional stability of implant702during placement, drilling, and fastening operations performed on implant702within a thoracic cavity. In some examples, placement tools704and706can be aligned with implant702to form an assembly having a narrow profile, allowing assembly700to pass through a relatively small incision opposite the rib to be repaired.

FIG. 8Ashows an isometric view of a fastener of an implant assembly, in accordance with an example of the present disclosure. Fastener804can include head830, shank832, and distal threaded portion834.

In some examples, head830can include a tool interface, such as a hexagonal tool or bolt interface, in one example. Head830can be of a diameter larger than a bone bore, as discussed further below. Shank832can have a diameter smaller than the bone bore where shank832can also have a smooth finish to allow for shank832to be inserted through the bone bore with relatively little force or interaction between shank832and the bone bore.

Threaded portion834can include threads configured to interface with a bore of an implant, such as fine threads or machine threads. Threaded portion834can also have a diameter smaller than the bone bore to allow fastener804to be quickly inserted through the bone bore by minimizing interaction between threaded portion834and the bone bore. In some examples, fastener804can be similar to a lag bolt or shoulder bolt, but having shank and threaded portions with multiple diameters.

FIG. 8Bshows an isometric view of an implant assembly, in accordance with an example of the present disclosure. Implant assembly800can include implant802and fastener804. Also shown inFIG. 8Bare rib portion50and skin portion56, through which bores52A-52C pass. Also shown inFIG. 8Bare orientation indicators Posterior and Anterior.

Rib portion50and skin portion56can be a rib and skin of a patient. Rib bores52A-52C can extend through skin portion56and rib portion50and can be created from the internal (posterior side) portion of the thoracic cavity, as discussed in further detail below.

Implant802can be similar to implant300discussed above, where implant802can include implant bore810, which can extend from an anterior side of implant802partially into implant802and terminating prior to extending through implant802to posterior side of implant802. In some examples, bore810can have a fine or machine thread configured to receive threaded portion834of fastener804.

In operation of some examples, bores52A-52C can be formed through rib portion50and skin portion56. Implant802can then be aligned such that implant bore810aligns with rib bore52C. Fastener804can then be inserted anterior to posterior into rib bore52C until threaded portion834engages bore810. Head830can then be engaged with a tool to rotate fastener804, driving threaded portion834into bore810until head830makes contact with rib portion50, preventing further anterior to posterior movement of fastener804. In some examples, threaded portion834can include locking threads configured to prevent over-rotation of fastener804into bore810and to prevent back-out of fastener804from bore810.

Because bore810does not extend through implant802, the tip of fastener804does not protrude into the thoracic space, limiting edges exposed to internal organs and tissues. Also, because no cavity is exposed to the internal thoracic space, ingrowth can be reduced, which can reduce risk of infection. Implant800also reduces palpability by using blind bores (or is not exposed to an anterior portion of rib50), such as bore810, which allow implant800to be installed on the posterior portion of rib50.

FIG. 9Ashows an isometric view of fastener904of implant assembly900, in accordance with an example of the present disclosure.FIG. 9Bshows an isometric view of implant assembly900, in accordance with an example of the present disclosure.FIGS. 9A and 9Bare discussed below concurrently.

In some examples, head930can include a tool interface, such as a hexagonal tool or bolt interface, in one example. Head930can be of a diameter smaller than bone bores52A-52C. Proximal threaded portion932can have a minor diameter D2smaller than a bone bore diameter D1and a major diameter D3can be larger than the bone bore diameter D1and larger than head930. Proximal threaded portion932can also have threads configured to engage bone, such as a coarse threading.

Distal threaded portion934can have a major diameter D4that is smaller than the bone bore diameter D1, such that distal threaded portion934can pass through bone bore52A with relatively little interaction with rib50. Distal threaded portion934can include threads configured to interface with bore910of implant902.

Rib portion50and skin portion56can be a rib and skin of a patient. Rib bores52A-52C can extend through skin portion56and rib portion50and can be created from the internal (posterior side) portion of the thoracic cavity, as discussed in further detail below.

Implant902can be similar to implant300discussed above, where implant902can include implant bore910, which can extend from an anterior side of implant902partially into implant902and terminating prior to extending through to posterior side of implant902. In some examples, bore910can have a fine or machine thread configured to receive threaded portion934of fastener904.

In operation of some examples, bores52A-52C can be formed through rib portion50and skin portion56. Implant902can then be placed against a posterior portion of rib50such that implant bore910aligns with rib bore52C. Fastener904can then be inserted anterior to posteriorly into rib bore52A until proximal threaded portion932engages rib bore52A. Head930can then be engaged with a tool to rotate fastener904, driving proximal threaded portion932into rib bore52A in a self-tapping fashion, until distal threaded portion934reaches implant bore910at which point distal threaded portion934can be threaded into implant bore910until distal threaded portion934is fully threaded into implant bore910. In some examples, distal threaded portion934can include locking threads configured to prevent over-rotation of fastener904into bore910and can prevent back-out of fastener904from implant bore910.

Because major diameter D4of distal threaded portion934has a diameter equal to or smaller than minor diameter D2of first threaded portion932, second threaded portion does not engage rib bore52A, which can increase fastening time and operational efficiency. Because major diameter D3can be larger than bone bore diameter D1and larger than head930, head930can be driven into the bone bore allowing fastener904to be driven into implant902until distal threaded portion934locks into implant bore910. During fastening, major diameter D3can self-tap into rib bore52A.

FIG. 10Ashows a posterior isometric view of implant1000, in accordance with an example of the present disclosure.FIG. 10Bshows an anterior isometric view implant1000, in accordance with an example of the present disclosure.FIGS. 10A and 10Bare discussed below concurrently.

Implant1000can include body1001, tool interface region1006(or notch1006), and bores1010a-1010n. Body1001can include flat portion1002and curved portion1004. In some examples, body1001can be malleable or bendable, such as at region1006, to allow the body1001to better match a rib contour or profile. This bendability may be achieved because region1006is relatively thinner than the rest of body1001, and/or because at least a portion of region1006is made of a different material than the rest of body1001.

Implant1000can be similar to implant300discussed above, except that implant1000includes tool interface1006, which can be a notch or a portion of curved portion1004having a reduced thickness. Notch1006can provide multiple functions, in some examples. For example, a placement tool can be coupled to tool interface1006as discussed in further detail below. Also, because notch1006has a relatively smaller thickness of curved portion1004, body1001can be bent at notch1006to create a curved profile of implant1000to match a patient's anatomy. In one example, body1001can be bent at notch1006to align a curvature of flat portion1002with a curvature of a patient's rib.

Implant1000can also differ in that it can include friction element1020. Friction element1020can extend outwardly from flat portion1002. In some examples, friction element1020can be configured to engage a rib to help maintain a desired position of implant1000relative to the rib. In other examples, implant1000can include multiple friction elements. In some other examples, implant1000can include no friction element (such as friction element1020), but can have an abrasive surface to minimize slipping of implant1000on a rib.

FIG. 11shows an isometric view of implant assembly1100, in accordance with an example of the present disclosure. Implant assembly1100can include flat portion1112, curved portion1114, and tool interface1116(or notch1116). Placement tool1104can include arms1122A and1122B, which can include pins1124A and1124B (only1124B is shown inFIG. 11), respectively.

Implant1100can be similar to implant1000described above with respect toFIG. 10and placement tool1104can be similar to either of placement tools400ofFIG. 4A or 500ofFIG. 4B, except that placement tool1104includes coupler1126. Coupler1126can include jaws1128A and1128B defining recessed portion1130, where jaws1128A and1128B can flex such that they are configured to receive notch1116of implant1102.

In some examples, coupler1126can include one or more bores configured to receive pins1124A and1124B to secure coupler1126to arms1122A and1122B, such that coupler1126is removably coupleable to tool1104. Because coupler1126can be removable, one type of placement tool can be used for multiple types of implants, reducing cost. In other examples, coupler1126can be fixed to tool1104, but can still pivot about pins1124A and1124B. In other examples, coupler1126can be rigidly secured to tool1104. In other examples, coupler1126can be rotatably secured to tool1104, but can be fixedly secured, such that coupler1126is not removable from tool1104.

In operation of some examples, jaws1128A and1128B can engage tool interface1126and can couple thereto in a snap-fit configuration, in one example, allowing notch1116of implant1102to engage recess1130. When implant1102contacts a rib, the reaction force from the rib can cause coupler1126to rotate about pins1124A and1124B rotating implant1102about tool1104. This feature allows implant1102to be self-aligning with the rib, which can save time during an operation.

FIG. 12shows a cross-sectional view implant1200, in accordance with an example of the present disclosure. Implant1200can be similar to implant1000, except that implant1200includes multiple notches1206A-1206N.

Body1201of implant1200can include one, two, three, four, five, six, ten, and the like notches. Each of notches1206A-1206N can have a relatively smaller thickness of body1201allowing body1201to be bent at any of notches1206A-1206N such that a curvature of implant1200to be matched to patient-specific anatomy. In some examples, body1201can be bent at only one notch, such as notch1206A, and in other examples, body1201can be bent at multiple notches, such as notches1206A,1206B, and1206C.

Also, notches1206A-1206N can provide multiple interfaces for a placement tool, such as tool1104ofFIG. 11. In this way, a tool can be attached to any of notches1206A-1206N as required for placement of implant1200along a posterior surface of a rib. For example, a placement tool can be placed at notch1206ain some examples and1206in other examples. In some other examples, one placement tool can be placed at a first notch, such as notch1206A, and another placement tool can be placed at a second notch, such as notch1206C.

FIG. 13shows an anterior isometric view of implant assembly1300, in accordance with an example of the present disclosure. Implant assembly1300can include template1302and placement tool1304. In some examples, discussed further below, template1302can be a template or guide. In some examples, template1302can be malleable or bendable to match a rib contour or profile.

Template1302can be similar to implant300, except that bores1310A-1310N can extend through template1302such that a drill and/or fastener can pass through each of bores1310A-1310N, allowing template1302to be used as a drilling guide or template for creating bores in ribs and skin.

Implant tool1304can interface with template1302such that template1302can pivot about the pins of implant tool1304. Implant tool1304can be similar to implant tool400ofFIG. 4; however, implant tool500ofFIG. 5can also be used to engage template1302. Operations using implant tool1304and template1302are discussed in further detail below.

FIG. 14Ashows an isometric view of a step of installing implant assembly1300, in accordance with an example of the present disclosure. Implant assembly1300can include template1302, tool1304, and drill bit1340. Template1302can include bores1310A-1310N. Also shown inFIG. 14Aare ribs50A and50B and skin portion56.

In operation of one example, template1302can be secured to tool1304and template1302can be inserted into thoracic cavity, as discussed above with respect toFIG. 6, and template1302can be aligned on rib50A. In some examples, a friction element can help maintain the position of template1302relative to rib50A.

With template1302placed on the posterior side of rib50A, drill bit1340can be passed through each of bores1310A-1310N to create bores in rib50A and adjacent skin portion56. In some examples, template1302can serve only as a drill guide or template, helping to create bores in rib50A and can be removed from the thoracic cavity thereafter. In other examples, template1302can also be used both as a drill guide and also as an implant.

Arms1322A and1322B can receive drill bit1340therebetween for drilling operations used to create bores in rib50A. Also, when using template1302as a drill guide, handle1320of tool1304can be rotated to provide clearance for drill bit1340as drill bit is moved between bores1310A-1310N. For example, handle1320can be rotated in direction R to provide clearance of operation of drill bit1340while creating a bore in rib50ausing bore1310N of template1302as a guide.

FIG. 14Bshows a top isometric view of the step ofFIG. 14Aof installing implant assembly1300, in accordance with an example of the present disclosure.FIG. 14Bis consistent withFIG. 14A, except thatFIG. 14Bshows bores58a-58nin rib50a.FIG. 14Balso shows fracture60of rib50A and shows how template1302can be positioned relative to fracture60such that bores58A-58N can be created around fracture60.

FIG. 15Ashows a top isometric view of another step of installing implant assembly1500A, in accordance with an example of the present disclosure. Implant assembly1500can include implant1502, tool1504, lag fasteners1550A and1550N and fasteners1552B,1552C, and1552D. Also shown inFIG. 15Ais rib50A, skin portion56, bone bores58A-58N, and fracture60.

The components of implant assembly1500A can be consistent with those of the implant assemblies described above.FIG. 15A, though, further shows how fasteners can be used to secure implant1502to rib50a.

In operation of one example where template1302(shown inFIGS. 14A and 14B) can be used only as a guide. After template1302has been used to create bone bore58a-58n, template (or guide)1302can be removed from the thoracic space and from placement tool1304or1504. Implant1502can then be secured to placement tool1504and inserted into the thoracic space and placed against rib50A, as shown inFIGS. 15A and 15B. Thereafter, in one example, lag fasteners1550aand1550N can be inserted into bone bores58A and58N from an anterior side of rib50aand skin portion56. Lag fasteners1550A and1550N can be inserted through rib50aand can be secured to implant1502without engaging bores of rib50A, to hold implant in position relative to rib50A. In some examples, fewer lag fasters can be used such as one or none. In other examples, more lag fasters can be used, such as 3, 4, 5, or 6.

Once lag fasteners1550A and1550N are in place, fasteners1552B-1552D can be inserted into bone bores58B-58D, respectively, to threadably engage bone bores58B-58D, until fasteners1552B-1552D threadably engage implant bores (not shown) of implant1502. Each fastener can then be torqued to a desired torque. Though not shown inFIG. 15A, bone bore15E can receive either a lag fastener (similar to lag fastener1550A) or a fastener having bone threads (similar to fastener1552b).

FIG. 15Bshows a top isometric view of another step of installing implant assembly1500B, in accordance with an example of the present disclosure. Implant assembly1500B can be the same as implant assembly1500A, except that implant assembly1500B can include placement guide1556. In some examples, placement guide1556can include bores configured to align with bone bores58A-58N and implant bores (only implant bore1510B shown), through which fasteners can pass. In one example, shown inFIG. 15B, bore1560can align the placement of fastener1552B with bone bore58B and implant bore1510B. In this way, guide1556can increase efficiency of securing fasteners to ribs and implants.

Because fasteners1550A and1550N and fasteners1552B-1552D can be secured through rib bore58A-58N external to the thoracic cavity, any debris produced by torqueing fasteners will be external to the thoracic cavity, potentially reducing complications caused by debris.

In another example, guide1556can be used as a drilling guide such that bone bores58A-58N are created from an anterior side of the ribs, which can be helpful in procedures where drilling from a posterior side is not desirable or not possible.

FIG. 16shows an isometric view of another step of installing implant assembly1600, in accordance with an example of the present disclosure. Implant assembly1600can include implant1602, placement tool,1604, lag fasteners1650aand1650n, and fasteners1652B-1652D.

As shown inFIG. 16, placement tool1604can include coupler1626, similar to that of implant assembly1100, discussed above.FIG. 16shows all of lag fasteners1650A and1650N and fasteners1652B-1652D securing implant1602to implant while coupler1626and placement tool1604hold implant1602against rib50A. Once implant1602is sufficiently secured to rib50A, coupler1626can be disengaged from implant1602and coupler1626and placement tool1604can be removed from the thoracic space.

FIG. 17shows an isometric view of a step of installing implant assembly1700, in accordance with an example of the present disclosure.FIG. 17shows implant1702secured to rib50awith the placement tool removed. Because implant assembly1700requires only a single posterior incision having a size relatively smaller than the size of the implant (such as implant1702) and because implant assembly requires small openings or incisions for each fastener, the overall wound size can be reduced over one that may be required for installation of a plate from an anterior side of a rib. Also, because implant1702is within the thoracic space (posterior side of rib50A), only fasteners1750are palpable from the anterior side of rib50A, which can be less palpability than can exist with anteriorly installed rib plates.

FIG. 18shows a flow chart of method1800, in accordance with an example of the present disclosure. The steps or operations of the method ofFIG. 18are illustrated in a particular order for convenience and clarity; many of the discussed operations can be performed in a different sequence or in parallel, and some operations may be excluded, without materially impacting other operations. The method ofFIG. 18, as discussed, includes operations performed by multiple different actors, devices, and/or systems. It is understood that subsets of the operations discussed in the method ofFIG. 18attributable to a single actor, device, or system could be considered a separate standalone process or method.

In operation of one example, method1800can begin at step1802where a bone bore can be created. In one example, bore52can be created in rib50, as shown inFIG. 1. At step1804, sutures can be passed through an implant. In one example, sutures108can be passed through implant102. At step1806, sutures can be passed through the bone bore. In one example, sutures108can be passed through bore52.

Then, at step1808, the sutures can be used to pull the implant up to the bone. In one example, sutures108can be used to pull implant102up to rib50. At step1810, a driver or hand can be used to pass a fastener through the implant. In one example, driver106can pass fastener104through implant102. Thereafter, the fastener can be threaded into bone at step1812. In one example, fastener104can be threaded into rib50using driver106. At step1814, proximal threaded portion reaches implant102, proximal threaded portion can be threaded into a bore of the implant. For example, a proximal threaded portion of fastener104can be threaded into bore110A of implant102. Once implant102is secure, the suture can be removed from the implant and rib bore. For example, suture108can be removed from implant102and rib bore52.

FIG. 19shows a flow chart of method1900, in accordance with an example of the present disclosure. Method1900can begin with step1902where a placement tool can be attached to a template. In one example, placement tool1304can be attached to template1302. At step1904, the template can be pivoted or rotated to align with the placement tool. In one example, as shown inFIG. 13, template1302can be aligned with placement tool1304. Then, at step1906, the template and placement tool can be introduced or inserted through the incision and in the thoracic opening. For example, template1302and placement tool1304can be inserted into thoracic opening54, as shown inFIG. 14A.

In some examples, before or after step1904and before step1906, several steps can be performed on a patient. In some examples, an incision can be made on the opposite side of the fracture (on a posterior side of a patient) and in between a pair of ribs (typically a pair situated near the transverse plane of the fractured rib). From the incision (or through the oral cavity and trachea), and one or more tools can be used to deflate one or more of the patient's lungs. After the lungs have been deflated, organs near the fracture can be rested/nested below the fractured rib.

Once inserted, the template can be aligned with a bone or rib at step1908where the template can be used to gently push against the fractured rib to generate the contour of the rib. For example, template1302can be aligned with rib50A. At step1910a drill bit or drill can be guided into position using a bore of the template. For example, drill bit1340can be guided to rib50A using implant bore1310N of template1302. The drill bit can then be used to create a bore in the bone or rib, soft tissue, and skin using the template as a guide at step1912. For example, drill bit1340can be used to create bore58N in rib50A using template1302as a guide.

After drilling, the guide and placement tool can be removed from the thoracic opening and the guide can be removed from the placement tool at step1914. Then, an implant can be attached to the placement tool at step1916. In some examples, prior to attaching the implant to the placement tool, the surgeon can bend the implant to match the contour generated with the template. For example, implant602can be bent to match template1302and can then be attached to placement tool604. At step1918, the implant can be pivoted or rotated to align with the placement tool. In one example, as shown inFIG. 6, implant602can be aligned with placement tool604. Then, at step1920, the implant and placement tool can be inserted into a thoracic opening. For example, implant602and placement tool604can be inserted into thoracic opening54. In some examples, the placement tool can then be used to hold the implant against the fractured rib.

At step1922, fasteners can be threaded into the bone bores and the implant bores from the outside of the patient and through the drilled holes until they engage and lock with the implant. For example, lag fasteners1550A and1550N and fasteners1552B-1552D can be inserted into rib bores58A-58N. At step2024, the placement tool can be detached from the implant. For example, placement tool1604can be detached from implant1602. At step1926, the placement tool can be removed from the thoracic opening and the procedure can be completed. For example, placement tool1604can be removed from the thoracic cavity through the posterior incision, leaving behind implant1602secured to rib50A. In some examples, additional fasteners can be secured to the implant after the placement tool is removed from the thoracic cavity. After removal of the plate holding implant, the organs can be replaced, the lungs can be inflated and the incision(s) can be closed. Because the implant can be secured within the thoracic space (on a posterior side of the rib), only the fasteners are palpable from the anterior side of rib50A, which can be less palpable than can exist with anteriorly secured rib plates. Further, because the drill creates the openings on the anterior side of the patient's ribcage, only small openings must be closed on the anterior portion of the patient, helping to reduce scarring on the anterior side of the patient's rib cage.

In some examples, methods1800and/or1900can be performed multiple times for attachment of multiple implants to multiple ribs or to span multiple fractures on the same rib. Each method can be followed by any other of the methods.

ADDITIONAL NOTES