Patent ID: 12251324

DETAILED DESCRIPTION OF THE DRAWINGS

While the concepts of the present disclosure are susceptible to various modifications and alternative forms, specific exemplary embodiments thereof have been shown by way of example in the drawings and will herein be described in detail. It should be understood, however, that there is no intent to limit the concepts of the present disclosure to the particular forms disclosed, but on the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the invention.

Terms representing anatomical references, such as anterior, posterior, medial, lateral, superior, inferior, etcetera, may be used throughout this disclosure in reference to both the orthopaedic implants described herein and a patient's natural anatomy. Such terms have well-understood meanings in both the study of anatomy and the field of orthopaedics. Use of such anatomical reference terms in the specification and claims is intended to be consistent with their well-understood meanings unless noted otherwise.

Referring now toFIGS.1-5, there is shown an alignment guide10for use with an implant insertion tool44for inserting an acetabular cup component into the acetabulum of a patient during an orthopaedic surgical procedure. As will be described in more detail below, the alignment guide10is configured to be assembled with the implant insertion tool44, and the radial angle of the alignment guide10may be adjusted after assembly as desired by the orthopaedic surgeon or caregiver. As described further below, the alignment guide10may be used with a variety of different types of insertion tools, including straight and curved implant insertion tools. Accordingly, the alignment guide10may improve ease of use and reduce operation time while being adaptable to surgeon preference. Additionally, in some embodiments, the alignment guide10may be constructed from lightweight materials at low cost. It should be appreciated that although the concepts of the present disclosure are herein described in regard to an implant insertion tool for use in an orthopaedic hip procedure, the concepts of the present disclosure may be utilized in the design of other types of alignment guides, in particular for other procedures where transverse alignment is required.

The illustrative alignment guide10has a unitary body formed from a single piece of molded polymer. For example, the alignment guide10may be formed from a sulfone polymer such as polyphenylsulfone (PPSU). Additionally or alternatively, in some embodiments, the alignment guide10may be formed from any resilient polymeric material. Alternatively, in other embodiments, the alignment guide10may be formed from metallic material.

The alignment guide10includes a clip12, a riser14, and an elongated indicator16. The clip12includes a pair of curved arms18,20that define an interior volume22, as well as an imaginary axis24that extends through the interior volume22. The arms18,20include an interior surface26that extends from a distal end28of the arm18to a distal end30of the arm20. The ends28,30define a slot32therebetween through which the interior volume22is accessible.

As described further below, when the alignment guide10is coupled to the implant insertion tool44, a portion of the implant insertion tool44passes through the slot32into the interior volume22, and the interior surface26of the arms18,20contacts or engages a corresponding mounting surface of the implant insertion tool44. Each end28,30of the corresponding arms18,20includes a corresponding chamfered edge34,36. Because the slot32is undersized relative to the body of the insertion tool44, the arms18,20are urged apart when the chamfered edges34,36engage the body of the implant insertion tool44, which increases the width of the slot32and allows the implant insertion tool44to pass into the interior volume22as shown inFIGS.2and3.

The riser14of the alignment guide10extends away from the clip12perpendicular to the axis24toward a dogleg joint38. Although the illustrative riser14is embodied as a post extending perpendicular from the clip12, it should be understood that the riser14may have another shape and/or extend at another angle away from the axis24in other embodiments. Additionally, in some embodiments, the riser14may be adapted to provide a gripping surface for a surgeon, for example by including mounds, knurling, or other grip-enhancing features.

The indicator16extends from the dogleg joint38of the riser14to a distal end40. The illustrative indicator16is embodied as a post; however, similar to the riser14, in other embodiments the indicator16may be otherwise shaped. The indicator16and the axis24define an indication angle42. The illustrative indication angle42is defined as 35 degrees; however, in other embodiments the indication angle42may be 40 degrees or another angle. In some embodiments, the magnitude of the indication angle42may be molded into the clip12or otherwise indicated visually on the alignment guide10via a label or text. As described further below, a surgeon may use the indicator16to visually measure and confirm the inclination angle of the acetabular cup as it is installed in the patient's hip. The surgeon may select among multiple alignment guides10based on the desired indication angle42.

The particular indication angle42may be selected based upon the desired surgical approach, the desired final inclination angle of the acetabular cup, the alignment of the patient's hip in relation to the operating table, and/or other factors. For example, in some embodiments, the angle of the patient's hip, the desired final inclination angle of the acetabular cup, and the indication angle42may sum to 90 degrees (i.e., vertical in relation to the operating room). As an example, for a posterior surgical approach, the patient alignment angle may be 10 degrees, the desired final inclination angle of the acetabular cup may be 45 degrees, and the indication angle42may be 35 degrees such that the indicator16is substantially vertical relative to the operating room when the acetabular cup is properly aligned to 45 degrees. As another example, for an anterior surgical approach, the patient alignment angle may be five degrees, the desired final inclination angle of the acetabular cup may be 45 degrees, and the indication angle42may be 40 degrees. Of course, other angles may be used.

Referring now toFIGS.2-5, in use, the alignment guide10may be attached to the implant insertion tool44as discussed above. The illustrative implant insertion tool44has an elongated metallic body46having an impact head48on its proximal end and an attachment mechanism50on its distal end. The body46defines an imaginary tool axis52that extends from the attachment mechanism50to the impact head48. The implant insertion tool44may have a straight body46or, similar to the tool shown inFIGS.10-12, in some embodiments the body46may be curved, for example to avoid patient anatomy.

The impact head48of the implant insertion tool44is illustratively embodied as a metallic strike plate formed in the body46. However, it should be appreciated that the strike plate could be embodied as a separate component welded or otherwise secured to the body46. In use, the surgeon holds the assembled implant insertion tool44via the body46and strikes impact head48with a surgical mallet, sledge, or other impaction tool to drive an acetabular cup component70into the patient's surgically-prepared acetabular surface74(seeFIG.13).

The body46includes a mounting surface54formed on part of the body46. The illustrative mounting surface54is embodied as a conic frustum; however, in other embodiments the mounting surface54may be cylindrical or have another shape. The body46further includes an attachment section56adjacent to the mounting surface54. In the illustrative embodiment, the attachment section56is narrower than the mounting surface54in at least one dimension. For example, the illustrative attachment part56includes flat sides58,60, which oppose each other to reduce the width of the attachment section56.

In use, the alignment guide10may be utilized by a surgeon with an implant insertion tool44to implant the acetabular cup component70into a surgically-prepared acetabulum84of a patient (seeFIG.13). As shown inFIG.3, the alignment guide10may be coupled, attached, or otherwise clipped to the implant insertion tool44at the attachment section56. To do so, the surgeon or other user places the clip12of the alignment guide10in contact with the attachment section56and then presses the alignment guide10in a downwardly direction62toward the implant insertion tool44. Illustratively, as the alignment guide10contacts the implant insertion tool44, the chamfered edges34,36engage with the flat sides58,60of the attachment part56and force the slot32open to allow the attachment section56into the interior volume22. The surgeon may slide the alignment guide10onto the implant insertion tool44in the direction62until the interior surface26contacts the implant insertion tool44. After contacting the implant insertion tool44, the clip12surrounds the tool axis52.

In some embodiments, as shown inFIG.4, the surgeon or other user may rotate the alignment guide10about the tool axis52. Because the mounting surface54and the interior surface26are relatively smooth, the alignment guide10may be freely rotated to any angle64about the tool axis52. The surgeon may select the angle based on individual preference, to adjust to patient anatomy, or for other reasons.

As shown inFIG.5, after selecting the appropriate rotational angle, the surgeon or other user presses or slides the alignment guide10in a direction66toward the mounting surface54. As the alignment guide10moves onto the mounting surface54, the tapered interior surface26of the alignment guide10engages against the conical frustum mounting surface54of the implant insertion tool44. In the illustrative embodiment, the interior surface26is formed so as to contact the mounting surface54at three contact points68of the interior surface26. The contact points68may be formed, for example, via mounds, tabs, ridges, or other features that protrude from the interior surface26. Of course, in other embodiments, additional contact points68may be used.

When engaged, the alignment guide10establishes a friction lock in position on the mounting surface54. After being locked in position, the alignment guide10remains at the rotational angle64selected by the surgeon due to frictional forces between the alignment guide10and the implant insertion tool44. The surgeon may unlock the alignment guide10by moving the alignment guide10in a direction opposite the direction66, which allows the surgeon to adjust the rotational angle of the alignment guide10. Although illustrated as establishing a taper fit inFIGS.2-5, it should be understood that in other embodiments, the alignment guide10may clip onto the implant insertion tool44using any suitable interference fit. For example, illustrative embodiments of alignment guides10that attach to the implant insertion tool44using an interference fit are shown below in connection withFIGS.6-12.

Referring now toFIGS.6-8, there is shown an alignment guide100for use with an implant insertion tool for inserting an acetabular cup component into the acetabulum of a patient during an orthopaedic surgical procedure. Similar to the alignment guide10, the illustrative alignment guide100has a unitary body formed from a single piece of molded polymer. For example, the alignment guide100may be formed from a sulfone polymer such as polyphenylsulfone (PPSU). Additionally or alternatively, in some embodiments, the alignment guide100may be formed from any resilient polymeric material. Alternatively, in other embodiments, the alignment guide100may be formed from metallic material.

Also similar to the alignment guide10, the alignment guide100includes a clip12, a riser14, and an elongated indicator16. The clip12includes a pair of curved arms18,20that define an interior volume22, as well as an imaginary axis24that extends through the interior volume22. The arms18,20include an interior surface26that extends from a distal end28of the arm18to a distal end30of the arm20. The ends28,30define a slot32therebetween which the interior volume22is accessible. The interior surface26forms a plano-concave curve that engages a cylindrical mounting surface154of an insertion tool144, as described further below.

As described further below, when the alignment guide100is coupled to the implant insertion tool144, the mounting surface154of the implant insertion tool144passes through the slot32into the interior volume22, and the interior surface26of the arms18,20contacts or engages the mounting surface154. The illustrative arms18,20further include rounded ledges102,104on the respective ends28,30. The ledges102,104curve away from the slot32and may allow for ease of attachment or removal of the alignment guide100similar to the chamfered edges34,36of the alignment guide10. For example, the arms18,20are urged apart when the rounded ledges102,104engage the body of the implant insertion tool144, which increases the width of the slot32and allows the implant insertion tool144to pass into the interior volume22as shown inFIGS.7and8. Additionally, a surgeon may press or pull on the ledges102,104to ease attaching or removing the alignment guide100, respectively. The illustrative clip12includes a relief opening106between the arms18,20that allows the arms18,20to separate.

The riser14of the alignment guide100extends away from the clip12and the axis24toward a dogleg joint38. The illustrative riser14includes a grouping of mounds or ridges108formed in the surface of the riser14to provide a gripping surface for a surgeon. The illustrative riser14is formed to be hollow. However, it should be understood that in other embodiments the riser14may be solid or otherwise shaped. For example, in some embodiments, the riser14may be embodied as a rod extending from the clip12to the dogleg joint38, similar to the riser14of the alignment guide10.

The indicator16extends from the dogleg joint38of the riser14to a distal end40. The illustrative indicator16is formed to be hollow; however, similar to the riser14, in other embodiments the indicator16may be solid or otherwise shaped. The indicator16and the axis24define an indication angle42. The illustrative indication angle42is defined as 35 degrees; however, in other embodiments the indication angle42may be 40 degrees or another angle. In some embodiments, the magnitude of the indication angle42may be molded into the clip12or otherwise indicated visually on the alignment guide100via a label or text. As described further below, a surgeon may use the indicator16to visually measure and confirm the inclination angle of the acetabular cup as it is installed in the patient's hip. The surgeon may select among multiple alignment guides10based on the desired indication angle42. The surgeon may select the particular indication angle42as described above in connection with the alignment guide10.

Referring now toFIGS.7-8, in use, the alignment guide100may be attached to the implant insertion tool144as discussed above. Similar to the implant insertion tool ofFIGS.2-5, the illustrative implant insertion tool144has an elongated metallic body146having an impact head148on its proximal end and an attachment mechanism150on its distal end. The body146defines an imaginary tool axis152that extends from the attachment mechanism150to the impact head148. The implant insertion tool144may have a straight body146or, similar to the tool shown inFIGS.10-12, in some embodiments the body146may be curved, for example to avoid patient anatomy. The body146includes a mounting surface154formed on a section of the body146. The illustrative mounting surface154is cylindrical.

The impact head148of the implant insertion tool144is illustratively embodied as a metallic strike plate formed in the body146. However, it should be appreciated that the strike plate could be embodied as a separate component welded or otherwise secured to the body146. In use, the surgeon holds the assembled implant insertion tool144via the body146and strikes impact head148with a surgical mallet, sledge, or other impaction tool to drive an acetabular cup component70into the patient's surgically-prepared acetabular surface74(seeFIG.13).

In use, the alignment guide100may be utilized by a surgeon with an implant insertion tool144to implant the acetabular cup component70into the surgically-prepared acetabulum84of a patient (seeFIG.13). As shown inFIG.8, the alignment guide100may be coupled, attached, or otherwise clipped to the implant insertion tool144at the mounting surface154. To do so, the surgeon or other user places the clip12of the alignment guide100in contact with the mounting surface154and then presses the alignment guide100in the downwardly direction62toward the implant insertion tool144. Illustratively, as the alignment guide100contacts the implant insertion tool144, the rounded ledges102,104engage with the cylindrical mounting surface154and force the slot32open to allow the mounting surface154into the interior volume22. The surgeon may slide the alignment guide100onto the implant insertion tool144in the direction62until the interior surface26contacts the implant insertion tool144. After the interior surface26contacts the implant insertion tool144, the clip12surrounds the tool axis152. When attached to the mounting surface154, the alignment guide100establishes an interference lock in position on the mounting surface154.

Similar to the alignment guide10shown inFIG.4, after attaching the alignment guide100to the implant insertion tool144, in some embodiments the surgeon may rotate the alignment guide100about the tool axis152. Because the mounting surface154and the interior surface26are relatively smooth, the alignment guide100may be freely rotated to any angle64about the tool axis52. The surgeon may select the angle based on individual preference, to adjust to patient anatomy, or for other reasons. Additionally or alternatively, in some embodiments the surgeon may remove the alignment guide100, reposition the alignment guide100at the desired angle64about the tool axis52, and then re-attach the alignment guide100at the desired angle64as discussed above.

Referring now toFIGS.9-12, another embodiment of an alignment guide200for use with an implant insertion tool for inserting an acetabular cup component into the acetabulum of a patient during an orthopaedic surgical procedure is shown. Similar to the alignment guides10,100, the illustrative alignment guide200has a unitary body formed from a single piece of molded polymer. For example, the alignment guide200may be formed from a sulfone polymer such as polyphenylsulfone (PPSU). Additionally or alternatively, in some embodiments, the alignment guide200may be formed from any resilient polymeric material. Alternatively, in other embodiments, the alignment guide200may be formed from metallic material.

Also similar to the alignment guides10,100, the illustrative alignment guide200includes a clip12, a riser14, and an elongated indicator16. The clip12includes a pair of curved arms18,20that define an interior volume22, as well as an imaginary axis24that extends through the interior volume22. The arms18,20include an interior surface26that extends from a distal end28of the arm18to a distal end30of the arm20. The ends28,30define a slot32therebetween which the interior volume22is accessible. The interior surface26includes a pair of teeth or other projections202,204that project into the interior volume22. Each tooth202,204is positioned at a respective end28,30of the corresponding arm18,20.

Referring now toFIGS.10-12, in use, the alignment guide200may be attached to an implant insertion tool244. Similar to the insertion tools44,144, the illustrative implant insertion tool244has an elongated metallic body246having an impact head248on its proximal end and an attachment mechanism250on its distal end. The body246defines an imaginary tool axis252that extends from the attachment mechanism250to the impact head248. Illustratively, the insertion tool244has a curved body246, which may be used to avoid soft tissue or other patient anatomy. However, in other embodiments the insertion tool244may have a straight body246similar to the insertion tools ofFIGS.2-5and7-8.

The body246of the insertion tool244includes a mounting surface254formed on a section of the body246. As best shown inFIG.10, the mounting surface254is generally cylindrical. The mounting surface254includes multiple ridges or steps206running parallel to the tool axis252. Each pair of ridges206is separated by a groove or valley208.

In use, as shown inFIG.11, the alignment guide200may be coupled, attached or otherwise clipped to the implant insertion tool244at the mounting surface254. To do so, the surgeon or other user places the clip12of the alignment guide200in contact with the mounting surface254and then presses the alignment guide200in the downwardly direction62toward the implant insertion tool244. The surgeon may slide the alignment guide200onto the implant insertion tool244in the direction62until the interior surface26contacts the implant insertion tool244. When in contact with the implant insertion tool244, the teeth202,204engage respective grooves208of the mounting surface254. The teeth202,204and a contact point210at the top of the interior surface26(shown inFIG.9) lock the alignment guide200to the insertion tool244with an interference fit. After contacting the implant insertion tool244, the axis24defined by the alignment guide200is parallel to the tool axis252, as shown inFIG.11.

In some embodiments, as shown inFIG.12, the surgeon may rotate the alignment guide200about the axis24after the alignment guide200is attached to the insertion tool244. As the surgeon rotates the alignment guide200, the teeth202,204engage respective ridges206and grooves208in the mounting surface254. The grooves208and ridges206cooperate to urge the teeth202,204to come to rest in engagement with respective grooves208, operating as detents that index rotation of the alignment guide200. Thus, the alignment guide200may be rotated by the surgeon to any of multiple predetermined angles212about the axis24, based on the arrangement of the ridges206and grooves208of the mounting surface254. The surgeon may select the angle212based on individual preference, to adjust to patient anatomy, or for other reasons. After rotation, the alignment guide200remains positively locked to the insertion tool244by the teeth202,204.

Referring now toFIG.13, an acetabular cup component being installed in the acetabulum of a patient's hip using an illustrative alignment guide10and implant insertion tool44is shown. However, it should be understood that the respective alignment guides100,200and insertion tools144,244may also be used in place of the alignment guide10and the insertion tool44. Once the alignment guide10and implant insertion tool44have been assembled in such a manner as described above, the surgeon secures an acetabular cup component70to the insertion tool44. For example, in some embodiments the acetabular cup component70may thread onto a threaded tip of the attachment mechanism50.

Thereafter, as shown inFIG.13, the surgeon uses the implant insertion tool44to position the acetabular cup component70such that its generally hemispherically-shaped bone-engaging surface72is inserted into the patient's surgically-prepared acetabular surface74in a desired orientation. The surgeon may use the indicator16of the alignment guide10to measure and adjust the inclination of the acetabular cup component70. In particular, the surgeon may adjust the angle of the insertion tool44until the indicator16is parallel with a vertical reference line76(i.e., pointing straight up). The vertical reference line76may be determined visually by the surgeon in relation to the floor, operating table, or other external reference. Positioning the indicator16such that it is parallel with the vertical reference line76ensures that the acetabular cup component70is positioned with a predetermined inclination angle (based on the particular indication angle42of the alignment guide10as described above). As shown, the riser14positions the indicator16away from the tool44and thus may improve visibility of the indicator16, for example by positioning the indicator16away from the surgeon's hands, patient anatomy, or other objects that could obscure visibility of the indicator16.

Once the acetabular cup component70is positioned in such a manner, the surgeon strikes the impact head48of the implant insertion tool44with a surgical mallet, sledge, or other impaction tool to drive the acetabular cup component70into the bone tissue until the acetabular cup component70is fully seated in the patient's surgically-prepared acetabular surface74.

The surgeon then releases the acetabular cup component70from the implant insertion tool44. For example, the surgeon may rotate the implant insertion tool44in a direction that loosens (i.e., unthreads) the threads of the tool44from a corresponding threaded hole of the acetabular cup component70.

After releasing the acetabular cup component70, the surgeon removes the alignment guide10from the insertion tool44. The surgeon pulls the alignment guide10away from the insertion tool44(i.e., opposite the direction62ofFIG.3), and the insertion tool44passes out of the interior volume22through the slot32. When removing the alignment guide10, the surgeon may grasp the riser14and pull the alignment guide10off the insertion tool44. Additionally or alternatively, if available, the surgeon may pull on one or more of the rounded ledges102,104to assist in removal of the alignment guide10. Thus, the alignment guide10may be removed by the surgeon using one hand.

While the disclosure has been illustrated and described in detail in the drawings and foregoing description, such an illustration and description is to be considered as exemplary and not restrictive in character, it being understood that only illustrative embodiments have been shown and described and that all changes and modifications that come within the spirit of the disclosure are desired to be protected.

There are a plurality of advantages of the present disclosure arising from the various features of the apparatus, system, and method described herein. It will be noted that alternative embodiments of the apparatus, system, and method of the present disclosure may not include all of the features described yet still benefit from at least some of the advantages of such features. Those of ordinary skill in the art may readily devise their own implementations of the apparatus, system, and method that incorporate one or more of the features of the present invention and fall within the spirit and scope of the present disclosure.