Example aspects here generally relate to surgical instruments used in minimal incision surgery aiding in the installation of orthopedic prosthesis, and more particularly, to a surgical instrument having a releasable connection to another surgical tool for preparing a bone site prior to the implantation of a hip prosthesis' femoral component during hip replacement surgery.
Joint implants, also referred to as, for example, joint prostheses or joint replacements, are long-term surgically implantable devices that are used to partially or totally replace diseased or damaged joints, such as a hip, a knee, a shoulder, an ankle, or an elbow, within the musculoskeletal system of a human or an animal. Artificial hip joints are generally ball and socket joints, designed to match as closely as possible the function of the natural joint. Generally, the artificial socket is implanted in one bone, and the artificial ball articulates in the socket. A stem structure attached to the ball is implanted in another of the patient's bones, securing the ball in position.
The ball and socket joint of the human hip unites the femur to the pelvis. The head of the femur or ball fits into the acetabulum of the pelvis, forming a joint which allows the leg to move forward, backward, and sideways in a wide range.
Various degenerative diseases and injuries may necessitate replacement of all or a portion of a hip using synthetic materials. Prosthetic components are generally made from metals, ceramics, or plastics, or combinations of them.
Total hip arthroplasty and hemi-arthroplasty are two well-known procedures for replacing all or part of a patient's hip. A total hip arthroplasty replaces both the femoral component and the acetabular surface of the joint. A hemi-arthroplasty may replace either the femoral component or the acetabular surface of the joint. The purpose of hip replacement surgery is to remove the damaged and wom parts of the hip and replace them with artificial parts, called prostheses, with the purpose of at least partially restoring the hip's function, including but not limited to, restoring the stability, strength, range of motion, and flexibility of the joint.
In total hip replacement surgery, a patient's natural hip is replaced by two main components: an acetabular cup component that replaces the acetabular socket, and the femoral component, or the stem-and-ball component that replaces the femoral head.
In order to install the acetabular cup, a surgeon prepares the bone by reaming the acetabular socket to create a surface for accepting a cup. The cup may be held in place by bone cement or an interference or press fit, or it may have a porous outer surface suitable for bony ingrowth. The new acetabular shell is implanted securely within the prepared hemispherical socket.
Next, the femur is prepared to receive the stem. The proximal end of the femur is at least partially resected to expose the central portion of the bone. In the central portion, a cavity is created that matches the shape of the implant stem. The top end of the femur is planed and smoothed so that the stem can be inserted flush with the bone surface.
It is highly desirable to adapt the surgical instruments used in preparation of the femoral bone during hip replacement to minimally invasive surgery, computer assisted surgery, or both. The instruments used in femoral preparation include, but are not limited to, osteotomes or chisels used for resecting at least a portion of the femoral head to expose the central portion of the femur, and broaches, reamers, and rasps, used to clean and enlarge the hollow center of the bone, creating a cavity that matches the shape of the femoral component's stem.
During hip replacement surgery, the surgeon opens a femoral intramedullary canal by removing a portion of the trochanteric fossa with an osteotome or a chisel, an instrument for surgical division or sectioning of bone. The surgeon then uses one or a series of increasing size cavity preparation devices, such as reamers or broaches, to prepare a cavity for installation of a femoral stem. By using a series of gradually increasing in size devices, the surgeon expands the intra-femoral cavity until the desired size and shape is created. Sometimes, the portion of the final broach inserted into the femoral cavity serves as a trial femoral stem.
It is generally desired to select and install the femoral stem of the largest size suitable for a particular patient. Electing the largest appropriate femoral stem helps to stabilize the femoral component in the femur, improves alignment, and reduces the potential of the femoral component's loosening and failure. There is a need for instruments and method for preparation of a femoral cavity that permit installation of an appropriately sized stem of the femoral component in order to improve alignment and stabilization of the femoral component in the patient with minimum interference the tissue of the patient.
In minimally invasive surgery, the need to insert and operate the femoral preparation instruments through smaller incisions may conflict with the proper instrument alignment needed to create the cavity of the largest possible size. For proper access and alignment, long incisions and other invasive procedures are often required. The single-incision lateral or posterior approach hip-arthroplasty procedure may simplify access to the femur. A direct anterior approach for minimally invasive total hip arthroplasty has become increasingly popular. Preparation of the femoral canal using this approach can be technically challenging. Instrumentation of the femur involves a posteromedial capsular release, extension and external rotation of the operative leg and elevation of the femur anteriorly. Curved offset femoral broaches have been specifically designed to safely prepare the femoral canal through this single incision. A broach handle with lateral and anterior offset for the direct anterior approach has been developed to reduce the need for leverage of the proximal femur for preparation of the cavity.
Because a surgeon may perform a left hip replacement surgery or a right hip replacement surgery, it is currently necessary that the surgeon have both left and right lateral offset broach handles. Similarly, depending on a patient's body type, i.e., large protruding mid-section, current offset broach handles may not have adequate offset to account for such patients. Thus, it is necessary to have a broach handle that is adaptable to different situations and conditions.
In summary, there is a current unrealized need for improved devices, systems and procedures adapted for use in minimally invasive surgery (MIS). There is a particular unrealized need for improved devices for preparation of a patient's femur for installing a femoral component of a hip prosthesis. Improved devices are desired that are adapted for introduction and operation through a smaller surgical incision than conventionally available devices. Also needed are improved devices, systems, and procedures that would minimize the damage to the flesh, muscle, and other soft tissues during insertion, operation, and withdrawal. At the same time, there is a need for improved devices, systems, and procedures that would improve sizing and aligning of the femoral components and reduce the risk of their loosening In general, devices and systems are needed that are easy and reliable to use and manufacture, minimizing tissue damage, simplifying surgical procedures, and are versatile, allowing for faster healing with fewer complications, requiring less post-surgical immobilization, and are less costly to produce and operate, as our instrument replaces the need for 3 handles; providing left, right and straight approach.
The foregoing and other problems and deficiencies in known broach handles are solved and a technical advantage is achieved by an articulating broach handle.
An example embodiment herein is an articulating surgical tool handle, comprising a force disc, three main sections, two articulating means, and means for releasably attaching a tool. Wherein the articulating means allow each of the three sections to rotate 360 degrees with respect to the other sections.
In a further example embodiment herein the two articulating means allows articulation of the two or more sections in discrete increments.
In another example embodiment herein the three main sections comprise a Main Grip, a Center Body
Section, a Broach Connect, and the two articulating means allow for a double offset left, double offset right and straight configuration.
In still a further example embodiment herein, in the double offset configuration, the Main Grip is offset spatially from the Broach and maintain parallel axes and compound axial configuration of the longitudinal Main Grip and Broach Connect Body.
In another example embodiment herein, the spatial offset of the Main and Broach Connect Body is adjustable by two articulating means.
In yet another example embodiment herein the discrete increments are of the range of 60 degree incremental rotation respectively to each joint.
There is also the ability to provide a compound angle off-set, wherein you can exceed the parallel axial embodiments of main body and connecting body to acquire the desired positional attitude for non-invasive surgery.
According to another example embodiment herein, the articulating means comprises a Push Button, wherein the Push Button allows for the adjustment of the position of the two or more sections relative to each other, and the cam mechanism allows for the two or more sections to be in a fixed position relative to the other of the two or more sections.
According to an example embodiment herein, a method is provided for using an articulating surgical tool handle to prepare a patient's femur for installing a prosthetic stem component into the medullary canal of the femur. The method comprises the steps of providing an articulating surgical tool handle to attach a broach for installing a prosthetic stem component. A surgeon determines whether the left or right hip is to operated on. Depending on which side, the surgeon configures the articulating surgical tool for that particular side. The articulating surgical tool handle comprises a force disc, a main grip (Main longitudinal section and force disc can be one piece), a center body section, a broach connect body section, a first articulating means connecting the main grip section and the center body section, a second articulating means connecting the center body section and the broach connect body section, and a broach connected to the broach connect body section via an adapter. The method further includes the steps of attaching a broach to the broach connect body section via the adapter, ensuring the engraving indicators align with each other, adjusting the first and second articulating means to spatially offset the main grip section from the broach connect body section, inserting the articulating surgical tool handle and broach into the medullary canal through a surgical incision, positioning the articulating surgical tool handle and broach, preparing the medullary canal by striking the force disc to create a femoral canal, and removing the articulating surgical tool handle and broach from the medullary canal. The articulating surgical tool handle can be configured for either a left or right hip replacement surgery, and depending on the physical characteristics of a patient, the spatial offset between the main longitudinal section and the broach section can be adjusted using one or both of the articulating means, (including a straight approach).
Other devices, apparatuses, methods, features, and advantages herein will be, or will become, apparent to one with skill in the art upon examination of the following figures and detailed description. It is intended that all such additional systems, methods, features, and advantages be included within this description, be within the scope of the invention, and be protected by the following claims.
The foregoing summary, as well as the following detailed description of the invention will be better understood when read in conjunction with the appended drawings. It should be understood, however, that the invention can be embodied in different forms and thus should not be construed as being limited to the embodiments set forth herein.
The present subject matter will now be described more fully hereinafter with reference to the accompanying figures, in which representative embodiments are shown. The present subject matter can, however, be embodied in different forms and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are provided to describe and enable one of skill in the art. Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the subject matter pertains. All publications, patent applications, patents, and other references mentioned herein are incorporated by reference in their entirety.
The attached Appendix 1 (33 sheets) and Appendix 2 (92 sheets) are considered parts of the present application and are therefore incorporated by reference herein in their entireties, as if set forth fully herein.
Example embodiments herein relate to an articulating broach handle with a releasable connection to a broach that has three sections that articulate 360 degrees with respect to each other. The specification describes a fifth prophetic embodiment. Embodiments 1 through 4 are described in Applicants' previous patent applications (USPTO Serial Nos. 16/691,271 and 15/627,723). Each embodiment is composed of hardened 420 stainless steel, hardened 440 steel and/or titanium. It is also contemplated that the inner components are constructed from either hardened 420 or hardened 440 stainless steel and the external components are constructed of titanium. However, other forms of surgical steel may be used; (304SS, 304L SS, 316SS, 420SS, 440SS, 430SS, 434SS). One of ordinary skill in the art will understand that the description of the invention is not limited to a broach handle.
The Main Grip 5100, depicted in
The Main Grip 5100 has a longitudinal linear shaft 5114 with a Main Grip Bend 5115 near the distal end 5116. The linear shaft includes mirrored Gripping Notches 5101 within the outer diameter of the linear (Main Grip) shaft for added instrument grip and provides overall weight reduction of the instrument. The linear shaft also includes mirrored scallops or radial serrations 5104 providing further instrument gripping capability. Preferably there are 14 (7 mirrored scallops, 14 total) mirrored scallops or radial serrations. It is envisioned that the number of mirrored scallops or radial serrations may vary. At the distal end 5116 of the Main Grip are two Main Grip Mating Surfaces 5105 which provide concentric alignment with the Center Body Bore 5204 (discussed down below). In between the Main Grip Mating Surfaces is a Main Grip Connecting Groove 5106 which provides linear joint attachment with the Center Body 5200 via Dowel 5400, allowing for 360-degree rotation. Proximal the Main Grip Mating Surfaces is a Positional Identifier 5111, a circular bore recess, for 60-degree incremental rotation with the Positional Identifier 5201 of the Center Body 5200. The distal end 5116 includes a Main Grip Thrust Face 5109 which provides a coincident planer surface for mating with the Center Body Mating Thrust Face 5205. The distal end of the Main Grip further includes a Main Grip Outside Diameter 5112 provides clearance for the Button Second Planer Surface 5507 of the Button Engaging Member 5509 of the Push Button 5500 and has six positional slots 5108.
When the Button Push 5500 is pressed (see
The bend 5115 is preferably between 50 and 80 degrees, and more preferably 67.5 degrees. The length of the Main Grip 5100 from the proximal end 5117 to the Bend 5115 is approximately 6.0 inches. From the Bend 5115 to the absolute distal end 5116 is approximately 1.0 inch.
The Main Grip distal end 5116 at the bend 5115 and beyond in the distal direction is cylindrical. The diameter of the Bend is 1.125″ and the absolute distal end has a diameter of 0.619″ inches. Also, a dual joining surface diameter of 0.796″ that slip fits within the adjoining connective bore of center body, proximally and distally. The above measurements and those following are exemplary figures. Other dimensions are contemplated.
The Center Body 5200 (
The proximal end 5214 includes six Positional Identifiers 5201. The Positional Identifiers are circular bored recesses for referencing 60-degree incremental positional rotations and align with the Positional Identifier 5111 on the Main Grip 5100 depending on the angle of rotation. At one position on the Center Body, there are two Positional Identifiers in line (see
The Center Body Outer Diameter Geometry 5202 provides the outer boundary geometry for anatomical clearance. As noted previously, the geometry of the Center Body exhibits a symmetrical 22.5-degree angle (
The Proximal and Distal Rotational Joints 5218, 5219 are identical (
The proximal end 5617 is similar in construct as the distal end of the Main Grip. The proximal end includes two Broach Connect Body Mating Outside Diameters 5605 separated by a Broach Connect Body Connecting Groove 5606. Broach Connect Body First Planer Surface 5603 provides coincident planer surface for Center Body Mating Planer Surface 5211. Broach Connect Body Outside Diameter 5602 provides clearance for the Push Button Second Planer Surface 5507 of the Engaging Member 5509 and has six positional slots 5601. The positional slots 5601 engages with Push Button Engaging Member 5505 allowing the Center Body 5200 to rotate with respect to the Broach Connect Body 5600 in 60-degree increments for 360-degree rotation. The positional slots engage with the Push Button Angled Locking Surfaces 5505 of the Push Button Engaging Member 5509. The Broach Connect Body Outer Body Radius 5604 provides the necessary anatomical clearance during use of the Broach Handle. Further, the Broach Connect Body Outer Body 5616 provides the necessary anatomical clearance while maintaining functional strength for unlimited procedures of the Broach Handle.
The distal end 5618 of the Broach Connect Body 5600 includes a Broach Connect Body Planer Surface 5608 which provides the anatomical clearance, weight reduction and rotational thrust support of the Lock Lever Planer Face/Surface 5904. Also, at the distal end 5618 are Left and Right Indicators 5619
(
Depicted in
Outer Diameter 5701. Left Pincher Angled Planer Surface 6207 provides the necessary anatomical clearance to the anatomy wound in case of over insertion.
The Left Pincher Bottom Planer Surface 6208 provides the necessary planer surface for the engagement and disengagement of the Broach 6100 via the Lock Pin Outer Diameter Surface 5801 and the Lock Pin Radial Undercut Groove 5804.
Depicted in
A unique feature of the present invention is that the Broach Handle can articulate with respect to the various sections comprising the Broach Handle. An advantageous feature of this articulation in combination with the bends of the various sections allows for the Main Grip to be offset spatially from the Broach Connect Body yet maintain parallel longitudinal axes. The amount of offset or spatial separation between the Main Grip and the Broach Connect Body section may be adjusted by the amount of articulation (rotation) between the Main Grip and the Center Body, and the Center Body with the Broach Connect Body. This offset is desirable depending on the physical features of the patient. That is, for a slender patient undergoing hip replacement surgery the surgeon does not require as much offset as for a patient who is more rotund about the midsection and hip area. By maintaining parallel but spatially offset longitudinal axes between the Main Grip and the Broach Connect Body, the force delivered by the surgeon onto the Force Disc is transmitted in the same linear direction onto the Broach Connect Body and ultimately the Broach.
Another beneficial feature is that it allows the surgeon to configure the instrument as either a Right or Left Instrument, depending on which hip is being replaced. The Broach Connect Body Engravings 5615, 5619 and 5620 together with Adapter Indicator 6009 and the Center Body Engravings 5203 aid the surgeon in identifying the particular configuration of the Broach Handle. As depicted in
Depending on the physical characteristics of the patient, a surgeon may need to offset the Force Disc of the Broach Handle from the linear axis of the Broach. As can be seen in
The aspects and embodiments of the present invention provide a method for improving the preparation of the bone for example the femur in a hip replacement surgery. As discussed, the articulating broach handle allows for quick and simple adjustments to the broach handle to accommodate for whether the surgeon is performing a right hip replacement or a left hip replacement, and the physical stature of the patient (protruding midsection or not).
Depending on if the surgeon will be performing a left hip or right hip replacement, the surgeon may need to articulate and configure the Broach Handle as either a left or right handle. Depending on the physical stature of the patient, the surgeon can increase or decrease the offset by rotating the three main sections of the Broach Handle 5000, Main Grip 5100, Center Body 5200 and Broach Connect Body 5600 with respect to each other using the Push Button mechanisms (Push Button 5500, Conical Spring 5300, Stainless Steel Dowel 5400).
Method of Use
The Broach Handle 5000 of the Fifth Embodiment allows a surgeon to configure the Broach Handle for a right lateral offset broach or left lateral offset broach. Using the Broach Handle of the Fifth Embodiment, a surgeon will select a Broach 6000 from one of the available manufacturers. Depending on the manufacturer of the Broach, the surgeon will select the appropriate Adapter 6100. The Broach is connected to the Broach Connect Body 5600 via the Adapter 6100 and is secured in place as discussed above.
Depending on the physical characteristics of the patient, the surgeon may need to offset the Force Disc of the Broach Handle from the linear axis of the Broach. The surgeon may adjust/swing/articulate the Main Grip and the Broach Connect Body with respect to each other and to the Center Body, offsetting the Force Disc for either a right lateral offset or a left lateral offset. This is accomplished by adjusting the various sections with respect to one another such that the angled surfaces are in contact witheach other. The relative positions of the sections are maintained until the surgeon engages the articulating mechanisms (Push Buttons) to adjust one section (Main Grip, Center Body, Broach Connect Body) with respect to the other section. The ability to articulate the various sections of the Broach Handle with respect to one another allows the Broach Handle to be used on either the left or right side.
Through the use of the Adapter 6100, broaches from different manufacturers may be used by the present invention.
Although the present invention has been described in considerable detail with reference to certain embodiments thereof, other embodiments are possible. Therefore, the spirit and scope of the appended claims should not be limited to the description of the embodiments contained therein. It should be understood that various changes, substitutions, additions and alterations can be made by one skilled in the art without departing from the spirit and scope of the invention as defined by the appended claims. Moreover, the scope of the present application is not intended to be limited to the particular embodiment(s) of the device, process, machine, manufacture and composition of matter, means, methods and or steps described in the specification. As one of ordinary skill in the art will readily appreciate from the disclosure herein, processes, machines, manufacture, composition of matter, means, methods or steps, presently existing or later to be developed that perform substantially the same function or achieve substantially the same result as the corresponding embodiments described herein may be utilized according to the present invention.
The present application claims the benefit of U.S. Provisional Application No. 63/297,947 filed on Jan. 10, 2022, and is a Continuation-in-Part of U.S. patent application Ser. No. 16/691,271, filed on Nov. 21, 2019, which is a Continuation of U.S. patent application Ser. No. 15/627,723, filed on Jun. 20, 2017 (now abandoned), which claims the benefit of U.S. Provisional Application No. 62/353,261, filed on Jun. 22, 2016, and U.S. Provisional Application No. 62/510,111, filed on May 23, 2017. Priority is hereby claimed to each of those former applications, and the entire contents of each of those applications are incorporated herein by reference in their entireties as if set forth fully herein.
Number | Date | Country | |
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63297947 | Jan 2022 | US | |
62353261 | Jun 2016 | US | |
62510111 | May 2017 | US |
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Parent | 15627723 | Jun 2017 | US |
Child | 16691271 | US |
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Parent | 16691271 | Nov 2019 | US |
Child | 17697765 | US |