KR20170013853A - Prosthesis positioning systems and methods - Google Patents

Abstract

Systems and methods acceptable to less skilled doctors who perform fewer replacements than more skilled doctors who perform more surgeries may be better suited to the needs of less skilled doctors And provides desirable performance potential. The system and method include localization of prostheses, particularly prostheses, having a preferred orientation relative to the patient ' s reference frame.

Description

{PROSTHESIS POSITIONING SYSTEMS AND METHODS}

This application claims the benefit of U.S. Patent Application Serial Nos. 14 / 585,056 and 14/584, 656 and also claims the benefit of both U.S. Patent Applications 61 / 921,528 and 61 / 980,188, Quoted for reference purposes.

The present invention relates generally to orthopedic systems and operations using artificial implants and, more particularly, to joint replacement therapies such as total hip replacement, including controlled placement and positioning of prostheses such as the replacement of the pelvic arch with the artificial prosthesis .

The subject matter discussed in the Background section should not be regarded as prior art due only to mention in the background section. Likewise, the issues mentioned or related in the subject and background section of the background section should not be considered as conventionally recognized. The subject matter of the background art represents only a different approach that can be inherent and self-inventive.

Hip replacement is surgery in which the hip is replaced with a prosthetic implant. There are a variety of other techniques that can be used, but all involve inserting the acetabular element into the ankle and precisely positioning it three-dimensionally (along the X, Y and Z axes).

In hip replacement (THR) surgery, there is an advantage in patient outcome when the operation is performed by a surgeon specializing in such surgery. Patients in surgeons who do not perform many surgeries may increase the risk of complications, especially complications arising from misplacement and positioning of acetabular components.

Incorrect placement and positioning can occur even when the surgeon understands and intends to properly insert and position the acetabular components. This is true, in some techniques, because the tools for actually installing acetabular components are crude, inaccurate, and unpredictable, resulting in poor placement results.

Are known in the art using automation and / or computer based navigation tools, e.g., X-ray fluoroscopy devices or computer guidance systems. There is a computer assisted surgical procedure that can be helpful to the physician in determining the correct orientation and position of the acetabular components. However, current techniques suggest that at some point the surgeon needs to use a hammer / ball bar that physically strikes the pin or alignment rod. The size of the force applied and the application position of the force are variables that are not controlled by these search tools. Thus, even when the acetabular component is properly oriented in position, it may actually be in an optimal position and orientation, even when the actual position and orientation are actually set in place and the acetabular component actually hits the actual position and orientation. In some cases, the tool used may actually be used to determine slight differences in position and / or orientation. However, once again, the physician must use a shock tool (eg hammer / toggle rod) that can strike the pin or alignment rod to attempt adjustment. However, the position obtained after adjustment and the orientation of the acetabular component may not actually be the desired position and / or orientation. It is possible to reduce the risk to the patient in a direction or position which is more familiar with the use of the surgeon and whose application of the adjustment tool is undesirable. In some cases, a very large impact force is applied to the prosthesis by the ball hitting the rod; This force makes it difficult to make the best fine adjustments and there is a risk of breaking and / or destroying the ribs in the impact stage.

What is needed is a system and method for improving the positioning of a prosthesis, particularly a prosthesis having a desired orientation with respect to a patient ' s reference frame.

A system and method for improving the positioning of a prosthesis, in particular a prosthesis having a desired orientation with respect to a patient ' s reference frame, is disclosed.

The following summary of the invention is provided to aid in an understanding of some technical features of hip replacement and does not necessarily describe the entirety of the present invention. A full understanding of the various aspects of the present invention can be obtained by reading the specification, claims, drawings, and summary in its entirety. The present invention is applicable to other surgical operations, including replacement of other joints that are replaced by artificial implants in addition to replacement of the ankle (hip socket) with an acetabular component (e.g., a cap). The use of both pneumatic and electric motor implementations achieves evidence for concept deployment.

The disclosed concept includes the creation of a system / method / tool / gun that vibrates an attached prosthesis, for example, the ankle cap. Guns will be used in surgeons' hands. The vibration energy can be used to insert (non-impact) and position the cap in the desired orientation (using current intra-motion measurement systems, navigation, fluoroscopy, etc.).

In one embodiment, the first gun-like device is used for precise impact of the acetabular component at the desired location and orientation.

In another embodiment, the second gun-like device is used by the first gun-like device for fine-tuning the orientation of the ankle, as established by conventional ball hobs and tampons or by other methods. However, the second key-like device may be used independently of the first key-like device for adjusting the acetabular components installed using other techniques. Likewise, the second gun-like device can be used independently of the first gun-like device, especially when the initial installation is close enough to the desired location and orientation. The embodiment is not necessarily limited to fine tuning as the particular embodiment allows full redirection. Some implementations can remove installed prostheses.

Yet another embodiment includes a third key-like device that combines the functions of the first key-like device and the second key-like device. This embodiment allows the surgeon to position, insert and otherwise position the acetabular component precisely with a single tool.

Yet another embodiment includes a fourth device for installing the acetabular component without the use of a ball bar and rod or other selection means for striking the acetabular component to impact the ankle. This embodiment imparts vibratory motion to the mounting rod coupled to the acetabular component that allows low force, non-shock mounting and / or placement.

A positioning device for an osteophyte cap placed in the bone includes a controller having a trigger and a selector, the osteophyte cap including an outer shell having a sidewall defining an inner cavity and an opening, the sidewall having a periphery around the opening, The ankle cap has a desired fore leg angle relative to the bone and a desired fore leg angle relative to the bone;

A support means having a proximal end and a distal end opposite the proximal end, the support means having a longitudinal axis extending from the proximal end to a distal end with a proximal end connected to the controller, An adapter coupled to the distal end; And a number N. [

Said number N being an integer greater than or equal to 2 and being associated with a controller-associated longitudinal axis and disposed generally parallel to the longitudinal axis, each actuator comprising an associated impact head arranged to strike a portion of the periphery, Provide an impact that strikes other parts of the periphery when the associated actuator is selected and triggered; Each impacted blow adjusts one of the angles to the bone.

In an apparatus for installing a ganglion cap placed on a pelvic bone, a ganglion cap includes a ganglion cap having a desired ganglion cap for the sidewalls and bones surrounding the perimeter of the opening, a desired abduction angle for the bone, And an outer shell having a sidewall defining an inner cavity and an opening therethrough,

The apparatus comprises: a controller including a trigger; A support means having a proximal end and a distal end opposite the proximal end, the support means having a longitudinal axis extending from the proximal end to a distal end with a proximal end connected to the controller, An adapter coupled to the distal end; And an oscillator connected to the controller and the support means, wherein the oscillator is configured to control a vibration frequency and a magnitude of vibration of the support means having the vibration frequency, wherein the magnitude of the vibration does not use an impact force applied to the ankle cap And is configured to install the ankle cap at the installation depth with the desired abutment angle and the desired foreground angle.

The prosthesis includes an attachment system that includes an oscillation engine that includes a controller coupled to a vibration machine that produces an original series of pulses having a pattern of occurrences, wherein the prosthesis is configured to be implanted into a portion of the bone at a desired implant depth The generation pattern defining a first duty cycle of the original series of pulses; And the pulse transmission assembly is connected to a prosthesis having a proximal end coupled to the oscillation engine and a distal end spaced from the proximal end and having the pulse transmission assembly including a connection system at the proximal end, Wherein the pulse transmission assembly is complemented by an attachment system configured to secure a fixed prosthesis with the pulse transmission assembly and the pulse transmission assembly generates an applied series of pulses responsive to a series of setup pulses to cause the fixed prosthesis to respond to an original series of pulses To communicate with the installation series of pulses; The applied series of pulses is configured to impart a vibratory motion to the fixed prosthesis to enable the placement of a fixed prosthesis in a portion of the bone within 95% of the desired implant depth without manual impact.

CLAIMS 1. A method of installing an acetabular cap on a prepared socket of a pelvic bone,

The ankle cap includes an outer shell having a sidewall defining an inner cavity and an opening, the cavity having a sidewall having a periphery around the opening, the ankle cap having a desired depth about the bone, a desired abduction angle about the bone, Having the desired foreground angle,

It involves the following steps:

(a) generating a pulse of the original series from an oscillation engine;

(b) communicating a pulse of the original series to a guttural cap that produces a pulse of the series communicated in the guttural cap;

(c) vibrating an ankle cap having a vibration having a predetermined vibration pattern in response to a pulse of the communicated series; And

(d) inserting an oscillating cap into the prepared socket within a first predefined threshold of installation depth with a desired abutment angle and foreground angle without using the impact force applied to the ankle cap.

In a method for inserting a prosthesis into a prepared position of a patient's bone at a desired insertion depth, the non-vibratory insertion force is within a first range to insert the prosthesis at a desired insertion depth. The method comprising:

(a) vibrating the prosthesis using a tool for producing a vibration prosthesis having a predetermined vibration pattern; And

(b) inserting the vibration prosthesis at a prepared position within a first predetermined threshold value of the desired insertion depth using the vibration insertion force of the second range. The second range then includes a set of values less than the minimum value of the first range.

Any of the embodiments described herein may be used singly or in any combination. The invention encompassed within this disclosure may include embodiments that are only partially mentioned or not mentioned in the summary.

While the various embodiments of the present invention are intended to improve various deficiencies of the prior art that may be discussed or referred to herein in more detail in one or more places, embodiments of the present invention do not necessarily improve only one of these deficiencies. That is, other embodiments of the invention may address other deficiencies that may be described herein. Some embodiments may solve some deficiencies or one deficiency that may be described in part herein, and some embodiments do not solve such deficiencies.

Other features, advantages and advantages of the present invention will become apparent upon review of the specification, including the specification, drawings and claims.

BRIEF DESCRIPTION OF THE DRAWINGS The accompanying drawings, which are incorporated in and constitute a part of the specification, and in which like reference numerals refer to the same or functionally similar elements through separate drawings, form a part hereof, and together with the description serve to explain the principles of the invention It serves to explain.

Figure 1 shows a representative installation gun.
Fig. 2 is a detailed right side view of the installation gun of Fig. 1;
Figure 3 shows a left side detail of the installation gun of Figure 1 and generally combined with Figure 2 to create the installation of Figure 1;
Figure 4 shows a second representative installation;
Figure 5 is an exploded view of the second representative installation system of Figure 4;
Figure 6 is a first exploded view of a pulse transmission assembly of the mounting system of Figure 4;
Figure 7 is a second exploded view of the pulse transmission assembly of the mounting system of Figure 4;
FIG. 8 is a diagram showing a third representative installation system; FIG.
Figure 9 is an exploded view of the third representative installation system of Figure 8;
10 is a schematic cross-sectional view of the iliac crest mispositioned on the pelvis;
FIG. 11 is a diagram illustrating the conventional use of a ball bar and a tambour applied mis-encoded and mispositioned direction turning force as shown in FIG. 10;
FIGS. 12-14 illustrate a reference frame for use in THR surgery, including an osseous prosthesis installed into the pelvis including the identified vertical axis;
FIG.
Figure 13 shows an orthogonal axis with associated frontal and cross-sectional views;
Figure 14 is another perspective view of a vertical axis with associated front and cross-sectional views; And
15 shows an encoded prosthesis including a set of pure points;
Figure 16 shows the positioning of the encoded prosthesis;
Figure 17 shows the automatic positioning of the encoded prosthesis;
18 is a schematic view of an embodiment of a positioning gun configured for prosthesis adjustment;
19-21 are schematic diagrams of an embodiment of a positioning gun configured for prosthesis adjustment;
FIG. 19 shows a typical positioning gun;
Fig. 20 is a detailed left side view of the positioning gun of Fig. 19;
21 is a detail detail on the right side of the location gun of FIG. 19, which, when combined with FIG. 20, produces FIG. 19; FIG.
22-24 illustrate the use of an impact ring for positioning an installed prosthesis;
22 shows an initial state of a prosthesis installed in advance with respect to an impact ring installed in a positioning system;
23 shows an intermediate state of a prosthesis pre-positioned with respect to an impact ring installed in a positioning system; And
24 shows a final state having a prosthesis positioned and positioned relative to an impact ring installed in a positioning system; And
25 shows an embodiment of a positioning system employing an impact ring;
26 shows an evolution of a version of a positioning system employing the impact ring shown in Fig. 25 with another version of a positioning system employing an impact ring;
Figs. 27-34 illustrate alternative embodiments for a positioning system using impact ring models; Figs.
27-28 illustrate a first alternative embodiment of a positioning system;
27 is a side view of the first alternative embodiment; And
28 is a plan view of a first alternative embodiment; And
29-30 show a second alternative embodiment of a positioning system;
29 is a side view of a second alternative embodiment; And
30 is a plan view of a second alternative embodiment; And
31-32 illustrate a third alternative embodiment of a positioning system;
31 is a side view of a third alternative embodiment; And
32 is a plan view of a third alternative embodiment; And
33 is a side view of a fourth embodiment of a positioning system; And
34 is a side view of a fifth embodiment of a positioning system;

Embodiments of the present invention provide a system and method for improving the positioning of a prosthesis, particularly a prosthesis having a preferred orientation relative to a patient ' s reference frame. The following description is presented to enable those skilled in the art to make and use the invention and is provided in the context of a patent application and its requirements.

Various preferred embodiments of the present invention will now be described, by way of example only, with reference to the accompanying drawings, in which: FIG. Accordingly, the invention is not intended to be limited to the embodiments shown but is to be accorded the widest scope consistent with the principles and features disclosed herein.

Justice

Unless otherwise defined, all terms including technical or scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the generic concept of the present invention pertains. It is to be understood that such commonly used definitions of terms such as those used in the foregoing should be interpreted as having a meaning consistent with their meanings in the context of the related art and the present invention and are not intended to be ideal or overly formal It should not be construed as meaning.

The following definitions apply to some of the features described for some embodiments of the present invention. This definition can be extended equally herein.

The term "or" includes "and / or ", and the term" and / or "includes any and all combinations of one or more of the associated enumerated items. When preceding a list of such elements, the expression "at least one" modifies the entire list of elements and does not modify individual elements of the list.

As used herein, the singular terms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. Thus, for example, references to an object may include multiple objects unless the context clearly dictates otherwise.

Also, as used herein and in the claims below, the "in" includes "in" and "on" unless the context clearly dictates otherwise. Whenever an element is referred to as being "on" another element, it should be understood that it may exist directly on or between the other elements. In contrast, when an element is referred to as being "directly on" another element, there are no other elements in between.

As used herein, the term "set" means one or more sets of entities. Thus, for example, a set of objects may comprise a single object or multiple objects. A set of objects may also be referred to as members of a set. A set of objects may be the same or different. In some instances, a set of objects may share one or more common characteristics.

As used herein, the term "adjacent" refers to being close or proximity. The adjacent objects may be spaced from each other or may be in actual or direct contact with each other. In some cases, adjacent objects may be joined together or formed integrally with each other.

As used herein, the terms "connecting," "connected," and " connecting, " Connected objects no longer have a substantial intermediate object or set of objects as they appear in the context.

As used herein, the terms "coupled," "connected," and " coupled, " The combined objects may be directly connected to each other or indirectly connected to each other by an indirect set of objects.

The terms "substantially" and "substantial" as used herein refer to a significant degree or range. When used in conjunction with an event or circumstance, the terms refer to the occurrence of an event or circumstance exactly as occurs when an event or situation, such as an exemplary tolerance level or variability description of the embodiments described herein, occurs with close approximation.

As used herein, the terms "optional" and "optionally" mean that the subsequently described event or circumstance may or may not occur, and such description includes instances where the event or circumstance occurs and instances in which it does not.

As used herein, the term "bone" refers to a rigid connective tissue that forms part of the vertebral skeleton, including the mineral bone tissue, particularly in the context of a living patient receiving prosthetic implant surgery on a portion of the cortical bone. Both the living patient and the surgeon for the patient are of great interest in reducing the risk associated with conventional implantation techniques, including inadequate placement and positioning of the prosthesis and damage / fracture of the bone within the scope of the patient's skeletal system and surgery .

As used herein, the term "size" refers to a characteristic dimension of an individual. Thus, for example, the size of the spherical object may refer to the diameter of the object. For non-spherical objects, the size of the non-spherical object may refer to the diameter of the corresponding spherical object in which the corresponding spherical object exhibits or has a particular set of inductable or measurable properties substantially identical to the non-spherical object. Thus, for example, the size of the aspherical object may refer to the diameter of the corresponding spherical object that exhibits substantially the same light scattering or other properties as the non-spherical object. Optionally, or in this regard, the size of the aspherical object may refer to an average value of various orthogonal dimensions of the object. Thus, for example, the rotating ellipsoid is the size of the object that can reference the minor axis of the average object of the long axis. By referring to a series of objects of a particular size, it is believed that the objects can have a size distribution around a particular size. Thus, the size of the set of entities used herein may refer to the normal size of the size distribution, such as average size, medium size or peak size.

As used herein, a ball or hammer generally refers to an orthopedic device made of stainless steel or other dense material having the weight of a carpenter hammer and a lump hammer of a masonry.

As used herein, the impact force for impacting the zygomatic component (e.g., ankle cap prostheses) is such that a hammer of a carpenter is used to hatch the nail until it is fully seated for about six hours, Includes a force that strikes the impact bar several times with a generally similar shaping device to the force that can be used to put it. Without being limited to the above definitions, in some cases the representative value includes a force of about 10 pounds per square inch.

The following description relates to improving the installation of a prosthesis over a wide range to the living bone of a surgical patient. The following discussion focuses primarily on hip replacement (THR) where the ankle cap prosthesis is placed on the patient's pelvis. The ankle cap is a complement to a ball and a stem (i.e., a femoral prosthesis) provided at the distal end of the femur connecting the ankle for repairing.

As mentioned in the background, the physician prepares the surface of the sciatic tract, which includes attaching the ankle prosthesis to the pelvis. Typically, such attachment involves passive implantation, which is used to strik a tamping rod in contact with a portion of the ankle prosthesis. Repeatedly striking the tampon, the ganglional prosthesis is advanced into the buccal cavity. Regardless of whether current tools such as computer navigation, fluoroscopy, and robots (other surgical instruments) are used, it is very difficult for the ankle prosthesis to settle in the proper depth from a proper direction to a series of hammer strikes.

After manual transplantation in this manner, the physician can apply a series of conditioning strokes around the ankle prosthesis to adjust to the desired orientation. Currently, this post-impact outcome is accepted as the surgeon believes that post-impact adjustments produce unstable changes that can not be predicted and thus do not guarantee any attempt to adjust post-impact.

In most cases, all surgeons, including inexperienced surgeons, can not achieve the desired orientation of the pelvic ganglion prosthesis as a conventional solution due to the unpredictability of directional changes in response to such an adjustment stroke. As described above, it is very common for most doctors to avoid any post-impact adjustments because they understand that they can easily introduce larger / larger errors without having a stable system or method that improves any particular orientation to be.

Computer navigation systems, fluoroscopy devices, and other measurement tools may provide surgeons with information about the current direction (real time) of the prosthesis during surgery and after the prosthesis is installed and deviations in the desired direction, Others) do not prevent torsional forces created by grafting / positioning strikes. The prosthesis can be located at the zygote based on the axial direction according to the torsional force generated by the striking of the tang ball. Even with the navigation system used with a robotic system (e.g., MAKO), securing the implant in the desired orientation prior to the impact would require that the actual implantation force be applied by the surgeon swinging the tackle bar manually to strike the stamp, The implant can not be guaranteed.

Behzadi medical devices (BMDs) can remove the rough method of prosthesis (ie, ankle cap) (ie, hammer, tamper and surgeon-applied mechanical implantation force). Surgeons using BMD can insert the prosthesis precisely and precisely with the proper force at the desired location. According to a detailed implementation, the installation includes insertion of a prosthesis into the patient's bones within a desired threshold of insertion depth and position measurement, etc., and also includes a metric for the insertion direction when appropriate and / or desired at a desired orientation Lt; RTI ID = 0.0 > a < / RTI > desired threshold. The use of BMD reduces the risk of fracture and / or fracture of the bones accommodating the prosthesis and allows fast, efficient and accurate (traumatic) placement of the prosthesis. BMD provides a possible interface for computer navigation support means (also available as all surgical measurement tools, including fluoroscopy) in installations where a light responsive touch is used.

The BMD includes various embodiments for the installation and / or positioning of the prosthesis and may be applied to a wide range of prostheses as well as the installation and / or positioning of the ankle prosthesis during THR.

Figure 1 shows an exemplary installation gun 100; 2 is a detailed right side view of the installation gun 100; Figure 3 is a left side detail view of the installation gun which, in combination with Figure 2, produces the view of Figure 1; Although the other implementations can use other mechanisms to create the desired oscillatory motion of the prosthesis in which it is installed, the set gun 100 appears to operate using pneumatic.

The gun gun 100 is used to precisely control (i) insertion of prosthetic components and (ii) one or both of the abduction angle and foreground angle. The mounting gun 100 preferably allows for the placement of both of the zygomatic caps into the ankle at the desired depth and orientation of the cap for both the fore and aft angle at the desired value. In Table I, the following reference numbers refer to the components shown in Figures 1-3:

TABLE I Device (100) Element

The mounting gun 100 includes a controller with a handle that supports an extension tube 142 that terminates in an adapter 146 connecting the cap 114. The operation of the trigger 130 initiates the movement of the extension tube 142. The motion is referred to herein as an installation force and / or installation motion that is considerably smaller than the impact force used in conventional replacement procedures. The outer housing 148 allows the operator to position and position the prosthesis 114 while the extension tube 142 moves inside. Some embodiments include a handle or other grip in addition to or in place of the housing 148 to allow the operator to grip and manipulate the gun 100 without interfering with a mechanism that provides direct transfer to the prosthesis. The illustrated embodiment includes a prosthesis 114 that is stably fixed by an adapter 146 that allows tilting and / or rotation of the gun 100 relative to any axis that is reflected in the positioning / orientation of the fixed prosthesis .

The mounting operation includes a constant, cyclic period, and / or any operation (amplitude and / or frequency) that allows the operator to install the cap 114 in a desired position (depth and / or direction) without application of impact force. One or more of the six degrees of freedom, including conversion and / or rotation of the adapter 146, relative to the X, Y, Z axes (e.g., / RTI > and / or oscillation / continuous rotation for different < RTI ID = 0.0 > axes). ≪ / RTI > The mounting operation may include a small amplitude of vibration and a continuous or intermittent very high frequency motion that allows the operator to easily install the prosthetic element at the desired location and preferably allows the operator to adjust the desired abduction and foreground angles.

In some implementations, the controller includes a stored program processing system that includes a processing unit that executes the retrieved instructions from the memory. Such an instruction may, for example, control the selection of operating parameters to automatically achieve a given value for depth, abduction and foreground, which are accepted by the physician with a computer navigation system. Optionally, the instructions may be used to supplement manual actions to supplement or suggest the selection of operational parameters.

More automated systems may not require consistent and invariant operating parameters, and that variable dynamic adjustment of operating parameters may be in accordance with the calibration profile and installation conditions of the cap installed in the ribs. The adjustment profile is a relatively easy feature that the depth, abduction and foreground angles can be adjusted in the positive and negative directions. In some situations, these values may not be the same, and the installation case may be extended to accommodate these differences. For example, a unit of force applied to a pure positive foreground can adjust the foreground in a positive direction by a first unit distance, while a unit of force applied to a pure negative foreground in the same situation is a unit different from the first unit 2 The distance unit can adjust the foreground in the negative direction. This difference can vary as a function of the magnitude of the actual angle. For example, as the foreground increases, the same unit of force will result in different response changes at the adjusted actual distance. The adjustment profile used assists the operator when selecting the applied actuator and impact force. Using the current real-time depth and direction feedback system allows the adjustment profile to dynamically select / modify operating parameters dynamically during the installation of the different stages. One set of operating parameters can be used primarily to set the implant depth and then another set is used when the desired depth is achieved so that fine adjustment of the abduction angle and foreground angle can be used without further impact force setting depth and / .

The device can make computer navigation perform better as the installation / adjustment force is reduced compared to the impact method.

This allows the required force to be more compatible with a computer navigation system used in medical surgery that does not have a function or control system in place that actually provides an impact force to seat the prosthetic component. Without it, the computer is demoted to a role in which the surgeon provides a post evaluation of the result of manually striking an orthotonic hitting ball. (It also provides previous information during the impact.) Immediate performance of the impact has a problem that indicates variations and errors in positioning and alignment of the prosthesis.

4 shows a second representative installation system 400 including a pulse transmission assembly 405 and an oscillating engine 410; 5 is an exploded view of a second representative installation system 400; 6 is a first exploded view of pulse transmission assembly 405; FIG. 7 is a second exploded view of the pulse transmission assembly 405 of the mounting system 400.

The mounting system 400 is in turn designed to provide a prosthesis that is configured to implant into a portion of the bone at a desired implant depth. The prosthesis includes some form of attachment system (e.g., one or more threaded inserts, mechanical couplers, links, etc.) and allows the prosthesis to be securely and rigidly secured to the object so that translation and / So that a direct corresponding translation and / or rotation of the fixed prosthesis appears.

The vibration engine 410 includes a controller coupled to a vibration system that produces an original series of pulses having an occurrence pattern. The generation pattern defines a first duty cycle of the original series of pulses comprising at least one first pulse amplitude, a first pulse direction, a first pulse duration and a first pulse time window. It is not suggested that the amplitude, direction, duration or pulse time window for each pulse of the original pulse series is uniform with respect to each other. The pulse direction may include rotation with respect to one or more of the three shafts and / or an operation with one of six orthogonal axes translating along one or more axes or six degrees of freedom. The vibration engine 410 includes an electric motor driven by energy from the battery, although motors and other energy sources may be used.

The pulse transmission assembly 405 includes a proximal end 415 coupled to the oscillating engine 410 and a distal end 420 connected to the prosthesis using a connector system 425 and spaced from the proximal end 420. The pulse transmission assembly 405 receives the original series of pulses at the oscillation engine 410 and generates a series of pulses with the mounting patterns in response to the original series of pulses. Like the generation pattern, the installation pattern defines a second duty cycle of the pulse-mounting series that includes a second pulse amplitude, a second pulse direction, a second pulse period, and a time window of the second pulse. It also does not suggest that the amplitude, direction, duration or pulse time window for each pulse of the set-up pulse series is uniform with respect to each other. The pulse direction may include rotation about one or more of the three shafts and / or translation along one or more axes of three orthogonal axes, with either of six degrees of freedom.

In some embodiments of the pulse transmission assembly 405, the series of pulses is closely matched if it is strongly connected to the original series and not the same between the two series. Some embodiments may include a more complex pulse transmission assembly 405 that produces a different or even different installation series than the original series.

The connector system 425 (e.g., one or more thread studs that complement the threaded insertion of a prosthesis or other complementary mechanical fastening system) is displaced at the proximal end 420. The connector system 425 is configured to securely and firmly retain the prosthesis. The attached prosthesis in this way becomes a fixed prosthesis when connected to the connector system 425.

The pulse transmission assembly 405 communicates an installation series of pulses with a fixed prosthesis and generates an applied series of pulses responsive to the installation series of pulses. Like the generation pattern and the installation pattern, the applied pattern defines a third duty cycle of the applied series of pulses including the third pulse amplitude, the third pulse direction, the third pulse duration, and the third pulse duration window. It also does not suggest that the amplitude, direction, duration or pulse time window for each pulse of the applied pulse series is uniform with respect to each other. The pulse direction may include rotation about one or more of the three shafts and / or translation along one or more axes of three orthogonal axes, with either of six degrees of freedom.

In some embodiments of the pulse transmission assembly 405, the application series of pulses is strongly coupled to the original series and / or the installation series and, if not identical, closely matched. Some embodiments may include a more complex pulse transmission assembly 405 that creates an application series that is different or very different from the original series and / or installation series. In some embodiments, for example, one or more components may be watertight (e.g., integrating pulse transmission assembly 405 and oscillation engine 410) with one another, so that the second series and second series are independent of each other , It is not the same and is approximate.

The application series of pulses is designed to impart vibratory motion to a fixed prosthesis to provide a prosthesis that is fixed to a portion of the bone to within 95% of the desired implant depth without manual impact. That is, in operation, the original pulse from the oscillation engine 410 is transmitted through a pulse transmission assembly 405 (with varying levels of fidelity due to implantation) to generate a vibration motion of the prosthesis fixed to the connector system 425 do. In a first embodiment, the oscillatory motion is implanted without prosthetic impact on the prosthesis, and the orientation of the implanted fixed prosthesis in the second mode can be adjusted by rotation of the mounting system 400 while the oscillatory motion is also active without a passive impact . In some embodiments, pulse generation may produce various vibrational motions optimized for different modes.

The mounting system 400 may include an optional sensor 430 (e.g., a flexible sensor, etc.) to provide a measurement (e.g., quantitative and / or qualitative) of the installed pulse pattern communicated by the pulse transmission assembly 405 ). The measurement is used as part of a manual or computer feedback system to aid in the installation of the prosthesis. For example, in some implementations, the desired applied pulse pattern (e.g., the oscillating motion of the prosthesis) of the applied series of pulses may be a function of a particular installed pulse pattern that can be measured and set through the sensor 430. [ Additionally or alternatively, the other sensor may be a physician or automated installation system operating a mounting system, such as a bone mineral density sensor or other mechanism, to specify the bone that receives the prosthesis to set the desired applied pulse pattern for optimal installation I can help.

6 and 7 illustrate a particular implementation of the pulse transmission assembly 405 and understand that there are several ways to generate and communicate an applied pulse pattern in response to a series of generated pulses from the generation and oscillation engines. 6 and 7 generate the dominant directional / axial pulses in response to the dominant direction / axis generated pulses from oscillation engine 410. [

The pulse transmission assembly 405 includes an outer housing 435 that includes an upper transfer assembly 640, a lower transfer assembly 645, and a center assembly 650. The center assembly 650 includes a dual anvil 655 that connects the upper transfer assembly 640 to the lower transfer assembly 645. The dual anvil 655 is shown in FIG. The outer housing 635 and the center assembly 650 include ports through which the sensor 630 is inserted into the center assembly 650 between the end of the dual anvil 655 and one of the upper / lower transfer assemblies.

Each of upper transmission assembly 640 and lower transmission assembly 645 includes support means 660 coupled to outer housing 435 by a pair of connectors. The transfer rod 665 is connected to each end of the double anvil 655 at its one end with a head and at its second end with a respective transfer rod 665 configured to strike the end of the double anvil 655 and the coupling structure, As shown in Fig. A compression spring 670 is disposed in each transfer rod 665 between the support means 660 and the head. The coupling structure of upper transmission assembly 640 receives a series of pulses generated in cooperation with oscillation engine 410. The coupling structure of the lower transfer assembly 645 includes a connector system 425 for securing the prosthesis. Some embodiments may include unshown adapters employing connector system 425 for certain prostheses and other adapters may allow use of other prostheses and pulse transfer assemblies 405. [

The center assembly 650 includes a support means 675 that is coupled to the outer housing 435 by a connector and receives two anvils 655 that are free to move within the support means 675. The heads of the upper transfer assembly and the lower transfer assembly are disposed within the support means 675 and are arranged to strike corresponding ends of the dual anvils 655 during generation of the pulses.

In operation, the oscillation engine 410 generates pulses that are transmitted through the upper transfer assembly 640 to the prosthesis fixed by the connector system 425. The pulse transmission assembly 405 receives the pulses generated using the transmission rod 665 with the pulse transmission assembly 405. The transfer rod 665 of the upper transfer assembly 640 moves within the support means of the upper transfer assembly 640 to communicate pulses to the dual anvil 655 moving within the support means 660. [ The dual anvil 655 in turn communicates a pulse to the transfer rod 665 of the lower transfer assembly 645 to create a vibratory motion of the prosthesis 425 secured to the connector system 425. The transfer rod 665 moves primarily in the longitudinal / axial direction (the longitudinal axis defined to extend between the proximal end 415 and the distal end 420) in the outer housing 435 in the illustrated embodiment. In this way, the physician can use the outer housing 435 with a manual fix when installing and / or positioning the vibrating prosthesis.

The use of separate transfer portions (e.g., upper, middle, lower transfer assemblies) for the pulse transfer assembly 405 may allow for loose coupling between the oscillating engine 410 and the fixed prosthesis. In this way, the pulses coming from the vibration engine 410 are converted into vibratory motion of the prosthesis that is applied to the bone during operation. Some embodiments can provide a stronger bond by fixing one component directly to another, or by replacing a single component with a pair of components.

8 shows a third representative installation system 800; 9 is an exploded view of the third representative installation system 800. Fig.

The embodiment of Figures 4-8 shows insertion of the prosthetic cap into the bone replacement substrate with ease and with very reduced force compared to the use of the tongue and tongue, especially as no impact is required. While the insertion is proceeding and the vibrating motion is applied to the prosthesis, the prosthesis can be positioned relatively easily by torqueing the handle / outer housing yarn to the precise desired placement / positioning. The insertion force is variable and ranges from 20 to 800 pounds of force. It is important to note that a considerably smaller force may be used in the present invention to apply the prosthesis to a bone matrix (in this case, an ankle prosthesis).

Similar to the mounting system 100 and the mounting system 400, the mounting system 800 is used to precisely control (i) installation of the prosthesis components and (ii) one or both of the abduction angle and the foreground angle. The mounting system 800 preferably allows for the placement of both of the zygomatic caps into the ankle at the desired depth and orientation of the cap for both the fore and aft angle with the desired value. In Table II, the following reference numbers refer to the components shown in Figure 8-9:

Table II: Device (800) Element

The mounting system 800 includes a controller with a handle that supports an extension rod terminating in a connection system connecting the prosthesis 830. The actuation of the trigger 804 initiates the operation of the extension rod.

The motion is referred to herein as an installation force and / or installation motion that is considerably smaller than the impact force used in conventional replacement procedures. The outer housing allows the operator to position and position the prosthesis while the extension rod moves inside. Some embodiments include handles or other grips in addition to or in place of a housing that allows a surgeon operator to hold and manipulate the mounting system 800 without interfering with a mechanism that provides direct transmission of the mounting operation. The illustrated embodiment includes a stably fixed prosthesis 830 that allows tilting and / or rotation of the mounting system with respect to any axis reflected in the positioning / orientation of the fixed prosthesis

The actuator is a pneumatically actuated vibrating device (an optional operating system can additionally or alternatively be used in addition to the pneumatic system) which provides shock and vibration action to the device to regulate the socket. The options include mechanical and / or electromechanical systems, motors, and / or engines. The actuator includes an air inlet 802, a trigger 804, a needle valve 806, a cylinder 814 and a piston 812.

Air is introduced through the inlet port 802 and the trigger 804 presses the piston valve 812 to the opposite end of the cylinder 814 by squeezing the needle valve 806 and introduces air into the cylinder 814. At the opposite end, the piston 812 presses the piston back to its original position and opens the port to allow air to enter.

This operation provides power for operation of the apparatus and functions of this embodiment up to 70 Hz. The frequency can be adjusted by the trigger 804 to an air pressure available at the air inlet 802. [

The piston 812 impacts the driver 816 and the driver 816 impacts the needle 820 of the needle block 818. The needle 820 strikes the anvil 824 directly connected to the prosthesis 830 via the connecting rod 828.

Suspension spring 822 provides flexibility to apply more or less total force. This flexibility allows more force to be applied to one side of the prosthesis 830 or forces applied equally around the prosthesis 830 to position the prosthesis 830 in the optimal / desired direction. The mounting system 800 illustrates a BMD having a pulsed transmission system that is more tightly coupled between the oscillating engine and the prosthesis 830. [

The coupling nature and form of pulse communication between the oscillating engine and the prosthesis can be modified in several different ways. For example, in some implementations, the needles 820 of the needle block 818 move independently, reacting differently to the movement of the piston 812. In other embodiments, the needles 820 and needle blocks 818 may be replaced with other cylinder structures, while in other embodiments the needles may be fused together or differently.

As shown, the two embodiments provide primarily longitudinal implementations, while the mounting system 800 is designed to allow the force of insertion / oscillation to be "steered" by applying a force concentrated on one or the other side of the prosthesis Design characteristics. Embodiments that also produce random vibrational motions that include "lateral" motion components in addition to or instead of predominantly longitudinal vibrational motion of the disclosed embodiments may be useful for installing prostheses in a variety of applications including THR surgery.

The installation system 400 and the installation system 800 include vibration engines that generate pulses at about 60 Hz. System 800 may operate at 48 to 68 Hz while system 400 may operate at 60 Hz. In the test, about four seconds of motion represents the desired insertion and alignment of the prosthesis (meaning about 240 cycles of the oscillating engine). Conventional surgery using a batting rod that hits the tamper to impact the cap properly is usually completed after the hammer / hitting ball has been hit 10 times.

Experiment

Both systems 400 and system 800 were tested on a bone substitute substrate with a standard Zimmerman zygote cap using standard techniques of reaming the prepared surface to a 1 mm size and inserting a 1 mm large cap. The substrate was chosen as the above concept, the best option for us to study high density foamed materials. It was recognized that certain properties of the bones would not be shown here (eg the ability to stretch the substrate before the error occurred).

Both versions show easy insertion and positioning of the prosthesis in the selected substrate. We were able to move the cap to the substrate relatively easily. There is no need for a hitting ball or hammer to apply a large impact. This experiment showed that the prosthetic cap could be inserted into the bone replacement substrate with much less force and more control than hitting it with a hammer or a tip ball. We speculate that the same phenomenon can be reproduced in human bones. We imagine the prosthetic cap to be easily inserted with very little force.

We also believe that while the cap is being inserted, the position of the cap can be visualized and adjusted directly into any internal motion measurement system (navigation, perspective, etc.). The present invention provides a system that allows insertion (insertion) of a prosthetic component with non-traumatic forces as opposed to traumatic forces.

Experimental Configuration-System 400

The vibration engine 410 includes a Craftsman G2 hammerhead necker that is used to propel a fairly large frame nail into a tree in a confined space by applying a series of small impacts very quickly, as opposed to the application of a very small number of large impacts.

The bone substitute is a 15 lb high density urethane foam representing the pelvic arch. It is usually made of a standard cutting tool used to clean a patient's injured organs. A 54 mm cap and a 53 mm cutter were used for the test.

In one test, the cap is fully inserted and inserted after 7 strokes using a tipball and a stamp. The redirection of the cap requires additional striking around the cap after being fitted to achieve the desired orientation. The feeling of inserting the bone into the bone and the consistency of the insertion are qualitatively determined.

The embodiment of the system 400 is used in place of the ball hitting and stamping methods. The insertion is performed much more gradually; So that the cap is guided to a position (depth and direction at the time of insertion). The final correction position can be easily achieved using lateral hand pressure to rotate the cap in the substrate while power is applied to the oscillation engine.

Other tests using sensors include general static load sensing performed to determine the static (non-shock) load by pushing the cap into the prepared socket model. This provides the basis for comparison with impact load tests. The prosthesis is provided with a screw-ready socket mounted on the cap to transfer the force applied on the bench vise. The handle of the vise is turned to apply a force to compress the cap on the socket until the cap is fully seated. The cap begins to move from the insertion force of about 200 pounds to the socket and the diameter of the cap inserted into the socket gradually increases as it increases to a maximum of 375 pounds held constant until the cap is fully seated.

The installation system 400 is then used to install the cap on similarly prepared sockets. Five tests are performed using the frame rate and setup procedure to determine how to get the most meaningful results. All tests use a 54 mm guttural cap. The oscillating engine is driven at the specified 60 shocks / sec. The first two tests are not fast enough to capture all the impact events, but are performed at 2000 frames / sec to assist in proper installation. Test 3 uses an oscillating engine in a socket that is already in use at 4,000 frames per second. Test 4 uses an oscillating engine in a foam socket not used at 53 mm at 4000 frames per second.

Test 3: In an already compressed socket, the cap is pulsed using the oscillation engine and pulse transmission assembly. Recorded blow between 500-800 pounds with an average recorded pulse duration of 0.8 ms.

Test 4: In an unused 53 mm socket, the cap is pulsed using the oscillating engine and pulse transmission assembly. Recorded blow between 250-800 pounds with an average recorded pulse duration of 0.8 ms. The insertion is completed in 3.37 seconds 202 impact heat.

Test 5: In unused 53mm socket, cap is inserted into standard hammer (see). Recorded impact between 500-800 pounds and average recorded pulse duration 22.0ms. The insert was completed in 4 seconds using a 10 impact heat for a total pressure time of 220 ms. This test is performed quickly to complete in 5 seconds compared to tests 3 and 4 where 240 hits were used in 4 seconds with a single hit time of 0.8 ms for a total pressure time of 192 ms.

In a rigorous comparative test, which does not directly compare between system 400 and system 800, the force typically used for installation with system 800 is lower than system 400 with element 10. This suggests that the installation system has certain optimization characteristics during operation.

There is a question as to whether the force can be modulated and the prosthesis cap can be easily inserted into the model and bone. What is the lowest force required to insert the prosthesis cap into the substrate using the open concept? What is the lowest force required to insert a prosthesis cap into a hard bone using this concept? What is the lowest force required to insert a prosthesis cap into a soft, osseointegrated bone using this concept? These are the questions that can be resolved in the implementation steps of the present invention in the future.

Basic studies can also be performed on the correlation between bone density and porosity at various ages (through prognostic studies) with appropriate force ranges and the required vibrational movement pattern to insert the caps using the present invention. For example, a physician may insert a sensing device into a patient's bone or use other assessment procedures to evaluate the porosity and density of the bone (e.g., during pre-operative planning or surgery). Once known, the density or other bone characteristics establish a proper vibration pattern, including the force range of the mounting system, and thus use at least the necessary force to insert and / or position the prosthesis.

BMD is a "mandatory" device for all medical device companies and surgeons. "Without BMD, the problem of transplantation is the latest advances in hip replacement surgery techniques (navigation, vision devices, MAKO / robotics, accelerometers / gyrometers, etc.) (Cap) positioning remains the biggest problem in hip replacement surgery, which is the final stage in which errors appear in the system and have not been addressed by the problem. There is considerable awareness of the location of implants in the pelvis during surgery, but the technique does not support the last step of implantation.

An embodiment of a BMD for processing various installation implementations (including installation and position) is shown and described in Figures 1-9 and the discussion above. In the majority of the disclosed embodiments, there is no requirement for post-installation positioning of the prosthesis as the prosthesis is inserted and aligned exactly as desired. FIGS. 10-34 illustrate a set of methods for resolving prosthesis misalignment after implantation of a prosthesis without precise alignment, regardless of the system or method implanted the prosthesis. As noted, some embodiments of the systems and methods disclosed in Figures 1-9 float " float "a previously installed prosthesis to allow accurate positioning, such as when it is determined to change the desired orientation for an installed prosthesis. Lt; / RTI > In the context of the purposes of the present invention, a float may be created by removing a force (e.g., static friction) that inhibits the surgeon from reorienting a misplaced prosthesis so that it can properly orient the prosthesis, and / RTI >

The system of the method of Figs. 12-34, when achieved with BMD positioning, is intended for use with navigation systems that provide real-time information during currently available surgical operations, as well as other various real-time monitoring systems, such as a fluoroscopic device and an accelerometer / gyrometer Conceptualization and want.

Fig. 10 is a schematic side view showing an iliac crest cup C erroneously positioned on a part of the pelvis P. Fig. Mispositioning refers to an implant prosthesis having a preferred orientation before achieving the desired orientation in the context. Fig. 11 shows the conventional use of the ball bar M and the tamper T to apply a deflection force to the un-encoded and incorrectly positioned clavicle cup C as shown in Fig.

In any case, the position of the patient's pelvis, the operating room table, and the prosthetic component are not observed during surgery (navigation) during the transplantation procedure, and Cap C ends up with less than desired position. This condition is often caused by a lack of control of the force caused by non-uniformly striking the ball bar M on the impact tamp T. [ Currently, various positions on the sides of the cup C are struck using the tampon T and the toggle bar M when the doctor changes the direction of the already capped cap C. [

The problem with this method is that the surgeon has no a priori idea of how the specific impact on the cap will change the specific alignment of the cap C. [ For example, while the physician knows that when a common portion of cup C is tamped (e.g., forward) it changes the varying degrees of foreground movement, the action may be abduction along the location of the impact (above or below the equator) ) Or some unwanted changes in adduction. It is fairly accurate that a physician does not know precisely the position and orientation to achieve the desired direction with full precision when using the Tamp T and the TAG probe M to correct the misalignment of the already implanted cap C.

Positioning the BMD is the result of an understanding / invention designed to provide a solution to this specific problem: how can a doctor correct the misplaced position of an already implanted cap C with some accurate measurements? Wherein the goal is to provide a mechanism for providing a measurable and predictable change to the position of the cap C by (1) defining, quantifying, digitizing, and encoding an already implanted prosthesis cap.

Figures 12-14 illustrate a reference frame used in THR surgery including an ankle prosthesis (e.g., cap C) installed in a pelvis including an identified X-Y-Z orthogonal axis. 12 shows an axis orthogonal to the reference frame; Figure 13 shows an orthogonal axis with an associated square plane F and a transverse plane T; Figure 14 is another perspective view of an orthogonal axis with an associated forward plane F and a transverse plane T;

In an operating room using a navigation system, the reference frame is mapped to the location of the patient on the operating room table. The anterior plane F and the transverse plane T are consequently set to pass through the ankle and consequently the cap C. [ The reference frame relates to any particular direction (e.g., the amount and range of specific foreground and abductor angles). In conventional surgery, the range is usually assigned as a challenge to achieving a certain amount. In some embodiments, different reference frames are used, but generally there is a method of mapping different reference frames for the reference frame described above.

Pure point :

The net points of the implanted cap are determined using the mathematical computations in the reference frame defined below. The given facts: the front frame F consists of the X and Z axes and the horizontal plane T consists of the X and Y axes.

The pure abduction point on the side of the cap is defined as the apex of the square plane F on the positive side of the Z axis when the cap is displaced to the front plane F

The pure adiabatic point on the side of the cap is defined as the lowest point on the front plane F on the negative side of the Z axis when displaced to the front plane F. [

The pure foreground point on the side of the cap is defined as the highest point on the Y axis of the horizontal plane T in the positive direction.

The point of pure excavation on the side of the cap is defined as the lowest point on the Y axis of the horizontal plane T in the negative direction.

The pure point is designed to create a side map of a cap installed for use with a positioning BMD system or tool. Once these four critical points are defined and encoded (actual and / or virtual encoding) on the edge of the cap along with the navigation software, additional points between them can be quantified with trigonometric calculations. In this context, the virtual encoding implies a flaw and mapping of pure points to the reference frame for the installed cap and does not require an indication of the type applied. In some embodiments of the present invention, there may be a method of directly transmitting these pure points to the physician in real time, such as various visual displays. Other implementations may provide indirect communication of pure points during use and operation of the system and method.

Figure 15 shows an encoded prosthesis 1500 that includes a set of pure points. The set includes: a pure adduction point 1520, a pure abduction point 1510, a pure foreground point 1515, and a pure escape point 1520. An intermediate point between adjacent pure points creates a fraction of two related points that can be determined by trigonometric function calculations.

Figure 16 shows a manual positioning system 1600 for an encoded prosthesis 1500 using a hammer M and a tamper T. [ The sides of the cap 1500 are now encoded with information (i.e., digitized and quantized in the reference frame). The physician now senses how to manipulate the inserted and misplaced encoding caps 1500 to produce the desired direction with the shape of the map. The surgeon understands that he knows the net point and that the impact on the side of the cap 1500 between the pure abduction and the pure forehead (eg 30 degrees frontal pure abduction (1605)) produces both abduction and foreground motion. Based on the calculation of the trigonometric function, the doctor now expects a higher increase in abduction than foreground. The impact force toward each plane is now quantified so that the physician can accurately, efficiently, and predictably achieve certain desirable directions.

FIG. 17 shows a positioning system 1700 with a positioning BMD 1705 of an inserted and misplaced and encoded prosthesis 1500. The positioning BMD 1705 appears as a tool that applies the pseudo S to the already implanted cap and simply "dials in" the desired alignment 1710. The net automated positioning BMD integrated in the computer navigation system 1715 corrects the position of the dormant and inserted and misplaced cap to the desired alignment (essentially an automated calibration process that eliminates surgical errors and uncertainties). The initial BMD represented by positioning BMD 1705 includes twelve actuators uniformly distributed around 360 degrees of cap (each actuator is separated 360 degrees around the edge of the cap).

The abovementioned additions to the BMD 1705 and the navigation software, pseudo S, in cooperation with the encoded cap 1500 proceed with the digitized and encoded cap (the pure point on the side of the cap is the reference frame Lt; / RTI > The physician S attaches, contacts or otherwise uses the BMD 1705 to control the orientation of the cap 1500. Since the BMD 1705 is used in some cases for other prostheses, the particular adapter for the prosthesis The positioning BMD 1705 is used for the inserted cap 1500 as having one or more of them. It is desirable to call the desired alignment with respect to the cap 1500 (e.g., an abduction of 40 degrees and a lightning angle of 20 degrees are initially inserted at 50 degrees of abutment angle and 30 degrees of lightning strikes and used with a misplaced cap). ). The computer navigation system 1715 calculates the easiest point to generate the desired change since the impact force on the cap produces a predictable increase / decrease of the abduction angle / foreground angle quantified by the computer navigation system 1715. [ Navigation system 1715 now selects the actuator of BMD 1705 corresponding to the point on the cap impacting the calculated point. After a correction impact such that a new point is known, a cap position remeasurement is performed and an available navigation system 1715 should be created. The cap now has a new alignment. The process is repeated until the desired alignment of the implantation cap is achieved. The computer navigation system 1715 configures this process through a feedback loop mechanism until the position of the cap is exactly the same as that invoked by the pseudo-S.

18 shows a schematic view of one embodiment of a positioning system 1800 that uses a positioning BMD 1805 configured to correct inserted and misplaced prostheses. While the system 1700 is designed with a purely automated optimal solution, other systems may also be implemented that include several passive and / or semi-automated steps. The system 1700 is designed to remove surgeons' anxieties and reassure patients as surgical removal of surgical errors, automation of the cap implantation process, and a better and more comprehensive system enable the use of hip replacement surgery. Regardless of the surgeon's experience with the system 1700, "complete cap placement" can be achieved. Regardless of the hospital and patient selected for THR surgery, the patient can be discharged with a "perfect cap" result. This idea was designed to eliminate problems of hip dislocation, wear, impulse, re-admission and re-operation and disposal.

The system 1800 is simply implemented using another embodiment of a positioning BMD 1805 that includes four orthogonal actuators whose pseudo S is aligned at a pure point. The physician S manually and individually actuates the actuators that change the cap placement to achieve the desired result with the computer navigation system 1705 providing each intermediate action result.

19-21 are detailed schematic views of an embodiment of a positioning gun 1900 configured to adjust a prosthesis with the implementation of a BMD 1805. FIG. Figure 19 shows a representative positioning gun 1900; 20 is a detailed left side view of the positioning gun 1900; Fig. 21 is a detailed view of the right side of the positioning gun 1900 shown in Fig. 19 when combined with Fig.

The positioning gun 1900 is used to precisely control the abduction and foreground angles of the acetabular cups that are installed at the ribs in the case of the prosthetic components. The following reference numerals in Table III refer to the components shown in Figures 19-21:

TABLE III: DEVICES (1900) COMPONENTS

The positioning gun 1900 essentially includes handle / grip control for a set of extended actuators disposed about the central support means. The adapter attached to the central support means is mounted on the regulating prosthesis and releasably connected thereto. The adapter is capable of relative movement between the central support means and the cap and provides a number of degrees of freedom that are desirable or necessary to enable the features implemented by the device (not all implementations include all features). The embodiment includes two degrees of freedom for rotation about each of the two vertical axes.

In one embodiment, the adapter permits proper freedom of movement of the cap to move in positive and negative fore and aft angles. The extended longitudinal actuator set includes four actuators equally distributed around the central support means at 90 degrees for each adjacent actuator. The actuator includes an actuator head that strikes a portion of the periphery of the rim of the ankle shell to provide controllable and variable longitudinal impact at the correct location of the edge. Preferably, the four actuators are each aligned with one of four pure foreground and abduction points (i.e., where the application of the longitudinal impact changes only one of the foreground or abduction).

To simplify the discussion, the controller is pneumatically or electronically driven and provides the ability to control the size and / or frequency of independent longitudinal actuators. A dial-on at the end of the controller can select one particular actuator to operate in response to the actuation of the trigger. The triggers apply a longitudinal impact to a desired point on the side of the cap, and when implemented as such, each pentagon controls only one of the four pure points, so that the ankle cap cooperates with a single actuator to create a positive foreground, A negative forehead, a positive abduction, or a negative abduction.

Control may be performed by manually activating (triggering) the actuators to select a particular set of one or more actuators. The motion causes one or more series of impacts to strike a particular position along the rim to adjust the angle to a desired value. The one or more impacts may have a constant or variable size. Each triggering action causes the actuator set to strike the rim at a selected position with the desired magnitude (predetermined or adjusted by the operator). Or each trigger action causes a series of strokes to occur, either the same or different (i.e., increasing in size from a low value to a high value to a range between predetermined limits). The number of strikes may be preset or contiguous as long as the operator maintains the triggering action. For example, the operator keeps connecting the trigger with the actuator until the trigger is released. Some implementations include triggers that allow the operator to control the magnitude of impact from a series of actuators, such as a light pull that causes a blow of a particular force and a larger pull of a trigger that causes a blow of a larger magnitude.

In some implementations, the controller includes a stored program processing system that includes a processing unit that executes the retrieved instructions from the memory. Such an instruction may be automatically activated to achieve values for abduction and foreground angles input by a computer-based pharmaceutical computing system or physician, such as selection of an actuator set and / or a computer navigation system.

Optionally, the command can be used to assist in manual operation to assist or suggest selection of actuator sets and / or actuating forces (not requiring that all sets of actuators strike the rim with the same size).

Thus, the effect (s) obtained in the operation of any one of the actuators of the selected set of actuators may include one or more of the same intensity of shock, any other combination or constant amplitude of the periodic shock set or constant that continues until the trigger is released, and / It can be frequency shock.

As discussed above, the four pure adjustment points are pre-matched and recognized to properly align the actuators during operator preparation. In some systems, four points may not be pre-mapped. In such a situation, the computer navigation system may respond to the first longitudinal impact to map four points. After mapping, the actuator can be properly relocated. In some embodiments, the adapter may provide rotational freedom of movement so that the actuator can rotate about the longitudinal axis of the central support means so that the actuator is all aligned properly with the pure position. Thereafter, the operator can select a specific actuator to appropriately and independently adjust the foreground and abduction.

In some implementations, it may be desirable to use the feedback of the navigation system to determine how many simultaneous actuators that all operate simultaneously in the cap adjust the desired fore and aft direction. For example, if one actuator is able to move the foreground 2 units in the proper direction while adding one undesired unit of abduction, the computer navigation system can simultaneously move multiple Actuators can be used.

Although a system using four actuators has been described above, other embodiments may include actuators that are uniformly distributed around a different number of actuators, the N number of actuators, N = 1-24, and most preferably around the sides of the ankle cap For example, for 24 caps, each actuator is 15 degrees apart from the adjacent actuator).

In the case of a more automated system, an even distribution of the actuators to the central support means is not required and the asymmetrical preparation may be more in accord with the adjustment profile of the cap on the ribs. The adjustment profile is a relatively easy characteristic that the abduction foreground angle can be adjusted in the positive and negative directions. In some situations, these values may not be the same and the positioning may be extended to accommodate such differences. For example, a unit of force applied to a pure positive foreground may adjust a positive foreground by a first unit of distance, while a unit of force applied to a foreground of pure sound under the same condition may be at a different distance from the first unit And the foreground can be adjusted in the negative direction by the second unit. This difference can vary as a function of the size of the actual angle (s). For example, as the foreground increases, other responses change in the actual distance at which the same unit of force is adjusted. The adjustment profile used is used to assist the operator in selecting the impact force and the operator to be applied.

In some implementations, the constraint of the system 1800 is that the physician S waits for the current direction information of the cap 1500 between the operation of the positioning BMD 1805 and considers its use despite the many advantages of the patient, It can make a doctor disappointed.

A solution to the problem of requiring remeasurement between operations is to facilitate the introduction of embodiments of positioning BMDs. One solution is to transmit the encoding information from the prosthesis to the positioning BMD. This paradigm eliminates the need to re-measure the position of the cap after all correction impacts and allows information about the desired position of the cap that is always held in place on the gun. This further includes mapping the encoding information of the positioning BMD to a reference frame that includes the operating room and the prosthesis.

22-24 illustrate the use of an impact ring 2200 for positioning an installed prosthesis (e.g., ankle cap C); Fig. 22 shows the initial state of the prosthesis C pre-installed with respect to the impact ring 2200 installed in the positioning system; Fig. 23 shows the intermediate state of the prosthesis C pre-installed in relation to the impact ring 2200 installed in the positioning system; Fig. 24 shows the final state with the prosthesis C arranged against the impact ring 2200 installed in the positioning system. The impulse ring 2200 operates the prosthesis C by fixing the desired direction in the reference frame and using the positioning BMD associated with the impulse ring 2200 and the positioning BMD is set by the impulse ring 2200 shown in the C- If you follow the desired direction, you achieve the desired direction.

25 shows an embodiment of a positioning system 2500 employing a positioning BMD 2505 including an impulse ring 2510. [ The system 2500 employs a computer navigation system 1715 to provide information to the BMD 2500 to set the impact ring 2510 on the appropriately oriented cap C of the pelvis P in this case. The BMD 2505 basically transmits the position information previously encoded on the side of the cap C to the impact ring 2513 using the navigation system 1715. [ Impact ring 2510 has a direction with respect to handle 2515 that can be adjusted (e.g., by a servo motor, etc.) to set the desired orientation within the reference frame of the operating room by use of a navigation system 1715. [

The position / plane of impulse ring 2510 is measured in the reference frame (as in the manner in which the plane of the implanted cap and pelvic bone is calibrated and known in the reference frame for the non-impact ring version of positioning BMD). The position of the BMD 2505 in the reference frame axis is also calibrated and known. The BMD 2505 is already implanted in the ankle, such as an attachment using an adapter, and is close to the misaligned cap. The desired plane for the impact ring 2510 is selected and provided to the navigation system 1715 to correspond to the ultimate angle of the desired fore and aft abutment angles for the post-procedure implanted cap. The following method of "calling" the desired plane is proposed (the axis of the BMD 2505 and the impact ring 2510 are held in a neutral position, referred to as the double orthogonal position). For the sake of convenience, the BMD 2505 may be pivoted within a designated cone (e.g., a 30 degree cone - other sizes are possible), while the impulse ring 2510 is pivotable between a handle 2515 and an impact ring (2510) changes to reflect the turn, thereby maintaining the desired direction. The BMD 2505 pivots around until the desired plane for the impact ring 2510 of the reference frame of the operating room is thereafter set by the navigation system 1715. The plane of the reference space is then registered with the navigation system 1715 and set in the navigation system at the desired angle of abduction and foreground for the cap C. [ At this point, the doctor can move the gun in a position that he is comfortable during the procedure. The BMD 2505 then adjusts to hold the impact ring 2510 in the same plane as the "desired plane ". At this point, the physician can move the BMD 2505 in a 30-degree cone in the space of the BMD 2505 to maintain the impact ring 2510 in the same plane as the "desired plane " Abduction and 20 degree foreground angle). If the impulse ring 2510 is set in the desired plane, the handle 2515 ramp at 5 degrees in one direction is at a corresponding 5 degree inclination of the impulse ring 2510 in the opposite direction to hold the impulse ring 2510 in the desired plane Lt; / RTI >

The feedback loop system operates in the following manner. The navigation 1715 measures the position and orientation of the BMD 2505 continuously and in real time. (E.g., within the 30 degree cone) of the axis of the BMD 2505 is measured by a computer navigation system 1715 and controlled using information from the navigation system to maintain the impact ring 2510 in the desired plane Is relayed to a microprocessor included with BMD 2505 as part of a stored computing system implemented with BMD 2505 when using a mechanism (e.g., a servo motor coupled to impulse ring 2510). The microprocessor uses the information to compute an error between the actual position of the BMD 2505 and the desired position of the BMD 2505. The microprocessor converts the two-dimensional specific error into two one-dimensional angular corrections and sends the new command to a control mechanism that performs the correction to the position of the impact ring 2510 moving to the desired plane. The control mechanism also has internal circuitry capable of maintaining a feedback loop mechanism that is operative to maintain the desired plane during movement or rotation of the other BMD 2505 during operation. In this manner, the BMD 2505 holds the impact ring 2510 so as to be flush with the desired plane in the reference frame. BMD 2505 then corrects the misaligned cap to the desired location (i.e., 40 abduction and 20 foreground in the example) so that at that point the impact ring 2510 and the implanted cap are flush with the one shown in Figure 24 The impact ring 2510 repeatedly hits the cap C.

That is, BMD 2505 functions as follows: BMD 2505 includes a microprocessor (circuit board) and one or more servos on a substrate. This servo always controls the position of impact ring 2510 in the reference frame. The BMD 2505 is attached to the cap C implanted through the adapter. The BMD 2505 may be pivoted about a 30 degree cone while maintaining the impulse ring 2510 in the desired direction as the servo compensates and adjusts the direction of the impulse ring 2510 to compensate for the pivoting motion. As the physician uses the device to shock the ring C to the reoriented cap C, the doctor moves the BMD 2505 until the positioning is comfortable. The BMD 2505 moves around until the desired plane for the impact ring appears and is registered by the navigation system 1715 in the reference frame (i.e., 40 abduction and 20 foreground for the example).

The doctor moves the BMD 2505, but the desired impact ring 2510 is automatically calibrated at all times to be the same as the desired plane, regardless of how the BMD 2505 is turning around. The physician then quickly engages the impact ring 2510 to actuate the rapidly repeating mechanical hammer so that the impingement ring strikes the misaligned cap C until the impact ring 2510 is coplanar with the cap C, Is corrected to the desired plane / alignment.

Some grafts that are now properly configured with a navigation system are known to have a gingival plane (e.g., 50 degrees of abduction, 10 degrees of forehead) in the operating room space and are easily located in the desired plane in the operating room reference frame (e.g., 40 degrees abduction and 20 degrees foreground ) Is calculated.

The proposed method is based on a double orthogonal configuration on the measurement surface of the ribs in the operating room space. Changes in double orthogonality lead to changes in the plane of the ganglion. The positioning BMD knows that the plane is registered by the navigation system and does not have a calibrated impact ring.

26 shows the development of one version of positioning BMD 2505 employing impact ring 2510 as shown in Fig. 25 for another version of positioning BMD 2605 employing impulse ring 2610. Fig. During testing and evaluation of BMD 2505, it has been discovered that impact ring positioning systems (e.g., servo motors) require strength and stiffness as the impact ring 2510 impact on the inserted cap is transmitted to the servo do.

The BMD 2605 includes an impact ring positioning system that is more rigid to allow the same real time retention of the desired plane with respect to the impact ring 2610 in response to problems associated with servo control. For example, a worm gear or other microprocessor feasible motor solution that provides sufficient stiffness allows a portion of the impact ring to strike a misplaced cap.

The more the impact ring and cap are misaligned, the greater the angular difference between the impact ring and the cap, resulting in a greater torsional / rotational response to the impact ring when striking the installed cap.

 The BMD 2505 provides excellent information about the desired plane and does not have the desired level of rigidity to hold the desired plane with respect to the impact ring when striking the cup for rearrangement while responding to pivoting motion during use. This allows the impact ring to be driven in the center while the impact is diverging at the edge causing rotational stress in the impact ring positioning system and the impact ring does not provide a clean focus energy transfer mechanism due to the misalignment of the desired plane with mis- Make sure you can not see. An alternative to the servo of the BMD 2505, such as the DC worm gear motor of the BMD 2605, can improve the stiffness, but a disadvantage is that relatively inefficient energy transfer is maintained.

Figures 27-34 illustrate alternative embodiments for a positioning system employing an impact ring model. 27-28 illustrate a first alternative embodiment of a positioning system 2700; Figure 27 shows a side view of a first alternative embodiment; 28 shows a top view of a first alternative embodiment. Positioning system 2700 includes a positioning BMD 2705 having N actuators 2710 (where N is an integer greater than or equal to 3) and using the end of the actuator (the end of three or more actuators defines the desired plane) It is used to define a virtual impact ring. The prosthesis C is rotatably connected to the BMD 2705 using a pivot joint 2715. In this manner, the action of the trigger 2720 causes all of the actuators to strike the prosthesis C simultaneously at the peripheral edge. The actuator strikes the desired planar prosthesis C to more efficiently transfer the relocation energy to the edge of the cap. The computer navigation system is used to set up the virtual impact ring.

FIGS. 29-30 illustrate a second alternative embodiment of a positioning system 2900; 29 is a side view of a second alternative embodiment; 30 is a plan view of a second alternative alternative embodiment. Positioning system 2900 includes a positioning BMD 2905 having a single relocatable actuator 2910 that is used to define virtual shocking using the end of the actuator. The prosthesis C is rotatably connected to the BMD 2905 using a pivot joint 2915. The operation of the trigger 2920 rotates the actuator 2910 around the central support means 2925 so as to position the actuator 2910 at the desired position around the circumference of the cap C, Allow the prosthesis C to strike at the edge. Actuator 2910 strikes prosthesis C to achieve the desired plane at the desired location and more effectively transfers the cap's repositioning energy. The computer navigation system is used to set up the virtual impact ring. As the actuator 2910 rotates relative to the support means 2925, the longitudinal extent of its end is shortened or elongated so as to track the end of the virtual impact ring having the desired plane above it in its full rotation with respect to said support means.

Figs. 31-32 illustrate a third alternative embodiment for a positioning system 3100. Fig. 31 shows a side view of a third alternative embodiment; 32 shows a top view of a third alternative embodiment. System 3100 includes a positioning BMD 3105 that conceptually combines BMD 1805 and BMD 2605. The actuators of the BMD 1805 are very efficient in energy transfer (they transmit energy similar to a tamper / hammer with minimal leakage). This is a desirable feature to be selected for the design. The impact of the BMD 2605 is attractive in that the ideal position of the cap within the ring operating room reference frame space is always known and maintained by the positioning BMD.

The desired direction information using the BMD 3105 is now transmitted back to the device itself. The position of the virtual impact ring is controlled by a specific virtual impact ring controller having four (or more, for example 4-24) actuators 3110. [ The control unit includes a microprocessor 3115, a motor driver 3120 having a rotary encoder, a DC motor 3125 and a worm gear 3130. The control unit always maintains the position of the virtual impact ring in the operating room reference frame space. The virtual impact ring is defined by the plane created by the tip of the actuator (four in BMD 3105).

The tip of the four actuators is adjusted so that the computer navigation system knows the location of the "virtual impact ring" in the operating room reference frame space. The BMD 3105 is attached to the implantation cap C with the adapter. The preferred arrangement is entered by the physician into the computer navigation system. The computer navigation system provides information / commands to the BMD 3105. The control knee of the BMD 3105 maintains the position of the virtual impact ring in the operating room reference frame space and thereafter the position of the virtual impact ring (the tip of the four actuators) and the implanted cap C are coplanar Actuates the four actuators 3110 to match in response to actuation of the trigger 3135 striking the peripheral edge 3140 to achieve the desired calibration.

33 is a side view of a fourth alternative embodiment for a positioning system 3300 in which the BMD 2505 of the system 3300 and the BMD 2905 combine aspects. The system 3300 includes a positioning BMD 3305 having a single relocatable actuator 3310 that strikes an implanted cap C that is misplaced at a particular point on the side to achieve the desired plane. The particular point is identified by the impulse ring 3315 controlled by the servo 3320. In this case, the servo 3320 is not part of the impact structure because the function in the mode maintains and defines the desired plane.

Impact ring 3315 is a slotted ring that serves to define the desired plane of the operating room frame of the reference space. The single actuator 3310 is repeatedly impacted at the edge of the cap of the point and rotated to the indicated point (which is the contact point between the implantation cap C and the slot ring) until the ring with the slot and the implanted cap C become coplanar . Servo 3320 and slotted impulse ring 3315 provide position information to BMD 3305 and actuator 3310 provides a high efficiency impact focused on the edge of cap C to provide the desired change in cap alignment. do.

Figure 34 is a side view of a fifth embodiment of a positioning system 3400 including a positioning BMD similar to BMD 1805 employing twelve actuators 3405 (arcuate separation rods evenly spaced 30 degrees around 360 caps) to be. The information about the BMD 1805 is preferably encoded at the edge of the cap using a computer navigation system. A potential drawback to the BMD 1805 along with some implementations is that it is not a mechanism to quickly measure cap orientation after impact and provide feedback to a computer navigation system. For some users, the measurement and feedback of information about the computer navigation system should occur quickly so that the navigation system and the positioning BMD perform multiple quick calibration strokes on the cap via the feedback loop mechanism.

The system 3400 reduces this problem by using three (or more) actuators as the planar calibrator 3410. These actuators are both provided as impact actuators and planar calibrators. In some embodiments, the extremities of the three specific actuators 3410 are encoded and used to define the planes in much the same way that they are calibrated to define a 'virtual impact ring' at the tip of the actuator. After each calibration blow is made by the system 3400, the three actuators 3410 are lowered (slid down) and touch the sides of the cap at different positions (just adjusted positions). A new plane NP is defined. The position of the plane is transferred back to the computer navigation system. The computer navigation system now calculates the difference between the new cap position and the desired cap position (called by the physician). The computer then provides a new command based on the given new location information. The point on the cap is calculated to provide the desired change in alignment and the corresponding actuator 3405 is initiated to make another incremental change in cap position. The position of the cap C is measured again by sliding the actuator 3410 (planar calibration). The process is repeated until the desired alignment of the cap C is achieved (i. E., NP matches the desired surface within the desired threshold). Ideally, future position changes of the cap can be measured by the optical or laser system, deviating from the need for "sliding planarization actuator 3410. " The change can relay information to the navigation system more quickly, Permitting quicker measurement and acquisition of the position. This allows the system 3400 to perform the required calibration blow very quickly, in order to obtain the desired cap alignment.

When tools such as positioning BMDs are developed, physicians are much more likely to adopt computer navigation for hip replacement surgery. In the US, more than 10% of physicians use computer navigation systems for THR surgery. Improvements to this adoption can occur for two reasons:

1. The doctor is now confident that the extra time spent in the operating room translates into a very meaningful difference. All physicians will have the happiness of adding ½ hour to their work for this simple goal.

2. Hip replacement surgery with navigation is usually slow because of the fact that the surgeon keeps track of the position of the equipment in relation to the pelvis. The physician no longer needs to move faster than during surgery when he knows that stable and effective tools at the end of surgery can be automated and correct and correct the final location of the gingival implants in the correct way.

BMD allows all real-time information technology to precisely and precisely utilize (tool) the transplantation of a chordal element (cap) within the pelvic arch. BMD devices associated with navigation technology and the use of fluoroscopy (another new measuring device) are the only devices that enable physicians at all levels to perform a complete hip replacement (hassle / low volume) for the placement of the ganglion component (cap).

With the use of BMD, surgeons can always be confident that they are doing well with positioning of the zygomatic component to achieve a "perfect cap". The concept of BMD therefore eliminates the most common causes of hip replacement surgery complications that have been plagued by physicians, patients, and the general public forever.

It is known to use ultrasonic devices primarily in connection with some aspects of THR for implant removal (some components may be installed using cement that can be softened using ultrasonic energy). Although some ultrasound devices using "ultrasound" energy may be some suggestions that can be used to insert the prosthesis for final fit, it is in the context of the femoral component and the devices are not currently considered to be actually used. Some embodiments of the BMD, by contrast, are considered to be simply implanted devices, such as in a positioner for a chord component in the THR, rather than simply a vibrating device (non-ultrasonic), and not an ultrasound. There is also a discussion that ultrasound devices can be used to make bone implants of prostheses. This is not a major goal of this aspect of the present invention, so BMD does not address the manufacture of bone. Some implementations of BMD may include similar or related features.

In some embodiments, the BMD includes devices associated therewith, as well as proper placement and positioning of the prosthesis (e.g., the zygomatic component) during implantation of the prosthesis. Particularly, some forms of vibration energy combined with various "real time measurement systems" are used to perfectly position the cap with minimal use of force. For example, prostheses, such as the ankle cap, resist insertion. Once inserted, the cap resists change in the insertion direction. The BMD of the present invention creates an insertion vibration motion of the fixed prosthesis that reduces the force against insertion. In some embodiments, a positioning vibration may be generated that reduces the force resisting the orientation change of the BMD. In some embodiments, with one vibration profile or another, two types of motion are created. For the purposes of the present invention, as described above, while the desired oscillatory motion can use the prosthesis, the oscillatory motion is characterized by "floating" the prosthesis as the prosthesis can be inserted and / . Some embodiments illustrate producing a prosthesis that vibrates in a predetermined vibration pattern. In some implementations, the predetermined vibration pattern is predictable and fully predefined. In another embodiment, the predetermined vibration pattern includes a ramping vibration motion in one or more degrees of freedom with an available degree of freedom (up to six degrees of freedom). That is, either the translation of the motion or the degree of freedom of rotation may have an intentional random component that varies from large to small for a vibrating prosthesis. In some cases, the random component of a particular motion may be large, and in some cases, motion may be prioritized. In other cases, the random component may be relatively small so that it is almost undetectable.

In addition to the pure points defined for rotation of pure abduction, pure adiabatic, pure forehead, and pure evulsion, in some implementations, an actuator that strikes a prosthesis inserted at another location in the middle of the pair of such pure points, . The non-pure point striking rotates the inserted prosthesis by a relative predetermined combination of abduction and retraction (depending on the degree of variation at the point of neat triangulation and adjacent points). In this context, it can be seen that the rotation may also include negative values for abduction and / or foreground, referred to herein as abduction and abduction. Also, the amount of one of the rotations relative to the pure point is zero.

The system and method are described in general terms to facilitate a detailed understanding of the preferred embodiments of the present invention. In the description herein, numerous specific details are set forth as examples of components and / or methods in order to provide a thorough understanding of embodiments of the invention. Some features and advantages of the present invention are achieved in this mode and are not necessary in all cases. Those skilled in the art will recognize that embodiments of the invention may be practiced without one or more of the specific details, or with other devices, systems, assemblies, methods, components, materials, components, and / or the like. In other instances, well-known structures, materials, or operations are not specifically shown or described in detail to avoid obscuring aspects of embodiments of the present invention.

Reference throughout this specification to "one embodiment", "one embodiment", or "a specific embodiment" means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment of the invention But not necessarily in all embodiments. Thus, in various places throughout this specification, "in one embodiment "," in one embodiment, " or "in a particular embodiment" In addition, certain features, structures, or characteristics of a particular embodiment of the invention may be combined in any suitable manner in one or more other embodiments. It is also to be understood that other variations and modifications of the described embodiments of the invention are possible in light of the above teachings and are considered to be part of the spirit and scope of the invention.

It will be appreciated that one or more of the components depicted in the figures / figures may also be performed with separate or integrated lifetimes and may even be removed or rendered inoperable in certain cases because they are useful in certain applications.

Also, any signal arrow in the drawings / figures should be considered only exemplary and not limiting unless specifically stated. A combination of components or steps is also considered recorded, and the term is predictable when the combination or separation is unclear.

The above description of the illustrated embodiments of the invention, including those described in the Summary, is not exhaustive or is not intended to be exhaustive or to limit the invention to the precise forms disclosed herein. While specific embodiments and embodiments of the invention have been described herein for purposes of illustration, various equivalent changes are possible within the spirit and scope of the invention as those skilled in the art will understand. As such, such modifications should be included within the spirit and scope of the invention in light of the foregoing description of illustrated embodiments of the invention.

Thus, while the present invention has been described with reference to these specific embodiments, it will be understood that variations, permutations and permutations of the modifications are intended in the foregoing disclosure, and in some embodiments, some features of the embodiments of the present invention, It will be understood that they may be employed without the corresponding use of other features without departing from the spirit and scope of the invention. Accordingly, many modifications may be made to adapt a particular situation or material to the essential spirit and scope of the invention. It is to be understood that the specific embodiments and claims disclosed as the best mode for carrying out the invention and / or the invention are not intended to be limited to the specific terminology which will be used hereinafter, But includes equivalents within the scope of the claims. Accordingly, the scope of the invention should be determined only by the appended claims.

Claims (26)

An apparatus for installing an acetabular cap disposed on a pelvic bone,
The ankle cap has a lateral wall defining peripheries around the opening and a lateral wall defining the inner cavity with a desired anchor depth for the bone, a desired abutment angle with respect to the bone, Shell and an opening,
The apparatus comprises:
A controller including a trigger;
A support means having a proximal end and a distal end opposite the proximal end, the support means having a longitudinal axis extending from the proximal end to a distal end with a proximal end connected to the controller, An adapter coupled to the distal end; And
And an oscillator connected to the controller and the support means,
Wherein the oscillator is configured to control a vibration frequency and a magnitude of vibration of the support means having the vibration frequency, wherein the magnitude of the vibration is determined by a desired external angle and a desired foreground angle without using an impact force applied to the rib- Wherein the guide member is configured to install the guide member. 2. The apparatus of claim 1, wherein the support means comprises 1-6 degrees of freedom with respect to the X, Y, and Z axes, and wherein the vibration magnitude includes a conversion direction, a rotation direction, an X- A pitch direction of the X-axis, a yaw direction of the Y-axis, a roll direction of the Z-axis, and combinations thereof. . 2. The apparatus of claim 1, wherein the controller, when executed by the processor, further comprises: a triggering set of vertical actuators, in response to an adjustment profile that actuates the one or more longitudinal actuators sets and produces a desired fore and aft angle for the bone, And a processor coupled to the memory storage program command for selecting to activate the ganglion cap. A prosthetic attachment system configured to be implanted into a portion of a bone at a desired implant depth,
The prosthesis, including the attachment system,
An oscillation engine comprising a controller coupled to the oscillating machine to generate an original series of pulses having an oscillation pattern, the oscillation pattern defining a first duty cycle of the original series of pulses; And
A pulse transmission assembly having a proximal end connected to the oscillation engine and a distal end spaced from the proximal end, the pulse transmission assembly comprising a connection system at the proximal end, the connection system comprising a connection configured to securely attach the prosthesis System and supplemented with the pulse transmission assembly to form a fixed prosthesis and the pulse transmission assembly generates a series of applied pulses responsive to a series of setup pulses to provide a pulse to the fixed prosthesis to respond to the original series of pulses Communicate with series; Wherein said applied series of pulses are configured to impart a vibratory motion to a fixed prosthesis to enable the placement of a fixed prosthesis within a portion of the bone within 95% of the desired implant depth without manual impact. 5. The apparatus of claim 4, wherein the pulse transmission assembly receives a pulse of the original series from the oscillation engine and generates a series of pulses having an installation pattern in response to the pulse of the original series,
A second pulse duration communicating an installation series of pulses to a fixed prosthesis that produces an applied series of pulses in response to a series of pulse setups, a second pulse duration communicating a series of pulses, a second pulse duration, And defining a second truety cycle of the installation series of pulses comprising a time window. 5. The apparatus of claim 4, wherein the pulse transmission assembly includes an elongated oscillating assembly having a body and a proximal end and a distal end facing the proximal end, the proximal end being disposed within the body and extending the oscillating entrainment out of the body And connected to a distal end comprising said connection system;
Wherein said elongated vibration assembly is configured to move relative to said body and to have at least one degree of freedom. 6. The method of claim 5, wherein the pulse transmission assembly comprises an elongated oscillating assembly having a body and a proximal end and a distal end facing the proximal end, the proximal end being disposed within the body, And connected to a distal end comprising said connection system;
Wherein said elongated vibration assembly is configured to move relative to said body and to have at least one degree of freedom. CLAIMS 1. A method of installing an acetabular cap on a prepared socket of a pelvic bone,
The orbicularoposterior cap includes an outer shell having a sidewall defining an inner cavity and an opening and having a sidewall having a perimeter around the opening, the oropharyngeal cap having a desired installation depth for the bone, a desired abduction angle for the bone, Having a foreground angle,
(a) generating a pulse of the original series from an oscillation engine;
(b) communicating a pulse of the original series to a guttural cap that produces a pulse of the series communicated in the guttural cap;
(c) vibrating an ankle cap having a vibration having a predetermined vibration pattern in response to a pulse of the communicated series; And
(d) inserting a vibrating cap into the prepared socket within a first predefined threshold of installation depth with a desired abutment angle and foreground angle without using the impact force applied to the ankle cap. A method of installing a zygomatic cap on a prepared socket. 9. The method of claim 8,
(e) orienting the vibrating capillary cap in a prepared socket within a third predetermined threshold of the desired forehead angle and a second predetermined threshold of the desired abductor angle. A method for inserting a prosthesis into a prepared position of a patient's bone at a desired insertion depth, the non-vibratory insertion force for inserting the prosthesis at a desired insertion depth is within a first range, the method comprising:
(a) vibrating the prosthesis using a tool for producing a vibration prosthesis having a predetermined vibration pattern; And
(b) inserting an oscillatory prosthesis at a prepared position within a first predetermined threshold value of a desired insertion depth using an oscillating insertion force in a second range, the second range being less than the minimum value of the first range ≪ / RTI > 11. The method of claim 10, wherein the second range is less than the first range. 11. The method of claim 10, wherein the prosthesis comprises a desired orientation with respect to the bone,
(c) orienting the prosthesis that vibrates into a second preset threshold value in a desired direction using a tool without manual impact applied to the prosthesis. 11. The method of claim 10, wherein said inserting step (b) comprises:
(b1) automatically determining the current insertion depth of the vibrating prosthesis using an automated depth determination tool; And
(b2) automatically determining the current insertion depth using the robot surgical tool until the current depth is within a first predetermined threshold. 13. The method of claim 12, wherein said inserting step (b) comprises:
(b1) automatically determining the current insertion depth of the vibrating prosthesis using an automated depth determination tool; And
(b2) automatically increasing the current insertion depth using the robot surgical tool until the current depth is within a first predetermined threshold. 13. The method of claim 12, wherein said inserting step (b) comprises:
(b1) automatically determining the current insertion depth of the vibrating prosthesis using an automated direction determination tool; And
(b2) automatically increasing the current insertion depth using the robot surgical tool until the current depth is within a second preset threshold. 16. The method of claim 15, wherein said step (c)
(c1) automatically determining the current insertion depth of the vibrating prosthesis using an automated direction determination tool; And
(c2) the current insertion depth is automatically adjusted using the robot surgical tool until the current insertion direction is within the second preset threshold value. 17. The method of claim 16, wherein the prosthesis comprises an ankle prosthesis. A surgical system for positioning a misplaced prosthesis cap that is inserted into a patient's pelvic bone within a first predetermined threshold value in a desired direction relative to a reference frame of the pelvic bone,
The system using a positioning system for setting a surgical orientation of a misplaced prosthesis cap comprising:
A positioning device responsive to the surgical direction identifies the group of actuators from the set of actuators and the group of actuators comprises a set of actuators in the pelvic bone And one or more actuators configured to predictably orient the prosthetic cap,
Wherein the positioning device further comprises a selector for activating the actuator group and is configured to initiate the striking at a location on the pre-set prosthetic cap to rotate the prosthetic cap in the reference frame at a predetermined relative amount of rotation of the abduction and foreground angles Surgical system. 19. The method of claim 18, wherein the set of actuators comprises four actuators, the position of the first actuator producing a pure abduction rotation of the prosthetic cap relative to the reference frame, Wherein the third actuator position produces a pure foreground rotation of the prosthetic cap relative to the reference frame and the fourth actuator position generates a pure evacuation rotation of the prosthetic cap relative to the reference frame. 20. The method of claim 19, wherein the set of actuators comprises an additional eight actuators, the positions of the additional eight actuators creating a preset combination of states of abduction and foreground rotation, respectively, Wherein the predetermined relative combination of rotation and foreground rotation is different from other predetermined relative combinations of abduction and foreground rotation. An automated surgical method for positioning a misplaced prosthesis cap that is inserted into a patient's pelvic bone within a first predetermined threshold of a desired direction relative to a reference frame of the pelvic bone,
A system using a positioning system for setting a surgical orientation of a misplaced prosthesis cap comprising:
(a) input the desired direction of the prosthetic cap to the robot tool;
(b) connecting a positioning device of the prosthetic cap, the positioning device being responsive to the robot tool;
(c) measuring the erroneous position of the prosthetic cap in the pelvic bone using the robot tool;
(d) comparing the erroneous direction with a desired direction to establish an erroneous direction error;
(e) initiating a directional calibration contact between the positioning device and one or more actuators of the prosthetic cap when the directional alignment error exceeds a preset threshold, said directional calibration contact including a predetermined relative amount of abduction and foreground rotation Rotate the prosthetic cap within the pelvic bone; And
(f) repeating steps (c) - (e) until the directional alignment error does not exceed the preset threshold value. A surgical method for encoding a set of orthogonal pure points on a prosthetic cap inserted into a pelvic bone of a patient placed in a surgical table in an operating room,
(a) sets a reference frame for the pelvic bone; After that
(b) using the robot tool to map a set of orthogonal pure points of the cap to a reference frame, said orthogonal pure point set comprising a first pure point for abduction, a second pure point for abduction, And a fourth pure point for evacuation. An automated surgical method for positioning a misplaced prosthesis cap that is inserted into a patient's pelvic bone within a first predetermined threshold of a desired direction relative to a reference frame of the pelvic bone,
A system using a positioning system for setting a surgical orientation of a misplaced prosthesis cap comprising:
(a) connecting a positioning device of a prosthetic cap, the positioning device comprising a plurality of actuators uniformly distributed around the prosthetic cap;
(b) measuring the erroneous position of the prosthetic cap within the pelvic bone during surgery; And thereafter
(c) actuating one or more of the plurality of actuators for a set of encoded pure points connected with a misplaced prosthesis cap to rotate the misaligned prosthesis cap during calibration adjustment by a predetermined relative amount of abduction and foreground rotation , ≪ / RTI >
Wherein said calibration adjustment predictably reduces the size of the false position of the prosthetic cap. 24. The method of claim 23, wherein the plurality of actuators comprises four actuators, the actuators corresponding to a set of encoded pure points. 24. The method of claim 23, wherein the plurality of actuators is four or more and the four actuators correspond to an encoded pure point set. 24. The method of claim 23, wherein the plurality of actuators comprises three or more actuators, one of the actuators corresponding to a pure point of one of the encoded pure point sets.

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