Positioning systems and methods for implanting an energy absorbing system

The present disclosure relates to positioning instruments and related methods for transplantation of energy absorption systems, and more specifically to tools and surgery for transplantation of energy absorption systems for the treatment of joints.

Joint replacement is one of the most popular and successful surgeries in modern orthopedic surgery, shaping the painful, arthritic, worn or diseased parts of the joint and allowing for range of motion. Replacement with the artificial surface is performed. When osteoarthritis is diagnosed, joint replacement is commonly performed. Due to their high invasiveness, such surgery is used as a last resort, requires a fairly long recovery period, and permanently alters the joint. Total joint replacement (also known as total joint formation) is surgery to replace all joint surfaces in a joint. Total arthroplasty is a semi-articular formation that replaces only the articular surface of one bone in one joint (half-articular formation), or an articular surface of only one of multiple compartments in a joint (eg, knee). It differs from unilateral angiogenesis, which replaces the surface of the thigh and tibia only medially or laterally of the joint.

<p num="0003"> In general, arthroplasty refers to orthopedic surgery that surgically alters a living joint in some way. Arthroplasty includes surgery to replace the arthritic or dysfunctional joint surface with something, and surgery to reshape or realign the joint by osteotomy or some other surgery. Like joint replacement, these other arthroplasty surgeries are highly invasive and require a relatively long recovery period. A common form of joint formation in the past is interstitial joint formation, which involves the insertion of some other tissue within the joint space (eg, skin, muscle or tendon) to separate the inflamed surface to the joint. Make surgical changes. Another traditional articular formation is excisional articulation, which removes the articular surface to leave scar tissue and fill the space. Other types of arthroplasty include resection arthroplasty, resurfacing arthroplasty, mold arthroplasty, cup arthroplasty, silicone replacement arthroplasty, to affect or restore or alter joint alignment. And there is osteotomy. If the joint formation is successful, the new joint surface obtained by the joint formation provides the same function in the joint as the removed joint surface. However, chondrocytes, the cells that control the development and maintenance of the joint surface, are either removed as part of arthroplasty or remain in competition with the resulting joint anatomical morphology. (?) Due to this, none of the above treatments for removing the joint surface has a cartilage protective effect.</p><p num="0004"> A widely accepted type of osteotomy is osteotomy, which surgically cuts the bone to improve alignment. Force imbalances and affected joint pain can occur if there is an inconsistency in the direction of load within the joint due to injury, bone abnormalities or illness. The purpose of osteotomy is to relieve pain by surgically realigning the bone in the joint by transferring the force exerted on the joint onto the less damaging joint surface. Such movement also increases the life of the joint. When dealing with osteoarthritis in the knee joint, this surgery involves surgical realignment of the joint by altering the joint alignment by cutting and reattaching one of the bones in the knee. It is said. This surgery is often used for younger, more active and heavier patients. Osteotomy used to treat osteoarthritis as the most frequently used high tibial osteotomy (HTO) (surgical realignment of the upper end of the tibia (tibia) to treat knee inconsistency) There is surgery, and this osteotomy often results in reduced pain and improved functionality. However, in the case of HTO, ligament instability cannot be dealt with, only mechanical alignment can be dealt with. Good results are obtained early on with HTO, but the results decline over time.</p><p num="0005"> Overload on joints has been found to be a major contributor to the progression of osteoarthritis disease. It has also been found that reduced load (eg, weight loss) can also reduce disease progression and pain.</p><p num="0006"> In certain approaches for the treatment of osteoarthritis, external devices (eg, braces or fixtures) are used to control the movement of the bones of the joint or apply a cross-load to the joint to apply the load. Move the joint from one side to the other. Several such approaches have resulted in reduced pain by reducing the load on the diseased joint, but lack of patient compliance or the device cannot promote and support the natural movement and function of the diseased joint. Eventually it fails because of something.</p><p num="0007"> In the case of certain traditional approaches for the treatment of osteoarthritis, it is also not possible to consider all the basic functions of the various structures of a joint in relation to its unique movements. In the ultimate successful approach, in addition to coping with load and movement in the joint, both the damping and energy absorbing functions of the anatomical form should be recognized and transplanted through the least invasive technique. It should be possible. With a relatively rigid device structure, substantial energy conservation is not possible. With such a relatively rigid structure, energy is transferred to the joint rather than being stored or absorbed. In contrast, bio-joint structures are composed of elements of different compliance characteristics (eg, bone, cartilage, synovial fluid, muscles, tendons, ligaments) as described above. These dynamic elements include relatively compatible elements (ligaments, tendons, fluids, cartilage) that allow substantial energy absorption and storage, and relatively high stiffness that allows efficient energy transfer. There is an element (bone) of. The cartilage in the joint is compressed under the application of force, and the resulting force displacement indicates the energy absorbed by the cartilage. In the presence of fluid in the cartilage, the response to fast-applied loads hardens and the response to slow-loaded loads diminishes. In this way, cartilage has the function of absorbing, storing and dissipating energy.</p><p num="0008"> Approaches have been developed for surgical implantation of devices for extra-articular mechanical energy absorption. Accurate and effective placement is important for the effectiveness of the transplanted extra-articular mechanical absorption device, further improving patient preparation and juxtaposition between device / anatomical morphology. It has proven to be more useful and necessary.</p><p num="0009"> With the above applications in mind, it has been found necessary to develop effective systems and tools for attaching extra-articular energy absorbers to the human anatomical form.</p><p num="0010"> In order for the energy absorbing device to function optimally, it is necessary to prevent the movement of the joint from being hindered by the energy absorbing device. Therefore, what is needed is a precise surgical approach for implanting devices that can respond to changes in range of motion and load and complement the underlying anatomical morphology or adjacent anatomical morphology. is there.</p><p num="0011"> The present disclosure satisfies the above and other needs.</p>

<p num="0012"> Briefly and generally, the present disclosure relates to the treatment of body joint disorders or inconsistencies using an energy absorption system without limiting the range of joint movement of a patient. Such diseases or inconsistencies are typically affected by osteoarthritis. As used herein, positioning devices and related methods used in the implantation of such energy absorption systems are described.</p><p num="0013"> The method of implanting the device in the joint includes a step of inserting a first reference marker into the first bone of the joint, a step of inserting a second reference marker into the second bone of the joint, and the first step. The step of connecting the reference marker and the second reference marker to the confirmation tool, and the joint is moved through a predetermined range of movement, and the confirmation tool is used to move the first reference marker and the second reference marker. The step of determining whether or not they are moving with each other within the desired kinematic pattern within the predetermined range of motion and, if the desired kinematic pattern is not achieved, re-do one of the reference markers. It includes a step of placing and a step of implanting the device on the joint.</p><p num="0014"> The confirmation tool for confirming the transplantation position of the extra-articular energy absorbing device in the joint is the tool body and the first connection component on the tool body, and the first connection component is the first. The first connecting component is configured to be connected to a first reference marker placed in the bone, the first connecting component allowing the tool to rotate with respect to the first bone. And the second connection component on the tool body, the second connection component being configured to be connected to a second reference marker placed in the second bone, said The second connecting component includes a second connecting component that allows the tool to rotate with respect to the second bone. At least one of the first and second connection components is movable with respect to the tool body. The confirmation tool includes a measuring instrument configured to provide the user with information about the position of at least one of the first reference marker and the second reference marker during the articulation of the joint.</p><p num="0015"> A system for placing an energy absorbing device in a joint includes a base that is configured to be anchored to a bone adjacent to the joint and a placement guide that is removable and attachable to the base. The placement guide includes offset components. One end of the offset component is connected to the placement guide and the other end of the offset component is configured to be in contact with the bone.</p><p num="0016"> The method of positioning the center of rotation of the implantable articulated joint device is to position the anatomical reference position on the bone with a tool having an X-ray opaque marker and to separate it from the anatomical reference position. Includes the step of marking the target position of the implantable articulated joint device by inserting a marker through an opening in the tool at a given distance and orientation.</p><p num="0017"> The method of implanting the energy absorbing device in the joint is a step of fixing the first basic component to the bone on the first lateral side of the joint and a step of attaching an absorbent material to the first basic component. The absorbent is restricted by a step having at least one joint and a step of temporarily limiting the joint of the absorbent to a limited range of motion by a removable restraint. The range of motion is smaller than the entire range of motion of the joint, with the step and the joint of the absorbent being temporarily restricted to the bone on the second side of the joint. It includes a step of positioning and fixing the basic components and a step of removing the restraint.</p><p num="0018"> The system for placing the energy absorbing device in the joint includes a base that is configured to be anchored to the bone adjacent to the joint. The base includes a first placement guide mounting surface and a first connector element, a placement guide that includes a second placement guide mounting surface, and a second connector adapted to mesh with the first connector element. Includes elements and offset components. The placement guide can be mounted to the base portion at the mounting position, whereby when the first second connector element and the second connector element are engaged, the first placement guide mounting surface and the second The placement guide mounting surface comes into contact.</p><p num="0019"> A method for positioning a base for implantation in a joint is a first method such that one end of the first reference marker is inserted into the bone and the other end of the first reference marker is free. A combination of a pre-assembled base and placement guide such that the step of inserting the elongated reference marker into the first bone of the joint and the first reference marker extend through a first guide hole in the placement guide. With the step of placing the joint on the bone and the combination and the second reference marker in the correct position, the second elongated reference marker is placed on the joint through the second guide hole in the placement guide. After the second reference marker is inserted into the bone by inserting it into the bone, the second reference marker has a predetermined relationship with the first bone and the second bone of the joint. Includes extending, steps.</p><p num="0020"> The tool for selecting one base from a plurality of bases having different base geometries for implantation in a joint is a tool body having a bone contact surface shape, wherein the bone contact surface shape is the 1 A tool body and a guide opening on the tool body that generally correspond to the bone contact surface shapes of the plurality of bases from which one base is selected so that the elongated reference marker extends through the guide opening. A guide opening and a seal corresponding to at least some of the plurality of bases, wherein the reference marker extends through the guide opening and the tool body has the desired alignment with the bone. When the tool body is placed on the bone of the joint so as to be taken, the reference marker is placed at a position with respect to the mark indicating one base portion to be selected, including a mark.</p><p num="0021"> For implantation in a joint, the method of selecting a base from multiple bases with different base geometries is such that one end of the elongated reference marker is inserted into the bone and the other end of the reference marker is free. A step of inserting the reference marker into the bone of the joint and a step of positioning the trial, in which the surface of the trial has a desired alignment with the bone portion and the free end of the reference marker is on the trial. A step of positioning to extend through the guide opening and a step of selecting one base from the plurality of bases depending on the position of the reference marker with respect to one or more stamps associated with the guide opening. And include.</p><p num="0022"> Other features of the energy absorption system and device will become apparent when the following detailed description is read with the accompanying drawings. In the drawings, the principle of the embodiment is shown exemplary.</p>

<figref num="1">It is a perspective view which shows the mechanical energy absorption system which can be transplanted extra-articularly.</figref><figref num="2">A side view is a side view showing a state in which the sheath is removed from the absorbent material of the system of FIG.</figref><figref num="3">It is a side view of the position confirmation tool for obtaining the correct position of the energy absorption system of FIG.</figref><figref num="4">It is a perspective view which shows how the confirmation tool of FIG. 3 was used on a patient.</figref><figref num="5">It is a perspective view of the confirmation tool of FIG.</figref><figref num="6A">FIG. 3 is a perspective view of a bullseye tool for inserting a reference marker into a bone at a desired position.</figref><figref num="6B">It is a top view of the part of the bull's eye tool of FIG. 6A.</figref><figref num="7A">FIG. 5 is a plan perspective view of an arrangement guide used to promote correct positioning of the base portion.</figref><figref num="7B">It is a side perspective view of the arrangement guide of FIG. 7A.</figref><figref num="8">FIG. 7 is a plan view showing a state in which the arrangement guide of FIG. 7A is temporarily attached to the base portion.</figref><figref num="9">It is a perspective view of the arrangement guide and the base part arranged so that the base part is attached to the bone of a patient.</figref><figref num="10">It is a perspective view of the base part attached to the patient's bone, and the placement guide is removed.</figref><figref num="11A">It is a side perspective view of the absorbent material positioning collar.</figref><figref num="11B">It is a lower perspective view of the absorbent material positioning collar of FIG. 11A.</figref><figref num="12">FIG. 11 is a plan view showing how the positioning collar of FIG. 11A is arranged between the base portion and the absorbent material.</figref><figref num="13A">It is a perspective view of the thigh trial according to the aspect of this invention.</figref><figref num="13B">It is a top view of the thigh trial according to the aspect of this invention.</figref><figref num="13C">It is a side view of the thigh trial by the aspect of this invention.</figref><figref num="14A">FIG. 5 is a plan view of a base portion forming a part of a system for arranging an energy absorbing device in a joint according to the aspect of the present invention.</figref><figref num="14B">FIG. 6 is a perspective view of a base portion forming a part of a system for arranging an energy absorbing device in a joint according to an aspect of the present invention.</figref><figref num="15A">FIG. 5 is a plan view of a placement guide that forms part of a system for placing an energy absorbing device in a joint according to aspects of the invention.</figref><figref num="15B">FIG. 5 is a perspective view of a placement guide that forms part of a system for placing an energy absorbing device in a joint according to aspects of the invention.</figref><figref num="16">FIG. 5 is a side view of a lock pin that forms part of a system for placing an energy absorbing device in a joint according to aspects of the invention.</figref><figref num="17A">It is a perspective view of the system for arranging the energy absorption device in a joint according to the aspect of this invention.</figref><figref num="17B">FIG. 5 is a plan view of a system for arranging energy absorbing devices in joints according to aspects of the present invention.</figref>

Refer to the drawing here. The drawings are provided non-limitingly for illustrative purposes. The present disclosure relates to devices for the treatment of body tissues. In applications related to the treatment of body joints, the described approach aims to reduce pain associated with the functioning of the disease or inconsistent components that form the body joints. Although the present invention is particularly suitable for solving problems associated with osteoarthritis, the energy manipulation itself achieved by the present invention is also suitable for a wider range of applications. In addition, the present invention is particularly suitable for the treatment of synovial joints (eg, knees, fingers, wrists, ankles and shoulders).

In one particular aspect, the energy absorption system of the present disclosure modifies the energy absorption and movement of a joint (eg, knee joint) during rotation. FIG. 1 shows a implantable energy absorption system for absorbing the forces normally transmitted through joints for pain relief (eg, pain associated with osteoarthritis).

U.S. Patent Publication No. 2009/0014016, which is incorporated herein by reference in its entirety, describes specific embodiments of extra-articular energy absorption systems. The geometry contained in these energy absorption systems is variable designed to minimize and complement the damping effects and energy absorption provided by the anatomical morphology of the body (eg, as found in body joints). Achieve energy absorption. It has been speculated that in osteoarthritis joints it may be necessary to absorb 1-40% of the force to varying degrees in order to minimize pain. Variable absorption in the range of 5-20% can be a goal in a particular application. In certain applications, a temporary extension (eg, less than 3 months) is used in the energy manipulation approach.

Here, with reference to FIG. 1, one embodiment of the energy absorption system 50 is illustrated. The energy absorption system 50 is secured to the knee joint to absorb at least some of the energy transmitted by the knee anatomical morphology. The energy absorption system 50 includes a proximal base 52 and a distal base 54. The proximal base 52 is located on the femur 56. The distal base 54 is located on the tibia 58 of a typical knee joint. Note that the parts of the bases 52 and 54 are contoured to fit the possible attachment surfaces of the femur 56 and tibia 58. The energy absorbing device 60 is also illustrated. The energy absorbing device 60 is arranged and mounted between the base portion 52 and the base portion 54. In FIG. 1A, the energy absorption system 60 is illustrated with the sheath 61. The sheath 61 covers the internal element, protects the moving element from colliding with the surrounding tissue, and prevents the surrounding tissue from being damaged by the device. For the purpose of illustration, the sheath 61 is not shown in FIG.

The energy absorption system 50 as shown includes two springs 62 and 64. However, other numbers of springs are also available. The energy absorption system 50 has an ability to absorb energy other than the kinetic energy from the joint. FIG. 1 shows how the knee joint is in a fully extended state. In the example of FIG. 1, the maximum load is applied to the springs 62 and 64 of the energy absorbing device 50 at the time of full extension during the stance phase of the walking cycle. When the knee joint is bent up to 90 ° (eg, during the swing phase of the gait cycle or when the patient is seated), the loads absorbed by the springs 62 and 64 from the knee are zero. In this example, when the energy absorbing device 50 is correctly placed on the knee, the device actively functions in the compressed state when the knee is in the fully extended state or near the fully extended state. The length of the energy absorbing device 50 increases as the knee swings from the fully extended state to the fully extended state, and then the energy absorbing device 50 increases as the knee swings from the fully extended state to the fully extended state. The length of the device is shortened so that the spring begins to compress between both ends of the device, absorbing at least a portion of the load normally received by the articulated surface of the knee.

When mounting the energy absorbing device 50 and the bases 52 and 54 on the joint, the energy absorbing device is prevented from "come to the lowest position" after the spring has achieved a predetermined amount of compression and the resulting load. The articulated surface of the knee carries a portion of the load along with the energy absorbing device.

With reference to FIGS. 1 and 2 again, one embodiment of the energy absorbing device 60 includes two machined springs 62 and 64. Each of these springs 62 and 64 is located around a guide (not shown). This guide supports the spring so as to allow compression of the spring when the knee is extended or at a low flexion angle, and the spring is placed in a no-load position when the knee is at a larger flexion angle. To support. The guide, with the springs 62 and 64 rearranged around, allows the other end of the telescope-type component (eg, the energy absorbing device 60) to move proximally and distally to each other in a linear path. It can take the form of a piston and barrel). The energy absorbing device also includes a proximal (thigh) end 66 and a distal (tibial) end 68. The proximal (thigh) end 66 and the distal (tibial) end 68 can be connected to the bases 52 and 54 by a known connection mechanism 70 (eg, taper lock).

As shown, the energy absorbing device 60 also includes two ball joints within the proximal end 66 and the distal end 68. These two ball joints allow the energy absorbing device 60 to rotate forward / backward, medial / lateral, and axial with respect to bases 52 and 54. The range of motion of the elements of the system can be determined by the bearing / socket geometry, the base / absorber geometry, and the relative position of the base with respect to the absorber at the time of final implantation. The same ball / socket arrangement can be provided on both sides of the knee joint, but different arrangements are also conceivable. Absorbent springs 62 and 64 from the medial compartment of the knee, while allowing the device to cover the entire range of motion of the knee by means of the ball / socket junction and the telescope portion of the absorber piston assembly. It works to absorb the load.

In order to maximize the functionality of the energy absorption system 50, the thigh base 52 and the associated spliced joint surface must be placed with high precision at the thigh end 66 of the energy absorption device 60. Positioning tools and related methods have been developed to facilitate the positioning of the proximal base 52 and the articulation.

Traditional or surgical approaches or minimally invasive approaches are taken to gain access to notable body joints or other anatomical forms. An arthroscopic approach is contemplated if it is rational in terms of both the transplantation of the energy-manipulated assembly and the achievement of assembly regulation.

In one approach for knee treatment, a implantable extra-articular energy absorber system is designed to reduce compartmental loading in the medial direction of the knee. The absorbent system includes two molding base elements, a kinematic load absorber, and a set of osteoscrews. The transplanted system is extra-articular and extracapsular and resides in the subcutaneous tissue on the medial aspect of the knee. The device is inserted through two small incisions. These two small incisions are above the medial femoral condyle and below the tibial plateau. The molded base element is secured to the medial cortex of the femur and tibia by bone screws.

With energy absorber 60, which has a spring value of about 20 pounds, it is possible to treat patients under 300 pounds. The higher the spring force, the greater the reduction in joint load, leading to greater relief of symptoms (ie, pain).

For the medial section of the knee of the average person with osteoarthritis, a spring or absorption corresponding to 20-60 lbs of absorbent set for 1 mm-10 mm compression and preferably 3-6 mm compression It has been found to be good to use with material elements. In one preferred embodiment, the absorbent is set to provide about 4 mm of such compression for a given load of about 40 lbs. Absorbents that absorb 40 lbs of load can release 25-40 lbs of load from the medial compartment of the patient's knee.

Base elements for the thigh and tibia can be molded to optimally fit the bone surface, and the bone contact surface can be plasma spray coated with porous titanium and / or hydroxyapatite. Promotes internal bone growth and improves osteointegration.

Using the position confirmation tool 100 shown in FIGS. 3 to 5 during surgery, the position of the thigh base 52 and the surface of the thigh joint of the absorbent material 60 are confirmed, and the position where the system 50 is most effective. To achieve. A suitable implantation position for System 50 is achieved when the springs 62 and 64 are placed in a compressed state during the gait swing phase (including full extension of the knee joint and small flexion angle). .. These springs are in a less compressed or uncompressed state when the knee flexion is 45 degrees, and the springs are preferably in an uncompressed state until the knee flexion is 90 degrees. Or almost uncompressed. This configuration corresponds to the configuration of the walking cycle in which the maximum force is applied when the knee joint is fully extended and these forces are significantly reduced when the knee is flexed during the walking swing phase.

The positioning tool 100, as described herein, confirms that the desired movement is obtained for a particular energy absorption system of a particular design to be implanted. Although the positioning tool 100 has been described as being used with the energy absorption system 50, the confirmation tool is designed to have a specific desired kinematic pattern as the joint moves in a specific range of motion. It should be understood that it can also be used to confirm the fixed position of the portable system of.

In order to use the positioning tool 100 in the method of implanting the energy absorption system 50, first, a first reference marker and a second reference marker are applied to the first bone and the second bone on the opposite side of the joint. Insert and then connect the first and second reference markers to the confirmation tool. Then, the confirmation tool 100 is used to determine whether the first reference marker and the second reference marker move to each other in a desired kinematic pattern. Examples of kinematic patterns are given below: 1) As the joint moves from the extended state to the flexed state, the reference markers move apart from each other; 2) The joint moves from the extended state to the flexed state. When moving, the reference markers stay within a specific defined distance to each other; 3) as the joint moves from the extended state to the flexed state, the reference markers move toward each other; and 4) the joint. As they move, the reference markers move apart from each other and then toward each other.

In addition to locating one or more of the bases 52 and 54, the locating tool 100 provides energy absorbing components of different sizes or configurations (eg, as described in U.S. Patent Publication No. 2009/0014016. It can also be used to select the energy absorption component 60 when it is available.

The position confirmation tool 100 includes the main body 102. The body 102 has a first end 110 attached to a reference marker within the patient and a second measuring instrument end 112 extending at an angle from the first end. The second instrument end 112 monitors the relative movement between the reference marker and the bone. The first end 102 of the tool 100 has a first connection point 104 at a fixed longitudinal position on the body. The first connection point 104 may include a guide hole and a guide ball, which allows the marker to rotate within the tool body 102, but does not allow the first connection point to translate. .. The first connection point may also include the offset 105 shown in FIG. Due to the offset 105, the tool is located away from the bone by the offset distance, which allows the tool to rotate more easily without interference from the bone. .. The tool 100 has a second connection point 106 in a position where it can be moved in the longitudinal direction. The second connection point 106 may also include a guide hole through the guide ball, which allows the marker to rotate within the tool body 102. The guide sphere at the second connection point 106 may also include an offset 105. These guide spheres allow the Tool 100 to use the first and second reference markers over the entire range of motion of the joint, even if the first and second reference markers are not perfectly parallel. Or it can rotate around the K wire.

The second connection point 106 is fixed to the flexible ribbon 108. The flexible ribbon 108 is longitudinally movable on the tool 100. The flexible ribbon 108 functions as a measuring instrument that monitors the mutual movement of the reference marker while moving the joint within a predetermined range of movement. Therefore, the second connection point 106 moves in the longitudinal direction on the confirmation tool 100 when the joint moves in the movement range. The confirmation tool 100 is used to determine whether the first reference marker and the second reference marker move with each other within the predetermined range of motion in a desired kinematic pattern. As described above, the desired kinematic pattern can be a pattern in which the reference marker moves in the distance direction as the joint moves from the extended state to the flexed state. If the desired kinematic pattern is not achieved, one of the reference markers is rearranged. Then, the new position is confirmed using the confirmation tool.

Other configuration confirmation tools 100 are also conceived that correspond to the movement between the first connection point 104 and the second connection point 106 and that confirm this movement in other ways. For example, a telescope-type confirmation tool 100 having a bar or identification band provided on the telescope portion can be used.

In one approach to surgical procedures, the patient's Blumensaat's line is identified in the first step of treatment. Blumensaat's line is a radiological and structural feature of the femur. Using Blumensaat's line as an anatomical radiomark, the acceptable and target areas for locating the center of rotation of the femoral socket just anterior and / or proximal to the center of rotation of the femur. Can be identified. As shown in FIG. 4, the reference marker 104 or K-wire is placed in the femur under fluorescence fluoroscopy or another imaging technique. The placement of the thigh reference marker 104 can be done manually without the assistance of a placement tool. Alternatively, the Bullseye Tool Guide 200 or other placement tool can be used to insert the reference marker 104 in the desired target area.

The bullseye tool 200 shown in FIGS. 6A and 6B is used as a guide to insert the K-wire 130 through the bullseye tool 200 through the patient's skin or after making a small incision into the femur. By providing anatomical and / or radiological landmarks (eg, the center of Blumensaat's line, the inferior and posterior regions of the femoral condyle), the K-wire is placed at the target region or location (using the bullseye instrument). Note that it will be possible to assist in the process of manual positioning (or without using the bullseye device). The bullseye tool positions an anatomical reference position (eg, the center of Blumensaat's line) and positions the center of rotation of the implant at a predetermined distance and direction away from the anatomical reference position. , Used to position the center of rotation of the thigh socket.

When the bullseye tool 200 is used, the central pin 202 of the bullseye tool is arranged on the midpoint of Blumensaat's line, and the bullseye tool is arranged. Rotate the tool until the two wings 204 of the tool are parallel to Blumensaat's line (along with an X-ray opaque marker). Vertically spaced X-ray opaque rings 206 are placed within the center of the Bullseye Tool 200, and when these rings are aligned (concentric), the Bullseye Tool is in the fluoroscopic view. It is perpendicular to the horizontal view and is properly aligned so that the reference marker 130 can be inserted perpendicular to the horizontal view. At this position, a K-wire or reference marker 130 is placed through the hole 208 in the tool 200 to position the center of rotation of the thigh socket of the energy absorbing device 60. As shown, the trajectories of the holes 208 are parallel to the imaging direction when the concentric rings are aligned. However, it is also possible to achieve the reference marker 130 for other orbits by changing the hole orbit in the Bullseye Tool 200.

The position of the hole 208 in the bullseye tool 200 is designed to be just anterior and proximal to the midpoint of the Blumensaat's line when the tool comes to a position as described above. Since the midpoint of Blumensaat's line has been found to be a good kinematic approximation of the center of rotation of the femur, placing the reference marker 130 anterior and proximal to the midpoint of Blumensaat's line will result in the femur. A starting point for discovering the center of rotation of the joint and achieving the desired kinematic pattern (the reference marker moves in the distance direction as the joint moves from the extended state to the flexed state) is obtained. I know that.

As shown in FIG. 4, the confirmation tool 100 is inserted through the tissue tunnel between the first and second incisions in the leg on the opposite side of the knee joint. The tool is placed on a first reference marker 130 placed in the femur and a second substantially parallel reference marker 132 is placed in the tibia through the connection point 106 of the tool. The distance between the first connection point 104 on the verification tool 100 and the second connection point 106 is the desired distance when attaching the base to the bone to accommodate the energy absorption component 60. Is selected so that it can be. Although the confirmation tool 100 has been described as acting partially under the patient's skin in a tissue tunnel, in some cases the entire confirmation tool may be placed under the patient's skin or outside the patient's skin. It should be understood that it may be done.

The verification tool 100 includes one or more bars, bands, grids, or other marks (eg, the 45 ° and 90 ° bars 120 and pointer 122 shown in FIG. 3). This 45 ° bar indicates the acceptable range of position for the pointer 122 when the joint is flexed at 45 °. This 90 ° bar indicates the acceptable range of position for the pointer 122 when the joint is flexed at 90 °. These bars are shown as an example only, and one or more other bars are also available. These bars are only a simple way to determine if the space between the reference markers is inadequate or excessive during joint articulation. If the space between the reference markers is inadequate or excessive, it indicates that it is necessary to move one or both of the reference markers in order for the energy absorbing device 50 to function best.

In one embodiment of the invention, the confirmation tool is placed on the thigh reference marker 130 as shown in FIG. 4, and the tibia reference marker 132 is inserted through the connection point 106 to obtain the thigh reference marker. Check the position. When placing the tibial reference marker 132, the pointer 122 should point to the zero mark 126. To simulate upright posture or load extension, the knee should be in an extended state and intra-articular by pulling the tibia medially to bring it closer to the medial joint space when the tibial reference marker 132 is placed. The medial relaxation of the should be eliminated. If the knee joint is not fully extended or the medial joint space is partially open when the tibial reference marker is placed, the confirmation tool 100 can be readjusted to zero mark 126 after correcting the knee position. Is. To confirm the position of the thigh reference marker, bend the knee in the range of motion while observing the position of the pointer 122 with respect to the bar 120 on the confirmation tool 100. For example, if the knee moves from the extended state to the 45 ° flexed state with the medial joint space closed, the pointer position should be within the 45 ° bar. In addition, if the knee moves from an extended state to a 90 ° flexion with varus, valgus, medial and lateral rotations, the pointer position should be within the 90 ° bar. If this confirmation is successful, the confirmation tool 100 can be removed and the thigh reference marker 104 is confirmed to be in the desired position of the center of rotation of the thigh junction 66. When the pointer moves to the outside of the bar during the above movement, it is necessary to adjust the thigh reference marker position as follows. This confirmation is performed under inspection.

If the criteria of the confirmation tool 100 are not met, the thigh reference marker 130 can be moved using the following guidelines. Outside the boundary of either the 45 ° bar or the 90 ° bar when the pointer does not enter either the 45 ° or 90 ° bar during the confirmation step or when the pointer is at the specified bending angle. If you move to, you need to insert a new reference marker at a short distance from the original reference marker 130. If the pointer does not enter either the 45 ° bar or the 90 ° bar at all during the confirmation step, the pointer is located in a region distal and / or anterior to the original marker by a distance of approximately 1-2 mm. A new reference marker needs to be inserted. If the pointer moves outside the boundary of either the 45 ° bar or the 90 ° bar during the confirmation step (moves completely beyond the bar), it is new in the area behind the original marker. A reference marker needs to be inserted. The original thigh reference marker 130 is then moved and the confirmation step is repeated with the new rearranged reference marker. It is not necessary to move the tibial reference marker 106. This is because it is possible to readjust the confirmation tool 100 to the zero position after inserting the new thigh reference marker 104.

If multiple energy absorbing devices 50 (ie, different sizes) are available, the confirmation tool may include additional marks or may have different sizes.

Although the confirmation tool 100 has been illustrated using the visual analog criteria pointer 122 and bar 120, it has been understood that other methods can be used as alternatives or additions for confirmation feedback. Should be. For example, the confirmation tool 100 may include visual feedback, auditory feedback, tactile feedback and / or digital feedback.

After confirming the acceptable position of the reference marker 130, the energy absorbing device 50 is implanted onto the joint by positioning the bases 52 and 54 on the bone using the instruments and methods described below. .. Specifically, the thigh base portion 52 is positioned at a suitable position with respect to the position of the reference marker 130, and the rotation center of the thigh joint portion 66 at the position of the reference marker is positioned.

To assist in positioning the thigh base 152, the thigh placement guides 300 shown in FIGS. 7A, 7B and 8 are temporarily attached to the thigh base 152. Temporarily attach the thigh placement guide 300 to the base to ensure that the thigh base 152 stays in the correct position when it is attached to the bone, and then remove the thigh placement guide 300 when the attachment is completed. .. The placement guide 300 is attached to the selected thigh base 152 by a guide knob 312 (FIG. 8). The guide knob 312 (FIG. 8) is fitted into the large distal hole 314 of the guide 300 and screwed into the bone threaded hole 330 of the base. The placement guide 300 includes a proximal guide hole 310. K-wires or other elongated components can be inserted into the proximal guide hole 310 for positioning. The placement guide also includes a hole 316 for receiving the reference 130 placed in the preceding step, along with an offset 318. The configuration of the holes 316 and offset 318 is such that when the absorbent 60 is attached to the thigh base, the absorbent thigh joint 66 is positioned to achieve the desired kinematics. The configuration is designed to position the thigh base 152. Specifically, the position of the hole 316 with respect to the base portion 152 corresponds to the position of the thigh joint portion 66 with respect to the base portion when the absorbent material 60 is attached to the base portion. Further, the offset 318 corresponds to the desired offset of the absorbent thigh joint 66 from the bone. The height of the offset 318 is preferably at least 2 mm so that sufficient clearance is obtained between the ball splicing joint of the absorbent and the bone when the absorbent is connected to the base. It would be nice to have it.

As shown in FIG. 9, the thigh base 52 is placed on the femur together with the attached placement guide 300 by sliding the placement guide hole 316 onto the pre-positioned reference marker 130. By arranging the guide wire in the guide wire hole portion 310 of the arrangement guide 300, the appropriate position of the thigh base portion 52 can be determined. The guide wire should extend generally perpendicular to the tibial plateau and generally parallel to the medial femoral condyle. The thigh base 52 is held in place by inserting one or more (preferably two or more) K wires 322 through the available K wire holes 320 within the thigh base. These K-wires 322 hold the femoral base 52 in place while placing the bone screw 332 through the bone screw hole 330. Examples of the bone screw include a combination of a single cortical spongy compression screw, a set screw, and a bicortical compression screw. The screws may be arranged before the arrangement guide 300 is removed from the base portion 52, or may be arranged after the arrangement guide 300 is removed from the base portion 52. Preferably, the placement guide can be removed from the base portion 52 by removing the guide knob 312 after screwing the base portion into the bone with a bone screw. FIG. 10 shows the arrangement of the thigh base portion 52 after the arrangement guide 300 is removed. After fixing the thigh base portion 52 to the bone, the base portion is in a state where the absorbent material 60 can be attached and the tibia base portion 54 can be fixed.

The thigh base 52 can be of different shapes and / or sizes and can be fitted to the left and right knees. The thigh placement guide 300 can be provided to work with different bases. In addition, if different absorbent configurations are available, the placement guide 300 can be provided in different ways to accommodate the absorbent.

A trial base may be used in addition to or as an alternative to the thigh placement guide 300 to position the desired placement and position of the thigh base 52. For example, it is possible to determine and mark the placement position of the base portion using the trial base portion in the form of a one-piece component having the shape of the combination of the base portion and the placement guide shown in FIG. In the case of a trial base portion, the trial may include an offset to determine the correct spacing of the articulation from the bone and may include a guide wire hole to assist in determining the angular position with respect to the joint surface.

In one embodiment, after the femur base 52 is fixed to the bone, the absorbent 60 to which the tibial base 54 is attached is inserted through a tissue tunnel between the patient's skin and bone and the absorbent socket 66 is inserted. Connect to the femur base 52. Further illustration and description of US Patent Publication No. 2009/0014016 for methods and instruments for connecting absorbent sockets 66 and 68 to bases 52 and 54. Such a connection between the socket and the base can be achieved by taper locks, lock pins, set screws, and the like. After connecting the absorbent material 60 to the femur base 52, the system is ready to attach the tibial base 54 to the patient's tibia.

The absorbent material positioning collar 400 to assist in proper alignment and positioning of the absorbent material 60 and positioning of the tibial base 54 is shown in FIGS. 11A and 11B. The trajectory setting of the thigh bearing 66 is important to achieve the desired movement of the absorber with respect to the movement of the knee and implantable system. If the bearing is on the wrong surface, one of the spheres / sockets can move poorly in at least one direction. The absorbent positioning collar 400 includes a handle 410, a thigh base that receives the recess 412, and a thigh socket that receives the recess 414. The positioning collar 400 also includes an optional K-wire hole 420 for temporarily fixing the positioning collar in place. The absorbent positioning collar 400 is designed to be temporarily placed between the thigh base 54 and the thigh socket 66, thereby assisting in positioning. The collar 400 sets the absorbent position with respect to the transplanted base 52. Due to the different anatomical structures, the collar 400 can also be configured to fix the absorbent material position, or the absorbent material can be angled in a limited range with respect to the base portion. It is also possible to configure to have. For example, if the overall range of motion of the articulated portion exceeds 100 degrees, the motion can be restricted by the collar 400 in order for the initial positioning to be less than 45 degrees (preferably about 20 degrees or less).

In addition to setting the absorbent angle position, the collar 400 may include one or more functions (features?) To set a desired range of offset distance between the absorbent and the underlying bone.

As shown in FIG. 12, the absorbent positioning collar 400 is placed on the thigh socket 66 of the absorbent 60, with the recesses 412 and 414 receiving the distal end of the thigh base and the thigh socket, respectively. .. The positioning collar 400 temporarily limits the movement of the thigh socket to a narrow range of movement. This narrow range of motion corresponds to the receptive position of the absorbent during full extension. The absorbent is in the proper position when the knee is fully extended and the internal reaction force over the knee eliminates the intermediate lateral relaxation of the joint. After that, the tibia base portion 54 can be fixed to the anterior inner surface of the tibia by first stabilizing with the K wire and then screw-fixing by the same method as that used for fixing the thigh base portion 52. In one embodiment, additional temporary tibial collars can be used to limit the available range of motion of the tibial joint during implantation.

Although the terms "spring" and "absorbent" are used throughout this description, these terms are other energy absorptions to achieve the functions of the invention as described in more detail herein. It is intended to include structures and conforming structures.

Screws are used to secure the thigh and tibial bases 52 and 54 to the bone, but those skilled in the art will use any fastening element known or developed in the art to achieve the desired fixation. Understand that it is possible to achieve. Although the illustrated bases 52 and 54 include 4-5 openings and screws, other embodiments of the base are intended to have any number of screw openings.

13A to 13C show the thigh trial 500 according to the aspect of the present invention. The Thigh Trial 500 serves as a tool for selecting one base from multiple bases with different base geometries for joint implantation (eg, to accommodate different patient anatomical structures). In addition, there are two or more types of thigh bases (eg, 40 ° base shape, 45 ° base shape, and 50 ° as disclosed in US Patent Application No. 12 / 755,335, which is incorporated entirely for reference. If provided separately in base shape). Trial 500 includes tool body 501. The tool body 501 has a bone contact surface 503. The shape of the bone contact surface 503 mainly corresponds to the shape of the bone contact surfaces of the plurality of base portions that are the selection sources of the one base portion. It is understood that the principles associated with thigh trials are applicable to other joints and joint elements.

The lower surface 503 of the body 501 generally conforms to the shape of the bone to which the base is attached. The top surface 505 of the body 501 facing away from the bone may be generally flat or any other convenient shape for gripping and manipulating the tool.

The guide opening 507 is provided on the tool body 501 and extends through the tool body. The opening 507 is sized to be accepted on a reference marker (eg, a K-wire placed on the bone). The guide opening 507 has a seal 509. The seal 509 is adjacent to the opening and corresponds to at least some of the plurality of bases. The guide opening 507 is generally conical, with the wide end 511 of the conical being located on one side of the tool body 501 opposite the bottom surface 503 of the tool body facing the bone. The seal 509 is placed on the tool body 501 at the conical wide end 511 of the guide opening 507. The guide opening 507 extends through the tool body 501. In the embodiments of FIGS. 13A-13C, the seal 509 is placed on the protrusion 513. The protrusion 513 includes two shafts 513a and 513b. A generally conical opening extends between these two shafts 513a and 513b.

During surgery to place the energy absorbing device, the tool body 501 is placed on the bone in the desired alignment with the bone of the joint. For the femoral trial 500, the elongated wire reference marker 130 (FIG. 9) is placed so that it extends generally perpendicular to the tibial plateau and generally parallel to the medial femoral condyle extending through the guide opening. Attached inside the bone. The long axis 515 of the tool body (Fig. 13B) aligns parallel to the long axis of the tibia, the trial base fits onto the femur geometry in a stable manner on the femur, and the reference marker extends through the guide opening 507. As shown, the tool body 501 is arranged.

A reference marker 130 extending through the guide opening 507 is then placed at a position relative to a mark 509 indicating a base to be selected from the plurality of bases. For example, embodiments of FIGS. 13A-13C can easily select one of the 40 ° base shape, 45 ° base shape, and 50 ° base shape disclosed in US Patent Application No. 12 / 755,335. Is intended. In the example of FIG. 13B, the seal 509 is in the form of marks labeled "40 °" and "50 °". A 45 ° base is indicated if the reference marker 130 is in the center of the conical guide opening 507 and is not in contact with either side. When the reference marker 130 touches the side of the conical mark with the "40 °" mark 509, the 40 ° base is indicated. When the reference marker 130 touches the side of the conical mark with the "50 °" mark 509, the 50 ° base is indicated.

14A to 14B show the base portion 600. 15A to 15B show the placement guide 700. FIG. 16 shows a lock pin 800 of the system 900 shown in FIGS. 17A-17B for placing an energy absorbing device at a joint (eg, a knee joint). System 900 is designed to be used when placing the femur base of an energy absorbing device on the patient's femur. However, it is understood that the principles associated with the system are applicable to other joints and joint elements. System 900 is designed to be placed from the bone surface along with the end of the base offset to accommodate the graft junction as disclosed in US Patent Application No. 12 / 755,335, which is incorporated for reference. Especially suitable for placement with various types of thigh bases.

The base portion 600 itself is shown in FIGS. 14A to 14B. The base 600 is configured to be anchored to the bone adjacent to the joint and has a body 601. The body 601 includes an inner surface 603 that faces the bone and generally conforms to the shape of the bone, and an outer surface 605 that faces away from the bone. The body 601 further includes a first placement guide mounting surface 607 and a first connector element 609.

The placement guide 700 itself is shown in FIGS. 15A to 15B. The placement guide 700 can be formed, for example, from molded plastic, and includes a second placement guide mounting surface 701, a second connector element 703 adapted to mesh with a first connector element 609, and an offset element 705. Including. The placement guide 700 can be mounted on the base 600 in the mounting position (shown in FIGS. 17A-17B), which allows the first connector element 609 and the second connector element 703 to engage when engaged. The first placement guide mounting surface 607 and the second placement guide mounting surface 701 come into contact with each other. The placement guide 700 is designed to be removable from the base 600 after the base 600 has been fixed to the bone, allowing socket elements (not shown in FIGS. 14A to 17B) to be attached to the base. become. After the socket is attached to the base, an absorbent material (not shown in FIGS. 14A to 17B) having a sphere that is received in the socket to form a jade joint is placed on the first placement guide mounting surface 607. It can be attached to the base part of.

The offset element 705 has a first end 707 and a second end 709. The first end of the offset element 705 is configured to contact the bone when the placement guide 700 is in the mounting position and the base 600 is in the fixed position to the bone. The offset element 705 further includes a longitudinal opening 711. The offset element 705 is fitted so that the reference marker 130 (FIG. 9) secured to the bone extends through the longitudinal opening when the placement guide 700 is in the mounting position and the base 600 is in the main fixation position. It is configured to be. The reference marker 130 typically takes the form of a wire mounted in the bone so as to extend generally perpendicular to the tibial plateau and generally parallel to the medial femoral condyle.

The placement guide 700 may be designed so that it can be mounted on the base 600 in only one mounting position. For example, the placement guide 700 may be shaped to fit between the arms 611. The arm 611 extends from the first placement guide mounting surface 607 to prevent the placement guide from rotating relative to the base 600.

The placement guide 700 further includes an elongated component 713. The elongated component 713 has a proximal guide hole (not shown) similar to the proximal guide hole 310 described in connection with the embodiments shown in FIGS. 7A-9. The elongated component 713 extends from the guide 700 toward the contralateral bone of the joint so that when the placement guide 700 is in the attachment position and the base 600 is in the fixed position to the bone, said on the bone. It is configured to facilitate the placement of the base.

The placement guide 700 further includes a lock arm 715. The lock arm 715 is adapted to engage the base 600 to lock the placement guide to the mounting position. The lock arm 715 extends from the body 717 of the placement guide 700 in the direction opposite to the second placement guide mounting surface 701 from the position of the offset element 705. The lock arm 715 extends around the engaging portion 613 of the base portion 600 to prevent the placement guide 700 from disengaging from the base portion while in this locked position. Since the lock arm 715 is flexible or crushable, it can be moved from the locked position and the placement guide 700 can be removed from the base 600. A removable pin 800 (shown in FIG. 16) engages the lock arm 715 to prevent the placement guide 700 from unlocking from its mounting position, with openings 719 and 721 in the lock arm as well as a second connector element 703. Extends through the opening 615 in the engaging portion 613 of the base portion.

System 900 is used to position the base 600 for implantation in the joint. This positioning places the first reference marker 130 on the first bone of the joint so that one end of the first reference marker 130 is inserted onto the bone and the other end of the first reference marker 130 is free. It is done by inserting. The system 900 takes the form of a pre-assembled combination base 600 with a placement guide 700 over the bone of the joint such that the first reference marker 130 extends through a longitudinal opening 711 within offset 705. Be placed. The longitudinal opening 711 serves as a first guide hole. The second elongated reference marker (eg, wire (not shown)) is close to within the elongated component 713 while positioning the system 900, which includes a combination of base 600 and placement guide 700, with the second reference marker. When the second reference marker is inserted into the bone by extending into the bone of the joint through the position guide hole, the second reference marker is the first bone and the second bone of the joint. It will extend while having a predetermined relationship with. As mentioned above in connection with the attachment of the base 52 in FIG. 9, the second reference marker is a guide that extends generally perpendicular to the tibial plateau and generally parallel to the medial femoral condyle. It can be a wire. After fixing the base portion 600 to the bone through the bone screw hole portion 617 via the bone screw, the pin 800 is removed and the lock arm 715 is moved from the locked position to the unlocked position to move the placement guide 700 to the base portion. Remove from 600.

The various embodiments described above are provided solely for illustrative purposes and should not be construed as limiting the inventions described in the claims. Those skilled in the art will appreciate a variety of modifications and alterations beyond the exemplary embodiments and uses illustrated and described herein, from the true intent and scope of the invention described in the claims below. It is easily recognized that it is possible in the invention described in the claims without deviation. In this regard, it is possible to obtain the desired structure by using various functions from the specific embodiment of the disclosed embodiment in the other functions of the disclosed embodiment.