Patent Grant
11123194
This invention relates in general to the field of designing tools for use during replacement of damaged cartilage in an articulating surface in a joint all comprising positioning marks. The present invention also confers to tools made using the design method according to the invention.
Pain and overuse disorders of the joints in the body is a common problem. The weight-bearing and articulating surfaces of the knees, and of other joints, are covered with a layer of soft tissue that typically comprises a significant amount of hyaline cartilage. The friction between the cartilage and the surrounding parts of the joint is very low, which facilitates movement of the joints under high pressure. The cartilage is however prone to damage due to disease, injury or chronic wear. Moreover it does not readily heal after damages, as opposed to other connective tissue, and if healed the durable hyaline cartilage is often replaced by less durable fibrocartilage. This means that damages of the cartilage gradually become worse. Along with injury/disease comes a problem with pain which results in handicap and loss of function. It is therefore important to have efficient means and methods for repairing damaged cartilage in knee joints.
The advantages of implants have stimulated a further development of smaller implants that can be implanted with less invasive surgery. In this development there has also been an effort to achieve small joint implants, suitable for repair of a small cartilage injury that have a minimal influence on the surrounding parts of the joint. In the surgical operation of implanting such small implants it is critical that the implant is positioned in a precise manner. If the implant is offset from its intended position it may cause an increased wear or load on the joint. For example, if the implant is tilted this may result in an edge that projects above the cartilage surface and causes wear on the opposing cartilage in the joint. Another example is the case that the implant is placed in a too shallow position, which may result in a too high top of the implant that causes the joint to articulate in an uneven manner and increase the load on an opposing point of the joint. For the patient, also small misplacements or deviations from an ideal position may result in pain, longer time for convalescence or even a surgical operation being done in vain and making it more difficult to repair the damage in the joint. A large burden is therefore placed on the surgeon not to misplace or misfit the implant. There is therefore a need for well fitting implants as well as tools that are designed to relieve and support the surgeon in the implant surgery.
The design of the implant and the surgical tools, in other words, the design of the surgical kit is crucial for the outcome of the implants life-time in a joint. Also, the parameters for designing are of uttermost importance for the result in these operations. Small differences in the design can make a huge difference in fit and life-time of an implant in the body, convalescence time for the patient, economic values due o surgery time, success of operations, also the number of successful operations will increase and the working conditions for the surgeon will be improved if the designing parameters are selected right etc.
There is a need for a design method for a guide for use during repair of a cartilage damage which is more user friendly for the surgeon than the guide tools known from prior art. There is a need for a guide tool which allows for small surgical cuts and also a design method which allows for producing small guide tools which still are stable and easy to use for the surgeon allowing for precise insertion of implants in a joint.
A prior art document which describe the design of an orthopedic implants and corresponding tools is for example:
EP2389905 A1 shows a design method for designing an individually designed surgical kit.
The general object of the invention is to solve the problem of designing an improved guide tool for use during cartilage repair for replacing damaged cartilage and also an improved design method for designing inserts tools and also implants. The design of the guide tool and the insert tools and the implant makes the surgical operation safer and results in better fitting implants, less surgeon dependent operation procedures and faster recovery of the patients after surgery due to that the implant guide can be made smaller and neater using this design method.
The object of the invention is achieved with a system for designing a guide tool and/or a surgical kit and or an implant.
The present invention relates to a design method for designing a guide tool 12 comprising a guide channel 54 for use during cartilage repair in a joint wherein the design method comprises;
In another embodiment the present invention relates to a design method for designing a guide tool 12 which is intended for use during cartilage repair in a joint wherein the design method comprises;
In another embodiment, the present invention relates to a design method for designing a guide tool 12 which is intended for use during cartilage repair in a joint wherein the design method comprises;
The present invention further relates to the different alternatives described below in any combination;
a design method for designing a guide tool 12 wherein the step for placement of the positioning mark of the guide tool in comparison to the joint where the guide tool is to be placed an in relation to a guide channel comprised in the positioning body 11 of the guide tool 12, and wherein the position mark placed on a top surface 52 indicate to the surgeon of how to place the guide tool on the joint during cartilage repair by that the placement of the positioning mark indicates a placement direction of the guide tool in relation to the joint.
A design method for designing a guide tool 12 wherein the placement of said positioning mark is on a top surface 52 or top of the guide channel or a surface which is visible for the surgeon during usage.
A method of designing a guide tool 12 according to the invention further comprising the steps of:
A method of designing a guide tool 12 wherein the direction pointed out by the position mark in relation to the joint where the guide is a direction such as; anterior or posterior, right lateral or left lateral, dorsal or ventral, proximal or distal in relation to the placement of the guide tool 12 in a joint.
A method of designing insert tools designed to comprise positioning marks which is designed to be aligned with the positioning mark of the guide tool 12 when the insert tools are placed in the guide tool in start position, indicating the correct rotational start position of the insert tools to the surgeon during use of the guide tool and insert tools during surgery.
A guide tool or insert tools or an implant designed according to any of the preceding claims
The design method of the invention may comprises the basic blocks of:
I. Determining physical parameters for a cartilage damage in a joint and then using this information in order to;
II. Generate design parameters of a medical implant 10.
III. Generate design parameters of a guide tool 12 for use during implantation of said implant.
The physical parameters as well as the design parameters are represented as digital data that is processed or generated by specifically designed computer program code portions executed in a data processing system. The system may be fully automated or may comprise portions of computer supported manual steps of for example selections. The design parameters resulting from the process are stored in a format suitable for use as input in an automated manufacturing process.
IV. Determine a positioning mark placement which placement helps the surgeon to determine the orientation of the placement of the guide tool in a joint and wherein the positioning mark for example may be chosen to be placed in a position on the guide tool which indicate an orientation selected from a position or direction on the patient which is known for the surgeon and based on the anatomy of a patient selected, for example selected from anterior or posterior, right lateral or left lateral, dorsal or ventral, proximal or distal orientation or axis direction.
and wherein blocks II-IV of the described design method above can be performed in any desired order.
The invention will be further explained with reference to the accompanying drawings which are exemplified embodiments according to the invention and not limiting the scope of the invention:
Design Method
The present invention is directed to a system, comprising a method, apparatus and computer programs, for designing a guide tool 12 comprising a positioning mark 500, and/or medical implant comprising a positioning mark 500, and/or associated tools comprising positioning marks and wherein said guide tool 12 insert tool 502 and implant 10 all comprises a positioning mark 500 marking out the same direction or axis in relation to the joint during use when replacing damaged cartilage in a joint. The associated set of tools is devised for the placement of an implant that replaces damaged cartilage in a joint and is adapted to the specific implant as well as a specific joint for which the implant is intended. The surgical kit provided by the present invention has the effect that successful implant insertion is less dependent on surgical circumstances and the skills of the surgeon compared to previously known implants. Due to the design and the function of using the positioning marking in guide tool and/or implant and/or inert tools gives improved implantation precision and a precise desired placement of the implant in the joint every time. The precision of the surgery is “built in” into the design of the tools.
The design system comprises the basic blocks of:
I. Determining physical parameters for a cartilage damage in a joint and then using this information in order to;
II. Generate design parameters of a medical implant 10.
III. Generate design parameters of a guide tool 12 for use during implantation of said implant.
The physical parameters as well as the design parameters are represented as digital data that is processed or generated by specifically designed computer program code portions executed in a data processing system. The system may be fully automated or may comprise portions of computer supported manual steps of for example selections. The design parameters resulting from the process are stored in a format suitable for use as input in an automated manufacturing process.
IV. Determine a positioning mark placement which placement helps the surgeon to determine the orientation of the placement of the guide tool in a joint and wherein the positioning mark 500 for example may be chosen to be placed in a position on the guide tool which indicate an orientation selected from a position or direction on the patient which is known for the surgeon and based on the anatomy of a patient selected, for example selected from anterior or posterior, right lateral or left lateral, dorsal or ventral, proximal or distal orientation or axis direction.
and wherein blocks II-IV above can be performed in any order.
In one embodiment according to the invention the design system is a system to design a guide tool 12 to be used to guide inserts tools and/or an implant or other cartilage repair objects comprises the basic blocks of:
I. Determining physical parameters for a cartilage damage in a joint and then using this information in order to;
II. Generate design parameters of a medical implant 10.
III. Generate design parameters of a guide tool 12 for use during implantation of said implant.
The physical parameters as well as the design parameters are represented as digital data that is processed or generated by specifically designed computer program code portions executed in a data processing system. The system may be fully automated or may comprise portions of computer supported manual steps of for example selections. The design parameters resulting from the process are stored in a format suitable for use as input in an automated manufacturing process.
IV. Determine placement for placement of a positioning mark 500 on the guide tool wherein the positioning mark 500 is designed to be aligned with the center 503 of said guide channel 54 in a determined joint axis 501 direction and thereby indicating a placement direction of the guide tool 12 in relation to the selected joint axis 501 during use of the guide tool 12. The direction is also indicated by placement of the positioning mark 500 of the guide tool 12 on a side of the guide channel which faces the chosen direction in relation to the joint.
The placement of the positioning mark on a guide tool, may be on top of the guide channel 54 or on top of the positioning body 11 on the side of the guide channel or at any place visible for the surgeon using the guide tool.
and wherein blocks II-IV above can be performed in any order.
In one embodiment according to the invention, the insert tools 502 and or the implant 10 is also designed to comprise a position mark 500, and the position of the position mark is designed to be on a surface which is visible for the surgeon during surgery and use of the insert tools 502 and or implant 10. Example of such surfaces are on the top of the insert tools, on a surface facing the surgeon during use of the insert tools, for example on a surface opposite to the surface facing the cartilage damage. The positioning marking 500 of an implant 10 may for example be on the articulate surface 15 of the implant, preferably not placed in the center but parted from the center of the implant or on a surface which is visible for the surgeon, or for example on a top surface of an insert tool pointing in the opposite direction compared to the cartilage contact surface 50 of the positioning body 11.
In another embodiment, the present invention relates to an individually design of surgical kit and/or a guide tool 12 comprising position marks and to a design method for design of such a kit.
In one embodiment, the placement of the position mark is determined by first determine the size, spread and placement of the cartilage contact surface in a computer model and then use this model of a cartilage contact surface and determine a direction, based on the virtual placement of the model cartilage contact surface on the simulated joint (or on an image of an individual 3D image of a joint surface). And after deciding the direction, place a virtual position mark on that place, which may be a place pointing in any direction in comparison to the placement of the guide tool in the joint, for example pointing in an anterior direction etc. The position mark is designed to be placed on a surface of the positioning body of the guide tool 12 which is a surface pointing in an opposite direction compared to the cartilage contact surface of the positioning body. The said placement of the positioning mark 500 is also determined in relation to the design of the guide channel 54 and its placement on the cartilage contact surface 50 of the guide tool 12.
This placement of said position mark on the guide tool 12 may then be used by the surgeon in order to place the individually designed guide tool in the right placement during surgery by knowing in which direction the positioning mark 500 is designed to point.
For example, if a guide tool 12 is designed to point in an anterior direction during knee surgery, and the guide tool 12 then has a positioning mark 500, placed for example on a side or on top of the guide channel or on a top surface 52 of the positioning body 12. Then the surgeon knows that the positioning mark 500 should point in an anterior direction if he placed the guide tool in a correct direction, see for an example in
A further effect of the invention is that the size of the cartilage contact surface can be designed to be smaller in area spread because the surgeon now know due to the positioning mark if the guide is placed in the correct position from start and does not need a large cartilage contact surface of the guide tool to “feel” when the guide is placed correctly.
In other embodiment, the design of the insert tools are also designed to comprise a position marking and the position marking of the insert tools is designed to coincide with the positioning mark of the guide tool 12 when the insert tools are placed within the guide tool in their first positions or their starting position. This alignment gives instruction to the surgeon about rotational start direction when using the insert tools 502.
This is exemplified in
See for example
In one embodiment the present invention comprises a design method for design of a surgical kit where one part is related to the design of a guide tool according to the present invention described herein and one part is directed to the design of insert tools 502 comprising positioning marks 500 which is aligned with the positioning marks of the designed guide tool when inserted in the guide tool 12 in a start position which indicating the correct rotational start position of the insert tools to the surgeon during use of the guide tool and insert tools during surgery.
The present invention concerns a guide tool 12 which is designed to comprising a cartilage contact surface 52 which is individually designed to correlate to a surface and curvature in the joint. Due to this the guide tool 12 according to the invention may be correctly placed in the joint in one predetermined direction. The direction is determined during the design of the guide tool 12.
This predetermined direction may now be easier to visually see for the surgeon when he receives a guide tool according to the invention, designed to have a predetermined positioning mark, indicating a predetermined position instructing the surgeon about how he should place the guide tool 12 on the cartilage surface in the joint.
I. Determining Physical Parameters for a Cartilage Damage in a Joint.
An image or a plurality of images representing a three dimensional image of a bone member of the joint in a patient's limb may be obtained by a selected one of a per se known imaging technology for non-invasive imaging of joints, such as magnetic resonance imaging (MRI), computerized tomography (CT) imaging or a combination of both, or other suitable techniques such as delayed Gadolinium-enhanced MRI of cartilage (dGEMRIC) techniques. The image of the joint should comprise a representation of cartilage in the joint as well as the underlying subchondral bone in the area of the cartilage damage. Image data making up a three dimensional image representation of the joint is stored in a digital format in a manner that enables to keep track of the dimensions of the real joint that the image depicts.
The image data is analyzed in a data processing system to identify and determine physical parameters for the cartilage damage. The physical parameters to determine comprise the presence, the location and the size and shape of the cartilage damage, as well as curvature of the surface contour of the cartilage or the subchondral bone in an area of the cartilage damage.
In one embodiment of the inventive concept the design system operates to determine physical parameters on images of the patient's individual joint and the current cartilage damage, and thereby produces an individually designed guide tool 12. In another embodiment the design system operates on a collection of images of joints constituting a statistical basis for determining physical parameters for producing a guide tool 12 adapted for a selected location and a selected size of cartilage damage in a joint of a selected size.
The following steps, not limiting the design method according to the invention are in one exemplifying embodiment comprised in determining the physical parameters of cartilage damage:
a. Obtaining image data representing a three dimensional image of a bone member of the joint.
By way of example, a sample of a set of several images which together represents a three dimensional image of a joint.
b. Identifying in the image data cartilage damage in an articulate surface of the bone member.
In an automated process a computer program may be adapted to scan the image data for predetermined characteristics of a spot of cartilage damage in the image data. In a process with a manual part in this step an operator would visually scan a displayed image of the joint and identify a spot that has the visual characteristics of cartilage damage.
c. Determining based on the image data the location of the cartilage damage. A set of data that represents a position of the cartilage damage in the joint is selected automatically or manually. The position data is for example stored as a set of defined coordinates in the image data.
d. Determining based on the image data the size and shape of the cartilage damage. Selected measurements for size and shape of the cartilage are calculated in the image date, for example by determining a boundary line for the healthy cartilage surrounding the cartilage damage. A circular cross-section shape is preferably selected such that it covers the cartilage damage with a perimeter at a predetermined safe distance from the fringes of the damaged cartilage. The size and shape data is for example stored as a set of perimeter and thickness data with a predetermined resolution.
e. Determining based on the image data the surface contour curvature of the cartilage and/or the subchondral bone in the joint in a predetermined area comprising and surrounding the site of cartilage damage.
The curvature of the surface contour is determined for example by per se known surface matching methods in image processing. The determined curvature information can be represented as an equation or as a set of image data. The determined curvature preferably comprises two subsets of curvature information. Firstly, one subset comprises the curvature of the contour portion that comprises the cartilage damage within the cross-section shape defining the selected boundary line for the area covering the cartilage damage. Secondly, the second subset comprises the curvature of a contour portion that surrounds the site of cartilage damage, preferably comprising mutually opposing sloping parts.
II. Generating Design Parameters for a Medical Implant (10).
Based on the physical parameters for the cartilage damage, design parameters for an implant are generated by processing the physical parameters in a design stage 95 according to a predetermined scheme for the shape of an implant in the specific surgical application.
The shape and size of the implant are calculated or selected dependent on the size and shape of the cartilage damage, and dependent on the curvature of the contour of the cartilage and/or of the subchondral bone in the area substantially coinciding with the cartilage damage, optionally a positioning mark is added to the articulate surface of said implant which indicate rotational positioning to the surgeon. The positioning mark 500 of the implant 10 may for example point out a direction in relation to the joint axis 501 or other anatomic dependent direction and may point out same direction as the positioning mark on the guide tool 12 used for placing said implant.
The following steps are in one non limiting exemplified embodiment of the design method of the invention comprised in generating design parameters for a medical implant 10:
f. Generating the contour curvature for an articulate surface of an implant body 27 dependent on said determined surface curvature of the cartilage and/or the subchondral bone.
The contour curvature for the articulate surface of the implant body is generated to correspond to the curvature that covers the cartilage damage.
g. Generating a cross-section for the implant body dependent on and substantially corresponding to said determined size and shape of the damaged cartilage.
The cross-section for the implant body is generated to correspond to the cross-section shape determined for the cartilage damage.
h. Generating an edge height 14 for the implant body that substantially corresponds to the thickness of healthy cartilage plus a selected height of a bone contacting part of the implant for countersinking the implant into a recess to be made in the bone to fit and receive the implant.
A first part of the edge height 14 for the implant body 27 is generated to correspond to the determined height of the healthy cartilage, and a second part corresponds to a countersink height selected automatically according to a predetermined scheme or selected manually by an operator.
i. Optionally generating a length and a cross-section profile for an extending post 23 extending from a bone contacting surface of the implant dependent on predetermined rules related to the size and shape of the cartilage damage.
The size and shape of the extending post is selected automatically according to a predetermined scheme or is selected manually by an operator.
The image based tool may also be configured for using predetermined shapes that are adapted to the determined physical parameters to automatically or manually fit to the cartilage damage and thereby generate the design parameters.
Generating design parameters for a guide tool 12 for implanting the implant.
The design parameters for the guide are generated dependent on the physical parameters for the cartilage damage and/or dependent on the design parameters for the medical implant.
The following steps are in one exemplified embodiment of the invention comprised in generating design parameters for a medical implant:
j. Generating the contact points for a cartilage contact surface 50 of a positioning body 11 dependent on said determined surface contour curvature of the cartilage and/or the subchondral bone in the joint in a predetermined area comprising and surrounding the site of cartilage damage, such that said cartilage contact surface 50 of the positioning body corresponds to and fits to said surface contour of the cartilage or the subchondral bone in the joint.
k. Generating the cross-section profile for a guide channel 54 in a guide body 13 extending from the positioning body, said guide channel 54 passing through said positioning body 11 and said guide body 13, the cross-section profile for the guide channel being generated dependent on and substantially corresponding to said determined size and shape of the damaged cartilage, and such that the guide channel 54 is designed to have a cross-sectional profile that corresponds to the cross-section of the plate shaped implant body 27, and such that the guide channel 54 is designed to have a muzzle 29 on the cartilage contact surface 50 of the positioning body at a position corresponding to the site of the diseased cartilage.
In further exemplifying embodiments inserts tools intended to be used inside the guide channel 54 may comprise positioning marks pointing in same direction as positioning mark on the guide tool 12;
Comprising of generating the cross-section profile for an insert tool to have a cross-sectional profile that corresponds to the cross-sectional profile of the guide channel 54 with a tolerance enabling the insert tool 8 to slide within the guide channel 54 further comprising a positioning mark pointing in same direction as the positioning mark on the guide tool 12.
Embodiments of the invention further comprise optional combinations of the following:
Generating design parameters for a drill bit 2 dependent on the design parameters for the extending post and such that a cross-sectional area for a drill bit is slightly smaller than the cross-sectional area for the extending post 23. Wherein the drill bit 2 is designed to comprise positioning marks pointing in same direction as the positioning mark present on the guide tool 12.
Generating design parameters for a cartilage cutting tool 6, 105 with a cross-sectional profile that is designed to correspond to the cross-sectional profile of the guide channel 54 with a tolerance enabling the cartilage cutting tool 6, to slide within the guide channel 54. Wherein the cutting tool is designed to comprise positioning marks pointing in same direction as the positioning mark present on the guide tool 12 indication in which rotational direction the cartilage cutting tool 6 should enter the guide channel 54 of the guide tool 12.
Generating design parameters for the implant comprises generating design parameters for an implant body 27 of the implant 10 being substantially flat, having a thickness 14 of approximately 0.5-5 mm.
Generating design parameters for the positioning body comprises generating design parameters for the cartilage contact surface of the positioning body having three contacting points 40, 42, 44, spread out around the guide body 13, for contacting parts of the joint in order to provide stable positioning of the guide tool 12 in the joint. Optionally designing the placement of the positioning mark on top said positioning body, so that the surgeon easily may see the mark during usage of the guide tool and wherein the positioning mark may point out a direction for placement of the guide tool in the joint in relation to the joint axis 501 or other anatomic dependent direction and may point out same direction as the positioning mark on the guide tool 12 used for placing said implant.
Generating design parameters for the guide channel 54 to have a height 31 of 3-10 cm.
Generating design parameters for the guide channel comprises generating design parameters for an orifice leading through the guide body 13 at the foot of said guide body.
Generating design parameters for a hammer tool 35 with a cross-sectional profile that is designed to correspond to the cross-sectional profile of the guide channel 54 with a tolerance enabling the hammer tool 35 to slide within the guide channel 54.
Details of the Surgical Kit
The Implant Structure
The implant is specially designed, depending on the knees appearance and the shape of the damage and in order to resemble the body's own parts, having a surface which preferably corresponds to a three dimensional (3D) image of a simulated healthy cartilage surface. The implant will be tailor-made to fit each patient's damaged part of the joint.
Implant Body
The implant body 27 is substantially plate shaped, meaning that the shortest distance (represented by 24 in
The area and the shape of the implant surface 15 are individual depending on the size of cartilage damage and location of the cartilage damage. The area and shape of the implant can be decided by the surgeon himself or be chosen from predetermined shapes. For instance the cross-section of the implant body 27 may have a circular or roughly circular, oval, triangular, square or irregular shape, preferably a shape without sharp edges (see
In general, small implants are preferred since they have a smaller impact on the joint at the site of incision and are also more easily implanted using arthroscopy or smaller open surgical procedures. The primary factor for determining the size of the implant is however the nature of the lesion to be repaired.
The Extending Post
The implant replaces an area of damaged cartilage in an articulating surface of a joint. Before the implant is placed in the desired position, the damaged cartilage is removed and also a part of the bone beneath, i.e. a recess fitting the implant is made in the bone. Furthermore, a hole can be drilled in the bone to fit the implant structure. The extending post of the implant or the rod-part 23 of the implant 10, is used for securing the implant 10 in the drilled hole of the bone. The length 22 of the extending post 23, extending from the implant head 27, is adjusted to a length needed to secure the implant 10 in the bone. The extending post 23 is intended to give a primary fixation of the implant 10, it provides mechanical attachment of the implant 10 to the bone in immediate connection with the surgical operation.
The position of the extending post 23 on the bone contact surface 21 can be anywhere on the bone contact surface 21 or the extending post 23 may have a central position.
The extending post 23 has a physical structure in the form of for example a cylinder or other shapes such as one or more of a small screw, peg, keel, barb or the like.
In one embodiment, the extending post 23 has a positioning part 25, where the positioning part 25 is located distal to the plate shaped implant body 27. The longitudinal symmetry axes of the first part of the extending post 23 and the positioning part 25 coincide. The diameter of the positioning part 25 is smaller than the diameter of the first part of the extending post 23.
The Guide-Tool
The guide channel 54 has an inner cross-sectional profile that is designed to correspond to the cross-section of the plate shaped implant body 10. In other words, the plate shaped implant body 10 fits the guide channel 54, with a slight tolerance to allow a sliding movement of the implant in the guide channel 54. The positioning body 11 has a mouth or muzzle 29 which is the guide channel's 54 opening on the cartilage contact surface 50. The mouth 29 is in a position on the cartilage contact surface 50, corresponding to the site of the diseased cartilage in a joint. The height 31 of the guide channel 54 must be sufficiently long to give support to the tools used inside the guide body 13. The height 31 is preferably higher than the thickness of the surrounding tissue. In this way, the opening of the guide channel 54 is easy to access for the surgeon. The height 31 of the guide channel 54 is between 1 and 10 cm, preferably 3-10 cm, and always sufficiently high to ensure stabilization of the tools that are to be inserted into the guide channel 54.
The guide tool 12 is easy to place due to the precise fit of the positioning body 11 on the cartilage surface. The guide tool 12 is designed to be inserted in as lesion which is as small as possible to be able to repair the specific cartilage damage. The height 31 of the guide channel 54 is sufficiently high to be easily accessible for the surgeon during surgery. In one embodiment, the top of the guide channel 54 is designed to project above the tissue surrounding the surgery cut when the guide tool is placed on the cartilage in a joint during surgery.
The size and shape of cartilage contact surface 50 of the guide tool 12 is determined depending on the size and shape of the damaged cartilage and thus on the cross section of the implant body 10 and the guide channel 54, and also depending on the position of the cartilage area in a joint. The size, shape or spread of the surface 50 is a consideration between the following aspects; minimize surgery lesion, maximize stability for guide tool 12, anatomic limitations on the site of the injury. Not all cartilage surfaces in a joint can be used for placement of the guide tool. A large spread of the cartilage contact surface 50 is to prefer to get good stability of the guide tool, however, a large surface area of the surface 50 may also lead to a large surgical intervention which is undesired. Thus the size of the cartilage contact surface 50 and of the positioning body 13 is determined by a balance between the desire to achieve good positioning stability and small surgical operations. Also, the cartilage contact surface 50 need not have a continuous, regular shape, but may have an irregular shape, as long as it gives adequate support and stable positioning of the guide tool 12. The cartilage contact surface may also consist of three separated points.
When designing the guide tool, the cartilage contact surface 50 can be designed to cover three points (40, 42, 44 for an example, see
The guide-tool 12 aids with exact precision removal of a volume of cartilage and subchondral bone and the guide tool 12 also guides the placement of the implant 10 in for example a knee. Placement of an exemplified embodiment of the guide-tool 12 on the cartilage surface on a knee can be seen in
The guide body 13 comprises an orifice, see
The guide tool according to the present invention is further designed to comprise a positioning mark 500, comprised in the structure of the positioning body or guide body or guide channel construction of the guide tool and wherein the positioning mark is aligned with the center 503 of the guide channel 54 in a chosen joint axis 501 direction.
The guide tool 12 may be placed in the joint using pins 506 and clams 507 for stabilization and fastening see for example in
The Insert Tool 502
The insert tool 502 is in different embodiments of the invention for example selected from; the cartilage cutting tool, the punch, the cartilage cut drill, the reamer guide, the drill guide or the hammer tool, implant dummy, cartilage cutter. The insert tool is used inside the guide channel 54 of the guide tool 12 and fits in the guide channel 54, with a slight tolerance to allow a sliding movement of the insert tool in the guide channel 54. The cross-sectional profile, and thus the circumferential shape of the insert tool, corresponds to the chosen cross-section of the implant surface 15 in size and shape
The Cartilage Cutting Tool
The cartilage cutting tool is a tool which is used to cut the cartilage in the joint around the area of damaged cartilage to prepare for the insertion of the implant. The cartilage cutting tool may for example be a punch 6 or a cartilage cut drill 105. It is used inside the guide channel 54 of the guide tool 12 and fits in the guide channel 54, with a slight tolerance to allow a sliding movement of the cartilage cutting tool in the guide channel 54. The cartilage cutting tool preferably cuts the cartilage so that the cut edges of the cartilage are sharp and smooth. These sharp and smooth edges are of great importance when the implant is placed into the prepared recess in the cartilage and bone. In one embodiment the cartilage cutting tool, in addition to cutting the cartilage, may also cut/carve/drill the underlying bone. A hole in the cartilage which is cut (punched or drilled) with the cartilage cutting tool according to the inventive concept ends up with a precise fit of the implant into the prepared cartilage since the cartilage cutting tool allows for an exact, precise cut. The recess in the cartilage and/or bone, made by the cartilage cutting tool always correspond to the chosen cross-section of the implant surface 15 in size and shape
In one exemplifying embodiment of the inventive concept the cartilage cutting tool is a punch 6. The punch 6 is a solid body with a hollow shape or recess 5 in one end. The recess 5 has sharp edges 60. The punch 6 is used to punch out and remove the damaged cartilage from the joint. The punch is to be placed inside the guide channel 54 of the guide tool 12, with the recess pointing down onto the cartilage. A hammer is then used to hammer the punch recess 5 through the cartilage. In this way the damaged cartilage is removed by punching. The depth 59 of the recess 5 on the punch 6 may be adjusted to the individual person's cartilage thickness. It is of great importance that the punch has sharp cutting edges 60.
The punch 6 fits the inside of the guide channel 54, with a slight tolerance to allow a sliding movement of the punch in the guide channel 54. The fit ensures the correct, desired placement of the punch on the cartilage surface and thus the precise removal of the damaged cartilage area. The punch preferably gives sharp precise edges of the remaining cartilage in the joint surrounding the removed cartilage piece, which is of importance when placing the implant 10 in the joint. The contour of the cutting edge 60, i.e. the contour of the surface of the cutting edge 60 that is to face and cut the cartilage, is in one embodiment designed to match the contour of the patient's cartilage and/or bone at the site of the joint where the punch is to cut. This further ensures that the cartilage will be properly and efficiently cut, giving sharp precise edges of the remaining cartilage as well as minimized damage to the underlying bone.
The length 56 of the punch 6 is in one embodiment longer than the height 31 of the guide channel 54. The length 56 of the punch 6 is preferably between 4 and 12 cm.
The cross-sectional profile, and thus the circumferential shape of the cutting edge 60, of the punch 6 corresponds to the chosen cross-section of the implant surface 15 in size and shape The cross-sectional profile of the punch varies in different realizations of the inventive concept between 0.5 cm2 and 20 cm2, between 0.5 cm2 and 15 cm2, between 0.5 cm2 and 10 cm2 or preferably between about 1 cm2 and 5 cm2.
In one exemplifying embodiment of the inventive concept the cartilage cutting tool is a cartilage cut drill. The cartilage cut drill is used to cut the cartilage in the joint around the area of damaged cartilage to prepare for the insertion of the implant with a cut-drill technique.
The cartilage cut drill 105 is a drill, with a drill body 111 and with sharp cutting edges 108 and a center marker 106. The cartilage cut drill 105 has a cross-sectional profile that is designed to correspond to the inner cross-sectional profile of the guide channel 54 with a tolerance enabling cartilage cut drill body 111 to slide within the guide channel 54. Also, the cross-sectional profile is designed to correspond to the cross-section of the implant.
The Reamer Guide
In one embodiment of the inventive concept the surgical kit comprises a reamer guide that is placed in the guide channel 54 before reaming the recess in the bone. The reamer guide placed in the guide channel 54 protects the cartilage surrounding the implant site while the reamer bit 4 is used inside the guide channel 54 of the guide tool 12.
The reamer guide 28, is a channel shaped structure with thin walls designed to fit the inside of the guide channel 54, with a slight tolerance to allow a sliding movement of the reamer guide 28 in the guide channel 54. In other words, the cross sectional profile of the reamer guide 28 fits the cross sectional profile of the guide channel 54 such that the reamer guide 28 may be used as a lining, lining the insides of the guide channel 54 (see
The Height Adjustment Device or Insert Tool
A height adjustment device 16 according to the invention comprises a male part 47 and a female receiving part 48 which when used together allows for stepwise adjustment of drill depth.
The male part is in the outermost position in a zero-mode and may from there be adjusted inwards allowing the surgeon stepwise the for example make stepwise deeper drill holes. When the height adjustment device 16 is in starting mode or outermost zero-mode the positioning marking of the guide tool 12 and the positioning marking of the height adjustment device are aligned, se for example
Thus, by being able to adjust the length 31 of the guide channel the surgeon is also able to adjust the depth of drilling and cutting into the bone. The length 31 of the guide channel may be varied since the guide body 13 and the height adjustment device 16 parts are able to move in relation to one another. Further, the male part 47 and the female receiving part 48 of the height adjustment device may be arranged such that the length 31 of the guide channel may be varied at certain stepwise intervals 115, e.g. at 200 μm or at 100-300 μm intervals or steps, or any other desired interval, see for example
The Drill-Guide
In one embodiment of the inventive concept the surgical kit comprises a drill guide 8 that is used to direct a drill for drilling a hole in the bone at the site of cartilage damage, for fastening of the extending post 23 of the implant 10 in the bone tissue. The drill guide 8 comprises a drill guide body and a guide channel 7 passing through the drill guide body. The guide channel 7 is designed to receive and guide the drill during the surgical procedure. The drill guide 8 is designed to fit the inside of the guide channel 54, with a slight tolerance to allow a sliding movement of the drill guide 8 in the guide channel 54, see
The guide channel 7 is designed to be positioned in the drill guide body such that the position corresponds to the desired position of the drill hole in the bone. The positioning of the guide channel 7 in the drill guide 8 is coordinated with the positioning of the extending post 23 on the bone contacting surface 21 of the implant to ensure correct positioning of the implant in the bone.
The length 62 of the drill guide 8 and thus the drill channel 7 is longer than the height 31 of the guide channel 54. The length is preferably 4-12 cm.
The cartilage contacting surface 64 of the drill guide 8 corresponds to the chosen implant surface 15 in size and shape. The surface 64 varies in different realizations of the inventive concept between 0.5 cm2 and 20 cm2, between 0.5 cm2 and 15 cm2, between 0.5 cm2 and 10 cm2 or preferably between about 1 cm2 and 5 cm2. In one embodiment the cartilage contacting surface 64 of the drill guide 8 is designed to match the contour of the patient's cartilage and/or bone at the site of the joint where the implant is to be inserted.
See
Drill-Bit
The surgical kit of the present inventive concept may also comprise a drill-bit 2, see
Reamer-Bit
The surgical kit of the present inventive concept may also comprise a reamer-bit. The reamer-bit 4 may have a depth gauge 3. The reamer bit 4 is used together with the guide-tool 12 and possibly the reamer guide 28. The reamer-bit 4 is used inside the guide channel 54, removing bone tissue, aided by the guide channel 54 and possibly the reamer guide 28. The depth gauge 3 on the reamer-bit 4 is supported by the top 30 of the guide channel 54 and by using this support the depth of the reamed bone recess can be controlled. The depth of the reamed recess in the bone is depending on the placement of the depth gauge 3 on the reamer-bit 4, and also depending on the height 31 of the guide-channel 54. The depth of the reamed surface is determined depending on the injury and on the desired implants size.
Hammer Tool
The optional hammer tool 35 (see
Implant Dummy and Dummy Reference
The implant dummy 36 and dummy reference 37, see
The implant dummy 36, see
The implant dummy 36 also has a top surface. The distance between the lower surface of the implant element 41 and the top surface corresponds to the distance that you get when adding the thickness 14 of the implant body 27 (corresponding to the depth of the recess in the bone plus the thickness of the corresponding cartilage). The dummy reference 37, see
To ensure that the implant dummy 36 is placed in a correct orientation in the recess of the bone, i.e. in an orientation that corresponds to the orientation that the implant 10 is to be inserted in, the top surface 43 and/or the implant element 41 may be provided with positioning mark 500. A corresponding positioning mark 500 is provided also on the implant dummy 36 and on the guide base 12.
This application is a divisional application of co-pending prior U.S. patent application Ser. No. 14/784,376, filed Oct. 14, 2015, which is the National Stage of International Application No. PCT/EP2013/057847, filed Apr. 15, 2013. The contents of each of these applications are incorporated herein in their entirety.
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| Child | 16148134 | US |
