WO1998007342A1 - Method of making injection molded orthotics - Google Patents
Method of making injection molded orthotics Download PDFInfo
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- WO1998007342A1 WO1998007342A1 PCT/US1997/014234 US9714234W WO9807342A1 WO 1998007342 A1 WO1998007342 A1 WO 1998007342A1 US 9714234 W US9714234 W US 9714234W WO 9807342 A1 WO9807342 A1 WO 9807342A1
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- WIPO (PCT)
- Prior art keywords
- corrected
- replicas
- contoured
- uncorrected
- replica
- Prior art date
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Classifications
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29D—PRODUCING PARTICULAR ARTICLES FROM PLASTICS OR FROM SUBSTANCES IN A PLASTIC STATE
- B29D35/00—Producing footwear
- B29D35/12—Producing parts thereof, e.g. soles, heels, uppers, by a moulding technique
- B29D35/122—Soles
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- A—HUMAN NECESSITIES
- A43—FOOTWEAR
- A43B—CHARACTERISTIC FEATURES OF FOOTWEAR; PARTS OF FOOTWEAR
- A43B7/00—Footwear with health or hygienic arrangements
- A43B7/14—Footwear with health or hygienic arrangements with foot-supporting parts
- A43B7/28—Adapting the inner sole or the side of the upper of the shoe to the sole of the foot
-
- A—HUMAN NECESSITIES
- A43—FOOTWEAR
- A43D—MACHINES, TOOLS, EQUIPMENT OR METHODS FOR MANUFACTURING OR REPAIRING FOOTWEAR
- A43D1/00—Foot or last measuring devices; Measuring devices for shoe parts
- A43D1/02—Foot-measuring devices
- A43D1/022—Foot-measuring devices involving making footprints or permanent moulds of the foot
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C33/00—Moulds or cores; Details thereof or accessories therefor
- B29C33/38—Moulds or cores; Details thereof or accessories therefor characterised by the material or the manufacturing process
- B29C33/3842—Manufacturing moulds, e.g. shaping the mould surface by machining
- B29C33/3857—Manufacturing moulds, e.g. shaping the mould surface by machining by making impressions of one or more parts of models, e.g. shaped articles and including possible subsequent assembly of the parts
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C33/00—Moulds or cores; Details thereof or accessories therefor
- B29C33/38—Moulds or cores; Details thereof or accessories therefor characterised by the material or the manufacturing process
- B29C33/3842—Manufacturing moulds, e.g. shaping the mould surface by machining
- B29C33/3857—Manufacturing moulds, e.g. shaping the mould surface by machining by making impressions of one or more parts of models, e.g. shaped articles and including possible subsequent assembly of the parts
- B29C2033/3871—Manufacturing moulds, e.g. shaping the mould surface by machining by making impressions of one or more parts of models, e.g. shaped articles and including possible subsequent assembly of the parts the models being organic material, e.g. living or dead bodies or parts thereof
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29L—INDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES
- B29L2031/00—Other particular articles
- B29L2031/48—Wearing apparel
- B29L2031/50—Footwear, e.g. shoes or parts thereof
- B29L2031/507—Insoles
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29L—INDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES
- B29L2031/00—Other particular articles
- B29L2031/753—Medical equipment; Accessories therefor
Definitions
- the present invention relates generally to orthopedic appliances. More particularly, the invention concerns a novel method for making injection molded, finished functional orthot- ics by using various critical measurements made of the patient's feet.
- Orthopedic appliances, or foot supports, having various shapes and configurations have been known for many years.
- the prior art ' appliances range from simple foam, leather, cork, or sponge rubber arch supports that can be purchased in drugstores to sophisticated, custom-fitted orthotics formed of various rigid or semirigid materials.
- These latter devices while much more effective than the former, are typically quite expensive and are generally constructed by orthopedic laboratories in accordance with detailed prescriptions provided by the examining doctor.
- Pronation may be simply described as the flattening or rolling inward of the foot as the foot strikes the ground as during walking or running. Excessive pronation can cause the tibia and fibula to rotate inwardly sometimes placing severe strain on the leg muscles. Supination, on the other hand, is the rolling outward of the foot during walking or running. When either of these motions become excessive, painful damage to the knees, ankles and feet can occur.
- the thrust of the Greenawalt method is to use the impression made in the crushable foam block to make various measurements, visual observations and touch evaluations which servo as the basis for constructing the corrective arch support.
- measurements are made of the length and width of the impression and observations of the position of the metatarsal heads, of plantar abnormalities in the inner and outer longitudinal arch and of the presence and degree of supination are made. These measurements and observations are then used in laying out the dimensions and sizes of the leather blanks which are to be used for constructing the corrective arch support.
- the neutral position ⁇ 1 the foot is the position wherein the foot is neither supinated nor pronated and the midtarsal joint is maximally pron.ilo .
- the foot typically transfers force most effectively.
- biomechanical terms the foot must ideally absoi b the force of gravity at heel contact and then create a rigid lever to correctly propel the body forward for the next step.
- the foot cannot absorb force nor can it create an effective lever for propelling the body forward in a proper manner.
- Such a problem can cause the foot structure to break down and, over time, lead to severe neck pain, back pain, foot pain, bunions, heel spurs, and the like.
- the "wedging step” involves first bisecting the posterior aspect of the calcaneus and then wedging the cast until this bisection is generally perpendicular to the horizontal plane.
- the wedging, per se, is generally accomplished by adding a plaster forefoot platform to the cast.
- the platform extends from about one centimeter proximal to the first metatar- sal head and the fifth metatarsal head to the sulcus area and spans the positive mold from the medial aspect (outside edge of first toe) to the lateral aspect (outside edge of fifth toe) .
- the wedged mold is then further modified with a plaster of paris buildup to account for fat pad expansion around the heel and along the lateral foot border, to allow for compression of the medial arch and transverse arch, and to create a smooth transition from the forefoot platform to the arch and mid oot.
- thi method involved thermal forming of a layer of polyolef i n plastic sheet over the lower surface of the corrected replica. ff the forming step is correctly done and the polyolef.in sheet is properly heated and cooled, the upper surface of the sheet wi 11 correspond substantially to the lower surface of the corrected replica.
- thermal forming is described in U.S. Patent No. 4,702,255 issued to Schenkel. However, if the forming step is incorrectly done, precise replication of the lower surface of the corrected replica w ll no result.
- i nns made within a single laboratory may be different from foot to foot .
- Further contributing to deficiencies in prior art oi hotics is the absence of reliable methods for analyzing the patient's foot impressions and the inability of a given oitho ic const lucted from the impression to, in fact, propei 1 y control the pat ient's foot.
- This information then made it possible to construct a number of forming masters for each of the identified families.
- the next step in the development was to analyze each new uncorrected replica received by the laboratory and identify it: with one of the previously identified families of uncorrected replicas which, when corrected, would produce a virtually identical finished orthotic.
- the forming master associated with the identified family was then used to form the finished orthotic for the newly received uncorrected replica rather than laboriously constructing * a corrected replica and using it to form the finished orthotic for the patient.
- a specific longitudinal and lateral position on a workpiece yields a particular height (z) positioning ol the machine tool.
- the machine tool is then guided along parallel paths tlirough the workpiece while the machine tool's height in automatic lly adjusted to conform with the desired surface contour.
- This patent discloses a foot impression unit which is provided with an array of gauging elements, a control mechanism for urging the gauging elements into contact with the undersui - face of a person's foot to form an impression of the undersurface of the foot and a sensing mechanism for scanning the gauging elements to produce digital signals indicative of the positions of the gauging elements.
- These digital signals are stored and processed by a computer to provide a stored data record serving as a digital representat on of the impression of the utjdersurface of the foot.
- the computer may also be employed to provide stored additional information for modifying that data record to compensate for a perceived defect of the foot with the x, y, : ⁇ . information derived.
- the custom-made shoe insert is made by a conventional computer controlled milling machine using the stored data for a particular patient. Once again, each order requires expensive and time consuming set-up and milling operations.
- the methods of the present invention uniquely overcome most of the drawbacks of the prior art processes for producing orthotics by providing a fast, accurate, efficient, and non-labor intensive injection molding process for making high qualit precision orthotics in very high volumes.
- one form of the method of the present invention for making an injection molded orthotic involves first selecting a mLiltiplici ty of uncorrected replicas of the human foot, each of which is to be later modified to create a corrected replica.
- the contoured lower surface of each uncorrected replica of the multiplicity of unconrected replicas selected is then analyzed to identify thereon a multiplicity of x, y coordinates. This done, the contoured surface is spaced apart from a reference plane and for each x, y coordinate Identified thereon, the distance between the coordinate and the reference plane, that is the z coordinate, is determined and recorded to develop a first set of x, y, z coordinate data.
- the >:, y, z coordinate data thus developed defines the topography of the lower surface of the patient's foot as replicated by the uncorrected replicas which were produced from negative casts taken by the examining doctor of the patient's foot.
- the negative casts received from the doctor, rather than the uncorrected replicas are analyzed to develop the firrt set of x, y, z data.
- each of the corrected replicas thus formed is used to produce a functional orthotic.
- Uach of the finished orthotics thus produced is then studied to identify (hose finished orthotics that are substantially functionally identical.
- the substantially identical finished orthotics are then grouped into a plurality of discreet, finished orthotic groups. Once these groups of finished orthotics are determined and appropriately identified, an injection mold for each family is constructed. The injection mold for each family is carefully constructed so that the internal cavity of the mold, when filled with a moldable plastic will produce a finished orthotic that is substantially identical to the plurality of finished orthotics which make up the particular group that was identified.
- each injection mold can then be identified with the particular group of uncori ected replicas from which the finished orthotic was derived.
- the x, y, z coordinate data corresponding to that group is identified and recorded and, in this way, a plurality of groups of x, y, z comparison data are developed. Each group of x, y, z comparison data is then identified with a particular injection mold.
- a newly received uncorrected replica can be analyzed and identified wi h a particular mold by compai - ing the x, y, z data of the uncorrected replica with the x, y, ? comparison data to determine the group with which it is most. closely associated. Once this is done, the proper mold can be selected. Then, using this mold, a precise orthotic cm readily be constructed for use by the patient. In actual practice, matching of the patient with the proper comparison x, ⁇ , ;. data group is accomplished by first developing x, y, z data for the contoured lower surface of the patient's foot.
- This patient x, y, z data is then compared with the earlier defined and tabulated comparison group data to identify the particular comparison group within which the patient x, y, z data falls. It is then a simple matter to identify the particular injection mold which corresponds to the selected group of comparison x, y, z data and to use that injection mold to produce the finished orthot ic for th; particular patient.
- An alternate method of the invention for developing compa ison x, y, z data which can be used to select the correct injection mold for a given patient involves the careful an lysis of the corrected replicas formed by traditional methods from the uncorrected replicas made using the impression provided by the examining doctor. More particularly, in accordance with this alternate method of the invention, the contoured lower surface of each corrected replica is analyzed to identity thereon a multiplicity of x, y coordinates. This done the contoured .surface of the corrected replica is spaced apart from a referred plane and the distance between the reference plane and each of the x, y coordinates is determined and recorded to develop a second set of x, y, 7. coordinate data. This second set of x, y, z data substantially defines the topography of the lower surface of the corrected replica, and reflects the corrections prescribed by the examining doctor that are believed necessary to properly control the foot functions of the particular patient.
- this data is studied to identify those corrected replicas that are substantially identical. This done the substantially identi-
- WO 98/07342 cal corrected replicas arc grouped into a plurality of discreet, corrected replica families. Once these families of corrected replicas are determined and approp iately identified, an injec ⁇ tion mold for each family is constructed. The injection mold or
- each family is carefully constructed so that the internal cavity of the mold, when filled with a moldablo plastic will produce a finished orthotic which is substantially identical to the plurality of finished orthotics formed using the particular family of corrected replicas.
- each injection mold can be identified with the particular group of uncorrected replicas which, when corrected, produces the finished orthotic that corresponds to the orthotic produced by the particular injection mold.
- the x, y, z, data corresponding to that group is identified and the plurality of groups of comparison x, y, z data can be developed.
- Another object of the invention is to provide a method of the aforementioned character in which the prescription data typically provided by the examining doctor can be used to quickly and easily identify a particular injection mold that will produce a finished orthotic that is substanti lly identical to that which would have been heat formed from a corrected replica of the patient's foot that was made by conventional prior art techniques.
- Another object of the invention is to provide a method of making a plurality of specially configured injection molds whicli can be used repeatedly to produce high quality, functional orthotics for virtually every type of problem for which fulicfiona I orthotics are prescribed by an examining doctor.
- Another object of the invention is to provide a method as described in the preceding paragraphs in which a definition of the contour of the patient's foot, piovided either by means of a negative or positive replica of the patient's foot, or by other contour data obtainable by scanning techniques, or the like, can be used to quickly and easily select the proper injection mold to be used in making an orthotic for a particular patient.
- Still another object of the invention i to provide a method of making precision functional orthotics by injection molding techniques, which techniques, are considerably more efficient and substantially less labor intensive than presently practiced, prior art techniques.
- Yet another object of the invention is to provide a method of making precision, higb-guality functional orthotics on an as- needed basis from a patient's foot contour data that is on file even in the absence of the original impression of the patient's foot, and in the absence of a corrected replica of the patient's foot.
- Figure 1 is a generally perspective view of one form of functional orthotic produced in accordance with the method of the invention.
- Figure 2 is a plan view of the lower SLirf ce of a corrected replica, which is formed by tradi ion l methods from the uncorrected replica which replicates the lower surface of the foot of the patient. Exemplary x, y coordinates used to identify the surface contour are indicated in the drawing.
- Figure 3 is a generally perspective view of the corrected replica shown in Figure 2, the contoured surface of which is spaced apart from a reference plane which is supe i posed over the contoured surface and from which z coordinates that J epresent. the distance between the x, y coordinates and the reference plane, can be determined.
- Figure 3 ⁇ is a fragmentary, illustrative view of a section of the corrected replica illustrating the manner of deter ination of the z components of the contoured surface.
- Figure 4 is an exploded, generally perspective view of one form of injection mold constructed in accordance with the method of the invention.
- Figure 5 is a generally diagrammatic representation of the various steps of one form of the method of the invention to produce an injection molded orthotic.
- Figure 6 is a generally perspective view of the orthotic: shown in Figure 1, the contoured surface of which is spaced apart from a reference plane which is superimposed over the contoured surface and from which z coordinates that represent the distance between the x, y coordinates and the reference plane, can be determined.
- Figure 7 is a generally perspective view of a foot impression of the character received from the examining doctor, the contoured surface of which is spaced apart from a reference plane which is superimposed over the contoured surface thereof and from which z coordinates that represent the distance between the x, y coordinates and the reference plane, can be determined.
- the three-dimensional, curved supporting surface 16 of the functional orthotic 14 includes the heel region 10 properly contoured to support the users heel, the ai ch region 20 contoured to properly suppoi t the usei s ai ch and the metatarsal region 22 disposed proximate the heads of the users metatarsal joints.
- the negative cast is used to make a plaster of paris positive, or uncorrected replica of the patient's foot.
- the uncorrected replica is then modified by the laboratory in accordance with the doctor's instructions to produce a corrected replica (see, for example, Figure 3) .
- the corrections made to the uncorrected replica may include wedging the heel portion by the addition of a plaster platform to simulate the foot in the neutral position.
- the wedged replica may then be furthet modified with strategically placed plaster of paris buildups to account for fat pad expansion around the heel and along the laleial foot border to allow for compression of the medial arch and t ansveise arcii and to create a smooth transition from the foot platform to the arch and mid-foot.
- thermoplastic material is appropriately trimmed and polished to produce the finished functional orthotic having the general physical characteri tics of the orthotic illusti-ated in Figure i.
- Figure 2 shows a corrected replica made from an uncorrected replica, which, in turn, was made from a foot impression provided by the examining doctot .
- Figure 5 depicts generally the methods of the invention and shows at the left margin of the drawing the progression of the methods, namely selection of the casts or impressions 24, selection of the uncorrected replicas 26 formed from the casts, and then analyzing either the selected corrected replicas ?R made from the uncorrected replicas, or, alternatively, analyzing the selected finished orthotics 14 to derive the coordinates necà y to make the fami ⁇ y of injection molds 30 of the invention.
- the first step of one form of the method of the invention for aking the injection molds and the finished orthotics involves the selection of a multiplicity of uncorrected replicas of the human foot, such as by way of simplification, replicas UR-1 through UR-10 ( Figure 5) which have been made from the negative casts or impressions 1-1 through T-no received by the lab ⁇ i toiy.
- Figure 5 shows only ten casts, ten uncorrected replicas, ten corrected replicas and fen finished orthotics, many thousands of casts, replicas and orthotics are in fact analyzed in the accomplishment of the method of the invention, but only ten of each are shown in Figure 5 in an attempt to simplify the explanation of the process of the invention.
- the next stop in the method of the invention involves identifying the multiplicity of functional orthotics 14, produced ft om the corrected replicas, for example, orthotics O-l through 0-10, as identified in O 98/07342
- Figure 5 which corrected replicas were made by conventional tech ⁇ niques from the multiplicity of corrected replicas 28, whicli are identified in Figure 5 as CR-1 through CR-I ⁇ .
- the func ⁇ tional orthotics O-l through O-.IO are carefully examined to
- first subgroups are identified by selecting from the multiplicity of functional orthotics O-l through 0-10 those finished orthotics which are of substantially identical configuration.
- orthotics 0-4, o-6 and 0-8 were grouped into first subgroup O-A, while orthotics o-9, o- 2 and O-10 were grouped into first subgroup O-C.
- Thi grouping was possible because it was determined that the contoured upper surfaces of orthotics 0-4, 0-6 and O-O were substantially identical, and that the contoured upper surfaces of orthotics 0-9, 0-2 and 0-10 were also substantially identical.
- orthotics 0-1 and 0-3 were grouped into subgroups 0-B and orthotics 0-5 and 0-7 were grouped into subgroups 0-D.
- the final step in one form of the method of the invention for making the injection molds comprises the stop of constructing for each of said plurality of subgroups an injection mold 30.
- the several injection molds constructed in accordance with the methods of the invention each have an internal cavity 30a ( Figure 4), which, when filled with a moldable plastic, will produce a finished orthotic having a contoured upper or foot engaging surface which is substant lly identical to the contoured upper surfaces of the functional orthotics that make up each of the subgroups, which upper surfaces are formed by pressing a heated thermoplastic blank against a correct replica in the manner previously described herein.
- the molds 30 are identified in Figure 5 as IM-1, IM-2, 1M-3 and IM-4.
- the x, y, z data for either the low contoured O 98/07342 surface of the corrected replica or the x, y, z data for the upper foot engaging contoured surface of the orthotic for each subgroup is known, the x, y, z data for the bottom shoe engaging surface of the orthotic can similarly be determined by methods well known to those skilled in the art such as by calculation or by using the same measurement techniques previously described for determining the x, y, z data for the contoured surface.
- the methods of the invention for making finished functional orthotics for particular patients using the injection molds thus developed obviously involves many of the same steps involved in the methods of the invention for making the injection molds.
- these methods include additional analysis of the information derived during mold development and also include the further important step of generating from the information derived sets of comparison data which can be recorded in comparison tables of x, y, z comparison data.
- developing this important comparison data generally comprises the steps of determining for each of the orthotic subgroups 0- ⁇ , 0-B, 0-C and 0-D the shape of the contoured surfaces of the foot impressions and uncorrected replicas which were used to construct the corrected replicas which, in turn, were used to form the orthotics that make up each of the orthotic subgroups 0- ⁇ , 0-B, 0-C, and 0-D. Then, after determining the shape of the shoe engaging surface of the particular patient for which the orthotic is to be constructed, this shape can be compared with the sets of comparison data developed to determine which subgroups of foot impressions and uncorrected replicas exhibit contoured surfaces that correspond most closely to the shape of the patients foot.
- the orthotics O 98/07342 formed from the corrected replicas made from the identified uncorrected replicas can be identified. Then it is an easy matter to select the correct mold to be used, which, of course, is the mold that will produce the orthotics thus identified.
- the derivation of the plurality of sets of comparison data necessary to construct an injection molded orthotic based on data derived from the examining doctor can be accomplished in several ways.
- the x, y, z data for the foot impressions which make up each subgroup that corresonds to orthotic subgroups 0-A, 0-B, 0-C, and 0-D can first be determined in the manner illustrated in Figure 7 of the drawings.
- the same x, y, z data can be developed in substantially the same manner through analysis of the uncorrected replicas which make up each subgroup that corresponds to the orthotic subgroups 0-A, 0-B, 0- C, and 0-D.
- Still another approach to the development of the comparison sets of x, y, z data involves the careful analysis of x, y, z data of the corrected replicas which were made from the uncorrected replicas selected for the study. More particularly, as depicted in Figure 2, in this particular form of the invention, the lower contoured surface of each of the multiplicity of corrected replicas constructed by the laboratory is analyzed in terms of a multiplicity of x, y coordinates of the general character shown by way of example in Figure 2. It is to be understood that in actual practice, many more x, y coordinates than those shown in the drawings were identified on the contoured surface of the corrected replicas. However, for sake of clarity of explanation, only a few such coordinates are shown in the drawings.
- the x or latitude lines are preferably spaced apart by a distance about 1.0 and 1.4 millimeters and the y, or longitude lines, are preferably spaced apart by a distance O 98/07342 of between about 0.5 and 0.7 millimeters (see Figures ) and 6).
- the foot impressions 24, uncorrected replica 26, or the finished orthotic 14, as the case may be, is positioned at a spaced-apart location from a reference plane "P" which is typically perpendicular to the bisection of the calcaneus in the manner depicted in Figures 3, 6, and 7. This done, the previously discussed z coordinates are determined.
- the z coordinates represent the distance between the reference plane "P" and each of the multiplicity of points on the contoured surface which are defined by the intersection oi the coordinate x, y lines (see also Figure 3 ⁇ ) .
- the z coordinates can be identified in a number of ways well known to those skilled in the art.
- impression units such as described in the previously mentioned prior art patent to Rolloff et al, No. 4,876,758 can be used in conjunction with a suitable computer and computer software to produce digital signals representative of the contoured surface under consideration.
- the contoured surfaces can be scanned directly using computer assisted scanning devices such as, for example, a laser digitizer of a character which is readily commercially available from sources such as Cyberware Company of Pacific Grove, California.
- corrected replicas are constructed from the multiplicity of uncorrected replicas UR-1 through UR-n, which, in turn were formed from impressions 1-1 through 1-n.
- the multiplicity of corrected replicas CR-1 through CR-n are first divided into subgroups wherein each corrected replica of a particular subgroup exhibits a substantially identical lower contoured surface.
- the resulting corrected replica subgroup would consist of corrected replicas CR- , CR-6 anil CR-8.
- the corrected replicas associated with orthotic subgroup 0-B would consist of corrected replicas CR-l and CR- .
- the corrected replica subgroups associated with orthotic subgroups 0-C and 0-D can readily be determined.
- the corrected replica or second subgroups are thus identified, it is then possible to identify a plurality of third subgroups by identifying for each third subgroup the uncorrected replicas UR-1 through UR-n which were corrected to form the corrected replicas which make up the second subgroup.
- the third subgroup of uncorrected replicas associated with the second subgroup of corrected replicas comprising CR-4, CR-6 and CR-8 consist of uncorrected replicas UR-4 , UR-6 and UR-fl .
- the third subgroup of uncorrected replicas associated with corrected replicas CR-1 and CR-3 consist of uncorrected replicas UR-1 and UR-3.
- the comparison tables of the invention can readily be developed. As previously discussed, these important comparison tables are used to select a particular mold 30 for a particular patient based upon the particular shape of the lower shoe engaging surface of the patient's foot.
- the x, y, z data previously developed for each of the multiplicity of corrected replicas or finished orthotics is analyzed and correlated with the appropriate uncorrected replica subgroup.
- a first set of x, y, z comparison data might consist of the x, y, z coordinate data for corrected replicas CR-4, CR-6 and O 98/07342
- a second set of x, y, z data might consist of the x, y, z coordinate data from corrected replicas CR-1 and CR-3 and so on.
- the mold 30 which is associated with that set is identified.
- the mold 30 which is associated with the first set of corrected replica comparison x, y, z data is designated as IM-1.
- the mold 30 which is associated with the second set of corrected replica comparison x, y, z data is designated as IM-2 and so on.
- the corrected replicas CR-4, CR-6 and CR-8 were constructed from uncorrected replicas UR-4 , UR-6 and UR-0, which, in turn, were formed from foot impressions or casts 1-4, 1-6 and I-B
- the correct mold for producing the orthotic for the new patient can be quickly identified in the following manner.
- the prescription data received which may include an impression of the patient's foot
- the x, y, z data for contoured lower surface of the patient's foot is determined in the manner illustrated in Figure 7.
- This patient's x, y, z data is then compared with the groups of x, y, z data found in the comparison table to identify the particular group within which the patient x, y, z data falls.
- the injection mold which corresponds to the selected comparison group of x, y, z data is identified, and, using the selected injection mold, the finished orthotic for the patient is then injection molded.
- the patient x, y, z data can be determined in a number of ways.
- physical measurements of the O 98/07342 impression received from the examining doctor can be used to identify the contour of the shoe engaging portion of the patient's foot.
- x, y cooi d Iiml.cs are first identified on the surface xif the cavity 24a of the impression ( Figure 7). This done, the z coordinates, which are the distances between a reference plane "P" spaced apart from cavity 24a and the points defined by the intersection of the x-y lines, are determined.
- z coordinates can be determined in a number of ways well known in the art such as, for example, through use of a depth gage, by electronic scanning or by using mechanical impression units of the general type described in U.S. Patent 4,876,758.
- this x, y, z data is obtained and recorded, it can be correlated in the manner shown in Figure 5 with the uncorrected and corrected replicas which evolve from the impressions and, finally with the first subgroups of orthotics produced from the corrected replicas.
- the multiplicity of sets of comparison data which make up the comparison tables can then be derived in the manner previously discussed and then used to select the correct injection mold for molding a finished orthotic for a given patient from which the patient x, y, z data has been determined.
Abstract
Description
Claims
Priority Applications (4)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
AU39788/97A AU3978897A (en) | 1996-08-19 | 1997-08-13 | Method of making injection molded orthotics |
DE69736845T DE69736845D1 (en) | 1996-08-19 | 1997-08-13 | METHOD FOR INJECTING AN ORTHESIS |
EP97937226A EP1011357B1 (en) | 1996-08-19 | 1997-08-13 | Method of making injection molded orthotics |
CA002260078A CA2260078C (en) | 1996-08-19 | 1997-08-13 | Method of making injection molded orthotics |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
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US08/699,393 US5746952A (en) | 1996-08-19 | 1996-08-19 | Method of making injection molded orthotics |
US08/699,393 | 1996-08-19 |
Publications (1)
Publication Number | Publication Date |
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WO1998007342A1 true WO1998007342A1 (en) | 1998-02-26 |
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Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
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PCT/US1997/014234 WO1998007342A1 (en) | 1996-08-19 | 1997-08-13 | Method of making injection molded orthotics |
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Country | Link |
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US (2) | US5746952A (en) |
EP (1) | EP1011357B1 (en) |
AU (1) | AU3978897A (en) |
CA (1) | CA2260078C (en) |
DE (1) | DE69736845D1 (en) |
WO (1) | WO1998007342A1 (en) |
Families Citing this family (31)
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DE735943T1 (en) * | 1993-12-22 | 1997-04-03 | Commer Spa | METHOD AND DEVICE FOR INJECTION MOLDING OF OBJECTS WITH A COMPLICATED SHAPE |
US5746952A (en) * | 1996-08-19 | 1998-05-05 | Professional Footcare International, Inc. | Method of making injection molded orthotics |
CA2231802A1 (en) * | 1998-04-15 | 1999-10-15 | Serge Brie | An aerated cushioning structure with a variable density throughout |
US6473667B1 (en) * | 2000-04-14 | 2002-10-29 | Joe Lee | Three dimension computer model full size grading system for processing a shoe model by a triangular geometry mode |
US6865442B1 (en) | 2000-10-24 | 2005-03-08 | Stephen J. Jared | Method of producing orthotic device utilizing mill path about perpendicular axis |
GB0027579D0 (en) * | 2000-11-11 | 2000-12-27 | Rs Scan Internat | Method and apparatus for obtaining neutral foot position and correction of pathological foot movements |
US20020071597A1 (en) * | 2000-12-13 | 2002-06-13 | Ravitz Marjorie C. | System and method for fitting shoes |
AU2002221031A1 (en) * | 2000-12-21 | 2002-07-01 | Bonus Ortho System A Islandi Hf. | A method for measuring a shape of a foot |
US6523206B2 (en) * | 2001-04-06 | 2003-02-25 | Steven P. Royall | Custom orthotic sandal and process for constructing |
US6854199B2 (en) * | 2001-09-28 | 2005-02-15 | Joseph Paul Polifroni | Layered arch support |
US6817115B2 (en) * | 2001-09-28 | 2004-11-16 | Joseph Paul Polifroni | Textured arch support device and method of manufacture |
US7153457B2 (en) * | 2001-10-15 | 2006-12-26 | Surefit, Inc. | Method for providing custom fit therapeutic footwear |
EP1474012A2 (en) * | 2002-01-25 | 2004-11-10 | Michael Robert Branger | Process for making orthotic insert, an orthotic insert, and a shoe comprising the orthotic insert |
US20040032052A1 (en) * | 2002-08-16 | 2004-02-19 | Meyers Andrew H. | Method of making a foot orthotic device |
WO2004017813A2 (en) * | 2002-08-22 | 2004-03-04 | Footcontrolle, Llc | Apparatus and methods for forming shoe inserts |
US7625349B2 (en) * | 2002-12-16 | 2009-12-01 | Daniel Bleau | Biomechanical custom made foot orthosis and method for making the same |
US7008386B2 (en) * | 2003-08-26 | 2006-03-07 | Acor Orthopaedic, Inc. | Foot orthotic |
US20050071935A1 (en) * | 2003-10-03 | 2005-04-07 | Shah Binith Ratilal | System and method for creating a custom article |
US7020990B2 (en) | 2004-01-13 | 2006-04-04 | M. Steven Khoury | Orthopedic device for distributing pressure |
US7392559B2 (en) * | 2005-04-28 | 2008-07-01 | Esoles L.L.C. | Method and apparatus for manufacturing custom orthotic footbeds |
US7552494B2 (en) * | 2005-04-28 | 2009-06-30 | Esoles, L.L.C. | Method and apparatus for manufacturing custom orthotic footbeds that accommodate the effects of tibial torsion |
US20070039208A1 (en) * | 2005-08-22 | 2007-02-22 | Fila Luxembourg S.A.R.L. | Adaptable shoe having an expandable sole assembly |
US20070163147A1 (en) * | 2005-09-21 | 2007-07-19 | Cavanagh Peter R | Method for Design and Manufacture of Insoles |
ITBO20060288A1 (en) * | 2006-04-14 | 2007-10-15 | Ideaslab Snc | SHOE MAKING AND RELATIVE PROCEDURE OF REALIZATION. |
US20080141562A1 (en) * | 2006-12-13 | 2008-06-19 | Fila Luxembourg S.A.R.L. | Adjustable arch support assembly |
US20090036811A1 (en) * | 2007-08-01 | 2009-02-05 | Tower Orthopedic Designs, Inc. | Orthosis casting form and method of making the same |
US8245378B2 (en) * | 2007-09-13 | 2012-08-21 | Nike, Inc. | Method and apparatus for manufacturing components used for the manufacture of articles |
US8551379B2 (en) | 2007-09-25 | 2013-10-08 | International Business Machines Corporation | Method and system of making digital image transfer thermoformed objects |
FR2939307B1 (en) * | 2008-12-09 | 2012-08-10 | Ghislaine France | PREFORMED SHELL FOR A FOOT HEEL |
DE102012017882A1 (en) * | 2012-09-11 | 2014-03-13 | Fatmir Langmeier | A method of producing an individualized, patient-data-based, modular sole-of-foot sole and identifying the materials and construction of an individualized, patient-data-based insole |
US10524535B2 (en) * | 2018-09-20 | 2020-01-07 | Igor Vainer | Shoe insole replacement method |
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US3121431A (en) * | 1961-06-05 | 1964-02-18 | Rosenhaft Isaac | Innersole |
US3320347A (en) | 1964-05-18 | 1967-05-16 | Monte H Greenawalt | Method of making an arch support by measuring an impression of a foot |
US3995002A (en) * | 1974-11-07 | 1976-11-30 | Brown Dennis N | Orthocasting system |
US4522777A (en) * | 1982-12-15 | 1985-06-11 | Peterson Laboratories | Method and apparatus for making corrected custom foot molds |
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US5586067A (en) * | 1994-07-19 | 1996-12-17 | Bcam International, Inc. | Support enhancing device and associated method |
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ES8205494A2 (en) * | 1980-03-18 | 1982-06-16 | Orea Mateo Fernando | Process for the normalized manufacture of shoes |
US4817222A (en) * | 1987-10-15 | 1989-04-04 | Shafir Aaron | Method and apparatus for making shoe lasts and/or shoe components |
US4868945A (en) * | 1987-11-02 | 1989-09-26 | Debettignies Jean | Biomechanically adapted custom footwear |
US5714098A (en) * | 1995-12-20 | 1998-02-03 | Nike, Inc. | Footwear fitting method |
US5746952A (en) * | 1996-08-19 | 1998-05-05 | Professional Footcare International, Inc. | Method of making injection molded orthotics |
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1996
- 1996-08-19 US US08/699,393 patent/US5746952A/en not_active Expired - Lifetime
-
1997
- 1997-08-13 WO PCT/US1997/014234 patent/WO1998007342A1/en active IP Right Grant
- 1997-08-13 EP EP97937226A patent/EP1011357B1/en not_active Expired - Lifetime
- 1997-08-13 CA CA002260078A patent/CA2260078C/en not_active Expired - Fee Related
- 1997-08-13 DE DE69736845T patent/DE69736845D1/en not_active Expired - Lifetime
- 1997-08-13 AU AU39788/97A patent/AU3978897A/en not_active Abandoned
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1998
- 1998-03-20 US US09/045,658 patent/US6042759A/en not_active Expired - Lifetime
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US3121431A (en) * | 1961-06-05 | 1964-02-18 | Rosenhaft Isaac | Innersole |
US3320347A (en) | 1964-05-18 | 1967-05-16 | Monte H Greenawalt | Method of making an arch support by measuring an impression of a foot |
US3995002A (en) * | 1974-11-07 | 1976-11-30 | Brown Dennis N | Orthocasting system |
US4522777A (en) * | 1982-12-15 | 1985-06-11 | Peterson Laboratories | Method and apparatus for making corrected custom foot molds |
US4702255A (en) | 1985-06-17 | 1987-10-27 | Schenkl Joseph L | Orthopedic apparatus |
US4876758A (en) | 1987-03-31 | 1989-10-31 | Amfit Inc. | System and method for forming custom-made shoe inserts |
US5054148A (en) | 1989-03-22 | 1991-10-08 | Paragon Podiatry Laboratories | Orthotic with textured surface and method for producing same |
US5586067A (en) * | 1994-07-19 | 1996-12-17 | Bcam International, Inc. | Support enhancing device and associated method |
Non-Patent Citations (1)
Title |
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See also references of EP1011357A4 |
Also Published As
Publication number | Publication date |
---|---|
AU3978897A (en) | 1998-03-06 |
CA2260078C (en) | 2006-11-07 |
EP1011357B1 (en) | 2006-10-18 |
CA2260078A1 (en) | 1998-02-26 |
DE69736845D1 (en) | 2006-11-30 |
US6042759A (en) | 2000-03-28 |
EP1011357A4 (en) | 2002-08-28 |
US5746952A (en) | 1998-05-05 |
EP1011357A1 (en) | 2000-06-28 |
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