JP2002540859A - Respiratory mask and manufacturing method thereof - Google Patents

Abstract

  (57) [Summary] A method for the manufacture of a respiratory mask, comprising contactlessly measuring the topography of a facial part and shaping the material for the mask based on the topography. Also disclosed is a mask so produced, means for its manufacture, and a database for storing patient topography data obtained by the method.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

FIELD OF THE INVENTION

The present invention relates to a method of making a respiratory mask, the means used in the method, the corresponding mask,
And a database for storing useful data in the method and the use of the database.

[0002]

BACKGROUND OF THE INVENTION

An important feature of respirators for medical and other fields is that they fit. That means making the mask effectively seal against the user's face when covering the nose and / or mouth. Respirators known in the art are manufactured in a number of standard sizes to provide an average fit for each group of users.

A better fit can be obtained if the mask is formed according to the geometric shape of the user's face. This could be achieved by applying the moldable plastic material directly to the user's face and curing it in place or after careful removal. The raw mask is provided with one or more openings to which conduits are connected for providing gas breathing and for directing exhaled air. The mask is also provided with a sealing means, such as a rubber foam rim, to seal around the face to the face and a means for holding it in place. This method could be called "direct" molding. Another method is to use a suitable material, such as plaster, to make a negative mold of the face in question, which is then replaced with a second positive mold that is properly reconstructing the face. Used to make. This positive mold is used as a base to make a raw mask that corresponds to what you take directly from the user described above, and processing using a positive mold is useful when time is short and to make a raw mask. It is advantageous when there are other constraints such as toxicities of some component of the prepolymer used. This method could be called "indirect" molding. The main drawback of this indirect molding method is its complexity and the resulting high cost. Both of these methods require that the person removing the patient's face be sufficiently skilled in the technique. For example, it is important not to apply excessive pressure when applying the mold. Failure to do so will result in a distorted face and a mask that will not fit well. Neither of these methods is suitable for the industrial production of individually adapted face masks. The present invention aims to overcome this important problem.

[0004]

[Object of the invention]

It is an object of the present invention to provide a method for making a respirator that fits individually to the person wearing it. Another object of the present invention is to provide a means for performing the process. Yet another object of the present invention is to provide such a mask. Yet another object of the present invention is to provide a database containing data that can be used when performing the process. Still other objects of the present invention will become apparent from the following description of the present invention and its preferred embodiments, which are appended to the appended claims.

[0005]

SUMMARY OF THE INVENTION

According to the invention, a method of the type described above involves non-contact measurement of the topography of a human face part, in particular by optical means, most preferably by laser means. The topographic data thus obtained (in the form of a number of spatial points characterized by Cartesian coordinates (x, y, z), for example) is stored in a suitable electronic storage medium, such as a computer hard disk. Is stored in Such non-contact measurements of topography can avoid deforming the face due to excessive pressure. This can therefore give a perfect fit. In the case of a nasal mask, it is most important to get a perfect fit for the nose. Therefore, non-contact measurement of the nose's own topography is a central issue of the present invention. Methods of non-contact measurement of topography are already known in the art; for example, US Patent No. 3,927,948 (Cox et al.); US Patent No. 5,110,203 (MacCabee); US Patent No. 5,114,226 (Godwin et al.). ); U.S. Patent No. 4,854,698 (Schmidt).

[0006] The mask may be applied to a suitable ablation machine such as an automatic milling machine cutter known in the art with a unit controlled by a suitable software and a microprocessor or the like using the topography data. Scraping machine). This mask is suitably manufactured from a mold blank roughly in the form of the desired product. Suitable polymeric materials are polypropylene, polystyrene, polycarbonate, polymethyl methacrylate and melamine formaldehyde copolymer. The outside of the mask is not important for a good fit and can be left blank. But only the inside of the blank needs to be scraped.

[0007] The mask, which has been milled in the desired form, is connected with conduits for the transfer of the gas to be sucked and the gas to be discharged, for example by means of glue, welding and snap-fastening means. It is likewise possible to provide the through-hole and possibly the conduit in the blank prior to shaving the material in order to obtain the desired topography provided with one or more through-holes.

The mask is also provided with means for holding it in place, for example, one or more straps.

According to a particularly preferred aspect of the invention, the lateral direction of the part of the user's face whose topography data is intended to be covered by the mask, in particular the lower part of the nose and in the immediate vicinity thereof And used to make replicas of parts that extend downward. This replica is made, for example, by the milling technique described above using one of the above-mentioned polymers or other suitable polymer, especially a rigid polyurethane foam. This replica is not approved for medical use because it is merely a mold for the final product, but can advantageously utilize materials having the desired physical properties. This replica preferably has a platform for air / gas connection, such as a cube or a three-dimensional body, whose flat surface (flat surface in a general sense) is particularly suitable for attaching the previous connection. Are suitable. The replica then applies an appropriate amount of a thermoplastic material, such as polypropylene, in a semi-liquid state at an appropriate temperature, to the replica,
It is then used to fabricate the mask by cooling it and removing it from it for finishing. It is important to use a replica material that does not easily deform at the temperature at which the semi-solid thermoplastic material is applied. In particular, it is desirable that the softening point of the polymer material used to make the replica be at least 20 ° C. higher than the softening point of the polymer material used to make the mask. This application of the thermoplastic material is preferably performed by vacuum molding (vacuum thermoforming). What has been said above on the outside of this blank applies equally to this preferred aspect of the invention. Thus, it is possible to produce one or more masks for a given patient.

According to another important and desirable aspect of the invention, this measurement of the topography is performed at one site, in particular a health care unit such as a clinic or doctor's office, and is thus obtained. The topographic data is then transferred to a manufacturing site equipped with automatic milling cutters and other machines. Data transfer from one site to another is suitably performed by electronic means via the Internet or telephone modem. Thus, the acquisition of patient data and the manufacture of the mask can be organized organically in the most economical way.

According to the present invention, there is disclosed or disclosed a respiratory mask manufactured by a process which includes non-contact measurement of the topography of a portion of a human face, especially by optical means, most preferably laser means. I have. An important advantage of this mask is its reduced size and weight due to its inherently good fit so that separately provided sealing means can be omitted if desired. Its simple design facilitates cleaning and, if necessary, sterilization. If an additional peripheral (partial or full) seal is applied inside the mask of the present invention, a relatively thin one is sufficient. A desirable material for such a seal is a soft polyurethane foam.

According to the present invention, a database is established which includes face topography data obtained by non-contact measurement, in particular optical measurement using, for example, laser means. Preferably, the data in the database is in Gaussian coordinate or position vector format. One advantage of storing and storing patient data in the form of a database is the ease of accessing them later for the manufacture of additional masks. It is advantageous from a cost standpoint to store the data rather than the physical ones made with reference to the data, such as individual molds, to store the individual molds and to make one out of many molds. The administrative task of searching for a mold is economically disadvantageous. The performance of the mold material, and thus that of the mold, can degrade during storage, while the data quality does not degrade.

According to the present invention, there is disclosed a means for making a face-applied respiratory mask that includes optical means for measuring the topography of the portion of the face on which the mask is to be applied. The fabrication means may further include an automated milling machine controlled by the data obtained through the measurement of the topography.

[0014]

[Brief description of the drawings]

The present invention will be described in more detail below with reference to embodiments shown in the drawings, which are preferred but do not serve to limit it. 1 shows a schematic sketch and a perspective view of a first embodiment of a respiratory mask according to the invention with a through hole for mounting a gas conduit; FIG. FIG. 3 is the mask of FIG. 1, thus viewed from the same direction; FIG. 3 is the mask of FIGS. 1 and 2 in the mounting position of the sagittal portion, and the portion to which it hits is shown. FIG. 4 is a perspective view of a nasal replica of a second embodiment of the respiratory mask of the present invention; FIG. 5 is a respiratory mask made using the replica of FIG. FIG. 6 is a side view of the mask of FIG. 5, and FIG. 7 is the mask of FIGS. 5 and 6, corresponding to that of FIG. FIG. 9 is a view from the AA section perpendicular to the support and (FIG. 4); FIG. 8 is removable FIG. 9 is a side view, corresponding to FIG. 6, of a third preferred embodiment of a respiratory mask of the present invention having a tube mounting portion; FIG. 9 is the mask of FIG. 8, corresponding to that of FIG. FIG. 10 is a cross-sectional view; and FIG. 10 is a schematic block diagram of a preferred embodiment of the method of the present invention.

[0015]

[Description of the preferred embodiment]

The respiratory nasal mask of the present invention shown in FIGS. 1-3 is shown without anchoring laces for clarity. In order to keep the mask in a predetermined position, of course, means other than a string can be used.

The mask made of a polycarbonate member has a central portion 1 centered on the nasal bridge 4 and lateral left and right wings 2 and 3. Central part 1
A cross section through is shown in FIG. It can be seen that this mask abuts approximately 2/3 of the bridge from the nose tip 5 upwards and extends downwardly from its nose to a point close to the upper upper lip 6 where it also abuts. Will. However, this mask does not abut the nasal septum 7 and thus leaves a space 8 which provides communication between the nostrils.
Lateral wings 2 and 3 extend close to the respective cheekbones. The abutting part is indicated by "9" in FIG. A through hole 10 (only one is shown) communicates with the space 8. FIG. 2 shows short, rigid tubes 11 and 12 mounted in holes 10 to serve as conduits for suction and discharge of air. In use, these tubes 11, 12 are connected to respective flexible tubes for transporting gas. Strings fixed to wings 2 and 3 for holding the mask in place are not shown.

The mask according to the present invention is manufactured as follows. Topography of the patient's nose and adjacent areas is measured by non-contact laser metrology for many points in the area of interest. The data for these points is stored in x, y, z format with respect to the origin (x, y, z = o) of the newly selected point set on the bridge of the nose. These data are transferred to the manufacturing plant by e-mail, for example. Either at the measurement site or at the manufacturing site, these data are converted to CAM format for control of a precision milling machine for the production of a replica of the face portion to which the mask is applied. Data for the air (gas) connection platform is also included in the CAM program. This (copying) program has been modified to limit shaving of the nasal septum and nostrils, thus allowing the posterior formation of the space 8. A rigid polyurethane foam was used as a replica material.

The finished replica is mounted in a vacuum mold apparatus, where the desired number of masks are manufactured by vacuum molding of polypropylene in the mid MW range.
The mask is provided with a pair of symmetrically arranged through holes 10, in which tubes 11 and 12 of high MW polypropylene are fixed by welding. These free ends have flexible polyvinyl chloride tubes (not shown)
A mounting part is provided for easy coupling with the motor. The mask is also provided with retaining straps (not shown); alternatively, air (gas) tubes 11 and 12 may be used to secure the mask to the patient.

The second embodiment of the respirator of the present invention shown in FIGS. 5 to 7 has only one straight air (gas) conduit tube 16 having two open ends. This is integrated in the mask at the air (gas) connection platform portion 17 of the mask, which is a section of the mask formed by the cuboid platform 15 associated with the replica of FIG. The lower space of the platform portion 17 communicates with the central portion (22) of the conduit tube 16 and here a part of its wall has been removed (FIG. 7), this mask being used for that person. This space under the platform portion 17 located under the nose portion 23, when applied to the intended face portion of the designed patient, is also to be arranged on its front side (lower side). It also communicates with the patient's nostrils. FIG. 7, in which the mask is shown in the sagittal section, also illustrates the location of the upper lip portion 19 and the nose bridge portion 20. FIG. 6, which is a view on the left side of the mask, also shows the wing 21 on its lateral left side.

The replica (FIG. 4) is mounted on a rectangular support with an adhesive. This is actually a replica blank mounted on the support 13 and the replica is then cut according to the instructions of the CAM. This blank has a contact surface in the form of a cube, and one base of which is glued to the support 13. Similarly, the nose tip 18 is shown. It is not necessary for this replica to have a corresponding lateral extension of the respiratory mask, as what is important for good fitting is primarily the nose and the immediate vicinity of the nose. Preferably, however, the support 13 and the replica 14 are manufactured from a mass of material in a milling machine.

Another preferred embodiment of the mask of the present invention shown in FIGS. 8 and 9 differs from that of FIGS. 4 to 7 in that there is a separating portion 60 for securing a flexible tube for gas transport. ing. This part 60 is fixed to the mask body by a snap connection 61. This embodiment, in which the lumen for the attachment of the flexible tube is indicated by 62, is advantageous from a manufacturing point of view and the disassembled mask is simpler than a mask with an integral tube fixing part. Since it can be cleaned, it is also advantageous in terms of hygiene. The tube fixing portion 60 and snap connection 61 can be made to a standard size for use with various masks. A particularly preferred embodiment of the method of the invention is shown in FIG. 10 in schematic block diagram form.

The topography of the nose and adjacent areas of the patient 25 is measured by non-contact laser metrology at a contour measurement site (CDS) such as, for example, a specialist's office. A rod-shaped assembly (not shown) in which the upper plane of the patient, which is substantially parallel to the plane on which the patient lies, can be displaced in the x and y directions by two step motors, respectively, with the patient turned upside down. The problematic part of the patient is scanned by a laser distance measuring probe, such as a sensor 24 of PreciMeter®, model CD12030-PH (Precimeter AB, Gothenburg, Sweden) mounted thereon. Only the motor 69 for displacing the sensor 24 in the x direction is shown in FIG. This contour measurement method is based on the principle of laser triangulation. The object to be measured is exposed to a narrow laser beam 26. Some of that light is reflected as 27 (only one reflection is shown). The reflected light is optically focused on a two-dimensional photosensitive device where a CCD (charge coupled device) generates a video signal. A change in the distance from the sensor to the object causes a displacement of the focal point of the reflected light along the CCD surface, resulting in a change in the signal which is processed and transmitted digitally through a cable for recording on a personal computer 28. By using appropriate software, the computer 28 also controls the displacement of the sensor by controlling the voltage applied to the stepper motor 69.

The contour data temporarily stored in the computer 28 at the end of the contour measurement period is located at a substantial distance A from the CDS site, for example typically 1 km or more. It is transferred to the mask production site (MPS). This data can be transported over the Internet or rather wirelessly via a modem and telephone line 29 associated with the PC. At the MPS site, this data is provided to the database 30 and stored for irregular periods. If a mask is desired, use a conversion routine to create a database of the data.
The location in 0 is located and it is transferred to the CAM microprocessor 31. The resulting ISO code is provided to the automatic milling machine 36 via a serial interface. The hard polyurethane foam blanks 33 are supplied one by one to a milling machine 32 via a conveyor belt 34. From the conveyor belt they are picked up and moved by the robot 35 for appropriate processing in the milling machine 32. According to the instructions of CAD, the blank 33
Is cut out by a cutter 37 which can be displaced in the x, y, z directions to form a contour 38, and creates a replica 39 of the nose of the patient 25 and its adjacent parts. The replica 39 is transported by the conveyor 40 to the vacuum molding machine 41. Blanks of the mask body in the form of a transparent polycarbonate disc 42 are fed to a heating station 44 on a conveyor 43, where they are subsequently heated to a temperature sufficient for vacuum molding. The heated blank 45 is then fed into the vacuum molding machine 41. One heated blank 45 is placed on replica 39 at a time. By applying a vacuum from a vacuum pump 67 through a vacuum line provided with valve means, the heating blank 45 is vacuum molded into the replica 39 and a raw mask body 46 is formed. After cooling, the raw mask body 46 is lifted from the replica 39 and transported via a connection section 47 to a finishing station 48. A second, third, etc. mask body may then be fabricated from the new heated blank using the same replica 39. After the desired number of raw mask bodies 46 have been fabricated, replica 64
Is picked up and moved by a robot 65 and loaded on a conveyor 66 and transported to a polyurethane collection station (not shown). At the finishing station 48, the raw mask body 46 is provided with holes 54, 55 for the tubing using fixed drills 51, 52 having telescopic tools 50 and 52. In this state, the raw mask main body 46 is shaped along a line 58 in a desired shape by using a small cutter 56 which is displaceable in the x and y directions on a plane on the raw mask main body 46. You. The finished mask body 61 is picked up and removed from the finishing station by a robot 57 and placed on a conveyor 62 for assembly and transport to a packing station 63. And there hole 5
A connecting pipe for connecting a flexible gas tube to 4, 55 is attached by hand. And it is packed there for delivery. The portion 59 cut off from the raw mask 46 is conveyed by a conveyor 60 to a polycarbonate collection station (not shown). Every work piece in the method of the present invention retains its particular identity throughout the entire manufacturing process by a process that is well controlled by data from database 30. For each mask body 61 arriving at the packing station 63, an ID label is printed by a label printer (not shown) and affixed to the mask or the box in which it is packed. Thus, the patient is guaranteed to receive his / her own mask.

[0024] Instead of the laser-based metrology described above, any suitable non-contact profilometry except photographic methods can be used in the method of the present invention. Although photographic techniques could in principle provide useful topographic information as well, their application is cumbersome and undesirable.

Another embodiment of the present invention measures contactless topography of a patient's face and determines a predetermined set of standard masks, such as a set of about 5 or more masks, especially about 10 or more. The method includes selecting a mask from the set of masks that most closely corresponds to the patient's topographic data.

Having described a few embodiments of a nasal respiratory mask and a method for its manufacture, one skilled in the art would apply this technique to a mouth or mouth-to-nose covering mask. Understand that is not difficult at all.

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Claims (27)

[Claims] 1. A method for making a respiratory mask comprising contactlessly measuring a topography of a facial part and shaping the material for the mask based on the topography. 2. The method of claim 1, wherein said measuring includes using optical means. 3. The method of claim 2 wherein said optical means includes laser means. 4. The method according to claim 1, wherein said topography is measured for a number of selected points. 5. The method of claim 4, wherein the data for each point is obtained in the form of a Gaussian coordinate or a position vector. 6. The method of claim 5, wherein the data of the point is stored in a medium for electronic storage. 7. The method of claim 4 wherein the point data is transferred from a topographic metrology site where measurements are made to a mask fabrication site where the material is shaped. 8. The method of claim 7, wherein the shaping comprises fabricating the topographic mask body by computer controlled shaving of the polymeric material. 9. The method of claim 8 including fabricating a through hole through which the means for coupling the flexible gas tube to the mask body is mountable. 10. The method of claim 7 wherein said shaping comprises making a replica of the topography by computer controlled cutting of the polymer material. 11. The method of claim 10, wherein said shaping comprises fabricating a mask body from a replica. 12. The method of claim 11, wherein the softening point of the polymer material used to make the replica is at least 20 ° C. higher than the softening point of the polymer material used to make the mask. 13. An optical system according to claim 1, wherein said optical means has photometric means.
the method of. 14. A respiratory mask manufactured by a process comprising non-contact measurement of topography of a portion of a human face. 15. The respiratory mask according to claim 14, wherein said non-contact measuring means includes optical means selected from the group consisting of laser means and photometric means. 16. A nose portion fabricated using a mechanically shaped replica of the nose portion using predetermined data for the air (gas) connection platform combined with the nose portion topography data. Respirator mask. 17. A method for making a respiratory mask that includes the use of a database containing face topographic data obtained by non-contact measurements. 18. The method according to claim 17, wherein the measurement is performed by an optical method selected from laser means and photometric means. 19. The method of claim 17 including obtaining data for an air (gas) connection platform separate from said non-contact measurement means. 20. A method according to claim 17, wherein said data is in the form of Gaussian coordinates or position vectors. 21. A means for making a respiratory facial mask, comprising non-contact means for measuring the topography of a portion of the face intended to be applied to the mask. 22. The means of claim 21 including optical means selected from laser means and photometric means. 23. The means according to claim 21 or 22, further comprising an automatic milling machine controlled by the data obtained through the measurement of the topography and independently obtained or selected data. 24. A database containing facial topography data obtained by non-contact measurements intended for use in making a respiratory mask. 25. The method of claim 24, wherein said measuring comprises using laser means.
Database. 26. A respiratory mask manufactured using the database according to claim 24 or 25. 27. A mask standard set manufactured according to the method of claim 1. Description: