RU2790784C1 - Medical device for guiding medical device for implantation of zygomatic implants and manufacturing method - Google Patents

Abstract

FIELD: dentistry; orthopaedics.

SUBSTANCE: group of inventions can be used in implantations, including zygomatic implants and implants for orthopaedic purposes. The medical device is oriented by way of orienting and guiding the medical device. The mechanism of the device contains the first and second sections. The first portion of the mechanism includes a contact point for positioning the EMPL at a selected location on the body portion of the BDY. The second section of the mechanism includes an operating module for guiding and maintaining this medical device. The mechanism provides movement of the contact element and the working module relative to each other in a two-way translational movement along a straight-line segment and keeps the medical device constantly aimed at the selected EMPL site. The operating module also supports a device guide for supporting a device drive including a powered drive for operating associated medical devices.

EFFECT: effect consists in the possibility to manually direct and drill a non-through channel in exact orientation towards an invisible target point without the help of other equipment.

37 cl, 22 dwg

Description

The field of technology to which the invention belongs

Embodiments of the invention relate to a medical device and methods of manufacturing such a medical device, in particular for use in dentistry and orthopedics, for example, implants, including zygomatic implants and implants for orthopedic purposes.

Description of related prior art

Implants and implants have been well known for many years, including zygomatic implants, which are dental implants in the maxillary bone.

Carlos Aparicio et al. published an article entitled “Zygomatic Implants: Indications, Methods and Results, and Code of Success for Zygomatic Implantation” in Periodontology 2000, Vol. 64, 2013, 1-18, available online at www.apariciozygomatic.com wp-content/uploads/2015/05/ Zygomatic-Success-Code_2.pdf, in which the extramaxillary implantation of the zygomatic implant in the skull is shown on page 3 as FIG. . 2. Intra-sinusal implantation of the zygomatic implant is shown on page 6 as FIG. 5.

In the catalog published on the Internet by Noris Medical of Nesher, Israel, at http://www.norismedical.com/products/catalog-2/, zygomatic implants, products and instruments for use with dental implants in general and with zygomatic implants , in particular, are presented on pages 22-25.

In US Patent No. 4,235,428, Jack H. Davis disclosed an orthopedic tool that improves the way in which bone through pins are inserted into bone fragments.

US Patent No. 4,257,411 issued to Kenneth O. Cho discloses a surgical drill guide adapted for temporary placement in the distal femur region to drill a bone canal through the femur region with great precision.

US Patent No. 4,848,327 to Kevin D. Perdue discloses a technique, procedure, and apparatus by which surgical pins or screws can be implanted into the body to secure an orthopedic nail to strengthen or reinforce or limit movement of a fractured bone.

International patent application WO 2010/054493 Al filed by Hans Stadler describes a device having a pulling element which is anchored in a first bone or bone fragment and which can be guided through a first bone canal into a second bone canal of a second bone or bone fragment.

US Patent No. 3,867,932 issued to Donald R. Huene discloses a block for connecting opposing segments of a broken bone using an improved clip to fix the segments in a mating manner.

US Patent Application No. 2007/0239168 filed by Thomas Kuenzi discloses a targeting device for inserting angle-determining long screws into a specific area of bone for optimal treatment of bone fractures using a plate/screw system(s),

US Patent Publication No. 20070055249, filed by David G. Jensen, discloses systems, devices, methods and kits for selectively making holes in bone plates to form threaded holes during insertion of bone plates.

The essence of the invention

A mechanism is presented for a medical device to guide a handpiece or a manually guided motorized drive to safely drill a non-through channel in the desired direction orientation.

The medical device 10 is intended for mechanically actuating and guiding medical devices such as drills, and for manually guiding implants and hand tools. The medical device has a mechanical mechanism having a first mechanism section and a second mechanism section.

The first section of the mechanism has a contact element for placement at a selected location on the body area. The second section of the mechanism has a working module for guiding and supporting the medical device 19. The mechanical mechanism provides the location of the contact element and the working module relative to each other in two directions along a straight line segment. In addition, the mechanical mechanism ensures that the medical device is constantly aimed at the selected location.

Also described is a method for manufacturing a medical device for implanting medical implants, including orthopedic implants, dental implants and ZI zygomatic implants. Also illustrated is an embodiment of a medical device in which the medical device structure is made from a solid and rigid piece of material.

Technical problem

The problem is that the user, most often a surgeon, has to manually guide and orient the hand-held canal drilling device, without the aid of imaging equipment and computational tools, in precise spatial orientation in a three-dimensional body volume. The problem is especially acute when a slight deviation of the drilled channel from the desired orientation is critical and can cause irreparable damage to the body. The chances of maintaining the desired direction and orientation of a manually guided drilled channel are rather doubtful. When precise orientation is critical, manual guidance is inappropriate. Deviation from the predetermined direction of drilling can lead to damage to the organ(s) affected by the drill, and the damage is sometimes irreparable. In other words, the problem is how to manually guide and drill a non-through channel in exact orientation towards an invisible target point without the help of other equipment. Such a problem occurs, for example, in the implantation of an intra-sinusal ZI zygomatic implant, as shown in FIG. B and C.

For purposes of illustration and orientation, FIG. A shows a portion of the BDY body including the BNE bone. The body may be a portion of a living organism, including skin, tissue, and bones, such as those of humans and animals. The area of the BNE bone not visible on examination is represented by dotted lines. A section of the BNE bone can be viewed at point A.

Consideration may be given to drilling a non-through BBOR link from an available NTRPNT entry point to, but no deeper than, the TRGTP target point. The TRGTP target point is hidden in the BNE bone, and the bone can be felt when touched from the outside BDYEX of the BDY body. The direct X-axis passes through the entry point NTRPNT and the target point TRGTP, enters the outer surface BDYEX of the body BDY at the selected location EMPL.

Such a problem occurs, for example, in the implantation of an intra-sinusal ZI zygomatic implant, as shown in FIG. B and C.

Fig. B is a front view of the patient's face showing the X-axis line. The X-axis indicates the direction chosen to drill the blind channel, which starts from the NTRPT entry located at point A on the maxillary gingiva MAX. The angles marked L and R around point A as the center of rotation indicate possible angular deviations from the X axis. Care must be taken to avoid deviations from the X axis to reduce damage to vital organs.

It is important to avoid such deviations from the x-axis. For example, the deviation by the angle R is represented as a channel crossing the orbit. However, angular deviations in the front view are not difficult to avoid, since they can be seen by extending the direction of the axis of the channel drilling tool. Rather, the problem is deviations in the cross-sectional plane passing through the X-axis perpendicular to the front view, as shown in FIG. C.

Fig. C is a schematic cross-section of the maxilla MAX representing the desired X-axis, the alveolar process ALVRG and entry point A. The crux of the problem to be solved is the angular deviations γ and δ from the X-axis, and around point A as the center of rotation. In contrast to the front view shown in Fig. B, cross section of FIG. C is hidden from view. Usually a hole is removed and made through the wall of the SNSWL maxillary sinus for visual inspection and to try to orient the drill. Despite this, such unwanted interference does not exclude unforeseen problems.

For zygomatic implantation, it is clear that the zygomatic implant ZI must be anchored in the zygomatic bone Z, represented approximately by dotted lines in FIG. B. The location of the zygomatic bone Z of the skull can be easily detected by the doctor by palpation of the face with the fingers, generally under the cavity of the orbit of the eye.

It is near and opposite the zygomatic bone Z that the physician or user of the medical device 10 and/or 310 will determine the placement of the selected EMPL site. Once the contact element 151 is located at the selected EMPL location, the user will have confidence that the required X-axis passes through the EMPL location and will exit through that defined location. The use of a dental device orienting device, or more specifically a dental drill orienting device, such as the medical device 10 and/or 310, provides confidence in the safety of implantation.

Solution

Fig. D illustrates an exemplary solution to this problem. The illustrated medical device 10 includes a mechanical mechanism 11 having a first section 12 and a second section 14. The first section 12 and the second section 14 are mutually connected to accommodate relative to each other in limited bi-directional translation along a straight line segment on the 10X axis. In FIG. D shows that the first section 12 supports the second section 14 and provides a mutual sliding translational movement of both sections. It can be said that each of the first section 12 and the second section 14 supports in a sliding manner.

The first section 12 supports the contact module 15, which holds the contact element 151, and the second section 14 supports the operating module 16. The contact element 151 is located on the BDY body at the location EMPL shown in FIG. A. The mechanical mechanism 11 is configured to continuously guide the longitudinal axis 199 of the medical device 19, such as the drill 19 supported by the work module 16, towards the contact member 151. In the description, the drill 194 may include predrill drills, finish drills , implant drills, blind canal drills and the like, for dental and orthopedic implants and medical interventions in general. By orienting towards each other, the medical device 19 and the contact element 151 are permanently positioned in linear alignment with the 10X axis and along the 10X axis of the medical device 10. Hence, when the contact element 151 is held in place by the EMPL and the medical device 19 is positioned at the entry point NTRPNT , the first and last are connected by the 10X axis. The X axis in Fig. A is coaxial with the 10X axis in FIG. D and both axes pass through the target TRGPT. Thus, when the medical device 19 is a drill driven by the work module 16, the blind channel BBOR will be aimed at the TRGTP target point. Thus, a solution to the problem is provided.

Useful results

The use of the medical device 10 ensures that, by means of the mechanically guided medical devices 19, they can be targeted from the NTRPNT entry point to the selected TRGTP target point and will not deviate from the straight line segment from the NTRPNT entry point to the TRGTP target point. Thus, damage to the patient, sometimes irreparable damage, is excluded.

Similarly, a stop member 20, or stop 20, is provided to limit the depth of the non-through BBOR and to prevent drilling further or deeper than desired, ie further and away from the target TRGTP. Thus, in the case of non-through channels, for example, for implants, physical damage to the body of the BDY is not allowed, the damage to which is sometimes irreparable.

The medical device 10 is independent and does not require external equipment, since it is designed to operate, for example, without the aid of imaging devices and/or computer processors running specialized computer programs.

The simplicity of the mechanical mechanism, the mechanical structure and the ease of use are additional excellent advantages of the medical device 10, in addition to light weight, rigidity and reliability, and being manufactured from medically practical suitable materials. Such materials may include metals, plastics and synthetic materials. In addition, the manufacturing of the medical device 10 can be achieved through conventional manufacturing processes.

Brief description of the drawings

Non-limiting embodiments of the invention are described with reference to the following description of exemplary embodiments in conjunction with the drawings. The drawings are generally not to scale and any measurements are for exemplary purposes only and are not necessarily limiting. In the drawings, identical structures, elements or parts which appear in more than one drawing are preferably indicated by the same or similar reference numeral in all drawings in which they appear and in which:

Fig. A-C and fig. D represent, respectively, the problem and the solution,

Fig. 1 is a schematic cross section through the upper jaw,

Fig. 2 - a medical device made in the form of a mechanical mechanism,

Fig. 3 illustrates guide bushings,

Fig. 4 - two planes of the mechanical mechanism,

Fig. 5-7 are alternative exemplary embodiments of the mechanical mechanism,

Fig. 8-19 are exemplary embodiments of a contact module and a contact block,

Fig. 20 - locking element supported by a mechanical mechanism,

Fig. 21 - locking element 21,

Fig. 22 - use of medical device 10 and

Fig. 23 - structural medical device 310.

Description of Embodiments

For the purpose of illustrating an exemplary problem, reference is made to dental surgery, for example, to the implantation of an intra-sinusal ZI zygomatic implant.

Fig. 1 is a cross section through the maxilla of the MAX. Cross section taken along the X axis of the ANCBR fixation channel drilled for implantation of the ZI intrasinus zygomatic implant. The ALVRG alveolar ridge lacks THT teeth, which however are represented by dotted lines.

In FIG. 1 on the profile line P, point A and point C limit the limits of the fixing channel ANCBR. Both points - and A, and C - are located on the X-axis. Anterior point A marks the entry point NTRPNT fixing channel ANCBR, while the entry point is located on the alveolar process ALVRG. Zygomatic implantation as an intervention usually requires the drilling of a non-penetrating BBOR canal, which is usually initiated by drilling at least one preliminary PRLMBR canal, followed by the formation of a canal to secure the ANCBR implant. The non-through BBOR canal usually starts at the NTRPNT entry point at anterior A, passes through the MXSNS maxillary sinus, and ends at the TRGPT target, near the Z zygomatic exit.

In FIG. 1 posterior point C indicates the TRGPT target point in the zygoma Z, while the target point may not extend outward. Going beyond the zygomatic bone Z means piercing the patient's face. Point C is reached after the fixation canal drill 193 has passed from the alveolar process ALVRG inward and through the maxillary sinus MXSNS and drilled the fixation canal ANCBR in the zygoma Z. Posterior point C is covered with TSS tissue and skin SKN of the face and is apparently located on the X axis fixing channel ANCBR. The X axis extends from the anterior point A through the MXSNS maxillary sinus, crosses the posterior point C, and then continues through the TSS tissue and SKN skin to the outer side of the face, thus to the outer side of the BDYEX body, through the user-selected EMPL site.

The user is generally a surgeon or physician, such as a dental or orthopedic surgeon, but the medical device 10, which is also a drill orienting device 10, may also be used by other medical practitioners.

It is the user who selects the location of the EMPL site on the skin SKN of the face to determine the orientation of the X axis, which means the choice of the orientation of the fixing channel ANCBR. The straight line segment from the anterior point A to the selected EMPL site will thus also pass through the posterior point C. Thus, the X-axis defines the axis of the fixation channel ANCBR, and thus also the spatial orientation of the zygomatic implant ZI.

mechanical mechanism

Fig. 2 schematically illustrates an exemplary embodiment of a medical device 10 implemented as a mechanical mechanism 11 including a first device section 12 and a second device section 14 that are interconnected for movement relative to each other. In FIG. 2, the relative motion is represented as a sliding motion, but alternatively, the relative motion may be other than sliding, and the mechanical mechanism 11 may include one or more bearings, clutches, hinges, hinges, or combinations thereof.

Each of the first and second portions 12 and 14, respectively, may be formed as a generally rectangular frame structure. The frame may be made from a set of first frame elements 120, forming the contour of the first section 12, and a set of second frame elements 140, forming the contour of the second section 14. When assembled, the first frame 12 and the second frame 14 can operate in mutually relative to bidirectional translational movement, and as an essentially flat mechanism. Substantially flat means in this case that the plane is not a geometric plane, but has some thickness, because, in fact, the first frame elements 120 and the second frame elements 140 are three-dimensional. With reference to the set of right-handed Cartesian coordinates shown in FIG. 2, the first section 12 and the second section 14 are located in the x-z plane. The first section 12 and the second section 14 can be translated in the same plane in the forward and reverse direction along the x-axis.

In the description, the terms "above", "above", "upper" and their synonyms refer to positive values along the z-axis, and the terms "below", "under", "lower" and their synonyms refer to negative values along the z-axis.

The first section 12 may have a generally rectangular shape formed by four first straight members 121 that include at least two parallel first transverse members 122, namely a first upper transverse member 123 and a first lower transverse member 124.

Perpendicular to the first transverse elements 122, the first section 12 may have two parallel first longitudinal elements 125, namely the first small longitudinal element 126, shorter than the longer first large longitudinal element 127. In FIG. 2, the first two transverse members 122 are shown to be parallel to the axis of the coordinate set, and the two first longitudinal members 125 are shown to be parallel to the z-axis.

Similarly, the first large longitudinal element 127 has a first additional section 128 and may thus be longer than the first small longitudinal element 126 by the first additional section.

As further described hereinafter, the first frame 12 may include two pairs of transverse linear bearings 13 or bushings 13 whose axis is parallel to the x-axis, such as one-piece bushings 13. Each of the longitudinal members 125 may support the connection of linear bearings 13 slides that are located on it at a distance from each other and parallel to each other and the x axis.

Each journal bearing 13 of the pair of journal bearings 13 supported by the first longitudinal members 126 is axially aligned with the opposing journal bearing 13 . Thus, a pair of plain bearings 13 located on the longer first large longitudinal member 127 are coaxially aligned with a pair of plain bearings 13 located opposite on the shorter first small longitudinal member 126. Obviously, the plain bearings 13 are chosen to slide onto second cross members 142.

The second section 14 may also have a generally rectangular shape formed by four second straight elements 141, including at least two parallel second transverse element 142, namely, the second upper transverse element 143 and the second lower transverse element 144. Perpendicular to the second elements 142 the second section 14 may have two second parallel longitudinal elements 145, namely the second small longitudinal element 146 and the second large longitudinal element 147, which is longer in comparison with it.

In FIG. 2, two second transverse straight members 143 are shown parallel to the x-axis of the coordinate system, and two longitudinal straight members 145 are parallel to the z-axis.

In addition, the second large longitudinal element 147 has a second additional section 148 and may thus be longer than the second small longitudinal element 146 by the amount of this second additional section.

Fig. 3 schematically illustrates two of the four guide bushes 13 mounted on the first large longitudinal member 127. FIG. 2 to connect the second section 14 to the first section 12, each of the two second transverse members 142, which have been previously connected to the second large longitudinal member 147, can be inserted into properly positioned and spaced bushings 13 located on both first longitudinal members 125. Distance 12D between the axes 131 of the bushings 13 mounted on the longitudinal element 125 is equal to the distance 14D between the axes 142X of the two second transverse elements 142, located parallel to the z-axis of the coordinate system shown in Fig.2. Thus, the second small longitudinal member 146 can be connected to both second transverse members 142 to form a second section 14. It should be noted that when a locking member 20 is provided, this latter may be mounted, for example, on one of the two second transverse members 142 prior to insertion. through the first set of bushings 13.

As soon as the two second transverse members 142 shown in FIG. 2 extend from two bushings 13 supported by a first large longitudinal member 127, a second small longitudinal member 146 shown in FIG. 2 can be fixedly connected to the second transverse members 142 to form a second section 14 within a rigid closed structure of four second straight members 141. Since the bushings 13 are supported in coaxial engagement with the second transverse members 142, the first section 12 and the second section 14 can slide freely. in bidirectional translational motion relative to each other. However, the second section 14 remains in the first section 12 and has limited translational freedom to move. In other words, when the second section 14 of the medical device 10 slides in the direction of the first section 12, in the direction of the positive values of the x-axis of the coordinate system shown in FIG. 2, the second large longitudinal element 147 will be delayed by the first small longitudinal element 126 of the first section 12. When the first section 12 slides away from the second section 14, thus expanding the medical device 10, the second small longitudinal element 146 of the second section 14 will delay the first large longitudinal element 127 of the first section 12. As described below, at least one translation locking member 20 may be adjustable to the second transverse member 142 to precisely limit the range of translational movement of the second section 14 relative to the first section 12.

In FIG. 2 shows that the second additional section 148, which is a continuation of the second large longitudinal element 147, is located parallel to the length of the first additional section 128, which is a continuation of the first large longitudinal element 127. The first and second additional sections, respectively 128 and 148, are appropriately located in of the same plane, but mutually opposite to each other, both for translational motion towards each other and translational motion away from each other. In other words, the second extension 148 can be translated in a first direction from the first extension 128 to expand and expand the medical device 10. To return and shrink the medical device 10, the second extension 148 is translated in a second direction opposite the first direction.

As shown in FIG. 4, such expansion or contraction may occur in the first plane 1PL, common to the first section and the second section, 12 and 14, respectively, and in the second plane 2PL, common to the first and second additional sections, 128 and 148, respectively. The second plane 2PL may be located at a predetermined angle α with respect to the first plane 1PL, wherein the angle α may be fixed or adjustable.

Alternative mechanical mechanisms

Fig. 5, 6 and 7 are schematic representations of alternative exemplary embodiments of many possible embodiments of the mechanical mechanism 11.

Fig. 5 illustrates a mechanical mechanism 11 in which, compared to FIG. 2, there is one difference, which is that the second section 14 supports the bearings 30. FIG. 6 is different from FIG. 2 in that the first and second frame elements, 120 and 140, respectively, are arranged perpendicularly and symmetrically with respect to the first and second additional sections, 124 and 128, respectively. In FIG. 7, the mechanical mechanism 11 is designed as a double flat bar-hinge mechanism, with the hinges having only one degree of freedom of movement.

contact module

As shown in FIG. 2, the first extension 128 supports a contact module 15 facing the second extension 148 which supports the operating module 16. The contact module 15 has a contact element 151 for contacting a BDY body site, such as a face. The term "body" BDY refers to a human or animal, while the BDY body may include tissue TSS, skin SKN and bones BNE, one of which may be located on the contact element 151. Alternatively, the contact element 151 may be located on the auxiliary element 157, is presented in fig. 9, and can be attached to the body of the BDY and be in contact with the body of the BDY, for example, with the help of an assistant or through the use of a belt or helmet-like device. The contact module 15 and the contact element 151 may be shaped according to the existing medical case, as well as suitable for operation and comfort when held in the hands of the user.

In FIG. 2, the medical device 19, supported by the working module 16, is represented coaxial with the X axis and directed towards the contact module 15. The medical device 19 is thus aligned and aimed at the contact element 151, or at the contact point 154, or at the EMPL site chosen user. However, although the medical device 19 is constantly aimed at a user-defined and selected EMPL site, the contact element 151 is not always in direct physical contact with the EMPL site, as described below,

In FIG. D medical device 19 is shown in the working position on the body of BDY. The axis 10X of the medical device 19 in FIG. D coincides with the X-axis shown in Fig. A, with the specified axis going from the entry point NTRPNT through the target point TRGPT to the selected location EMPL. The longitudinal axis 199 of the medical device 19 is directed towards the spiked contact element 151, which is to be located at the selected location of the EMPL. The tip of the stud 152 is an X-axis contact point 154, said contact point being in common with the selected EMPL site. Thus, the orientation selected by the user on the straight line segment from the NTRPNT entry point to contact point 154 is precisely defined. This accuracy of orientation allows the user to drill multiple adjacent, non-overlapping channels from various NTRPNT entry points to their respective selected EMPL locations, and moreover, without the danger of these channels intersecting. The user is thus provided with the orientation(s) for channels which he himself has chosen as safe for operation. The term "safe" means "not causing damage to the organs of the anatomy of the body BDY".

Thus, with the tip 198 of the medical device 19 at the NTRPNT entry point and the tip 153 of the spike 152 at the selected EMPL site, the medical device 10 is properly positioned. For example, when the medical device 10 is properly positioned by the user, it is accurately aimed to guide and orient the medical device 19 in a direction along which, for example, an IMPBR implantation channel can be safely drilled.

The contact module 15 can be made according to the type of surgical intervention or according to the selected EMPL site, or according to the auxiliary element 157 to which the contact element 151 will be attached, or also depending on the medical conditions. In addition, the shape of the contact element 151 can be customized as desired or needed. In addition, the ease of manipulation or holding of the contact element 151 can be increased by attaching to it a special manipulation device, not shown in the drawings.

Below with reference to FIG. 8-19 describe schematic exemplary illustrations of some exemplary embodiments of the contact module 15, which may be located on the free end section 1281 of the first additional section 128.

In FIG. 8 and 9 illustrate the contact element 151 located at or near the free end 1281 of the additional section 128. The contact element 151 may be in the form of a spike 152, which may be suitable in particular for use of the medical device 10 on the BNE bone. When positioned at the selected location EMPL of the BDY body, the tip 153 of the stud 152 defines a contact point 154 that coincides with both the tip 153 of the stud and the EMPL site.

In FIG. 10 and 11 shows a contact element 151 in the form of a contact ball 155 which makes contact with the BDY body at the contact point 154. like a contact ball 155. Similarly, spatially symmetrical elements like ellipsoids or hemispheres can also be used as contact elements 151, although this is not shown in the drawings. In FIG. 12 is an exemplary partial cross-section of an accessory 157 that is positioned between the contact ball 155 and the selected EMPL site, which is targeted by the axis 199 of the medical device 19. The contact ball 155 is not located at the selected EMPL site and is not in contact with the selected EMPL site. However, the user can visually locate and identify the selected location of the EMPL, which he has identified and optionally marked through the open hole 1510 that penetrates the accessory 157. NTRPNT entry points to the selected EMPL location.

In FIG. 13 shows an open hole 1510, or finger window 159, or finger hole 1531, which is located in the free end portion 1281 of the first additional portion 128. The open hole 1510 is selected such that, when positioned in place EMPL, the fingertip of the FNGRTP can pass through it so to create hand tactile contact with the FNGRTP fingertip as contact point 154, which matches the EMPL site. Prior to insertion of the FNGRTP fingertip into the open hole 1510, the open hole 1510 provides a visual check and study of the EMPL site. The EMPL site can be pre-marked with the MRK label.

In FIG. 14 shows a free end section 1281 of an additional section 128, to which, for example, the contact element 151 is fixedly fixed, say, by means of releasable mechanical fasteners 160 or latches, or by other such means known to a person skilled in the art. As a rule, in general for the contact elements 151, the removable contact element 158 may be removable, replaceable, and interchangeable with various other contact elements. In addition, the contact element 151 has a finger window 159, such as an open hole 1510, whether round or not, through which the FNGRTP fingertip can pass just enough to touch and probe the selected EMPL site. The contact point 154, at the center of the finger window 159 or open hole 1510, is shared with the EMPL site. The longitudinal axis 199 of the medical device 19 is thus aimed at the selected EMPL site, which can be located and felt through the finger window 159.

It should be noted that for the stud 153, the tip 153 of the stud 152 defines the contact point 154 to be located at a user-selected EMPL location. However, for example, when the contact member 151 is configured as the contact ball 155, the contact point 154 of the ball 155 is not limited to a single point on the surface of the contact ball 155. Regardless, the physical contact point on the BDY body must be the selected location of the EMPL.

In FIG. 15 and 16 are partial cross-sectional views of a schematic exemplary embodiment of a contact member 151 configured as a hinge mechanism 1511 having at least three degrees of freedom of rotation to provide increased ease of use. Fig. 16 is a partial cross-sectional side view taken along plane A-A shown in FIG. 15. The hinge mechanism 1511 can be connected to the free end section 1281 of the first additional section 128, or connected to it by the connecting element 1515, which is connected to it indirectly. Mainly, the hinge mechanism 1511 may include a core 1512, a connecting rod 1513, and a pin support 1514. The core 1512 of the hinge mechanism 1511 can thus be connected to the first additional section 128 or intermediate connecting element 1515.

In FIG. 15, a groove 1521 located in the x-y plane of the coordinate system is cut either in the first portion 128 or in the intermediate connector 1515. The groove provides a sliding fit for the free end 1516 of at least three pins 1517 that are fixedly cantilevered to the core 1512. Thus , the core 1512 can rotate about an axis parallel or coaxial with the z-axis of the Cartesian coordinate system.

In FIG. 15 and 16, a single through pin 1517 fixedly connected to the core 1512 and extending through the core 1512 supports the connecting rod 1513. The through pin 1517 is parallel to the y-axis of the Cartesian coordinate system, the axis of which is included in the sheet of paper. The end portions of the through pin 1517 are embedded in the core 1512. As shown in FIG. 16, the middle section of the through pin 1517 intersects the channel 1520. The core channel 1520 divides the core 1512 into two legs 1527 of the core, between which the connecting rod 1513 is supported by the through pin 1517. connecting rod 1513. The through pin 1517 is located at the center of curvature of the curved bore 1518. Thus, the stem 1513 is free to rotate clockwise CCW and counterclockwise ACCW, from one end of the curved bore 1518 to the other end, as represented by the arrows labeled respectively CCW and CCW. The connecting rod 1513 can thus rotate within a range of at least 120° in the x-z plane of the coordinate system.

Two connecting rod arms 1522 extend from the curved bore 1518, one arm 1522 from each end of the curved portion 1519 in which the curved bore 1518 is cut, and extend parallel to the Cartesian z-axis. At the free end 1523 of the connecting rod arms 1522 and between them, the pin support 1514 is held in a removable and replaceable manner. The finger support 1514 may be configured as a washer 1524 having an open channel and a washer channel 1525 whose center is the contact point. The washer 1524 is fixedly connected to two coaxially aligned and diametrically opposed pins 1526. Each pin 1526 is rotatably supported for rotation by the free end 1523 of each arm 1522 of the connecting rod. In FIG. 15, two pins 1526 are shown parallel to the x-axis of the coordinate system. To replace the pin rest 1514, the two connecting rod arms 1522 can be manually resiliently moved apart, the pin rest 1514 can be removed and replaced with another such pin rest 1514. The puck channel 1525 is sized so that when positioned in the EMPL site, the FNGRTP fingertip can pass through just enough to make tactile contact with the EMPL site. Optionally, the EMPL site may be pre-labeled MRK. Before inserting the FNGRTP fingertip into the open washer channel 1525, the finger rest 1514 allows visual inspection and inspection of the EMPL site. It should be noted that finger supports 1514 are interchangeable and available in various sizes and shapes to suit the user performing the intervention.

In FIG. 17 shows an alternative to a washer-shaped finger support 1514 in the form of a finger socket 1529 that can substantially enclose the tip of the FNGRTP of the finger located therein. The finger socket 1529 may be fixedly connected to two coaxially aligned and diametrically opposed pins 1526. Each pin 1526 is rotatably supported for rotation by the free end 1523 of each connecting rod arm 1522. The fingertip hole 1539 of the finger socket 1529 that encloses the FNGRTP fingertip may operate in the same manner as the washer channel 1525. The fingertip of the FNGRTP extends into the finger socket 1529 through the finger hole 1531, and the center of the fingertip hole 1539 or open hole 1510 is the contact point 154.

In FIG. 18 depicts a cross-sectional superimposition of washer finger support 1514 and finger socket 1529, showing that the FNGRTP fingertip can be considered as contact point 154 for both finger support 1514 and finger socket 1529. Finger supports 1514 and finger socket 1529 may be selectively interchangeable and have a variety of sizes and configurations to suit the user, EMPL site, and type of intervention.

The open washer channel 1525 and the fingertip hole 1539 of the finger socket 1529 are preferred for inspecting and touching the selected EMPL site. The user can indicate the selected location EMPL by overlaying the location recognition mark MRK shown in FIG. 17, for example, a cross, a dot or a circle with a dot in the middle. Such an MRK mark can be easily detected visually through the open channel 1525 of the puck or through the fingertip hole 1539 of the finger socket 1529. Thus, it is simple to locate the center of the washer channel 1525, or tip hole 1539, on the MRK mark. An additional advantage relates to the implantation of the ZI zygomatic implant into the Z zygoma. Typically, the layer of TSS tissue and SKN skin separating the EMPL site from the TRGTP target is rather thin. Therefore, the FNGRTP fingertip in the finger rest 1514 located at the EMPL site can easily sense the approach of an approaching operating motorized medical device 19. Such tactile detection is possible long before the medical device 19 leaves the zygomatic bone Z. The user will thus be able to stop drilling. BBOR blind channel, for example, when the TRGTP target point is reached, and prevent the IMPBR blind implant channel from going beyond the TRGTP target point.

For use of the medical device 10, after the preliminary medical preparation steps, an EMPL site and an NTRPNT entry point are first selected, and each of them may optionally be marked with an MRK label, if necessary. The contact point 154 of the contact element 151 is then positioned and rigidly held at the selected EMPL site, or may be appropriately positioned relative to it on the X-axis and in continuation of the X-axis extending from the NTRPNT entry point to the EMPL site. Optionally, contact member 151 may be held in place by an assistant, who may alternatively hold accessory member 157, if not attached to the BDY's body, by means of a harness or helmet-like device. Thus, the tool drive 18 is prepared as described below and is connected to the tool guide 17.

Working module

In FIG. 19 shows an operating module 16 which is fixedly connected to the free end section 1481 of the second additional section 148, and precisely oriented in the direction of the contact element 151. The operating module 16 is designed to support medical devices 19 and includes mainly a device guide 17 and 18 fixture drive. The tool guide 17 may be connected to the second additional section 148 or to its inner side 148a which faces the first additional section 128 shown in FIG. 2, or with its outer section 148b, which faces from the first additional section 128. The drive 18 of the device, which can be made as an independent module, is associated with the guide 17 of the device and is releasably engaged with it from the outside 148b of the second additional section. 148.

As shown in FIG. 2, the device guide 17 is fixedly and permanently aimed in an orientation facing the contact module 15. Thus, the longitudinal axis 199 of the medical device 19 supported by the device guide 17 is constantly coaxially aligned with the X axis, oriented in the direction and aimed at the contact point 154 contact element 151.

It is the configuration of the mechanical mechanism 11 that ensures that the longitudinal axis 199 of the medical device 19, such as the medical device 19 or the medical dental device 19, supported by the device guide 17, remains permanently aligned with the contact point 154. This alignment remains correct both when stopped and during of mutual relative movement between the first section 12 and the second section 14 of the mechanical mechanism 11. The medical device 10 ensures that, regardless of the spatial position and inclination of it and the working module 16, as soon as the contact element 151 is located at the selected location of the EMPL, and at the same time, the tip 198 of the medical device 19 is at the NTRPNT entry point, medical device 19 is targeted at the TRGTP target point. In other words, the medical device 19 is aimed at the contact element 151 or contact point 154, which is located at the EMPL site, on a straight line common linear axis X and 10X, which passes through the NTRPNT entry point and the TRGTP target point, as shown in FIG. D.

Fig. 19 illustrates a schematic embodiment of the work module 16 showing that the tool guide 17 includes a guide bush 172 which may support at least one adapter bush 173. The guide bush 172 may be fixedly but removably and replaceably connected to the second additional section. 148, for example, through the use of threads. The guide bush 172 is connected in coaxial alignment along the X axis, which passes through the contact point 154 shown in FIG. 2 and has a larger guide bush inlet diameter 174 followed by a smaller guide bush bore 175 relative thereto. The adapter sleeve 173 has a transfer sleeve 176 outer diameter 177 of the adapter sleeve that is configured to fit into the larger inlet diameter 174 of the guide sleeve 172. In addition, the adapter sleeve 173 has an outer diameter 177 adapter sleeve designed to guide and support the smaller inner diameter 175 guide bushing. In addition, the adapter sleeve 173 has an inner diameter 178 of the adapter sleeve that can be adapted to guide and support a special medical device 19 therein. medical device 19 of a specific diameter.

For example, guide sleeve 172 may have a smaller guide sleeve inner diameter 175 of a nominal size of 6 mm, and may be fitted to an adapter sleeve 173 having an adapter sleeve inner diameter 178 configured to guide a medical device 19 with a diameter of 4.2 mm. Such a medical device 19 may be a zygomatic implant fixation hole drill 183 or a zygomatic implant ZI, or another type of medical instrument. To drill the PRLBR pilot bore, the guide bushing 172 can be matched with an adapter bushing 173 having an inner diameter 178 of the adapter bushing corresponding to the diameter of the pilot drill 192, say 2.8 mm. Various medical devices 19 may be supported by the operating module 16 to take advantage of good targeting of the TRGPT target, in particular when the TRGPT target is hidden from view, such as in the case of a ZI zygomatic implant or when drilling a non-penetrating BBOR.

In FIG. 16 also shows a device actuator 18 which is actuated from the outside 148b of the second additional portion 148. The operating device 180 may include a medical device 19 to be powered or manually operated. The operating device 180 may thus include a motorized drive 181, such as a hand held handpiece 182 to which the medical device 19 is attached.

In use, the fixture guide 17 may need to be adjusted to the diameter of the dental fixture 19 supported by the fixture drive 18. However, if appropriate, the nominal bore of the guide bush 172 may be used. The bushing 173 is then inserted through the larger bore diameter 174 of the bushing 172 into the relatively smaller guide bore 175 by comparison. Insertion of the bushing 173 is stopped by the steps 179 of the guide sleeve that is located inside the larger inner diameter 174 of the guide sleeve 172. Finally, the medical device 19, either connected to the tip 182 or manually operated, is inserted into the inner diameter 178 of the adapter sleeve or into the smaller inner diameter 175 of the guide sleeve and is taken out of it.

Locking element

In FIG. 2 shows a motion restricting element 20 located on the second upper transverse element 143. The stop element 20 is designed to stop movement in one direction by abutting against the first small longitudinal element 126. Although not shown in the drawings, the movement restricting stop element 20 can be installed on the second lower transverse member 144. In addition, the locking member 20 may be located on both second transverse members 141. In general, the stopper member 20 is stopped by abutting the first longitudinal member 125. Alternatively, an additional second side locking member 201 may be attached to the second a portion 14 for supporting the locking element 20, as shown in FIG. 20. The movement-restricting stop member 20 located on the second transverse member 142 or on the additional stop member 201 can be manually adjusted by coarse adjustment or fine adjustment. Preferably, the locking element 20 is adapted for both coarse and fine adjustment.

In FIG. 20 schematically depicts an exemplary embodiment of a mechanical mechanism 11 having an additional stop member 201 having a circular cross section parallel to the first and second cross members 122 and 142, respectively. Preferably, the stop member 201 is a threaded rod. One end of the locking element 201 is connected to the second small longitudinal element l46, and the other end is connected to the second large longitudinal element 147. The passages 202, open in both first longitudinal elements 125, allow free movement through the locking element 201. The locking element 20 is represented resting on the locking element. element 201 located between the first small longitudinal element 126 and the second large longitudinal element 147.

Fig. 21 is a schematic partial cross-sectional illustration of an exemplary embodiment of an adjustable motion restricting stop member 20, or stop 20 for short. module 15, and vice versa. Stopper 20 allows the user to select the desired longitudinal separation distance 210, or separation gap 210 shown in FIG. 2, between the tip 198 of the medical device 19 and the contact element 151, by finely adjusting the placement of the stopper 20. The selected longitudinal distance 210 can thus be set as a limit beyond which the mutual relative motion between the operating module 16 and the contact module 15 cannot be reduced. For example, with the contact module 15 firmly fixed in place of the EMPL and with the tip 198 of the medical instrument 19, such as the medical drill 194, positioned at the entry point of the NTRPNT, the selected motion-restricting position of the stopper 20 allows the user to drill the BBOR blind channel to the selected user-defined channel length limits, but no further or deeper. By properly adjusting the motion restricting stopper 20, the user can thus safely drill the blind hole BBOR to exactly the desired depth, while the drilling depth can be limited so as not to go beyond the target TRGPT.

In FIG. 21 shows a stopper 20 to be placed on, for example, a threaded side stopper 201 having a small thread pitch. The spring-loaded piston 203 supports a blade 204 which is pushed between the threads of the locking element 201 by means of the elastic element 205. The elastic element 205, such as the coil spring 205, has a first end that abuts against the lower portion of the piston 203. The second end of the elastic element 205 abuts against the inner the bottom of the glass 206.

The glass 206 "hangs" on the side stop element 201, which passes through it through two diametrically opposed holes 211 of the glass provided in it. The holes 211 of the cup can be made as longitudinal slots intended for the free passage of the locking element 201 therein. The pusher 209, which supports the button 207, is mounted on the piston 203. press on the elastic element 205, two diametrically opposite slots 213 of the pusher can be combined with two diametrically opposite holes 211 of the glass, so that the transverse locking element 201 passes through both the slots of the glass and through the slots of the pusher, through 211 and 213, respectively.

With the blade 204 engaged with the threaded stop member 201, it is easy to manually rotate the stopper 20 around the stopper 201. With each full rotation of the stopper 20, the blade 204 moves a distance equal to the thread pitch of the transverse stopper element 201. For precision and fine adjustment, the stopper 20 can a thread having a small pitch, from 0.5 mm to 1 mm, should be preferred.

To move the stopper 20 in coarse adjustment by translational movement along the transverse stop member 201, which can be faster than through rotation in fine adjustment, the button 207 is pressed to apply pressure on the pusher 209 and piston 203, which, when pressed, disengage the blade 204 from the threads. of the threaded locking member 201. Two diametrically opposed open plunger slots 213 provided in the plunger 209 allow the transverse locking member 201 to pass through them, and further enable the plunger 209 to move perpendicularly and in the direction of the transverse locking member 201. Therefore, when the plunger 209 is pressed, the plunger 209 presses on piston 203, which in turn compresses spring 205. Thus, blade 204 disengages from the threads of lock member 201, and lock 20 can be translated in two directions for coarse adjustment of position.

Preferably, the stopper 20 provides two functions: fine adjustment of the selected longitudinal distance 210 by pivoting around the stopper element 201, as well as coarse adjustment and faster translational movement due to pushing the pusher 209 and sliding along the stopper element 201.

To assemble the stopper 20, the elastic element or spring 205 is inserted into the cup 206, and the piston 203 is installed on it, and the blade 204 is installed at a distance from the spring 205. Then the pusher 209 is installed on the piston 203. Then, by pushing the button 207, the pusher 209 is pressed against the spring-loaded piston 203. If necessary, the button 207 can be rotated to achieve alignment of two diametrically opposed slots 213 of the pusher with two diametrically opposed slots 211 of the glass. The stop member 201 then passes through the aligned pusher holes 213 and cup holes 211, and then the button 207 is released to allow the blade 204 to engage the threads of the stop member 201.

Medical device use 10

As described in Wikipedia on the Internet in the article "Zygomatic Implant", ZI zygomatic implants are used for dental rehabilitation when there is insufficient BNE bone in the maxilla. The medical device 10 can be used for both intramaxillary and extramaxillary zygomatic implantation. An example simplified for use in describing intramaxillary implantation and for using the medical device 10 in comparison of directional versus non-directional conventional implantation is described below with reference to FIG. 1 and 22.

In FIG. 22 is a simplified and brief illustration of an exemplary use of a ZI intramaxillary zygomatic implantation medical device 10 with reference to FIG. 1. First, the second section 14 of the medical device 10 is moved away from the first section 12. Then, the working module 16 is formed by attaching a device driver 18 thereto, which supports the dental device 19 connected to the tip 182 and driven by the tip 182. An adapter sleeve 173 may be used. The position of the stopper 20 is adjustable. The contact element 151 of the contact module 15 is located on the face of the patient, on the skin SKN opposite the zygomatic bone Z, on which the user has already selected the site EMPL by manual palpation. With the contact element 151 in place of the EMPL and the tip 198 of the dental tool 19 at the entry point of the NTRPNT, as shown in FIG. 1, tip 182 drills a blind hole. The blind hole BBOR is drilled to a stop by the stopper 20 and/or by finger sensing of the approach of the drill 194. The tip 182 is then withdrawn from the guide 17 of the tool. Finally, a manually inserted and secured dental fixture 19, optionally via fixture guide 17, can be used to complete the implantation.

It should be noted that the use of the medical device 10 does not allow for inconsistencies associated with the free manual non-directional direction of orientation and the drilling depth of the channel.

Mechanical design

Fig. 23 schematically illustrates a further exemplary embodiment of a medical device 10 as a structural medical device 310 constructed as a one-piece mechanical structure 311. Unlike the mechanical mechanism 11 described above herein, the mechanical structure 311 can be fabricated as a single rigid and reliable unit. , that is, one piece of material including a contact block 315 and a guide block 316. Mechanical structure 311 includes a first structural section 312 and a second structural section 314, which are mutually rigidly connected together by a third structural section 313 to form a rigid, generally arcuate forms.

Structural medical device 310 may be made from materials suitable for medical use, which may include metals, plastics, and synthetic materials. The fabrication of the structural medical device 310 may be achieved through conventional manufacturing processes, including additive printing, which processes are well known to those skilled in the art. Structural medical device 310 can be made in a variety of sizes and shapes, from which one structural device 310 of the proper size and shape for a particular medical procedure can be selected.

In the description, the terms "up", "above", "upper" and their synonyms refer to positive z-axis values, and the terms "down", "under", "bottom" and their synonyms refer to negative z-axis values.

As shown in FIG. 23, the first structural region 312 supports a contact block 315 facing a guide block 316 which is supported by the second structural region 314. The contact block 315 may be identical or similar to one of the embodiments of the contact block 15 described with reference to FIG. 8-14 for the mechanical mechanism 11. The contact block 315 has a contact element 3151 for making contact with the outside of the BDY's body, such as the face. The term "body" BDY means belonging to a living being, while the body BDY may include tissue TSS, skin SKN and bones BNE, on which one of the contact element 151 or 3151 may be located. Alternatively, the contact element 3151 may be located on the auxiliary element 157 as shown in FIG. 12. The accessory 157 may be held in contact with the body of the BDY, for example by an assistant or by a belt or helmet-like device, but this is not shown in the drawings. The contact block 315 and the contact element 3151 may be shaped according to the requirements of the existing medical case, as well as for ease of operation and comfortable holding in the hands of the user. Optionally, a contact element 3151 identical or similar to those in the embodiments of the contact module 15 described above with reference to FIG. 14-18 for the mechanical mechanism 11 may be used at the first end 3121 of the first structural portion 312.

In FIG. 23, the guide block 316 for supporting and guiding the dental appliances 19 includes a guide tube 3161, shown coaxially aligned along the X axis and aimed at the contact block 315. The medical devices 19 are thus aimed axially at the contact element 3151, or contact point 3154, or an EMPL site selected by the user to locate contact block 315 thereon. However, although medical device 19 is constantly aimed at a user-defined and selected EMPL site, contact element 151 is not always in direct physical contact with the EMPL site, as described below. .

In FIG. D shows the medical device 19 in working position on the body of BDY. The longitudinal axis 199 of the medical device 19 coincides with the X-axis shown in FIG. A, passing from the NTRPNT entry point through the TRGPT target point to the selected EMPL site. The longitudinal axis 199 of the medical device 19 is aimed at the spiked contact element 151 or 3151 located at the selected location of the EMPL. The tip 3153 of the stud 152 or 3152 is the contact point 154 located on the X axis. Thus, the orientation direction selected by the user on the straight line segment from the NTRPNT entry point to the contact point 154 is precisely determined. This orientation accuracy allows the user to drill a plurality of adjacent, non-overlapping channels. The user is thus provided with the channel orientation(s) he himself has chosen as safe to tamper with. Safety means no danger of damage to the organs and anatomy of the BDY body. Thus, with the tip 198 of the medical device 19 located at the NTRPNT entry point and the tip of the spike 152 or 3152 located at the selected EMPL site, the medical device 10 is properly positioned. For example, when properly positioned by the user medical device 10 and structural medical device 310 are accurately aimed at the accurately aimed and oriented medical device 19 in a direction along which a non-through BBOR channel, such as an IMPBR implant channel, can be safely drilled. The contact block 315 may be configured according to the type of surgery and/or according to the selected EMPL site on the BDY body region to which the contact element 151 or 3151 is attached, or to the auxiliary element 157 or 3157. In addition, the shape of the contact element 151 or 3151 may be customized according to desire or need. In addition, the ease of handling or holding the contact member 3151 can be improved by associating with it a special device for easy handling, which is not shown in the drawings.

The following will briefly describe with reference to FIG. 8-19 are schematic illustrations of several exemplary embodiments of a contact block 315 that may be located on the first structural portion 312.

In FIG. 8 and 9 illustrate a contact element 151 or 3151 in the form of a spike 152 or 3152, which may be suitable in particular for use of a medical device 10 on a BNE bone. When positioned at the selected location EMPL of the BDY body, the tip 153 or 3153 of the stud 152 defines a contact point 154 or 3154 coinciding with the tip 153 or 3153 of the stud.

In FIG. 10 and 11, a contact element 151 or 3151 is shown in the form of a contact ball 155 making contact with the BDY body at contact point 154 or 3154. A contact element 151 or 3151 ending as a hemisphere can be as effective as a contact ball 155.

In FIG. 12 is an exemplary partial cross-sectional view of an auxiliary member 157 positioned between the contact ball 155 and the selected EMPL site, which is targeted by the longitudinal axis 199 of the medical device 19. The contact member 151 or 3151 having the contact ball 155 is not positioned at the selected EMPL site. However, the user can visually locate and identify the selected EMPL site, which he has identified through the opening 1510 provided in the auxiliary element 157, to locate it on a straight line segment from the NTRPNT entry point to the TRGTP target point, as shown in FIG. D. FIG. 13 and 14 shows the free end section 1281 of the first additional section 128, or the first end 312 of the first structural section 312, in which the contact element 151 or 3151 or the contact element 151 or 3151 is formed, for example, fixedly attached, say, by removable mechanical latches 160 or by means of another attachment connected to the second additional section 148 by means known to those skilled in the art. The contact element 3151 or 151 may be removable, interchangeable and replaceable with other contact elements different from this. In addition, the contact element 151 or 3151 may have a finger window 159, such as an open hole 1510 or 3158, through which the tip of the FNGRTP finger can pass enough to touch and probe the selected EMPL site. The center of the finger window 159 or open hole 3158 can be considered as the contact point 3151 or 154. The longitudinal axis 199 of the medical device 19 is aimed at the selected EMPL site detected by the finger window 159 or 3158.

The contact element 3151 may also be in the form of a hinge mechanism 1511 for attachment to the first structural portion 312 as described in connection with FIG. 15-18 above in this document.

In FIG. 23 shows the structural guide 171 of the mechanical structure fixture 311 connected to the second end 3142 of the second structural portion 314, fixedly attached in a precisely oriented direction. The structural guide 171 of the device is designed to support medical devices 19 and is configured to support the drive 18 of the device. The structural guide 171 of the tool is fixedly connected to the end 3142.

Device actuator 18 may be coupled to and inserted into device structural rail 171 from outside 3142b of second structural portion 314. Operating device 180 may include a medical device 19 to be powered by a motor or manually. The operating device 180 may thus include a motorized actuator 181, such as a hand held handpiece 182 to which a medical device 19 is attached. transmitted to the working device 180 relative to the structural guide sleeve 1721. This is in contrast to the simultaneous movement of the guide 17 of the tool along with the drive 18 of the tool, as occurs when using a mechanical mechanism 11.

It is the configuration of the mechanical structure 311 that ensures that the longitudinal axis 199 of the medical device 19, such as an orthopedic device or dental device, supported by the structural guide 171 of the device, remains permanently aligned with the contact element 151 or 3151, or with the contact point 154 or 3154. Structural medical device 310 ensures that, regardless of its spatial position and inclination, once the contact element 151 or 3151 is placed at the selected EMPL site and the tip 198 of the medical device 19 is at the NTRPNT entry point, the medical device 19 is aimed at the TRGTP target point. In other words, the medical device 19 is aimed at the contact point 154 located at the EMPL site, on a straight X or 10X axis passing through the NTRPNT entry point and the TRGTP targeting point, as shown in FIG. D.

In FIG. 23 illustrates a schematic embodiment of a structural fixture guide 171 configured as a structural guide bushing 1721 that is fixedly connected to the end 3142 of the second structural portion 314. The structural guide bushing 1721 is connected coaxially with the X axis passing through the contact point 154 or 3154, as shown, respectively. , in FIG. 2 and 23. The structural guide bushing 1721 may be configured as a guide tube 3161 having a smaller inside diameter 175 that can be taken as the nominal inside diameter. The smaller inner diameter 175 may be configured to receive and support any of the adapter sleeves 173, or have a smaller inner diameter 178 that is designed to guide and support a particular medical device 19.

Similar to the guide bushing 172 of the mechanical mechanism 11, the structural guide bushing 1721 may have a smaller guide bushing inner diameter 175, which may have a nominal diameter of 6 mm, for example, and may correspond to a bushing 173 having a bushing inner diameter 178 suitable for guiding a medical fixtures 19 with a diameter of 4.2 mm. Such a medical device 19 may be a zygomatic implant fixation hole drill 193 or a medical implant such as a ZI zygomatic implant or other type of medical instrument. To drill the PRLMBR pre-channel, a bushing 173 can be inserted into the guide bushing 172 having a bushing inner diameter 179 corresponding to the diameter of the pre-drilling drill 192, say, 2.8 mm in diameter. Various sizes of adapter sleeve 173 may be provided to fit and support a plurality of medical devices 19. A plurality of medical devices 19 may be supported by the structural device rail 171 to ensure precise targeting of the TRGPT target, particularly when the TRGTP target is hidden from view, such as in the case of ZI zygomatic implant or when drilling a non-through BBOR canal for other purposes. Alternatively, the structural guide bushing 1721 may have a smaller guide bushing inner diameter 175 to suit the particular medical device 19.

Use of the structural medical device 310

Structural medical device 310 is another embodiment of medical device 10, but both provide guidance to ensure proper implantation of implants in the desired and selected directional orientation. The use of the structural medical device 310 is similar to the use of the medical device 10, in that the structural medical device 310 is manufactured as a single piece, as opposed to the first section 12 and the second section 14 of the medical device 10.

First, while not being expandable and retractable, a structural medical device 310 that is shaped and sized appropriate for a given intervention must be selected from a selection of such devices. Secondly, the working module 16 is formed by attaching to it the device driver 18, which supports the dental device 19, which is connected to the tip 182 and actuated by the tip 182. An adapter sleeve 173 can be used. The contact element 151 of the contact module 15 is located on the face of the patient , on the skin SKN opposite the zygomatic bone Z, on which the user selected the EMPL site by palpation. The dental fixture 19 is inserted so that it protrudes from the structural guide sleeve 1721.

With the contact member 151 in place of the EMPL and the tip 198 of the dental tool 19 advanced to the entry point of the NTRPNT as shown in FIG. 1, tip 182 drills a blind hole. The blind channel BBOR is drilled to a stop by finger palpation detection of the approach of the drill 194. The tip 182 is then withdrawn from the structural guide 171 of the fixture. Finally, insertion and fixation of the dental fixture 19 by hand, optionally by means of the structural guide 171 of the fixture, can be used to complete the implantation.

It should be noted that the use of the structural medical device 310 is not inconsistent with respect to the free manual non-guided direction of orientation and the drilling depth of the canal.

Thus, the medical device 10 and the method of guiding the medical device 19 have been described. The medical device 10 is generally intended for use by surgeons or doctors like dental surgeons, but is not limited to this field of medicine. Medical device 19 is considered as medical instruments and medical products used to perform a medical intervention or medical procedure. Such instruments may include drills, medical implants, and osteotomy instruments, powered or manually operated.

The medical device 10 may have a mechanical mechanism 11 having a first portion 12 of the mechanism that includes a contact module 15 supporting a contact element 151, which may represent a particular contact point 154, such as the tip of a spike, or have a surface point that can contact body region BDY. The term "body" BDY refers to the body of a living vertebrate organism and includes bone BNE, skin SKN and tissue. The location for the contact element 151 to make contact with the body of the BDY is determined by the user of the medical device 10 as the selected location of the EMPL.

The mechanical mechanism 11 may also have a second portion 14 of the mechanism, including an operating module 16, which is designed to guide and support the medical device 19. The term "guiding" means maintaining the desired direction of orientation. In other words, preventing the medical device 19 from deviating in an orientation direction other than the desired direction, which deviation may occur, for example, from encountering obstacles, which causes a deviation from the desired direction.

The mechanical mechanism 11 is additionally configured to move the contact element 151 and the working module 16 relative to each other. One of the two connecting elements, including the contact element 151 and the working module 16, can remain stationary, while the other of the two connecting elements can move closer to it or further away from the other. Relative movement can thus be bi-directional, but limited translational movement along a limited straight line segment. In addition, the mechanical mechanism 11 keeps the medical device 19 constantly and continuously aimed at and in the direction of the user-selected EMPL site. This thus also means that the mechanical mechanism 11 keeps the medical device 19 permanently and continuously aimed at the contact element 151 located at the selected location of the EMPL.

The operating module 16 is further configured to support a plurality of different medical devices 19, and to support the device guide 17 as well as the device guide 17 associated to operate with the device drive 18. The guide 17 of the device can support at least one of the guide sleeve 172 to guide the medical device 19, while the guide sleeve 172 is designed to support one or more adapter sleeves 173. The drive 18 of the device is designed to support a power drive 181, for example, a portable mechanical tool 182 with which the medical instrument 19 can be connected and to drive the medical device 19. The actuator 18 of the device is independent of the medical device 10 and of the mechanical mechanism 11. Therefore, the device guide 17, which is fixedly connected to the mechanical mechanism 11, is open to accommodating and guiding the hand-held medical instrument 19 for its manual operation, or before or after attaching the drive 18 of the device to work with the guide 17 of the device. In operation, the power drive 181 and the tool guide 17 can remain connected together by being held by a hand.

The contact element 151 supported by the contact module 15 may have an open hole 1510 that is intended to be inspected through it by visual inspection and/or manual tactile palpation of the selected EMPL site. The selected location of the EMPL may be located on the BDY body area including BNE bone, TSS tissue and SKN skin, as well as on the auxiliary member 157. The open hole 1510, which is open in the contact member 151, allows the user to inspect the accessory member 157 through it, or by visual inspection and/or by manual tactile palpation. It should be noted that the contact element 151 may be designed as a hinge mechanism 1511. The user is the operator of the medical device 10. In addition, the open hole 1510 may be selected to have the desired geometric shape.

The mechanical mechanism 11 is further configured to support at least one stopper 20. The at least one stopper 20 is designed to prevent further translational movement with the closing of the mechanism 11, thus preventing the first section 12 and the second section 14 of the mechanical mechanism 11 from being brought together. , for example, to prevent deeper drilling of the BRE channel. The locking element 20, which is supported and connected to the mechanical mechanism 11, can be controlled and fixed on it, but is removable, for adjustment to the desired location. In this way, it is possible to adjust the separation gap 210 which separates the contact element 151 and/or its contact point 154 and the tip 198 of the medical device 19 in an adjustable manner. BBOR channel. Adjustment of the position of said at least one stopper 20 may be obtained by either one or both of the fine adjustment control and the coarse adjustment control. The contact point 154 of the contact element 151 may further be designed to be placed on the auxiliary element 157, which is supported on the body of the BDY. However, care is required, such as the use of tactile palpation and/or visual inspection, to maintain contact point 154 in position along a straight line segment aimed at the selected EMPL site.

The first section 12 and the second section 14 of the mechanical mechanism 11 are configured to operate in the first operation plane 1PL. The first additional section 128 is connected to the first section 12, which supports the contact module 15, and the second additional section 148 is connected to the second section 14, which supports the working module 16. Both the first additional section 128 and the second additional section 148 are configured to work in the second planes of work 2PL. However, the first operation plane 1PL and the second operation plane 2PL may be either the same plane or different planes. However, the medical device 10 is further configured to hold an independent handheld device of rigid mechanical construction. In addition, the medical device 19 remains constantly aimed at the open hole 1510 along a straight line segment, regardless of the movement and immobility of the mechanical mechanism 11 and at least one of the medical devices 19. In addition, the device guide 17 is further configured to support at least one medical device 19 aimed at the contact point of the contact element 151, and the actuator 18 of the device is configured to actuate said at least one medical device 19 by itself and in combination with at least one of a rectilinear translational movement, a rotational movement, and a reciprocating - progressive movement.

In another exemplary embodiment, the medical device 10 may be implemented as a structural medical device 310 having a mechanical structure 311 for guiding and orienting the medical device 19. The structural medical device 310 may support a first structural region 312, a second structural region 314, and a third structural region, with In this case, these three sections are rigidly connected together. The structural medical device 310 may have a curved C shape in which one end of the C supports the contact block 315 and the other end of the C supports the structural guide 171 of the device.

The first structural portion 312 may support a contact block 315 having a contact member 3151 designed to be placed on a selected EMPL site in the BDY body region, and the second structural portion 314 may support a structural device guide 171 that holds and guides the medical device 19. In addition, the mechanical structure 311 is configured to continuously guide and aim the longitudinal axis 199 of the medical device 19 at the contact element 3151. Thus, the mechanical structure 311 is designed to keep the medical device 19 aimed at the contact element 3151 in coaxial alignment relative to each other along a straight line segment.

The structural fixture guide 171 may be configured to support at least one dental fixture 19 and at least one adapter sleeve 173. The contact member 3151 may have an open hole 3158 designed to be inspected through it by at least one of visual inspection and tactile palpation. a selected EMPL site located on a BDY body site including BNE bone, TSS tissue, and SKN skin.

The contact point 3154 of the contact element 3151 may further be designed to be placed on the auxiliary element 157, which can be supported on the body of the BDY and oriented along a straight line segment. However, care is required, such as tactile palpation and/or visual inspection, to keep the contact point 154 in position along a straight line segment aimed at the selected EMPL site.

Structural medical device 310 may be implemented as an independent portable device of rigid mechanical structure 311 and may be manufactured through an additive printing process.

The contact element 3151 may be configured to support the hinge mechanism 1511.

The structural guide 171 of the device is further configured to operate in conjunction with a portable power actuator 181 to which the medical device 19 is connected. motion, rotary motion and reciprocating motion.

Industrial Applicability

The medical device 10 and the structural medical device 310 are suitable for manufacturing by the medical device and medical instrument industry.

Link List

# Name

α angle

β angle

γangle

δ angle

A forward point

ALVRG alveolar process

ANCBR channel for anchoring the implant

BBOR blind channel

BDY body

BDYEX outer side of the body

BNE bone

BNPRT small open area

BRE channel

C target point

DRLL drill

EMPL selected location

FGR finger

FNGRTP fingertip

MRK label

MXSNS maxillary sinus

NTRPNT entry point

P profile line

PIV turn

PRLBR pre-channel

SNSWL sinus wall

SKN leather

THT teeth

TRGTP target point

TSS fabric

ZI zygomatic implant(ation)

1PL first work plane

2PL second work plane

10 medical device or drill orientation device

10X axis targeting device

11 mechanical movement

12 first section

13 longitudinal bearings

14 second section

15 pin module

16 working module

17 fixture guide

18 fixture drive

19 medical device

20 stop or stop element

120 first frame element

121 first straight element

122 first cross member

123 first upper transverse member

124 first lower cross member

125 first longitudinal element

126 first small longitudinal element

127 first large longitudinal element

128 first additional section

128a inner side of the first additional section 128

129 locking element

1281 section of the free end of element 128

12D axle spacing 131

12M straight element

14D distance 14D between axles 142X

13 axle distance 131

131 axles in the first section

14 second section

140 second frame element

141 second straight element

142 second cross member

42X axles on the second section

143 second upper cross member

144 second lower cross member

145 second longitudinal element

146 second small longitudinal element

147 second large longitudinal element

148 second additional section

148a inner side of the second additional section

148b outer side of the second additional section

1481 section of the free end of element 148

151 contact elements

152 spike

153 spike tip

154 contact point

155 contact ball

156 contact hemisphere

157 auxiliary element

158 removable contact element

159 finger window

160 fasteners

1510 open hole

1511 hinge mechanism

1512 core

1513 connecting rod

1514 finger support

1515 intermediate element

1516 free end of element 1517

1517 through pin

1518 curved channel

1519 curved section of element 1513

1520 core channel

1521 groove

1522 connecting rod arm

1523 free end of element 1522

1524 puck

1525 washer channel

1526 pin

1527 core branch

1528 element center 1530

1529 finger socket

1530 hole for the fingertip of element 1529

1531 finger hole

171 structural fixture guide

1721 structural guide bush

172 guide bush

173 adapter sleeve

174 larger inner diameter of the guide bush

175 smaller inner diameter of the guide bush

176 transfer flange

177 adapter sleeve outer diameter

178 inner diameter (reducing sleeve)

179 guide bush pitch

180 working device

181 mechanized drives

182 tip

19 medical device

190 medical instrument

191 osteotomy instruments

192 pre-drill

193 drill for fixing/implantation channel

194 drill

195 medical implant

196 insertion and fastening tool

197 depth gauge

198 medical device tip

199 longitudinal axis of element 19

20 stop or stop element

201 locking element

202 stop pass

203 piston

204 blade

205 elastic element

206 glass

207 button

209 pusher

210 longitudinal distance or separation gap

211 glass hole

213 pusher slot

310 structural medical device

311 mechanical structure

312 first structural section

3121 first end of element 312

313 third structural section

314 second structural section

3142 end of the second section of element 314

3142a inner side of element 3142

3142b outer side of element 3142

315 contact block

3151 contact element

3152 spike

3153 spike tip

3154 contact point

3157 auxiliary element

3158 open hole

316 guide block

3161 guide tube

Claims (79)

1. A medical device 10 for guiding a medical device 19 for implanting zygomatic implants, which contains: mechanical mechanism 11, containing: a first section 12 of the mechanism connected to the first additional section 128, and including a contact element 151 or a contact point 154, configured to be located at a selected location of the EMPL on the body section BDY, and a second section 14 of the mechanism connected to the second additional section 148, and including an operating module 16 configured to guide and support the medical device 19, while the mechanical mechanism 11 is additionally configured to: provide displacement of the contact element 151 and the working module 16 relative to each other in two-way translational movement along a segment of a straight line, and maintain the medical device 19 constantly aimed at the selected EMPL site through the open hole 1510 of the contact element 151, while the specified hole is intended for visual inspection and/or tactile palpation of the selected EMPL site through it, wherein the first section 12 and the second section 14 are located in the first operation plane 1PL, and the first additional section 128 and the second additional section 148 are located in the second operation plane 2PL, and the first work plane 1PL and the second work plane 2PL are either the same plane or different planes. 2. The apparatus of claim 1, wherein the mechanical mechanism 11 is further configured to aim the medical device 19 at the contact element 151. 3. The device according to claim 1, in which the working module 16 is additionally configured to support medical devices 19. 4. The apparatus of claim. 1, in which the work module 16 is further configured to support at least one of the guide 17 of the fixture, and the guide 17 of the fixture, which is associated with the actuator 18 of the fixture. 5. The apparatus of claim 4, wherein the tool guide 17 supports at least one of the guide bush 172 and the guide bush 172 which supports the adapter bush 173. 6. The apparatus of claim 4, wherein the device drive 18 is configured to support a power drive 181 to which the medical instrument 19 is connected and to drive the medical device 19. 7. The apparatus of claim 6, wherein the power drive 181 is a portable power tool 182. 8. The device of claim. 1, in which the contact element 151 is designed to be located on the selected site EMPL of the body BDY, including bone BNE, tissue TSS and skin SKN, as well as to be located on the auxiliary element 157 connected to the body. 9. The apparatus of claim 1, wherein the contact element 151 has an open hole 1510 designed to be inspected through it by at least one of visual inspection and manual tactile palpation, such that drilling of the blind hole BBOR is stopped when the approach of the drill 194 is detected by palpation. . 10. The device according to any one of paragraphs. 1 or 6, in which the mechanical mechanism 11 is further configured to support at least one stopper 20 designed to controllably adjust the location of a predetermined separation gap 210 that separates the contact point 154 of the contact element 151 and the tip 198 of the medical device 19. 11. The apparatus of claim 10, wherein the controlled adjustment of the location of the stopper 20 includes at least one of a fine adjustment control and a coarse adjustment control. 12. The device according to claim 1, in which: the contact point 154 of the contact member 151 is further adapted to be located on the auxiliary member 157 which rests on the body of the BDY, and contact point 154 remains located on a straight line segment directed to the selected EMPL location. 13. The apparatus of claim 1, wherein the first operation plane 1PL and the second operation plane 2PL are arranged at an angle α relative to each other, wherein the angle α is one of a fixed angle and an adjustable angle. 14. The device according to claim 1, which is additionally made as an independent portable device of a rigid mechanical design. 15. The apparatus of claim 9, wherein the contact element 151 is designed as a hinge mechanism 1511 having at least three degrees of freedom of rotation. 16. Apparatus according to claim 6 wherein, in operation, the power drive 81 and tool guide 17 remain connected together by being held by the hand. 17. The device according to claim 9, wherein the medical device 19 is constantly aimed at the open hole 1510 along a straight line segment, regardless of the movement and immobility of the mechanical mechanism 11 and the movement of at least one of the medical devices 19. 18. The device according to claim 4, in which: the device guide 17 is further configured to support at least one medical device 19 aimed at the contact member 151, and device drive 18 is configured to actuate said at least one medical device 19 alone and in combination in at least one of linear translational motion, rotational motion, and reciprocating motion. 19. The device of claim. 10, wherein said at least one stopper 20 is adjustable to limit the depth of penetration of the medical device 19 into the blind channel of the BBOR. 20. The device of claim 9, wherein the opening 1510 is selected to be of the desired geometry so that the FNGRTP fingertip passes through to provide manual tactile contact with the EMPL site. 21. A method for manufacturing a medical device 10 for directing a medical device 19 for implanting zygomatic implants, characterized in that it contains the steps in which: manufacture a mechanical mechanism 11, while: providing a first section 12 of the mechanism connected to the first additional section 128 and having a contact element 151 made to be located at the selected location of the EMPL on the body section of the BDY, provide a second section 14 of the mechanism connected to the second additional section 148 and having an operating module 16 made to support the medical device 19, wherein the first section 12 and the second section 14 are located in the first operation plane 1PL, and the first additional section 128 and the second additional section 148 are located in the second operation plane 2PL, and the first operation plane 1PL and the second operation plane 2PL are located either in the same plane or in different planes, a mechanical mechanism 11 is adapted to aim the longitudinal axis 198 of the medical device 19 at the open hole 1510 of the contact element 151, which is intended to be visually inspected through it by visual inspection and/or tactile palpation of the selected EMPL site, and to providing a mutual relative displacement between the working module 16 and the contact element 151 in a two-way translational motion along a straight line segment and in a constant mutual aiming of the medical device 19 in an orientation directed along a straight line segment, and form the contact element 151 as a hinge mechanism 1511 having at least three degrees of freedom of rotation. 22. The method of claim. 21, in which the work module 16 is additionally designed to support medical devices 19. 23. The method according to claim 21, in which: the work module 16 includes a tool guide 17 and a tool driver 18 that can be inserted into and out of the tool guide 17, and removing the device drive 18 from the device guide 17 allows the latter to support and guide the medical devices 19 within it. 24. The method of claim 23, wherein the fixture guide 17 is configured to support and guide the dental fixtures 19 by using adapter sleeves 173 of suitable diameter. 25. The method of claim. 24, in which the adapter sleeves 173 are supported in the guide 17 of the device in a removable engagement within it and with the possibility of releasable removal from it. 26. The method according to claim 23, in which: the fixture drive 18 is designed to support a portable power drive 181 designed to provide movement to the dental fixture 19 supported by it, and portable motorized drive 181 is a tip 182. 27. The method according to claim 21, in which: contact element 151 has an open hole 1510 adapted for: location at the selected EMPL site, and providing verification through visual inspection and tactile palpation of the selected EMPL site through the specified open hole 1510. 28. The method of claim 21 wherein the hinge mechanism 1511 includes a pin support 1514 that is removable and replaceable. 29. The method according to claim 23, in which: the device guide 17 is further adapted to support at least one medical device 19 aimed at the contact member 151, and device drive 18 is configured to drive said at least one medical device 19 alone and in combination in at least one of linear translational motion, rotational motion, and reciprocating motion. 30. The medical device 10 for guiding the medical device 19 for implanting zygomatic implants selected as the motor-driven medical device 19, which contains: mechanical mechanism 11 supporting: the first section 12 connected to the first additional section 128, which supports the contact element 151, configured to be located at the selected location of the EMPL on the body section BDY, a second section 14 connected to a second additional section 148, which supports, holds and guides the device 19, while the first section 12 and the second section 14 are located in the first work plane 1PL, and the first additional section 128 and the second additional section 148 are located in the second plane operation 2PL, and the first plane of operation 1PL and the second plane of operation 2PL are either the same plane or different planes, while the mechanism 11 is additionally configured to constantly guide and aim the fixture 19 at the open hole 1510 of the contact element 151 and to provide : displacement of the contact element 151 and fixture 19 relative to each other in a two-way translational movement along a straight line segment, and visual inspection of the EMPL site and / or manual tactile contact with it with the tip of the FNGRTP finger through the open hole 1510, wherein the fingertip of the FNGRTP senses the approach of an approaching motor-driven medical device 19. 31. The device according to claim 30, in which: the mechanical mechanism 11 is configured to support the medical device 19 aimed at the contact member 151 in coaxial alignment with respect to each other along a straight line segment, and the contact member 151 supports a finger window 159 so that the fingertip of the FNGRTP can touch the EMPL site. 32. The device according to claim 30, in which: the first plane 1PL and the second plane 2PL are at an angle α relative to each other, and said angle α is one of a fixed angle and an adjustable angle. 33. The device of claim. 30, wherein the contact element 151 is configured to be placed on a selected site EMPL, which is located on the body site BDY, including bone BNE, tissue TSS and skin SKN. 34. The apparatus of claim 31, wherein the contact element 151 is further adapted to be positioned on an auxiliary element 157 to be held in contact with the body of the BDY. 35. The device according to claim 30, in which the contact element 151 is additionally made as a hinge mechanism 1511. 36. The apparatus of claim 30, wherein the contact member 151 is configured as a hinge mechanism 1511 having at least three degrees of freedom of rotation to provide increased ease of use. 37. The device according to claim 30, in which the motor-driven medical device 19 is configured to be actuated by a hand-held motorized actuator 181, alone or in combination, in at least one of a linear translational motion, a rotational motion, and a reciprocating motion.

Images