MXPA97006125A - Localized method and apparatus - Google Patents

Abstract

The present invention relates to an apparatus for determining an external location corresponding to a musculoskeletal lesion, comprising: an annular ring defining a marker capable of being removably placed at an external site adjacent to a musculoskeletal lesion, the ring being formed at least part of a material at least partially visible through a means to visualize the musculoskeletal injury and being dimensioned to cause minimal damage to the musculoskeletal injury, and an elongated band to secure the annular ring to the external site, the band having portions of opposite ends respectively connected to diametrically opposed arched sections of the ring, so that a central spatial region circumscribed by the ring, is practically unobstructed by the

Description

"LOCALIZER METHOD AND APPARATUS" BACKGROUND OF THE INVENTION 1. FIELD OF THE INVENTION This invention relates to apparatuses and methods for treating and / or therapeutically diagnosing musculoskeletal injuries by ultrasound. Ultrasonic therapy is particularly appropriate for accelerating the healing of bone and muscle injuries - fractures, tears, tensions and the like - but it is also applicable to other injuries. 2. DESCRIPTION OF THE RELATED TECHNIQUE The use of ultrasound to treat and evaluate therapeutically bone injuries is already known. The application of ultrasound of appropriate parameters in appropriate dosages in an appropriate external location adjacent to the bone lesion, accelerates natural healing with few or no detrimental side effects. For patients with reduced scarring ability, such as elderly people, ultrasonic therapy may activate the healing of bone lesions that would otherwise require prosthetic replacement or leave the patient permanently incapacitated. U.S. Patent No. 4,530,360 issued to Duarte ("Duarte") discloses a basic therapeutic technique and apparatus for applying ultrasonic pulses of an operative surface, placed on the skin in a location adjacent to a bone lesion. The "operating surface" of an ultrasonic delivery system, as the term is used in this application, is the exposed tangible surface of the system that transmits the ultrasonic pulses to the environment. For systems where the surface of the transducer is exposed, the operating surface is the surface of the transducer. Duarte provides a scale of radiofrequency signals to create ultrasound, ultrasound power density levels, a duration scale for each ultrasonic pulse, and a frequency scale of the ultrasonic pulse. The duration of daily treatment is also described. US Patents Nos. 5,003,965 and 5,186,162 both issued to Talish and Lifshey (Patent • 965 of Talish "and Patent Number '162 of Talish", respectively) describe an ultrasonic delivery system in which the radiofrequency generator and the transducer both form part of the a modular applicator unit that is placed in the location of the skin. The signals that control the duration of the ultrasonic pulses and the repetition frequency of the pulse are also generated from the applicator unit. Patents '965 of Talish and' 162 of Talish also describe an apparatus for fixing the applicator unit so that the operative surface is adjacent to the location of the skin. In Patents Number '965 of Talish and Number' 162 of Talish, the skin is surrounded by a plastered bandage, while in the US Patent Number 5,211,160 issued to Talish and Lifshey ("Patent Number '160 of Talish") the apparatus of describes to be mounted on uncovered body parts (ie, without a plastered bandage or other medical wrap). Patent Number '160 of Talish describes several improvements for the applicator unit. Duarte, Patents Numbers' 965 of Talish, Number '162 of Talish and Number' 160 of Talish, all are incorporated in this application by reference. Even when the systems described in these references and others disclose a basic therapeutic method and apparatus for a person skilled in the art, they do not disclose a method or apparatus for positioning the operative surface adjacent to the skin for therapeutic treatment. The placement of the operative surface at the location of the outer skin approximated by the lesion leads to the optimal ultrasonic therapy received. If the operative surface is not positioned correctly, the ultrasound received in the lesion can be attenuated and the reduction in the healing time is less than ideal. Therefore, an object of the invention is to provide methods and apparatus for determining an external location corresponding to an internal injury. An external location includes a location on the skin, a cast bandage, or other medical wrapping. A specific object of the invention is to provide a method for delivering ultrasonic treatment at a location on the skin that corresponds to an internal injury, in particular, a musculoskeletal injury.

COMPENDIUM OF THE INVENTION To achieve these objects, the present invention includes an apparatus for determining an external location corresponding to a musculoskeletal lesion comprising a marker capable of being removably placed in an external location adjacent to a lesion, the marker being formed, at least in part from a material, at least partially visible through a means to visualize the lesion. The visualization of the lesion can be carried out with X-rays, for example, and, for that case, the marker would be formed of a visible material in an X-ray, such as, for example, stainless steel. The present invention also includes a method for determining an external location corresponding to an internal lesion comprising the steps of placing a marker at an external location adjacent to an internal lesion, simultaneously visualizing the marker and the internal lesion and marking an approximate external location. which corresponds to the internal injury. When X-rays are used to simultaneously visualize the marker and the internal lesion, the X-ray is used to prepare a map of the approximate external location corresponding to an internal lesion. The present invention also includes a method for delivering an ultrasonic treatment at a location on the skin that corresponds to an internal injury, comprising the steps of placing a marker at an external location adjacent to the internal lesion, and simultaneously smoothing the marker and the internal injury, mark an approximate external location corresponding to the internal lesion and place an operative surface of an ultrasonic delivery system adjacent to the approximate skin location corresponding to the internal lesion. When the skin is surrounded with a plastered edge or other medical wrap, an approximate external location is first determined on the plastered bandage or medical wrap corresponding to the internal lesion. The plastered bandage or medical wrap is then partially removed exposing the approximate location of the skin corresponding to the internal lesion, thus allowing access so that the operative surface is placed adjacent to the skin.

BRIEF DESCRIPTION OF THE DRAWINGS Preferred embodiments of the invention are described below with reference to the drawings, which are described as follows: Figure 1 is a perspective view of a locating ring and band; Figure 2 is a perspective view of a locating ring and band mounted adjacent to a member with the plastered edge surrounding it; Figure 3 is a perspective view of a template placed centrally above a mark on the plaster bandage; Figure 4 is a detailed perspective view of the plaster bandage with a removed section and an attachment for stopping and aligning an ultrasonic treatment module; Figure 5 is a perspective view of the attachment that is secured in the plaster cast in the removed section; Figure 6 is a perspective of the plastered bandage, the accessory and a lid for the accessory; Figure 7 is a detailed perspective view of a treatment module aligned with the fitting; Figure 8 is a detailed perspective view of an attachment attached to a bare member, and Figure 9 is a detailed perspective view of an attachment and a treatment module affixed to a bare member; DETAILED DESCRIPTION OF THE PREFERRED MODALITIES Figure 1 shows an apparatus 10 included in the invention in the form of a locating ring 14 with a band having two sections 18,22. The ring 14 is constructed of a material that can be seen in a selected medical display system. Therefore, if X-rays are used, the ring 14 is at least partially opaque to the X-ray radiation; if infra-red radiation is used, ring 14 is at least partially opaque to infra-red radiation; if magnetic resonance imaging is used, the ring 14 is at least partially paramagnetic. The dimensions of ring 14 of Figure 1 are a function of the size of the patient, the size and location of the lesion of the display system used. For a fracture of bone in an average human limb, and for visualization systems using X-rays, infra-reds and magnetic resonance imaging, for example, the diameter of the ring can nominally be 3.81 centimeters, the ring may be a rigid protruding torus of metallic material of diameter in cross section nominally .51 millimeters. If the display system uses ultrasound in the above-mentioned circumstances, the ring is essentially flexible and flat, so that it can be contoured on a surface that is placed adjacent to, thereby allowing the transducer to move across the surface and the ring. The band of Figure 1 has two sections 18,22, each section is fixed to the ring 14. The two sections 18,22 have a hook-and-loop type fastener assembly so that they can be held together. Other adjustment fastening means may be substituted. Figures 2 to 7 demonstrate a sequence of the invention in the method. The following description assumes that the medical display system is an X-ray but that it is easily adaptable to other systems, including those to which reference is made above. Figure 2 shows the apratus 10 of Figure 1 attached with bands to a member with a plaster bandage 34. The locator ring 14 is initially placed in the bandage 34 plastered at a site corresponding to the fracture of the bone. This initial position is a preliminary approximation of the external location of the bone fracture, and may be based on the X-rays taken previously, or the physician's or patient's recall of the point of the lesion on the surface. An external X-ray of the fractured region is taken to include the location ring 14. Although the initial position of the locating ring 14 with respect to the internal lesion is a preliminary approach, in many cases the initial placement will be sufficiently accurate so that the X-rays will illustrate the internal lesion surrounded by the ring 14.

The X-ray shows the position of the bone fracture in relation to the location ring 14. The X-ray is used as a guide to locate at the mark 38 the corresponding point in the plaster bandage in relation to ring 14 of actual location. The mark 38 provides an approximate external location of the plaster cast of the bone fracture. If greater accuracy is required, the ring 14 can be centered around the mark 38, another X-ray is taken, and a new mark (not shown) is made on the plaster cast based on the location of the bone fracture relative to the ring. in the X ray. The successive iterations of the relocation of the localization ring 14 and the X-rays of the site will yield even greater accuracy. As shown in Figure 3, a rectangular template 42 is pressed against the plaster bandage 34 and is centered on the mark 38 of the external location of the cast bandage 34 of the bone fracture. The contour of the inner edges of the insole opening is traced in the plastered bandage 34, and the drawn portion of the cast bandage is removed so that the opening in the plaster bandage 46 exposes the skin as shown in Figure 4. Also as shown in Figure 4, the removed portion of the plaster bandage receives a felt pad 50 of approximately the same thickness as the plaster bandage. The pad 50 also has a cylindrical bore that receives the pad 54 of cylindrical felt. The template 42, and consequently the opening in the plastered dressing 46, is smaller than the flange 62 of an accessory 58 in order to retain and align an ultrasonic treatment module so that the flange 62 engages the surface of the plaster bandage that it surrounds the opening 46 when it is placed above the opening 46. The accessory 58 also has a circular opening 66 and bayonet holding projections 70. The opening 66 has essentially the same diameter as the pad 54 of the cylindrical felt. Figure 5 shows an attachment 58 positioned above the opening of the plaster bandage 34 and the felt pad 50 so that the opening 66 and the cylindrical felt pad 54 are aligned coaxially. The attachment 58 partially compresses the felt pad 50 (as seen in Figure 4) against the skin as its flange 62 (seen in Figure 4) engages the plaster bandage 34, thereby bringing the pressure of the removed portion of the cast bandage when the felt pad attaches the skin. Figure 6 shows a lid system for accessory 58 to be used when the daily ultrasonic treatment is completed. A cap 74 has a cylindrical portion 78 that extends toward the opening 66 of the fitting 58. The cap 74 has grooved projections 82 on the cylinder 78 that engage the bayonet projections 70 in the fitting 58. The cylindrical felt pad 54 is placed in the opening 66 and the cylindrical portion 78 is inserted into the opening 66, with the projections 82 notched off from the bayonet projection 70. The slotted projections 82 are configured to allow the cover 74 to be maintained at a predetermined depth relative to the fitting 58. This allows correct pressure on the felt pad 54. The lid 74 is pressed against the felt pad 54 until the pressure exerted by the lid 74 and the cylindrical felt pad 54 against the skin approaches the pressure of the plaster bandage 34. This pad 54 creates a pressure on the surface of the pad. the skin when the accessory is closed by the cover 74, in order to inhibit window edema in that location. (Felt cushion 54 may also consist of essentially flat circular layers that can be removed one layer at a time, in order to adjust the thickness of the felt pad and the resulting pressure against the skin). The cap 74 is then oscillated so that the slotted projections 82 engage the bayonet projections 70.

Figure 7 is a detailed perspective view of the treatment module 90 of the accessory 58. The projection 94 of the module has slotted projections 98 which engage the bayonet projections 70 positioned adjacent the external surface of the accessory 58. With the cover 74 and the cylindrical felt pad 54 (shown in Figure 6) removed, the projection 94 of the module fits within the opening 66 of the fitting 58 (and the perforation of the felt pad 50), and is inserted with the dented grooved projections 98 of the projection 70 of bayonet. The operative surface 102 of the module 90 is pressed adjacent the skin 106 and the module 90 is rotated so that its slotted projections 98 engage the bayonet projections 70. The slotted projections 98 are configured to allow the treatment module 90 to be maintained at a predetermined depth relative to the fitting 58. Ultrasonic treatment then begins. The operative surface 102 is normally pre-coated with a coupling gel before it is inserted into the fitting 58 and engages the skin 106. The gel may be contained adjacent the operative surface 102 using a gel sac, a gel vesicle or a similar container.

Figure 8 shows another variation of the invention, with an attachment 106 attached to a bare member 110 by means of a band 114. The radial flange 118 of the accessory 106 engages the skin, and a foam backing 122 is compressed when the web 114 it is held and squeezed. The accessory 106 is placed at the approximate location of the skin of the bone lesion using a method analogous to that described above; that is, a locating ring is fixed directly on the limb at a location on the outer skin in the vicinity of the lesion, X-rays are taken of the lesion and the ring, and the location of the approximate skin of the lesion is marked. bone in the skin using the relative positions of the lesion and the ring in the X-ray as a guide. A non-permanent mark using a magic marker or temporary tatu, for example, can be used in the approximate skin location so that the accessory 106 can be removed when there is no treatment and set back exactly for ultrasonic therapy. Figure 9 is a detailed perspective view of the treatment module 134 and the accessory 106 in use in a bare member 110. As above, the projection 138 of the module fits within the opening 126 of the accessory 106. The placement of the module 134 for ultrasonic therapy continues as shown above; the projection 138 of the module is inserted into the offset projection 142 of the bayonet projections 130. The end of the projection 138 of the module housing the operable surface 146 is pressed against the skin 150 (again, the operating surface is normally pre-coated with a coupling gel) and the module 134 is then rotated so that its slotted projection 142 engages bayonet projections 130. Then begins the ultrasonic treatment. It will be understood that various modifications may be made to the various embodiments of the present invention disclosed herein without departing from its spirit and scope. For example, various sizes and shapes of the locator ring are proposed, as well as different types of building material. Also, some modifications can be made in the configuration of the pieces. For example, the locator ring can be placed using an elastic band or even an adhesive tape. Similarly, various modifications can be made to the sequence of the invention described above in the method without deviating from the spirit and scope. For example, the attachment tab itself can be used to mark the opening in the plaster bandage instead of using a template. Therefore, the aforementioned description should not be construed as limiting the invention but only as presenting the preferred embodiments of the invention. Those skilled in the art will envision other modifications within the scope and spirit of the present invention as defined by the claims that will be presented below.

Claims (32)

R E I V I N D I C A C I O N S

1. The apparatus for determining an external location corresponding to an internal lesion comprising: a marker capable of being removably placed at an external site adjacent to an internal lesion, the marker being formed at least in part from a material at least partially visible through the medium for the visualization of the internal lesion.

The apparatus according to claim 1, further comprising means for securing the marker at an external site adjacent to the internal lesion.

3. The apparatus according to claim 2, wherein the means for securing the marker is a band.

4. The apparatus according to claim 3, wherein the band further comprises an adjustment mede.

5. The apparatus according to claim 4, wherein the adjustment means is a hook-and-loop type fastener assembly.

6. The apparatus according to claim 5, wherein the marker is a metal ring.

The apparatus according to claim 4, wherein the adjustment means is a buckle.

The apparatus according to claim 1, wherein the marker is a metal ring.

The apparatus according to claim 2, wherein the means for securing the marker is an elastic band.

The apparatus according to claim 1, wherein the material is at least partially opaque to X-ray radiation.

The apparatus according to claim 1, wherein the material is at least partially opaque to the infrared radiation.

12. The apparatus according to claim 1, wherein the marker is essentially planar and flexible, whereby the marker conforms to the contour of an external location adjacent to an internal lesion.

13. The apparatus according to claim 1, wherein the material is at least partially paramagnetic.

14. The method for determining an external location that corresponds to an internal injury, comprising the steps of: a) placing a marker in an external location adjacent to an internal lesion; b) visualize the marker and the lesion simultaneously; and c) mark an approximate external location corresponding to the internal lesion.

The method according to claim 14, wherein the step of placing a marker at an external location adjacent to an internal lesion includes the step of securing the marker at an external location adjacent to the internal lesion.

The method according to claim 15, wherein the step of placing a marker at an external location adjacent to the internal lesion includes placing an opening in the marker at the external location adjacent to the internal lesion.

17. The method according to claim 16, wherein the step of simultaneously visualizing the marker and the internal injury includes taking X-rays of the marker and the internal lesion.

The method according to claim 17, wherein the step of taking X-rays includes focusing the X-ray cathode in the opening, so that the internal lesion is surrounded by the marker on the X-ray image.

The method according to claim 18, wherein the step of marking an approximate external location corresponding to the internal lesion includes determining the position of the approximate external location relative to the marker, correlating the position of the internal lesion with respect to the marker. in the X-rays.

The method according to claim 19, wherein the step of marking an approximate external location adjacent to the internal lesion includes one or more iterative steps of adjusting the position of the marker to a new external location determined by the position of the internal lesion as visualized in the X-rays, and take new X-rays of the internal lesion and the frame.

21. The method according to claim 16, wherein the step of simultaneously visualizing the marker and the internal lesion includes forming magnetic resonance images of the marker and the internal lesion.

22. The method according to claim 21, wherein the step of forming nuclear magnetic resonance imaging includes placing the opening of the marker and the internal lesion within the magnetic resonance imaging trainer so that the internal lesion is surrounded by the marker on the magnetic resonance image.

23. The method according to claim 22, wherein the step of marking an approximate external location corresponding to the internal lesion includes determining the position of the approximate external location relative to the marker, correlating the position of the internal lesion with respect to to the marker on the magnetic resonance image.

The method according to claim 23, wherein the step of marking an approximate external location corresponding to the internal injury includes one or more iterative steps of adjusting the position of the marker to a new external location determined by the position of the Internal lesion as visualized in the magnetic resonance image, and take another magnetic resonance image of the internal lesion and the frame.

The method according to claim 16, wherein the step of placing a marker at an external location adjacent to an internal lesion includes placing the marker against a location on the skin adjacent to the internal lesion.

The method according to claim 25, wherein the step of simultaneously displaying the marker and the internal lesion includes simultaneously imagering the marker and the internal lesion with ultrasound.

The method according to claim 26, wherein the step of forming ultrasonic images includes the placement of an ultrasonic transducer above the location of the skin adjacent to the internal lesion and the marker, so that the internal lesion remains surrounded by the opening in the marker in the ultrasonic image.

The method according to claim 27, wherein the step of marking an approximate external location corresponding to the internal lesion includes determining an approximate location of the skin of the internal lesion in relation to the marker, correlating the position of the lesion internal in relation to the marker in the ultrasonic image.

The method according to claim 28, wherein the step of marking an approximate external location corresponding to the internal injury includes one or more iterative steps of adjusting the marker placement to a new location of the skin determined by the position of the internal lesion as visualized in the ultrasonic image.

30. The method for delivering an ultrasonic treatment to a location on the skin that corresponds to an internal injury, comprising the steps of: a) placing a marker at an external location adjacent to an internal lesion; b) simultaneously display the marker and the internal lesion; c) marking an approximate external location corresponding to the internal lesion, and d) placing an operative surface of an ultrasonic delivery system adjacent to the approximate skin location corresponding to the internal lesion. The method according to claim 30, wherein the step of marking an approximate external location corresponding to the internal lesion includes the step of marking a medical skin wrap. The method according to claim 31, wherein the step of placing the operative surface adjacent to the approximate skin location corresponding to the internal lesion includes the step of removing the medical wrap and marking and exposing the skin.