MXPA97006256A - Containment structure of - Google Patents

Abstract

The present invention relates to an apparatus and methods for providing and using a gel containment structure within an ultrasonic delivery system. The apparatus includes a special bladder (10), a pad or other wrapping means to be placed adjacent to the transmitting surface (22) so that the coupling gel retained adjacent to the transmission surface (22). The method for supplying ultrasonic energy includes enclosing the coupling gel on the transmitter surface (22) so that the coupling gel retained adjacent the transmission surface (22). The method for supplying ultrasonic energy includes enclosing the coupling gel on the transmission surface (22), placing the coupling gel encased against the skin or other external location corresponding to the internal lesion, and directing the ultrasonic waves emitted on the surface. of transmission (22) through the conduction gel enclosed towards the location of the skin corresponding to the inter

Description

"GEL CONTAINMENT STRUCTURE" BACKGROUND OF THE INVENTION 1. FIELD OF THE INVENTION This invention relates to the therapeutically treatment and / or evaluation of musculoskeletal injuries by ultrasound and, more particularly, to a gel containment structure. 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 a bone lesion, accelerates natural healing with few or no harmful side effects. For patients with reduced scarring ability, such as the elderly, ultrasonic therapy can stimulate the healing of bone lesions that otherwise require prosthetic preposition or permanently disable the patient.

U.S. Patent No. 4,530,360 issued to Duarte ("Duarte" discloses a basic therapeutic technique and an apparatus for applying ultrasonic pulses from an operative surface placed on the skin at a site adjacent to the bone lesion. The ultrasonic delivery system, as the term is used in this application, is the exposed tangible surface of the system that transmits the ultrasonic pulses into the environment For some systems, the operating surface may be the transducer surface itself, whereas in others may be a surface layer on the top surface of the transducer.Duarte provides a scale of radiofrequency signals to create the ultrasound, ultrasound power density levels, a duration scale for each ultrasonic pulse and a frequency scale of the ultrasonic pulse The duration of the daily treatment is described. US Patents Nos. 5,003,965 and 5,186,162 both issued to Talish and Lifshey ("Talish '965" and "Talish' 162", respectively) describe an ultrasonic delivery system in which the RF generator and the operating surface both form part of a unit Modular applicator that is placed adjacent to the location of the skin. The signals controlling the duration of the ultrasonic pulses and the pulse repetition frequency are generated separately from the applicator unit. The Talish Patents Number '965 and Talish Number' 162 also describe an apparatus for securing the applicator unit so that the operative surface is adjacent to the location of the skin. The Talish Patent Number '965 and the Talish Patent Number' 162, the skin is surrounded by a plastered bandage, while in US Pat. No. 5,211,160 issued to Talish and Lifshey ("Talish '160") the apparatus is described for mounted on exposed body parts (ie, in a cast bandage and other medical wrap). The Talish Patent Number '160 also describes the various improvements to the applicator unit. It is already known in the art that ultrasonic pulses are rapidly attenuated in gases, such as air and that, consequently, the propagation of the ultrasonic pulses from the operating surface to the lesion must be through a medium consisting of solids and liquids. , so that the ultrasonic impulses are transmitted efficiently. Since it is often not possible to press the operating surface completely level against the location of the outer skin corresponding to an internal lesion, the ultrasonically conductive coupling gel (to which reference will now be made as "coupling gel") is used. between the operative surface and the skin to ensure a continuous contact. In fact, the most recent systems implement a small area between the operative surface and the skin for the coupling gel, thus excluding any direct contact between the operative surface on the skin. The Talish Patent Number '162 describes this system. The Patents of Duarte, of Talish Number '965, of Talish Number' 162 and of Talish Number '160, all are incorporated in this application by reference. Even when the systems described in these references and others disclose the underlying therapeutic method and apparatus for a person skilled in the art, they do not disclose how to fully contain the coupling gel to the region between the skin and the operative surface. . Previously, the coupling gel was often simply placed on the operating surface. When the operative surface and the skin were put together for treatment, the gel was expelled by tightening towards the neighboring regions. This is especially undesirable when the ultrasonic treatment is delivered through an opening in a medical wrapping, such as a plaster bandage, because the gel soils the adjacent interior portions of the medical wrapping. Other systems contain gel, but imperfectly. For example, in the system described in the Talish Patent Number '162, the gel is injected into a small area created by a circumferential edge formation: between the operative surface and the skin. Even in this system, however, the squeezing gel comes out between the edge and the skin when an excess of gel is injected to ensure that the area is completely filled. Therefore, an object of this invention is to provide an apparatus for containing the coupling gel essentially towards the interface between the operative surface and the skin.

COMPENDIUM OF THE INVENTION To achieve these objects, the present invention includes an ultrasonic delivery system for therapeutic use having a base, an ultrasonic generation means mounted on the base, the ultrasonic generation means includes an exposed operative surface capable of being placed adjacent to a location of the skin, and a wrapping means for sealingly retaining the coupling gel, essentially adjacent to the operative surface. The enclosing medium can be used in conjunction with almost any type of ultrasonic delivery system, including a module system or a more traditional portable system. The envelope: it can adopt many designs that are, in part at least, a function of the constitution of the supply system. In general, many ultrasonic delivery systems have a telescopic portion on the operative surface exposed on the end face, thereby allowing the operative surface to be positioned adjacent to the skin. This includes Duarte's portable system, as well as a modular system, such as the Talish Patent Number '162. For these systems, the enclosing means may be a non-porous bladder with an elastic opening that extends above the end face of the telescopic portion, including the operative surface. The body of the bladder can also be made of an elastic or encased material, which can be lengthened above the end face of the telescopic portion, including the operative surface. Alternatively, an ultrasonic or chemically activatable porous bladder may be used to contain the coupling gel. In these embodiments, the bladder material is essentially non-porous until activated by either ultrasound application or chemical application, such as by rubbing the bladder with alcohol. Once activated, the pores open and exude the ultrasonically conductive coupling gel. It is also visualized that a preformed ultrasonically conductive polyurethane disk is placed intermediate the operating surface of the ultrasonic generating means and the skin, to provide a conductive conduit for the generated ultrasound energy. Alternatively, the polyurethane bladder can be used having an ultrasonically conductive coupling gel placed therein. In these embodiments, the disc or bladder can be placed independently in an operating position between the skin and the ultrasonic generation means. The enclosing means may also be a similar layer in nature, or a lens cap. The cap fits over the end face of the telescopic portion, including the operating surface, so that the cover band frictionally engages the telescopic portion. The cover band may consist of a flexible and resilient material such as plastic. The cover of the lid can also be flexible and resilient, or it can be docile, such as a thin plastic. The enclosing means may also be a closed pouch or pad that can be attached to the end face of the telescopic portion, covering the operative surface with a portion of the pouch or pad. The present invention also includes a method for delivering ultrasonic therapy to an internal sample from an ultrasonic delivery system having a base housing, an ultrasonic generation means with an exposed operating surface, comprising the steps of sealingly enclosing the coupling gel. essentially adjacent to the operative surface, placing the encased coupling gel adjacent to an external location corresponding to the internal lesion, and directing the ultrasonic waves emitted on the operating surface through the enclosed coupling gel to the corresponding external location to the internal injury. Preferably, a thin film of the coupling gelmineral oil, glycerin, water or other ultrasonically conductive material is spread or dispersed through the external surface of the bladder to improve the functioning of the transducer. This method for delivering ultrasonic therapy may include placing the coupling gel on an operative surface, and lengthening an opening of the bladder to receive the operative surface within the bladder. The gel can be applied to the operative surface and then the bladder is placed over the gel and the operated surface. Alternatively, the gel can be placed in the bladder and bladder with the gel enclosed and then placed above the operative surface. At least a part of the surface of the bladder opposite the operative surface is then placed adjacent to a location on the skin corresponding to an internal lesion. This method for delivering the ultrasonic therapy may also include adhering a portion of the surface area with a closed bladder containing the conductive gel to at least part of the operative surface. At least a part of the surface of the bladder opposite the operative surface is then placed adjacent to a location on the skin corresponding to an internal lesion.

BRIEF DESCRIPTION OF THE DRAWINGS Preferred embodiments of the invention will now be described with reference to the drawings, which are described as follows: Figure 1 is a perspective view of a conductive gel bladder covering the front end from a telescopic portion of an ultrasonic treatment module; Figure 2 is a cross-sectional side view of a conductive gel bladder covering the front end of a telescopic portion of an ultrasonic treatment module; Figure 3 is a perspective view of a conductive gel pad with a portion attached to the front end of a telescopic portion of the ultrasonic treatment module; Figure 3A is a perspective view of an integral gel bladder configured to be placed between the operating surface of the ultrasonic treatment module and the skin; Figure 3B is a perspective view of an integral ultrasonically conductive polyurethane disk configured to be placed between the operating surface of the ultrasonic treatment module and the skin; Figure 4 is a cross-sectional side view in a module type ultrasonic delivery system adjacent to a skin location, with a gel bladder retaining the conductive gel between the operative surface and the location of the skin; and Figure 5 is a perspective view of a portable module type ultrasonic delivery system including an ultrasonically conductive gel bladder configured to be used in fractures of the clavicle.

DETAILED DESCRIPTION OF THE PREFERRED MODALITIES Referring to Figures 1 and 2, a conductive gel bladder 10 of the present invention is shown covering the front telescopic portion 14, an ultrasonic treatment module 18. In particular, the bladder 10 of gel covers the operative surface 22 of the module 18, which remains essentially coplanar with the front end of the telescopic portion 14. The bladder 10 of gel is constructed of a thin docile plastic, or equivalent material, and completely covers the front end of the telescopic portion 14 including the operative surface 22. Alternatively, the gel bladder 10 can be constructed of an encapsulated ultrasound conducting material that can be elongated above the front end of the telescopic portion 14. This is best suited for systems such as that shown in the Talish Patent '162, wherein the front end of the telescopic portion 14 has a small circumferential edge that extends slightly beyond the operating surface 22 in an axial direction. The bladder 10 of gel has an opening 26 through which the front end of the telescopic portion 14 is inserted. The perimeter of the opening 26 has an elastic property which, in its non-elongated state, is smaller than the perimeter of the front end of the telescopic portion 14. In this way, the opening 26 must be lengthened to insert the front end of the telescopic portion 14 into the bladder 10 of gel. Once inserted, the elongated opening 26 partially contracts to contact the telescopic portion 14, but still remains in an elongated state. The friction created between the elongated aperture 26 and the telescopic portion 14 prevents the bladder 10 from being detached from the telescopic portion 14. The elastic property of the opening 26 may be an elastic band fixed adjacent the opening 26 of the bladder 10 of gel. This is more appropriate for a gel bladder 10 constructed of a docile plastic, for example. If the body of the bladder 10 of gel is constructed of an ultrasonically conductive encapsulated material, for example, then the opening 26 will be inherently elastic even though 26 reinforcing layers of the encapsulated material can be constructed normally around the opening. The bladder 10 of gel can be constructed of either a porous or non-porous material, depending on the desired application. Preferably, when using a porous material, for example, PTFE filter material, the pores are capable of expanding during the application of a chemical activator, such as for example alcohol. This allows the pores to be extruded to the conductive material only after they have come into contact with the chemical activator. The perimeter of the opening 26 is elastic in the preferred embodiment. Non-elastic configurations and materials, such as a pull cord with a clamping mechanism, or an ultrasonic conductive adhesive layer adjacent to the opening, can of course be substituted. The perimeter of the opening 26 can also be made of a material that shrinks when heat is applied, so that the opening 26 contracts in order to sealingly engage the telescopic portion 14. The entire bladder 10 of gel can be made of a material that shrinks when heat is applied. Figure 3 shows an alternative embodiment of the present invention in the form of a gel pad 40. The gel pad 40 is a sealed (or capable of closing) unit with a back portion 44 that adheres to the front end of the telescopic portion 14, including the operative surface 22, covering the operative surface 22. The ultrasonically conductive adherent may be a gummed surface placed in layers on the back portion 44 with a thin removable film covering it. The front portion 48 of the gel pad 40 is of a docile material, such as thin plastic that can take the outline of the location of the skin that its press against it during ultrasonic therapy. Figures 3a and 3b show additional alternative gel pad embodiments of the present invention. The gel pad 40a of FIG. 3a is similar in structure to the gel pad 40 of FIG. 3, ex that it does not have a tacky back portion. The gel pad 40b of FIG. 3b is a newly integrated ultrasonically conductive polyurethane disk without an adherent layer adhering to an operating surface. The gel pads 40a, 40b of Figures 3a and 3b, respectively, are configured to be more adaptable to a module type ultrasonic delivery system which will be described below. Specifically, these gel pads 40a, 40b are configured to be received within the opening of an accessory that is fixed adjacent the location of the skin and that is pressed between the skin and the operating surface of the ultrasonic delivery system, when the module attaches the accessory. Figure 4 shows the gel bladder of the Figures 1 and 2 used during ultrasonic therapy. The module 18 is positioned adjacent the skin location 50 which corresponds to a lesion 54, so that the front surface of the gel bladder 10 (i.e., the surface opposite the operative surface 22) engages the location 50 of the skin. The gel within the bladder 10 of gel and the surface of the bladder 10 of gel adjacent to the location 50 of the skin, form a continuous non-gaseous coupling between the operative surface 22 and the location 50 of the skin, while containing in the gel essentially towards the region between the operative surface 22 and the skin location 50. In a module system, module 18 is normally interconnected with and held in place adjacent to skin location 50 by an attachment 58 attached adjacent skin location 50. As shown in Figure 4, these module systems can also be adapted to the skin covered with a cast bandage 62 or other medical wrapping.

As will be appreciated, the ultrasonic waves are rapidly quenched in gases, so that the ultrasonically conductive coupling gel in the gel bladder 10 and the front portion of the gel bladder 10 engaging the skin location 50 provide a continuous path non-gaseous for the ultrasonic probes between the operative surface 22 and the bone lesion 54. The gel bladder 10 essentially restricts the gel to the region between the operative surface 22 and the bone location 50, where it is needed. Without the bladder 10 of gel, a large amount of the gel exits by pressure from the region between the operative surface 22 and the location 50 of the skin, where it creates an undesirable contamination of the plastered bandage 62 or other medical wrapping. Depending on the composition of the material of the bladder 10 of gel, it may be necessary to apply a thin layer of ultrasonically conductive coupling gel or an ultrasonically conductive material on the front surface of the gel bladder 10 which couples the skin location 50. This thin layer of material removes any remaining tiny spaces between the bladder 10 of gel and the location 50 of the skin, while the amount that is pressed out towards the adjacent areas, if any, is negligible.

Referring to Figure 5, a preferred embodiment of the present invention is shown in application to a patient with a clavicle fracture. Clavicle fractures present a particularly difficult problem to efficiently apply ultrasound to a site adjacent to the fracture. This is caused by the uneven topography of the skin and the musculoskeletal structure in the clavicle region and the difficulty in maintaining the operative surface of the transducer housing in the orientation necessary for effective treatment. As described and shown above, the gel bladder is sufficiently elastic to conform effectively to the configuration of the topography of the skin adjacent to a fracture site. The pressure normally applied to the gel bladder and the location of the skin, such as that provided by the module system of Figure 4 aids in shaping. The bladder can advantageously be coated with an ultrasonically conductive material, such as, for example, ultrasonically conductive coupling gel or other ultrasonically conductive material. For a clavicle injury, the housing 110 of the transducer is held in place by a harness 114 that includes a mounting portion 116 and a dependent weighted belt 118. The strap 118 is passed over the patient's chest and back and with a gel bladder / transducer housing placed operatively adjacent to the fracture site of the clavicle. In this way, the gel bladder serves to efficiently conduct the ultrasound energy to the fracture site, while the harness 114 helps maintain the transducer housing in a uniform position for treatment. It will be understood that various modifications may be made to the various embodiments of the present invention disclosed herein without deviating from its spirit and scope. For example, different sizes and shapes of the gel containment medium are proposed, as well as various construction materials. Likewise, different odficaciones can be made in the configuration of the pieces. For example, when using a gel bladder with an opening, the opening can be tape attached to the telescopic portion of the ultrasonic treatment module, thereby containing the gel. Also, the gel supply tube can be configured to lie along the telescopic portion of the transducer housing and the interface with the interior of the gel bladder when the gel bladder is placed above the telescopic portion, this will allow Additional gel is delivered to the bladder during treatment, if necessary. Similarly, various modifications can be made to the sequence of the invention described above in the method without deviating from its spirit and scope. For example, when a closed bag contains the conductive gel, part of the bag may adhere to the operating surface before the gel is inserted into the bag and the bag is closed. Therefore, the foregoing 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 (31)

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

1. An ultrasonic delivery system for therapeutic use that has a base; an ultrasonic generation means mounted on the base, the ultrasonic generating means includes an exposed operative surface capable of being placed adjacent to a location on the skin; and a wrapping means for sealingly retaining the coupling gel essentially adjacent to the operating surface.

2. The ultrasonic delivery system according to claim 1, wherein the enclosing means is a liner positioned adjacent the operative surface.

3. The ultrasonic delivery system according to claim 1, wherein the enclosing means is a bladder with an opening for covering the operating surface of the ultrasonic delivery system.

4. The ultrasonic delivery system according to claim 3, wherein the bladder is formed of non-porous material.

5. The ultrasonic delivery system according to claim 3, wherein the bladder is formed of a chemically activated porous material.

The ultrasonic delivery system according to claim 1, wherein the enclosing means is a cover for covering the operating surface of the telescopic portion of the ultrasonic delivery system.

The ultrasonic delivery system according to claim 1, wherein the enclosing means is a closed bladder with means for securing a portion of the outer surface of the bladder adjacent to the operative surface.

The ultrasonic delivery system according to claim 1, wherein the enclosing means consists of at least part of a material that is selected from the group consisting of rubber, polyurethane elastic and compliant plastic.

9. The ultrasonic delivery system for therapeutic use having a base defining a forward planar region; an ultrasonic generation means within the base having an exposed operative surface capable of being placed adjacent to a skin location, the exposed operative surface is housed adjacent and parallel to the front planar region; and a bladder to retain the conductive gel essentially adjacent to the operative surface.

10. The ultrasonic delivery system according to claim 9, wherein the bladder is formed of a non-porous material.

The ultrasonic delivery system according to claim 9, wherein the bladder is formed of a chemically activated porous material.

12. The ultrasonic delivery system according to claim 9, wherein the bladder has an opening for receiving the distal end of the base, whereby the bladder covers the operative surface.

The ultrasonic delivery system according to claim 12, wherein the perimeter of the bladder opening is capable of expanding to receive the distal end of the base.

The ultrasonic delivery system according to claim 12, wherein the bladder is elastic and has a smaller surface area than the front planar region, whereby the bladder is elongated to receive the distal end of the base and cover the operative surface.

15. An ultrasonic delivery system for therapeutic use having: a base with a telescopic portion, one end of the telescopic portion defining a forward planar region; an ultrasonic generation means within the base having an exposed operative surface capable of being positioned adjacent a skin location, the exposed operative surface is housed adjacent and parallel to the forward planar region of the telescopic portion; and a closed bladder containing conductive gel coupled essentially adjacent to the operative surface.

16. An ultrasonic delivery system according to claim 15, wherein a portion of the outer surface of the bladder includes a means for detachably securing the bladder from the operative surface.

17. An ultrasonic delivery system according to claim 15, wherein a portion of the outer surface of the bladder includes an adherent to adhere the bladder to the operative surface.

18. An ultrasonic delivery system for therapeutic use having: an ultrasonic treatment module with a telescopic portion, the distal end of the telescopic portion defining a forward planar region; an ultrasonic generating means housed within the ultrasonic treatment module and including an exposed co-planar operating surface in the planar, forward region of the telescopic portion; an attachment capable of being positioned to retain and align the ultrasonic treatment module with the operative surface adjacent to a location on the skin; a bladder with an expandable opening for receiving the distal end of the telescopic portion, and sealingly retaining the coupling gel essentially between the operative surface and the location of the skin.

19. An ultrasonic delivery system according to claim 18, wherein the bladder is formed of a non-porous material.

20. An ultrasonic delivery system according to claim 18, wherein the bladder is formed of an activated chemically-permeate porous material.

21. An ultrasonic delivery system for therapeutic use comprising: an ultrasonic treatment module with a telescopic portion, the distal end of the telescopic portion defining a forward planar region; an ultrasonic generating means housed within the ultrasonic treatment module and including an exposed operating surface approximately co-planar with the forward planar region of the telescopic portion; an attachment capable of being positioned to retain and align the ultrasonic treatment module with the operative surface adjacent to a location on the skin; a closed non-porous bladder containing conductive gel, with an ultrasonically conductive adherent on a portion of its outer surface that adheres to the operative surface to retain the coupling gel essentially between the operative surface and the location of the skin.

22. The method for delivering ultrasonic therapy to an internal lesion from an ultrasonic delivery system having a base housing an ultrasonic generating means and an exposed operative surface, comprising the steps of: a) sealingly enclosing the coupling gel essentially adjacent to the operating surface; b) place the enclosed coupling gel adjacent to an external location corresponding to the internal lesion; and c) directing the ultrasonic waves emitted at the operating surface through a conducting gel enclosed in the external location corresponding to the internal lesion.

The method according to claim 22, wherein the step of sealingly enclosing the conductive gel essentially adjacent to the operative surface includes the step of placing the conductive gel on the operative surface.

The method according to claim 22, wherein the step of sealingly enclosing the conductive gel essentially adjacent to the operative surface includes placing a bladder above the operative surface.

25. The method according to claim 22, wherein the step of sealingly sealing the conductive gel essentially adjacent to the operative surface includes placing the conductive gel on the operative surface and elongating an opening of the bladder and receiving the operative surface within. the bladder.

The method according to claim 25, wherein the step of placing the enclosed coupling gel adjacent to an external location corresponding to the internal lesion includes the step of placing at least part of the external surface of the bladder. opposite to the operative surface adjacent to a location of the skin corresponding to an internal lesion.

The method according to claim 22, wherein the step of sealingly sealing the conductive gel essentially adjacent to the operative surface includes the step of adhering a portion of the surface area of a closed bladder containing the conductive gel towards minus a part of the operating surface.

The method according to claim 27, wherein the step of placing the enclosed coupling gel adjacent to an external location corresponding to the internal injury includes the step of placing at least part of the external surface of the opposite bladder. to the operative surface adjacent to the location of the skin corresponding to an internal lesion.

29. The method according to claim 22, wherein the external location corresponds to the internal lesion comprising a human clavicle region.

30. The method according to claim 22, wherein the step of sealingly enclosing the conductive gel essentially adjacent to the operative surface includes placing a non-porous bladder above the operative surface.

31. The method according to claim 22, wherein the step of sealingly sealing the conductive gel essentially adjacent to the operative surface includes placing a bladder formed of a chemically activated porous material above the operative surface.