TISSUE BRIDGE FOR DIRECTING FORCES ON A TISSUE SURFACE

专利摘要:
Tissue bridge for directing forces on a tissue surface The present invention relates to medical devices that include predefined structures for dispensing forces on a tissue surface in a living organism, and are used to adjust spatial relationships, orientations and forces mechanics in a patient care area. the treatment area can be a wound, an incision, or an area surgically accessed within a patient, which includes oppositely arranged sections that heal more efficiently and with less scarring when force vectors of a particular magnitude and direction are applied to the area of treatment. the medical device provides a structure that can be pre-strained through a planned deformation that develops desirable spatial and mechanical relationships across the tissue surface for alignment, compression, advancement, eversion, inversion, distraction, rotation, angulation, and control or voltage modulation across the treatment area.
公开号:BR112013025232B1
申请号:R112013025232-4
申请日:2012-03-30
公开日:2021-06-29
发明作者:Felmont Eaves
申请人:Felmont Eaves；
IPC主号:

专利说明:

Cross Reference to Related Orders
[0001] The present application claims the priority benefit and fully incorporates by reference two co-pending US provisional applications which have been assigned serial number 61/469,966 filed March 31, 2011 and serial number 61/470,158 filed on March 31, 2011. Both provisional patent applications are incorporated by reference as if set forth in full herein. Field of Invention
[0002] The present invention relates to a medical device for approximation, alignment, distraction, fixation or compression of opposite regions along a tissue surface. In particular, the device refers to a medical device that is manufactured in a first shape and rest state, which is deformed prior to placement on a tissue surface in a patient and which reverts to the resting shape after placement, thus providing fabric-shaping forces across a treatment area. Background of the Invention
[0003] Many types of medical treatments incorporate devices that keep parts of the body in a particular setting for healing. For example, cuts, wounds and surgical incisions benefit from being held together in a fixed arrangement to promote efficient healing and to minimize scarring. Over the centuries, many mechanisms have been created to align opposing fabric planes. Other devices include adhesives, clamps, screws, rods, staples, tapes, rope-like elements (sutures, ligatures) or other mechanisms. Each of these approaches has a range of different qualities that can include flexibility versus stiffness, loose alignment versus compression, inversion versus eversion of a surface, internal versus external application, and temporary application versus permanent application of devices. Many of these approaches require opposing elements to be aligned prior to fixation (eg tape, adhesives) while in other instances the elements are aligned as fixation is applied (eg sutures, staples).
[0004] A wide variety of strategies and mechanisms have been employed to affect and control relationships between tissue surfaces and thus promote the desired therapeutic effects. For example, U.S. Patent No. 4,702,251 (Sheehan 1987) illustrates the use of a dressing that adheres to the patient's skin and forms a bridge over a tissue surface to align and cause skin eversion. U.S. Patent Publication 20090240186 (Fang) discloses a dressing device that includes sections attached to both sides of the wound and a lifting portion that is gripped to join the wound sections together. See also, U.S. Patent No. 815,264 (Chambers 1906) (disclosing a suture bridge); U.S. Patent No. 2,371,978 (Perham 1941) (disclosing a clamp to retain the ends of a wound); and U.S. Patent No. 3,487,836 (Niebel 1968) (disclosing a surgical band stitch). The lifting portion includes sections of the dressing that adhere to each other to apply approach forces to opposite sections of a wound.
[0005] The repair of a surgical or traumatic wound by approximating the wound margins is a prototypical example and in this action tissue surfaces need to be brought into alignment with an appropriate degree of tension to promote wound healing without adversely affecting perfusion of the fabric. Eversion of the wound margins, as in the closure of cutaneous wounds, encourages wound healing, approximation of the deeper margins of the deep subcutaneous tissue, and an optimal scar appearance. Advancing tissue to close tissue defects, compressing tissue to promote healing (eg, treating fractures or reducing hypertrophic scars and keloids), and distracting or expanding tissue to alter tissue dimensions are all examples. additional actions where the relationships between tissue surfaces and the forces acting on them need to be controlled.
[0006] Until now many devices and mechanisms have been used for these purposes and the device or mechanism selected may differ significantly in order to address the specific clinical situation, the characteristics of the tissues being treated and other factors. Surgical needles and sutures, surgical staples, adhesives, tapes, rigid plates and screws, rods, clips, tissue expanders and distractors are all examples of the variety of devices and mechanisms that can be employed to position and control tissue for therapeutic purposes. With any given tissue type and clinical situation, more than one of these options can be considered. With any given tissue type and clinical situation more than one of these options can be considered, each having advantages and disadvantages. In a given situation, factors that may represent advantages are easy application, stability or security of the approximation, adjustability, point-to-point approximation and a non-traumatic device-tissue interface. Similarly, factors that can represent disadvantages are added cost and complexity, the persistence of device elements (foreign body) within the wound bed that can adversely affect healing or the risk of infection, the need to remove the device and pain over application or removal with a subsequent requirement for anesthesia. Other wound treatment characteristics or closure mechanisms can affect wound healing or scar appearance, such as the relative elasticity of the closure allowing responses to mechanical forces, the inflammatory reaction that can be generated by the hydrolysis of absorbable closure materials, and pressure points or tissue puncture points that create new healing points outside the immediate tissue healing zone.
[0007] In addition to the need to control tissue orientation and alignment, the mechanical environment of tissues significantly affects healing. The increased tension through wound healing not only leads to an increased risk of wound dehiscence in the acute treatment period, but also significantly affects the chronic wound healing process, leading to increased healing and an increased risk of hypertrophic scars and keloids. Factors that increase wound tension tend to have poorer healing characteristics, examples of which include the presence of chronic swelling, gravitational forces (eg, a sternal wound site that is impacted by the weight of the breasts) or mechanical forces (for example, on the surface of a joint extender where normal joint movement can increase the tension on the skin). Incisional closures, where no tissue is removed and subsequently the tension is lower, tend to have better healing characteristics than excisional procedures, where tissue removal increases the subsequent wound closure tension. Increased wound tension has been shown to lead to increased numbers of fibroblasts, increased collagen deposition, changes in fibroblast orientation, and changes in the level of certain biochemicals, among other effects. Reducing stress on wound healing by mechanical means is an accepted strategy to aid healing and scar appearance. In addition to tension reduction, in some circumstances a compressive mechanical environment is used in the treatment, such as in the treatment of established hypertrophic scars and keloids or in the treatment of bone wounds (bone fracture or osteotomies).
[0008] Along these lines, an example of a device that is used to direct intended forces on a fabric surface is presented in published U.S. Patent Publication 20120035521 (Zepeda 2012). Zepeda's application reveals a kit that includes a dressing applicator that applies a predetermined tension through a dressing placed over the patient's wounded skin. Tension projected into the dressing is applied to the skin after affixing the dressing to the skin and removing the applicator from the dressing. The dressing applicator has numerous parts and connectors that must be configured before use and add complexity to the device.
[0009] In the art of medical devices used for tissue treatment, there continues to be a need for a medical device that is capable of applying a particularly directed force vector across the tissue surface, without the need for costly and complex parts and parts. inside the device.
[0010] Thereby, there is provided a medical device for approximation, distraction from alignment, fixation, stabilization or compression of opposing members comprising: a central section capable of compression and decompression; side sections on each side of the center section; and areas over the device for attaching the device directly to the patient's tissue. The device has a predefined shape and state when at rest, and is capable of distortion or deformation to carry potential force particularly designed into the device for application to a tissue surface. In one modality, deformation is achieved by distorting the shape of a device and adjusting the distance between opposite sides of the center section or the distance between side sections that attach to the patient. After application to the patient, potential forces on the device are released as the device reverts to its original resting state. The connection between the device and the tissue surface resists the device's natural tendency to revert to a resting position, and produces a desired resultant force across the tissue surface. Depending on the direction and magnitude of the potential forces carried to the device by the deformation, the resulting forces on the tissue surface move the tissue surface sections to the desired positions for more efficient healing and/or less scarring.
[0011] The loading of potential forces to the device can be accomplished by squeezing or compressing sides of the device against each other before applying the device to a tissue surface. As the device tends to open to return to the resting state, the device provides a distracting or opening force across the treatment area. Alternatively, the device can be stretched or opened from side to side so that, after application to a tissue surface, the device provides a closing or approximation force across the treatment area. The size and magnitude of the resulting forces on the tissue surface are pre-planned by applying the appropriate deformation forces to the medical device prior to securing the device over a treatment area.
[0012] In one embodiment, the medical device is a tissue bridge that connects to a tissue surface through attachment zones on the underside of the device. The device includes a center section that connects to opposing side sections and the underside of each side section includes a respective attachment zone for direct placement onto a tissue surface such as the patient's skin or other anatomical structure. The center section is designed to extend over a treatment area. The transition sections, or bosses, extend from the center section to the side sections to provide a continuous structure that can be formed into a one-piece construction. The shape of the center, side and transition sections can be customized to provide a desired net force across the treatment area.
[0013] The tissue bridge can be deformed to carry potential forces on the structure prior to placing the tissue bridge on a tissue surface. Deformation can be performed manually, mechanically or with the assistance of a tissue bridge applicator. The applicator provides a convenient tool for wrapping the tissue bridge, providing a deformation force to charge the tissue bridge with potential energy, applying the tissue bridge to a tissue surface and then separating from the tissue bridge as needed or desired.
[0014] In yet another embodiment of the invention, the tissue bridge may incorporate a two-piece construction in which a tissue bridge connects to an elastomeric strip that adheres to a patient (e.g., a dressing). By deforming the fabric bridge and carrying potential force into it, the two-piece construction also stretches or deforms the elastomeric strip for placement on a fabric surface through a treatment area. In this mode, the elastomeric strip and tissue bridge provide medical intervention across the tissue surface. In this embodiment, the fabric bridge can be held in place with the elastomeric strip or removed to reduce the resulting force across the fabric surface.
[0015] The two-piece modality can be configured as a combination of a fabric bridge and a dressing. The fabric bridge can have an arcuate shape or it can be a smooth body adhering to the dressing. In one configuration, the fabric bridge and elastomeric dressing are both smooth so that neither the bridge nor the dressing are under tension in a resting state and are prone to bending without deforming any component. Generally known adhesives of varying strength can be used to secure the dressing to the tissue surface and to secure the tissue bridge to the dressing. The connection between the tissue bridge and the dressing may allow the tissue bridge to be removed from the dressing after the dressing is applied to a treatment area.
[0016] The tissue bridges disclosed here are useful as standalone devices or used in combination with one another. In another embodiment, a plurality of tissue bridges may be arranged across a tissue surface to provide a scaffold for placing layered materials (e.g., bandages, adhesive sheets, medicinal sheets) over a series of tissue bridges. For embodiments in which the fabric bridges include raised portions over a treatment area, the series of fabric bridges may hold an adhesive sheet so that the fabric bridges and topsheet form a conduit with a defined space between the area. of treatment and the sheet. This space can be used for additional medical intervention as described below (ie, drainage, irrigation, surveillance, drug delivery and anesthesia).
[0017] In general, the devices disclosed herein act to force transmission and modulation through a bridge or conduit between tissue surfaces, acting through the attachment zones. The fabric bridge can take on a wide variety of designs depending on the characteristics of the fabric being treated, the method of attachment to the fabric surfaces, the geometric configuration of the device, the direction and magnitude of the forces required, the property(s) ) of the material(s) component(s) or fabric(s), esthetics, need for secondary fixations or other factors. In order to generate different simple force vectors, effective fixations and geometric configurations necessary for different clinical situations, each of these characteristics can be modified independently or in any combination producing a spectrum of configurations, modalities and effects, and the huge range of such variations are obvious to those skilled in the art.
[0018] The fabric bridge described and claimed here exerts its effect through a process of "pre-loading" or "pre-tensioning" whereby the bridge and/or fabric surfaces, being approached, are subject to a force deformational that is applied before the time of device fixation and that is released after total or partial fixation of the device to tissue surfaces. After releasing this deformation force, the potential forces generated within the device and/or tissues are released to act on the tissue surfaces until the moment the device is removed, absorbed, released, separated or until the tissue characteristics change from such that the device is brought to an unstressed configuration.
[0019] The resulting vectors applied to the fabric surfaces are a function of the rotational stiffness of the device (k=M/0) as a function of the device dimensions, geometry and elastic moduli of the building materials; the method, amplitude, direction and placement of the pre-conduction force applied before application; the stitches and methods of attachment to tissue surfaces; and mechanical characteristics of the fabric. The deformation force can be applied to the bridge or tissue, or it can be applied to both. When the deformational “pre-load” or “pre-tension” force is applied to a tissue bridge, it is applied in such a way that the force does not exceed the elastic limit of the device and, after fixation of the tissue plane and release of the deformation force, the potential energy thus transferred to the bridge can exert its effects on the tissues. When a force is applied directly to the tissues, external mechanical forces are applied to the tissues to control their force positions and environments relative to the bridge prior to fixation time. When force is applied only to tissues, the bridge can be either an elastic or inelastic construction.
[0020] In addition to the control of forces and spatial relationships between tissues upon release (static control or static shielding), the bridge also works to control the mechanical forces to which tissues can be subjected after application (dynamic control or dynamic shielding) . For example, if there is tissue swelling centrally near the junction where the surfaces are brought together across the bridge, the elastic nature of the bridge allows this increased pressure to be relieved through submission to a compensatory distortion in proportion to the force generated within the tissues. , thus relieving tissue tension. If tissues are subjected to a laterally directed force vector, i.e. when there is a distracting force such as with lateral tissue swelling or resulting from movement on tissue surfaces, the bridge may also distort relative to the force vectors applied, thus absorbing the force and shielding of the junction area from said forces. If a centrally directed force vector, i.e. a compressive force, is applied from either or both sides of the surface junction, i.e. tissue, the bridge may undergo a centrally directed distortion, with the absorption of external compression proportional to the applied torsional force. In this way the bridge provides both a dynamic response to changes in tissue strength and a dynamic shielding of the zone close to the intersection between tissue surfaces, as well as static tension control and shielding when the mechanical environment is not a flow.
[0021] If the bridge is a rigid model, any asymmetric forces lateral to the bridge can be transmitted to the opposite side and, similarly, the zone close to the intersection between the tissue surfaces is shielded. When the bridge has some degree of elasticity and a lateral tissue force vector is applied in an asymmetric manner, the dispersion of forces will be a combination of absorbing the deformation force within the bridge as well as transmitting the forces through the bridge structure to the fabric(s) on the opposite side. In these ways, the device functions as a power conduit.
[0022] A bridge features a central section or sections or body(s), and side sections or members that are connected to a transmission zone. Each of these sections can be of different dimensions, appearance, curves, angles or appearance as dictated by specific clinical needs and tissue characteristics. The device is non-linear such that the center section is not on the same surface as the side sections, and can rest above a projected line between the side segments or at other angles relative to the surface of the attached tissue surfaces. The device may or may not demonstrate bilateral symmetry. Within a given device, the side segments can be of identical or varied designs, and the side sections can vary in number, orientation, dimension, materials, construction, or method of attachment.
[0023] In one embodiment, the center section demonstrates an outer curve, and the transition zone demonstrates an opposite inner curve. By making the height of the apex of the center section above the upper connecting surfaces, the arc of rotation of the device with deforming force is elongated. By making the center section thicker or wider, or modifying it with ridges or other supplementary supports, the relative rotational stiffness of the center section is increased, which will change the magnitude of the deforming force needed to generate the same degree of deformation as the section. central by pre-loading. Other points of relative strength and weakness can then be configured to create areas of deformation and areas that are not subjected to deformation. Multiple curves or angles can be incorporated into the center section, and holes, slits, grooves, protrusions, depressions or other features can be used to provide secondary functions such as tissue suspension, interaction with an applicator device or facilitation of supplemental fixation , such as sutures or staples.
[0024] Similar to the central section, the transition zone and the side sections can be of virtually infinite shapes, characteristics and surface characteristics, and the modification of these characteristics affects the transmission of force and the functioning of the device. For example, the shoulder can be configured to be straight (ie, in line with the lateral segment) and simultaneously relatively thin and therefore more flexible, it can produce the shape and function of a transition curve between the central and central segments. sides. Similarly, the side segments can be made thicker closer to the transition curve, thus providing effective but thinner force transmission away from the transition curve, thus facilitating device attachment. The side section may demonstrate slits, grooves, notches, holes, pins, hooks, or other features that facilitate bonding to both tissue surfaces and secondary functions. The side section may also contain extensions, such as bonded meshes, tapes, adhesive strips, brackets, or other features that may facilitate bonding or function.
[0025] The side sections can be linked to the center section in a variety of configurations so as to produce the desired shape in preload, loaded (distorted) and applied situations. By modifying the location and binding zone, the application and method can be changed in a wide variety of ways. For example, if the bonding zone is at the midpoint of the length of the side section, the distorting force can then be applied such that both a flattening of the center section as well as an increase in the angulation of the transition point between the segment. central and side section can be produced. This increases the distance between the medial heads of the lateral segment in the pre-application configuration, so that when the device is applied, the medial heads of the lateral segments make contact with the first tissue surfaces, then as the angle The transitional transition is resumed by releasing the distortion force, the ligated tissues are mid-advanced, and the remainder of the lateral section can then be ligated. This central advance can either create a desired reduction in tension on the tissues in the centrally located zone or, if a larger advance is created, an actual compressive force can be applied. In an alternative embodiment, if the transmission point between the central and lateral segments is close to the lateral terminal of the lateral segment, then this creates a larger arc of rotation. Changing the relative elasticity or stiffness of the transition zone, the angle or curve to which it is connected, the resulting angle between the central segment and the lateral segment, or any combination of these, can change the resulting forces generated upon application and responses to changes in the environment of the mechanical tissue. For example, if the transition zone between the central and lateral segments is made very flexible or articulated and the lateral section is adhered to tissue surfaces, a lateralization force will not affect the relative eversion or inversion of the side member, as with its binding being flexible, it will simply and passively follow the changes in direction of the surfaces of the lateral tissues. All tension forces from the lateralization fabric will be transmitted to the central segment. Alternatively, if the transition zone between the center and side segments is made relatively rigid, both the center and side sections as well as the transition zone will undergo a deformation force absorption change.
[0026] Other configurations or structural features can be similarly designed to change the device's response to deformational loading, tissue force interactions, and post-application mechanical force changes. These include, but are not limited to, joints, joints, pivot points, dimension changes, curves, angles, slopes, kinks, relative strength or weakness points, structural reinforcements, applicator attachment points, or other design elements. BRIEF DESCRIPTION OF THE DRAWINGS
[0027] Having described the invention in general terms, reference will now be made to the accompanying drawings, which are not necessarily drawn to scale, and in which:
[0028] Figures 1A to 1B show a perspective view of a fabric bridge as described here.
[0029] Figure 2 shows a view of the upper surface of a fabric bridge as disclosed here.
[0030] Figure 3 shows a side elevation view of a fabric bridge preloaded with force as disclosed here.
[0031] Figure 4 shows a side elevation view of a fabric bridge in a resting position with the compact sides facing each other.
[0032] Figure 5 illustrates a fabric bridge and adhesive combination as disclosed here.
[0033] Figure 6 illustrates a fabric bridge and an adhesive combination of Figure 5 preloaded through deformation for application to a fabric surface.
[0034] Figures 7A to 7D illustrate a deformation sequence of a tissue bridge from a rest state for application to a tissue surface, in accordance with the invention herein.
[0035] Figure 8 illustrates a tissue bridge that has angled side sections in a state of rest, in accordance with the disclosure here.
[0036] Figure 9 illustrates the fabric bridge of Figure 8, deformed by preloading force on it, and applying a distraction force across a treatment area.
[0037] Figures 10A to 10C illustrate accessories that can be used in combination with a fabric bridge, in accordance with the invention disclosed herein.
[0038] Figure 11 illustrates various attachment mechanisms for applying a fabric bridge to a fabric surface, in accordance with this invention.
[0039] Figure 12A illustrates a tissue bridge defining openings for medical access to a treatment area.
[0040] Figure 12B illustrates a bottom plan view of a fabric bridge having adhesive layers on it.
[0041] Figures 13A to 13D illustrate the use of a fabric bridge either alone or in combination with an entire treatment area.
[0042] Figures 14A to 14D illustrate tissue bridges that have multiple expanders through a central section.
[0043] Figure 15 illustrates a tissue bridge dispenser and applicator for use with a tissue bridge as disclosed herein.
[0044] Figures 16A and 16B illustrate an accessory for manual loading of a fabric bridge as disclosed herein.
[0045] Figures 17A to 17D illustrate tissue bridge modalities as disclosed herein in use with secondary devices for preloading the tissue bridge with potential force.
[0046] Figures 18A to 18C illustrate the use of a fabric bridge, according to this invention, and the use of a guide rod for placement within a treatment area.
[0047] Figures 19A to 19V illustrate various shapes and configurations, both of the center and side sections, of tissue bridges, in accordance with this disclosure.
[0048] Figures 20A to 20B illustrate a tissue bridge applicator for preloading a tissue bridge with force and applying the tissue bridge to a patient.
[0049] Figures 21A to 21D illustrate modalities of tissue bridges as disclosed herein with articulated and rotatable joints.
[0050] Figures 22A to 22B illustrate a tissue bridge defining an opening in a central section and accommodating a medical instrument therein.
[0051] Figures 23A to 23B illustrate a fabric bridge applicator as set forth below in Figure 20, which accommodates preloading and bridging of multi-purpose fabrics onto a treatment surface.
[0052] Figure 24 illustrates a composite fabric bridge that includes a removable applicator and a flexible sheet that provides tension along a treatment area.
[0053] Figures 25A to 25B illustrate a fabric bridge, as set forth hereinafter, and which connect a flexible sheet by means of appropriate adhesives to a treatment area.
[0054] Figures 26A to 26F illustrate various combinations of a fabric bridge with adhesives and other bandages.
[0055] Figures 27A to 27B illustrate a fabric bridge used in conjunction with quilting and an adhesive sheet.
[0056] Figure 28 illustrates a fabric bridge, in accordance with this disclosure, which incorporates sections of adhesive layers that have varying strength and peelability along a fabric surface.
[0057] Figures 29A to 29D illustrate a fabric bridge, in accordance with this disclosure, and which uses a fabric bridge in combination with a stretched flexible sheet for placement by means of tabs. DESCRIPTION OF THE PREFERRED MODALITY(S)
[0058] The present invention will now be described more fully below, with reference to the accompanying drawings, in which preferred embodiments of the invention are shown. This invention may, however, be incorporated in many different forms and should not be construed as limited to the embodiments set forth below; moreover, these embodiments are provided so that this disclosure will be exhaustive and complete, and will fully convey the scope of the invention to those skilled in the art. Similar numbers refer to the whole.
[0059] The present invention relates to a device, referred to herein as a tissue bridge (10), for aligning, approaching, fixing and/or compressing/distracting pieces of a tissue surface (5). It should be understood that while the tissue bridge (10) may be designed to align and secure various and different types of elements, for the purpose of explaining the present invention, its applicability to wound healing will be utilized.
[0060] In a first embodiment illustrated in figures 1 to 9, the device is a tissue bridge (10) that directs the resulting forces on a tissue surface (5) and particularly traverses a treatment area (28). For the purposes of this disclosure, the term "tissue surface" encompasses all tissue types and combinations in patients. The "tissue surface" is not limited to any one surface or tissue type, but is intended to refer generally to points on a patient's body to which a tissue bridge can be connected. A tissue surface can include, without limitation, more than one surface in or on a patient's body. In one embodiment, the fabric bridge (10) can be formed in a one-piece construction so that the transitions between sections of the device are smooth (ie, the fabric bridge (10) and may require no parts. mounted separately or from connectors). Many commonly used techniques are available to produce the fabric bridge (10), which include but are not limited to injection molding, stamping, precision cutting or any other process that yields a one-piece construction.
[0061] The tissue bridge (10) set forth hereinafter is described with respect to its application to a tissue surface (5) and traverses a treatment area (28). The terms "tissue surface" and "treatment area" are not intended to encompass all commonly used means of the terms and are not limiting of the invention or the environments in which they are used. For example, a tissue surface (5) encompasses, without limitation, all anatomical features of a human or animal, such as the skin, other organs or the interfaces within the anatomy (for example, the interface between the bones and the muscle). The treatment area (28) extends through generalized regions of the anatomy, and includes portions of a tissue surface affected by applying a tissue bridge (10) over a patient.
[0062] Figures 1 to 9 show the general concept of a tissue bridge and a type of use as a medical device in the context of wound healing. Figures 1A and 1B show a first configuration of a tissue bridge (10) in a resting state, prior to implantation onto a tissue surface. Similarly, Figure 8 provides more detailed features of another modality of a similar device. In all embodiments of the fabric bridge (10), the resulting forces on a fabric surface (5) are pre-projected into the fabric bridge (10) to produce a desired effect on a fabric surface (5). For example, figures 6, 7, and 9 illustrate the tissue surface (5) encompassing opposite sides of a wound or incision through which the tissue bridge (10) extends and directs pre-planned forces.
[0063] Beginning with Figure 1A and Figure 1B, a tissue bridge (10) is capable of directing forces on a tissue surface (5) to achieve a desired healing effect, as previously noted. The tissue bridge (10) includes a central section (12) that will extend over a treatment area (28) over a patient. The central section (12) includes a higher region or apex (A) and a first and second side (12A, 12B) extending from the apex. The center section can include detachable sections that are modular and removable from one another. The center section (12) can be flexible (either inherently or by incorporating flexible regions within the center section body). In this sense, the center section can be described as a flexible bow with dimensions that can be customized for desired flexibility and elasticity (ie, regions of the tissue bridge can be made thicker or thinner as needed). The first and second respective side sections (11A, 11B) extend from the first and second sides (12A, 12B). The embodiment of figures 1 and 8 shows respective transmission regions (19A, 19B) between the central section and the side sections. Figure 1 shows that the fabric bridge (10) is originally manufactured with a separation distance at rest (D1) between the first and second sides (12A, 12B) and a separation distance at rest (L1) between each side section (11A, 11B). As used herein, the term "at rest" is used in the common sense, where a fabricated fabric bridge (10) has a natural shape and state in which it rests "at rest" before any external forces act on it. .
[0064] In one embodiment, the tissue bridge is made of a polymer that allows deformation of the tissue bridge (10) to potential load forces within the structure prior to application of the device to the tissue surface (5). The polymeric nature of the tissue bridge (10) provides sufficient elasticity to the overall structure so that the tissue bridge (10) will tend to return or at least attempt to return to its original shape after deformation. Supporting the tissue bridge (10) in a deformed position therefore "charges" the tissue bridge with potential energy. By applying the fabric bridge (10) to the fabric surface (5) in a force-laden state (ie, by deforming the structure and maintaining the deformation until application), the fabric bridge (10) particularly releases forces directed onto the tissue surface (5) in a resulting vector, which was previously planned and designed to roughly lead to a desired result. The deformation of the tissue bridge (10) can be calculated and precisely defined, in terms of change, for the tissue bridge structure so that the tissue bridge exerts particular resultant forces on a tissue surface when the user connects the bridge. of tissue to the patient. The elastic nature of the tissue bridge also gives the device a dynamic quality that moves with the tissue as scarring or other activity takes place across a treatment area. The tissue bridge disclosed here is pliable enough to self-adjust to both the patient's own body movements and to accommodate incremental adjustments that occur to a tissue surface over time. The center section, the transmission zones or overhangs and the side sections can have particularly designed modules of elasticity, which can be symmetrical or asymmetrical. The device can be of a one-piece construction or it can include parts that are detachable from one another.
[0065] Figures 7A to 7D show a representative series of schematic drawings in which a tissue bridge (figure 7A) was distorted (figure 7B), applied to the tissue surface (figure 7C), and caused tissue eversion (5 ) through a treatment area (figure 7D). This is just one example of using a tissue bridge (10) to move tissue within a tissue surface (5) to a desired state of healing (i.e. tissue eversion in Figure 7D promotes healing and minimizes scar depression; by removing tension across the treatment area (28) it also reduces overall scarring). The fabric movement is the result of forces directed from the fabric bridge (10) onto the fabric surface (5). The resulting forces on the tissue surface are the direct result of deformation of the tissue bridge, prior to application to the patient; since the tissue bridge (10) reverts from its deformed state towards its resting state, the tissue bridge moves the tissue in a pre-planned manner.
[0066] Figure 1B provides a geometric summary of a fabric bridge used, according to the schematics of Figures 7A to 7D. The resultant forces leading to the fabric configuration of Figure 7D are realized through distortion of the fabric bridge (10) prior to application to the fabric surface (5). As shown in Figure 3, this distortion includes separating the sides (12A, 12B) of the central section (12) of the fabric bridge (10) from a resting distance (D1) to a distorted distance (D2) . From another perspective, distortion or preloading of the device is accomplished by changing the distance between the side sections (11A, 11B) connected to the center section (12). Consequently, the fabric bridge (10) includes a maximum distortion induced separation distance (Figure 3, D2) between the first and second sides (12A, 12B) and a maximum distortion induced separation distance (Figure 3, L2) between the side sections of the fabric bridge (10).
[0067] The fabric bridge (10) directs forces, carried into the device through deformation, on a fabric surface (5) through connecting the fabric bridge (10) to the fabric surface (5) by means of zones linking connections (16A, 16B) on the side sections (11A, 11B) (ie, the bottom of the side sections). When the side sections (11A, 11B) are attached to the fabric surface, the first and second sides (12A, 12B) of the center section (12) are separated by a distance between the preset rest separation distance (D1) and the maximum distortion-induced separation distance (D3). From another perspective, when the side sections (11A, 11B) are fixed to the fabric surface, the side sections are separated by a distance between the preset rest separation distance (L1) and the maximum distortion-induced separation distance (L2).
[0068] To illustrate another type of resultant forces available from a tissue bridge, Figure 4 shows a tissue bridge embodiment (10) which is in a position close to a rest state. In this configuration, the dimensions between the sides of the center section (D3) and between the side sections (L3) are minimized during fabrication. Loading the device of Figure 4, therefore, includes maximizing these distances prior to applying the device to the tissue surface (i.e., stretching the device away). Upon application to the tissue surface, the device (10) tends to return to its near rest state and draws the tissue surface sections together.
[0069] Figure 8 illustrates yet another modality of the fabric bridge (10) and shows that the side sections (11A, 11B) can be configured at any angle relative to the central section (12). The fabric bridge of Figure 8 is shown in Figures 9A to 9C as being preloaded with forces that ultimately distract or separate a fabric surface (28). The side sections (11A, 11B) of the tissue bridge (10) can be fabricated in the upward direction which indicates from a lower transitional shoulder (19) the direction of the apex (A) of the device. The device of figure 8 is loaded by slanting the side sections down towards a fabric surface (5) (figure 9B) and connecting the device (10) through a treatment area (28) by means of adhesives. commonly used (17). As shown in Figure 9C, the tissue bridge (10) has sufficient elasticity to move back to its at-rest position upon attachment to the tissue surface (5). The resulting forces (R1 and R2), from the tissue bridge (10), drag the tissue surface away (i.e., present a distracting force along the treatment area (28), as shown in Figure 9C ).
[0070] The fabric bridge (10) and its application to a fabric surface (5) can be described according to the geometric construction of the device. The geometric terms are used only to describe the construction of the device and do not limit the invention in any way. For example, Figure 1B and Figure 8 illustrate the respective angles or arcs between the component sections of the fabric bridge (10). In this sense, the tissue bridge, both in Figure 1B and in Figure 9, can be described as incorporating a central section (12) that extends over a treatment area (28) over a patient. The fabric bridge (10) additionally includes respective first and second side sections (11A, 11B), which adjoin the center section along respective connecting segments (13), on which the connecting segments (13) rest inside a simple horizontal surface (H). As previously noted, the connecting segments (13) and the horizontal surface (H) are merely geometric references in space and do not limit the invention in any way. These terms are used to provide a geometric perspective rather than showing tangible parts of the invention.
[0071] The side sections (11A, 11B) extend into a rest position at respective angles (θ) from the horizontal surface (H). The respective bonding zones (16) on the side sections (11A, 11B) provide areas for connecting the side sections to the fabric surface (5).
[0072] From a geometric perspective, the fabric bridge (10) can be described as it extends around a horizontal geometric axis (x) and a vertical geometric axis (y), both of which are geometric references non-limiting. The horizontal geometric axis includes respective midpoints (M1, M2, M3) of the connecting segments (13) between the side and center sections, as well as the midpoint of an imaginary geometric line segment connecting the side sections (11A, 11B ). The vertical geometric axis of the fabric bridge extends from an apex (A) of the central section (12) to the midpoint (M3) of the geometric line segment connecting the lateral sections. In this sense, the side sections of the fabric bridge (12) are represented according to the angle at which the side sections (11A, 11B) extend from the horizontal axis (x) of the fabric bridge (10). In the embodiment of figure 1B, the angle formed by a first lateral section (11A) and the geometric horizontal axis (x) is between 180 and 270 degrees. The angle formed by the second side section (11B) and the horizontal axis (x) is between 270 and 360 degrees. References to degrees refer to the standard quadrant system for ease of reference.
[0073] The configuration of figure 8, however, shows a different set that produces different resultant forces. In figure 8, the angle formed by the first side section (11A) and the horizontal axis (x) is between 90 and 180 degrees. The angle formed by the second side section (11B) and the horizontal axis (x) is between 0 and 90 degrees. The fabric bridge (10) can therefore be constructed in a resting state with several assemblies for connecting the side sections (11A, 11B) and the center section (12). The different angles at which the side sections extend, as noted in Figures 1B and Figure 8, provide distinctly different rotational forces to a tissue surface, as evidenced by the different results shown in Figures 7D and 9C.
[0074] The tissue bridge (10) can be attached to a tissue surface (15) on a patient through many mechanisms. Figures 1 and 7A to 7D illustrate that an adhesive layer (17) can be attached to a lower part of each side section (11A, 11B) along the attachment zones (16A, 16B). The adhesive layers (17) bond to the fabric surface. Other bonding methods can be used, depending on the environment in which tissue bridging is applied. Figures 11 and 12 show that the tissue bridge may include apertures (23) defined within the tissue bridge body to allow liquid adhesives, staples, screws and other mechanical fasteners to attach the tissue bridge to the tissue surface (5) . Combinations of these binding mechanisms can be used in certain certain situations. As shown in Figure 12B, the bottom of the fabric bridge (10) may have grooves or ribbed sections for dispensing adhesives along the entire bottom of the fabric bridge (10) (i.e., a liquid adhesive placed over the bottom of device moves through slots even for dispensing).
[0075] It does not matter which type of bonding mechanism is used as the tissue bridge (10) is configured to apply forces across a tissue surface (5) and apply a medical treatment to the area under the tissue bridge. The types of treatments available using the tissue bridge include, but are not limited to: (i) tension reduction across the treatment area with forces directed from the side sections towards said center section, (ii) compression the treatment area; (iii) approximation of tissue surface sections along the treatment area; (iv) tissue surface alignment sections along the treatment area; (vi) tissue fixation and (vii) modulation of forces around the wound.
[0076] The tissue bridge (10) can also be used in combination with other tools that are useful for medical intervention across a treatment area. Figures 10A to 10C illustrate that the tissue bridge (10) accommodates a pad (32A) that can dispense additional medications (e.g. antibiotics, wound healing medications, anesthesia) or provide an absorption surface (e.g. gauze). Figure 10B illustrates that the tissue bridge (10) can serve as a protective cap to cover a tissue surface when an implanted device (32B) extends within the tissue surface and requires protection. The tissue bridge (10), therefore, can be used over tissue that includes an incision or a wound or that merely requires protection without touching the tissue. Along these lines, the fabric bridge (10) may incorporate a center section (12) that includes an extension (39) that serves as a guide to direct the user in positioning the center section (12) to a particular point on the fabric surface. In this sense, the extension (39) can be placed on the surface of the fabric (5) before fixing the fabric bridge (10). Alternatively, the extension (39) may be placed within an incision or opening of the treatment area (28), particularly along one side of an opening in the tissue surface, prior to attachment of the tissue bridge (10) and drag the treatment area (28) to a nearby position. Figure 12A shows that the central section (12) can define openings (26) that allow the user to access the treatment area from the top of the device. The openings (26) may allow medical treatment such as the application of liquid medications through the openings (26).
[0077] The tissue bridge can be used with a standalone device as shown in figures 7, 9, and 13A. In different embodiments, shown schematically in figures 13B, 13C and 13D, multiple tissue bridges are applied in series across a tissue surface (5) for medical treatment. Multiple tissue bridges can be joined by a common connector, which can also serve a medical purpose, such as closing a wound or other treatment area. Figure 13B illustrates that the fabric bridge (10) can be used as part of a system in which specialized forces directed onto a treatment area (28) are designed to treat an entire section of a tissue surface. In the example of Figure 13B, the section includes a contoured incision or opening in the tissue surface and tissue bridges (10) are placed along the contour in a strategic configuration to promote wound healing with less scarring.
[0078] Figure 13C illustrates a different type of system for medical treatment in which a series of tissue bridges (10) serves as a structure for creating a space between a treatment area (28) and the central section of the tissue bridge (10). The curvature or protruding nature of the central section of the fabric bridge provides a protective space over the treatment area. The open space formed through a series of tissue bridges can form a channel through which medical intervention is accessible. Figure 13C illustrates that the structure presented by a series of fabric bridges (10) can also serve to secure an applied sheet (43) or the layer of material that additionally protects the treatment area (28). An applied sheet (eg, a polymeric adhesive sheet) allows the user to stabilize a covered channel between the applied sheet (43) and the treatment area (28) for medical intervention. For example, a pump can be connected to the covered channel to drain the treatment area (28), irrigate the treatment area (28) or apply suction to the treatment area (28). Of course, the applied sheet or adhesive must have the structural stability to withstand such uses (ie, by applying suction and creating a vacuum under the sheet, the sheet will not break). The embodiment of Figure 13C further shows that a separate conduit (36) can fit within the covered channel. The separate conduit (36) can be a tubing that delivers medication or accomplishes another purpose such as irrigating or draining a wound. With a covered channel extending through a treatment area (28) and serving as a medical intervention region, tissue bridges (10) can be applied to a tissue surface (5) with a secondary adhesive (41) to ensure proper stability.
[0079] If a tissue bridge (10) is used as a stand-alone device (figures 7, 9, 13A) or in combination (figures 13B to 13D), the shape of the tissue bridge (10) and the way in which it deforms during loading are customizable for each manual application. For example, figures 14A, 14B, and 14C show that the center section may include additional parts (53a, 54a) that are deformable to charge the tissue bridge (50) with potential energy to be distributed over the entire treatment area ( 58). At the top of Figure 14A, a tissue bridge (50) exists in a resting position prior to deformation. Upon deformation of this "double handle" modality, the deformable parts (53a, 54a) expand and the sides are attached to a treatment area (58) by means of adhesive sections (51).
[0080] As in other embodiments disclosed above, the tissue bridge (50) is designed for direct attachment to a patient via adhesive sections (51). The modality illustrated in Figure 14, however, incorporates a separate dressing (55) between the adhesive sections (51) in the tissue bridge (50) and in the treatment area (58). Figure 14C shows that upon application to the treatment area, the tissue bridge (50) reverts back to its shape and rest state (Figure 14A). The compressive forces binding the fabric along the treatment area (58) are illustrated in Figure 14C by arrows within the fabric surface and pointing toward the treatment area (58).
[0081] The "double turn" modality of Figure 14 is an example that shows how the general concept of a tissue bridge encompasses various modalities in which the shape of the device is designed to produce a particular set of resultant forces on a surface of the fabric. fabric. The tissue bridge regions, which are deformed to preload energy and potential force into the device, can be any size and shape. These deformable areas can also be formed from any type of material that produces the force vector within a desirable range of magnitudes and directions. Although Figure 14A shows two accessible regions or loops (53A, 54A), through a central section Figure 14B shows that even deformable loops alone can be configured in various shapes and sizes, such as compressed expanders (53B, 54B) shown in Figure 14B. The compressed expanders (53B, 54B) are significantly more linear as opposed to the arcuate configuration of Figure 14A, and the sides of each expander (53B, 54B) are manufactured to lie close together in a restful state. The different configurations for the respective expanders allow customization of the forces resulting from each fabric bridge. Figures 14A and 14B show that by designing the center and side sections of a fabric bridge with custom shapes formed from suitable materials, the fabric bridge can generate numerous forces of particular magnitude and direction desired for placement on a fabric surface.
[0082] Figure 14 also shows that a single tissue bridge (50) can incorporate multiple expanders (53A, 53B, 54A, 54B) along a one-piece body to increase the magnitude of pre-charged potential energy in the device. . By forming a tissue bridge with a plurality of expanders (53A, 53B, 54A, 54B), the device generates a resultant force vector of altered magnitude relative to the height of the expander as compared to a tissue bridge using only one expander the same size. In fact, the fabric bridge (50) shown in Figure 14 allows the height of each expander (as measured from the horizontal axis noted above (x)) to be minimized, thereby creating a lower profile for the bridge. fabric on the fabric surface. In other words, the "double turn" mode shown in Figure 14 generates a net force that would otherwise be achieved with a much larger center section (ie, a single expander device would require an increased height of the center section as measured by from the horizontal axis (x)).
[0083] The fabric bridge (10) disclosed here is adaptable for use with numerous connections and secondary instruments to ensure efficient deformation and force loading as well as placement on a patient. Figures 15-18 illustrate examples of accessories that can be incorporated into a system that uses a tissue bridge to promote wound healing. These figures are included as examples only and are not limiting of the invention in any way.
[0084] Figure 15 shows that tissue bridges can be incorporated into a dispenser (60) that contains a large amount of individual tissue bridges (D). The embodiment of Figure 15 shows that fabric bridges are dispensed from an opening (64) within the dispenser (60) by means of a roll of tape or other adhesive (R). The dispenser (60) is configured to move the tissue bridges (D) out of the dispenser, along a channel, having an angled dimension that presses over the center section (12) of a tissue bridge to preload the tissue bridge to direct application over a patient. The dispenser in Figure 15 is just one example of a dispenser that stores a large amount of tissue bridges, dispenses tissue bridges, and serves as a direct applicator of a preloaded tissue bridge over a treatment area.
[0085] Figures 16A and 16B are additional examples of how the tissue bridges (10) disclosed herein can incorporate additional features that allow for convenient application of a tissue bridge (10) over a patient treatment area. Figure 16A shows a type of specialized ring (63) that a user can spend on respective rings, as illustrated in Figure 16B. The rings (63A, 63B) each include connecting projections (62) extending from the respective bodies of the rings such that the projections are parallel to the wearer's rings when worn. The tissue bridge connectors (61A, 61B) are shown in more detail in Figure 16B and, in one example, are close to a transitional shoulder (19A, 19B), which may be arcuate or angled in construction, and include regions of variable thickness or custom. A user can access the connectors (61A, 61B) manually or with a secondary instrument to load the tissue bridge (10) by expanding the center section (12). In the example in Figure 16, the connectors (61A, 61B) can be accessed with tie rings (63A, 63B) used on two non-adjacent user rings. The user connects the rings (63A, 63B) to the connectors (61A, 61B) to conveniently expand the center section (12) via the transitional shoulders (19A, 19B), while simultaneously pressing on the apex (A) of the center section (12) ). Instead of pressing on the center section manually, the user can also choose to employ a plunger (65) shown in figure 17A to press and expand the center region 12. The mode of figures 15-17 presents examples of ways in which manual loading of potential force within the fabric bridge is more efficiently realized with custom accessories. Consequently, the fabric bridge can be included with a kit of secondary instruments that aid in the use of the fabric bridge.
[0086] The above-noted secondary instrument kit for use with the tissue bridge may also include a side expander (66) shown in Figure 17B. The side expander (66) allows the tissue bridge (10) to be loaded through the side sections (11A, 11B), connecting the side expander (66) to the respective side sections (11A, 11B). In one embodiment, the side expander (66) has a shape and associated dimensions that mate with a slot, passage or other attachment point of the side section (68) to facilitate device deformation and potential force preload. in him. Figure 17C shows that a hand held deformation mechanism (69) (eg, a stapler) may include projections (69a, 69b, 69c) that fit on opposite sides of a fabric bridge (10) to expand the bridge of fabric. The shape of the stapler pins can be changed or customized to suit the shape of the particular fabric bridge.
[0087] In addition to secondary instruments that preload a tissue bridge (10), the tissue bridge can also be associated with devices that aid in the placement of a tissue bridge. For example, the body of a fabric bridge (10) can include measurements, marks, scales or other visual indicators useful in measuring an accurate placement for the fabric bridge (10) on the surface of the fabric (5). The fabric bridge can also accommodate a guide rod (72A) that includes laterally extending stabilization arms (72B) connecting to side sections (11A, 11B) of a fabric bridge (10). The guide rod (72A) is shown in Figure 18A as being useful for placement against one side of a treatment area (28) to facilitate bringing an opposite side of the treatment area into alignment with the guide rod (72A) (Figures 18B, 18C). Generally, figures 17B, 17C and 18 show exemplary embodiments of secondary instruments that can be used to load the stitch fabric bridge at the outer ends of the device rather than operating only on the center section (12).
[0088] The fabric bridge (10) accommodates any shape and size necessary to produce a desired resultant force in a particular direction on a fabric surface (5). Figure 19 of this disclosure shows over twenty proposed shapes and configurations for the side sections (11A, 11B), the center sections (12) and the transitional sections (19) that can be included in any fabric bridge (10). Figure 19A shows a top view of a fabric bridge and includes a taper device across the top portion of the center section (112) and expands the width of the side sections (114, 116) for a custom embodiment. Figure 19B expands the nip device longitudinally along the center section (112), around the side sections (114, 116) and uses adhesive tabs (115,117) extending from the side sections to attach the fabric bridge to the surface. of the fabric. Figure 19C illustrates significantly modified and customizable formats for a top view of the present fabric bridge (214). Figure 19D shows that a fabric bridge (312) may include more than one side section (314, 315, 316) to apply particularly directed forces across a larger surface area on a fabric surface or to generate converging forces from multiple directions. Figures 19E-19O illustrate respective cross sections of various fabric bridges that are possible when fabricating the fabric bridge as a one-piece instrument with uniquely designed portions that provide an appropriate set of resultant forces. In particular, Figure 19G includes side folds (17A, 17B) to accommodate an applicator. Figure 19H includes handles (18A, 18B) for manually expanding the fabric bridge around a vertical geometric axis. Figure 19J connects the fabric bridge to a fabric surface by means of pins (31A, 31B), which are also useful for attaching adhesive sheets, as shown in other embodiments of this invention, such as Figure 29. figures 19M through 190 show that different resultant forces can be achieved by connecting the center section, and the transitional shoulders at different points along the side sections. Figures 19P-19V show increasingly specialized types of fabric bridges in which the shape produces a desired net force. In Figure 19P, the shape of the side sections (11) is symmetric, so that different regions of a treatment area (28) are affected by different resultant force vectors. Figures 19Q and 19R indicate that the central region (12) can be encircled with radially extending side sections to close circular incisions or other wounds that benefit from the resultant forces that all emanate around the treatment area. Figure 19S shows that the side sections (11) can be any number and any combination of shapes, depending on the surface area of the fabric over which the side section will be placed. Figures 19T and 19V provide symmetric force vectors also on one side of a treatment area, whether bonded with adhesive directly over the fabric bridge (19T) or with an adhesive tape extending over the side sections (19V). Figure 19U shows that the fabric bridge 10 can have any simple shape (eg a rectangle) and define an opening of appropriate dimensions to adjust the resulting forces on the fabric surface.
[0089] Figures 20-29 expand the concept of a tissue bridge in areas of medicine that require specialized ways to apply the tissue bridge, varying degrees of symmetry through the tissue bridge structure and accessories that promote the use of the bridge of tissue on tissue surfaces, which may not be homogeneous (ie, the tissue surface that has a bone portion and a muscle portion, with different requirements for binding). For example, Figure 20 shows that the fabric bridge (10) can be used with an applicator (80) which defines an opening (82) for receiving the center section (12) of the fabric bridge. The edges of the applicator (80) surrounding the opening (82) connect to the tissue bridge (10) and this connection can be temporary or permanent. The applicator (80) of Figure 20A is just one example of the shape and orientation of an applicator for the tissue bridge, and includes a flexible region (84) along its mid-section for angular movement of opposite applicator sections ( 80). By tilting the applicator (80) along the flexible region (84) the bonded tissue bridge deforms in a direction to preload the potential force on the tissue bridge (10). Figure 20C shows a top perspective view of a tissue bridge loaded with applicator (80) still in place after deformation of the tissue bridge. The embodiment of Figure 20C is ready for placement across a fabric surface (not shown).
[0090] Figure 21 illustrates several examples of fabric bridges manufactured with multi-piece assemblies, connected by joints or movable joints (14A, 14B). Figure 21 includes embodiments in which the structural features of the fabric bridge (10) are connected, in varying configurations, to achieve different purposes on a fabric surface. For example, similar to figures 19M, 19N and 19O, figures 21A through 21D show that the center section (12) can be connected to the side sections (11A, 11B) at different points along the side sections (ie, the figure 21A connects to the center section at the midpoint of the side section, figure 21B connects to a medial area of the side sections, and figure 21C connects to the outer ends of the side sections). Each of the configurations shown in Figure 21 includes hinge assemblies (14A, 14B) so that the angle of rotation for the fabric bridge is adjustable by moving the side sections up and down. The hinges (14A, 14B) can include a ratchet function, which holds the hinge assembly in place at a desired angle. Figure 21D further incorporates a rotation function by a joint (14C) at the apex of the central section (12). The swivel joint (14C) provides a mechanism for further customizing the device to fit along a fabric surface that is non-linear.
[0091] In yet another embodiment of secondary instruments used with the tissue bridge disclosed here, Figure 22 shows the central section (12) of the tissue bridge (10) may define a central section opening (88) through which a user performs medical intervention in a treatment area (28). The opening (88) is available for visual inspection, drug application or for insertion of another tool such as the clamp (93) shown in figure 22. Figure 21A shows that the user can insert the clamp (93) through the opening (88) and pulling a fabric surface along the treatment area (28) as shown in Figure 22B. Clamp 93 can be inserted to align tissues before the tissue bridge is preloaded, during the period it is preloaded, or even after the tissue bridge is loaded as potential force. In one example, the staple (93) can bring tissues into close proximity before the preloaded bridge is attached to the tissues, thus facilitating both the alignment and centering of the tissue bridge over the treatment area.
[0092] The tissue bridge, revealed as a stand-alone device in figure 1, can be used in combination as shown in figure 13B. In this way, a series of fabric bridges (10) traverse a treatment area and provide resultant forces along a user-defined path. Whereas fabric bridges can be preloaded to apply varying degrees of force in magnitudes and directions designed to produce a desired result at different points along the treatment area. Along these lines, the fabric bridge applicator of Figure 20 can be fabricated to accommodate multiple fabric bridges as shown in Figures 23A and 23B. The applicator (85) defines numerous applicator openings (82A-82E) so that the fabric bridges (10A-10E) connect to the applicator for simultaneous loading and attachment to a tissue surface. By tilting the applicator (85) along a flexible area (87), a bonded tissue bridge (10A-10E) is deformed and loaded with potential force. In one modality, the applicator disappears from the tissue bridges after application to a tissue surface. In other arrangements, the applicator may remain in place for additional protection at the user's discretion.
[0093] The fabric bridge applicator (85) shown in Figure 23A can currently be used to bond forces along a fabric surface by means of a sheet or extensible dressing (90). In this embodiment, the tissue bridge applicator (85) operates without the self-standing tissue bridges (10A-10E) and instead applies the flexible sheet (90) across a treatment area. In this sense, the fabric bridge applicator (85) and the flexible sheet (90) are essentially a "two-piece" fabric bridge with the elastic function of the bridge provided by an elastic element (90) and the rigid feature of non-compressibility of the bridge being provided by the applicator (85). This modality essentially shows a composite tissue bridge that is applied as a two-piece bridge and as the tissue surface heals (ie, swelling decreases), the tissue bridge applicator (85) can be removed, leaving it behind. the flexible sheet.
[0094] This embodiment of the invention allows the flexible sheet (90) and the fabric bridge applicator (85) to be manufactured and transported in a flexible arrangement, without the applicator (85) nor the sheet (90) being under stress of tension. This is useful because the flexible sheet (90) can be a dressing, adhesive, or other type of sheet formed from a polymer that deforms and decomposes over time when under constant tension. The flexible embodiment of Figure 24 illustrates one way in which a fabric bridge applicator and associated sheet perform the functions of a fabric bridge by connecting the sheet across a treatment area. By unfolding the applicator (85), the user extends the sheet (90) to a pre-projected tension level. Placing the sheet over the treatment area returns the sheet (90) to its resting state before being unfolded, and placing the resulting forces across the treatment area (i.e., an extended sheet applied to the surface of the fabric will pull inwardly). The flexible sheet (90) can be bonded to the fabric surface by known adhesives, whether permanent or temporary. Figures 25A and 25B show that a similar dressing application can be performed with the autonomous tissue bridge (10) connected to a dressing (90). Figure 25A indicates a loose, tension-free region (22) within the flexible sheet (90) that allows the fabric bridge (10) to be preloaded by deforming the central section (12) and the side sections (11) , while simultaneously extending the flexible sheet (90). Figure 25B shows the embodiment of Figure 25A with a preloaded fabric bridge (10) extending the flexible sheet (90) for placement over a treatment area (28) with suitable adhesive layers (17, 93).
[0095] Modalities that combine a tissue bridge (10) with a dressing or dressing functions add yet another dimension to the utility of the tissue bridge concept. The fabric bridge (10) can be used to place a fabric, an absorbent sheet, a protective covering or an adhesive layer over a treatment area for medical intervention on the surface of the tissue (5). In this regard, the fabric bridge 10 can be formed integrally with a dressing or other sheet that adheres to a fabric surface. Figures 26A-26F illustrate this concept by showing the fabric bridge (10) formed with bonded adhesive layers (17A, 17B). The adhesive layers (17A, 17B) are not limiting of the invention, but are merely examples of the types of sheets that can be used with a tissue bridge so that the entire combination is used to treat a patient. The embodiments showing the adhesive layers (17A, 17B) connected to the side sections (11A, 11B) provide a means for deforming the fabric bridge (10) by removing a support from the adhesive layers (17A, 17B). Other embodiments (Figures 26E, 26F) show that the fabric bridge can be used to apply the adhesive sheet over the adhesive sheet treatment area (17A, 17B), spanning the entire fabric bridge footprint. Figures 27A and 27B show that sheets used in combination with a tissue bridge can be medicinal layers, adhesive layers, tensioning sheets or other layers of material used to direct force or other medical intervention onto a tissue surface. The tissue bridge can be between these layers (Figure 27A) or can be bonded over the layers (Figure 27B).
[0096] Figure 28 incorporates a padding layer (32) in a central section (12) of the fabric bridge (10). The cushion layer (32) can deliver medications, absorb fluid, or merely provide comfort to a painful or sensitive area on a tissue surface. The side sections (11A, 1IB) of the tissue bridge (10) accommodate adhesive layers (17A, 17B, 17C, 17D) for connecting the tissue bridge and a patient over a treatment area. The embodiment of Figure 28 allows each adhesive layer to have a varying degree of adhesion to the fabric surface. For example, the upper adhesive layers (17A, 17D) can disappear from the fabric surface very easily, while the inner sections of the adhesive layers (17B, 17C) require greater degrees of force for removal. Alternatively, the inner adhesive layers can be easily removable so that a partially bonded fabric bridge can be repositioned prior to placing most of the side sections on a fabric surface. Most of the lateral sections in this modality could then be stronger and securely attach the device only when the most effective position has been determined. Similarly, the tissue bridge (10) can direct large compressive or distracting forces along the regions of the deeper layers (17B, 17C) and forces of lesser magnitude along the upper regions (17A, 17D).
[0097] In a final set of figures illustrating the invention disclosed here, the embodiment of Figure 19H has been expanded to show an environmental use of the fabric bridge (10), having tabs or handles (18A, 18B) that can be manually attached to expand the tissue bridge (10). The fabric bridge (10) then expands the medical sheet (90) placed through a treatment area on a surface of the fabric (5). Figure 29A shows the tissue bridge (10) in its resting state prior to deformation. Figure 29B shows a preloaded fabric bridge in accordance with this invention. In Fig. 29C, the tissue bridge and medicinal sheet operate as a combination tissue bridge to cause the eversion of the treatment area and the reduction of tension across the tissue surface in the region of the treatment area. In Figure 29D, the tissue bridge (10) has been removed, leaving the medicine sheet and showing a lower level of eversion across the treatment area (28).
[0098] The fabric bridges disclosed here can be made from a number of polymeric materials (eg, plastics) that provide proper elasticity for preloading and release forces and sufficient stiffness to hold the device on a tissue surface. Fabrication systems common to these types of materials can be used to create fabric bridges to desired specifications. A one-piece construction is useful for efficiently fabricating fabric bridges, but the device can incorporate multiple pieces as needed at the user's discretion. The adhesives, adhesive sheets and flexible sheets disclosed above are similarly commonly used by those skilled in the art of adhesives and polymeric sheets. Tissue bridges can be coated for medical purposes or for patient comfort (eg a silicone coating that reduces abrasion or friction of the tissue bridge and simultaneously incorporates the healing effect into a treatment area).
[0099] Many modifications and other embodiments of the inventions presented herein will come to mind of those skilled in the art to which these inventions belong, taking advantage of the teachings presented in the foregoing descriptions. Therefore, it is to be understood that the inventions are not to be limited to the specific embodiments disclosed and modifications and other embodiments are intended to be included within the scope of the appended claims. Although specific terms are used here, they are used in a generic and descriptive sense only and not for limiting purposes.

权利要求:
Claims (9)
[0001]
1. Fabric bridge (10, 50, 312) for directing forces on a fabric surface (5), the fabric bridge (10, 50, 312) comprising: a center section (12, 112) configured to be extending over a treatment area (28, 58) in a patient, said central section (12, 112) comprising first and second sides, characterized in that said central section (12, 112) is flexible to allow said first and second sides have (i) a predefined separation distance at rest between said first and second sides while the fabric bridge (10, 50, 312) is in a resting state and (ii) a separation distance induced maximum distortion between said first and second sides while the fabric bridge (10, 50, 312) is in a deformed state, wherein the distortion induced separation distance is greater than the separation distance at rest; respective first and second side sections (11A, 11B; 114, 116) extending from said first and second sides, each of said first and second side sections (11A, 11B; 114, 116) having opposite top and bottom faces and sections of opposite inner and outer ends; and respective connection zones (16) on said undersides of said side sections (11A, 11B; 114, 116), wherein said attachment zones (16) are configured for connection of said side sections (11A, 11B; 114, 116) to the surface of the fabric (5) such that said first and second sides of a said central section (12, 112) are separated by a distance between the predefined separation distance at rest and the separation distance induced by distortion maximum, wherein said first side of said center section (12, 112) is connected to said top face of said first side section (11A, 114) at a position between said inner and outer end sections of said first side section (11A, 114) so that in the rest state: said inner end section of said first side section (11A, 114) extends inwardly from said first side of said center section (12, 112) to a area over which said central section (12, 112) extends and, and said outer end section of said first side section (11A, 114) extends outwardly from said first side of said center section (12, 112) in a direction away from the area over which said section center (12, 112) extends, wherein said second side of said center section (12, 112) is connected to said upper face of said second side section (11B, 116) in a position between said inner end sections. and outer of said second side section (11B, 116) so that in the rest state: said inner end section of said second side section (11B, 116) extends inwardly from said second side of said center section (12, 112) to the area over which said center section (12, 112) extends, and said outer end section of said second side section (11B, 116) extends outwardly from said second side of said central section (12, 112) in a direction away from the area over which said central section tral (12, 112) extends, and wherein the fabric bridge (10, 50, 312) is elastically biased towards the at-rest state to make the first and second side sections (11A, 11B; 114, 116) rotate with respect to said center section (12, 112) to apply forces to the fabric surface (5) in response to: serially applying a distorting force to the fabric bridge (10, 50, 312), serially applying the fabric bridge (10, 50, 312) in the deformed state to the fabric surface (5), and serially releasing the distorting force.
[0002]
2. Fabric bridge (10, 50, 312) according to claim 1, characterized in that said connection zones (16) comprise an adhesive to connect the fabric bridge (10, 50, 312) to the fabric surface (5).
[0003]
3. Fabric bridge (10, 50, 312), according to claim 1, characterized in that it comprises markings measured on a surface of the fabric bridge (10, 50, 312).
[0004]
4. Fabric bridge (10, 50, 312) according to claim 1, characterized in that said side sections (11A, 11B; 114, 116) accommodate a connector for securing the fabric bridge (10, 50, 312) to the surface of the fabric (5).
[0005]
5. Fabric bridge (10, 50, 312) according to claim 1, characterized in that it comprises respective transitional shoulders between said first and second sides of said central section (12, 112) and said first and second side sections (11A, 11B; 114, 116).
[0006]
6. Fabric bridge (10, 50, 312), according to claim 1, characterized in that it comprises a conduit configured for irrigation, drainage or application of drugs to the treatment area (28, 58).
[0007]
7. Fabric bridge (10, 50, 312), according to claim 1, characterized in that said central section (12, 112) comprises a flexible arch.
[0008]
8. Fabric bridge (10, 50, 312) according to claim 1, characterized in that said first and second respective side sections (11A, 11B; 114, 116) are joined to said central section (12 112) along respective connecting segments, wherein said connecting segments lie within a common horizontal plane, said side sections (11A, 11B; 114, 116) extending into a rest position at respective angles from said horizontal plane.
[0009]
9. Fabric bridge (10, 50, 312), according to any one of claims 1 to 8, characterized in that said connection between said first side of said central section (12, 112) and said face The upper face of said first side section (11A, 114) comprises a movable joint and said connection between said second side of said center section (12, 112) and said upper face of said second side section (11B, 116) comprises a movable joint.

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同族专利:

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公开号 | 公开日

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CA2830918A1|2012-10-04|

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BR112013025232A2|2019-12-17|

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KR102191430B1|2020-12-15|

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AU2012236205A1|2013-10-17|

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KR20210060664A|2021-05-26|

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US20190261989A1|2019-08-29|

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AU2016262734A1|2016-12-15|

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KR20190130671A|2019-11-22|

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KR102256092B1|2021-05-24|

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AU2012236205B2|2016-08-25|

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CN103533900B|2016-12-28|

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EP2691029A4|2015-06-24|

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US10327774B2|2019-06-25|

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AU2016262734B2|2019-12-19|

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JP2014516288A|2014-07-10|

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WO2012135735A3|2013-02-07|

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WO2012135735A2|2012-10-04|

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CN106725645A|2017-05-31|

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CN103533900A|2014-01-22|

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KR20200141538A|2020-12-18|

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US20180125492A1|2018-05-10|

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AU2016262734C1|2020-05-07|

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KR102046977B1|2019-11-20|

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KR20140020993A|2014-02-19|

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EP2691029A2|2014-02-05|

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US20140128819A1|2014-05-08|

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法律状态:
2019-12-31| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|

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2020-02-18| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|

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2021-01-05| B07A| Application suspended after technical examination (opinion) [chapter 7.1 patent gazette]|

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2021-05-04| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|

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2021-06-29| B16A| Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 30/03/2012, OBSERVADAS AS CONDICOES LEGAIS. |

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2022-01-11| B25A| Requested transfer of rights approved|Owner name: EMRGE, LLC. (US) |

优先权:

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申请号 | 申请日 | 专利标题

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US201161470158P| true| 2011-03-31|2011-03-31|

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US201161469966P| true| 2011-03-31|2011-03-31|

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US61/470,158|2011-03-31|

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US61/469,966|2011-03-31|

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PCT/US2012/031638|WO2012135735A2|2011-03-31|2012-03-30|Force modulating tissue bridge|

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