Cellulite treatment systems and methods

Abstract

Systems and methods for treating cellulite include devices that apply or involve methods that separate membranes to eliminate or reduce the appearance of cellulite. In one method, an interventional tool is placed between tissue layers to engage and treat the membranes connecting the tissue layers containing fat deposits therebetween.

Description

Technical Field

[0001] The present disclosure generally relates to systems and methods for treating cellulite. This application claims the benefit of and priority to U.S. Patent Application No. 62 / 702,314, filed July 23, 2018; U.S. Patent Application No. 62 / 736,016, filed September 25, 2018; U.S. Patent Application No. 62 / 798,515, filed January 30, 2019; U.S. Patent Application No. 62 / 802,368, filed February 7, 2019; and U.S. Patent Application No. 62 / 8254,447, filed March 28, 2019, the entire contents of which are hereby incorporated by reference. Background Art

[0002] There is a continuing need for an effective method to treat cellulite (also known as gynecological lipodystrophy, tuberous liposclerosis, edematous fibrosclerotic panniculopathy, panniculitis, obesity edema, panniculitis deformans, or status protrusus cutis). Furthermore, there is a need for an active treatment that prevents future or recurrence of cellulite and is easy and effective to use.

[0003] It is reported that more than 85% of women suffer from cellulite, which indicates that cellulite is a physiological condition rather than a pathological condition. It is not believed that the presence of fat in the reticular dermis alone causes cellulite. Cellulite can be described as the herniation of subcutaneous fat in the fibrous connective tissue, which manifests as dents in the skin. This fat load may cause stress acting on the connective tissue between the fat lobules. Due to the orientation of the subcutaneous fibrous structure that defines the chamber containing fat cells, such dents are more common in women than in men. In fact, it is believed that it is this structure that has led to the occurrence of cellulite rather than being overweight. Typically, cellulite appears in the pelvic region, including the buttocks, lower limbs and abdomen.

[0004] Beneath the epidermis, the subcutaneous fat layer is contained between dermal layers connected by septa, which act as connective tissue between the dermal layers. In men, the septa are arranged more randomly and densely, in a crisscross configuration, while in women, the septa are arranged more generally parallel. Furthermore, men have a thicker dermis and septa that are more angled relative to the skin surface, while women have a relatively thinner dermis that thins with age and septa that are perpendicular to the skin surface. Furthermore, women with cellulite experience thickening of the septa in the area of ​​the cellulite, and tensioning of the septa causes the cellulite to protrude. In women, the biological purpose of storing fat in adipose tissue is to ensure sufficient caloric availability during pregnancy and lactation. Increased fluid retention or proliferation of adipose tissue within this subcutaneous fat layer can further contribute to the appearance of cellulite, with the septa maintaining a primary distance between the dermal layers, forming indentations and protruding pockets between the septa. Over time, the septa may stretch and then eventually contract and stiffen, holding the tissue layers at a fixed distance, but the pockets between such septa may expand, contributing to the appearance of cellulite.

[0005] Various approaches have been adopted to treat or address cellulite. Early treatments involved attempts to increase circulation and fat oxidation in the area where cellulite is present. Here, substances such as hyaluronic acid and aminophylline were injected into the targeted area to reduce cellulite. Other methods involved electroporation of the targeted area, followed by mesotherapy or the application of dermatological creams or other supplements to the cellulite. Massage can be used to supplement these approaches or alone to promote fat reabsorption or increased excretion of fluids and toxins in the treated area. Ultrasound has also been proposed to disrupt subcutaneous tissue and fat and has been used in conjunction with liposuction. Low acoustic pressure combined with microbubble infiltration has also been used to reduce the appearance of cellulite, as has the use of other energy sources such as lasers and radiofrequency. Such methods are characterized by limited or unpredictable results. More recently, cutting the membrane in the subcutaneous area with a blade or needle has been employed. Previous methods have been found to be labor-intensive and very traumatic to the tissue, resulting in bleeding, bruising, hard tissue nodules, a long and painful recovery period, and inconsistent results.

[0006] Therefore, there is a need for effective and efficient methods to treat, minimize or eliminate cellulite using simple systems that minimize trauma. These methods should be associated with predictable results and be relatively easy to adopt.

[0007] The present disclosure addresses these and other needs. Summary of the Invention

[0008] Briefly and generally, the present disclosure relates to cellulite treatment systems and methods involving apparatus that facilitate stretching, redirecting, disrupting, cutting, slicing, and / or tearing a membrane or membranes in cellulite, depending on the system used and the force applied by the user. In one aspect, the treatment method involves a tissue cutting or slicing system.

[0009] In one embodiment, the cellulite treatment device is mounted at the distal portion of the shaft and is sized and shaped to be advanced between tissue layers. In one particular aspect, one or more of a series of tools can be used to move the treatment device across the fibrous septum connecting the upper and lower fascial platforms within the skin to act on the septum and, depending on the tool used and the force applied by the user, stretch, redirect, tear, disrupt, cut, or sever the septum. In doing so, the targeted subcutaneous connective tissue associated with the surface defect is modified directly with minimal impact on the surrounding vascular and lymphatic systems, and fat can be more evenly distributed and the skin can take on a smoother appearance.

[0010] In one or more aspects, the cellulite treatment system embodies a tool that facilitates the ability to reach and treat all targeted areas of cellulite appearance through a single or limited number of access points through the skin. In certain aspects, such a tool is sized, shaped, and configured to be suitable (e.g., a diameter of less than or equal to about two millimeters and a blunt anatomical tip) for positioning itself within and advancing between tissue layers without assistance from external skin stabilizing structures (such as a suction device). Access points through the skin are employed, such as high on the hip below where the bikini or underwear straps are located and along the crease or transition between the buttocks and thighs. Identification and assessment of the targeted septum is accomplished by pushing, pulling, or tensioning the septum in an area believed to be associated with cellulite appearance on the outside of the skin. It has been recognized that the membranes that cause dimples or indentations are located at various angles and positions relative to the dimples or indentations observed on the skin and are not necessarily directly beneath such cellulite manifestations, and treatment systems and methods are configured to identify the membranes that cause the appearance of cellulite that has been marked on the skin and target those membranes for treatment while leaving intact adjacent membranes, blood vessels, etc. Furthermore, a range of membranes, such as a small subset or a larger number, may be the structure that causes a particular dimple or indentation.

[0011] In one approach, an anesthetic is injected percutaneously or subcutaneously into the treatment site. A cellulite treatment system is subcutaneously inserted over the treatment site and used to identify the membrane causing the indentation or dimpling by pushing or pulling various membranes to create an indentation in the skin in the targeted area. A cutting or slicing device or membrane-disrupting structure is subcutaneously placed at the treatment site and used to act upon and cut, slice, or disrupt the membrane tissue. In one particular aspect, the patient is instructed to tighten their buttocks and / or leg muscles to facilitate identification of the targeted area, and release of the membrane causing the indentation or dimpling is confirmed after septal treatment. Alternatively, the physician may apply pressure to the skin above or pull from below the treatment target in a rostral-to-caudal direction. Remote imaging or ultrasound or fluorescence energy may be used to visualize the procedure. Treatment structures may be resized or reconfigured to complete treatment of a specific area. The treatment device is then repositioned to treat additional areas. The treatment device can be configured to treat multiple areas simultaneously or sequentially without removal from the patient, or a point treatment approach may be employed. Langer's lines can be used as a reference for directing treatment. Additionally, through one or more access points, various treatment trajectories can be guided, and in some applications, a steerable introducer is used to access the treatment area. Additionally, anti-inflammatory agents, collagenase, deoxycholic acid, salicylic acid, glycolic acid, hyaluronic acid, or cellulite treatment drugs can be administered separately or directly at the intervention site by an interventional device or other procedural instrument. Aspects of the present invention include specifically identifying membranes that cause the appearance of cellulite, severing or separating those membranes, intraoperatively confirming the separation of those membranes, and preventing the recurrence of cellulite.

[0012] In various aspects, the treatment device may include one or more of blunt-tipped scissors, guillotine-type angled blades, protruding links, laterally opening hooks or V-shaped structures, internal hooks, beveled hooks, rotating structures or blades, cutting balloons or scalpels, selective cauterization structures, or energy transmission structures to disrupt, cut, segment, or incise tissue and / or control bleeding. In one particular approach, the treatment device includes a mechanical septum cutting element, such as a blade or sharp surface, that cooperates with a septum hooking element to hook the septum and then cut, segment, tear, or disrupt the septum. One or more of the septum hooking element and the septum cutting element can be converted from a hooking configuration to a cutting configuration and from a cutting configuration to a hooking configuration or a storage configuration. In another particular approach, the treatment device is embodied in an elongated member that can be inserted through the skin, is capable of expanding at least one region from a smaller state to a wider state, and when in the wider state can be configured to hook the targeted septum and cut, segment, or disrupt the targeted septum. In one or more alternative or additional aspects, cutting or disrupting is accomplished using electrical or thermal means, such as a monopolar or bipolar configuration, or a hot wire configured to address bleeding and facilitate cutting.

[0013] In some methods, the cellulite treatment system also includes illumination, such as a strong light disposed at or emitted through the tip of the treatment structure or placed along or at strategic locations on the treatment structure, for the purpose of tracking the advancement of the tool toward the treatment site and locating intradermal structures at the treatment site. In this way, direct visualization of the treatment device by transillumination through the skin is provided, and subcutaneous positioning and application of the treatment device is facilitated by the operator.

[0014] Furthermore, objective measurement devices are included in the treatment system to assess treatment results. In one approach, energy, such as an intense light or laser, is emitted and received by a measurement device, which scans the surface of the treated area. The measurement device creates a complete three-dimensional map of all cellulite relative to normal skin. By comparing the improvement in the volume of the divots compared to a normal, idealized surface, the operator can calculate the total and local volume benefits of the treatment and track improvements over time.

[0015] Additionally, the disclosed devices and structures are used for body contouring, wrinkle reduction, acne scarring treatment, and / or skin repositioning. Variable length foam padding or spacers and other structures such as subcutaneous attachment structures that are absorbent or permanent are used to achieve such purposes.

[0016] These and other features of the present disclosure will become apparent to those skilled in the art after reviewing the details of the systems and methods as more fully described below. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] Figure 1A and Figure 1B is a perspective view depicting cellulite on a subject's skin and a plan for treating the cellulite.

[0018] Figure 1C is a top view depicting treatment across and along the Langer lines of a subject lying on a treatment table.

[0019] Figure 1D is a top view depicting a cellulite treatment assembly and method for treating cellulite.

[0020] Figures 1E to 1N is a partial cross-sectional view depicting an embodiment of a membrane disposed beneath the surface of the skin.

[0021] Figures 1O to 1R is a partial cross-sectional side view depicting an alternative method of transillumination.

[0022] Figures 2A to 2B is a top view depicting one embodiment of a scissor assembly.

[0023] Figures 3A to 3Eis a top view depicting an embodiment of a hook and v-shaped structure for treating cellulite.

[0024] Figures 4A to 4B is a top view depicting the processing structure involving the hook processing structure.

[0025] Figures 5A to 5C It is a top view depicting the hook and the sliding method of handling the structure.

[0026] Figures 6A to 6B is a top view depicting the segmented processing structure.

[0027] 7A to 7N are top views and partial cross-sectional views depicting a processing device with a link hooking and cutting structure.

[0028] Figures 7O to 7P is an isometric view depicting one embodiment of a processing system and processing apparatus.

[0029] Figures 7R to 7X are top views and partial cross-sectional views depicting additional features of the processing apparatus.

[0030] Figures 8A to 8C It is a perspective diagram depicting the components of a point processing system.

[0031] Figures 8D to 8K is a side view depicting an additional method of handling the structure.

[0032] Figures 8L to 8V are cross-sectional diagrams depicting various treatments involving the lasso.

[0033] Figures 9A to 9B is a cross-sectional diagram depicting an atherectomy-type device and its use.

[0034] Figures 10A to 10C is a side view depicting components of another processing system.

[0035] Figure 11 is a side view depicting components of yet another processing system.

[0036] 12A to 12C is a top view depicting an alternative approach to the processing system.

[0037] 13A to 13F are bottom and top views, depicting yet another approach to handling the system.

[0038] 14A to 14F are bottom and perspective views depicting another embodiment of a processing system.

[0039] Figures 15A to 15F are perspective and top views depicting yet another embodiment of a processing system.

[0040] 16A to 16C are perspective diagrams depicting alternative or additional features of a processing system.

[0041] 17A to 17C is a perspective view depicting additional features of the processing system.

[0042] 18A to 18C is a perspective view depicting yet further features of the processing system.

[0043] Figures 19A to 19B is a partial cross-sectional side view depicting alternative or additional features of a handle for a processing system.

[0044] 20A to 20F is a side partial cross-sectional view and a top view depicting another embodiment of a processing system.

[0045] Figures 21A to 21C is a side partial cross-sectional view depicting another approach to a handle assembly for a handling system.

[0046] Figures 22A to 22C is a side partial cross-sectional view illustrating yet another approach to a handle assembly for a handling system. DETAILED DESCRIPTION

[0047] Before describing the present systems and methods, it should be understood that this disclosure is not limited to the particular embodiments described, as such may, of course, vary. It should also be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting, as the scope of the present disclosure will be limited only by the appended claims.

[0048] In the case of providing a range of values, it should be understood that unless the context clearly indicates otherwise, each intermediate value (to one-tenth of the lower limit unit) between the upper and lower limits of the range is also specifically disclosed. Each smaller range between any stated value or intermediate value in the stated range and any other stated value or intermediate value in the stated range is encompassed in the present disclosure. The upper and lower limits of these smaller ranges can be independently included in the range or excluded from the range, and each range in which any limitation, no limitation, or two limitations are included in the smaller range is also encompassed in the present disclosure, subject to the impact of the limitations particularly excluded in the stated range. In the case where the stated range includes one or both of the limitations, the scope excluding either or both of those included limitations is also encompassed in the present disclosure.

[0049] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure belongs. Although any methods and materials similar or equivalent to those described herein can be used in the practice or testing of this disclosure, the preferred methods and materials are now described.

[0050] It must be noted that as used herein and in the appended claims, plural referents are not encompassed when the quantifier is not applied unless the context clearly dictates otherwise. Thus, for example, reference to "a system" includes reference to one or more systems and equivalents thereof known to those skilled in the art, and so forth.

[0051] refer to Figure 1A to Figure 1B , a person is shown developing cellulite 200 around their thighs and buttocks. In one treatment method, the indentations and / or depressions characteristic of the cellulite 200 that are intended to be treated are identified or circled with markings 204, preferably while the patient is standing because for most patients, when they lie prone, the appearance of their cellulite disappears due to gravity pulling in different directions. In another embodiment, computer imaging equipment is used to locate and mark the indentations and / or depressions. Figure 1A to Figure 1B , 44 indentations and depressions are marked for possible treatment. The physician treating the patient determines the instrument insertion site 210 and path 212 that most effectively treats cellulite under the skin with the fewest insertion sites and instrument paths. Preferably, the instrument insertion site is selected in a wrinkle or fold of the skin, such as where the buttocks meet the thigh or in a wrinkle between the buttocks, where it is not visible when the buttocks naturally meet, to achieve an improved cosmetic outcome after the surgical healing period. In some patients, the inner thigh is selected as the insertion site because this location is visually inconspicuous as it heals. Such a treatment path is preferably selected by the operator using a straight edge that curves toward or conforms to the patient's contours, or it can be automatically generated using a computerized controller programmed to most effectively address and measure cellulite located in a predefined treatment site. The computerized controller can be associated with a scanner that identifies specific indentations and areas for treatment, such as by employing laser technology. In this regard, the computerized controller includes programming specific to cellulite treatment and is used in conjunction with electronic and mechanical devices and contains or comprises a non-transitory computer-readable storage medium and a computer program mechanism embedded therein to both identify treatment areas and prescribe primary and alternative approaches to treatment. In another embodiment, a computerized visualization and treatment planning device is used to assist the physician in determining the insertion site location and the path to be taken to the marked target.

[0052] Once the treatment method is planned, the patient lies prone on the treatment table. Alternatively, due to the minimally invasive nature of the current method, the patient can be treated while standing (especially for a small number of treatment targets), or while standing and leaning forward on a support, or alternatively between standing and leaning forward so that gravity can help identify and confirm treatment of the targeted septa. In addition, the measurement device creates a complete three-dimensional map of all cellulite relative to normal skin. By noting and comparing the improvement in the volume of the divot or dent compared to the normal idealized surface, the operator can calculate the total and local volume benefit of the treatment and track the improvement over time.

[0053] In a particular method, e.g. Figure 1C As shown, cellulite treatment follows or references Langer's lines 214 present in the tissue. Langer's lines 214 correspond to the natural orientation of tissue fibers in the human body and are generally parallel to the orientation of muscle fibers. Langer's lines 214 can be used as a reference for treating cellulite. Notably, cellulite appears to be related to and falls on the Langer's lines. In one approach, multiple treatment targets along the Langer's lines are treated from a single approach 216, with the Langer's lines 214 providing a map along which treatment is to be performed. Thus, for illustrative purposes, treatment can be directed along Langer's lines 214, as shown on the thigh, or alternatively, for illustrative purposes, treatment can be performed transversely to Langer's lines 214, as shown on the buttocks, to target the diaphragm. Treatment can also be directed at various locations around connective tissue or the diaphragm. That is, the diaphragm can be acted upon, stretched, redirected, torn, cut, sliced, ruptured, or otherwise destroyed from various sides or angles relative to the diaphragm. Thus, the diaphragm can be treated from above, below, or from the side to achieve optimal results. For example, in certain circumstances, gravity may be most effectively utilized by treating specific connective tissues from above, where the treatment force placed on the connective tissue coincides with the direction of gravity or the direction in which gravity most normally acts on a standing body, as it has been observed that cellulite is often most noticeable on standing individuals.

[0054] Now go to Figure 1D , shows a cellulite treatment assembly 220 that includes a handle 222 and an elongated member or needle-like structure preferably having a diameter of two millimeters or less, such as structure 224 extending longitudinally from the handle. A force gauge (electronic or mechanical) may be provided to ensure that a predetermined amount of force is applied to the tissue to prevent over- or under-stretching when testing the diaphragm. A treatment device 225 capable of acting on, stretching, dividing, cutting, or disrupting one or more of the connective tissues is disposed at a distal portion of the elongated member 224 (e.g., Figures 1E to 1N). All cutting devices can be combined with or further stimulated with RF, laser, ultrasound or thermal energy to perform cutting and coagulation together or separately. In some aspects, there may be a single access site or two access sites, one high on the hip and the other along the crease or transition between the buttocks and the thigh or on the inner thigh. Such locations are characterized by the fact that they can be easily hidden naturally or with clothing. Treatment targets, depressions and indentations that have been marked on the skin surface when the patient is standing typically disappear when the patient is prone because gravity acts on the skin and underlying connective tissue in different directions, making the ink mark obvious but the indentation or depression not obvious. The disclosed interventional device is configured so that a user can approach the target location and first use the interventional device to push, pull or otherwise tension the diaphragm in the targeted area under the skin to identify the specific diaphragm affecting the target and / or which is the cause of the cellulite manifestation. In other words, the septum under the skin is pulled or pushed to find the septum that creates the dent or depression in the skin surface. For some treatment targets, taking an approach from an approach located below the treatment target, advancing the end of the interventional device beyond the treatment target and then pulling downward (effectively in a "downward" direction if the patient is standing) can provide a better way to recreate the dent when the patient is lying down (for example, for treatment targets on the legs). One or more strain gauges can be incorporated into the treatment device to help identify the targeted septum and assess the progress and completion of the treatment of the septum. This facilitates targeting critical septa in a less impactful manner, thereby ideally minimizing bruises or other problems associated with cutting or destroying a large area around the target. Therefore, various methods of treating fat lumps that appear as dents or depressions 200 in the skin surface are shown herein. In addition, a handle portion can be used to create a depression in the skin through which the interventional device can be inserted subcutaneously. The treatment regimen is selected to insert the interventional instrument based on the subject's anatomical structure because it involves a septum 350 connecting the tissue layers that define the chamber that retains fat or other tissue. If necessary, while anesthetic and / or sedative agents are in effect, ultrasound can be used to assess the subcutaneous trajectory and depth of the various connective tissue bands causing surface irregularities. Ultrasound assessment can help select a specific trajectory for the desired depth. Ultrasound assessment can also help strategically position the distal portion of the treatment instrument at the junction between the connective tissue and the dermis or fascia.

[0055] like Figure 1E As shown, the targeted location of the cellulite 200 to be treated is marked on the surface of the skin at 204. This is done while the patient is standing so that the cellulite is best seen. Figure 1F As schematically shown in , when the individual lies down, the cellulite may decrease or disappear, and if this occurs, the marker identifies and confirms the location of the cellulite.

[0056] In one aspect, the distal portion of the cellulite treatment assembly 220 is inserted through the skin and the blunt tip is directed upward into close proximity with the dermis as the tip moves toward the septum 350 ( Figure 1G ) is advanced to the vicinity of the marked location 204, where the tip can be tracked. The inventors have discovered that, in the case of a flexible membrane 350, the distance from the marked location 204 to the location where the treatment assembly 220 is inserted into the skin is preferably at least about 2 cm, allowing sufficient distance to pull and disrupt the membrane 350 without the tip of the cellulite treatment assembly leaving the skin during the process. Additionally, the depth beneath the skin at which the septum 350 is preferably acted upon (i.e., cut, cleave, tear, stretch, redirect (e.g., crisscross), or disrupt) is identified and determined. After determining the subcutaneous depth assessed for cutting, cleaving, tearing, stretching, redirecting (e.g., crisscrossing), or disrupting the septum 350, the cellulite treatment assembly or other tool with a pointed or blunt tip is inserted through the skin, between the subcutaneous tissue layers, and advanced toward the septum 350. In one approach, the distal portion of the cellulite treatment assembly is configured with an illuminating tip 352 that is bright enough to be seen through the skin. The intensity of the light emitted by tip 352 can be set to a specific constant level so that septum 350 is severed or otherwise affected at a preferred depth below the skin, with the light appearing as a circle or projection of a predetermined size at the skin's level. Thus, the treatment device is advanced to the targeted site. At the targeted site, the user adjusts the depth of the treatment tool tip so that the circle or projection of light is of the predetermined size. The septum 350 is tested, and if confirmed as a treatment target, the septum 350 is treated while maintaining the circle or projection at the predetermined size. The user can also use the size of the circle or projection of light to maintain the depth of the treatment tool tip as it is advanced below the skin to the treatment target. In an alternative or additional aspect, a sharp tip is employed to create a pathway to the targeted tissue, allowing the tool to create a desired path within the tissue and between tissue layers. It is anticipated that the depth to which these tools are advanced will be between approximately 3 mm and approximately 10 mm below the skin's surface, but it is contemplated that smaller or greater depths may be optimal for specific subjects. In any case, the selected depth is chosen to cut, sever, disrupt, tear, stretch, or reorient the subject's septum 350. Furthermore, in one embodiment, it will be appreciated that the device 220 is formed of a substantially rigid material such that a consistent plane beneath the skin surface is accessible.

[0057] The location of the interventional tool is determined using palpation, direct visualization (e.g., transillumination or endoscopy), or non-invasive visualization (e.g., ultrasound or fluoroscopy), or other means (such as markings along the length of the tool and the path of the tool within the tissue), or the interventional tool is provided with radiopaque markings and the tool is placed below the location where cellulite (e.g., a dimple) appears on the subject's skin. Advancing the treatment device through the septum 350 and to the location where the treatment device 225 is best suited to accomplish the identification of the targeted septum and cellulite removal or minimization treatment. Figures 1H to 1J As shown, in one method, the treatment device 225 is passed over the septum 350, the hook is deployed and then pulled proximally to tension the septum 350, such as by hooking the septum ( Figure 1K In another approach, the treatment device 225 is advanced laterally a few millimeters, preferably about 1 mm to about 10 mm, more preferably about 3 mm to about 6 mm, past the target location, and the hook is deployed and then swept laterally toward the target site, followed by proximal pulling to hook and tension the septum. During these and other steps, transillumination can be used to track the treatment device and guide the procedure. Marker 204 can facilitate targeting of the septum 350 while using transillumination to visualize the position of the treatment device 225. In other approaches, a separate device can be used to act on the septum 350 to determine if such a septum is the source of an indentation or depression that appears on the outside of the skin. Such an auxiliary device can be placed away from the target site (i.e., the lesion) and configured to apply tension to the surface of the skin in a predetermined direction to generate gravity and visualize the lesion when the patient is in a prone position (i.e., the wider area of ​​the adhesive is attached to a spring mechanism so that a predetermined force is applied relative to the surface of the skin in the direction in which the skin moves under gravity when the patient is standing). Use of this additional device can further aid in identifying and locating the lesion and allow confirmation that the treatment is effective. Moreover, in various approaches, a portion of the elongated member can be configured to transition from a smaller state to a wider or larger state, wherein in the wider or larger state, a cutting surface (i.e., a sharp edge or energy) is presented to cut tissue, the device being sized and shaped for insertion through the skin and subcutaneously affecting one or more areas of the septum.

[0058] It should be noted that the membranes that cause the indentation or depression may appear at different angles and locations relative to the indentation or depression that appears on the skin rather than directly below the indentation or depression, and may be caused by one or only a few membranes that cause the indentation or depression at a distance. Therefore, the action of certain membranes in this way will be reflected in some change in the indentation or depression on the skin. The correspondence between the mark 204 made on the skin and the indentation being formed or reformed is determined. If the initial membranes 350 that the user pressed or pulled with the tool do not produce another indentation or depression in the marked area 204, the user releases those initial membranes that were acted on and repositions the tool at a different membrane and presses or pulls again. This is repeated until the membranes that caused the indentation or depression at the marked location are identified ( Figure 1K Once the correct septum is identified, the tool 225 is manipulated to cut, sever, disrupt, redirect, stretch, or tear the septum 350 connecting the tissue layers. In one approach, the blade 353 is deployed and presented for treatment ( Figure 1L ). In another method, a balloon (not shown) is inflated to disrupt the septum.

[0059] After the correct membrane has been cut, divided, destroyed, stretched, redirected or torn, the treatment element 225 is moved back to its initial collapsed configuration. The treatment element is then advanced beyond the marked treatment position, the treatment element (e.g., hook) is deployed and then pulled back below the marked treatment position to confirm that all of the membranes that caused the marked indentation or depression have been separated intraoperatively. If the membranes have not been separated intraoperatively, the tool is manipulated to cut, divide, destroy, stretch, redirect or tear additional membranes. These steps are repeated until all of the membranes that caused the marked indentation or depression have been cut or sufficiently stretched and cannot be re-created intraoperatively using the tool. Such manipulation results in the selective destruction, tearing, cutting or dividing of the targeted membrane 350 and the removal or minimization of the indentation and cellulite appearance on the skin ( Figure 1M Thereafter, the treatment element (eg, hook and / or blade) is retracted rearward ( Figure 1N partially collapsed), and the tool 220 is moved away from the site to remove it from the body or reposition it in any direction along and within the targeted tissue plane to treat another area.

[0060] refer to Figures 1O to 1RIn additional or alternative approaches, a second light source 354, such as an LED (or other light source), is disposed along the cellulite treatment assembly 220 near or alternatively at the illuminating tip 352. In various approaches, the light source (such as an LED chip) may be disposed at the tip of the treatment device or elsewhere along the treatment device with wires running proximally for operator control, or the light source may be generated by an optical fiber extending along the device or to a tip having an LED, or the light source is disposed within a proximal location, such as a handle of the treatment device. By so configuring such light sources 352, 354, the depth of the cellulite treatment assembly 220 within the tissue may be assessed. Figures 1O to 1P As shown, when the cellulite treatment assembly 220 is positioned within a first relatively shallow desired depth, the light sources 352, 354 appear to be spaced apart and define a discrete pattern ( Figure 1P When the cellulite treatment component 220 is placed deeper into the tissue ( Figures 1Q to 1R ), the light sources 352 and 354 overlap due to the natural dispersion of the light emitted from the light sources 352 and 354 ( Figure 1RThe operator of the treatment system can determine the depth of the cellulite treatment assembly 229 by noting the discrete patterns of light or the degree of light overlap, the dispersion of the emitted light, and the intensity of the light emitted from the light sources 352 and 354. This allows the operator to guide the distal end of the treatment assembly to the desired treatment location while maintaining the desired depth beneath the skin. The light sources 352 and 354 can also have different colors to aid in determining the orientation of the cellulite treatment system 220 within the tissue through illumination. Furthermore, for example, the second light source 354 can emit red light, while the illumination tip 352 can emit white light, though it is noted that any variation of colors can also be employed. Furthermore, the color of the light can change depending on the configuration of the treatment device, such as, for example, when sheathed or stowed, the device can project white or a first color, and change to another or a second color when a portion of the device is deployed or before or after use (such as when cutting tissue). A strain gauge can be configured to communicate with and cooperate with the light source to sense the load placed on the treatment device during treatment, thereby causing the light source to change color and signal the progress or completion of targeted treatment. Additionally, a second light source 354 can be used to position the cellulite treatment system relative to the treatment target area by transilluminating through the skin. Another benefit of the second light source is that it can indicate to the user where the hook and blade are positioned relative to the targeting diaphragm. Moreover, as the treatment tool is pulled proximally through the treatment target area, the illuminating tip 352 lets the user know when the hook and blade have been pulled through the targeted area. Also note that the light sources 352, 354 can be positioned at various alternative locations along the treatment device and can be spaced apart from each other by various amounts. Moreover, the cellulite treatment system can include more than two light sources of the same or different colors. In another embodiment, different colors of light can be used to indicate the status of the distal end of the instrument. For example, a red light can be used to indicate that the hook and blade are inside the instrument to advance under the skin, then a white light can be used to indicate that the hook is deployed, and then a red light can be used to indicate when the blade is deployed.

[0061] After treatment of one targeted area is completed, the procedure is repeated to treat other targeted areas. Thus, the same device can be used to access tissue layers beneath other sites or depressions present in the skin. Notably, in one embodiment, the device is capable of delivering anesthetic as needed or desired when progressing to additional or new locations. Thus, a system is provided that is configured to treat all targeted areas on the buttocks and thighs through a limited number of small access sites, including through a single access site. It will be appreciated that the system may also include a structure that allows the assembly to be steered to a subcutaneous treatment site. In such an embodiment, the device will be configured to define a longitudinally flexible material, and the instrument will be steered to the desired location within the tissue. Furthermore, in certain applications, the device has a stiffness that varies along its length. In another embodiment, the treatment device is embodied in a deflectable catheter.

[0062] Additionally, in certain embodiments, the cellulite treatment system includes a squeezing tool that reproducibly applies lateral force on the skin to emphasize the indentation or appearance of cellulite, thereby obtaining pre- and post-treatment effects without requiring the patient to stand up and / or having to remove the interventional tool. The squeezing tool may be embodied, for example, in a clamp having elongated feet on opposing sides thereof, or may include four fingers that pull radially inward once deployed on the surface of the skin and activated above or near the targeted cellulite area. Additionally, the patient is guided to tighten their buttocks and / or leg muscles while lying on the operating table or while standing to both identify the treatment site and confirm the treatment. In another embodiment, a skin stabilizer, such as a suction stabilizer, may be used to help control the depth to which the cellulite treatment tool advances beneath the skin and maintain the targeted position as the tool advances.

[0063] about Figures 2A to 2B , shows blunt-tipped scissors 360 disposed at the distal portion of the cellulite treatment assembly 220. The blunt-tipped scissors 360 are advanced beneath the skin to the target site and used to target a suspected septum. As in each of the disclosed methods and devices, if the action of such a septum causes some change that manifests as an indentation or depression in the skin, the treatment structure (here, the scissors 360) is manipulated to disrupt, cut, or sever the septum. Thus, the scissors 360 are opened, and the septum is placed between their blades. Next, the blades are advanced against or closed around the septum, thereby cutting, slicing, or severing the septum, thereby relieving tension between tissue layers and eliminating or minimizing the appearance of an indentation or depression in the skin. Actuation of the scissors is accomplished from the proximal end of the treatment device, such as by pulling a wire or advancing and pushing an elongated member (not shown) associated with the scissor device. Illumination can be provided by a light 362 disposed proximally to the scissors 360, allowing transillumination to be used to track the position of the distal portion of the treatment assembly 220. Additionally or alternatively, in each of the disclosed embodiments, illumination can be provided via a light guide from an external light source or via one or more LEDs. Illumination assists the user in positioning the treatment device and correct depth placement, as transillumination decreases with increasing depth of the tool. In one aspect, the amount of illumination is set to ensure the correct depth of the treatment device or structure, with the targeted illumination level adjusted for skin type, thickness, presence of fat, and pigment. In each of the disclosed methods, once the selected septum or targeted septum is cut, divided, or disrupted, the cellulite treatment device can be advanced or repositioned to treat additional targeted areas from the same or different skin from which the device was inserted.

[0064] Figures 3A to 3EVarious methods for laterally protruding tissue action and / or cutting structures are shown in FIG. The distal portion of the cellulite treatment assembly may embody a laterally opening hook arm 370 that rotates relative to a longitudinal axis 372 to alternately display a diaphragm action and / or diaphragm cutting structure ( Figures 3A to 3B ). The hook arm 370 is configured to swing from a longitudinal configuration directed proximally parallel to the axis 372 to a laterally projecting configuration, thereby capturing and tensioning the diaphragm once the device is advanced beyond the targeted position and then retracted. Here again, such action on the diaphragm can confirm that the diaphragm that causes the indentation or depression in the skin surface is the one being targeted, as such action with the diaphragm will be reflected in a physical change in the skin surface. The damage is caused by tensioning the diaphragm against the narrow edge of the hook arm 370 or its cutting or sharp edge. The outwardly facing portion of the arm 370 can define a rough blunt structure, and the cutting edge can be positioned within the acute angle defined by the arm 370. With this structure, as the diaphragm is dragged within the acute angle defined by the arm 370, increased tension can be used to cooperate with the constrained cutting edge. Figures 3A to 3B In the embodiment, the transillumination function is provided by a lamp 376 disposed at the terminal end of the device, and in Figures 3C to 3D In the assembly shown in FIG, a slit 378 formed on the axis near the terminal end allows light energy to be dispersed. Figure 3E In the embodiment of the present invention, the cutting and septum action structure is embodied in a single movable arm 380, and the lighting is provided near the hinge 382, ​​but the lighting can also be located at the terminal end of the device. As in the previous embodiment, the exposed edge of the arm 380 can be blunt or sharp for cutting or dividing. Moreover, here, the arm 380 is arranged in a longitudinal configuration in a distal direction parallel to the axis 372 to advance between tissue layers and cause the arm 380 to protrude laterally outward to capture and cut or divide the targeted septum. Actuation of the action and cutting structure can be achieved by manipulating a lever positioned proximally or a trigger connected to the lever via a wire or at a longitudinal axis (not shown). Once the desired area has been treated, additional targeted areas can be addressed.

[0065] The distal portion of the cellulite treatment assembly 220 may alternatively or additionally embody an internal static hook 388 ( Figure 4A ) to treat a targeted area from one or more skin insertion sites. The terminal end of the assembly or the hook itself 388 can be used to be placed around tissue and act on and test the tissue to identify targeted membranes. The sharp edge within the hook can be used to act on and cut the membranes that have been targeted and identified as being associated with the appearance of cellulite on the skin. Figure 4BAs shown, a concentric sliding tube 390 can be additionally provided that can be actuated from the proximal end of the cellulite treatment assembly to move proximally and distally relative to the hook 392. The tube 390 can include a selectively sharp edge, or can be blunt, thereby cooperating with the hook 392 to capture, cut, divide, tear, or destroy the septum. The assembly can further be advanced in a rotational manner to cut or sever the septum. Cutting tissue using the tube 390 results in the removal of a segment from the septum because the spaced incisions are made simultaneously through the septum.

[0066] like Figures 5A to 5C As shown, in a related method for treating multiple treatment sites, a cutting, slicing, or disrupting assembly additionally or alternatively includes a longitudinally extendable and retractable sheath 393 that alternately covers and exposes a hook 392 and further embodies an extendable and retractable guillotine-like blade 394. Blade 394 is sized and shaped to slide within the opening defined by hook 392 and cut tissue captured by hook 392. Thus, in its distal position, sheath 393 contributes to the assembly defining a structure suitable for advancement to the treatment site. The sheath is retracted by manipulating a structure connected to sheath 393, located at the proximal end of the assembly, thereby exposing hook structure 392. Hook 392 is used to engage and capture targeted tissue to test whether the targeted tissue is associated with the appearance of cellulite on the skin. While the hook maintains the septum in the captured position, guillotine-like blade 394 is advanced by operating a proximally positioned actuator (not shown) to slice or cut the captured septum, thereby eliminating or minimizing the appearance of cellulite.

[0067] Now turn Figures 6A to 6B , illustrates another approach for the distal portion of a cellulite treatment system 220. Here, a two-part hook assembly 396, 397 is held together on an angled surface 398 by a tensioning force (such as a spring or a wire or shaft connected thereto). When one segment rotates relative to the other, an angle is formed between the two segments. It will be appreciated that the length of this hook-like structure can be adjusted to suit specific needs. Additionally, selected edges of the hook assembly can be sharp or blunt. In one particular aspect applicable to each of the disclosed embodiments, the hook can be covered in an elastomer such that when the elastomer is tensioned, the elastomer shifts, exposing the sharp edge. When untensioned, the sharp edge is securely enclosed. In another approach, a spring-loaded sheath can replace the elastomer. Manipulating the two-part hook assembly 396, 397 within tissue and between tissue layers allows for targeting and identification of septa, as well as for segmenting, cutting, or disrupting the targeted septa, as described herein.

[0068] Now refer to 7A to 7D, the cutting, slicing or destroying processing assembly is defined by the protruding link arrangement. The first link 400 includes a blade 401 and is rotatably attached to the second link 402 at one end. The opposite end of the first link 400 slides relative to the longitudinal axis 405. The second end of the second link 402 is rotatably attached to a distal point on the axis 405. In one embodiment, when the drive shaft 407 attached to the opposite end of the first link 400 is advanced, the links 400, 402 completely overlap ( Figure 7C ) to create a hook arrangement sized and shaped to engage tissue and test membranes to determine whether such membranes are associated with the appearance of cellulite on the patient's skin. In this arrangement, the blade structure 401 is not exposed, but is protected or covered by the second link 402. When a cutting or slicing action is desired, such as upon targeting a selected membrane, the drive shaft 407 is slightly retracted, exposing the blade structure 401, thereby presenting a sharp edge to cut the hooked membrane (see Figure 7D To store the links 400, 402 for advancement or repositioning between tissue layers, the shaft 407 is fully retracted, which causes the links 400, 402 to assume a co-linear and parallel relationship with the shaft.

[0069] In related methods, such as Figures 7E to 7G As shown, a first link 400 defines a curved blade rotatably connected to a second link 402, the second link including a generally triangular or pointed protrusion 408 sized and shaped to cover the blade 401 when the assembly is placed in the hooked configuration (see FIG. Figure 7F When the drive shaft 407 (shown in dotted lines) is manipulated to expose the blade 401 (see Figure 7G ), the blade 401 can be used to cut the septum. When the treatment device is advanced to and between intervention sites, the drive shaft 407 is retracted so that the assembly defines a lower profile in which the first link 400 and the second link 402 are generally longitudinally aligned ( Figure 7E ).like Figures 7H to 7K As shown, the rotatable connection between the first link 400 and the second link 402 can additionally or alternatively be characterized by a slotted arrangement 409. With such a connection, the protrusion 408 can be smaller, resulting in a smaller overall profile of the treatment device. Notably, the septum hooking arrangement ( Figure 7J ), the end of the first link 400 is located in a proximal position within the slot 409, and the smaller protrusion 408 of the second link 402 overlaps the blade 401. In the septum cutting configuration ( Figure 7K ), the end of the first link 400 assumes a distal position within the slot 409, so that the blade 401 is exposed for cutting. Figures 7L to 7NAs shown, in another embodiment, the first link 400 can also define a straight blade 401. In this approach, the protrusion 408 is larger so that when the device is placed in the hook configuration ( Figure 7M ) provides the necessary coverage of the blade 401. Each of the aforementioned devices may also additionally or alternatively include other of the features disclosed herein, such as structures that provide transillumination as well as radiofrequency cutting and coagulation.

[0070] refer to Figures 7O to 7P , shows an embodiment of a cellulite treatment system 940 that can be used to treat cellulite (in combination with Figure 11 Described in more detail). As shown in the figure ( Figure 7O ), the distal portion of the processing system 940 is configured with a processing device 925. Here, it is shown Figure 7L To the processing device of Figure N with hook configuration ( Figure 7P ) is located at the distal end of the processing device 940. Any of the disclosed processing devices may be configured at the distal end of the processing system 940.

[0071] like Figures 7Q to 7S As shown, the treatment device may alternatively or additionally include a wire 410 rotatably attached to the second link 402. Here, the proximal portion of the wire 410 serves as a structure that can be advanced and retracted to configure the treatment device to the closed, hooked, and cutting positions. In addition, the wire 410 is formed into a coil 411 (see Figure 7S ), the coil provides for the closed configuration ( Figure 7Q ) and cutting configuration ( Figure 7S ) between the moving wire 410 necessary strength and robustness. In the diaphragm hook configuration ( Figure 7R ), the second link 402 covers the wire 410, thereby prohibiting the wire from being exposed to the targeting septum, and the coil 411 is aligned with the second blade 402. In its closed configuration ( Figure 7Q ), the treatment device defines a low profile that is suitable for advancement to and between treatment targets. The proximal edge of the wire can be sharpened to create a cutting edge. Additionally or alternatively, the wire can be an electrode attached to a radiofrequency generator so that the wire can be used for electrocautery or RF cutting of targeted tissue.

[0072] In other alternative or additional aspects, such as Figures 7T to 7U As shown, the elongated member 224 of the cellulite treatment device can embody a tubular shape, including an inner lumen 412 extending therethrough, which provides space for an optical fiber 414. Notably, from a cross-sectional view, the remaining space not occupied by the optical fiber 414 defines a crescent shape. In one approach, the tubular portion terminates at the treatment device 225.

[0073] like Figures 7V to 7X As shown, similarly, in one or more embodiments, the lumen 412 of the elongated member 224 can be sized and shaped to separately accommodate one or more additional septum-forming, cutting, slicing, or disrupting treatment devices 225 or for injecting anesthetics, medications, or transferring other substances (such as fillers or fat) before, during, or after treatment. In one approach, the treatment site can be inflated or filled with material at or during the treatment procedure, rather than using a separate device and procedure to accomplish this. Notably, each of the disclosed embodiments can be combined in a similar manner to provide a combined cellulite treatment assembly.

[0074] In an alternative embodiment, the septum may be spot treated using a cellulite treatment system 800 that is configured to address one intervention site at a time. Thus, the cutting structure may be inserted perpendicular to the skin to accomplish the treatment, or may be advanced beneath the skin in a direction generally parallel to the surface of the skin or at an angle relative to the surface of the skin. Furthermore, the structure of each of the disclosed tissue action and cutting devices may alternatively or additionally be configured for treatment. In one particular aspect, the cutting action is rotational such that the knife structure rotates at a controlled speed that is configured to cut the septum in a manner determined by the observed septum structure at the intervention site. The knife is alternatively or additionally configured to accomplish the cutting action by acting against or dragging the knife against the targeted septum. Again, here, the extent to which the dragging is performed is determined by the septum and the inherent structure of the septum. In one approach, the system 800 includes an elongated handle 802 that is provided for an operator to grasp (see Figures 8A to 8C ). The needle assembly 804 extends longitudinally from the handle 802. The needle 804 is configured to create an insertion site near a specific cellulite targeted area or directly into the indented cellulite site. In addition, it is through the needle assembly 804 that the interventional site instrument is advanced to address and treat the septum below the indented manifestation on the subject's skin. Additionally, in one embodiment, the dilator may include or cooperate with a scalpel, a selective cauterization structure, or an energy transmission structure to dissect tissue and / or control bleeding. In one method, once the correct depth is approached, the cutting tool is swept 360 degrees to cut the surrounding septum. Additionally or alternatively, an endoscope may be used in an assembly including a knife to cut the septum in a targeted manner. That is, the septum observed by the endoscope is targeted for cutting with the knife. Here, direct visual confirmation of the treatment is provided.

[0075] In one embodiment, the needle 804 can be fabricated with a stopper 810 that can be positioned along the needle 804 as needed or as dictated by a particular procedure or anatomical structure. The stopper 810 is positioned so that when the needle 804 is placed within the tissue, its terminal end is positioned at a desired depth, such as between tissue layers connected by a septum. A lateral opening 822 is also provided at the terminal end of the needle 804. It is through this lateral opening 822 that an interventional device (such as a knife, scalpel, cautery structure, or energy transmission device) is advanced between the tissue layers. Such a device is then used to selectively treat the septum located beneath the skin for the purpose of eliminating or reducing the appearance of cellulite. Once it is determined that the treatment has been successful, the cellulite treatment system 800 is removed and used at another location where cellulite has occurred.

[0076] Now turn Figures 8D to 8J , further aspects of a tool for treating cellulite in an alternative method are shown. This structure can also be used as Figure 1D The distal structure of the cellulite treatment assembly is shown in FIG. Figure 8D The treatment device may be equipped with a wire comprising a link 830, the manipulation of which serves to push out a cutting blade 831 having a size and shape suitable for cutting connective tissue. Figure 8E As shown, the distal portion of the point treatment device may be equipped with a wire arranged to be advanced to define a loop 832 having a gauge that facilitates employing the structure to cut tissue. Alternatively, RF energy may be employed to cut the septum. Figures 8F to 8G Depicted is a deformable hypotube 834 that is expandable such that two or more arms 836 protrude to define blades for cutting in another non-atraumatic treatment method. Figure 8H A balloon structure 840 is shown attached to a needle hypotube 842 that can be inflated beneath the indentation to eliminate or reduce the appearance of cellulite. Finally, in another non-invasive approach ( Figures 8I to 8J ), the distal portion of the point treatment device can be made with a blade 850 that cuts for deployment, and at least the blade is configured to rotate and cut connective tissue.

[0077] like Figure 8K As shown, the expander 410 can form the distal portion of the cellulite treatment device and is additionally equipped with a longitudinally extending blade 853 that is deployed when the expander 410 is expanded. The blade 853 is configured to act and cut the targeted tissue or septum in an alternative treatment method. Such cutting is used in an alternative to non-invasive methods and is accomplished by rotating or otherwise advancing, sweeping, or retracting the expander 410. The assembly is not expanded and retracted from the intervention site (such as through a tube) after use.

[0078] In yet another treatment method, a lasso 859 is formed and forms the distal portion of the cellulite treatment assembly and can be passed through a shaft 861 ( Figures 8L to 8O ) A curved wire that advances and retracts can be deployed around the septum 350 within the targeted area. Pulling the lasso 859 to reduce its defined perimeter causes the septum 350 to be cut and the cellulite to be treated. In one aspect, the lasso is formed from a nitinol wire, or a preformed wire or segment thereof. The lasso 859 is wrapped around the targeted septum and, upon tightening, cuts the septum. One method involves cutting the targeted area without moving the shaft, thereby providing a controlled treatment method.

[0079] like Figures 8P to 8T As shown, the lasso 859 may additionally or alternatively define a tube, and the assembly may additionally include a wire 863 slidably disposed within the tubular structure. After targeting the septum 350, the lasso structure 859 is partially deployed around the septum 350 by pushing it out of the shaft 861. The wire 863 is then advanced within the lasso 859 and emerges from the terminal end of the lasso 859 ( Figure 8Q ). The wire 863 is then advanced toward a slot or opening 865 formed in the shaft 861 and retained therein. Thereafter, the lasso 859 is further advanced to the shaft 861 and acts therewith to define a complete hoop or ring ( Figure 8R The lasso 859 is then tightened around the targeted septum 350 to cut, slit, or disrupt the septum as desired ( Figure 8T Alternatively, the complete hoop can remain in its larger hoop configuration, and the entire device can be pulled proximally to sever or disrupt the surrounding septum. After treating the targeted tissue, the lasso 859 and wire 863 are pulled proximally through the shaft 861 so that they are disengaged from the slot 865 and fully or partially retracted within the shaft 861, allowing the treatment device to be used in an additional location.

[0080] In a related lasso processing method ( Figures 8U to 8V ), a pair of elongated tubes 867, 868 are provided that can be configured to be arranged in a generally parallel arrangement around the targeting septum 350. The lasso 859 advances within the first tube 867 and out of its terminal end and toward the second tube 868 ( Figure 8U ). The lasso 859 is then captured by the second tube 868, causing the treatment device to encircle the targeted septum 350. The assembly is then pulled proximally to cut, dissect, or disrupt the targeted tissue. Following treatment, the lasso 859 is retracted within the first tube 867 and released from engagement with the second tube 868. The assembly is then positioned to treat additional areas as necessary.

[0081] Atherectomy blade 902 (see Figures 9A to 9B) can also be alternatively or additionally configured to remove tissue through an opening 904 on the side of the instrument, which can be used in certain auxiliary, more invasive treatment methods. The cutting structure 906 is attached to an elongated actuator 908 via a block or other connection 910. Manipulation of the actuator 908 causes the cutting structure 906 to act on the targeted tissue. An inner lumen 912 is also provided as a conduit for applying suction to the intervention site so that the severed or macerated tissue 912 can be removed. This device can be used to collect fat for subsequent placement at a site that has been treated with an expander and used to fill the space created. The cutter 902 can also be used as a primary treatment device for cutting membranes to treat cellulite.

[0082] Now turn Figures 10A to 10C , shows a preferred embodiment of a treatment system 920 that can be used in conjunction with one or more of the previously described devices for treating targeted tissue. Treatment system 920 includes a handle 922 and an elongated member 924 extending longitudinally from handle 922. As described above, a force gauge or sensor (electronic or mechanical) can be provided to ensure that a predetermined amount of force is applied to the tissue to prevent over- or under-stretching when testing the diaphragm. In addition, a treatment device 925 capable of acting on, dividing, cutting, or disrupting one or more of the connective tissues is disposed at a distal portion of elongated member 924. Thus, any one or more of the treatment devices described herein can define treatment device 925. All of the cutting devices can be combined with or further stimulated with RF, laser, ultrasound, or thermal energy to perform cutting and coagulation together or separately.

[0083] The handle 922 is equipped with a button or sliding trigger 926 that is configured to slide along the top surface of the handle 922. The trigger 926 is attached to the proximal portion of a shaft or wire 928, the distal portion of which is associated with or attached to a treatment device 925. In the closed configuration, the trigger 926 is positioned in its most proximal position ( Figure 10A ), and the treatment device 925 maintains a generally longitudinally aligned configuration. When so configured, the treatment system 920 can be positioned or repositioned to accomplish the desired cellulite treatment. Moving the trigger 926 to its distal-most position in turn causes the shaft or wire 928 to advance distally and place the treatment device 925 in a configuration (e.g., for hooking the targeted tissue) Figure 10B ). Retracting the trigger 926 to the intermediate position exposes the cutting structure (such as a blade or cutting wire), thereby configuring the treatment device 925 to cut, divide, or destroy the targeted tissue ( Figure 10C). A detent or other cooperating structure may be incorporated into the handle or trigger to secure the trigger in one or more positions, as well as to provide tactile feedback regarding positioning. Additionally, the system 925 may alternatively or additionally include any of the previously described functionalities, such as structures for providing transillumination as well as radiofrequency cutting and coagulation.

[0084] like Figure 11 As shown, in another embodiment, a treatment system 940 includes a handle 942 and an elongated member 944 extending from the handle. A shaft or wire (not shown) disposed within the elongated member 944 is attached to the treatment device 925, and alternatively or additionally, a rotatable trigger 946 is attached to the lower distal portion of the handle 942. A slider 947 is disposed within the handle 942, attached to the shaft or wire, and associated with and cooperating with the trigger 946. When the trigger 946 is released, a constant force spring 950 is associated with and cooperating with the slider 947 to retract the cutting structure of the treatment device 925. Additionally, a transillumination structure is disposed within the handle 942 and includes a battery compartment 952 and an electrical switch 954 for turning on and off a light source (e.g., an LED) disposed at the distal end of the treatment system 940.

[0085] Pulling the trigger 946 fully causes the treatment device 925 to be configured in a hooked configuration, wherein the cutting structure of the treatment device 925 is protected. Upon slightly releasing the trigger 946, the spring 950 retracts the shaft or wire associated with the treatment device 925 and positions the shaft or wire within a detent on the slider 947 to signal tactile feedback to the user that the cutting structure of the treatment device 925 is exposed. Full release of the trigger 946 causes the spring 950 to fully retract the shaft or wire, thereby placing the treatment device 925 in a closed or undeployed position. The treatment system 940 can then be repositioned and manipulated again to treat additional areas.

[0086] Figures 12A to 18C Various additional embodiments of the processing device are described in

[0014] 12A to 12C , the cutting, slicing or destroying processing assembly is defined by a protruding link arrangement. The first link 1400 includes a blade 1401 and is rotatably attached to a second link 1402 at one end. The opposite end of the first link 1400 slides relative to a longitudinal axis 1405 (shown as at least partially transparent). The axis 1405 defines a housing for supporting and accommodating the link arrangement. The second end of the second link 1402 is rotationally attached to a distal point on the axis 1405. A drive shaft or push rod 1407 is rotatably or pivotally attached to the opposite end of the first link 1400, and the second link 1402 includes a generally triangular or pointed protrusion 1408 that is sized and shaped to shield the blade 1401 from contacting tissue when the assembly is placed in a hooked configuration. When the push rod 1407 is fully retracted ( Figure 12A ), the blade 1401 is encased within the body of the longitudinal shaft 1405. It should be noted that in the fully retracted configuration, the first and second links 1400, 1401 form an obtuse angle, and the protrusions 1408 extend a relatively small distance from opposite sides of the longitudinal axis. When the push rod 1407 is fully advanced to the stop, the protrusions 1408 contact the push rod 1407, and the blade 1401 is again protected by the protrusions 1408 ( Figure 12B ). It is in this configuration that the processing device can be used to hook up targeting membranes and test membranes to determine whether such membranes are associated with the appearance of cellulite on the patient's skin. In one embodiment, the push rod 1407 is retracted from its fully advanced position and retracted approximately 0.070 inches (see Figure 12C , wherein blade 1401 is shown as transparent for illustrative purposes, blade 1401 is exposed and presented to act upon and cut, sever, or disrupt the targeted septum. The treatment device also has a blunt atraumatic tip 1406 that allows the treatment device to be advanced through subcutaneous tissue virtually atraumatically. In all embodiments, blunt tip 1406 can accommodate a light emitting diode, which can be a light emitting diode or accommodate the end of an optical fiber, to facilitate transillumination through the skin for user guidance with knowledge of the location of the treatment device tip.

[0087] It will be appreciated that, additionally or alternatively, the tip in any of the disclosed embodiments may be shaped so as to be characterized by or associated with a low introduction and advancement force through and within the patient's skin and anatomy, while providing a low likelihood of damaging tissue. Thus, the tip may have a bullet nose shape or a short dilator tip shape, or may define a sharp profile or trocar-type configuration for ease of advancement or tracking. Additionally, the tip may be retractable, reconfigurable, or otherwise define a sharp configuration only when the tip is subjected to a predetermined level of resistance. In one particular approach, a spring-loaded cover or shield is configured around the tip such that when subjected to a defined resistance, the cover or shield is removed to expose the sharp tip, which is configured to facilitate advancement of the treatment device or reduce the force through the patient's anatomy.

[0088] In an alternative approach ( 13A to 13D), the second link 1402 includes a blade 1401 with a sharp protrusion 1403, and the first link 1400 acts as a blocker to shield the main portion of the blade 1401 from contacting tissue when the treatment device is in the hook configuration. When the treatment device is in the hook configuration, the sharp protrusion 1403 extends proximally from the pivot between the first link 1400 and the second link 1402 so that when the user pulls the treatment device proximally, the pivot position, which serves as the leading portion of the device during retraction, does not get stuck in the tissue, but rather cuts the tissue, so that the user can hook the diaphragm with the main portion of the first link 1400 and feel the resistance of the diaphragm. It is worth noting that in the fully retracted position ( Figure 13A ), the first link 1400 and the second link 1401 define an obtuse angle, and when the push rod 1407 is almost fully advanced ( Figure 13B ), the majority of the blade 1401 is protected by the second link 1402. Thus, the structure is in the form of a hook to facilitate hook capture and provide a portion of the blade 1403 unprotected near the connection between the first 1400 and second links 1402. When the user retracts the treatment device proximally, the push rod 1407 is fully advanced to fully expose the blade 1401 to cut, sever or destroy the targeted septum (see FIG. 13C to FIG. 13D ; Figure 13D The first blade is shown as transparent for illustrative purposes).

[0089] When employing one or more of the disclosed embodiments in a treatment procedure, it is anticipated that in some circumstances it may be preferable not to disrupt the snagged septum, and in such circumstances, it may be desirable to release or disengage the snagged septum. In some methods, to release or disengage, the treatment device will be advanced or twisted away from the snagged septum. Therefore, it will be recognized that challenges exist in that when the treatment device is in a snagged configuration, there may be additional septum or other tissue in the area that may be inadvertently re-acted by the treatment device, and storage of the treatment device may be inhibited by adjacent patient anatomy. References Figures 13E to 13F , including a hinged arrangement 1400, 1402 or by pivoting relative to a longitudinal axis 1405 from a hooking configuration ( Figure 13E ) to the collapsed configuration ( Figure 13F ) benefit from the fact that when the treatment device is sheathed or stowed, the blocking link 1400 (or similar structure) moves to push the septum 350 or other tissue away from the treatment device. This action does not require the treatment device to be advanced further within the patient's anatomy and ensures that the septum 350 or other tissue does not become undesirably trapped. Moreover, when stowed, the links 1400, 1402 dislodge any tissue that may have been trapped within the longitudinal axis 1405, and the links 1400, 1402 ultimately occupy the space within the longitudinal axis 1405.

[0090] Now turn 14A to 14F , yet another method of handling the device is shown. Here, two parallel arranged and hinged first links 1420, 1422 are provided, which are arranged to block or shield the blade 1401 attached to or forming the edge of the second link 1402. The first links 1420, 1422 each define a curved or yoke-like member with a unique profile that is designed to selectively shield the second link 1402, and the first end 1424 of each is rotatably or pivotally attached to the pusher 1407 and the second end 1426 is rotatably or pivotally attached to the second link 1402. The parallel arrangement of the first links 1420, 1422 provides additional strength to the hooking and cutting positions. When the push rod 1407 is fully retracted ( Figure 14A and Figure 14D ), curved portions of first links 1420, 1422 protrude from opposite sides of longitudinal axis 1405 (shown as at least partially transparent), from which the links extend when deployed to hook or cut, sever, or disrupt the membrane. To present the tissue hooking configuration, push rod 1407 is advanced such that first links 1420, 1422 completely shield or block blade 1401 (see FIG. Figure 14B and 14E ;exist Figure 14E For illustrative purposes, one first link 1420 is shown as transparent) to avoid contact with tissue. The push rod 1405 is fully advanced to fully expose the blade 1401 (see Figure 14C and 14F ), and thereby presenting blade 1401 to cut, dice or destroy targeted tissue.

[0091] like Figures 15A to 15F As shown, the treatment device may alternatively or additionally include a first push rod 1430 and a second push rod 1432, the first push rod 1430 being configured to manipulate a first link 1434 that articulates or pivots, and the second push rod 1432 being configured to manipulate a second link 1436 that articulates or pivots comprising the surface of the blade 1401. When the push rods 1430, 1432 are in the fully advanced position ( Figure 15A and Figure 15D ), the first link 1434 and the second link 1436 are generally parallel and stowed within the longitudinal axis 1405 (which is shown as at least partially transparent). Retracting the push rods 1430, 1432 is used to protrude the first link 1434 and the second link 1436 from the stowed position (see Figure 15B , C, E, F). Retracting the push rod similarly causes the first link 1436 to overlap the blade 1401 but leaves it fully exposed ( Figure 15C and Figure 15F) to cut, cut or destroy the targeted tissue, but when the push rod 1430 associated with the first link 1434 advances to a different extent than the second push rod 1432, a portion of the blade 1401 may be shielded or blocked by the first link 1434 ( Figure 15B ), thereby presenting a structure for hooking the target tissue, or a portion of the blade 1401 may be shielded ( Figure 15E ), thus presenting both a hooking and a cutting structure. This embodiment may also have a rough blunt tip 1406.

[0092] In some additional or alternative aspects, the robustness of the blade mechanism of the treatment device can be enhanced by reinforcing the pivot point, increasing the strength of the longitudinal shaft, and improving blade concealment during insertion and advancement within tissue and hooking the tissue. Figure 16A As shown, a weld pin or swaged tube 1450 may be used at the connection between the first link 1400 and the second link 1402. Furthermore, a mechanical connection, such as a weld pin or swaged tube, may form a connection between the second or more second links 1402 and the distal portion of the longitudinal shaft 1405. Such a pivot point may be defined by, for example, a pin or tube having a diameter of approximately 0.025 inches in one or more embodiments and may be used at one or more rotational or pivotal connections of the processing system. Additionally, from Figures 16B to 16C As best seen in FIG, the first link 1400 including the blade 1401 may be configured between a pair of second links 1402 (one link shown as transparent), rather than being hidden by or cooperating with a single first link 1400.

[0093] like 17A to 17C As shown, in an alternative or additional method, when the links 1400, 1402 are fully retracted and contained within the longitudinal shaft 1405 ( Figure 17A ) when the handling system lacks a protruding structure. The first link 1400, which serves as a blocking or blunting element, may be spring-loaded so that it shields the blade 1401 ( Figure 17B ), until a critical force is reached, and then blade 1401 ( Figure 17C) to cut, slice, or disrupt the targeted septum. After cutting or slice, the blade 1401 can be configured to re-sheath automatically, or an actuator, such as a button, can be provided to re-sheath the blade 1401. In this approach, the linkage has two positions: sheathed and deployed. This reduces the overall force requirement because there is no need for the user to engage the hook structure under excessive force. Thus, the blade 1401 is completely sheathed or contained within the longitudinal shaft 1405 during navigation and can be deployed when necessary. In this way, the longitudinal shaft 1405 can be formed, for example, from a hypotube, with fewer cutouts for ejecting and storing the linkages 1400, 1402. This structure or related functionality can be incorporated into any of the disclosed embodiments to provide spring-loaded cutting, requiring a controlled amount of force to expose the blade for cutting. This embodiment can also have a blunt tip 1406.

[0094] In a related approach (see 18A to 18C ), a blocking or hooking function is provided by a pair of curved or angled first links 1400. In the stowed configuration, the curved or angled links 1400 protrude from opposite sides of the longitudinal axis 1405 from the deployment or handling side of the axis 1405 ( Figure 18A ). However, like the previous method, the blocking or shielding first links 1400 are spring loaded so that they sit on opposite sides and shield the blades 1401 ( Figure 18B ) until a critical force is reached and then the blade is exposed ( Figure 18C ) to cut, slice or destroy the targeted septum. Here again, after cutting or slice, the blade 1401 can be configured to automatically re-sheath, or an actuator such as a button can be provided to re-sheath the blade 1401, and the linkage has two positions, namely, sheathed and deployed.

[0095] Now refer to Figures 19A to 19B , shows a handle 1922 of a processing device including a trigger or slider assembly 1926 including a depressible button 1928. The handle 1922 includes a track 1929 along which the button 1928 is aligned. Such an arrangement may be incorporated into one or more of the previously disclosed processing systems. Figure 19AAs shown, in one embodiment, button 1928 is biased relative to track 1929 by coil spring 1930. Slider assembly 1926 is attached to drive shaft or pusher 1407, which is connected to a processing device (not shown) and facilitates manipulation of the processing device. Button 1928 can be depressed to release the lock or other interaction between button 1928 and track 1929, allowing slider assembly 1926 to slide relative to handle 1922. Releasing button 1928 causes the button to engage track 1929 and slide into locking interaction with one of a series of cutouts 1932 formed in track 1929. It should be noted that when not locked to track 1929, the button 1928 of the slider assembly can engage track 1929 and slide along the track between locked positions. Such cutouts 1932 are arranged and positioned so that when the slider assembly 1926 is locked to the track 1929, the treatment device is positioned in one or more of a sheath, hook, or cutting position within the tissue and relative to the targeted septum. Thus, a secure action is provided between the slider assembly 1926 and the handle 1922, as well as a tactile sense for the user of the position and state or configuration of the treatment device. Figure 19B As shown, button 1930 is biased by a leaf spring 1934 rather than a coil spring. Also, here, button 1928 is configured to be individually actuatable and defines a structure that is depressible independently of the sliding structure of slider assembly 1926, thereby providing alternative discrete control of the sliding and locking functions.

[0096] 20A to 22C Some additional methods of processing the system are shown in FIG. 20A to 20C As shown, handling system 1940 includes a handle assembly 1942 including a slider 1943 biased by a spring 1944 and configured to translate along a portion of a body 1946 of handle assembly 1942. A button 1947 vertically projects from an upper surface of slider 1943, with button 1947 connected to or associated with a boss 1948 positioned within a slot formed in slider 1942. Boss 1948 also slides along and is configured to register with a ramp 1949 or other active structure formed in handle body 1946. Furthermore, a lever 1950 is rotatably attached to slider 1943, the lever including a curved slot 1951 that receives a boss 1952 that projects from a bracket 1953. Each of the slider 1943 and the bracket 1953 is attached to one or more longitudinally extending members 1954 that are associated with a handling device 1956 attached to a terminal portion thereof (see Figures 20D to 20F). An optional light and energy source unit 1995 (e.g., a light emitting diode and battery) is attached to the proximal end of the handle assembly 1942. An optical fiber (not shown) extends distally through the handle assembly 1942 and the longitudinal axis of the treatment device 1956 to a distal portion of the longitudinal axis to transmit light from the light and energy source unit 1995 to the distal portion of the treatment device 1956 to provide transillumination through the skin for the user.

[0097] In the stowed position of the handling device (see Figure 20A and Figure 20D ), the slider 1943 is in its most proximal position and the spring 1944 is mostly compressed. As the slider 1943 translates forward ( Figure 20B and Figure 20E ), spring 1944 extends, and slider boss 1948 is temporarily and fixedly aligned along ramp 1949. As a result of this action, longitudinally extending member 1954 advances to manipulate treatment device 1956. It is in this configuration that treatment device 1956 is in a deployed but covered configuration, intended to hook or otherwise act upon the targeted septum. By then depressing rotatable lever 1950 via the interaction of lever 1950 and bracket 1953, longitudinally extending member 1956 is advanced slightly further in the distal direction to expose treatment device sharp link or blade 1957 (see Figure 20C and Figure 20F ), a sharp link or blade 1957 is configured to cut, sever, or disrupt the septum. Of note, a spring (not shown) is disposed between the lever 1950 and the bracket 1953 to bias the lever 1950 to return the treatment device 1956 to a locked and hooked configuration. After the treatment device 1956 has been manipulated as desired at the interventional site, the slide button 1947 is depressed to release the action between the slider boss 1948 and the ramp 1949, thereby permitting the spring 1944 to return the slider 1943 to its proximal position and stow the treatment device 1956 for further use or removal from the interventional site. In an alternative approach, the system 1940 would lack the lever 1950, and an additional spring (not shown) would be configured to allow the bracket 1953 to advance only when the treatment device 1956 encounters a predetermined resistance, at which point the blade 1957 is exposed. In this manner, the tool is easier to use and the cutting step after hooking the septum is less likely to be omitted.

[0098] In another method ( Figures 21A to 21C), a processing system 1960 includes a handle assembly 1962 including a slider 1963 biased by a spring 1964, the slider 1963 also being configured to translate along a portion of a body 1966 of the handle assembly 1962. Here, rather than providing a button to unlock the slider 1963, the slider 1963 is configured to rotate relative to the body 1966, and the slider 1963 itself includes a boss 1968 that slides along a ramp 1969 or other active structure formed in the handle body 1966 and is configured to align along the ramp or other active structure. Also, here, a lever 1970 is rotatably attached to the slider 1962, the lever including a curved slot 1971 that receives a boss 1972 that projects from a bracket 1973. Each of the slider 1962 and the bracket 1973 is attached to one or more longitudinally extending members 1976 that are connected to a processing device (not shown, but such as a handle 1976) attached to a terminal portion thereof. FIG. 20D to FIG. 20F ) associated with the structure depicted in .

[0099] When the handling device is in the stowed position (see Figure 21A ), the slider 1962 is in its most proximal position and the spring 1964 is mostly compressed. As the slider 1962 translates forward ( Figure 21B ), spring 1964 extends, and slider boss 1968 becomes temporarily and fixedly aligned along ramp 1969, and longitudinally extending member 1976 advances to manipulate the treatment device. It is in this configuration that the treatment device is in a deployed but covered configuration, intended to hook or otherwise act upon the targeted septum. Thereafter, by depressing rotatable lever 1970, longitudinally extending member 1976 is advanced slightly further in the distal direction via the interaction of lever 1970 and bracket 1973 to expose the sharpened rod or blade of the treatment device (see Figure 21C ). In this configuration, the treatment device is configured to cut, sever, or disrupt the targeted septum. A spring (not shown) is disposed between the lever 1970 and the bracket 1973 to bias the lever 1970 to return the treatment device to the locked and hooked configuration. After the treatment device has been manipulated as desired at the intervention site, the slide button 1962 is depressed and rotated to release the action between the slider boss 1968 and the ramp 1969, thereby permitting the spring 1964 to return the slider 1962 to its proximal-most position and stow the treatment device.

[0100] like Figures 22A to 22C As shown, the treatment device 1980 may additionally or alternatively include a handle assembly 1982 including a slider 1984 configured to slide along the body of the handle assembly 1982. When the slider 1984 is in its most proximal position ( Figure 22A), the treatment device (not shown) is in the stowed position. The slider 1984 is attached to a pair of rotatable angled members 1986, 1987, each of which has an end rotatably attached to the handle body and the slider 1984, respectively. The forwardly positioned rotatable member 1986 also includes an extension 1988 that is rotatably attached to a rotatable bracket 1989, which in turn is rotatably attached to a longitudinally extending member 1990 having a treatment device (not shown) attached to a distal portion thereof. A button 1992 protrudes vertically from the slider 1984, and the button 1992 is associated with a boss 1993 that is configured to align along a portion of the body of the handle assembly 1982 (see Figure 22B ). When positioned so that the slider 1984 advances along the handle body and the boss 1993 is aligned within the recess 1994 formed in the handle body, the treatment device is deployed but at least partially covered to present a structure for hooking or engaging the targeting septum. By pressing the button 1992, the boss 1993 of the slider 1984 can be disengaged from the recess 1994, thereby permitting the slider 1992 to be further advanced distally. In doing so, the longitudinally extending member 1990 can be further advanced to expose the cutting portion of the treatment device to cut, divide or act on tissue and complete the desired interventional treatment. The slider 1992 can then be returned to either the stowed position or the deployed but covered position as needed for further interventional steps. Thus, this approach provides a mechanism that scales up small movements of the handle assembly so that the configuration of the treatment device (e.g., containment, hooking or cutting position) is more apparent to the user.

[0101] In the aforementioned embodiments described, a "ballpoint pen" type mechanism may be used in the handle assembly so that after the hook and / or sharp edge tears or cuts the diaphragm, the connecting rod automatically retracts after the force acting on the connecting rod when it tears or cuts the diaphragm is suddenly reduced.

[0102] In another embodiment, a coil is deployed from a distal portion of the treatment device and rotated to wrap a membrane into the coil to reform the targeted cellulite on the skin surface, and then the user pulls the coil to disrupt or cut the membrane, or uses a knife to sever the membrane.

[0103] Thus, various methods for cellulite treatment methods and devices are presented. The disclosed methods are configured to provide an effective and focused approach to treating, minimizing, and preventing cellulite. The disclosed methods can also be used to repair and reduce the appearance of cellulite in a targeted manner. Furthermore, the disclosed active treatments are easy to use and effective.

[0104] Some of the specific aspects of the present disclosure include one or more of the following: treating only the septum locally that causes the indentation or depression in the skin; minimizing bruising; accessing all treatment targets from limited cosmetically acceptable access points; capturing and retaining the septum as it is divided; intraoperatively confirming the treatment target; using needle-sized tools for small openings; and transilluminating to identify tool tip locations.

[0105] Although the present disclosure has been described with reference to specific embodiments thereof, it will be understood by those skilled in the art that various changes may be made and equivalents may be substituted without departing from the true spirit and scope of the present disclosure. In addition, many modifications may be made to adapt a particular situation, material, composition of matter, process, process step or steps to the purpose, spirit and scope of the present disclosure. All such modifications are intended to be within the scope of the present disclosure.

Claims

1. A cellulite treatment device for treating manifestations of cellulite associated with a membrane treatment site on a patient's skin, the device comprising: handle; a shaft extending longitudinally from the handle, the shaft being sized and shaped to be inserted into tissue and advanced between tissue layers to the septum treatment site without assistance from a tissue stabilizing structure applied to the patient's skin; as well as a diaphragm action and disruption assembly at a distal portion of the shaft, wherein the diaphragm action and disruption assembly includes a laterally projecting link forming a laterally open hook configuration to test a diaphragm to determine whether the tested diaphragm is associated with cellulite manifestations when the diaphragm action and disruption assembly is in a diaphragm tensioning position; as well as An actuator for actuating the diaphragm apply and destroy assembly, the actuator being on the handle, wherein the actuator positions the diaphragm apply and destroy assembly in at least a stowed position, the diaphragm tensioned position, and a diaphragm destroyed position. The device according to claim 1 , further comprising a transillumination structure.

3. The apparatus of claim 2, wherein the transillumination structure is embodied as a light positioned along a distal portion of the shaft. The apparatus of claim 3 , wherein the light is one or more of an LED or a light guide.

5. The apparatus of claim 1, wherein the membrane action and disruption assembly is a blunt-ended pair of scissors.

6. The apparatus of claim 1 wherein the diaphragm activation and disruption assembly comprises selected sharp edges.

7. The apparatus of claim 1, wherein the laterally protruding links form a laterally open V-shaped structure.

8. The apparatus of claim 1, wherein the laterally projecting links comprise guillotine-style blades that are longitudinally extendable and retractable.

9. The device of claim 1, wherein the diaphragm activation and destruction assembly comprises an internal hook.

10. The apparatus of claim 1, wherein the diaphragm action and breaking assembly comprises an angled hook.

11. The apparatus of claim 1 , wherein the laterally projecting link comprises a rotating structure or a blade.

12. The apparatus of claim 1, wherein the membrane action and disruption component comprises a cutting balloon.

13. The apparatus of claim 1, wherein the membrane action and disruption assembly comprises a scalpel.

14. The apparatus of claim 1, wherein the membrane action and disruption assembly comprises a selective cautery structure or an energy delivery structure.

15. The apparatus of claim 1 further comprising an objective measurement device that scans the targeted area and creates a complete three-dimensional map of cellulite relative to the normal skin surface.

16. The apparatus of claim 1 further comprising an anesthetic agent and an anesthetic agent infusion subassembly.

17. The apparatus of claim 1, wherein the shaft is steerable.

18. The device of claim 1, wherein the device is configured for delivering a drug to the treatment site.

19. The device of claim 18, wherein the drug is an anti-inflammatory agent, salicylic acid, glycolic acid, hyaluronic acid, or a cellulite treatment drug.

20. The device of claim 1, wherein the device is configured to deliver an anesthetic to the treatment site percutaneously or subcutaneously.

21. The apparatus of claim 1, wherein the membrane action and disruption component is configured to stretch, cut, or otherwise disrupt membranes associated with the cellulite manifestations.

22. The apparatus of claim 15, wherein the objective measurement device cooperates with a controller to automatically create a processing path.

23. The apparatus of claim 1, wherein the apparatus is housed in a single device.

24. The apparatus of claim 1, wherein the apparatus defines a point treatment device and includes a needle having a lateral opening through which an interventional instrument is deployed and recaptured.

25. An apparatus according to claim 1, wherein the laterally protruding links include a first link rotatably attached to a second link and a drive shaft attached to the first link, the first link, the second link and the drive shaft being contained within a longitudinal axis, wherein manipulation of the drive shaft causes the first link and the second link to protrude laterally from the axis.

26. The apparatus of claim 1, wherein the laterally projecting link comprises a first link rotatably attached to a second link, the first link comprising a blade.

27. The apparatus of claim 1, wherein the laterally projecting link comprises a first link rotatably attached to a second link, and the second link comprises a blade.

28. The apparatus of claim 1, wherein the laterally projecting link comprises a first link rotatably attached to a second link, wherein the first link is configured to cover at least a portion of the second link in the second position.

29. The apparatus of claim 1, wherein the laterally projecting link comprises a first link rotatably attached to a second link, wherein the first link and the second link are configured to define a septum hooking structure and a septum disrupting structure.

30. The apparatus of claim 1, wherein the laterally projecting link comprises a blade having a portion extending beyond the pivot connection.

31. The apparatus of claim 1, wherein the laterally projecting links comprise a plurality of first links rotatably attached to a second link, the plurality of first links being configured to receive the second link therebetween.

32. The apparatus of claim 1, wherein the laterally projecting links comprise a first link rotatably attached to a second link, a first push rod attached to the first link, and a second push rod attached to the second link.

33. An apparatus according to claim 1, wherein the laterally protruding link includes a first link rotatably attached to a second link, the second link rotatably attached to a longitudinal axis, wherein welded pins or swaged tubes are used at the attachment of the first link to the second link and at the attachment of the second link to the longitudinal member.

34. The apparatus of claim 1 , wherein the laterally projecting link comprises a first link rotatably attached to a second link and a blade formed on the second link, wherein the first link is configured to shield the second link in a second position and is spring loaded such that the first link shields the second link until subjected to a predefined force during use and then presents the blade to disrupt tissue.

35. The apparatus of claim 1 , wherein the laterally projecting link comprises a pair of first links rotatably attached to a second link and a blade formed on the second link, wherein the pair of first links are configured to shield the second link in a second position and are spring-loaded such that the first link shields the second link until subjected to a predefined force during use and then presents the blade to disrupt tissue.

36. The apparatus of claim 1, further comprising a push rod associated with the laterally projecting link, the handle comprising a spring-biased button configured to lock the push rod in a plurality of positions.

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