Cellulite treatment system and method

Abstract

To provide an effective and efficient approach for treating, minimizing or removing cellulite with a simple system that minimizes trauma.SOLUTION: A system and method for treating cellulite that includes or is a device that applies separating septa to eliminate or reduce the appearance of cellulite. In one approach, the interventional tool is positioned between the tissue layers to engage and treat the septal wall that spans between the tissue layers where the fatty deposit is contained.SELECTED DRAWING: Figure 1A-1B

Description

[Technical Field]

[0001] This disclosure generally relates to systems and methods for treating cellulite. This application claims the benefit of and priority to U.S. Patent Application Nos. 62 / 896,676, filed September 6, 2019, 62 / 911,111, filed October 4, 2019, and 63 / 049,705, filed July 9, 2020, the entire contents of which are incorporated herein by reference. [Background technology]

[0002] There is a continuing need for effective approaches to treat cellulite, also known as gynecomastia, nodular liposclerosis, edematous fibrosclerosis, panniculosis, edematous liposclerosis, demospaniculosis deformans, or status protoscutis. Additionally, there is a need for a simple, effective, proactive treatment method that prevents future occurrence or recurrence of cellulite.

[0003] More than 85% of women report having cellulite, suggesting that it is a physiological condition rather than a pathological one. The mere presence of fat in the reticular dermis is not thought to be sufficient to cause cellulite. Cellulite is a herniation of subcutaneous fat within fibrous connective tissue, manifesting as dimples in the skin. This fat load can lead to stress on the connective tissue located between the fat lobules. These dimples are more common in women than men due to the orientation of the subcutaneous fibrous structures that define the chambers containing fat cells. In fact, this structure, rather than excess weight, is thought to be the cause of cellulite's appearance. Cellulite often occurs in the pelvic region, including the buttocks, lower legs, and abdomen.

[0004] The subcutaneous fat layer beneath the epidermis is contained between dermal layers connected by septa, which function as connective tissue between the dermal layers. In men, septa are more randomly and densely arranged in a crisscross pattern, whereas in women, septa are generally more parallel. Furthermore, men have a thicker dermis, with septa at an angle to the skin surface, whereas women have a relatively thinner dermis that thins with age, resulting in septa becoming perpendicular to the skin surface. Furthermore, in women with cellulite, septa thicken in areas with cellulite, leading to tension and accentuating the cellulite. In women, fat accumulation in adipose tissue has a biological purpose: to ensure sufficient calories for pregnancy and lactation. Increased fluid retention and adipose tissue proliferation in this subcutaneous fat layer can further lead to the appearance of cellulite, with septa maintaining the initial distance between the dermal layers, resulting in depressions and pockets between the septa becoming distended. Over time, the septa stretch and then contract and stiffen, keeping the tissue layers at a consistent distance, but the pockets between the septa can expand and exacerbate the appearance of cellulite.

[0005] Various approaches have been used to treat or address cellulite. Early treatments attempted to increase circulation and fat oxidation in areas exhibiting cellulite. Substances such as hyaluronic acid and aminophylline were injected into targeted areas to reduce cellulite. Other approaches include electroporation of the target area followed by mesotherapy, or the application of dermatological creams or supplements to the cellulite. These approaches can be complemented by massage, or massage can be used alone to increase fat resorption or promote fluid and toxin drainage in the treatment area. Ultrasound has also been proposed to destroy subcutaneous tissue and fat and has been used in combination with liposuction. Low acoustic pressure combined with microbubble injection has also been employed to reduce the appearance of cellulite, as have the use of other energies such as lasers and radiofrequency waves. These approaches have been characterized by limited or unpredictable results. More recently, cutting septa with blades or needles in the subcutaneous area has been employed. Previous approaches have proven to be labor intensive and highly traumatic to the tissue leading to bleeding, bruising, tough tissue knots, long and painful recoveries, and inconsistent results.

[0006] Therefore, there is a need for effective and efficient approaches to treat, minimize, or eliminate cellulite in a simple system that minimizes trauma, that is associated with predictable results, and that is relatively easy to employ.

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

[0008] In brief and general terms, the present disclosure relates to cellulite treatment systems and methods that include devices that facilitate stretching, redirecting, disrupting, cutting, slicing, and / or tearing septa or septa at the site of cellulite, depending on the system used and the force applied by the user. In one aspect, the treatment approach includes a tissue cutting or slicing system.

[0009] In one embodiment, the cellulite treatment device is attached to the distal end of the shaft and is sized and shaped to be advanced between tissue layers. In one particular aspect, the fibrous septa connecting the upper and lower fascia plateaus within the skin can be transected with the treatment device using one or more of a series of engaging tools, and depending on the tool used and the force applied by the user, the septa can be stretched, realigned, torn, disrupted, cut, or incised. By doing so, the targeted subcutaneous connective tissue associated with the surface defect can be directly modified with minimal impact on the surrounding vascular and lymphatic systems, fat can be more evenly distributed, and the skin can have a smoother appearance.

[0010] In one or more embodiments, the cellulite treatment system embodies a tool that facilitates the ability to reach and treat all target cellulite-appearing areas through a single or limited number of entry points through the skin. In certain aspects, such a tool is sized, shaped, and configured (e.g., about 2 millimeters or less in diameter and a blunt dissecting tip) to be positioned within and advanced between tissue layers by itself without assistance from an external skin-stabilizing structure such as a suction device. Entry points that penetrate the skin are employed at high points on the buttocks, such as bikini or underwear straps, or along the crease or transition between the buttocks and thighs. Identification and evaluation of target septa is accomplished by pushing, pulling, or otherwise tensioning the septa in areas of the skin believed to be associated with the appearance of cellulite. Recognizing that the septa causing divots or depressions may be at various angles and locations relative to the divots or depressions observed in the skin and may not necessarily be directly underlying such cellulite appearances, treatment systems and methods are configured to identify the septa responsible for the cellulite appearance marked on the skin and provide targeted treatment to those septa, leaving adjacent septa, blood vessels, etc. Additionally, a small subset or more septum-like areas may be the structures causing a particular divot or depression.

[0011] In one method, an anesthetic is injected percutaneously or subcutaneously into the treatment area, a cellulite treatment system is inserted subcutaneously over the treatment area, and various septa are used to identify the septa causing the depression or indentation by pushing or pulling on them, creating a depression in the skin of the target area. A cutting or slicing device or septum disruption structure is then placed subcutaneously in the treatment area and employed to engage, cut, slice, or destroy the septal tissue. In one specific embodiment, the patient is instructed to clench their gluteal and / or leg muscles to facilitate identification of the target area, confirming the release of the septa causing the depression or indentation after septum treatment. Alternatively, the physician can push the skin over the treatment target from a cranial to coccygeal direction or pull from underneath the treatment target. Remote imaging, ultrasound, or fluoroscopic energy can be used to monitor the treatment. Resize or alternate configurations of the treatment structure can be employed 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, and can also take a spot treatment approach. Langa lines can be used as a reference for directing treatment. Furthermore, various treatment trajectories can be directed through one or more portals, and in certain applications, steerable introducers can be used to access the treatment area. Furthermore, anti-inflammatory agents, collagenase, deoxycholic acid, salicylic acid, glycolic acid, hyaluronic acid, or cellulite treatment agents can be applied separately or directly at the intervention site via an interventional device or other procedural instrument. Aspects of the present invention include identifying the septa responsible for the appearance of cellulite, cutting or separating those septa, intraoperatively confirming that separation of those septa has been achieved, and preventing the reappearance of cellulite.

[0012] In various embodiments, the treatment device can include one or more of blunt scissors, guillotine-type angled blades, protruding connectors, side-opening hooks or V-shaped structures, internal hooks, bevel hooks, rotating structures or blades, cutting balloons or harmonic scalpels, selective cauterization structures, or energy transmission structures for disrupting, cutting, slicing, or dissecting tissue and / or controlling bleeding. In one particular approach, the treatment device includes a mechanical septum-cutting element, such as a blade or sharp surface, which cooperates with a septum hook element to both hook and then cut, slice, tear, or destroy the septum. One or more of the septum hook element and the septum-cutting element are convertible from a hook configuration to a cutting configuration, from a cutting configuration to a hook configuration, or to a retracted configuration. In another particular approach, the treatment device is embodied in a transdermally insertable elongate member that can expand at least one region from a small state to a large state and is configurable to both hook and cut, slice, or destroy the target septum when in the large state. In one or more alternative or additional aspects, cutting or disruption is accomplished with electrical or thermal means, such as a monopolar or bipolar structure or a hot wire configured to address bleeding and facilitate cutting.

[0013] The cellulite treatment system may also include, in certain approaches, illumination such as bright lights configured at or emitted through the tip of the treatment structure, along the treatment structure, or placed at strategic locations, for the purpose of tracking the advancement of the tool to the treatment site and locating the intradermal structures at the treatment site. In this way, direct observation of the treatment tool by transillumination through the skin is provided, and subcutaneous positioning and execution is readily available to the operator.

[0014] Additionally, objective measurement devices are included in the treatment system to evaluate treatment results. In one approach, light energy, such as bright light or laser light, is emitted and received by the measurement device, and the surface of the treatment area is scanned. The measurement device creates a complete three-dimensional map of all cellulite lesions relative to normal skin. By comparing the volumetric improvement of the divots to the normal idealized surface, the operator can calculate the overall and local volumetric benefits of the treatment and track improvement over time.

[0015] Additionally, the disclosed devices and structures may be employed for body sculpting, wrinkle removal, acne scar treatment, and / or skin repositioning. Foam fillers or spacers of various lengths, and other structures such as subcutaneously attached structures, either absorbable or permanent, may be used to achieve such purposes.

[0016] These and other features of the present disclosure will become apparent to those skilled in the art upon reading the details of the systems and methods more fully described below. [Brief explanation of the drawings]

[0017] [Figure 1A-1B] 1A and 1B are perspective views showing cellulite on a subject's skin and a plan for treating the cellulite.

[0018] [Figure 1C-1D] Figure 1C is a top view showing treatment across and along the Langa lines of a subject lying on a treatment table. Figure 1D is a top view showing a cellulite treatment assembly and approach for treating cellulite.

[0019] [Figures 1E-1H] 1E-H are partial cross-sectional views showing an embodiment for treating septa below the skin surface.

[0020] [Figures 1I-1L]1I-L are partial cross-sectional views showing an embodiment for treating septa below the skin surface.

[0021] [Figure 1M-1N] 1M-N are partial cross-sectional views showing an embodiment for treating septa below the skin surface.

[0022] [Figure 1O-1R] 1O-R are partial cross-sectional side views showing an alternative approach to trans-illumination.

[0023] [Figures 1S-1V] Figures 1S-T are perspective and side views showing the use of a template in a treatment procedure, and Figures 1U-V are top and side views showing another approach to the use of a template in a treatment procedure.

[0024] [Figure 1W-1Y] 1W-Y are schematic diagrams showing subassemblies of the approach to the light-generating assembly.

[0025] [Figure 1Z-1AA] Figure 1Z is a partial cross-sectional view showing a further step in the treatment method, and Figure 1AA is a perspective view showing placement of a treatment strip over the treated area.

[0026] [Figures 2A-2D] 2A-D are top views showing an alternative embodiment of a scissor device.

[0027] [Figures 3A-3F] 3A-F are top views showing embodiments of hook and V structures for treating cellulite.

[0028] [Figures 4A-4D] 4A-D are top and perspective views showing a healing structure embodying a hook healing structure.

[0029] [Figures 4E-4G] 4E-G are top and perspective views showing a healing structure embodying a hook healing structure.

[0030] [Figures 5A-5F] 5A-F are top views showing the hook and slide approach to the treatment structure.

[0031] [Figure 5G-5I] Figures 5G-I are top views showing the hook and slide approach to the treatment structure.

[0032] [Figures 6A-6B] 6A-B are top views showing the segmented treatment structure.

[0033] [Figures 7A-7D] 7A-D are top views showing a treatment device with interlocking hooks and cutting structures.

[0034] [Figures 7E-7G] 7E-G are top views showing a treatment device with interlocking hooks and cutting structures.

[0035] [Figure 7H-7K] 7H-K are top views showing a treatment device with interlocking hooks and cutting structures.

[0036] [Figures 7L-7N] 7L-N are top views showing a treatment device with interlocking hooks and cutting structures.

[0037] [Figures 7O-7P] 7O-P are isometric views of one embodiment of a processing system and processing device.

[0038] [Figure 7Q-7S] 7Q-S is a top view showing additional features of the treatment device.

[0039] [Figure 7T-7X] 7T-X are top and partial cross-sectional views showing additional features of the treatment device.

[0040] [Figure 7Y-7AA] 7Y-AA are side views illustrating yet another approach to the treatment device.

[0041] [Figures 7AB-7AE] 7AB-AE are side views showing an alternative approach to blade construction.

[0042] [Figures 8A-8C] 8A-C are perspective views showing the components of a spot treatment system.

[0043] [Figure 8D-8J] 8D-J are side views showing additional approaches to the processing structure.

[0044] [Figure 8K] FIG. 8K is a side view showing an additional approach to the processing structure.

[0045] [Figure 8L-8O] 8L-O are cross-sectional views illustrating various treatment approaches including lassoing.

[0046] [Figure 8P-8T] 8P-T are cross-sectional views showing various treatment approaches including lassoing.

[0047] [Figure 8U-8V] 8U-V are cross-sectional views illustrating various treatment approaches including lassoing.

[0048] [Figure 9A-9B] 9A-B are cross-sectional views illustrating an atherectomy-type device and its use.

[0049] [Figures 10A-10C] 10A-C are side views showing components of another treatment system.

[0050] [Figure 11] FIG. 11 is a side view showing additional components of the treatment system.

[0051] [Figures 12A-12C] 12A-C are top views showing a further approach to the processing system.

[0052] [Figures 13A-13D] 13A-D are bottom and top views illustrating yet another approach to a processing system.

[0053] [Figures 13E-13F] 13E-F are bottom and top views illustrating yet another approach to a processing system.

[0054] [Figures 13G-13J] 13G-J are bottom and top views showing yet another approach to a processing system.

[0055] [Figures 14A-14C] 14A-C are bottom views of another embodiment of a processing system.

[0056] [Figures 14D-14F] 14D-F are perspective views of another embodiment of a processing system.

[0057] [Figures 15A-15C] 15A-C are perspective views illustrating yet another embodiment of a processing system.

[0058] [Figures 15D-15F] 15D-F are top views of yet another embodiment of a processing system.

[0059] [Figures 16A-16C] 16A-C are perspective views showing alternative or additional features of the processing system.

[0060] [Figures 17A-17C] 17A-C are perspective views showing further features of the processing system.

[0061] [Figures 18A-18C] 18A-C are perspective views illustrating further features of the processing system.

[0062] [Figures 19A-19C] 19A-C are top views illustrating another alternative approach to the processing system.

[0063] [Figures 20A-20B] 20A-B are partial cross-sectional side views showing alternative or additional features of a handle for a processing system.

[0064] [Figures 21A-21C] 21A-C are partial cross-sectional side views illustrating further embodiments of a processing system.

[0065] [Figures 21D-21F] 21D-F are top views illustrating further embodiments of a processing system.

[0066] [Figures 22A-22C] 22A-C are side partial cross-sectional views showing an alternative approach to a handle assembly for a processing system.

[0067] [Figures 23A-23C] 23A-C are side partial cross-sectional views illustrating yet another approach to a handle assembly for a processing system.

[0068] [Figures 24A-24C]24A-C show perspective, side and cross-sectional views of a preferred embodiment of a processing system.

[0069] [Figure 24D-24E] 24D-E are side views of a preferred embodiment of a processing system.

[0070] [Figure 24F-24H] 24F-H are cross-sectional views of a preferred embodiment of a processing system.

[0071] [Figures 24I-24J] 24I-J are perspective views showing alternative tip assemblies. DETAILED DESCRIPTION OF THE INVENTION

[0072] Before the present systems and methods are described, it is to be understood that this disclosure is not limited to particular embodiments described, as such may, of course, vary. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting, since the scope of the present disclosure will be limited only by the appended claims.

[0073] Where a range of values ​​is provided, unless the context clearly indicates otherwise, it is understood that each intervening value, to the tenth of the unit of the lower limit, between the upper and lower limits of that range is also specifically disclosed. Each subrange between any stated or intervening value in a stated range and any other stated or intervening value in that stated range is encompassed within the disclosure. The upper and lower limits of these smaller ranges may independently be included or excluded, and each range in which either, either, or both upper limits are included in the smaller range is also encompassed within the scope of the disclosure, subject to any specifically excluded limits in the stated range. Where a stated range includes one or both of the limits, ranges excluding either or both of those included limits are also encompassed within the disclosure.

[0074] 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.

[0075] It should be noted that as used in this specification and the appended claims, the singular forms "a," "an," and "the" include plural references unless the context clearly dictates otherwise. Thus, for example, reference to a "system" includes a reference to one or more systems and equivalents thereof known to those skilled in the art.

[0076] 1A-B, a person is shown exhibiting cellulite 200 on their thighs and buttocks. In one approach to treatment, the dimples, linear depressions, and / or other depressions characteristic of the cellulite 200 intended to be treated are identified or circled with markings 204, preferably while the patient is standing, since for most patients, the appearance of cellulite disappears when lying on their stomach due to gravity pulling in different directions. The patient may be asked to protrude or squeeze tissue to aid in identifying the treatment area. An approximately 8 mm area around the target depression, linear depression, or other depression is marked on the patient's skin to identify an area for the physician to identify the fibrous septa responsible for creating the depression, linear depression, or other depression. Such margins can assume various shapes dictated by the cellulite or depression formed in the patient's anatomy and can be defined, for example, as a circular, oval, or D-shaped treatment margin, and the margin can encompass one or more target areas. In another embodiment, a computerized image processing device is used to locate and mark dimples and / or depressions. In Figures 1A-B, 44 depressions and depressions are marked for possible treatment. The physician treating the patient determines the instrument insertion site 210 and path 212 that will most effectively treat the cellulite while minimizing the amount of insertion site and instrument path under the skin. Preferably, the instrument insertion site is selected within a skin crease or fold, such as where the buttocks meet the thigh, in a location that is not visible when the buttocks are in natural contact, for improved cosmesis after the treatment healing period. For certain patients, the inner thigh is selected as the insertion site, which becomes less noticeable as healing occurs, or the outer thigh area or upper buttock is used as an alternative or additional insertion site. Such treatment paths can be selected by the operator, preferably using straight edges that curve or contour to fit the patient, or can be automatically generated by employing a computerized controller programmed to most efficiently address and measure the cellulite present in the predefined treatment site.The computerized controller can be associated with a scanner that identifies specific depressions and areas for treatment, such as by employing laser technology. In this regard, the computerized controller contains programs specific to cellulite treatment and is used in conjunction with electronic and mechanical devices, consisting of or including a non-transitory computer-readable storage medium and computer program mechanisms embedded therein, to both identify treatment areas and plan 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 location of the insertion site and the path to the marked target.

[0077] Once the treatment approach is planned, the patient lies prone on the treatment table. Alternatively, due to the minimally invasive nature of the current approach, especially for a small number of treatment targets, the patient can be treated while standing, leaning forward on a support while standing, or somewhere between standing and leaning forward, allowing gravity to aid in identifying the target septum and confirming treatment. The patient can also be asked to thrust or clench their muscles to aid in identifying the treatment area. Furthermore, the device creates a complete 3D map of all cellulite areas relative to normal skin. By comparing the volumetric improvement of divots and dimples to a normal, idealized surface, the operator can calculate the overall and local volumetric effect of the treatment and track improvement over time.

[0078] In one specific approach, as shown in FIG. 1C, cellulite treatment follows or references Langa lines 214 present in tissue. Langa lines 214 correspond to the natural orientation of tissue fibers present in humans and are recognized to be generally parallel to the orientation of muscle fibers. Langa lines 214 can be used as a reference for treating cellulite. Notably, cellulite appears to be related to and fall along the location of the Langa lines. In one approach, multiple treatment targets along the Langa lines are treated from a single entry 216, with the Langa lines 214 providing a map along which treatment is achieved. Thus, treatment can be directed along the Langa lines 214, as shown in the thigh for illustrative purposes, to treat targeted septa, or, additionally or alternatively, treatment can be performed laterally relative to the Langa lines 214, as shown in the buttock for illustrative purposes, to treat targeted septa. Treatment can also be directed to various locations relative to the connective tissue or septum. That is, the septum can be engaged, stretched, redirected, torn, cut, sliced, ruptured, or disrupted from various sides or angles relative to the septum. Thus, the septum can be treated from above, below, or to the side for best results. For example, as cellulite has been observed to be most visible in standing individuals in certain situations, treatment may be most effective from above certain connective tissues to take advantage of the direction of gravity, or the direction that works best for a standing body. Furthermore, when using limited thigh line treatment, rather than destroying or treating the entire underlying septum associated with a linear depression in the skin, treatment involves approaching the linear depression perpendicularly or obliquely to it, releasing only a portion of the underlying septum. The treatment instrument is reheated and slightly repositioned, such as by a few millimeters, thereby leaving an area of ​​septum undisrupted or treated, followed by disrupting or treating additional septa, and then reheating, repositioning, and further disrupting or treating septa as needed.

[0079] Turning now to FIG. 1D, a cellulite treatment assembly 220 is shown, including a handle 222 and an elongated member or needle-sized structure 224 extending longitudinally therefrom, preferably a structure 224 having a diameter of 2 millimeters or less. A force gauge (electronic or mechanical) may be provided to ensure that a predetermined amount of force is applied to the tissue when testing the septum to prevent over- or under-tensioning. The distal end portion of the elongated member 224 comprises a treatment device 225 capable of engaging, stretching, slicing, cutting, or disrupting connective tissue (e.g., FIGS. 1E-1N). All cutting means can be combined with or further energized with RF, laser, ultrasonic, or thermal energy to produce cutting and coagulation, either together or separately. Additionally, the cutting means can include one or more blades that are highly sharp, hardened, or coated (e.g., titanium nitride or Teflon). In certain embodiments, a single entry site or two entry sites may be performed on each side of the patient, one at the high point of the buttocks and the other along the crease or transition between the buttocks and thighs or on the inner thighs. Such sites are characterized by their ability to be easily concealed by nature or clothing. Treatment targets, depressions, and dimples marked on the skin surface while the patient is standing often disappear when the patient lies prone. The disclosed interventional device is configured to allow a user to approach a target location and first use the interventional device to push, pull, or otherwise tension septa in the target area under the skin to identify specific septa affecting the target and / or septa responsible for the appearance of cellulite. In other words, the user pulls or pushes the septa under the skin to locate the septa that cause a depression or indentation on the skin surface. Notably, sufficient force is employed to pull or push the septa to create a depression or indentation in the skin, and the resulting depression or indentation is evaluated to determine whether it corresponds to the target depression or indentation marked for treatment. If so, the engaged septum is treated as described herein, and the process is repeated for all target treatment areas.The operator also confirms that all of the septa associated with the target depression or depression have been treated with the treatment device and that all of the septa associated with the target depression or depression have been completely released. It is recognized that septa define a complex network of connections between tissue layers beneath the skin in and around the cellulite target area, and that septa include "webs," "trunks," and "branches from the trunk" that connect the tissue layers. It is also recognized that septa are quite elastic and can stretch approximately 10-20 mm before creating a depression associated with the target area. Therefore, to ensure that all septa associated with the treatment target have been severed, multiple passes within the treatment target area may be necessary to ensure the entire network of septa is severed. Particular attention must be paid to secondary septa, as they are difficult to identify unless primary septa are also severed. Secondary septa are septa that create shallower or smaller depressions than primary septa. While shallow depressions are not noticeable when the patient is standing, once the primary septa are cut and the deeper depressions are eliminated, the shallow and small depressions caused by secondary septa become more noticeable. Furthermore, secondary septa and septa patterns are anticipated and subsequently identified in areas where cellulite appears in multiple or closely spaced areas. This allows for a precise approach to the elimination of connective septa, cutting only those associated with the targeted cellulite while releasing the hooked septa that create depressions outside the treatment area. By taking multiple precise passes under the target area, all cellulite-forming septa, both primary and secondary, are addressed.

[0080] For some treatment targets, approaching the treatment target from an entry point located below the treatment target, advancing the end of the interventional device past the treatment target, and then pulling downward (effectively "down" if the patient is standing), may provide a better approach to reshaping the septum when the patient is lying down, for example, for treatment targets in the legs. One or more strain gauges can be incorporated into the treatment device to aid in identifying the target septum and to assess the progress and completion of septum treatment. This facilitates targeting critical septa in a less traumatic manner, ideally minimizing bruising or other problems associated with cutting or destroying a large area around the target. Thus, various approaches for treating cellulite, which is expressed as a depression or dimple 200 on the skin surface, are presented herein. Additionally, a handle portion can be employed to create a depression in the skin into which an interventional device can be inserted subcutaneously. Treatment regimens are selected for insertion of interventional instruments based on the subject's anatomy relative to the septa 350, which connect tissue layers defining chambers that hold adipose or other tissue. If desired, while under anesthesia and / or sedation, ultrasound can be used to assess the subcutaneous trajectory and depth of the various connective tissue bands responsible for the surface irregularities. Ultrasound assessment can aid in the selection of a specific trajectory for the desired depth. Ultrasound assessment can also aid in strategic placement of the distal tip portion of the treatment tool at the junction between the connective tissue and the dermis or face.

[0081] As shown in Figure IE, the target location of cellulite 200 to be treated is marked 204 on the surface of the skin. This can be done while the patient is standing to best view the cellulite. As shown schematically in Figure IF, cellulite may be reduced or eliminated when the individual is lying down, and should this occur, the marking identifies and confirms its location.

[0082] In one embodiment, a local anesthetic is applied subcutaneously to the treatment site. In one approach, a long anesthetic needle is tunneled beyond the marked treatment site, and anesthetic is administered along the tunneled path below the marked site. It may be desirable to apply additional local anesthetic percutaneously using a short needle so that the anesthetic extends beyond the marked target site. The distal end portion of the cellulite treatment assembly 220 is then inserted through the skin, and the blunt tip is guided to the vicinity of the dermis so that it can be tracked as it is advanced toward the septum 350 (FIG. 1G) near the marked location 204. Of note, the distal end of the cellulite treatment assembly 220 in any of the disclosed embodiments may also define a tapered profile and include a tapered nosecone configured to assist in advancing the device between tissue layers (see, e.g., FIG. 24B). The entry site is selected to minimize postoperative healing while limiting the use of anesthesia. The inventors have found that, given the elasticity of the septum 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, providing sufficient distance to pull and break the septum 350 without the tip of the cellulite treatment assembly emerging from the skin in the process. Additionally, the depth below the skin at which the septum 350 is preferably engaged (i.e., cut, slice, tear, stretch, redirect (e.g., crisscross), or break) is identified and determined. After determining the subcutaneous depth to be accessed for cutting, slicing, tearing, stretching, redirecting (e.g., crisscross), or breaking the septum 350, a cellulite treatment assembly or other tool having a sharp or blunt tip is inserted through the skin, advanced between the subcutaneous tissue layers, and advanced toward the septum 350. In one approach, the distal end portion of the cellulite treatment assembly is configured with an illuminated tip 352 that is sufficiently bright to be seen through the skin. The intensity of the light emitted by tip 352 can be set to a specific constant level such that the light that appears at skin level as a circle or projection is of a predetermined size at a desired depth below the skin for cutting or otherwise engaging septum 350. The treatment tool is then advanced to the target site. At the target site, the user adjusts the depth of the treatment tool tip so that the light circle or projection is a predetermined size. Instead of having an illuminated tip, an illumination element can be located proximal to the treatment device 225. For example, the light source 354 (see FIG. 10 ) can provide the illumination. In this embodiment, the light projection can be positioned below or to the side of the target site so that the light circle or projection is at a predetermined location and indicates that the treatment element has exceeded the predetermined location. The septum 350 is tested, and if confirmed as a treatment target, the septum 350 can be treated while maintaining the circle or projection at a predetermined size. The user can also use the size of the circle or light projection to maintain the depth of the treatment tool tip as it advances subcutaneously to the treatment target. Alternatively or alternatively, a sharpened tip can be employed to create access to the target tissue, allowing the tool to create a desired path not only within the tissue but also between tissue layers. The depth to which these tools are advanced is expected to be between about 3 mm and about 10 mm below the skin surface, although smaller and larger depths are also expected to be optimal for particular subjects. It is recognized that a more superficial treatment depth is particularly effective in cutting all septa associated with the treatment site, and that secondary septa can be cut and severed on an initial pass within the treatment site. Thus, in a relatively superficial approach, the treatment device is advanced at a depth closer to the dermis than to the superficial fascia. In any event, the selected depth is chosen to cut, slice, disrupt, tear, stretch, or redirect the subject's septa 350. It will be further understood that, in one embodiment, the device 220 is formed from a substantially rigid material to access a consistent plane below the skin surface.

[0083] The location of the interventional instrument is determined by palpation, direct visualization (e.g., transillumination or endoscopy), non-invasive visualization (e.g., ultrasound or fluoroscopy), or other means, such as markings along the length of the instrument and its path through the tissue, or by providing the interventional instrument with radiolucent markers, and the instrument is positioned on the subject's skin at the site where cellulite (e.g., dimples) is found. The treatment instrument is advanced through the septum 350 until the treatment instrument 225 is optimally positioned to identify the target septum and achieve cellulite removal or minimization treatment. As shown in Figures 1H-J, in one approach, the treatment device 225 is passed over the septum 350, the hooks are deployed, and then pulled proximally to hook or otherwise tension the septum 350 (Figures 1K). In another approach, the treatment device 225 is passed several millimeters laterally, preferably about 1 to about 10 millimeters, more preferably about 3 to about 6 millimeters, beyond the target location, and the hooks are deployed and then swept laterally toward the target, followed by proximal pulling to tension and stretch the septum. In one embodiment, during initial deployment, the hook structure defines a relatively flat angle, i.e., the hook edge is at about 80 degrees relative to the long axis of the elongated member 224, which results in substantial reach for the treatment instrument. Once it is time to cut or otherwise engage the septum 350, the treatment instrument 225 is manipulated so that its blade or other cutting surface is exposed at a steeper angle suitable for cutting, such as about 70 degrees relative to the long axis of the elongated member 224 (see also FIGS. 13A-B). During these and other steps, transillumination can be employed to track the treatment instrument and guide the procedure. The markings 204 can facilitate targeting of the septum 350 while using transillumination to view the location of the treatment device 225. In another approach, a separate device can be employed to engage the septum 350 to determine if such septum is the cause of a dip or depression that appears on the outside of the skin.Such a secondary device can be positioned remotely from the target (i.e., the lesion) and configured to apply tension to the skin surface in a predetermined direction while the patient is lying down to create the effect of gravity and visualize the lesion (i.e., a wide area of ​​adhesive attached to a spring mechanism so that a predetermined force is applied relatively parallel to the skin surface in the direction that gravity moves the skin when standing). This additional device may further aid in the identification and localization of the lesion and confirm that treatment has been effective. In various approaches, a portion of the elongate member can be configured to transition from a narrow state to a wide or wide state, where the wide or wide state presents a cutting surface (i.e., a sharp blade or energy) for cutting tissue, and the device has a size and shape that can be inserted through the skin to engage one or more areas of the subcutaneous septum.

[0084] It is noted that the septa causing the dimple or depression may not be directly underneath the dimple or depression, but may come from various angles and positions relative to the dimple or depression seen on the skin, and there may be only one or a few septa or multiple septa causing the dimple or depression remotely. Thus, engaging a septa in this way will reflect some change in the dimple or depression on the skin. A determination is made regarding the correspondence between the marks 204 made on the skin and the dimples that form or re-form. If the first septa 350 that the user pushes or pulls with the tool do not reproduce the dimple or depression in the marked area 204, the user releases the first septa that were engaged, repositions the tool with different septa, and pushes or pulls again. This is repeated until the septa causing the dimple or depression at the marked location are identified (Figure IK). Once the appropriate septum is identified, the tool 225 is manipulated to cut, slice, disrupt, redirect, stretch, or tear the septum 350 connecting the tissue layers. In one approach, the blade 353 is deployed and presented for the procedure (FIG. 1L). In another approach, a balloon (not shown) is inflated to disrupt the septum.

[0085] After the appropriate septa have been cut, disrupted, stretched, or reoriented, the treatment element 225 is returned to its initial folded configuration. The treatment element is then advanced beyond the marked treatment location, the treatment element (e.g., hook) is deployed, and then retracted below the marked treatment location to confirm that all of the septa responsible for the marked depression or depression have been separated intraoperatively. Again, multiple passes are made to ensure that all cellulite-producing septa, including secondary septa, have been cut. If not, the tool is manipulated to cut, disrupt, stretch, or realign additional septa. This procedure is repeated until all septa involved in forming the marked depression or depression have been cut or sufficiently stretched, and the depression or depression will not be re-formed intraoperatively with the tool. Alternatively, to ensure sufficient isolation of the marked treatment areas, treatment can be performed with the patient lying down, followed by having the patient stand up from the treatment table and allowing gravity to guide the treatment. If the patient is standing, measures should be taken to maintain sterility and appropriate draping should be applied. If necessary, additional treatment can be performed on untreated areas. This results in selective rupture, tearing, cutting, or slicing of the targeted septum 350 and the elimination or minimization of the appearance of pitting and cellulite on the skin (FIG. 1M). The treatment elements (e.g., hooks and / or blades) are then retracted (partially folded in the figure) and the tool 220 is removed from the site for withdrawal from the body or repositioning in any direction along and within the target tissue surface to treat additional areas.

[0086] 10R, in an additional or alternative approach, a second light source 354, such as an LED (or other light source, such as the tip of a light-emitting fiber), is configured along the cellulite treatment assembly 220, proximate the irradiating tip 352; or, if the cellulite treatment assembly has a first light source proximate the treatment element, the second light source can be at the tip 352. In various approaches, a light source, such as an LED chip, can be configured at or otherwise along the tip of the treatment device with electrical wires running proximally for control by the operator, or the light source can be generated by an optical fiber extending along or to the tip of the device, where the LED or light source is configured in a proximal location, such as the handle of the treatment device. By so configuring such light sources 352, 354, the depth of the cellulite treatment assembly 220 within tissue and the location of the treatment element and / or tip can be assessed. It is noteworthy that the light source or sources are positioned between tissue layers such that the structure configured to treat the septum is positioned distally beyond the target septum or laterally relative to the target, but at least adjacent to the target distance, so that the septum is efficiently and effectively hooked, engaged, and severed. As shown in FIG. 10P, when the cellulite treatment assembly 220 is positioned within a first, relatively shallow, desired depth, the light sources 352, 354 appear spaced apart and define a discrete pattern when viewed through the skin via transillumination (FIG. 1P). When the cellulite treatment assembly 220 is positioned deeper within tissue (FIGS. 1Q-R), the light sources 352, 354 overlap due to the natural dispersion of light emitted from the light sources 352, 354 (FIG. 1R). The operator of the treatment system can determine the depth of the cellulite treatment assembly 229 by noting the degree of overlap of the discrete light pattern or light, and the dispersion and intensity of the light emitted from the light sources 352, 354. Thus, the operator can guide the distal end of the treatment assembly to the desired treatment location while maintaining the desired depth below the skin. The light sources 352, 354 can also be different colors to aid in determining the orientation of the cellulite treatment system 220 within the tissue through illumination.Furthermore, it should be noted that the second light source 354 can emit, for example, red light, while the illuminated tip 352 can emit white light, while any color variation can be employed. The color of the light can also vary depending on the configuration of the treatment device, e.g., the device can emit white or a first color when sheathed or retracted, and change to another or a second color before or after use, such as when a portion of the device is deployed or tissue is cut. A strain gauge can be configured to communicate and cooperate with the light source to sense the load on the treatment device during treatment, thereby driving a color change in the light source and signaling the progress or completion of the targeted treatment. Furthermore, the second light source 354, or one light source proximal to the treatment element, can be employed via transillumination through the skin to position the cellulite treatment system relative to the treatment target area. Another advantage of a second light source, or one located proximally, is that it can indicate to the user where the hooks and blades are located relative to the target septum, so that the hooks are properly positioned once deployed. In one embodiment, the second light source 354 is located between approximately 5 mm and 20 mm behind the first light source 352. In another embodiment, one proximally located light source is located between approximately 1 mm and approximately 25 mm behind the treatment element. Also, as the treatment tool is pulled proximally through the treatment target area, the illuminated tip 352 can notify the user that the hooks and blades have been pulled through the target area. Furthermore, it should be noted 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. The cellulite treatment system can also include more than two light sources, either of the same color or different colors. In another embodiment, different colored lights can be used to indicate the status of the distal end of the tool. For example, a red light can be used to indicate that the hooks and blades are inside the tool for advancement under the skin, a white light can be used to indicate that the hooks are deployed, and a red light can be used to indicate that the blades are deployed.

[0087] After treatment of one target area is complete, the procedure is repeated to treat other target areas. Thus, the same device can be employed to access other sites or tissue layers beneath existing skin depressions. Of note, in one embodiment, the device is capable of delivering anesthetic as needed or desired when advancing to additional or new sites. Thus, a system configured to treat all target sites in the buttocks and thighs through a limited number of small entry sites, such as through a single entry site, is provided. It will be appreciated that the system may further include structure that allows the assembly to be maneuverable into the subcutaneous treatment site. In such an embodiment, the device is configured to define a longitudinally flexible material, allowing the instrument to be maneuvered 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.

[0088] Additionally, in certain embodiments, the cellulite treatment system includes a squeezing tool that reproducibly applies lateral force to the skin to accentuate the appearance of cellulite, allowing pre- and post-treatment effects without the patient needing to stand and / or removing the interventional tool. The squeezing tool can be embodied, for example, as a clamp with elongated legs on opposite sides, or it can include four fingers that are deployed on the surface of the skin and pull radially inward when activated on or adjacent to the target cellulite area. Additionally, while lying on the treatment table or standing, the patient is instructed to clench their buttocks and / or leg muscles to simultaneously identify the treatment site and confirm the treatment. In another embodiment, a skin stabilizer, such as a suction stabilizer, can be used to control the depth to which the cellulite treatment tool is advanced beneath the skin and to help maintain the target position as the tool is advanced.

[0089] In one or more approaches, the treatment system can additionally or alternatively include a template 500 to aid in locating and identifying the treatment site (see FIGS. 1S-U). In one approach (FIGS. 1S-T), the handle 222 of the treatment assembly 220 is configured to releasably engage the proximal end 501 of the template 500, where the length of the template 500 matches and is parallel to the length of the elongated member 224 of the treatment assembly 220. The distal end portion of the template 500 includes an opening 502 positioned and sized and shaped to correspond to the treatment device 225 configured at the end of the treatment device elongated member 224. The opening 502 thus indicates where the treatment device 225 will be deployed. One or more additional markings can also be included on the template 500 to identify the location of other structures on the treatment assembly 220. In use, the elongated member 224 is positioned between tissue layers, and the template 500 is placed on the skin outside the body, with the opening 502 of the template 500 positioned over a previously marked or otherwise judiciously identified cellulite depression targeted for treatment. In this approach, the treatment assembly 220 can lack a light to provide transillumination, or this embodiment can be used in combination with transillumination. Once so positioned, the treatment assembly 220 is manipulated to cut the septum associated with the targeted treatment site. In an alternative approach (FIGS. 1U-V), the template 500 can define a structure not connected to the treatment assembly 220 and is configured to be placed outside the skin with its opening 502 positioned over the area targeted for treatment. The size of the opening 502 can additionally or alternatively be used to set or confirm the proper depth of the treatment device 225; i.e., when the transillumination fills the opening, the operator knows the treatment device 225 is at the desired depth. Therefore, this approach contemplates including a treatment assembly 220 that includes a light 352 that provides transillumination to aid in proper positioning of the treatment device 225 .Once light is transilluminating through the opening 501 in the template 500, the treatment device 225 can be manipulated to cut the target septum.

[0090] The optical transmission assembly can assume a variety of configurations (see FIGS. 1W-Y). In one approach, light source 354 is a 5 mm red LED or other LED that provides light of the desired wavelength. As shown in FIG. 1W, light generated by light source 354 is directed through a spherical lens 355, which transmits and focuses the light energy to the proximal end of optical fiber 357. Light fiber 357 includes a ferrule 358 with an entrance chamfer that functions to direct the light transmitted from spherical lens 355 (e.g., H-K9L glass) into light fiber 357, allowing light to enter the side as well as the end of the fiber. Compared to other approaches, such an assembly generates less heat, draws less current, and is associated with reduced component costs and comparable or greater optical output. That is, while generating significantly less heat, in one embodiment, the disclosed arrangement employs a 500 micron optical fiber while drawing 100 mAmps to generate 3.5 mW of light. An alternative arrangement is shown in Figure IX, which involves an assembly further including a collimating lens 359 that facilitates further focusing of the light energy from the light source 354 onto the spherical lens 355. Here, the ferrule is not needed as a guide because the collimating lens facilitates the necessary focusing.

[0091] As shown in FIG. 1Y, in one embodiment, the optical fiber 357 is configured within a sheath 359 that extends substantially the length of the elongated member 224 of the treatment device. The distal end of the optical fiber 357 exits at an angle relative to the elongated member 224 and through a hole formed in the elongated member. A portion of the wall cut into the elongated member 224 provides support for the sheath 359. A clear epoxy or other adhesive or resin is employed to affix the optical fiber 357 in place so that it is positioned to project light outside the elongated member 224. The elongated actuation member 226, to which the treatment device (not shown) is attached, is configured to provide space for the sheath 359 and optical fiber 357 assembly and to facilitate and allow longitudinal movement relative thereto.

[0092] After or concurrently with treatment, an appliance 355 configured to stretch and temporarily hold the skin is placed on the skin above or associated with the treated septum 350 or treatment area (see FIGS. 1Z-1AA). FIG. 1AA shows a subject's buttocks after treatment, where the skin has lost its dimples. It should be recognized that in some areas above the treatment area, wrinkles may temporarily remain on the skin. In one approach, the skin stretching and holding appliance 355 is embodied as a stiff or inelastic strip that includes adhesive at least along its length or along spaced portions of the underside of the strip. The skin stretching and holding appliance has sufficient rigidity so that when a user bends the appliance along its length and releases the bending force, the appliance attempts to return to its full length. In use, the user bends the appliance slightly, flexing the end of the appliance and placing the adhesive end of the appliance on the skin overlying the treated dimple or treatment area. The user then releases the appliance. When the device returns to its full length, it applies gentle tension across the skin, maintaining a smooth surface over the treated dimple or treatment area, including the previously depressed area, during the tissue healing phase of the underlying tissue. The device is compact enough to allow the patient to sit, stand, or walk normally while applying a gentle amount of tension to a small area (e.g., about 1 to about 4 cm). A variety of different configurations of the device can be used, and the device can be positioned at various angles relative to the treatment area. For example, the strips can be positioned perpendicular to the length of the dimple, along the length of the dimple, at various angles relative to it, or above or below it. Additionally, the skin stretch retainer can define a star-shaped or other configuration (not shown) that functions to stretch the skin in multiple dimensions relative to the dimple. The skin stretch retainer 355 is intended to be temporarily applied to the skin over the treatment area to aid healing without leaving a dimple behind, and can remain on the skin for several hours or days. In another embodiment, an elastic strip can be placed on the opposite side of the treated dimple or area.The elastic strip has adhesive on each end so that one end can be placed on the skin surface near or center of the treatment area, then stretched slightly away from the treatment area, and the other end can be placed on the skin surface under tension so that when the elastic strip is released by the user, the slight tension of the elastic strip gently pulls and smooths the skin. A second elastic strip can be applied in the same manner on the opposite side of the first elastic strip, or elsewhere, to apply slight tension in the opposite direction to smooth the skin between the first and second elastic strips. Additional elastic strips can be placed around the treated dimple or area as desired, for example, 120 degrees apart, to provide slight tension in three directions. Also, as described herein, fillers can be inserted or injected under the skin at the treatment area to further aid in anatomical healing as desired and without leaving a dimple in the skin.

[0093] 2A-D, an approach to blunt-tip scissors 360 configured at the distal end portion of the cellulite treatment assembly 220 is shown. The blunt-tip scissors 360 are advanced beneath the skin and used to engage suspected septa. As in each of the disclosed approaches and devices, if such septal engagement results in any change to the depression or indentation expressed on the skin, the treatment structure, here scissors 360, is manipulated to disrupt, cut, or slice the septum. Thus, the scissors 360 are opened, and the septum is placed between its blades. The blades are then advanced or closed against the septum, thereby cutting, slicing, or severing it, thus relieving tension between the tissue layers and eliminating or minimizing the appearance of the depression or indentation on 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 associated with the scissors arrangement. Illumination may be provided by a light 362 configured proximal to the scissors 360, so that transillumination can be employed to track the position of the distal portion of the treatment assembly 220. Additionally or alternatively, in each of the disclosed embodiments, illumination may be provided via a light guide from an external light source or via one or more LEDs. The illumination aids the user in both locating and properly positioning the treatment device, as transillumination decreases as the tool's depth increases. In one aspect, the amount of illumination is set to ensure the proper depth of the treatment device or structure, and the targeted illumination level is adjusted for skin type, thickness, fat, and the presence of pigment. As shown in Figures 2C-D, in one embodiment, the first scissors arm 363 is rotatably attached to a curved link 364, which in turn is rotatably attached to a push rod 365. The second scissors arm 366 includes a curved slot 367 that receives a boss 368 extending from a pusher of the treatment device to guide the movement of the second scissors arm 366. Additionally, first and second scissor arms 363, 366 are rotatably mounted at the distal end of the treatment device to provide controlled scissoring movement of the arms.Longitudinal movement of push rod 365 via connection with link 364 and interaction of curved slot 367 and boss 368 causes scissor arms 363, 366 to transform from a closed (FIG. 2C) configuration to an open (FIG. 2E) configuration and between. In each of the disclosed approaches, once the selected or targeted septum is cut, sliced ​​or disrupted, the cellulite treatment device can be advanced or repositioned to treat additional target areas from the same or a different dermal insertion device.

[0094] Various approaches to laterally extensible tissue engaging and / or cutting structures are shown in Figures 3A-F. The distal end portion of the cellulite treatment assembly can embody side-opening hook arms 370 that rotate relative to a longitudinal shaft 372 to alternately display septum engaging and / or septum cutting structures (Figures 3A-B). The hook arms 370 are configured to swing out from a proximally oriented longitudinal configuration parallel to the shaft 372 to a laterally extruding configuration to capture and tension the septum as the device is advanced beyond the target location and then retracted. Again, such engagement with the septum is reflected in a physical change in the skin surface, thereby confirming that the septum responsible for creating the depression or indentation in the skin surface is being targeted. Tensioning the septum against the narrow edge of the hook arms 370 or against its cutting or sharpened edge results in disruption. The outwardly facing portions of the arms 370 can define a blunt configuration, and the cutting edge can be positioned within the acute angle defined by the arms 370. In this configuration, increased tension can be employed to cooperate with a limited cutting edge as the septum is retracted within the acute angle defined by the arms 370. In Figures 3A-B, the transillumination function is provided by a light 376 configured at the distal end of the device, while in the assembly shown in Figures 3C-D, a slit 378 formed in the shaft proximal to the distal end allows for dispersion of light energy.

[0095] In FIG. 3E, the cutting and septum engagement structure is embodied in a single moving arm 380, with the illumination located near the hinge 382, ​​although it is also possible to locate the same at the distal end of the device. As with the previous embodiment, the exposed edge of the arm 380 can be blunt or sharp for cutting or slicing. Also here, the arm 380 assumes a distally oriented longitudinal configuration parallel to the shaft 383 for advancement between tissue layers, and the arm 380 extends laterally outward to capture and cut or slice the target septum. Actuation of the engagement and cutting structure can be achieved by manipulation of a proximally located lever or trigger connected thereto via a wire or longitudinally oriented shaft (not shown). Once the desired area has been treated, additional target areas can be treated. Referring to FIG. 3F, the cutting and septum engagement structure includes a pair of moving and rotating arms 381 that operate in a scissor-like fashion, rotating about a hinge 382 when a push rod 365 rotatably attached to the first arm 381 advances within the shaft 383. A second arm 381 is also rotatably mounted at a distal point within shaft 383. Arm 381 includes a sharp edge for severing the septum. During treatment, septum 350 is loaded laterally within arm 381, thereby allowing tension to follow severing of septum 350 as push rod 365 advances. In one embodiment, septum 350 is hooked by torquing the treatment device so that septum 350 is captured within arm 381 in an open scissors configuration to assess septum 350. Once septum 350 is identified for severing, arm 381 would be closed to complete the cut. Arm 381 itself can be curved to capture the septum and thus prevent it from being swept away prior to severing.

[0096] The distal end portion of the cellulite treatment assembly 220 can alternatively or additionally embody an internal static hook 388 (FIG. 4A) for treating target areas from one or more skin insertion sites. The end of the assembly, or the hook itself 388, can be positioned relative to tissue and employed to engage and test the tissue to identify target septa. A sharpened edge within the hook can be used to engage and sever targeted and identified septa associated with the appearance of cellulite on the skin. As shown in FIG. 4B, a concentric sliding tube 390 actuatable from the proximal end of the cellulite treatment assembly can additionally be provided to move proximally and distally relative to the hook 392. The tube 390 can include a selectively sharpened edge or can be blunted to thus cooperate with the hook 392 to capture, cut, slice, tear, or destroy septa. The assembly can further be advanced in a rotational manner to cut or slice septa. When tube 390 is used to cut tissue, simultaneous, spaced cuts are made through the septum, thereby removing portions from the septum.

[0097] As shown in Figures 4B-C, tube 390 can alternatively or additionally include a hook cover or closer 399. Hook cover or closer 399 is attached to the distal end of tube 390 and is advanceable to engage hook 392, closing the hook opening. So configured, hook 392 can be moved within the patient's anatomy without snagging tissue structures within the superficial fat space. Disengaging hook cover or closer 399 from hook structure 392 allows hook 392 to present a structure for engaging a target septum.

[0098] 4E-F, an alternative approach to the stationary hook 388 is shown. Although not shown, the distal end of the stationary hook 388 can include a light source and can be deployable from a slide tube 390. A sharp edge 389 on the dorsal side of the hook 388 is used to engage and sever a targeted, identified septum associated with the appearance of cellulite on the skin. Here, the septum is hooked, and the stationary hook 388 is twisted to sever the septum. The device can also be used in combination with a slide tube (not shown) or a separate blade with a sharp edge to engage and sever the septum.

[0099] 4G, hook 388 can be deployable from tube 390 rather than being stationary. Again, hook 388 includes a cutting edge or longitudinally extending, protruding sharp structure 389 for cutting the septum. With hook 388 deployed, the septum is captured and then cut by twisting and pulling the septum against hook 388 and sharp edge 389.

[0100] As shown in FIGS. 5A-C, in a related approach to treating multiple treatment sites, the cutting, slicing, or disrupting assembly additionally or alternatively includes a longitudinally retractable sheath 393 that alternately covers and exposes hooks 392, and further includes a retractable guillotine-like blade 394. The blade 394 is sized and shaped to slide within the opening defined by the hooks 392 and cut the tissue snapped by the hooks 392. Thus, in its distal position, the sheath 393 facilitates the assembly to define a structure suitable for advancement to the treatment site. Retraction of the sheath 393 through manipulation of a structure connected to it, located at the proximal end of the assembly, exposes the hook structure 392. The hook 392 is used to engage and capture target tissue to test whether the target tissue is associated with the appearance of cellulite on the skin. While the hooks maintain the septum in a captured position, the guillotine blade 394 advances through operation of a proximally located actuator (not shown) to slice or cut the captured septum, thereby eliminating or minimizing the appearance of cellulite.

[0101] In an alternative approach (FIGS. 5D-I), a hook structure 392 is rotatably mounted to the shaft 383 or sheath 393 and configured to protrude laterally to capture and assess the septum 350. A blade 394 sized and shaped to slide within the sheath 393 is configured to define a retractable, guillotine-like blade arrangement for severing the septum captured by the hook 392. As shown in FIGS. 5D-F, the blade 394 is advanced distally until it reaches a gap or opening 395 in the sheath, where it protrudes laterally to engage the hook structure 394 (here defined by a linear protruding member) laterally beyond where the hook 394 captured the septum 350. Further advancement of the blade 394 moves the blade 394 along the hook 392, engaging and severing the captured septum. In another embodiment (FIGS. 5G-I), the hook 392 itself is curved or angled to effectively capture the septum 350. In this approach, blade 392 advances distally to engage hook 392 (FIG. 5H) and advances further along hook 392 to sever the septum 350 captured by hook 392 (FIG. 51). Blade 392 may be at the end of a flexible or pivoting elongate structure such that it can protrude laterally from sheath 393. Here, the distal end of blade 394 exhibits a V-shape configured to facilitate capturing and precisely severing the target septum 350.

[0102] 6A-B, yet another approach to the distal end portion of the cellulite treatment system 220 is shown. Here, a two-segment hook assembly 396, 397 is held together by tension (such as a spring or a wire or shaft connected thereto) on an angled surface 398. When one segment is rotated 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 sharpened or blunted. In one particular aspect applicable to each of the disclosed embodiments, the hooks can be covered with an elastomer so that when the elastomer is tensioned, it displaces, thus exposing the sharpened edge. When not under tension, the sharp edge is safely enclosed. Alternatively, a spring-loaded shield can be used in place of the elastomer. Manipulation of the two-segment hook assembly 396, 397 within tissue and between tissue layers allows for both engagement and identification of the target septum, as well as slicing, cutting or disrupting the target septum as described herein.

[0103] 7A-D, a cutting, slicing, or disrupting treatment assembly is defined by a protruding link arrangement. A first link 400 includes a blade 401 and is rotatably attached at one end to a second link 402. This positioning of the blade 401 proximal to the blocker second link 402 facilitates helping to minimize tissue adhesion to the links 400, 402 and tissue ejection from the treatment device. That is, actuation of the blade away from the blocker not only cuts the target septum, but also functions to move tissue away from any gaps in the structure formed by or between the links of the treatment device. In each of the disclosed embodiments, the length of the first and second links, or cutting, slicing, or disrupting treatment assembly, is generally selected to allow for engagement, engagement, and severance of the target septum.

[0104] When the device is actuated, the opposite end of the first link 400 slides relative to the longitudinal shaft 405. The second end of the second link 402 is rotatably secured to a distal point on the shaft 405. In one embodiment, as the drive shaft 407 attached to the opposite end of the first link 400 advances, the links 400, 402 fully overlap (FIG. 7C), creating a hook arrangement sized and shaped to engage tissue and test the septum to determine whether such septum is associated with the appearance of cellulite on the patient's skin. In this arrangement, the blade structure 401 is not exposed; rather, it is protected or covered by the second link 402. Once a cutting or slicing action is desired, such as once the selected septum is targeted, the drive shaft 407 is slightly retracted, thereby exposing the blade structure 401 to present a sharp edge for severing the hooked septum (see FIG. 7D). To retract the links 400, 402 for advancement or repositioning between tissue layers, the shaft 407 is fully withdrawn so that the links 400, 402 assume a collinear and parallel relationship with the shaft.

[0105] In a related approach, as shown in FIGS. 7E-G, a first link 400 defines a curved blade rotatably connected to a second link 402 that includes a generally triangular or pointed protrusion 408 sized and shaped to cover the blade 401 when the assembly is placed in a hooked configuration (see FIG. 7F). When the drive shaft 407 (shown in phantom) is manipulated to expose the blade 401 (see FIG. 7G), the blade 401 can be employed to cut the septum. When the treatment device is advanced to and between intervention sites, the drive shaft 407 is withdrawn such that the assembly defines a low profile in which the first 400 and second links 402 are generally longitudinally aligned (FIG. 7E). As shown in FIGS. 7H-K, the rotatable connection between the first 400 and second links 402 can additionally or alternatively be characterized by a slot arrangement 409. With such a connection, the protrusion 408 can be smaller, resulting in a smaller overall profile for the treatment device. Notably, in the septum hooking configuration (FIG. 7J), after the drive shaft 407 is pulled slightly proximally, the end of the first link 400 resides in a proximal position within the slot 409, with the small protrusion 408 of the second link 402 overlapping the blade 401. In the septum cutting configuration (FIG. 7K), the end of the first link 400 assumes a distal position within the slot 409, such that the blade 401 is exposed for cutting. Referring to FIGS. 7L-N, in another embodiment, the first link 400 can also define a straight blade 401. In this approach, the protrusion 408 is therefore larger to provide the necessary coverage of the blade 401 when the device is positioned in the hooking configuration (FIG. 7M). Each of the aforementioned devices can also additionally or alternatively include other of the features disclosed herein, such as structures providing transillumination and radiofrequency cutting and coagulation.

[0106] Referring to Figures 70-P, one embodiment of a cellulite treatment system 940 (described in more detail in connection with Figure 11) that can be employed to treat cellulite is shown. As shown (Figure 70), the distal end portion of treatment system 940 is configured with a treatment device 925. Here, the treatment device of Figures 7L-N is shown positioned at the distal end of treatment device 940 in a hooking configuration (Figure 7P). Any of the disclosed treatment devices may be so configured at the distal end of treatment system 940.

[0107] As shown in Figures 7Q-S, 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 into the closed, hooking, and cutting positions. Furthermore, the wire 410 is formed into a coil 411 (see Figure 7S) that provides the strength and rigidity necessary to move the wire 410 between the closed position (Figure 7Q) and the cutting position (Figure 7S). In the septum-hooking configuration (Figure 7R), the second link 402 covers the wire 410, preventing it from being exposed to the target 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 suitable for being advanced to and between treatment targets. The proximal-facing edge of the wire can be sharpened to create a cutting edge. Additionally or alternatively, the wire may be an electrode attached to a radio frequency generator so that the wire may be used for electrocautery or RF ablation of target tissue.

[0108] 7T-U, the elongated member 224 of the cellulite treatment device can embody a tubular shape including a lumen 412 extending therethrough, which provides space for the optical fiber 414. Notably, the remaining space not occupied by the optical fiber 414 defines a crescent shape from a cross-sectional perspective. In one approach, the tubular portion terminates at the treatment device 225.

[0109] 7V-X, in one or more embodiments, the lumen 412 of the elongate member 224 can be sized and shaped to individually accommodate one or more additional septum-engaging, cutting, slicing, or destructive treatment devices 225, or for injection of anesthetics, drugs, or other substances, such as fillers or fat grafts, before, during, or after treatment. In one approach, the treatment area can be medicated or filled with substances simultaneously with or during a treatment procedure, rather than using separate devices and procedures to accomplish the same. Of note, each of the disclosed embodiments can be combined in a similar manner to provide a combination cellulite treatment assembly.

[0110] Referring to Figures 7Y-AA, a relatively long treatment assembly can include, for example, an additional approximately 3 mm (or a total length in the range of approximately 5-10 mm) for specific purposes, allowing for less lateral movement of the longitudinal member supporting the treatment device to achieve the treatment function. Again, a first link 400 includes a blade 401, one end of which is rotatably attached to a second link 402. Positioning the blade 401 proximal to the blocker second link 402 facilitates minimizing tissue adhesion to the links 400, 402 and tissue ejection from the treatment device. Actuation of the blade away from the blocker not only cuts the target septum, but also functions to deflect tissue away from any gaps in the structure formed by or between the links of the treatment device. As shown in Figure 7Y, in the closed or stowed configuration, the treatment device links 400, 402 present a low-profile assembly. When the drive shaft attached to the first link 400 is advanced, the first and second links 400, 402 assume a hooking configuration (FIG. 7Z) in which the second link 400 blocks the blade 401 of the first link 400. When the drive shaft is withdrawn a predetermined amount, the blade 401 is exposed and assumes a cutting configuration (FIG. 7AA). When the drive shaft is fully withdrawn, the links 400, 402 return to a folded or retracted configuration. In each of the disclosed embodiments, the length of the first and second links or cutting, slicing, or disruption assemblies is generally selected to allow for engagement, hooking, and severing of the target septum. Furthermore, as shown in FIGS. 7AB-AE, the cutting edge of the blade can be multi-edged, variable, and / or serrated along the length of the blade, configured on one or both sides of the member defining the blade in any particular embodiment to provide the desired cutting function.

[0111] In an alternative embodiment, spot treatment of septa is possible using a cellulite treatment system 800 configured to address one intervention site at a time. Accordingly, the cutting structure can be inserted perpendicular to the skin to achieve treatment, or can be advanced beneath the skin in a direction generally parallel to or at an angle relative to the skin's surface. Furthermore, each structure of the disclosed tissue engagement and cutting device can alternatively or additionally be configured for use in treatment. In certain aspects, the cutting action is rotary in character, with the cutter structure rotating at a controlled speed configured to cut the septum in a manner dictated by the septum structure observed at the intervention site. Alternatively or additionally, the cutter is configured to achieve the cutting action by engaging or dragging the cutter against the target septum. Again, the extent to which drag is performed is determined by the septum and its inherent structure. In one approach, the system 800 includes an elongated handle 802 provided for gripping by an operator (see FIGS. 8A-C). Extending longitudinally from the handle 802 is a needle assembly 804. The needle 804 is configured to create an insertion site adjacent to a specific cellulite target area or to be inserted directly into a dimpled cellulite site. Furthermore, it is through the needle assembly 804 that an interventional device is advanced to address and treat septa present under dimples or other depressions on the subject's skin. Furthermore, in one embodiment, the dilator can include or cooperate with a harmonic scalpel, selective cauterization structure, or energy transmission structure to ablate tissue and / or control bleeding. In one approach, once the correct depth is accessed, the cutting device is swung 360 degrees to cut the surrounding septum. Additionally or alternatively, an endoscope can be employed in an assembly that includes a cutter to cut the septum in a targeted manner. That is, the septum viewed by the endoscope is the target for cutting by the cutter. This provides direct visual confirmation of the procedure. In one embodiment, the needle 804 may be formed with a positionable stop 810 along the needle 804, as desired or dictated by the particular procedure or anatomy. The stop 810 is positioned so that, when the needle 804 is placed in tissue, its distal end is positioned at a desired depth, such as between tissue layers connected by a septum. The distal end of the needle 804 is further provided with a side opening 822. It is through this side opening 822 that an interventional device, such as a cutter, scalpel, cauterizing structure, or energy delivery device, is advanced between the tissue layers. Such a device is then employed to selectively treat underlying septa in order to eliminate or reduce the appearance of cellulite. Once treatment is determined to be successful, the spot cellulite treatment system 800 is then removed and employed in another location exhibiting cellulite.

[0112] Turning now to Figures 8D-J, further embodiments of tools employed for the treatment of cellulite using alternative approaches are shown. Such structures may also be employed as the distal end structure of the cellulite treatment assembly shown in Figure 1D. Referring now to Figure 8D, the treatment device may comprise a wire including a linkage 830 operating to push out a cutting blade 831 sized and shaped to cut connective tissue. As shown in Figure 8E, the distal end portion of the spot treatment device may comprise a wire advanceably arranged to define a loop 832, the loop having a gauge that facilitates the structure employed to cut tissue. Alternatively, RF energy may be employed to cut the septum. Figures 8F-G show a deformable hypotube 834 that can be expanded to have two or more arms 836 protruding to define cutting blades in another atraumatic approach to treatment. Figure 8H illustrates a balloon structure 840 attached to a needle hypotube 842 that can be expanded under depressions to remove or reduce the appearance of cellulite. Finally, in another non-ear approach (Figure 81-J), the distal end portion of the spot treatment device can be formed with blades 850 for cutting for deployment, at least one configured to rotate and cut connective tissue.

[0113] As shown in FIG. 8K, the dilator 410 can form the distal end portion of the cellulite treatment device and can further include longitudinally extending blades 853 that are deployed when the dilator 410 is expanded. The blades 853 are configured to engage and cut the target tissue or septum in an alternative approach to treatment. Such cutting is employed in an alternative atraumatic approach and is achieved by rotating or otherwise advancing, sweeping, or retracting the dilator 410. The assembly is not expanded and is withdrawn from the intervention site after use, such as through a tube.

[0114] In yet another treatment approach, a curved wire forming a lasso 859, forming the distal end portion of the cellulite treatment assembly and advanceable and retractable through a shaft 861 (FIGS. 8L-O), can be deployed about the septum 350 within the target zone. Pulling the lasso 859 to reduce the circumference it defines results in cutting the septum 350 and treating the cellulite. In one embodiment, the lasso is formed from a nitinol wire or a preformed wire or segment thereof. The lasso 859 surrounds the targeted septum and, through clamping, cuts the septum. One approach involves cutting the target area without moving the shaft, thus providing a controlled approach to treatment.

[0115] As shown in FIGS. 8P-T, lasso 859 can additionally or alternatively define a tube, and the assembly can additionally include a wire 863 slidably configured within the tubular structure. After septum 350 is targeted, lasso structure 859 is partially configured about septum 350 by being pushed out of shaft 861. Wire 863 is then advanced within lasso 859 and out the end of lasso 859 (FIG. 8Q). Wire 863 is then advanced toward and retained in a slot or opening 865 formed in shaft 861. Lasso 859 is then advanced further up shaft 861 and engages with shaft 861, thereby defining a completed hoop or loop (FIG. 8R). Lasso 859 is then pulled tight about the targeted septum 350 to cut, slice, or break the septum as desired (FIG. 8T). Alternatively, the completed hoop can remain in its large hoop-like configuration and the entire device can be pulled proximally to slice or disrupt the enclosed septum. After treating the target tissue, lasso 859 and wire 863 are pulled proximally through shaft 861 to disengage from slot 865 and be fully or partially retracted within shaft 861 so that the treatment device can be used in additional locations.

[0116] In a related lasso treatment approach (FIGS. 8U-V), a pair of elongated tubes 867, 868 are provided that can be configured in a generally parallel arrangement about the target septum 350. The lasso 859 is advanced within the first tube 867 and exits its distal end toward the second tube 868 (FIG. 8U). The lasso 859 is then captured by the second tube 868 so that the treatment device surrounds the target septum 350. The assembly is then pulled proximally to cut, slice, or destroy the target tissue. After treatment, the lasso 859 is withdrawn within the first tube 867 and released from engagement with the second tube 868. The assembly is then positioned as needed to treat additional areas.

[0117] An atherectomy-style cutter 902 (see FIGS. 9A-B) may alternatively or additionally be configured to remove tissue through a side opening 904 in the instrument and may be used in certain adjunctive, more traumatic approaches to treatment. 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 engage the target tissue. A lumen 912 is further provided as a conduit for applying suction to the intervention site so that cut or eroded tissue 912 may be removed. This device may be employed to harvest fat for subsequent placement in the treated area with a dilator and to fill the resulting space. The cutter 902 may also be employed as a primary treatment device for cutting septa to treat cellulite.

[0118] 10A-C, one preferred embodiment of a treatment system 920 that can be used in conjunction with one or more of the previously described devices for treating target tissue is shown. The treatment system 920 includes a handle 922 and an elongated member 924 extending longitudinally from the 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 when testing the septum to prevent over- or under-tensioning. Additionally, the distal end portion of the elongated member 924 is configured with a treatment device 925 that can one or more of engage, slice, cut, or disrupt connective tissue. Thus, any one or more of the treatment devices described herein can define the treatment device 925. All cutting means can be combined with or further energized with RF, laser, ultrasound, or thermal energy to produce cutting and coagulation, either together or separately.

[0119] The handle 922 includes a button or sliding trigger 926 configured to slide along the top surface of the handle 922. The trigger 926 is attached to a proximal end portion of a shaft or wire 928, the distal end portion of which is associated with or attached to a treatment device 925. In the closed configuration, the trigger 926 is positioned at its proximal-most position (FIG. 10A), and the treatment device 925 maintains a generally longitudinally aligned configuration. So configured, the treatment system 920 can be positioned or repositioned to achieve a desired cellulite treatment. Moving the trigger 926 to its distal-most position, in turn, advances the shaft or wire 928 distally, placing the treatment device 925, for example, in a configuration for hooking the target tissue (FIG. 10B). Pulling the trigger 926 to an intermediate position exposes a cutting structure (e.g., a blade or cutting wire), thereby configuring the treatment device 925 to cut, slice, or destroy the target tissue (FIGS. 11A-11C). Detents or other cooperating structures can be incorporated into the handle or trigger to secure the trigger in one or more positions while providing tactile feedback regarding positioning. Further, system 925 can alternatively or additionally include any of the functionality described above, such as structures for providing transillumination and radiofrequency cutting and coagulation.

[0120] 11 , 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) configured within the elongated member 944 is attached to the treatment device 925, and alternatively or additionally, a rotatable trigger 946 is attached to a lower, distal portion of the handle 942. Configured within the handle 942 is a slider 947 attached to the shaft or wire and associated with and cooperating with the trigger 946. A constant force spring 950 is associated with and cooperating with the slider 947 to retract the cutting structure of the treatment device 925 when the trigger 946 is released. Additionally, a transillumination structure is configured 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) configured at the distal end of the treatment system 940.

[0121] Fully squeezing the trigger 946 configures the treatment device 925 into a hooked configuration in which the cutting structure of the treatment device 925 is protected. Slightly releasing the trigger 946 causes the spring 950 to retract the shaft or wire associated with the treatment device 925, positioning the shaft or wire within a detent on the slider 947 and providing 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 operated to treat additional areas.

[0122] Various additional embodiments of processing devices are described in Figures 12A-18C. Referring to Figures 12A-C, a cutting, slicing, or disrupting processing assembly is again defined by a protruding link arrangement. A first link 1400 includes a blade 1401 and is rotatably attached at one end to a second link 1402. The opposite end of the first link 1400 slides relative to a longitudinal shaft 1405 (shown as at least partially transparent). The shaft 1405 defines a housing for supporting and containing the link arrangement. A second end of the second link 1402 is rotatably secured to a distal point on the shaft 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 sized and shaped to shield the blade 1401 from contact with tissue when the assembly is placed in the hooking configuration. When the push rod 1407 is fully retracted (FIG. 12A), the blade 1401 is sheathed within the body of the longitudinal shaft 1405. Note that in the fully retracted configuration, the first and second links 1400, 1401 form an obtuse angle, and the protrusion 1408 extends a relatively small distance from the opposite side of the longitudinal shaft. When the push rod 1407 is fully advanced and stopped, the protrusion 1408 contacts the push rod 1407, and the blade 1401 is again shielded by the protrusion 1408 (FIG. 12B). In such a configuration, the treatment device can be used to hook target septa and test the septa to determine whether such septa are associated with the appearance of cellulite on the patient's skin. When the push rod 1407 is withdrawn from its fully advanced position, in one embodiment on the order of approximately 0.070 inches (see FIG. 12C , in which the blade 1401 is shown transparent for illustrative purposes), the blade 1401 is exposed and presented to engage and cut, slice, or destroy the target septum. The treatment device also has a blunt, atraumatic tip 1406 that allows the treatment device to be advanced through subcutaneous tissue with little trauma. In all embodiments, the blunt tip 1406 can house a light emitting diode (LED) or the tip of a fiber optic to facilitate transillumination through the skin by the user for use in guidance to locate the tip of the treatment device.

[0123] Additionally or alternatively, it will be appreciated that the tip of any of the disclosed embodiments can be configured to feature or associate with low entry and advancement forces through a patient's skin and anatomy, while simultaneously presenting a low potential for tissue damage. Thus, the tip can assume a bullet-like point or short dilator tip shape, or can define a sharpened profile or trocar-type configuration for ease of advancement or tracking. Furthermore, the tip can be retractable, reconfigurable, or define a sharpened configuration only when the tip presents a predetermined level of resistance. In one particular approach, a spring-loaded cover or shield is configured about the tip such that, upon encountering a predetermined resistance, the cover or shield is removed to expose a sharpened tip configured to facilitate advancement of the treatment device or reduce force across the patient's anatomy.

[0124] In an alternative approach (FIGS. 13A-D), the second link 1402 includes a blade 1401 with a sharpened 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 hooking configuration. When the treatment device is in the hooking configuration, the sharpened protrusion 1403 extends proximally from the pivot between the first link 1400 and the second link 1402, allowing the user to feel the resistance of the septum hook with the main portion of the first link 1400 as the pivot position as the leading portion of the device during retraction does not hook onto tissue but rather cuts through it. Notably, in the fully retracted position (FIG. 13A), the first and second links 1400, 1401 define an obtuse angle, and when the push rod 1407 is nearly fully advanced (FIG. 13B), the majority of the blade 1401 is shielded by the second link 1402. In this manner, the structure is both presented in a hook configuration to facilitate hook capture while simultaneously providing a portion of the blade 1403 unprotected near the connection between the first and second links 1400, 1402. With the push rod 1407 fully advanced, the blade 1401 is fully exposed for cutting, slicing, or breaking the target septum (see FIGS. 13C-D; FIG. 13D shows the first blade as transparent for illustrative purposes) when the treatment device is retracted proximally by the user.

[0125] It is anticipated that when employing one or more of the disclosed embodiments in a treatment procedure, it may be preferable not to disrupt the uncinate septum; in such cases, it may be desirable to release or disengage the uncinate septum. Some approaches involve advancing or twisting the treatment tool away from the uncinate septum to release or disengage. It is recognized, therefore, that challenges exist in that additional septum or other tissue may be present in the area that may be unintentionally re-engaged by the treatment device when in the hooked configuration, and that retraction of the treatment device may be hindered by adjacent patient anatomy. Referring to FIGS. 13E-F, treatment devices including hinge link arrangements 1400, 1402, or similar structures that transition from a hook-like configuration (FIG. 13E) toward a retracted configuration (FIG. 13F) by pivoting relative to a longitudinal shaft 1405 would benefit from the blocking link 1400 (or similar structure) moving to displace the septum 350 or other tissue away from the treatment device when the treatment device is sheathed or retracted. This action does not require additional advancement of the treatment device within the patient's anatomy and ensures that the septum 350 or other tissue is not undesirably entrapped. Furthermore, when retracted, the links 1400, 1402 free any tissue that may have become trapped within the longitudinal shaft 1405, and the links 1400, 1402 ultimately occupy such space within the longitudinal shaft 1405.

[0126] In additional or alternative embodiments (see FIGS. 13G-J), the treatment device includes a first link 1400 defining a curved or angled structure that blocks the blade 1401 formed on the second link 1402. By adopting such a curved or angled configuration, the first link 1400 obscures or creates a space that would otherwise exist between the first link 1400 and the longitudinal axis 1405 when the first link 1400 and the second link 1402 are positioned in the hooking position (FIGS. 13G and I) and / or the cutting position (FIGS. 13H and J). The curved or angled link 1400 thus blocks tissue from lodging in the space between the link and the longitudinal shaft, which would interfere with manipulation of the link during use and when attempting to retract the link. A pair of such blockers can alternatively be configured on each side of the second link to assist in removing tissue.

[0127] Recognizing the need to eliminate gaps where tissue may undesirably become lodged, various elastomeric sheaths can be configured between the links to occupy such gaps or spaces. The sheaths would expand during link extension and translation and retract into place when the links are retracted during advancement or withdrawal of the treatment device. Also, to aid in the clearance of unwanted tissue lodged between the rotating links, high-pitch helices can be employed at the hinges between the links so that the space between the rotating links changes or increases as the links are retracted, thereby disengaging the previously lodged tissue. Alternatively or additionally, protrusions 1403 can extend over the pivots between the links to prevent tissue from engaging in or at the pivots. Furthermore, the links can be formed from nitinol or other highly plastically deformable materials to create a single-piece hingeless structure that can be formed into a cutting and hooking configuration. Additionally, the sheath can be configured internally or externally on the longitudinal shaft to wipe tissue from the links, and the shaft can include longitudinally extending wipers configured about slots in which the links are housed and deployed, similar to wipers configured within window slots on an automobile.

[0128] 14A-F, yet another approach to a treatment device is shown. Here, two parallel-arranged, articulating first links 1420, 1422 are provided that are positioned to block or shield a blade 1401 attached to or formed on the edge of a second link 1402. Each of the first links 1420, 1422 defines a curved or yoke-shaped member having a unique profile designed to selectively shield the second link 1402, a respective first end 1424 rotatably or pivotally attached to a pusher 1407, and a second end 1426 rotatably or pivotally attached to the second link 1402. The parallel-arranged first links 1420, 1422 provide additional strength for the hooking and cutting positions. When the push rod 1407 is fully retracted (FIGS. 14A and 14D), the curved portions of the first links 1420, 1422 protrude from opposite sides of the longitudinal axis 1405 (shown at least partially transparent) along which the links extend when deployed for hooking, cutting, slicing, or disrupting a septum. To present a tissue-hooking configuration, the push rod 1407 is advanced such that the first links 1420, 1422 completely shield or block the blade 1401 (see FIGS. 14B and 14E; one first link 1420 is shown as transparent in FIG. 14E for illustration purposes) from contacting tissue. Fully advancing the push rod 1405 operates to fully expose the blade 1401 (see FIGS. 14C and 14F), thus presenting the blade 1401 for cutting, slicing, or disrupting the target tissue.

[0129] As shown in Figures 15A-F, the treatment device can alternatively or additionally include first and second push rods 1430, 1432, where the first push rod 1430 is configured to operate an articulating or pivoting first link 1434 and the second push rod 1432 is configured to operate an articulating or pivoting second link 1436 that includes the blade 1401 surface. When the push rods 1430, 1432 are in a fully advanced position (Figures 15A and 15D), the first link 1434 and the second link 1436 are generally parallel and housed within the longitudinal shaft 1405 (shown at least partially transparent). Retracting the push rods 1430, 1432 operates to extend the first 1434 and second 1436 links from their housed positions (see Figures 15B, C, E, F). When the push rods are equally extended, the first link 1436 overlaps but is fully exposed to cut, slice, or break the target tissue (FIGS. 15C, 15F). However, when the push rod 1430 associated with the first link 1434 is advanced to a different extent than the second push rod 1432, the first link 1434 can shield or block a portion of the blade 1401 (FIG. 15B), thereby providing a structure for hooking the target tissue, or can shield a portion of the blade 1401 (FIG. 15E), thereby providing a structure for both hooking and cutting. This embodiment can also have a blunt tip 1406.

[0130] In additional or alternative aspects, the robustness of the blade mechanism of the treatment device can be enhanced by strengthening the pivot point, increasing the strength of the longitudinal shaft, and improving blade hiding during insertion and advancement into tissue and tissue engagement. As shown in FIG. 16A , a weld pin or swage tube 1450 can be used at the connection between the first link 1400 and the second link or links 1402. Also, a mechanical joint such as a weld pin or swage tube can form the connection between the second link or links 1402 and the distal portion of the longitudinal shaft 1405. Such a pivot point, defined by, for example, a pin or tube with a diameter of about 0.025 inches, in one or more embodiments can be used at one or more rotational or pivotal connections in the treatment system. Furthermore, as best seen in Figures 16B-C, the first link 1400 including the blade 1401 can 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.

[0131] In an alternative or additional approach, as shown in Figures 17A-C, when the links 1400, 1402 are fully retracted and housed within the longitudinal shaft 1405, the processing system lacks protruding structures (Figure 17A). The first link 1400, acting as a blocking or blunting element, can be spring-loaded to shield the blade 1401 formed on the second link 1402 until a critical force is reached (Figure 17B), after which the blade 1401 is presented to cut, slice, or destroy the target septum (Figure 17C). After cutting or slicing, the blade 1401 can be configured to automatically resheath, or an actuator, such as a button, can be provided to resheath the blade 1401. With this approach, the links have two positions: sheathed and deployed. Similarly, the user is not forced to engage the hooking mechanism with excessive force, reducing overall force requirements. Thus, the blade 1401 is fully sheathed or housed within the longitudinal shaft 1405 during navigation and deployed when needed. In this manner, the longitudinal shaft 1405 can be formed, for example, from hypotube, reducing the number of cuts required to eject and retract the links 1400, 1402. Such structures or related functionality can be incorporated into any of the disclosed embodiments, thus providing a spring-loaded cut that requires a constant, controlled amount of force to expose the blade for cutting. This embodiment may also have a blunt tip 1406.

[0132] In a related approach (see FIGS. 18A-C), the 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 the opposite side of the longitudinal shaft 1405 from the deployed or treatment side (FIG. 18A). However, as in the previous approach, the blocking or shielding first links 1400 are spring-loaded to reside on the opposite side and shield the blade 1401 until a critical force is reached (FIG. 18B), after which the blade is exposed to cut, slice, or disrupt the target septum (FIG. 18C). Again, after cutting or slicing, the blade 1401 can be configured to automatically resheath, or an actuator such as a button can be provided to resheath the blade 1401, resulting in two positions of the links: sheathed and deployed.

[0133] As shown in FIGS. 19A-B, the treatment device includes a first link 1400 rotatably attached at one end to a distal end of a pusher 1407 and at its opposite end to a midpoint of a second link 1402. Actuation of the push rod 1407 transforms the links 1400, 1402 from a closed (FIG. 19A) configuration to an open (FIG. 19B) configuration and between them. The second link 1402 itself is angled obtusely, and the portion of the second link 1402 extending beyond its connection to the first link 1400 provides a structure for hooking the septum and may further include a sharp edge defining a blade 1401. Notably, the blade may be omitted. Advancement of the pusher 1407 thus results in extension of the links 1400, 1402, forming a proximally facing scissor-type mechanism. During use, the deployed structure captures the targeted septum for evaluation. When it is determined that the captured septum should be severed, the push rod 1407 is retracted, causing the two links 1400, 1402 to pass each other to have a cutting action either through sharpened cutting edges or through overlapping interference of blunt edges. Additionally, as shown in FIG. 19C, the blade edge 1401 can extend only a portion of the length of the second link 1402. In this way, when partially deployed, the second link 1402 exhibits structure for severing the septum, but when fully opened, the second link 1402 includes a length of structure near its connection to the first link 1400 that is designed to hook but not cut the captured septum.

[0134] 20A-B, a treatment device handle 1922 is shown that includes a trigger or slider assembly 1926 that includes a depressible button 1928. The handle 1922 includes a track 1929 along which the button 1928 registers. Such an arrangement can be incorporated into one or more of the previously disclosed treatment systems. As shown in FIG. 20A, the button 1928, in one embodiment, is biased against the track 1929 by a helical spring 1930. The slider assembly 1926 is attached to a drive shaft or pusher 1407 that connects to and facilitates operation of the treatment device (not shown). The button 1928 is depressible to release a lock or other engagement between the button 1928 and the track 1929, thereby allowing the slider assembly 1926 to slide relative to the handle 1922. Releasing the button 1928 results in the button engaging the track 1929 and allowing it to slide into locking engagement with one of a series of cutouts 1932 formed in the track 1929. Note that when not locked in the track 1929, the slider assembly button 1928 can engage and slide along the track 1929 between locked positions. Such cutouts 1932 are arranged and positioned such that when the slider assembly 1926 is locked in the track 1929, the treatment device is positioned in one or more of a sheathing, hooking, or cutting position within the tissue and relative to the target septum. The positive engagement between the slider assembly 1926 and the handle 1922 thus provides a tactile feel to the user regarding the positioning and state or configuration of the treatment device. As shown in FIG. 20B , rather than a helical spring, the button 1930 is biased by a leaf spring 1934. Also here, button 1928 is configured to be separately actuatable, defining a structure that can be depressed independently from the sliding structure of slider assembly 1926, thereby providing alternative, discrete control of the sliding and locking functions.

[0135] A further approach to a processing system is shown in Figures 21A-23C. As shown in Figures 21A-C, a processing system 1940 includes a handle assembly 1942 including a slider 1943 biased by a spring 1944, the slider 1943 configured to translate along a portion of a body 1946 of the handle assembly 1942. A button 1947 protrudes perpendicularly from the top surface of the slider 1943, the button 1947 being connected to or associated with a boss 1948 that rides in a slot formed in the slider 1942. The boss 1948 is also configured to slide and register along a ramp 1949 or other engagement structure formed in the handle body 1946. Also, a lever 1950 rotatably attached to the slider 1943 includes a curved slot 1951 that receives a boss 1952 protruding from a bracket 1953. Each of the sliders 1943 and brackets 1953 is attached to one or more longitudinally extending members 1954 associated with or connected to a treatment device 1956 attached to a distal portion thereof (see FIGS. 21D-F). Attached to the proximal end of the handle assembly 1942 is an optional light and energy source unit 1995, such as a light emitting diode and a battery. Extending through the handle assembly 1942 and the longitudinal shaft of the treatment device 1956 to a distal portion of the longitudinal shaft are optical fibers (not shown) that 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 to the user.

[0136] In the treatment device stowed position (see FIGS. 21A and 21D), the slider 1943 is in its most proximal position and the spring 1944 is mostly compressed. As the slider 1943 translates forward (FIGS. 21B and 21E), the spring 1944 expands, causing the slider boss 1948 to temporarily assume fixed registration along the ramp 1949. This action causes the longitudinally extending member 1954 to be advanced to manipulate the treatment device 1956. In this configuration, the treatment device 1956 is in a deployed but covered configuration intended to hook or otherwise engage the target septum. Subsequent depression of the rotatable lever 1950, through interaction of the lever 1950 and the bracket 1953, causes the longitudinally extending member 1956 to advance slightly distally, exposing a treatment device sharpening link or blade 1957 (see FIGS. 21C and F), which is configured to cut, slice, or break the septum. Notably, a spring (not shown) is configured between the lever 1950 and the bracket 1953 to bias the lever 1950 to return the treatment device 1956 to the locked, hook configuration. After desired manipulation of the treatment device 1956 at the intervention site, the slider button 1947 is depressed to release the engagement between the slider boss 1948 and the ramp 1949, thereby allowing the spring 1944 to return the slider 1943 to its proximal-most position and store the treatment device 1956 for further use or removal from the intervention site. In an alternative approach, the system 1940 would lack the lever 1950, and an additional spring (not shown) would be configured to allow advancement of the bracket 1953 only when the treatment device 1956 offers a predetermined resistance, permitting exposure of the blade 1957. In this manner, the tool would be easier to use and less likely to omit the cutting step following hooking the septum.

[0137] In another approach (FIGS. 22A-C), a treatment system 1960 includes a handle assembly 1962 including a slider 1963 biased by a spring 1964, the slider 1963 also 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 configured to slide and register along a ramp 1969 or other engagement structure formed in the handle body 1966. Also here, a lever 1970 rotatably attached to the slider 1962 includes a curved slot 1971 that receives a boss 1972 protruding from a bracket 1973. Each of the slider 1962 and bracket 1973 is attached to one or more longitudinally extending members 1976 (not shown, e.g., such as the structure shown in Figures 21D-F) associated with / having a treatment device attached to its distal end.

[0138] When the treatment device is in the stowed position (see FIG. 22A), the slider 1962 is in its most proximal position and the spring 1964 is mostly compressed. As the slider 1962 translates forward (FIG. 22B), the spring 1964 expands, the slider boss 1968 becomes temporarily and fixedly registered along the ramp 1969, and the longitudinally extending member 1976 advances to operate the treatment device. In this configuration, the treatment device is in a deployed but covered configuration intended to hook or otherwise engage the target septum. Thereafter, by depressing the rotatable lever 1970, through the interaction of the lever 1970 and the bracket 1973, the longitudinally extending member 1976 is advanced slightly distally, exposing the sharpened link or blade of the treatment device (see FIG. 22C). In this configuration, the treatment device is configured to cut, slice, or disrupt the target septum. A spring (not shown) is configured 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 desired manipulation of the treatment device at the intervention site, the slider 1962 is depressed and rotated to release the engagement between the slider boss 1968 and the ramp 1969, thereby allowing the spring 1964 to return the slider 1962 to its proximal-most position and stow the treatment device.

[0139] As shown in FIGS. 23A-C, the treatment device 1980 can 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 proximal-most position (FIG. 23A), the treatment device (not shown) is in a stowed position. The slider 1984 is attached to a pair of rotatable angled members 1986, 1987, each end of which is rotatably attached to the handle body and the slider 1984, respectively. The forward rotatable member 1986 further includes an extension 1988 rotatably attached to a rotatable bracket 1989, which is in turn rotatably attached to a longitudinally extending member 1990 having a treatment device (not shown) attached to its distal end portion. A button 192 protrudes perpendicularly from the slider 1984, and the button 192 is associated with a boss 1993 configured to register along a portion of the body of the handle assembly 1982 (see FIG. 23B ). When the slider 1984 is advanced along the handle body and so positioned with the boss 1993 registered within a 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 target septum. By depressing the button 1992, the boss 1993 of the slider 1984 can disengage from the recess 1994, thereby allowing the slider 1992 to be advanced further distally. In doing so, the longitudinally extending member 1990 can be further advanced to cut, slice, or engage tissue and expose a cutting portion of the treatment device to achieve the desired interventional treatment. The slider 1992 can then be returned to either the stowed position or the deployed but covered position, as desired, for further interventional steps. This approach therefore provides a mechanism for scaling up small movements of the handle assembly so that the configuration of the treatment device (eg, stowed position, hook position, or cut position) is more apparent to the user.

[0140] In the previous embodiments described, a "ballpoint pen" type mechanism can be used in the handle assembly so that after the hook and / or sharp blade tears or cuts the septum, the link automatically restores itself when the force on the link suddenly decreases as the septum is torn or cut.

[0141] In another embodiment, a coil is deployed from a distal portion of the treatment device, the septum is wrapped around the coil and rotated to recreate the targeted cellulite on the skin surface, and the coil is then pulled by the user to break or cut the septum, or a cutter is used to cut the septum.

[0142] Referring now to FIGS. 24A-H, a treatment system embodying the specific functionality and a select number of features described above is shown. The treatment system includes a handle assembly 2000 from which an elongated member 2002 extends. The handle assembly 2000 defines a contoured profile sized and shaped to fit conveniently within an operator's hand. Various actuation members 2004 are provided on the handle assembly 2000, the manipulation of which effects the deployment of a treatment device 2010 employed to engage, test, and / or sever a septum. The elongated member 2002 has a length and cross-sectional shape configured to be disposed between tissue layers and is advanced and extended to a septum present within the target treatment area. The distal end 2012 (FIG. 24B) of the treatment system includes a treatment device 2010. While various embodiments can configure any number of the treatment devices described at the end of the elongated member 2002, FIG. 24B illustrates a treatment device similar to that shown in FIGS. 13A-B. Additionally, the distal end of elongate member 2002 includes a nosecone 2014 sized and shaped to facilitate atraumatically advancing the treatment system through subcutaneous tissue in the subepidermal space. Such a nosecone may be configured in any one of the described treatment devices or systems.

[0143] The distal end 2012 portion of the treatment system (FIG. 24B) also includes an exit port 2020 for an optical fiber 2022 that provides the transillumination functionality described above. As shown in a cross-sectional view of the treatment system (FIG. 24C), the optical fiber 2022 extends distally from an optical energy source and focusing assembly 2030 configured within the handle assembly 2000. The optical fiber 2022 extends distally through the handle and within the elongate member 2002 to the exit port 2020 (see also FIGS. 24D-E). Referring to FIG. 24D, a battery 2032 energizes an LED 2034 that generates optical energy through a spherical lens 2036 and transmits it to the optical fiber 2022, in an arrangement similar to that shown in FIG. 1W. As best seen in FIG. 24E, the optical fiber 2022 is routed laterally through the exit port 2020 such that the optical fiber 2022 is positioned to provide selective transillumination. Notably, the optical fiber 2022 is disposed adjacent to a pusher member 2038 that is configured to actuate the treatment device 2010 .

[0144] 24F-H, operation of the actuation members of the handle assembly 2000 is described. The actuation member 2004 is configured to slide within a gap 2040 formed in the upper surface of the handle assembly 2000. The first actuator subassembly 2042 includes a lower portion operably connected to the pusher member 2038, which in turn is connected to the treatment device. The second actuator subassembly 2044 includes a lower slotted region 2046 that slidably receives a boss 2048 attached to the pusher member 2010. When the treatment device 2010 is in the sheathed configuration (see, e.g., FIG. 24F and FIG. 13A), the first and second actuator subassemblies 2042, 2044 are positioned within a proximal portion of the handle gap 2040. To unsheath and configure the treatment device 2010 in the hooked position (see, e.g., FIGS. 24G and 13B), the first and second actuator subassemblies 2042, 2044 are slid into the handle gap 2040 to a distal position within the gap. Distal advancement of the first and second actuator subassemblies moves the pusher member 2038 distally, thereby rotating the blunt and sharpened links at their distal ends into the hooked position. Depressing and holding the second actuator subassembly 2044 slightly moves the pusher member 2028 distally, thereby passing through a boss 2048 that slides along an angled slot 2046, placing the treatment device 2010 in the cutting configuration (see, e.g., FIGS. 24H and 13C). Assisted by a retraction spring within the handle, the treatment device can be reset to either the sheath or hooked configuration, positioned as deemed necessary by the operator during the cellulite treatment procedure.

[0145] In an alternative or additional feature of any of the disclosed embodiments (FIGS. 241-J), the distal end of the treatment system can include a retractable knife 2050 sized and shaped to puncture the skin. Thus, the knife 2050 is sized and shaped to create a desired minimally traumatic opening in the skin, instead of the physician using a scalpel blade to create a small puncture wound. In one approach, the knife 2050 is employed when the treatment device is in the sheathed position 2052. In use, the operator deploys the knife 2050 to create an incision in the skin. The knife 2050 is then retracted by the physician into the nosecone with a button on the handle, and the treatment system is used as described herein. Alternatively, the knife 2050 can be configured like a laparoscopic safety trocar so that, once initially employed to pierce the skin, the knife 2050 automatically retracts into the device tip. The knife 2050 can also be configured to be selectively deployed to perform cutting functions within and between tissue layers.

[0146] Accordingly, various approaches to cellulite treatment methods and devices are presented. The disclosed approaches are configured to provide an effective and focused approach to treating, minimizing, and preventing cellulite. The disclosed approaches can also be used to repair and reduce the appearance of cellulite in a targeted manner. Furthermore, the disclosed active treatment modalities are easy to use and effective.

[0147] Some of the specific aspects of the present disclosure include one or more of: focused treatment of only the septa causing skin depression or depression; minimization of bruising; access to all treatment targets through limited, cosmetically acceptable entrances; capture and retention of septa while separating them; intraoperative confirmation of treatment targets; needle diameter sized tools for small openings; and transillumination identification of tool tip location.

[0148] While the present disclosure has been described with reference to specific embodiments thereof, it will be apparent to those skilled in the art that various modifications may be made, and equivalents 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 objective, spirit and scope of the present disclosure. All such modifications are intended to be within the scope of the present disclosure.

Claims

1. 1. A method comprising: a cellulite treatment system for treating the appearance of cellulite on a patient's skin associated with a septum treatment area, the method comprising: Gaining access to a location between tissue layers connected by a septum; advancing a cellulite treatment system to a target site having a mechanical septum disruption element cooperating with a septum hooking element; deploying the bulkhead hook element in a first position that shields the bulkhead breaching element; engaging the selected septum and determining whether the selected septum region is associated with the appearance of cellulite; transitioning the bulkhead hooking element to a second position to expose the bulkhead breaching element; Isolating, among the selected septa, specific septa associated with the appearance of cellulite; A method comprising: placing an appliance configured to temporarily stretch the skin over a portion of the skin associated with the target site to smooth the skin.

2. 10. The method of claim 1, further comprising creating a treatment regimen that includes using the same insertion site to treat multiple sites.

3. The method of claim 1 , wherein the septum hooking element operates to tension a selected septum.

4. The method of claim 1 , further comprising employing transillumination to track the positioning of the cellulite treatment device between tissue layers.

5. 10. The method of claim 1, further comprising providing a cellulite treatment system having a shaft sized and shaped to be inserted into tissue and advanced between tissue layers to a septal treatment site without assistance from a tissue stabilization structure applied to the patient's skin.

6. 10. The method of claim 1, further comprising providing a tissue cutting, slicing or disrupting structure to the cellulite treatment system and operating the tissue cutting, slicing or disrupting structure to cut, slice, disrupt, realign or rupture septa connecting tissue layers.

7. 10. The method of claim 1, further comprising scanning the subject's skin to identify treatment areas and develop a treatment regimen, wherein the date of the scan is stored so that the effectiveness of the treatment can be evaluated.

8. The method of claim 1 further comprising employing a tube to remove a portion of the septum.

9. 10. The method of claim 1, further comprising providing a plurality of cellulite treatment devices, combining the devices into a single combined assembly, and performing a cellulite treatment procedure using the single combined assembly.

10. 10. The method of claim 1, further comprising confirming that certain of the selected septa are separated, the particular septa being associated with the appearance of cellulite.

11. if the septa associated with the appearance of cellulite remain intact, engaging additional selected septa to determine whether the additional selected septa regions are associated with the appearance of cellulite; The method of claim 1 , further comprising isolating specific septa from the additionally selected septa that are associated with the appearance of cellulite.

12. 1. A cellulite treatment system for treating the appearance of cellulite on a patient's skin associated with a septum treatment area, comprising: The handle and an elongated member insertable through the skin and capable of expanding at least one region from a smaller state to a wider state to subcutaneously engage one or more regions of the diaphragm, the wider state being configurable to define not only a structure for hooking the diaphragm but also a structure for cutting or breaking the diaphragm, the distal end portion of the elongated member being shaped like a columella; an optical transmitter assembly, the optical transmitter assembly including a light source, a spherical lens, and an optical fiber.

13. The system of claim 12 , wherein in the wide state, at least one cut surface is exposed.

14. The system of claim 12 , wherein the at least one cutting surface is sharp.

15. 13. The system of claim 12, wherein the widened state is capable of tensioning tissue to produce at least some of the effect of cellulite that appears on the surface of the skin prior to treatment.

16. 13. The system of claim 12, further comprising a light associated with the elongate member, the light being visible through the surface of the skin and capable of identifying the location of a treatment site.

17. 13. The system of claim 12, wherein the treatment system includes tactile feedback to indicate when the treatment device is positioned for cutting.

18. The system of claim 12 , further comprising a light source configured along the processing system, the light source being operated from a proximal end of the processing system.

19. the septum-cutting structure is embodied as a distally directed scissors structure; The scissors structure comprises: a first scissor arm rotatably mounted to a curved link rotatably mounted to the push bar; a second scissor arm including a curved slot that receives a boss extending from the longitudinal axis of the treatment device and guides movement of the second scissor arm; 13. The system of claim 12, wherein the first scissor arm and the second scissor arm are rotatably mounted to distal ends of the elongated member.

20. The system of claim 12 , wherein the septum cutting structure is a laterally extending scissor structure.

21. The system of claim 12 , wherein the bulkhead hooking structure includes a sharp edge on an underside of the hooking structure.

22. the septum hooking structure is rotatably mounted to the elongated member and configured to project laterally to capture and assess a septum; 13. The system of claim 12, wherein the septum cutting structure is a blade sized and shaped to slide along the elongated member and configured to define a retractable guillotine-like blade arrangement for severing a septum captured by the septum hooking structure.

23. the bulkhead hooking structure and the bulkhead cutting structure include a first link having one end rotatably attached to a distal end of the pusher and an opposite end rotatably attached to a midpoint of a second link; 13. The system of claim 12, wherein actuation of a pusher converts the first link and the second link from a closed configuration to an open configuration, the second link assuming an obtuse angle, and a portion of the second link extending beyond its connection to the first link to define a bulkhead hooking structure.

24. 13. The system of claim 12, further comprising a template sized and shaped to be placed on the patient's skin to facilitate identification of the treatment area beneath the skin.

25. a first link including a blade and a second link defining a blocker; the first link and the second link are configured to protrude from the elongated member; 13. The system of claim 12, wherein the second link defines a curved or angled structure that occupies a space between the first link and the elongated member when the first link protrudes from the elongated member such that no gap is formed between the first link and the second link and the elongated member.

26. further comprising a ferrule configured around the optical fiber; The system of claim 12 , wherein the ferrule includes a chamfer for directing optical energy into the optical fiber.

27. The system of claim 12 further comprising an LED for providing the light energy.

28. The system of claim 12 , further comprising a collimating lens configured to focus light energy from the light source.

29. further comprising an elongate sheath extending within the elongate member; The system of claim 12 , wherein the elongate sheath is sized and shaped to receive an optical fiber.

30. 30. The system of claim 29, wherein a hole is formed in the elongated member to provide an exit for light energy projected by the distal end of the optical fiber.

31. The system of claim 12 further comprising a distal tip with a retractable knife.

32. 1. A method comprising: a cellulite treatment system for treating the appearance of cellulite on a patient's skin associated with a septum treatment area, the method comprising: Gaining access to a location between tissue layers connected by a septum; advancing a cellulite treatment system along a superficial pathway, the cellulite treatment system having a mechanical septum disruption element cooperating with a septum hooking element; placing the bulkhead hook element in a first position shielding the bulkhead breaching element; engaging the selected septum to determine whether the selected septum is associated with the appearance of cellulite, and pulling the selected septum a distance of approximately 10-20 mm to attempt to recreate a depression associated with the appearance of cellulite; transitioning the bulkhead hooking element to a second position to expose the bulkhead breaching element; The method includes isolating, from among the selected septa, particular septa associated with the appearance of cellulite.

33. 33. The method of claim 32, further comprising making multiple passes within the target treatment area with the cellulite treatment system to identify and ablate cellulite-causing septa.

34. 33. The method of claim 32, further comprising identifying secondary septa after cutting one or more septa and cutting secondary septa associated with the appearance of cellulite on the skin in the target area.

Images